As filed with the Securities and Exchange Commission on July 31, 2009
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.) |
9901 IH 10 West, Suite 800
San Antonio, TX, 78230
(210) 477-8537
FAX (210) 477-8547
(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
Title of Each Class of Securities to be Registered | Amount to be Registered | Proposed Maximum Offering Price | Proposed Maximum Aggregate Offering Price | Amount of Registration Fee | ||||||||||
| Common Stock, par value $0.0001 per share | 2,558,686 | $ | 1.50 | (1) | $ | 3,838,029 | $ | 214.16 | ||||||
| Common Stock, par value $0.0001 per share (3) | 394,187 | $ | 1.50 | (2) | $ | 591,281 | $ | 32.99 | ||||||
| Common Stock, par value $0.0001 per share (4) | 50,000 | $ | 2.00 | (2) | $ | 100,000 | $ | 5.58 | ||||||
| Common Stock, par value $0.0001 per share (5) | 1,513,247 | $ | 3.00 | (2) | $ | 4,539,741 | $ | 253.32 | ||||||
| 4,516,120 | $ | 9,069,051 | $ | 506.05 | ||||||||||
| (1) | Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457 of the Securities Act based upon a per share amount of $1.50, based on the price at which the securities were previously sold. There is currently no trading market for the Registrant's common stock. The price of $1.50 is a fixed price at which the selling stockholders identified herein may sell their shares until the Registrant's common stock is quoted, if ever, at which time the shares may be sold at prevailing market prices or privately negotiated prices. |
| (2) | Fee based on exercise price applicable to shares issuable upon exercise of warrants in accordance with Rule 457(g). |
| (3) | Represents shares of Common Stock issuable upon the exercise (at a price of $1.50 per share) of outstanding warrants. |
| (4) | Represents shares of Common Stock issuable upon the exercise (at a price of $2.00 per share) of outstanding warrants. |
| (5) | Represents shares of Common Stock issuable upon the exercise (at a price of $3.00 per share) of outstanding warrants. |
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.
SUBJECT TO COMPLETION, DATED JULY 31, 2009
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
4,516,120 Shares
Common Stock
This prospectus relates to the resale of 4,516,120 shares of our common stock, by the selling stockholders identified on pages 32 of this prospectus (“Selling Stockholders”). We will not receive any proceeds from the sale of these shares by the selling stockholders.
Our common stock is not presently traded on any market or exchange, and we have not applied for listing or quotation on any public market. We anticipate seeking sponsorship for the trading of our common stock on the National Association of Securities Dealers OTC Bulletin Board upon the effectiveness of the registration statement of which this prospectus forms a part. However, we can provide no assurance that our shares will be traded on the OTC Bulletin Board or, if traded, that a public market will materialize. The Selling Stockholders will sell at a price of $1.50 per share until our shares are quoted, if ever, on an exchange in which a market develops or trading facility on which the shares are traded, and thereafter, at prevailing market prices or privately negotiated prices.
Our principal executive offices are located at 9901 IH 10 West, Suite 800, San Antonio, Texas, 78230, telephone number 210-477-8537.
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 ” on page 4 of this prospectus.
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 [_________]
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TABLE OF CONTENTS
| Page | |
| FORWARD LOOKING STATEMENTS | 4 |
| RISK FACTORS | 4 |
| USE OF PROCEEDS | 10 |
| DIVIDEND POLICY | 10 |
| DETERMINATION OF OFFERING PRICE | 10 |
| OUR BUSINESS | 10 |
| PROPERTIES | 19 |
| MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 19 |
| LEGAL PROCEEDINGS | 26 |
| MANAGEMENT | 26 |
| EQUITY COMPENSATION PLAN INFORMATION | 29 |
| CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 30 |
| PRINCIPAL STOCKHOLDERS | 31 |
| SELLING STOCKHOLDERS | 32 |
| DESCRIPTION OF SECURITIES | 38 |
| MARKET FOR COMMON EQUITY & RELATED STOCKHOLDER MATTERS | 40 |
| SHARES ELIGIBLE FOR FUTURE SALE | 40 |
| PLAN OF DISTRIBUTION | 41 |
| INDEMNIFICATION OF DIRECTORS AND OFFICERS | 43 |
| LEGAL MATTERS | 43 |
| EXPERTS | 43 |
| INTERESTS OF NAMED EXPERTS AND COUNSEL | 43 |
| WHERE YOU CAN FIND MORE INFORMATION | 43 |
| FINANCIAL STATEMENTS | 44 |
You may rely only on the information contained in this prospectus. We 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 any securities other than those registered by this prospectus, nor is it an offer to sell or a solicitation of an offer to buy securities 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.
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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, 2008, filed with the Securities and Exchange Commission (“SEC”) on March 30, 2009 as well as all subsequent Quarterly Reports on Form 10-Q. As used in this prospectus, unless context otherwise requires, the words “we,” “us,”“our,” “the Company” and “GenSpera” refer to GenSpera, Inc. Also, any reference to “common shares,” “Common Stock,” “common shares” or “Common Shares” refers to our $.0001 par value common stock.
FORWARD LOOKING STATEMENTS
This prospectus contains forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"), which are intended to convey our expectations or predictions regarding the occurrence of possible future events or the existence of trends and factors that may impact our future plans and operating results. These forward-looking statements are derived, in part, from various assumptions and analyses we have made in the context of our current business plan and information currently available to us and in light of our experience and perceptions of historical trends, current conditions and expected future developments and other factors we believe are appropriate in the circumstances. You can generally identify forward looking statements through words and phrases such as “believe”, “expect”, “seek”, “estimate”, “anticipate”, “intend”, “plan”, “budget”, “project”, “may likely result”, “may be”, “may continue” and other similar expressions.
When reading any forward-looking statement you should remain mindful that actual results or developments may vary substantially from those expected as expressed in or implied by such statement for a number of reasons or factors, including but not limited to:
| · | our research and development activities, the development of a viable commercial product, and the speed with which regulatory authorizations and product launches may be achieved; |
| · | whether or not a market for our product develops and, if a market develops, the rate at which it develops; |
| · | our ability to sell our products; |
| · | our ability to attract and retain qualified personnel to implement our business plan and growth strategies; |
| · | our ability to develop sales, marketing, and distribution capabilities; |
| · | the accuracy of our estimates and projections; |
| · | our ability to fund our short-term and long-term financing needs; |
| · | changes in our business plan and corporate growth strategies; and |
| · | other risks and uncertainties discussed in greater detail in the section captioned “Risk Factors” |
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 before purchasing 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 some or all of your investment.
Risks Relating to Our Stage of Development
As a result of our limited operating history, you cannot rely upon our historical performance to make an investment decision.
Since inception in 2003 and through March 31, 2009 we have raised approximately $4,131,000 in capital. During this same period, we have recorded accumulated losses totaling $6,616,252. As of March 31, 2009, we had working capital of $461,623 and a deficiency in stockholders’ equity of $1,355,587. Our net losses for the two most recent fiscal years ended December 31, 2007 and 2008 have been $691,199 and $3,326,261, respectively. Since inception, we have generated no revenue.
Our limited operating history means that there is a high degree of uncertainty in our ability to: (i) develop and commercialize our technologies and proposed products; (ii) obtain approval from the United States Food and Drug Administration (“FDA”); (iii) achieve market acceptance of our proposed product, if developed; (iv) respond to competition; or (v) 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 will be able to fully develop, commercialize, market, sell or derive revenues from our business.
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We will need to raise additional capital to continue operations.
We currently generate no cash. We have relied entirely on external financing to fund operations. Such financing has historically come primarily from the sale of common stock to third parties, loans from our Chief Executive Officer and the exercise of warrants/options. We have expended and will continue to expend substantial cash in the development and pre-clinical and clinical testing of our proposed products. We will require additional cash to conduct drug development, establish and conduct pre-clinical and clinical trials, support commercial-scale manufacturing arrangements and provide for the marketing and distribution of our products if developed. We anticipate that we will require an additional $7 million to take our lead drug through Phase II clinical evaluation, currently anticipated to occur in the fourth quarter of 2011.
In June and July of 2009, we raised an aggregate of $3,088,000 from the private placement of our securities. We anticipate, based on current proposed plans and assumptions relating to our operations and financing, that our current working capital as of March 31, 2009 and the proceeds of the offering will be sufficient to satisfy contemplated cash requirements through October of 2010, assuming we do not engage in an extraordinary transaction or otherwise face unexpected events or contingencies, any of which could affect cash requirements. As of July 31, 2009, we had cash on hand of approximately $2,740,000. Presently, the Company has an average monthly cash burn rate of approximately $176,000. We expect this average monthly cash burn rate to remain constant over the next fifteen months, assuming we do not engage in an extraordinary transaction or otherwise face unexpected events or contingencies. Accordingly, we will need to raise additional capital to fund anticipated operating expenses after October of 2010. We cannot assure you that financing whether from external sources or related parties will be available if needed or on favorable terms. If additional financing is not available when required or is not available on acceptable terms, we may be unable to fund operations and planned growth, develop or enhance our technologies, take advantage of business opportunities or respond to competitive market pressures. Any negative impact on our operations may make the raising of capital more difficult.
Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable, we may have to delay, reduce the scope of or eliminate one or more of our research, development or commercialization programs or product launches or marketing efforts. Any such change may materially harm our business, financial condition and operations.
Our long term capital requirements are expected to depend on many factors, including:
| · | our development programs; |
| · | the progress and costs of pre-clinical studies and clinical trials; |
| · | the time and costs involved in obtaining regulatory clearance; |
| · | the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
| · | the costs of developing sales, marketing and distribution channels and our ability to sell our products; |
| · | competing technological and market developments; |
| · | market acceptance of our proposed products, if developed; |
| · | the costs for recruiting and retaining employees, consultants and professionals; and |
| · | the costs for educating and training physicians about our products. |
We may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. If adequate funds are not available, we may be required to significantly reduce or refocus our development and commercialization efforts.
Raising needed capital in the future may be difficult as a result of our limited operating history.
When making investment decisions, investors typically look at a company’s historical performance in evaluating the risks and operations of the business and the business’s future prospects. Our limited operating history makes such evaluation and an estimation of our future performance substantially more difficult. As a result, investors may be unwilling to invest in us or such investment may be on terms or conditions which are not acceptable. If we are unable to secure such additional finance, we may need to cease operations.
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Our independent auditors have issued a qualified report as of and for the year ended December 31, 2008 with respect to our ability to continue as a going concern.
For the year ended December 31, 2008, our accountants issued a report relating to our audited financial statements which contains a qualification with respect to our ability to continue as a going concern because, among other things, our ability to continue as a going concern is dependent upon our ability to develop a product and generate profits from operations in the future or to obtain the necessary financing to meet our obligations and repay our liabilities when they come due. However, during 2009 we have raised approximately $3,788,000 through our private placements and we expect that our cash on hand of approximately $2,740,000 at July 31, 2009 will be sufficient to fund operations through October of 2010.
We may not be able to commercially develop our technologies.
We have concentrated our research and development on our drug technologies. Our ability to generate revenue and operate profitably will depend on our 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 pre-clinical and clinical evaluation of our therapeutic agents will 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 will exhibit an enhanced efficacy relative to competing therapeutic modalities such that they will be adopted by the medical community. Without significant adoption by the medical community our agents will have limited commercial potential which will likely result in the loss of your entire investment.
Inability to complete pre-clinical and clinical testing and trials will impair our viability.
We have recently submitted our first Investigational New Drug application (“IND”) to the FDA in order to commence clinical trials. On July 24, 2009, we were notified by the FDA that our IND was on clinical hold pending our response to certain questions provided by them concerning the clinical trial design. Even if we receive clearance from the FDA to commence trials, the outcome of the trials is uncertain and, if we are unable to satisfactorily complete such trials, or if such trials yield unsatisfactory results, we will be unable to commercialize our proposed products. No assurances can be given that the clinical trials, if commenced, will be successful. The failure of such trials could delay or prevent regulatory approval and could harm our ability to generate revenues, operate profitably or remain a viable business.
Our additional financing requirements will result in dilution to existing stockholders.
We will require additional financing in the future. We are authorized to issue 80 million shares of common stock and 10 million shares of preferred stock. Such securities may be issued without the approval or consent of our stockholders. The issuance of our equity securities in connection with a future financing will result in a decrease of our current stockholders’ percentage ownership.
Risks Relating to Intellectual Property and Government Regulation
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 patents, as the foundation of our business. Our intellectual property rights may come under challenge. No assurances can be given that, even though issued, our current and potential future patents will survive claims alleging invalidity or infringement on other patents. The viability of our business will suffer if such patent protection becomes limited or is eliminated.
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 protecting intellectual property 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. At present, we are not aware of any infringement of our intellectual property. In addition to our patents, we 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 will be enforced by a foreign court. In the event our intellectual property is misappropriated or infringed upon and an adequate remedy is not available, our future prospects will greatly diminish.
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Our proposed products may not receive FDA approval.
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. We have recently submitted our first IND application to the FDA. On July 24, 2009, we were notified by the FDA that our IND was on clinical hold pending our response to certain questions provided by them. There is no assurance that we will be able to adequately respond to the questions provided by the FDA or that even if such questions are answered, that the IND application will be granted on a timely basis, if at all. We cannot assure you that we will successfully complete any clinical trials in connection with any such IND application. Further, we cannot yet accurately predict when we might first submit any product license application for FDA approval or whether any such product license application would be granted on a timely basis, if at all. As a result, we cannot assure you that FDA approval for any products developed by us will be granted on a timely basis, if at all. Any delay in obtaining, or failure to obtain, such approvals could have a materially adverse effect on the commercialization of our products and the viability of the company.
Risks Relating to Competition
Our competitors have significantly greater experience and financial resources.
We compete against numerous companies, many of which have substantially greater financial and other resources than us. Several such enterprises have research programs and/or efforts to treat the same diseases we target. Companies such as Merck, Ipsen and Diatos, as well as others, have substantially greater resources and experience than we do and are situated to compete with us effectively. 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 Relating to Reliance on Third Parties
We intend to rely exclusively upon the third-party FDA-approved manufacturers and suppliers for our products.
We currently have no internal manufacturing capability, and will rely exclusively on FDA-approved licensees, strategic partners or third party contract manufacturers or suppliers. Should we be forced to manufacture our products, we cannot give you any assurance that we will be able to develop internal manufacturing capabilities or procure third party suppliers. In the event we seek third party suppliers, they may require us to purchase a minimum amount of materials or could require other unfavorable terms. Any such event would materially impact our prospects and could delay the development and sale of our products. Moreover, we cannot give you any assurance that any contract manufacturers or suppliers that we select will be able to supply our products in a timely or cost effective manner or in accordance with applicable regulatory requirements or our specifications.
General Risks Relating to Our Business
We depend on Craig A. Dionne, PhD, our Chief Executive Officer, and Russell Richerson PhD, our Chief Operating Officer, for our continued operations.
The loss of Craig A. Dionne, PhD, our Chief Executive Officer, or Russell Richerson, PhD, our Chief Operating Officer, would be detrimental to us. We currently maintain a one million dollar “key person” life insurance policy on the life of Dr. Dionne but do not maintain a policy on Dr. Richerson. Our prospects and operations will be significantly hindered upon the death or incapacity of either of these key individuals. We currently do not have written employment agreements with Messrs Dionne or Richerson.
We will require additional personnel to execute our business plan.
Our anticipated growth and expansion into areas and activities requiring additional expertise, such as clinical testing, regulatory compliance, manufacturing and marketing, will require the addition of new management personnel and the development of additional expertise by existing management. There is intense competition for qualified personnel in such areas. There can be no assurance that we will be able to continue to attract and retain the qualified personnel necessary for the development of our business.
Our business is dependent upon securing sufficient quantities of a natural product that 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 functions by dramatically raising the levels of calcium inside cells, which leads to cell death. 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 Spain. We currently secure the seeds from Thapsibiza, SL, a third party supplier. There can be no assurances that the countries from which we can secure Thapsia garganica will continue to allow Thapsibiza, SL to collect such seeds and/or to do so and export the seeds derived from Thapsia garganica to the United States. In the event we are no longer able to import these seeds, we will not be able to produce our proposed drug and our business will be adversely impacted.
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The current manufacturing process of G-202 requires acetonitrile.
The current manufacturing process for G-202 requires the common solvent acetonitrile. Beginning in late 2008, there has been a worldwide shortage of acetonitrile for a variety of reasons, and this shortage is predicted to last at least until the end of 2009 and possibly into future years. We have also observed that the available supply of acetonitrile is of variable quality, some of which is not suitable for our purposes. If we are unable to successfully change our manufacturing methods to avoid the reliance upon acetonitrile, we may incur prolonged production timelines and increased production costs. In an extreme case this situation could adversely affect our ability to manufacture G-202 altogether, thus significantly impacting our future operations.
In order to secure market share and generate revenues, our proposed products must 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 accept and utilize them. We are attempting to develop products that will likely be first approved for marketing in late stage cancer where there is no truly effective standard of care. If approved for use in late stage, the drugs will then be evaluated in earlier stage where they would represent substantial departures from established treatment methods and will 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 the drugs for us to accurately predict our major competitors. Nonetheless, the degree of market acceptance of any of our developed products will depend on a number of factors, including:
| · | our demonstration to the medical community of the clinical efficacy and safety of our proposed products; |
| · | 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. |
If the health care community does not accept our products for any of the foregoing reasons, or for any other reason, our business will be materially harmed.
We may be required to secure land for cultivation and harvesting of the seeds derived from Thapsia garganica.
We believe that we can satisfy our needs for 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 by the FDA, our current supply of Thapsia garganica may not be sufficient for the anticipated demand. We estimate that in order to secure sufficient quantities of Thapsia garganica for the commercialization of a product comprising G-202, we will need to secure approximately 100 acres of land to cultivate and grow Thapsia garganica. We anticipate the cost to lease such land would be $40,000 per year but have not yet fully assessed what other costs would be associated with a full-scale farming operation. There can be no assurances that we can secure such acreage, or that even if we are able to do so, that we could adequately 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 and will adversely impact our business.
Thapsia garganica and Thapsigargin can cause severe skin irritation.
It has been known for centuries that the plant Thapsia garganica can cause severe skin irritation when contact is made between the plant and the skin1. Skin plasters made from the plant have been part of the Medical Pharmacopeia2 in Western Europe as recently as the 1930s. The therapeutic action of the plaster is that of a severe counter-irritant. In 1978, thapsigargin was determined to be the skin-irritating component of the plant Thapsia garganica. The therapeutic component of our products, including our lead product G-202, is derived from thapsigargin. We obtain thapsigargin from the above-ground seeds of Thapsia garganica. These seeds are harvested by hand and those conducting the harvesting must wear protective clothing and gloves to avoid skin contact. Although we obtain the seeds from a third-party contractor located in Spain, and although the contractor has contractually waived any and all liability associated with collecting the seeds, it is possible that the contractor or those employed by the contractor may suffer medical issues related to the harvesting and subsequently seek compensation from us via, for example, litigation. No assurances can be given, despite our contractual relationship with the third party contractor, that we will not be the subject of litigation related to the harvesting
1 Christensen, S.B., Norup, E., and Rasmussen, U. (1984) in: Natural Products and Drug Development (Krogsgaard-Larsen, P., Christensen, S.B. and Kofod, H., eds.) pp 405-417, Munksgaard, Copenhagen.
2 Medical Pharmacopeia is a book containing an official list of medicinal drugs together with articles on their preparation and use.
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The synthesis of 12ADT must be conducted in special facilities.
There are a limited number of facilities qualified to handle toxic agents for the manufacture of therapeutic 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 will 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 manufacturing our therapeutic compounds, the Company’s business and future prospects will be adversely affected.
Our lead therapeutic compound, G-202, has not been subjected to large scale manufacturing procedures
To date, G-202 has only been manufactured at a scale adequate to supply early stage clinical trials. There can be no assurances that the current procedure for manufacturing G-202 will work at a larger scale adequate for commercial needs. In the event G-202 cannot be manufactured in sufficient quantities, our future prospects could be significantly impacted.
We have no product liability insurance.
The testing, manufacturing, marketing and sale of human therapeutic products entail an inherent risk of product liability claims. We cannot assure you that substantial product liability claims will not be asserted against us. We have no product liability insurance. In the event we are forced to expend significant funds on defending product liability actions, and in the event those funds come from operating capital, we will be required to reduce our business activities, which could lead to significant losses.
We cannot assure you that adequate insurance coverage will be available in the future on acceptable terms.
Any significant claim would have a material adverse effect on our business, financial condition and results of operations. Insurance availability, coverage terms and pricing continue to vary with market conditions. We will endeavor to obtain appropriate insurance coverage for insurable risks that we identify. We may not be able to obtain appropriate insurance coverage. The occurrence of an uninsured claim may have an adverse material effect on our business.
Risks Relating Our Common Stock
There is no public market for our securities.
There is no public market for our securities. An investment in our common stock should be considered totally illiquid. No assurances can be given that a public market for our securities will ever materialize. Additionally, even if a public market for our securities develops and our securities become traded, the trading volume may be limited, making it difficult for an investor to sell shares.
We face risks related to compliance with corporate governance laws and financial reporting standards.
The Sarbanes-Oxley Act of 2002, as well as related new rules and regulations implemented by the Securities and Exchange Commission and the Public Company Accounting Oversight Board, require changes in the corporate governance practices and financial reporting standards for public companies. These new laws, rules and regulations, including compliance with Section 404 of the Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting (“Section 404”), will materially increase the Company's legal and financial compliance costs and make some activities more time-consuming and more burdensome. As a result, management will be required to devote more time to compliance which could result in a reduced focus on the development thereby adversely affecting the Company’s development activities. Also, the increased costs will require the Company to seek financing sooner that it may otherwise have had to.
Starting in 2007, Section 404 of the Sarbanes-Oxley Act of 2002 requires that the Company's management assess the Company's internal control over financial reporting annually and include a report on its assessment in its annual report filed with the SEC. Effective December 15, 2009 for a smaller reporting company, the Company's independent registered public accounting firm is required to audit both the design and operating effectiveness of its internal controls and management's assessment of the design and the operating effectiveness of its internal controls.
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 employees, we rely heavily on direct management oversight of transactions, along with the use of legal and accounting professionals. As we grow, we expect to increase our number of employees, which will enable us to implement adequate segregation of duties within the Committee of Sponsoring Organizations of the Treadway Commission internal control framework.
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We do not intend to pay cash dividends.
We do not anticipate paying cash dividends in the foreseeable future. Since we do not anticipate paying dividends, any gains on your investment will need to come through an increase in the price of our common stock. The lack of a market for our common stock makes such gains highly unlikely.
Our board of directors has broad discretion to issue additional securities which may greatly impact the value of our common stock.
We are entitled under our certificate of incorporation to issue up to 80,000,000 common and 10,000,000 “blank check” preferred shares. Blank check preferred shares provide the board of directors broad authority to determine voting, dividend, conversion, and other rights. As of July 31, 2009, we have issued and outstanding 15,107,279 common shares and we have 5,801,939 common shares reserved for issuance upon the exercise of current outstanding options, warrants and convertible securities. Accordingly, we will be entitled to issue up to 59,090,782 additional common shares and 10,000,000 additional preferred shares. Our board may generally issue those common and preferred shares, or options or warrants to purchase those shares, without further approval by our shareholders based upon such factors as our board of directors may deem relevant at that time. Any preferred shares we may issue shall 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 will be required to issue a large amount of additional securities to raise capital to further our development and marketing plans. It is also likely that we will be required to 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. We cannot give any assurance that we will not issue additional common or preferred shares, or options or warrants to purchase those shares, under circumstances we may deem appropriate at the time.
Our Officers and Scientific Advisors beneficially own approximately 43% of our outstanding common shares.
Our Officers and Scientific Advisors own approximately 43% of our issued and outstanding common shares. As a consequence of their level of stock ownership, the group will substantially retain the ability to elect or remove 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 mergers and other changes of corporate control, 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.
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 $5,231,022 upon the exercise of warrants in the event they are exercised for cash. We will use the proceeds received from the exercise of warrants, if any, for working capital.
DIVIDEND POLICY
We have never paid or declared cash dividends on our common stock, and we do not intend to pay or declare cash dividends on our common stock in the foreseeable future.
DETERMINATION OF OFFERING PRICE
The Selling Stockholders will initially offer their shares at $1.50 per share until such time as or common stock becomes traded on an exchange or over the counter, if ever. Once traded, the shares will be offered at prevailing market prices, privately negotiated prices, or in any other fashion as described in the section of this Prospectus entitled “Plan of Distribution.” The selling price has no relationship to any established criteria of value, such as book value or earnings per share. The price was chosen arbitrarily.
OUR BUSINESS
Our History
We are a biotechnology company focused on the discovery and development of pro-drug cancer therapeutics, an emerging medical science. A pro-drug is an inactive precursor of a drug that is converted into its active form only at the site of the tumor. We were incorporated as a Delaware corporation in 2003.
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In early 2004, the intellectual property underlying the our technologies was assigned from Johns Hopkins University to the technologies’ co-inventors, Dr. John Isaacs, Dr. Soren Christensen, Dr. Hans Lilja and Dr. Samuel Denmeade. The Co-inventors granted us an option to license the intellectual property in return for our continued prosecution of the patent portfolio containing the intellectual property. This option was exercised in early 2008 by reimbursement of past patent prosecution costs previously incurred by Johns Hopkins University. Subsequently, the co-inventors assigned us the intellectual property in April of 2008. Our activities during the period of 2004-2007 were limited to the continued prosecution of the relevant patents.
Dr. John Isaacs and Dr. Sam Denmeade serve on our Scientific Advisory Board as Chief Scientific Advisor and Chief Medical Advisor, respectively. Dr Soren Christensen and Dr. Hans Lilja also serve on the Company’s Scientific Advisory Board. We currently have no oral or written agreements with Johns Hopkins University with regard to any other intellectual property or research activities.
The Potential of Our Pro-Drug Therapies
Cancer chemotherapy involves treating patients with cytotoxic drugs (compounds or agents that are toxic to cells). Chemotherapy is often combined with surgery or radiation in the treatment of early stage disease and it is the preferred, or only, treatment option for many forms of cancer in later stages of the disease. However, major drawbacks of chemotherapy include:
| Side effects | Non-cancer cells in the body are also affected, often leading to serious side effects. |
| Incomplete tumor kill | Many of the leading chemotherapeutic agents act during the process of cell division - they might be effective with tumors comprised of rapidly-dividing cells, but are much less effective for tumors that contain cells that are slowly dividing. |
| Resistance | Cancers will often develop resistance to current drugs after repeated exposure, limiting the number of times that a treatment can be effectively applied. |
Pro-drug chemotherapy is a relatively new approach to cancer treatment that is being investigated as a means to get higher concentrations of cytotoxic agents at the tumor location while avoiding the toxicity of these high doses in the rest of the body. An inactive form of a cytotoxin (referred to as the “pro-drug”) is administered to the patient. The pro-drug is converted into the active cytotoxin only at the tumor site.
We believe that, if successfully developed, pro-drug therapies have the potential to provide an effective therapeutic approach to a broad range of solid tumors. We have proprietary technologies that we believe appear, in animal models, to meet the requirements for an effective pro-drug. In addition, we believe that our cytotoxin addresses two other issues prevalent with current cancer drugs - it kills slowly- and non-dividing cancer cells as well as rapidly dividing cancer cells, and does not appear to trigger the development of resistance to its effects.
Our Technology
Our technology supports the creation of pro-drugs by attaching “masking/targeting agents” (agents that simultaneously mask the toxicity of the cytotoxin and help target the cytotoxin to the tumor) to the cytotoxin “12ADT”, and does so in a way that allows conversion of the pro-drug to its active form selectively at the site of tumors. We own patents that contain claims that cover 12ADT as a composition of matter.
Cytotoxin
12ADT is a chemically modified form of thapsigargin, a cytotoxin that kills fast-, slow- and non-dividing cells. Our two issued core patents, both entitled “Tissue Specific Prodrug,” contain claims which cover the composition of 12ADT.
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Masking/Targeting Agent
We use peptides as our masking/targeting agents. Peptides are short strings of amino-acids, the building blocks of many components found in cells. When attached to 12ADT, they can make the cytotoxin inactive - once removed, the cytotoxin is active again. Our technology takes advantage of the fact that the masking peptides can be removed by chemical reactors in the body called enzymes, and that the recognition of particular peptides by particular enzymes can be very specific. The peptides also make 12ADT soluble in blood. When it is removed, 12ADT returns to its natural insoluble state and precipitates directly into nearby cells.
How we make our pro-drugs
How our pro-drugs work
Our Approach
Our approach is to identify specific enzymes that are found at high levels in tumors relative to other tissues in the body. Upon identifying these enzymes, we create peptides that are recognized predominantly by those enzymes in the tumor and not by enzymes in normal tissues. This double layer of recognition adds to the tumor-targeting found in our pro-drugs. Because the exact nature of our masking/targeting peptides is so refined and specific, they form the basis for another set of our patents and patent applications on the combination of the peptides and 12ADT.
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Our Pro-Drug Development Candidates
We currently have four pro-drug candidates identified based on this technology, as summarized in the table below (at this time we are only developing G-202):
| Pro-Drug Candidate | Activating enzyme | Target location of activation enzyme | Status | ||||
| G-202 | Prostate Specific Membrane Antigen (PSMA) | The blood vessels of all solid tumors | · | Investigational New Drug Application planned is filed with the US Food and Drug Administration. Currently on Clinical Hold pending our response to questions. | |||
| G-114 | Prostate Specific Antigen (PSA) | Prostate cancers | · | Validated efficacy in pre-clinical animal models (Johns Hopkins University) | |||
| G-115 | Prostate Specific Antigen (PSA) | Prostate cancers | · | Validated efficacy in pre-clinical animal models (Johns Hopkins University) | |||
| Ac-GKAFRR-L12ADT | Human glandular kallikrein 2 (hK2) | Prostate cancers | · | Validated efficacy in pre-clinical animal models (Johns Hopkins University) | |||
Strategy
Business Strategy
We plan to develop a series of therapies based on our pro-drug technology platform and bring them through Phase I/II clinical trials.
Manufacturing and Development Strategy
Under the planning and direction of key personnel, we expect to outsource all of our Good Laboratory Practices (“GLP”) preclinical development activities (e.g., toxicology) and Good Manufacturing Practices (“GMP”) manufacturing and clinical development activities to contract research organizations (“CRO”) and contract manufacturing organizations (“CMO”). Manufacturing will also be outsourced to organizations with approved facilities and manufacturing practices.
Commercialization Strategy
We intend to license our drug compounds to third parties after Phase I/II clinical trials. It is expected that such third parties would then continue to develop, market, sell, and distribute the resulting products.
Market and Competitive Considerations
G-202
Our primary focus is the opportunity offered by our lead pro-drug candidate, G-202. We believe that we have validated G-202 as a drug candidate to treat various forms of solid tumors; including breast, urinary bladder, kidney and prostate cancer based on the ability of G-202 to cause tumor regression in animal models of these diseases. We filed our first IND for G-202 on June 23, 2009. On July 24, 2009 we were notified by the FDA that our IND is on clinical hold pending our response to certain questions regarding our trial design. Pending clearance by the FDA we plan to begin the clinical evaluation of G-202 in late 2009. We hope to eventually demonstrate that G-202 is more efficacious than current commercial products that treat solid tumors by disrupting their blood supply.
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Potential Markets for G-202
We believe that if successfully developed, G-202 has the potential to treat a range of solid tumors by disrupting their blood supply. It is too early in the development process to determine target indications. The table below summarizes a number of the potential United States patient populations which we believe may be amenable to this therapy and represent potential target markets.
| Estimated Number of | Probability of Developing (birth to death) | |||||||
| Cancer | New Cases (2006) | Male | Female | |||||
| Prostate | 234,460 | 1 in 6 | - | |||||
| Breast | 214,640 | n/a | 1 in 8 | |||||
| Urinary Bladder | 61,420 | 1 in 28 | 1 in 88 | |||||
| Kidney Cancer | 38,890 | n/a | n/a | |||||
Source: CA Cancer J. Clin 2006; 56;106-130
The clinical opportunity for G-202
We believe that current anti-angiogenesis drugs (drugs that disrupt the blood supply to tumors) validate the clinical approach and market potential of G-202. Angiogenesis is the physiological process involving the growth of new blood vessels from pre-existing vessels and is a normal process in growth and development, as well as in wound healing. Angiogenesis is also a fundamental step in the development of tumors from a clinically insignificant size to a malignant state because no tumor can grow beyond a few millimeters in size without the nutrition and oxygenation that comes from an intimately associated blood supply. Interrupting this process has been targeted as a point of intervention for slowing or reversing tumor growth. A well known example of a successful anti-angiogenic approach is the recently approved drug, AvastinTM, a monoclonal antibody that inhibits the activity of Vascular Endothelial Growth Factor (“VEGF”), which is important for the growth and survival of endothelial cells.
These types of anti-angiogenic drugs have only a limited therapeutic effect with increased median patient survival times of only a few months. Our approach is designed to destroy both the existing and newly growing tumor vasculature, rather than just block new blood vessel formation. We anticipate that this approach will lead to a more immediate collapse of the tumors nutrient supply and consequently an enhanced rate of tumor destruction.
G-202 destroys new and existing blood vessels in tumors
Competition
The pharmaceutical, biopharmaceutical and biotechnology industries are very competitive, fast moving and intense, and expected to be increasingly so in the future. Although we are not aware of any competitor who is developing a drug that is designed to destroy both the existing and newly growing tumor vasculature in a manner similar to G-202, there are several marketed drugs and drugs in development that attack tumor-associated blood vessels to some degree. For example, Avastin TM is a marketed product that acts predominantly as an anti-angiogenic agent. Zybrestat TM is another drug in development that is described as a vascular-disrupting agent that inhibits blood flow to tumors. It is impossible to accurately ascertain how well our drug will compete against these or other products that may be in the marketplace until we have human patient data for comparison.
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Other larger and well funded companies have developed and are developing drug candidates that, if not similar in type to our drug candidates, are designed to address the same patient or subject population. Therefore, our lead product, other products in development, or any other products we may acquire or in-license may not be the best, the safest, the first to market, or the most economical to make or use. If a competitor’s product or product in development is better than ours, for whatever reason, then our ability to license our technology could be diminished and our sales could be lower than that of competing products, if we are able to generate sales at all.
Patents and Proprietary Rights
Our success will likely depend upon our ability to preserve our proprietary technologies and operate without infringing on the proprietary rights of other parties. However, we may rely on certain proprietary technologies and know-how that are not patentable or that we determine to keep as trade secrets. We protect our proprietary information, in part, by the use of confidentiality and assignment of invention agreements with our employees, consultants, significant scientific collaborators and sponsored researchers that generally provide that all inventions conceived by the individual in the course of rendering services to us shall be our exclusive property.
The intellectual property underlying our technology is covered by certain patents and patent applications previously owned by the Johns Hopkins University ("JHU"). In early 2004, the intellectual property underlying the Company’s technologies was assigned from JHU to the co-inventors, Dr. John Isaacs, Dr. Soren Christensen, Dr. Hans Lilja and Dr. Samuel Denmeade, who in turn granted us an option to license the intellectual property in return for our continued prosecution of the patent portfolio. This option was exercised in early 2008 by payment to the co-inventors of past patent prosecution costs previously incurred by Johns Hopkins University (approximately $122,000) and additional fees (approximately $62,000) to cover the tax consequences of such payments to the co-inventors. Subsequently, the co-inventors assigned us the intellectual property in April of 2008 and we recorded these assignments in the United States Patent & Trademark Office. By virtue of the April 2008 assignments, we have no further financial obligations to the inventors or to JHU with regard to the assigned intellectual property. JHU retains a paid-up, royalty-free, non-exclusive license to use the intellectual property for non-profit purposes. Each of the co-inventors remains affiliated with the Company as a member of the Scientific Advisory Board.
| Number | Country | Filing Date | Issue Date | Expiration Date | Title | ||||||
| Patents Issued | |||||||||||
| 6,504,014 | US | 6/7/00 | 1/7/2003 | 6/6/2020 | Tissue specific pro-drug (TG) | ||||||
| 6,545,131 | US | 7/28/00 | 4/8/2003 | 7/27/2020 | Tissue specific pro-drug (TG) | ||||||
| 6,265,540 | US | 5/19/98 | 7/24/2001 | 5/18/2018 | Tissue specific pro-drug (PSA) | ||||||
| 6,410,514 | US | 6/7/00 | 6/25/2002 | 6/6/2020 | Tissue specific pro-drug (PSA) | ||||||
| 7,053,042 | US | 7/28/00 | 5/30/2006 | 7/27/2020 | Activation of peptide pro-drugs by HK2 | ||||||
| 7,468,354 | US | 11/30/01 | 12/23/08 | 11/29/2021 | Tissue specific pro-drug (G-202, PSMA) | ||||||
| Patents Pending | |||||||||||
| US 2004/0029778 | US | 11/30/01 | Pending | N/A | Tissue specific pro-drugs (PSMA) | ||||||
| PCT/US01/45100 | WO | 11/30/01 | Pending | N/A | Tissue specific pro-drugs (PSMA) | ||||||
| US 2006/0183689 | US | 8/24/05 | Pending | N/A | Activation of peptide pro-drugs by HK2 | ||||||
| US 2006/0217317 | US | 11/18/03 | Pending | N/A | Activation of peptide pro-drugs by HK2 | ||||||
| US 2008/0247950 | US | 3/15/07 | Pending | N/A | Activation of peptide pro-drugs by HK2 | ||||||
| US 2007/0160536 | US | 1/6/2006 | Pending | N/A | Tumor Activated Pro-drugs (PSA,G-115) | ||||||
| US 2009/0163426 | US | 11/25/08 | Pending | N/A | Tumor specific pro-drugs (PSMA) |
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When appropriate, we will continue to seek patent protection for inventions in our core technologies and in ancillary technologies that support our core technologies or which we otherwise believe will provide us with a competitive advantage. We will accomplish this by filing and maintaining patent applications for discoveries we make, either alone or in collaboration with scientific collaborators and strategic partners. Typically, we plan to file patent applications in the United States. In addition, we plan to obtain licenses or options to acquire licenses to patent filings from other individuals and organizations that we anticipate could be useful in advancing our research, development and commercialization initiatives and our strategic business interest.
Manufacturing & Development
12ADT is manufactured by chemically modifying the cytotoxin thapsigargin, which is isolated from the seeds of Thapsia garganica, a plant found in the Mediterranean. Our pro-drug, G-202, is then manufactured by attaching a specific peptide to 12ADT.
Outsource Manufacturing
To leverage our experience and available financial resources, we do not plan to develop company-owned or company-operated manufacturing facilities. We plan to outsource all drug manufacturing to contract manufacturers that operate in compliance with GMP. We may also seek to refine the current manufacturing process and final drug formulation to achieve improvements in storage temperatures and the like.
Supply of Raw Materials – Thapsibiza SL
To our knowledge, there is only one commercial supplier of Thapsia garganica seeds. In April 2007, we obtained the proper permits from the United States Department of Agriculture (“USDA”) for the importation of Thapsia garganica seeds. In January 2008, we entered into a sole source agreement with this supplier, Thapsibiza, SL. The material terms of the agreement are as follows:
| Term | The term of the agreement is for 5 years. | |
| Exclusivity | Thapsibiza shall exclusively provide Thapsia garganica seeds to the Company. The Company has the ability to seek addition suppliers to supplement the supply from Thapsibiza, SL. | |
| Pricing | The price shall be 300 Euro/kg. Thapsibiza may, from time to time, without notice, increase the price to compensate for any increased governmental taxes. | |
Minimum Order | Upon successfully securing $5,000,000 of equity financing, and for so long as the Company continues to develop drugs derived from thapsigargin, the minimum purchase shall be 50kg per harvest period year. | |
| Indemnification | Once the product is delivered to an acceptable carrier, the Company shall be responsible for an injury or damage result from the handling of the product. Prior to delivery, Thapsibiza shall be solely responsible. |
Government Regulation
The FDA, as well as drug regulators in state and local jurisdictions, imposes substantial requirements upon the clinical development, manufacturing and marketing of pharmaceutical products. The process we are required by the FDA to complete before our drug compound may be marketed in the U.S. generally involves the following:
| · | Preclinical laboratory and animal tests; |
| · | Submission of an IND, which must become effective before human clinical trials may begin; |
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| · | Adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for its intended use; |
| · | Submission to the FDA of an New Drug Application (“NDA”); and |
| · | FDA review and approval of an NDA. |
The testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on an expeditious basis, if at all. Preclinical tests include laboratory evaluation of the drug candidate, its chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the drug candidate. Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring such studies to be replicated. In some cases, long-term preclinical studies are conducted while clinical studies are ongoing.
The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND, which must become effective before we may begin human clinical trials. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. Our submission of an IND may not result in FDA authorization to commence clinical trials. All clinical trials must be conducted under the supervision of a qualified investigator in accordance with good clinical practice regulations. These regulations include the requirement that all prospective patients provide informed consent. Further, an independent Institutional Review Board (“IRB”) at each medical center proposing to conduct the clinical trials must review and approve any clinical study. The IRB also monitors the study and must be kept informed of the study’s progress, particularly as to adverse events and changes in the research. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if adverse events occur.
Human cancer drug clinical trials are typically conducted in three sequential phases that may overlap:
| · | Phase I: The drug candidate is initially introduced into cancer patients and tested for safety and tolerability at escalating dosages, |
| · | Phase II: The drug candidate is studied in a limited cancer patient population to further identify possible adverse effects and safety risks, to evaluate the efficacy of the drug candidate for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
| · | Phase III: When Phase II evaluations demonstrate that a dosage range of the drug candidate may be effective and has an acceptable safety profile, Phase III trials are undertaken to further evaluate dose response, clinical efficacy and safety profile in an expanded patient population, often at geographically dispersed clinical study sites. |
Our business strategy is to bring our drug candidates through Phase I/II clinical trials before licensing them to third parties who would then further develop the drugs and seek marketing approval. Once the drug is approved, the third party licensee will be expected to market, sell, and distribute the products in exchange for some combination of up-front payments, royalty payments, and milestone payments. Management cannot be certain that we, or our licensees, will successfully initiate or complete Phase I, Phase II, or Phase III testing of our product candidates within any specific time period, if at all. Furthermore, the FDA or the IRB or the IND sponsor may suspend clinical trials at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk.
Concurrent with clinical trials and pre-clinical studies, we also must develop information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with GMP requirements. The manufacturing process must be capable of consistently producing quality batches of the experimental drug, and management must develop methods for testing the quality, purity, and potency of the final experimental drugs. Additionally, appropriate packaging must be selected and tested.
The results of the drug development efforts and pre-clinical and clinical studies are then submitted to the FDA as part of an NDA for approval of the marketing and commercial shipment of the product. The FDA reviews each NDA submitted and may request additional information, rather than accepting the NDA for filing. In this event, the application must be resubmitted with the additional information included. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the FDA accepts the NDA for filing, the agency begins an in-depth review of the NDA. The FDA has substantial discretion in the approval process and may disagree with our, or our licensees’, interpretation of the data submitted.
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The review process may be significantly extended by FDA requests for additional information or clarification regarding information already provided. Also, as part of this review, the FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation. The FDA is not bound by the recommendation of the advisory committee. Manufacturing establishments are also subject to inspections prior to NDA approval to assure compliance with GMPs and with manufacturing commitments made in the relevant marketing application.
Under the Prescription Drug User Fee Act (“PDUFA”), submission of an NDA with clinical data requires payment of a fee to the FDA, which is adjusted annually. For fiscal year 2009, that fee is $1,247,200. In return, the FDA assigns a goal (often months) for standard NDA reviews from acceptance of the application to the time the agency issues its “complete response,” in which the FDA may approve the NDA, deny the NDA if the applicable regulatory criteria are not satisfied, or require additional clinical data. Even if this data is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. If the FDA approves the NDA, the product becomes available for physicians to prescribe. Even if the FDA approves the NDA, the agency may decide later to withdraw product approval if compliance with regulatory standards is not maintained or if safety problems are recognized after the product reaches the market. The FDA may also require post-marketing studies, also known as Phase IV studies, as a condition of approval to develop additional information regarding the efficacy and safety of a product. In addition, the FDA requires surveillance programs to monitor approved products that have been commercialized, and the agency has the power to require changes in labeling or to prevent further marketing of a product based on the results of these post-marketing programs.
Satisfaction of the above FDA requirements or requirements of state, local and foreign regulatory agencies typically takes several years. Government regulation may delay or prevent marketing of potential products for a considerable period of time and impose costly procedures upon our activities. Management cannot be certain that the FDA or any other regulatory agency will grant approval for our lead product G-202 (or any other products we may develop, acquire, or in-license) under development on a timely basis, if at all. Success in preclinical or early-stage clinical trials does not assure success in later-stage clinical trials. Data obtained from preclinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications or uses. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business.
Any products manufactured or distributed by us, or our licensees, pursuant to the FDA clearances or approvals are subject to pervasive and continuing regulation by the FDA, including record-keeping requirements, reporting of adverse experiences with the drug, submitting other periodic reports, drug sampling and distribution requirements, notifying the FDA and gaining its approval of certain manufacturing or labeling changes, complying with certain electronic records and signature requirements, and complying with the FDA promotion and advertising requirements. Failure to comply with these regulations could result, among other things, in suspension of regulatory approval, recalls, suspension of production or injunctions, seizures, or civil or criminal sanctions. Management cannot be certain that our present or future subcontractors or licensees will be able to comply with these regulations and other FDA regulatory requirements.
Our product candidates are also subject to a variety of state laws and regulations in those states or localities where our lead product G-202 (and any other products we may develop, acquire, or in-license) will be marketed. Any applicable state or local regulations may hinder our ability to market our lead product G-202 (and any other products we may develop, acquire, or in-license) in those states or localities. In addition, whether or not FDA approval has been obtained, approval of a pharmaceutical product by comparable governmental regulatory authorities in foreign countries must be obtained prior to the commencement of clinical trials and subsequent sales and marketing efforts in those countries. The approval procedure varies in complexity from country to country, and the time required may be longer or shorter than that required for FDA approval. We may incur significant costs to comply with these laws and regulations now or in the future.
The FDA’s policies may change, and additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Moreover, increased attention to the containment of health care costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on our business. Management cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.
Other Regulatory Requirements
The U.S. Federal Trade Commission and the Office of the Inspector General of the U.S. Department of Health and Human Services (“HHS”) also regulate certain pharmaceutical marketing practices. Also, reimbursement practices and HHS coverage of medicine or medical services are important to the success of procurement and utilization of our product candidates, if they are ever approved for commercial marketing.
We are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with these laws and regulations now or in the future. Management cannot assure you that any portion of the regulatory framework under which we currently operate will not change and that such change will not have a material adverse effect on our current and anticipated operations.
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Employees
As of July 31, 2009 we employed 2 individuals who are also our 2 executive officers.
PROPERTIES
Our executive offices are located at 9901 IH 10 West, Suite 800, San Antonio, TX, 78230. We lease this facility consisting of approximately 200 square feet, for $1800 per month inclusive of receptionist, telecommunication, and internet services. Our lease expires on September 30, 2009.
We also rent a virtual office at 12100 Wilshire Blvd, 8th Floor, Los Angeles, CA 90025 to maintain a business presence in that state and for meetings with participants who are located within travel distance to Los Angeles so as not to require travel exclusively to our executive office in San Antonio. This contract carries forward on a month by month basis at a charge of $210 per month.
The aforesaid properties are in good condition and we believe they will be suitable for our purposes for the next 12 months. There is no affiliation between us or any of our principals or agents and our landlords or any of their principals or agents.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
This Management’s Discussion and Analysis of Financial Condition and Results of Operations section (“MD&A”) contains statements and information about management’s view of our future expectations, plans and prospects, that constitute forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those we anticipate. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Our MD& is organized as follows:
| • | Overview — Discussion of our business and plan of operations, overall analysis of financial and other highlights affecting the company in order to provide context for the remainder of MD&A. |
| • | Significant Accounting Policies — Accounting policies that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts. |
| • | Results of Operations — Analysis of our financial results comparing: (i) the first quarter of 2009 to the comparable period in 2008; and (ii) our financial results for 2008 to 2007. |
| • | Liquidity and Capital Resources — A discussion of our financial condition and potential sources of liquidity. |
The various sections of this MD&A contain a number of forward-looking statements. Words such as “expects,” “goals,” “plans,” “believes,” “continues,” “may,” and variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, and other characterizations of future events or circumstances are forward-looking statements. Such statements are based on our current expectations and could be affected by the uncertainties and risk factors described throughout this filing and particularly in the Risk Factors section of this Prospectus. Our actual results may differ materially.
Overview
We are a development stage company focused on the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. Our operations are based in San Antonio, TX.
Management's Plan of Operation
We are pursuing a business plan related to the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. We are considered to be in the development stage as defined by SFAS No. 7, “Accounting and reporting by Development Stage Enterprises“.
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Business Strategy
Our business strategy is to develop a series of therapeutics based on our target-activated pro-drug technology platform and bring them through Phase I/II clinical trials. At that point, we plan to license the rights to further development of the drug candidates to major pharmaceutical companies. We believe that major pharmaceutical companies see significant value in drug candidates that have passed one or more phases of clinical trials, and these organizations have the resources and expertise to finalize drug development and market the drugs.
Plan of Operation
We have made significant progress in key areas such as drug manufacture, toxicology, and pre-clinical activities for our lead compound G-202.
For the manufacture of G-202, we have secured a stable supply of source material (Thapsia garganica seeds) from which thapsigargin is isolated, have a sole source agreement with a European supplier, Thapsibiza, SL, and have obtained the proper import permits from the USDA for these materials. We have also identified a clinically and commercially viable formulation for G-202 and have manufactured sufficient G-202 to supply our Phase I clinical needs. We have also determined that the stabilities of seeds, manufacturing intermediates and final drug substance are more than sufficient to allow reliable manufacture and stability of drug substance.
Definitive toxicology studies in rats and monkeys were launched in early September. We received final reports of the studies results in the second quarter of 2009.
On June 23, 2009, we submitted our first IND for G-202 to the FDA. On July 24, 2009, we received notification from the FDA that our IND was on clinical hold pending our response to certain questions provided by the FDA concerning the design of the proposed clinical trial. We anticipate responding to the FDA’s questions and receiving approval to proceed with our clinical trials during the third quarter of 2009. Over the next twelve months we plan to focus on clinical trials of G-202 in cancer patients.
Finally, we will continue to protect our intellectual property position particularly with regard to the outstanding claims contained within the core PSMA-pro-drug patent application in the United States. We will also continue to prosecute the claims contained in our other patent applications in the United States.
We anticipate that during 2009, and much of 2010, we will be engaged in the conduct of the Phase I clinical trial of G-202, and, if appropriate, extension into a Phase II clinical trial of G-202. The purpose of a Phase I study of G-202 is to evaluate safety, understand the pharmacokinetics (the process by which a compound is absorbed, distributed, metabolized, and eliminated by the body) of the drug candidate in humans, and to determine an appropriate dosing regime for the subsequent clinical studies. We currently plan to conduct the Phase I study in refractory cancer patients (those who have relapsed after former treatments) with any type of solid tumors. This strategy is intended to facilitate enrollment and perhaps give us a glimpse of safety across a wider variety of patients. We expect to enroll up to 30 patients in this Phase I study at: (i) Johns Hopkins Oncology Center (Michael Carducci, MD as Principal Investigator); and (ii) University of Wisconsin Comprehensive Cancer Center (George Wilding, MD as Principal Investigator). We are currently negotiating contracts for conduct of the Phase I studies. The final terms of the contracts have not yet been determined.
Assuming successful completion of the Phase I clinical program, we expect to conduct a Phase II clinical trial to determine the therapeutic efficacy of G-202 in cancer patients. Although we believe that G-202 will be useful across a wide variety of cancer types, it is usually most efficient and medically prudent to evaluate a drug candidate in a single tumor type within a single trial. It is currently too early in the pre-clinical development process to determine which single tumor type will be evaluated, but we expect that over 40 patients will be required for an appropriate evaluation over a total time span of 18 months.
We have identified 4 pro-drug candidates: G-202, G-114, G-115 and Ac-GKAFRR-L12ADT. At this time, we are engaged solely in the development of G-202. It is anticipated that the development of the remaining candidates will not commence until we have sufficient resources to devote to their development and in all likelihood this will not occur until after the development of G-202.
Through March 31, 2009, the vast majority of costs incurred have been devoted to G-202. We estimate that we have incurred costs of approximately $235,000 related to G-114, G-115 and Ac-GKAFRR-L12ADT. All of these costs were incurred prior to December 2007, at which time we began focusing solely on G-202. The balance of our costs, aggregating approximately $3,499,000, was incurred in the development of G-202. For the three months ended March 31, 2009 and 2008, approximately $310,000 and $151,000, respectively, was incurred in the development of G-202.
It is estimated that the development of G-202 will occur as follows:
It is estimated that the Phase I clinical trial will cost approximately $2,000,000 and will be completed in the third quarter of 2010.
Phase II clinical studies will cost an additional $4,200,000 and will be completed in the fourth quarter of 2011. Phase III Clinical trials will cost approximately $25,000,000 and will be completed in the fourth quarter of 2014. If all goes as planned, we may expect marketing approval in the second half of 2015 with an additional $3,000,000 spent to get the NDA approved. We do not expect material net cash inflows before late 2015.
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The Phase III estimated costs are subject to major revision simply because we have not yet entered clinical testing of our drug in patients. The estimates will become more refined as we obtain clinical data.
At this time, we have suspended the development of our other drug candidates, G-114, G-115 and Ac-GKAFRR-L12ADT. As a result we are unable to reasonably estimate the nature, timing and estimated costs and completion dates of those projects at this time.
We currently have budgeted $2,110,000 in cash expenditures for the twelve month period following the date of this prospectus, including (1) $894,000 to cover our projected general and administrative expense during this period; (2) $1,216,000 for research and development activities and (3) $0 for debt repayment. In order to cover these expenses, we anticipate undertaking a series of financings.
The amounts and timing of our actual expenditures may vary significantly from our expectations depending upon numerous factors, including our results of operation, financial condition and capital requirements. Accordingly, we will retain the discretion to allocate the available funds among the identified uses described above, and we reserve the right to change the allocation of available funds among the uses described above.
Significant Accounting Policies
Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Note 1 of the Notes to Financial Statements describes the significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below. We do not believe that there have been significant changes to our accounting policies during the quarter ended March 31, 2009, as compared to those policies disclosed in the December 31, 2008 financial statements except as disclosed in the notes to financial statements..
A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements are fairly stated in accordance with accounting principles generally accepted in the United States, and present a meaningful presentation of our financial condition and results of operations. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements:
Use of Estimates — These financial statements have been prepared in accordance with accounting principles generally accepted in the United States and, accordingly, require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Specifically, our management has estimated the expected economic life and value of our licensed technology, our net operating loss for tax purposes and our stock, option and warrant expenses related to compensation to employees and directors and consultants. Actual results could differ from those estimates.
Fair Value of Financial Instruments — For certain of our financial instruments, including accounts payable, accrued expenses and notes payable, the carrying amounts approximate fair value due to their relatively short maturities.
Cash and Equivalents — Cash equivalents are comprised of certain highly liquid investments with maturity of three months or less when purchased. We maintain our cash in bank deposit accounts, which at times, may exceed federally insured limits. We have not experienced any losses in such accounts.
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Intangible and Long-Lived Assets — We follow SFAS No. 144, "Accounting for Impairment of Disposal of Long-Lived Assets ", which established a "primary asset" approach to determine the cash flow estimation period for a group of assets and liabilities that represents the unit of accounting for a long lived asset to be held and used. Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. Long-lived assets to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. We have not recognized any impairment losses.
Research and Development Costs — Research and development costs include expenses incurred by the Company for research and development of therapeutic agents for the treatment of cancer and are charged to operations as incurred.
Stock Based Compensation — We account for our share-based compensation under the provisions of FASB Statement No. 123(R), “Share-Based Payment”, (“FAS 123R”). We adopted FAS 123R as of January 1, 2006, using the modified prospective application method. Prior to January 1, 2006 we applied the provisions of FAS 123, “Accounting for Stock-Based Compensation”.
We are a development stage company focused on the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. Our operations are based in San Antonio, TX.
Result of Operations
Our results of operations have varied significantly from year to year and quarter to quarter and may vary significantly in the future.
First Quarter of 2009 Compared to First Quarter of 2008
Revenue
The company did not have revenue for the three months ended March 31, 2009 and 2008, respectively. We do not anticipate any revenues for 2009.
Operating Expenses
Operating expense totaled $509,219 and $525,592 for the three months ended March 31, 2009 and 2008, respectively. The decrease in Operating expenses is the result of the following factors.
| Three Months Ended March 31, | ||||||||
| 2009 | 2008 | |||||||
| Operating expenses | ||||||||
| General and administrative expenses | $ | 199,717 | $ | 374,791 | ||||
| Research and development | 309,502 | 150,801 | ||||||
| Total expense | $ | 509,219 | $ | 525,592 | ||||
General and Administrative Expenses
G&A expenses totaled $199,717 for the three months ended March 31, 2009 compared to $374,791 for the same period of 2008. The decrease of $175,074 or 47% for the three months ended March 31, 2009 compared to the comparable period in 2008 was primarily attributable to decreases of approximately $241,000 in compensation and consulting expense and $8,000 in insurance expense, offset by an increase of approximately $60,000 in professional fees.
Research and Development Expenses
Research and development expenses totaled $309,502 for the three months ended March 31, 2009 compared to $150,801 for the same period of 2008. The increase of $158,701 or 105% for the three months ended March 31, 2009 compared to the comparable period in 2008 was attributable to increases of approximately $68,000 in compensation expense and approximately $81,000 in costs associated with manufacture and other expenses related to our lead drug.
Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, and compensation and consulting costs.
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Other Expenses
Other expenses totaled $1,048,331 and $1,606 for the three months ended March 31, 2009 and 2008, respectively.
| Three Months Ended March 31, | ||||||||
| 2009 | 2008 | |||||||
| Other expense: | ||||||||
| Finance Cost | $ | (472,938 | ) | $ | — | |||
| Change in fair value of derivative liability | (572,785 | ) | — | |||||
| Interest income (expense) | (2,608 | ) | (1,606 | ) | ||||
| Total other expenses | $ | (1,048,331 | ) | $ | (1,606 | ) | ||
Finance Cost
Finance Cost totaled $472,938 for the three months ended March 31, 2009 compared to $0 for the same period of 2008. The increase of $472,938 for the three months ended March 31, 2009 compared to the comparable period in 2008 was primarily attributable to a $415,976 charge for the fair value of additional warrants issued when the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered plus a $51,864 charge for the fair value of additional warrants issued as consideration for the extension of the maturity dates of notes payable.
Change in fair value of derivative liability
Change in fair value of derivative liability totaled $572,785 for the three months ended March 31, 2009 compared to $0 for the same period of 2008. The increase of $572,785 for the three months ended March 31, 2009 compared to the comparable period in 2008 was the result of a change to the accounting treatment of our issued and outstanding warrants which contain certain anti-dilution provisions.
In June 2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities , paragraph 11(a), and should be classified as a liability and marked-to-market. The Company has assessed its outstanding equity-linked financial instruments and has concluded that warrants issued during 2008 with a fair value of $734,617 on January 1, 2009 are required to be reclassified from equity to a liability. Fair value at January 1, 2009 was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 144%; and (4) an expected life of the warrants of 2 years.
As a result of our February offering described in Note 2 to our financials statements contained in this Report, the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered. These anti-dilution provisions resulted in the exercise price of these warrants being reduced from $2.00 from $1.50. Additionally, we are obligated to issue holders of these warrants an additional 506,754 warrants, and we are obligated to file a registration statement for the common stock underlying such warrants pursuant to the registration rights agreement entered into in connection with the July and August 2008 financing. We have recorded the fair value of the additional warrants as a derivative liability upon issue. The fair value of the warrants of $415,976 was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 149%; and (4) an expected life of the warrants of 2 years.
At March 31, 2009 we recalculated the fair value of our warrants subject to derivative accounting and have determined that their fair value at March 31, 2009 is $1,723,377. The fair value of the warrants was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 156%; and (4) an expected life of the warrants of 2 years. We have recorded an expense of $572,785 during the three months ended March 31, 2009 related to the change in fair value during that period.
Interest expense
Interest expense totaled $2,608 for the three months ended March 31, 2009 compared to $1,606 for the same period of 2008. The increase of $1,002 for the three months ended March 31, 2009 compared to the comparable period in 2008 was attributable to an increase in debt outstanding in 2009, partially offset by interest earned on deposits.
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Year Ended December 31, 2008 Compared to the Year Ended December 31, 2007
| Years ended December 31, | ||||||||
| 2008 | 2007 | |||||||
| Operating expenses: | ||||||||
| General and administrative expenses | $ | 854,294 | $ | 389,799 | ||||
| Research and development | 2,432,991 | 294,440 | ||||||
| Total operating expenses | 3,287,285 | 684,239 | ||||||
| Loss from operations | $ | (3,287,285 | ) | $ | (684,239 | ) | ||
Operating losses increased from $684,239 in 2007 to $3,287,285 in 2008. The increase of $2,603,046 was the result of an increase of $464,495 in general and administrative expenses, from $389,799 in 2007 to $854,294 in 2008, and an increase in research and development expenses of $2,138,551, from $294,440 in 2007 to $2,432,991 in 2008. The increase in expenses is directly attributable to the availability of cash resulting from our private placements in 2008 and late 2007, enabling us to implement our business plan.
Research and Development Expenses
Research and development expenses for the years ended December 31, 2008 and 2007 were $2,432,991 and $294,440 respectively. The increase in 2008 is directly attributable to the availability of cash resulting from our private placements in 2008 and late 2007 and consequent implementation of the development program for G-202. The 2008 increase results primarily from increases in expenditures for toxicology and other studies and manufacturing.
Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, and compensation and consulting costs.
Under the planning and direction of key personnel, we expect to outsource all of our GLP preclinical development activities (e.g., toxicology) and GMP manufacturing and clinical development activities to CROs and CMOs. Manufacturing will be outsourced to organizations with approved facilities and manufacturing practices.
Prior to the assignment of the patents to GenSpera in 2008, we had an exclusive option to license 5 issued patents and 3 patent applications pending worldwide. The previous owner of the intellectual property, John Hopkins University, agreed to assign the patents underlying the technology to our co-founders (the “Assignee Co-Founders”) in return for their assumption of future patent fees and costs, and patent attorney fees and costs, associated with all of the assigned technology. In exchange for us continuing to pay for these future costs, the Assignee Co-Founders entered into world-wide, exclusive option agreements with us. Therefore, we have continued to pay these costs as we have used the technology prior to the actual assignment.
General and Administrative Expenses
General and administrative expenses for the years ended December 31, 2008 and 2007 were $854,294 and $389,799 respectively. The increase in 2008 results from increases in compensation and consulting expense of approximately $106,000, professional fees of approximately $215,000, rent expense of approximately $38,000, insurance of approximately $22,000 and various other expenses of approximately $83,000 and is directly attributable to the availability of cash resulting from our private placements in 2008 and late 2007, enabling us to implement our business plan.
Other Expense
Other expense for the years ended December 31, 2008 and 2007 was $38,976 and $6,960, respectively, consisting of interest expense and finance costs. The increase in 2008 results primarily from a charge of $30,160 related to a penalty for the late filing of our registration statement.
Net Loss
Net losses for the years ended December 31, 2008 and 2007 were $3,326,261 and $691,199 respectively, resulting from the expenses described above.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No.157, Fair Value Measurements (“SFAS 157”). SFAS 157 defines fair value to be the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and emphasizes that fair value is a market-based measurement, not an entity-specific measurement. It establishes a fair value hierarchy and expands disclosures about fair value measurements in both interim and annual periods. SFAS 157 is effective for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years. We adopted SFAS 157 on January 1, 2008 which did not have a material impact on our financial position and results of operations. We also adopted the deferral provisions of the Financial Accounting Standards Board Staff Position No. 157-2, which delays the effective date of SFAS No. 157 for all nonrecurring fair value measurements of non-financial assets and liabilities until fiscal years beginning after November 15, 2008.
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Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. SFAS No. 157 also expands disclosures about instruments measured at fair value and establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
Level 1 — Quoted prices for identical assets and liabilities in active markets;
Level 2 — Quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and
Level 3 — Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
We designate cash equivalents as Level 1. As of September 30, 2008, and December 31, 2007, we did not have any cash equivalents, therefore there were no assets measured at fair value.
In February 2007, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 159, The Fair Value Option for Financial Assets and Financial Liabilities-Including an Amendment of FASB Statement No. 115 (“SFAS 159”). SFAS 159 permits entities to measure eligible assets and liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS 159 is effective for fiscal years beginning after November 15, 2007. We adopted SFAS 159 on January 1, 2008 and did not elect the fair value option which did not have a material impact on our financial position and results of operations.
In December 2007, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 141R, Business Combinations , and Statement of Financial Accounting Standards No. 160, Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 . These new standards significantly change the accounting for and reporting of business combination transactions and noncontrolling interests (previously referred to as minority interests) in consolidated financial statements. Both standards are effective for fiscal years beginning on or after December 15, 2008, with early adoption prohibited. These Statements are effective for the Company beginning on January 1, 2009. The Company is currently evaluating the provisions of FAS 141(R) and FAS 160.
In March 2008, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 161, Disclosures About Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 . This new standard enhances the disclosure requirements related to derivative instruments and hedging activities required by FASB Statement No. 133 . This standard is effective for fiscal years and interim periods beginning after November 15, 2008, with early adoption encouraged. We adopted the required provisions of SFAS 161 on January 1, 2008 and the adoption did not have a significant impact on our financial position and results of operations.
Liquidity and Capital Resources
Liquidity and Capital Resources
Since our inception, we have financed our operations through the private placement of our securities and loans from Craig Dionne, our Chief Executive Officer. At July 31, 2009 we have cash on hand of approximately $2,740,000. Our currently average monthly cash burn rate is approximately $173,000. We anticipate that our available cash will be sufficient to finance most of our current activities for at least the next fifteen months from July 31, 2009, although certain activities and related personnel may need to be reduced.
| Three Months Ended March 31, | ||||||||
| 2009 | 2008 | |||||||
| Cash & Cash Equivalents | $ | 661,360 | $ | 664,266 | ||||
| Net cash used in operating activities | $ | (572,915 | ) | $ | (242,001 | ) | ||
| Net cash used in investing activities | — | (184,168 | ) | |||||
| Net cash provided by financing activities | 699,985 | 500,000 | ||||||
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Net Cash Used in Operating Activities
In our operating activities we used $572,915 for the three months ended March 31, 2009 compared to $242,001 for the same period of 2008. An increase in net loss of approximately $1,030,000 was partially offset by increases in noncash expenses of approximately $803,000.
Net Cash Used in Investing Activities
In our investment activities we used $0 for the three months ended March 31, 2009 compared to $184,168 for the same period of 2008. The decrease in investment activities of $184,168 for the three months ended March 31, 2009 compared to the comparable period in 2008 was attributable to the $184,168 cost associated with acquisition of key intellectual property in 2008.
Net Cash Provided by Financing Activities
During the three months ended March 31, 2009 we raised approximately $700,000 through the sale of common stock units. During the comparable period of 2008 we received proceeds of $500,000 upon the exercise of warrants.
Listed below are key financing transactions we have entered into. Also, please refer to the section of this Report entitled “ Recent Sales of Unregistered Securities ” for a further description of the following transactions:
| • | During November of 2007, we sold an aggregate of 1,300,000 common shares resulting in gross proceeds of $650,000. |
| • | During March of 2008, we issued 1,000,000 common shares upon the exercise of outstanding warrants which resulted in gross proceeds to us of $500,000. |
| • | During July and August of 2008, we sold an aggregate of 2,320,000 units resulting in gross proceeds of $2,320,000. |
| • | In February and April of 2009, we sold 500,000 units resulting in gross proceeds of approximately $750,000. |
| • | In June and July of 2009, we sold 2,025,344 units resulting in gross proceeds of approximately $3,038,000. |
We have incurred significant operating losses and negative cash flows since inception. We have not achieved profitability and may not be able to realize sufficient revenue to achieve or sustain profitability in the future. We do not expect to be profitable in the next several years, but rather expect to incur additional operating losses. We have limited liquidity and capital resources and must obtain significant additional capital resources in order to sustain our product development efforts, for acquisition of technologies and intellectual property rights, for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, for general and administrative expenses and other working capital requirements. We rely on cash balances and the proceeds from the offering of our securities, exercise of outstanding warrants and grants to fund our operations.
The source, timing and availability of any future financing will depend principally upon market conditions, interest rates and, more specifically, on our progress in our exploratory, preclinical and future clinical development programs. Funding may not be available when needed — at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate some or all of our research and product development programs, planned clinical trials, and/or our capital expenditures or to license our potential products or technologies to third parties.
LEGAL PROCEEDINGS
As of the date of this prospectus, there are no material pending legal or governmental proceedings relating to our company or properties to which we are a party, and to our knowledge there are no material proceedings to which any of our directors, executive officers or affiliates are a party adverse to us or which have a material interest adverse to us.
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MANAGEMENT
Directors
The following sets forth our current directors and information concerning their ages and background. All directors hold office until the next annual meeting of stockholders and until their respective successors are elected, except in the case of death, resignation or removal:
| Name | Principal Occupation | Age | Director Since | |||
| Craig A. Dionne, PhD | Chief Executive Officer, Chief Financial Officer, President and Director of GenSpera | 52 | 11/03 | |||
| John M. Farah, Jr., PhD | Vice President Intercontinental Operations at Cephalon (NASDAQ: CEPH) | 56 | 02/08 | |||
| Scott Ogilvie | President and CEO of Gulf Enterprises International, Ltd. | 54 | 02/08 |
Craig A. Dionne, PhD, age 52, has over 21 years experience in the pharmaceutical industry, including direct experience of identifying promising oncology treatments and bringing them through the clinic. For example, he served for five years as VP Discovery Research at Cephalon, Inc. where he was responsible for its oncology and neurobiology drug discovery and development programs. Dr. Dionne has also recently served as EVP at the Prostate Cancer Research Foundation. In addition to extensive executive experience, Dr. Dionne’s productive scientific career has led to 6 issued patents and co-authorship of many scientific papers.
John M. Farah, Jr., Ph.D., age 56, is VP Intercontinental Operations at Cephalon (Nasdaq:CEPH), which he joined in 1992 after six years as a discovery research scientist at G.D. Searle and Co. He is responsible for ensuring corporate support and managing sales performance of international partners in the Americas and Asia Pacific with specific growth initiatives for Cephalon in China and Japan. His prior roles included the responsibility for promoting and negotiating R&D and commercial alliances with multinational and regional pharmaceutical firms, and responsibilities in scientific affairs, product licensing and academic collaborations. He currently serves on the board of directors of Aeolus Pharmaceuticals (AOLS.OB).
Scott Ogilvie, age 53, is President and CEO of Gulf Enterprises International, Ltd, (“Gulf”) a company that brings strategic partners, expertise and investment capital to the Middle East and North Africa. He has held this position since August of 2006. Mr. Ogilvie also serves as Chief Operating Officer of CIC Group, Inc., an investment manager, a position he has held for the last five years. He began his career as a corporate and securities lawyer with Hill, Farrer & Burrill, and has extensive public and private corporate board experience in finance, real estate, and technology companies. Mr. Ogilvie currently serves on the board of directors of Neuralstem, Inc. (NYSE AMEX:CUR), Innovative Card Technologies, Inc. (NASDAQ:INVC) and Preferred Voice Inc, (OTCBD:PRFV).
Executive Officers and Significant Employees
The following sets forth our current executive officers and information concerning their age and background:
| Name | Position | Age | Position Since | |||
| Craig A. Dionne, PhD | Chief Executive Officer, Chief Financial Officer and President | 52 | 11/03 | |||
| Russell Richerson, PhD | Chief Operating Officer and Secretary | 57 | 07/08 |
Craig A. Dionne, PhD. – See Bio in Directors Section
Russell Richerson, PhD, age 56, has over 25 years experience in the Biotechnology/Diagnostics industry, including 11 years at Abbott Laboratories in numerous management roles. Most recently, he has served as Vice President of Diagnostic Research and Development at Prometheus Laboratories (2001-2004) and then as Chief Operating Officer of the Molecular Profiling Institute (2005-2008).
Family Relationships
There are no family relationships between any director, executive officer, or person nominated or chosen by the registrant to become a director or executive officer.
Code of Ethics
We have adopted a "Code of Ethics” that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of our code can be viewed on our website at www.genspera.com.
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Committees
The board of directors currently does not have an audit, nomination, or compensation committee. Due to our size and limited resources and employees, our board has determined that the functions of such committees, including the compensation committee, will be undertaken by the entire board. Upon securing additional financing and the hiring of additional employees, the board of directors anticipates the creation of free standing committees. Executive compensation is determined by the entire board.
Independent Directors
For purposes of determining independence, the Company has adopted the definition of independence as contained in NASDAQ Market Place Rules 4200. Pursuant to the definition, the Company has determined that Messrs. Ogilvie and Farah qualify as independent.
Executive Compensation
Summary Compensation
The following table sets forth information for our most recently completed fiscal year concerning the compensation of (i) the Principal Executive Officer and (ii) all other executive officers of GenSpera, Inc. who earned over $100,000 in salary and bonus during the last most recently completed fiscal years ended December 31, 2008 and 2007 (together the “Named Executive Officers”). No other employees earned a salary over $100,000 in the last completed fiscal years.
Name and principal position (a) | Year (b) | Salary ($) (c) | Bonus ($) (d) | Stock Awards ($) (e) | Option Award ($) (f)(2) | Nonequity Incentive Plan compensation ($) (g) | Non-qualified deferred compensation earning ($) (h) | All other Compensation ($) (i)(1) | Total ($) (j) | |||||||||||||||||||||||||
Craig Dionne, PhD Chief Executive Officer/Chief Financial Officer | 2008 | $ | 240,000 | $ | 240,000 | |||||||||||||||||||||||||||||
| 2007 | $ | 20,000 | (1) | $ | 20,000 | |||||||||||||||||||||||||||||
Russell Richerson, PhD Chief Operating Officer Secretary | 2008 | $ | 100,000 | (2) | $ | 100,000 | ||||||||||||||||||||||||||||
_______________________________________________
| (1) | During 2007 Dr. Dionne forwent compensation until such time as we secured financing. In December of 2007, upon securing financing, Dr. Dionne began receiving a salary. |
| (2) | During 2008, Dr. Richerson forwent second quarter compensation in the amount of $50,000. Dr. Richerson began receiving a salary in July of 2008 |
Employment Agreements and Arrangements
At present, there are no written employment agreements with any of our executive officers. Our board of directors has approved an annual salary for Dr. Dionne in the amount of $240,000 and for Dr. Richerson in the amount of $200,000. Additionally, we have agreed to reimburse Messrs Dionne and Richerson up to $1,500 per month for health insurance. We anticipate entering into a formal written employment agreement with Dr. Dionne and Dr. Richerson in the future.
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Outstanding Equity Awards at Fiscal Year-End
There were no unexercised options; stock that has not vested; equity incentive; or awards that were outstanding as of the end of the last completed fiscal year with regard to our Named Executive Officer.
Director Compensation
The following table summarizes the compensation for our board of directors for the fiscal year ended December 31, 2008:
| Name | Fees Earned or Paid in Cash ($) | Stock Awards ($) | Option Awards ($) | Non-Equity Incentive Plan Compensation ($) | Nonqualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | ||||||||||||||||||
| (a) | (b) | (c) | (d) | (e) | (f) | (g) | (h) | ||||||||||||||||||
| Scott Ogilvie | $ | 25,225 | (1) | $ | 25,225 | ||||||||||||||||||||
| John Farah | $ | 18,052 | (2) | $ | 18,052 | ||||||||||||||||||||
| Richard Burgoon | $ | 50,000 | (3) | 16,548 | (4)(5) | 4,203 | (5) | $ | 70,751 | ||||||||||||||||
________________________________________________________
| (1) | Includes: (i) options to purchase 100,000 common shares at $0.50 per share of which 50,000 options vested immediately with the balance vesting quarterly over a two year period commencing on March 31, 2008; and (ii) fully vested options to purchase 15,000 common shares at $1.00 per share. As of December 31, 2008, Mr. Ogilvie had an aggregate of 115,000 options, 90,000 of which were vested. |
| (2) | Includes options to purchase 100,000 common shares at $0.50 per share of which 50,000 options vested immediately with the balance vesting quarterly over a two year period commencing on March 31, 2008. As of December 31, 2008, Mr. Farah had an aggregate of 100,000 options, 75,000 of which were vested. |
| (3) | Includes 100,000 shares of common stock issued as compensation for services. |
| (4) | Includes options to purchase 100,000 common shares at $0.50 per share of which 50,000 options vested immediately with the balance vesting quarterly over a two year period commencing on March 31, 2008. As of December 31, 2008, Mr. Burgoon had an aggregate of 100,000 options, 75,000 of which were vested. |
| (5) | On September 30, 2008, Mr. Burgoon resigned as a director. As a result, we have reported his compensation as follows: (i) Option Awards of $16,548 attributed to 68,750 options vested through his termination date; and (ii) Other Compensation of $4,203 consisting of 31,250 options that will vest as compensation for services rendered subsequent to his resignation. |
EQUITY COMPENSATION PLAN INFORMATION
The following table sets forth information with respect to our 2007 Stock Plans as of December 31, 2008.
| (a) | (b) | (c) | ||||||||||
| Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights | Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights | Number of Securities Remaining Available for Future Issuance under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) | ||||||||||
| Equity compensation plans approved by security holders | ||||||||||||
| 2007 Stock Plan, as amended | 575,000 | $ | 0.51 | 925,000 | (1) | |||||||
| Equity compensation plans not approved by security holders | N/A | N/A | N/A | |||||||||
| Total | 575,000 | $ | 0.00 | 925,000 | (1) | |||||||
(1) Our 2007 Stock Plan, as amended, is considered an “Evergreen Plan.” Pursuant to the terms of the plan, on the 1st day of each fiscal year, the number of shares issuable under the plan is increased to 1,500,000. As of January 1, 2009, the number of securities remaining available for future issuance under the plan was 1,500,000.
29
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
We believe the terms and conditions set forth in such agreements are reasonable and customary for transactions of these types. Information regarding disclosure of an employment relationship or transaction involving an executive officer and any related compensation solely resulting from that employment relationship or transaction is incorporated by reference from the section of this Prospectus entitled “Executive Compensation.”
Information regarding disclosure of compensation to a director is incorporated by reference from the section of this Prospectus entitled “Director Compensation.”
| · | Between December 2003 and December 2006, we entered into five convertible notes with Craig Dionne, our Chief Executive Officer, pursuant to which we have borrowed an aggregate of $155,000. The notes bear an interest rate of 4.2% and mature at various dates through December 6, 2011. Interest accrued through February 29, 2008 was $15,859. On March 7, 2008 we issued 31,718 shares of common stock as payment of this amount. | |
| · | On November 10, 2006, we issued options to purchase an aggregate of 150,000 common shares to the Company’s officers, directors and certain shareholders as compensation for services provided to the Company. The options vested at grant and have a term of 10 years. The options were granted as follows: (i) 111,250 to Mr. Burgoon, a former director; (ii) 8,875 to Mr. Dionne, a director and Chief Executive Officer; (iii) 10,000 to Mr. Richerson, our Chief Operating Officer; and (iv) 10,000 to each of Messrs. Isaacs and Denmeade, each an advisor to the Company and a beneficial owner of 5% or more of the Company’s common shares. The options had an exercise price of $0.01 and a term of 10 years. The options were exercised in 2007 pursuant to their terms | |
| · | On May 14, 2007, our Board of Directors approved the acceleration of outstanding common stock options that were previously issued to Messrs Isaacs and Denmeade, our Scientific Advisors, as compensation. As a result of the acceleration, 10,500 common stock options because immediately vested. The options have an exercise price of $0.0016 and a term of 10 years. | |
| · | On January 7, 2008, we granted 100,000 shares of common stock, valued at $50,000, to a Mr. Burgoon, a former director, as compensation for serving on the board. The shares vested upon grant. | |
| · | On February 1, 2008, we granted each of Messrs Isaacs and Denmeade, our Scientific Advisors, common stock purchase options to purchased 60,000 shares, as compensation for joining the Company’s scientific advisory board. The options have an exercise price of $0.50 per share. The options vest in equal installments quarterly over a period of three years commencing March 31, 2008, and lapse if unexercised on January 31, 2018. | |
| · | In March of 2008, we granted options to purchase an aggregate of 300,000 (100,000 each) common shares to our directors Messrs Farah and Ogilvie as well as our former director Mr. Burgoon. Each director received options to purchase 100,000 common shares at an exercise price of $0.50 per share. Each director’s grant vests 50,000 upon grant with the balance vesting quarterly over a period of two years commencing March 31, 2008, and lapses if unexercised on April 1, 2018. | |
| · | On March 11, 2008 we exercised our option to license certain intellectual property from Messrs Isaacs and Denmeade. As consideration for the option exercise, we paid each of Isaacs and Denmeade: (i) $37,995.90 which they immediately transferred to John Hopkins University as repayment of past patent costs; and (ii) $18,997 as a “gross-up” to pay for relevant tax consequences of the option exercise payment. | |
| · | In April of 2008, Messrs Isaacs and Denmeade transferred to the Company their interest in the intellectual property licensed on March 11, 2008. | |
| · | In October of 2008, we granted options to purchase an aggregate of 15,000 common shares to our director Scott Ogilvie at an exercise price of $1.00 per share. The options vested on the date of grant and lapse if unexercised on October 16, 2018. |
| · | On February 17, 2009, we entered into a modification with Craig Dionne, our Chief Executive Officer and Chairman with regard to our 4% Convertible Promissory Note issued to Mr. Dionne in the amount of $35,000. Pursuant to the modification, Mr. Dionne agreed to extend the maturity date of the Note from December 2, 2008 to December 2, 2009. Mr. Dionne had previously deferred repayment of the note. As consideration for the modification, we issued Mr. Dionne a common stock purchase warrant entitling Mr. Dionne to purchase 11,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term and contains certain anti-dilution provisions requiring us to adjust the exercise price and number of shares upon the occurrence of a stock split, stock dividends or stock consolidation. |
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PRINCIPAL STOCKHOLDERS
The following table sets forth, as of July 31, 2009, information regarding beneficial ownership of our capital stock by:
| · | each person, or group of affiliated persons, known by us to be the beneficial owner of 5% or more of any class of our voting securities; |
| · | each of our current directors and nominees; |
| · | each of our current named executive officers; and |
| · | all current directors and named executive officers as a group. |
Beneficial ownership is determined according to the rules of the SEC. Beneficial ownership means that a person has or shares voting or investment power of a security and includes any securities that person or group has the right to acquire within 60 days after the measurement date. This table is based on information supplied by officers, directors and principal stockholders. Except as otherwise indicated, we believe that each of the beneficial owners of the common stock listed below, based on the information such beneficial owner has given to us, has sole investment and voting power with respect to such beneficial owner’s shares, except where community property laws may apply.
| Common Stock | |||||||||||
| Name and Address of Beneficial Owner(1) | Shares | Shares Underlying Convertible Securities(2) | Total | Percent of Class(2) | |||||||
| Directors and named executive officers | |||||||||||
| Craig Dionne, PhD | 2,438,662 | 339,138 | 2,773,144 | 18.4 | % | ||||||
| Russell B. Richerson, PhD(3) | 925,000 | 925,000 | 6.1 | % | |||||||
| John M. Farah, PhD | 81,250 | 81,250 | * | ||||||||
| Scott Ogilvie | 96,250 | 96,250 | * | ||||||||
| All directors and executive officers as a group (4 persons) | 3,363,662 | 511,982 | 3,875,644 | 25.7 | % | ||||||
| Beneficial Owners of 5% or more | |||||||||||
| John T. Isaacs, PhD(4) | 1,271,528 | 25,000 | 1,296,528 | 8.6 | % | ||||||
| Samuel R. Denmeade, M.D (5) | 1,271,528 | 25,000 | 1,296,528 | 8.6 | % | ||||||
| * | Less than one percent. |
(1) | Except as otherwise indicated, the persons named in this table have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them, subject to community property laws where applicable and to the information contained in the footnotes to this table. Unless otherwise indicated, the address of the beneficial owner is GenSpera, Inc., 9901 IH-10 West, Suite 800, San Antonio, TX 78230. |
(2) | Pursuant to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership includes any shares as to which a shareholder has sole or shared voting power or investment power, and also any shares which the shareholder has the right to acquire within 60 days, including upon exercise of common shares purchase options or warrant. There are 15,107,279 shares of common stock issued and outstanding as of July 31, 2009. |
(3) | 5050 East Gleneagles Drive, Tucson, AZ 85718 |
(4) | 13638 Poplar Hill Road, Phoenix, MD 21131 |
(5) | 5112 Little Creek Drive, Ellicott City, MD 21043 |
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SELLING STOCKHOLDERS
This prospectus relates to the offering and sale, from time to time, of up to 4,516,120 shares of our common stock held by the stockholders named in the table below (“Selling Stockholders”), which amount includes common shares issuable upon the exercise of warrants held by the Selling Stockholders.
The shares being registered related primarily to: (i) shares underlying warrants issued as a result of anti-dilution provisions (“Anti-Dilution Warrants”); (ii) shares issued and underlying warrants issued during our February 2009 offering (“February Offering”); (iii) shares issued and underlying warrants issued during our June and July 2009 offering (“June Offering”); and (iv) shares and shares underlying warrants issued to consultants for services provided (“Consultant Warrants”).
Anti-Dilution Warrants
In July and August of 2008 we sold an aggregate of 2,320,000 units resulting in gross proceeds of $2,320,000 or $1.00 per unit. Each unit consisted of: (i) 1 share of common stock; and (ii) ½ common stock purchase warrant. The warrants have a term of 5 years and an exercise price of $2.00 per shares subject to certain anti-dilution adjustments. During of 2009 the Company completed the February Offering and sold an aggregate of $750,000 units at a price per unit of $1.50 (“Offering”). As a result of the February Offering, certain anti-dilution provisions in the warrants held by investors who participated in our July and August, 2008 offering were triggered. The result of these anti-dilution provisions was that the exercise price of warrants issued during our July and August 2008 offering were reduced from $2.00 to $1.50; and we issued the investors in the offering warrants to purchase an additional 506,754 common shares at $1.50. We are registering herein the shares underlying 394,187 of the addition 506,754 warrants which we issued.
February Offering
In February and April of 2009 we completed the offering of 500,000 units resulting in gross proceeds of $750,000 or $1.50 per unit. Each unit consists of: (i) one share of common stock; and (ii) one half common stock purchase warrant. 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 in the future and certain price and volume conditions are met. We are registering herein the: (i) 500,000 common shares, and (ii) 250,000 common shares underlying the warrants, issued pursuant to the February Offering.
June Offering
In June and July of 2009 we completed the offering of 2,025,344 units resulting in gross proceeds of $3,038,000 or $1.50 per unit. Each unit consists of: (i) one share of common stock; and (ii) one half common stock purchase warrant. 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 in the future and certain price and volume conditions are met. We are registering herein the: (i) 2,025,344 common shares, and (ii) 1,012,679 common shares underlying the warrants, issued pursuant to the June Offering. We are also registering: (i) 33,334 common shares; and (ii) 83,895 common shares underlying warrants, that were issued to finders in connection with the offering.
Consultant Warrants and Common Shares
We have issued shares and warrants to consultants and service providers in exchange for services and reimbursement. We are registering 200,000 common shares underlying warrants, that have been issued to consultants as compensation or for reimbursement of expenses.
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.
Set forth below is information, to the extent known to us, setting forth the name of each Selling Shareholder 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 shares are sold. The footnotes provide information about persons who have investment voting power for the Selling Shareholders and about material transactions between the Selling Shareholders and the Company.
32
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 table 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, been employed by or otherwise has had any material relationship with us or our affiliates during the three years prior to the date of this prospectus; or (ii) is a broker-dealer, or an affiliate of a broker-dealer.
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.
33
| Common Shares Owned Before Sale (1) | ||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares being registered | ||||||||||||||||
| Bristol Investment Fund, Ltd.(3) | 500,000 | 166,667 | 666,667 | 4 | % | 41667 | ||||||||||||||
| G. Tyler Runnels or Jasmine Niklas Runnels TTEES The Runnel Family Trust dtd 1-11-20(4) | 375,000 | 83,334 | 458,334 | 20834 | ||||||||||||||||
| Richard Hull, PhD | 295,000 | 33,334 | 328,334 | 2 | % | 8334 | ||||||||||||||
| IRA FBO J. Steven Emerson Rollover II Pershing LLC as Custodian | 250,000 | 166,667 | 416,667 | 3 | % | 41667 | ||||||||||||||
| Steven Michell Sack PSP U/A DTD 01/01/1994 | 200,000 | 66,667 | 266,667 | 2 | % | 16667 | ||||||||||||||
| Kathryn F. Hopper | 130,000 | 20,000 | 150,000 | 1 | % | 5000 | ||||||||||||||
| Robert O'Mara | 153,334 | 43,334 | 196,668 | 1 | % | 56,668 | ||||||||||||||
| Subhash C. Gulati | 110,000 | 6,667 | 116,667 | 1 | % | 1667 | ||||||||||||||
| Ajax Partners(5) | 100,000 | 66,667 | 166,667 | 1 | % | 16667 | ||||||||||||||
| JAG MULTI INVESTMENTS LLC(6) | 100,000 | 66,667 | 166,667 | 1 | % | 16667 | ||||||||||||||
| Robert R. Kauffman | 100,000 | 66,667 | 166,667 | 1 | % | 16667 | ||||||||||||||
| Steven Mitchell Sack | 100,000 | 66,667 | 166,667 | 1 | % | 16667 | ||||||||||||||
| New Giles, LLC (7) | 75,000 | 50,000 | 125,000 | 1 | % | 12500 | ||||||||||||||
| Samax Family Limited Partnership(8) | 75,000 | 50,000 | 125,000 | 1 | % | 12500 | ||||||||||||||
| Jay R. Solan | 75,000 | 16,667 | 91,667 | 1 | % | 4167 | ||||||||||||||
| Richard W. Green | 75,000 | 16,667 | 91,667 | 1 | % | 4167 | ||||||||||||||
| D. Carl Lustig, III | 75,000 | 50,000 | 125,000 | 1 | % | 12500 | ||||||||||||||
| Windermere Insurance Co. Ltd.(9) | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Christopher Miglino | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Doris Sutz Roth IRA | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Dr. Arnold Yoskowitz and Regina Yoskowitz | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Gerald B. Lichtenberger | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| John Peter Christensen | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Joseph Giamanco | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Philip S. Sassower | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Mitchell J. Sassower | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Jerry A. Lubliner, M.D. | 50,000 | 33,334 | 83,334 | 1 | % | 8334 | ||||||||||||||
| Alan Schwartz | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| Arthur Dunkin | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| Faith Griffin & John A. Lenhart JTWROS | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| IRA FBO John Curley, Pershing LLC as Custodian | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| Patrick Hund | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
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| Common Shares Owned Before Sale (1) | ||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares being registered | ||||||||||||||||
| Rhonda Wesolak, Individual Retirement Account, RBC Capital Markets Corp Cust | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| John G. Korman | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| A.C. Providenti | 25,000 | 16,667 | 41,667 | 0 | % | 4167 | ||||||||||||||
| Benjamin Hill | 21,667 | 13,334 | 35,001 | 0 | % | 12501 | ||||||||||||||
| Donald L. Stahl | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Leslie M. James | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Nathan Sugerman | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Robert B. Greene | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Klaus Peter Eichner | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Gary J. Faden | 12,500 | 8,334 | 20,834 | 0 | % | 2084 | ||||||||||||||
| Mercer Capital, Ltd.(10) | 20,667 | 20,667 | 0 | % | 5167 | |||||||||||||||
| Andrew B. Dorman(11) | 5,667 | 5,667 | 0 | % | 1417 | |||||||||||||||
| David S. Lustig(11) | 2,774 | 2,774 | 0 | % | 694 | |||||||||||||||
| Nicole H. Tavernier(11) | 667 | 667 | 0 | % | 167 | |||||||||||||||
| Mark P. Eichner(11) | 227 | 227 | 0 | % | 57 | |||||||||||||||
| Jeffrey J. Kraws | 25,000 | 25,000 | 0 | % | 25,000 | |||||||||||||||
| Karen B. Goldfarb | 25,000 | 25,000 | 0 | % | 25,000 | |||||||||||||||
| Kemmerer Resources Corp.(12) | 150,000 | 150,000 | 1 | % | 150,000 | |||||||||||||||
| John L. Kemmerer, JR. 1970 Trust (13) | 690,000 | 345,000 | 1,035,000 | 7 | % | 1,035,000 | ||||||||||||||
| Photon Global Ltd. (14) | 333,334 | 166,667 | 500,001 | 3 | % | 500,001 | ||||||||||||||
| Gregory P. Zeller | 166,667 | 83,334 | 250,001 | 2 | % | 250,001 | ||||||||||||||
| Far Hills Capital, LLC (15) | 133,334 | 66,667 | 200,001 | 1 | % | 200,001 | ||||||||||||||
| Cynthia P. Stafford Trust (16) | 133,334 | 66,667 | 200,001 | 1 | % | 200,001 | ||||||||||||||
| Jonathan Meyers | 66,667 | 33,334 | 100,001 | 1 | % | 100,001 | ||||||||||||||
| Gene Mulvihill | 66,667 | 33,334 | 100,001 | 1 | % | 100,001 | ||||||||||||||
| Robert L. and Natacha Stafford | 66,667 | 33,334 | 100,001 | 1 | % | 100,001 | ||||||||||||||
| Horemheb Investments, LLC (17) | 66,667 | 33,334 | 100,001 | 1 | % | 100,001 | ||||||||||||||
| Robert L. Stafford Jr. Trust (18) | 66,667 | 33,334 | 100,001 | 1 | % | 100,001 | ||||||||||||||
| Equity Trust Company, d.b.a. Sterling Trust, Custodian FBO: John Sanderford | 46,667 | 23,334 | 70,001 | 0 | % | 70,001 | ||||||||||||||
| Peter Cunningham | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Gordon W. Clark, Jr. | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Edward J. Foley, III | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
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| Common Shares Owned Before Sale (1) | ||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares being registered | ||||||||||||||||
| Held Under Will of Joan P. Foley FBO Edward J. Foley, III - Lifetime Trust | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Edward J. Foley, III, 2009 GRAT | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Francis O'Connor | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Frank E. Walsh, III | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Bass Family Trust | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Brian Thebault | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Voiceified Technologies, LLC (19) | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Kihong Kwon, M.D. | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Iroquois Master Fund, Ltd. (20) | 33,334 | 16,667 | 50,001 | 0 | % | 50,001 | ||||||||||||||
| Roxy Transportation Co., Inc. (21) | 25,000 | 12,500 | 37,500 | 0 | % | 37,500 | ||||||||||||||
| William Stewart | 22,223 | 11,112 | 33,335 | 0 | % | 33,335 | ||||||||||||||
| Bernard B. Markey | 22,223 | 11,112 | 33,335 | 0 | % | 33,335 | ||||||||||||||
| Diamond II Investments, LLC (22) | 22,223 | 11,112 | 33,335 | 0 | % | 33,335 | ||||||||||||||
| Ravenwood Partners, LLC (23) | 20,000 | 10,000 | 30,000 | 0 | % | 30,000 | ||||||||||||||
| John Sanderford | 20,000 | 10,000 | 30,000 | 0 | % | 30,000 | ||||||||||||||
| Terry Sholty Strada | 16,667 | 8,334 | 25,001 | 0 | % | 25,001 | ||||||||||||||
| John Amorosa | 16,667 | 8,334 | 25,001 | 0 | % | 25,001 | ||||||||||||||
| Glen Bliwise | 16,667 | 8,334 | 25,001 | 0 | % | 25,001 | ||||||||||||||
| Joseph C. Roselle | 16,667 | 8,334 | 25,001 | 0 | % | 25,001 | ||||||||||||||
| Schuyler L. Merrihew | 16,667 | 8,334 | 25,001 | 0 | % | 25,001 | ||||||||||||||
| Kihong Kwon, M.D., Custodian, UGMA for Connor Merrihew | 16,000 | 8,000 | 24,000 | 0 | % | 24,000 | ||||||||||||||
| Kihong Kwon, M.D., Custodian, UGMA for Mason Kwon | 16,000 | 8,000 | 24,000 | 0 | % | 24,000 | ||||||||||||||
| Timothy V. O'Connor | 10,000 | 5,000 | 15,000 | 0 | % | 15,000 | ||||||||||||||
| Jarmila Cunningham | 8,334 | 4,167 | 12,501 | 0 | % | 12,501 | ||||||||||||||
| Bernard B. Markey, Individual 401(K) ETRADE Custodian | 6,667 | 3,334 | 10,001 | 0 | % | 10,001 | ||||||||||||||
| Timothy V. O'Connor Roth IRA | 6,667 | 3,334 | 10,001 | 0 | % | 10,001 | ||||||||||||||
| Brandon Hill | 3,334 | 1,667 | 5,001 | 0 | % | 5,001 | ||||||||||||||
| Sequoia Global Partners, LLC (24) | 73,228 | 73,228 | 0 | % | 73,228 | |||||||||||||||
| Walter H. Bass, LLC (24) | 10,667 | 10,667 | 0 | % | 10667 | |||||||||||||||
| 6,103,686 | 3,139,934 | 9,243,620 | 58 | % | 4,516,120 | |||||||||||||||
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| (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 15,107,279 common shares outstanding as of July 31, 2009. |
| (2) | Assumes the sale of all common shares registered pursuant to this registration statement. |
| (3) | 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) | G. Tyler Runnels and Jasmine Niklas Runnels, as Trustees, have voting and dispositive control with respect to the securities being offered. |
| (5) | Richard Stone, Managing Partner, has voting and dispositive control with respect to the securities being offered. |
| (6) | James Coren, member has voting and dispositive control with respect to the securities being offered. |
| (7) | Leonard Pearlman, Managing Director, has voting and dispositive control with respect to the securities being offered. |
| (8) | Andrew Margulies, General Partner, has voting and dispositive control with respect to the securities being offered. |
| (9) | John Scardino, Director, has voting and dispositive control with respect to the securities being offered. |
| (10) | Len Demer, Managing Director, has voting and dispositive control with respect to the securities being offered. Mercer Capital, Ltd. is a registered broker dealer. |
| (11) | Individual is an associated person of Mercer Capital, Ltd. |
| (12) | John L Kemmerer, III has voting and dispositive control with respect to the securities being offered. |
| (13) | Peter F. Nejes and Dennis Powers, as trustees, have voting and dispositive control with respect to the securities being offered. |
37
| (14) | Rene de Villiers has voting and dispositive control with respect to the securities being offered. |
| (15) | Steve Sciaretta has voting and dispositive control with respect to the securities being offered. |
| (16) | Cynthia Stafford, as trustee, has voting and dispositive control with respect to the securities being offered. |
| (17) | Robert Stafford, Jr. has voting and dispositive control with respect to the securities being offered. |
| (18) | Robert Stafford, Jr., as trustee, has voting and dispositive control with respect to the securities being offered. |
| (19) | Robert L. Magaletta has voting and dispositive control with respect to the securities being offered. |
| (20) | Joshua Silverman has voting and dispositive control with respect to the securities being offered by Iroquois Master Fund Ltd. Mr. Silverman disclaims beneficial ownership of the shares. |
| (21) | Peter C. Cunningham, has voting and dispositive control with respect to the securities being offered. |
| (22) | Lorrie Allegra has voting and dispositive control with respect to the securities being offered. |
| (23) | Greg Bolloten has voting and dispositive control with respect to the securities being offered. |
| (24) | Walter H. Bass has voting and dispositive control with respect to the securities being offered. The warrants were issued as a finder’s fee. |
DESCRIPTION OF SECURITIES
General
As of July 31, 2009, our authorized capital stock consisted of:
| · | 80,000,000 shares of common stock, par value $0.0001; and |
| · | 10,000,000 shares of “blank check” preferred stock, par value $0.0001. |
As of July 31, 2009, 15,107,279 shares of common stock were issued and outstanding and 0 shares of preferred stock were issued and outstanding. All of our currently issued and outstanding shares of capital stock were validly issued, fully paid and non-assessable under the Delaware General Corporation Law, as amended, or the DGCL.
Set forth below is a summary description of all the material terms of our common stock and warrants. This description is qualified in its entirety by reference to our amended and restated certificate of incorporation, bylaws and form of warrants, each of which is filed as an exhibit to this registration statement.
Common Stock
The holders of our common stock are entitled to one vote per share on each matter submitted to a vote at a meeting of our stockholders, except to the extent that the voting rights of our shares of any class or series of stock are determined and specified as greater or lesser than one vote per share in the manner provided by our certificate of incorporation. Our stockholders have no pre-emptive rights to acquire additional shares of our common stock or other securities. Our common stock is not subject to redemption rights and carries no subscription or conversion rights. In the event of liquidation of our company, the shares of our common stock are entitled to share equally in corporate assets after satisfaction of all liabilities. All shares of our common stock now outstanding are fully paid and non-assessable. Our bylaws authorize the board of directors to declare dividends on our outstanding shares. As of July 31, 2009, 15,107,279 shares of common stock were issued and outstanding.
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Preferred Stock
We may issue our preferred shares from time to time in one or more series as determined by our board of directors. The voting powers and preferences, the relative rights of each series, and the qualifications, limitations and restrictions thereof may be established by our board of directors without any further vote or action by our shareholders. As of July 31, 2009 there were no shares of our preferred stock issued and outstanding.
Warrants
Anti-Dilution Warrants
The warrants have a term of 5 years and an exercise price of $1.50 per shares subject to anti-dilution adjustments. The anti-dilution adjustments provide for adjustment of the warrant exercise price and number of shares issuable upon exercise in the event the Company: (i) declares a stock dividend or split; (ii) undertakes subsequent equity sales are a price below $2.00 per share; (iii) undertakes a rights offering; (iv) there is a pro-rata distribution to the Company’s shareholders; or (v) in the event of a fundamental transaction. The warrants are also callable by the Company in the event: (a) the Company’s shares are publically traded in the future; (b) the shares trade above $4.00 per share for 20 consecutive trading days; (c) the average daily volume over the 20 consecutive trading days exceeds 75,000; and (d) there is an effective registration statement covering the underlying shares.
February and June Offering Warrants
In connection with our February and June Offerings we issued the investors in those offerings warrants. The warrants have a term of 5 years and an exercise price of $3.00 per shares subject to anti-dilution adjustments. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The provisions do not provide for any adjustment in the event of subsequent equity sales or transactions. The warrants are also callable by the Company in the event: (a) the Company’s shares are publically traded in the future; (b) the shares trade above $5.00 per share for 20 consecutive trading days; (c) the average daily volume over the 20 consecutive trading days exceeds 75,000; and (d) there is an effective registration statement covering the underlying shares.
Consultant Warrants and Common Shares
The terms of the consultant warrants are typically negotiated on an individual basis. Notwithstanding, the warrants typically have a term of five years and an exercise price equal to or greater than the last previously completed offering. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The provisions do not provide for any adjustment in the event of subsequent equity sales or transactions.
Registration Rights
From inception, we have completed a number of private offerings. As part of the private placement, we entered into a registration rights agreements with the investors under which we agreed to file the registration statement of which this prospectus is a part in order to register (1) the common shares issued in the private placement; and (2) the common shares issuable upon the exercise of the warrants.
The registration rights agreement required us to use our best efforts to:
| · | file the registration statement with in certain period of time after a triggering event, usually the first closing (“Filing Deadline”); |
| · | have the registration agreement declared effective within a certain amount of days after the Filing Deadline (“Effectiveness Deadline”); and |
| · | maintain the registration statement continuously effective until the date that the shares covered by this prospectus may be sold pursuant to Rule 144 of the Securities Act without any manner of sale or volume restrictions. |
If we fail to file the registration statement by the Filing Deadline, have the registration statement declared effective by the Effectiveness Deadline, or the registration statement does not stay effective, we are obligated to pay the holder a penalty.
The exact Filing Deadline, Effective Deadline, amount of penalty and the form of payment is determined on a transaction by transaction basis. For a more complete description of our obligations under each registration statement, we refer you to the form of each such registration rights agreements filed as exhibits to this registration statement.
39
MARKET FOR COMMON EQUITY & RELATED STOCKHOLDER MATTERS
Holders
There exists no market for our common stock. Private sales or transfers are permitted under the respective state and Federal securities laws, subject to compliance with exemptions set forth under the respective statutory guidelines. As of July 31, 2009, we had 126 common shareholders of record.
Options, Warrants and Convertible Securities
As of July 31, 2009, there were outstanding common share purchase options, warrants and convertible securities entitling the holders to purchase up to 5,801,939 common shares at exercise prices between $0.50 and $3.00 with an average weighted exercise price of $1.63 per share.
SHARES ELIGIBLE FOR FUTURE SALE
To date, there has been no market for our common stock. In the event a public market for our shares develops, future sales of substantial amounts of our common stock in the public market could adversely affect prevailing market prices from time to time. Further, since only a limited number of shares will be available for sale shortly after this offering because of certain contractual and legal restrictions on resale described below, sales of substantial amounts of our common stock in the public market after the restrictions lapse could adversely affect the prevailing market price and our ability to raise equity capital in the future.
Sale of Restricted Shares
As of July 31,2009 we will have 15,107,279 shares of common stock outstanding. Of these shares, the shares sold in this offering will be freely tradable without restriction under the Securities Act, except for any shares purchased by our “affiliates” as that term is defined in Rule 144 under the Securities Act. In general, affiliates include executive officers, directors, and 10% stockholders. Shares purchased by affiliates will remain subject to the resale limitations of Rule 144.
Upon completion of this offering, 5,950,881 shares of common stock will be “restricted securities,” as that term is defined in Rule 144 under the Securities Act. These restricted securities are eligible for public sale only if they are registered under the Securities Act or if they qualify for an exemption from registration under rules 144 or 701 under the Securities Act, which are summarized below.
As a result of the lock-up agreements described below and the provisions of Rule 144 and Rule 701 of the Securities Act, the shares of our common stock (excluding the shares sold in this offering or issuable upon the exercise or conversion of a security) will be available for sale in the public market as follows:
| Date | Number of Shares | |||
| On the date of this prospectus | 6,207,780 | |||
| Within 90 days after the date of this prospectus | 6,707,780 | |||
| Between 90 and 360 days after the date of this prospectus(1) | 15,107,279 | |||
| 365 days after the effective date of this prospectus(1) | 15,107,279 | |||
______________________________________
(1) shares may be subject to volume limitations as a result of certain shareholders affiliate status.
Lock-Up Agreements
Our directors, executive officers, and certain other stockholders are subject to lock up agreements, generally providing that they will not offer, sell, contract to sell, or grant any option to purchase or otherwise dispose of our common stock or any securities exercisable for or convertible into our common stock owned by them until December 31, 2009. Despite possible earlier eligibility for sale under the provisions of Rules 144 and 701, shares subject to lock-up agreements will not be salable until these agreements expire or are waived by prior investors. The Lock-Up Agreements were entered into in connection with our July and August 2008 offering. Approximately 6,312,280 or 41.2 % of our outstanding shares of common stock will be subject to such lock-up agreements.
Rule 144
Generally, Rule 144 (as amended effective February 15, 2008) provides that an affiliate who has beneficially owned “restricted” shares of our common stock for at least six months will be entitled to sell on the open market in brokers’ transactions, within any three-month period, a number of shares that does not exceed the greater of:
| • | 1% of the number of shares of common stock then outstanding; or |
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| • | the average weekly trading volume of the common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale. |
In addition, sales under Rule 144 are subject to requirements with respect to manner of sale, notice, and the availability of current public information about us.
In the event that any person who is deemed to be our affiliate purchases shares of our common stock in this offering or acquires shares of our common stock pursuant to one of our employee benefits plans, sales under Rule 144 of the shares held by that person are subject to the volume limitations and other restrictions described in the preceding two paragraphs.
The volume limitation, manner of sale and notice provisions described above will not apply to sales by non-affiliates. For purposes of Rule 144, a non-affiliate is any person or entity who is not our affiliate at the time of sale and has not been our affiliate during the preceding three months. Once we have been a reporting company for 90 days, a non-affiliate who has beneficially owned restricted shares of our common stock for six months may rely on Rule 144 provided that certain public information regarding us is available. The six month holding period increases to one year in the event we have not been a reporting company for at least 90 days. However, a non-affiliate who has beneficially owned the restricted shares proposed to be sold for at least one year will not be subject to any restrictions under Rule 144 regardless of how long we have been a reporting company.
Rule 701
Under Rule 701, each of our employees, officers, directors, and consultants who purchased shares pursuant to a written compensatory plan or contract is eligible to resell these shares 90 days after the effective date of this offering in reliance upon Rule 144, but without compliance with specific restrictions. Rule 701 provides that affiliates may sell their Rule 701 shares under Rule 144 without complying with the holding period requirement and that non-affiliates may sell their shares in reliance on Rule 144 without complying with the holding period, public information, volume limitation, or notice provisions of Rule 144.
Form S-8 Registration Statements
We intend to file one or more registration statements on Form S-8 under the Securities Act as soon as practicable after the completion of this offering for shares issued upon the exercise of options and shares to be issued under our employee benefit plans. As a result, any shares acquired upon the exercise of such options will be freely tradable in the public market.
PLAN OF DISTRIBUTION
The Selling Stockholders will sell at a price of $1.50 per share until our shares are quoted, if ever, on a stock exchange in which a market develops or trading facility on which the shares are traded. Thereafter, the Selling Stockholders and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their shares of common stock on any stock exchange in which a market develops or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling shares:
| · | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| · | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| · | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| · | an exchange distribution in accordance with the rules of the applicable exchange; |
| · | privately negotiated transactions; |
| · | settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
| · | broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
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| · | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| · | a combination of any such methods of sale; or |
| · | any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell shares under Rule 144 under the Securities Act of 1933, as amended (the “ Securities Act ”), if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.
In connection with the sale of the common stock or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The Selling Stockholders may also sell shares of the common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the Common Stock. In no event shall any broker-dealer receive fees, commissions and markups which, in the aggregate, would exceed eight percent (8%).
Any securities acquired by an underwriter or related persons during 180 days prior to the filing date of this prospectus or after the filing date of this registration statement shall be deemed to be underwriting compensation by FIINRA. Securities excluded from underwriting compensation pursuant to FINRA Rule 2710(d)(5), shall not be directly or indirectly be offered, sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities by any person agree to offer or sell, transfer, assign, pledge, hypothecate or subject to hedging, short sale, derivative, put or call transaction such shares for a period of 180 days after the effective date of this registration statement except as provided for in FINRA Rule 2710(g)(2).
The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the shares. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
Because Selling Stockholders may be deemed to be “underwriters” within the meaning of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act including Rule 172 thereunder. In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144 rather than under this prospectus. There is no underwriter or coordinating broker acting in connection with the proposed sale of the resale shares by the Selling Stockholders.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the shares may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the shares have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale shares will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale shares may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.
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Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale shares may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of shares of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Corporation Laws of the State of Delaware and the Company's Bylaws provide for indemnification of the Company's Directors for expenses actually and necessarily incurred by them in connection with the defense of any action, suit or proceeding in which they, or any of them, are made parties, or a party, by reason of having been Director(s) or Officer(s) of the corporation, or of such other corporation, except, in relation to matter as to which any such Director or Officer or former Director or Officer or person shall be adjudged in such action, suit or proceeding to be liable for negligence or misconduct in the performance of duty. Furthermore, the personal liability of the Directors is limited as provided in the Company's Articles of Incorporation.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling the Company pursuant to the foregoing provisions, the Company has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is therefore unenforceable.
LEGAL MATTERS
The Silvestre Law Group, P.C. will issue a legal opinion as to the validity of the issuance of the shares of common stock offered under this prospectus.
EXPERTS
The financial statements as of December 31, 2008 and 2007 and for each interim period since December 31, 2008, included in this prospectus and in the registration statement of which it forms a part, have been so included in reliance on the report of RBSM LLP, our independent registered public accounting firm, appearing elsewhere in this prospectus and the registration statement of which it forms a part, given on the authority of said firm as experts in auditing and accounting.
INTERESTS OF NAMED EXPERTS AND COUNSEL
No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the shares of common stock was employed on a contingency basis or had, or is to receive, in connection with the offering, a substantial interest, directly or indirectly, in the registrant nor was any such person connected with the registrant as a promoter, managing or principal underwriter, voting trustee, director, officer or employee.
WHERE YOU CAN FIND MORE INFORMATION
We will file annual, quarterly and other reports, proxy statements and other information with the SEC. You may read and copy any document we file at the public reference facilities of the SEC at 100 F Street, NE, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference rooms. Our SEC filings are also available to the public at the SEC’s web site at http://www.sec.gov and at our website at http://www.genspera.com. We will furnish our stockholders with annual reports containing audited financial statements.
This prospectus is part of a registration statement on Form S-1 that we filed with the SEC. Certain information in the registration statement has been omitted from this prospectus in accordance with the rules and regulations of the SEC. We have also filed exhibits and schedules with the registration statement that are excluded from this prospectus. For further information you may:
| · | read a copy of the registration statement, including the exhibits and schedules, without charge at the SEC’s public reference rooms; or |
| · | obtain a copy from the SEC upon payment of the fees prescribed by the SEC. |
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FINANCIAL INFORMATION
GENSPERA INC.
(A Development Stage Company)
CONDENSED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2009 | 2008 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 661,360 | $ | 534,290 | ||||
| Total current assets | 661,360 | 534,290 | ||||||
| Intangible assets, net of accumulated amortization of $15,348 and $11,511 | 168,820 | 172,657 | ||||||
| Total assets | $ | 830,180 | $ | 706,947 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 142,750 | $ | 238,817 | ||||
| Accrued interest - stockholder | 6,987 | 5,399 | ||||||
| Convertible note payable - stockholder, current portion | 50,000 | 50,000 | ||||||
| Total current liabilities | 199,737 | 294,216 | ||||||
| Convertible note payable, net of discount of $5,948 and $11,046 | 157,652 | 152,554 | ||||||
| Convertible notes payable - stockholder, long term portion | 105,000 | 105,000 | ||||||
| Derivative liabilities | 1,723,378 | - | ||||||
| Total liabilities | 2,185,767 | 551,770 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock, par value $.0001 per share; 10,000,000 shares authorized, none issued and outstanding | - | - | ||||||
| Common stock, par value $.0001 per share; 80,000,000 shares authorized, 12,953,392 and 12,486,718 shares issued and outstanding | 1,295 | 1,249 | ||||||
| Additional paid-in capital | 5,259,370 | 4,922,174 | ||||||
| Deficit accumulated during the development stage | (6,616,252 | ) | (4,768,246 | ) | ||||
| Total stockholders' equity (deficit) | (1,355,587 | ) | 155,177 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 830,180 | $ | 706,947 | ||||
See accompanying notes to unaudited condensed financial statements.
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GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF LOSSES
FOR THE THREE MONTHS ENDED MARCH 31, 2009 AND 2008
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
| Cumulative Period | ||||||||||||
| from November 21, 2003 | ||||||||||||
| (date of inception) to | ||||||||||||
| Three Months ended March 31, | March 31, | |||||||||||
| 2009 | 2008 | 2009 | ||||||||||
| Operating expenses: | ||||||||||||
| General and administrative expenses | $ | 199,717 | $ | 374,791 | $ | 1,489,259 | ||||||
| Research and development | 309,502 | 150,801 | 3,733,909 | |||||||||
| Total operating expenses | 509,219 | 525,592 | 5,223,168 | |||||||||
| Loss from operations | (509,219 | ) | (525,592 | ) | (5,223,168 | ) | ||||||
| Finance cost | (472,938 | ) | - | (512,727 | ) | |||||||
| Change in fair value of derivative liability | (572,785 | ) | (863,241 | ) | ||||||||
| Interest expense, net | (2,608 | ) | (1,606 | ) | (17,116 | ) | ||||||
| Loss before provision for income taxes | (1,557,550 | ) | (527,198 | ) | (6,616,252 | ) | ||||||
| Provision for income taxes | - | - | - | |||||||||
| Net loss | $ | (1,557,550 | ) | $ | (527,198 | ) | $ | (6,616,252 | ) | |||
| Net loss per common share, basic and diluted | $ | (0.12 | ) | $ | (0.06 | ) | ||||||
| Weighted average shares outstanding | 12,699,314 | 9,411,846 | ||||||||||
See accompanying notes to unaudited condensed financial statements.
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GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY
FROM DATE OF INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
| Deficit | ||||||||||||||||||||
| Accumulated | ||||||||||||||||||||
| Additional | During the | |||||||||||||||||||
Common Stock | Paid-in | Development | Stockholders' | |||||||||||||||||
Shares | Amount | Capital | Stage | Equity | ||||||||||||||||
| Balance, November 21, 2003 | - | $ | - | $ | - | $ | - | $ | - | |||||||||||
| Sale of common stock to founders at $0.0001 per share in November, 2003 | 6,100,000 | 610 | (510 | ) | - | 100 | ||||||||||||||
| Contributed services | - | - | 120,000 | - | 120,000 | |||||||||||||||
| Net loss | - | - | - | (125,127 | ) | (125,127 | ) | |||||||||||||
| Balance, December 31, 2003 | 6,100,000 | 610 | 119,490 | (125,127 | ) | (5,027 | ) | |||||||||||||
| Contributed services | - | - | 192,000 | - | 192,000 | |||||||||||||||
| Stock based compensation | - | - | 24,102 | - | 24,102 | |||||||||||||||
| Net loss | - | - | - | (253,621 | ) | (253,621 | ) | |||||||||||||
| Balance, December 31, 2004 | 6,100,000 | 610 | 335,592 | (378,748 | ) | (42,546 | ) | |||||||||||||
| Contributed services | - | - | 48,000 | - | 48,000 | |||||||||||||||
| Stock based compensation | - | - | 24,100 | - | 24,100 | |||||||||||||||
| Net loss | - | - | - | (126,968 | ) | (126,968 | ) | |||||||||||||
| Balance, December 31, 2005 | 6,100,000 | 610 | 407,692 | (505,716 | ) | (97,414 | ) | |||||||||||||
| Contributed services | - | - | 144,000 | - | 144,000 | |||||||||||||||
| Stock based compensation | - | - | 42,162 | - | 42,162 | |||||||||||||||
| Net loss | - | - | - | (245,070 | ) | (245,070 | ) | |||||||||||||
| Balance, December 31, 2006 | 6,100,000 | 610 | 593,854 | (750,786 | ) | (156,322 | ) | |||||||||||||
Shares sold for cash at $0.50 per share in November, 2007 | 1,300,000 | 130 | 649,870 | - | 650,000 | |||||||||||||||
| Shares issued for services | 735,000 | 74 | 367,426 | - | 367,500 | |||||||||||||||
| Contributed services | - | - | 220,000 | - | 220,000 | |||||||||||||||
| Stock based compensation | - | - | 24,082 | - | 24,082 | |||||||||||||||
| Exercise of options for cash at $0.003 per share in March and June, 2007 | 900,000 | 90 | 2,610 | - | 2,700 | |||||||||||||||
| Net loss | - | - | - | (691,199 | ) | (691,199 | ) | |||||||||||||
| Balance, December 31, 2007 | 9,035,000 | 904 | 1,857,842 | (1,441,985 | ) | 416,761 | ||||||||||||||
| Exercise of options for cash at $0.50 per share on March 7,2008 | 1,000,000 | 100 | 499,900 | - | 500,000 | |||||||||||||||
| Sale of common stock and warrants at $1.00 per share - July and August 2008 | 2,320,000 | 232 | 2,319,768 | - | 2,320,000 | |||||||||||||||
| Cost of sale of common stock and warrants | - | - | (205,600 | ) | - | (205,600 | ) | |||||||||||||
| Shares issued for accrued interest | 31,718 | 3 | 15,856 | - | 15,859 | |||||||||||||||
| Shares issued for services | 100,000 | 10 | 49,990 | - | 50,000 | |||||||||||||||
| Stock based compensation | - | - | 313,743 | - | 313,743 | |||||||||||||||
| Contributed services | - | - | 50,000 | - | 50,000 | |||||||||||||||
| Beneficial conversion feature of convertible debt | - | - | 20,675 | - | 20,675 | |||||||||||||||
| Net loss | - | - | - | (3,326,261 | ) | (3,326,261 | ) | |||||||||||||
| Balance, December 31, 2008 | 12,486,718 | 1,249 | 4,922,174 | (4,768,246 | ) | 155,177 | ||||||||||||||
| Cumulative effect of change in accounting principle | - | - | (444,161 | ) | (290,456 | ) | (734,617 | ) | ||||||||||||
| Warrants issued for extension of debt maturities | - | - | 51,864 | - | 51,864 | |||||||||||||||
| Stock based compensation | - | - | 29,554 | - | 29,554 | |||||||||||||||
Sale of common stock and warrants at $1.50 per share - February 2009 | 466,674 | 46 | 699,939 | - | 699,985 | |||||||||||||||
| Net loss | - | - | - | (1,557,550 | ) | (1,557,550 | ) | |||||||||||||
| Balance, March 31, 2009 (Unaudited) | 12,953,392 | $ | 1,295 | $ | 5,259,370 | $ | (6,616,252 | ) | $ | (1,355,587 | ) | |||||||||
See accompanying notes to unaudited condensed financial statements.
46
GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2009 AND 2008
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2009
(Unaudited)
| Cumulative Period | ||||||||||||
| from November 21, 2003 | ||||||||||||
| (date of inception) to | ||||||||||||
| Three months ended March 31, | March 31, | |||||||||||
| 2009 | 2008 | 2009 | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net loss | $ | (1,557,550 | ) | $ | (527,198 | ) | $ | (6,616,252 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Amortization | 3,837 | - | 15,348 | |||||||||
| Stock based compensation | 29,554 | 267,465 | 875,243 | |||||||||
| Warrants issued for financing costs | 467,840 | - | 467,840 | |||||||||
| Change in fair value of derivative liability | 572,785 | - | 863,241 | |||||||||
| Contributed services | - | - | 774,000 | |||||||||
| Amortization of debt discount | 5,098 | - | 14,727 | |||||||||
| Increase in accounts payable and accrued expenses | (94,479 | ) | 17,732 | 165,596 | ||||||||
| Cash used in operating activities | (572,915 | ) | (242,001 | ) | (3,440,257 | ) | ||||||
| Cash flows from investing activities: | ||||||||||||
| Acquisition of intangibles | - | (184,168 | ) | (184,168 | ) | |||||||
| Cash used in investing activities | - | (184,168 | ) | (184,168 | ) | |||||||
| Cash flows from financing activities: | ||||||||||||
| Proceeds from sale of common stock and warrants | 699,985 | 500,000 | 4,130,785 | |||||||||
| Proceeds from convertible notes - stockholder | - | - | 155,000 | |||||||||
| Cash provided by financing activities | 699,985 | 500,000 | 4,285,785 | |||||||||
| Net increase in cash | 127,070 | 73,831 | 661,360 | |||||||||
| Cash, beginning of period | 534,290 | 590,435 | - | |||||||||
| Cash, end of period | $ | 661,360 | $ | 664,266 | $ | 661,360 | ||||||
| Supplemental cash flow information: | ||||||||||||
| Cash paid for interest | $ | 79 | $ | - | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||||||
| Non-cash financial activities: | ||||||||||||
| Accrued interest paid with common stock | $ | - | $ | 15,859 | ||||||||
See accompanying notes to unaudited condensed financial statements.
47
GENSPERA, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
FOR THE THREE MONTH PERIODS ENDED MARCH 31, 2009 AND 2008
(Unaudited)
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES
A summary of the significant accounting policies applied in the preparation of the accompanying financial statements follows.
Business and Basis of Presentation
GenSpera Inc. (“we”, “us”, “our company “, “our”, “GenSpera” or the “Company” ) was formed under the laws of the State of Delaware in 2003. We are a development stage company, as defined by Statement of Financial Accounting Standards (“SFAS”) No. 7. GenSpera, Inc. is a pharmaceutical company focused on the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. Our operations are based in San Antonio, Texas.
To date, we have generated no sales revenues, have incurred significant expenses and have sustained losses. Consequently, our operations are subject to all the risks inherent in the establishment of a new business enterprise. For the period from inception on November 21, 2003 through March 31, 2009, we have accumulated losses of $6,616,252.
The accompanying unaudited condensed financial statements as of March 31, 2009 and for the three month periods ended March 31, 2009 and 2008 and from date of inception as a development stage enterprise (November 21, 2003) to March 31, 2009 have been prepared by GenSpera pursuant to the rules and regulations of the Securities and Exchange Commission, including Form 10-Q and Regulation S-X. The information furnished herein reflects all adjustments (consisting of normal recurring accruals and adjustments) which are, in the opinion of management, necessary to fairly present the operating results for the respective periods. Certain information and footnote disclosures normally present in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to such rules and regulations. The company believes that the disclosures provided are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the audited financial statements and explanatory notes for the year ended December 31, 2008 as disclosed in the company's 10-K for that year as filed with the SEC, as it may be amended.
The results of the three months ended March 31, 2009 are not necessarily indicative of the results to be expected for the pending full year ending December 31, 2009.
Going Concern
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements during three month period ended March 31, 2009 and from inception to March 31, 2009 the Company has incurred losses of $1,557,550 and $6,616,252 respectively. Additionally the Company has generated no sales revenues. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
In order to address our capital requirements, we intend to seek to raise additional cash for working capital purposes through the public or private sales of debt or equity securities, the procurement of advances on contracts or licenses, funding from joint-venture or strategic partners, debt financing or short-term loans, or a combination of the foregoing. We may also seek to satisfy indebtedness without any cash outlay through
48
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
the private issuance of debt or equity securities. There can be no assurance the Company will be successful in its effort to secure additional equity financing.
If operations and cash flows continue to improve through these efforts, management believes that the Company can continue to operate. However, no assurance can be given that management's actions will result in profitable operations or the resolution of its liquidity issues.
The accompanying financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Although these estimates are based on management's best knowledge of current events and actions the Company may undertake in the future, actual results may differ from those estimates.
Research and Development
Research and development costs include expenses incurred by the Company for research and development of therapeutic agents for the treatment of cancer and are charged to operations as incurred. Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, and compensation and consulting costs.
GenSpera incurred research and development expenses of $309,502, $150,801 and $3,733,909 for the three months ended March 31, 2009 and 2008, and from November 21, 2003 (inception) through March 31, 2009, respectively.
Loss Per Share
We use SFAS No. 128, “Earnings Per Share” for calculating the basic and diluted loss per share. We compute basic loss per share by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. There were 4,517,867 common share equivalents at March 31, 2009 and 1,971,094 at March 31, 2008. For the three month periods ended March 31, 2009 and 2008, these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share.
Change in Accounting Principle
In June 2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities , paragraph 11(a), and should be classified as a liability and marked-to-market. The statement is effective for fiscal years beginning after December 15, 2008 and is to be applied to outstanding instruments upon adoption with the cumulative effect of the change in accounting principle recognized as an adjustment to the opening balance of retained earnings. The Company has assessed its outstanding equity-linked financial instruments and has concluded
49
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
that effective January 1, 2009, warrants issued during 2008 with a fair value of $734,617 on January 1, 2009 will need to be reclassified from equity to a liability. The cumulative effect of the change in accounting principle on January 1, 2009 is an increase in our derivative liability related to the fair value of the warrants of $734,617, a decrease in additional paid-in capital of $444,161, based on the fair value of the warrants at date of issue, and a $290,456 increase to the deficit accumulated during development stage to reflect the change in fair value of the derivative liability from date of issue to January 1, 2009.
Recent Accounting Pronouncements
In December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in Consolidated Financial Statements-an amendment of ARB No. 51” (SFAS 160). SFAS 160 requires that non-controlling (or minority) interests in subsidiaries be reported in the equity section of the company’s balance sheet, rather than in a mezzanine section of the balance sheet between liabilities and equity. SFAS 160 also changes the manner in which the net income of the subsidiary is reported and disclosed in the controlling company’s income statement. SFAS 160 also establishes guidelines for accounting or changes in ownership percentages and for deconsolidation. SFAS 160 is effective for financial statements for fiscal years beginning on or after December 15, 2008 and interim periods within those years. The adoption of SFAS 160 did not have a material impact on our financial position, results of operations or cash flows.
In March 2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities-an amendment of FASB Statement No. 133” (SFAS 161). SFAS 161 requires enhanced disclosures about an entity’s derivative and hedging activities and thereby improves the transparency of financial reporting. SFAS 161 is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application encouraged. The adoption of SFAS 161 did not have a material impact on our financial position, results of operations or cash flows.
Effective January 1, 2009, the Company adopted the Financial Accounting Standards Board's Staff Position (FSP) on the Emerging Issues Task Force (EITF) Issue No. 03-6-1, “Determining Whether Instruments Granted in Share-Based Payment Transactions are Participating Securities.” The FSP required that all unvested share-based payment awards that contain nonforfeitable rights to dividends should be included in the basic Earnings Per Share (EPS) calculation. This standard did not affect the financial position or results of operations.
In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, “Recognition and Presentation of Other-Than-Temporary Impairments” (“FSP FAS No. 115-2”). FSP FAS No. 115-2 provides guidance in determining whether impairments in debt securities are other than temporary, and modifies the presentation and disclosures surrounding such instruments. This FSP is effective for interim periods ending after June 15, 2009, but early adoption is permitted for interim periods ending after March 15, 2009. The Company plans to adopt the provisions of this Staff Position during the second quarter of 2009, but does not believe this guidance will have a significant impact on its financial statements.
In April 2009, the FASB issued FSP FAS No. 157-4, “Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly” (“FSP FAS No. 157-4”). FSP FAS No. 157-4 provides additional guidance in determining whether the market for a financial asset is not active and a transaction is not distressed for fair value measurement purposes as defined in SFAS No. 157, “Fair Value Measurements.” FSP FAS No. 157-4 is effective for interim periods ending after June 15, 2009, but early adoption is permitted for interim periods ending after March 15, 2009. The Company will apply the provisions of this statement prospectively beginning with the second quarter 2009, and does not expect its adoption to have a material effect on its financial statements.
50
In April 2009, the FASB issued FSP FAS No. 107-1 and APB 28-1, “Interim Disclosures about Fair Value of Financial Instruments” (“FSP FAS No. 107-1 and APB 28-1”). This FSP amends FASB Statement No. 107, “Disclosures about Fair Values of Financial Instruments,” to require disclosures about fair value of financial instruments in interim financial statements as well as in annual financial statements. APB 28-1 also amends APB Opinion No. 28, “Interim Financial Reporting,” to require those disclosures in all interim financial statements. This standard is effective for interim periods ending after June 15, 2009, but early adoption is permitted for interim periods ending after March 15, 2009. The Company plans to adopt FSP FAS No. 107-1 and APB 28-1 and provide the additional disclosure requirements beginning in second quarter 2009.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the AICPA, and the SEC did not, or are not believed by management to, have a material impact on the Company's present or future financial statements.
NOTE 2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY
We are authorized to issue 80,000,000 shares of common stock with a par value of $.0001 per share and 10,000,000 shares of preferred stock with a par value of $.0001 per share.
On February 17, 2009, we entered into a modification with Dr. Dionne with regard to our 4% Convertible Promissory Note issued to Dionne in the amount of $35,000 (“Note”). Pursuant to the modification, Dr. Dionne agreed to extend the maturity date of the Note from December 2, 2008 to December 2, 2009. As consideration for the modification, the Company issued Dr. Dionne a common stock purchase warrant entitling him to purchase 11,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. We have recorded a financing expense of $9,353 during the three months ended March 31, 2009 related to the fair value of the warrants, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 156%; and (4) an expected life of the warrants of 2 years.
On February 17, 2009, we entered into a modification with TR Winston & Company, LLC (“TRW”) with regard to the Company’s 5% Convertible Debenture issued to TRW in the amount of $163,600. Pursuant to the modification, TRW agreed to extend the maturity date of the debenture from July 14, 2009 to July 14, 2010. As consideration for the modification, the we issued TRW a common stock purchase warrant entitling TRW to purchase 50,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. We have recorded a financing expense of $42,511 during the three months ended March 31, 2009 related to the fair value of the warrants, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 156%; and (4) an expected life of the warrants of 2 years.
On February 19, 2009, we entered into a Securities Purchase Agreement with a number of accredited investors. Pursuant to the terms of the Securities Purchase Agreement, we sold the investors units aggregating approximately $700,000 “Offering”. The price per unit was $1.50. Each unit consists of: (i) one share of the Company’s common stock; and (ii) one half Common Stock Purchase Warrant. 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.
As a result of offering, the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered. These anti-dilution provisions resulted in the exercise price of these warrants being reduced from $2.00 from $1.50. Additionally, we are obligated to issue holders of these warrants an additional 506,754 warrants, and we are obligated to file a registration statement for the common stock underlying such warrants pursuant to the registration rights agreement entered into in connection with the July and August 2008 financing. We have recorded a financing expense of $415,976 during the three months ended March 31, 2009 related to the fair value of the additional warrants, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 149%; and (4) an expected life of the warrants of 2 years. Because these additional warrants are subject to the same anti-dilution provisions as the original 2008 warrants we have recorded the fair value of the warrants as a derivative liability.
51
NOTE 3 – DERIVATIVE LIABILITY
In June 2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities, paragraph 11(a), and should be classified as a liability and marked-to-market. The Company has assessed its outstanding equity-linked financial instruments and has concluded that warrants issued during 2008 with a fair value of $734,617 on January 1, 2009 are required to be reclassified from equity to a liability. Fair value at January 1, 2009 was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 144%; and (4) an expected life of the warrants of 2 years.
As a result of our February offering described in Note 2, the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered. These anti-dilution provisions resulted in the exercise price of these warrants being reduced from $2.00 from $1.50. Additionally, we are obligated to issue holders of these warrants an additional 506,754 warrants, and we are obligated to file a registration statement for the common stock underlying such warrants pursuant to the registration rights agreement entered into in connection with the July and August 2008 financing. We have recorded the fair value of the additional warrants as a derivative liability upon issue. The fair value of the warrants of $415,976 was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 149%; and (4) an expected life of the warrants of 2 years.
At March 31, 2009 we recalculated the fair value of our warrants subject to derivative accounting and have determined that their fair value at March 31, 2009 is $1,723,377. The value of the warrants was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.875%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 156%; and (4) an expected life of the warrants of 2 years. We have recorded an expense of $572,785 during the three months ended March 31, 2009 related to the change in fair value during that period.
52
REPORT OF INDEPENDENT REGISTERED CERTIFIED PUBLIC ACCOUNTING FIRM
Board of Directors
GenSpera Inc.
San Antonio, TX
We have audited the accompanying balance sheets of GenSpera Inc., a development stage company, as of December 31, 2008 and 2007, and the related statements of losses, statement of stockholders' equity, and cash flows for each of the two years in the period ended December 31, 2008 and the period November 21, 2003 (date of inception) through December 31, 2008. These financial statements are the responsibility of the company's management. Our responsibility is to express an opinion on the financial statements based upon our audits.
We conducted our audits in accordance with standards of the Public Company Accounting Oversight Board (United States of America). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatements. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of GenSpera Inc., a development stage company, at December 31, 2008 and 2007 and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2008 and the period November 21, 2003 (date of inception) through December 31, 2008 in conformity with accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1, the Company has a generated negative cash outflows from operating activities, experienced recurring net operating losses, and is dependent on securing additional equity and debt financing to support its business efforts. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to this matter are described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ RBSM LLP | |
| New York, New York | RBSM LLP |
| March 30, 2009 |
53
GENSPERA INC.
(A Development Stage Company)
BALANCE SHEETS
DECEMBER 31,2008 and 2007
| 2008 | 2007 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 534,290 | $ | 590,435 | ||||
| Total current assets | 534,290 | 590,435 | ||||||
| Intangible assets, net of accumulated amortization of $11,511 | 172,657 | - | ||||||
| Total assets | $ | 706,947 | $ | 590,435 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 238,817 | $ | 3,874 | ||||
| Accrued interest - stockholder | 5,399 | 14,800 | ||||||
| Convertible note payable - stockholder, current portion | 50,000 | 35,000 | ||||||
| Total current liabilities | 294,216 | 53,674 | ||||||
| Convertible note payable, net of discount of $11,046 | 152,554 | - | ||||||
| Convertible notes payable - stockholder, long term portion | 105,000 | 120,000 | ||||||
| Total liabilities | 551,770 | 173,674 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $.0001 per share; 10,000,000 shares authorized, | ||||||||
| none issued and outstanding | - | - | ||||||
| Common stock, par value $.0001 per share; 80,000,000 shares authorized, | ||||||||
| 12,486,718 and 9,035,000 shares issued and outstanding | 1,249 | 904 | ||||||
| Additional paid-in capital | 4,922,174 | 1,857,842 | ||||||
| Deficit accumulated during the development stage | (4,768,246 | ) | (1,441,985 | ) | ||||
| Total stockholders' equity | 155,177 | 416,761 | ||||||
| Total liabilities and stockholders' equity | $ | 706,947 | $ | 590,435 | ||||
See accompanying notes to financial statements.
54
GENSPERA, INC.
(A Development Stage Company)
STATEMENTS OF LOSSES
FOR THE YEARS ENDED DECEMBER 31, 2008 AND 2007
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO DECEMBER 31, 2008
| Cumulative Period | ||||||||||||
| from November 21, 2003 | ||||||||||||
| (date of inception) to | ||||||||||||
| Years ended December 31, | December 31, | |||||||||||
| 2008 | 2007 | 2008 | ||||||||||
| Operating expenses: | ||||||||||||
| General and administrative expenses | $ | 854,294 | $ | 389,799 | $ | 1,289,542 | ||||||
| Research and development | 2,432,991 | 294,440 | 3,424,407 | |||||||||
| Total operating expenses | 3,287,285 | 684,239 | 4,713,949 | |||||||||
| Loss from operations | (3,287,285 | ) | (684,239 | ) | (4,713,949 | ) | ||||||
| Finance cost | (39,789 | ) | - | (39,789 | ) | |||||||
| Interest income (expense), net | 813 | (6,960 | ) | (14,508 | ) | |||||||
| Loss before provision for income taxes | (3,326,261 | ) | (691,199 | ) | (4,768,246 | ) | ||||||
| Provision for income taxes | - | - | - | |||||||||
| Net loss | $ | (3,326,261 | ) | $ | (691,199 | ) | $ | (4,768,246 | ) | |||
| Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.10 | ) | ||||||
| Weighted average shares outstanding | 11,030,657 | 7,103,904 | ||||||||||
See accompanying notes to financial statements.
55
GENSPERA, INC.
(A Development Stage Company)
STATEMENT OF STOCKHOLDERS' EQUITY
FROM DATE OF INCEPTION (NOVEMBER 21, 2003) TO DECEMBER 31, 2008
| Deficit | ||||||||||||||||||||
| Accumulated | ||||||||||||||||||||
| Additional | During the | |||||||||||||||||||
| Common Stock | Paid-in | Development | Stockholders' | |||||||||||||||||
| Shares | Amount | Capital | Stage | Equity | ||||||||||||||||
| Balance, November 21, 2003 | - | $ | - | $ | - | $ | - | $ | - | |||||||||||
| Sale of common stock to founders at $0.0001 | ||||||||||||||||||||
| per share in November, 2003 | 6,100,000 | 610 | (510 | ) | - | 100 | ||||||||||||||
| Contributed services | - | - | 120,000 | - | 120,000 | |||||||||||||||
| Net loss | - | - | - | (125,127 | ) | (125,127 | ) | |||||||||||||
| Balance, December 31, 2003 | 6,100,000 | 610 | 119,490 | (125,127 | ) | (5,027 | ) | |||||||||||||
| Contributed services | - | - | 192,000 | - | 192,000 | |||||||||||||||
| Stock based compensation | - | - | 24,102 | - | 24,102 | |||||||||||||||
| Net loss | - | - | - | (253,621 | ) | (253,621 | ) | |||||||||||||
| Balance, December 31, 2004 | 6,100,000 | 610 | 335,592 | (378,748 | ) | (42,546 | ) | |||||||||||||
| Contributed services | - | - | 48,000 | - | 48,000 | |||||||||||||||
| Stock based compensation | - | - | 24,100 | - | 24,100 | |||||||||||||||
| Net loss | - | - | - | (126,968 | ) | (126,968 | ) | |||||||||||||
| Balance, December 31, 2005 | 6,100,000 | 610 | 407,692 | (505,716 | ) | (97,414 | ) | |||||||||||||
| Contributed services | - | - | 144,000 | - | 144,000 | |||||||||||||||
| Stock based compensation | - | - | 42,162 | - | 42,162 | |||||||||||||||
| Net loss | - | - | - | (245,070 | ) | (245,070 | ) | |||||||||||||
| Balance, December 31, 2006 | 6,100,000 | 610 | 593,854 | (750,786 | ) | (156,322 | ) | |||||||||||||
| Shares sold for cash at $0.50 per share | ||||||||||||||||||||
| in November, 2007 | 1,300,000 | 130 | 649,870 | - | 650,000 | |||||||||||||||
| Shares issued for services | 735,000 | 74 | 367,426 | - | 367,500 | |||||||||||||||
| Contributed services | - | - | 220,000 | - | 220,000 | |||||||||||||||
| Stock based compensation | - | - | 24,082 | - | 24,082 | |||||||||||||||
| Exercise of options for cash at $0.003 per share | ||||||||||||||||||||
| in March and June, 2007 | 900,000 | 90 | 2,610 | - | 2,700 | |||||||||||||||
| Net loss | - | - | - | (691,199 | ) | (691,199 | ) | |||||||||||||
| Balance, December 31, 2007 | 9,035,000 | 904 | 1,857,842 | (1,441,985 | ) | 416,761 | ||||||||||||||
| Exercise of options for cash at $0.50 per share | ||||||||||||||||||||
| on March 7,2008 | 1,000,000 | 100 | 499,900 | - | 500,000 | |||||||||||||||
| Sale of common stock and warrants at $1.00 per | ||||||||||||||||||||
| share - July and August 2008 | 2,320,000 | 232 | 2,319,768 | - | 2,320,000 | |||||||||||||||
| Cost of sale of common stock and warrants | - | - | (205,600 | ) | - | (205,600 | ) | |||||||||||||
| Shares issued for accrued interest | 31,718 | 3 | 15,856 | - | 15,859 | |||||||||||||||
| Shares issued for services | 100,000 | 10 | 49,990 | - | 50,000 | |||||||||||||||
| Stock based compensation | - | - | 313,743 | - | 313,743 | |||||||||||||||
| Contributed services | - | - | 50,000 | - | 50,000 | |||||||||||||||
| Beneficial conversion feature of convertible debt | - | - | 20,675 | - | 20,675 | |||||||||||||||
| Net loss | - | - | - | (3,326,261 | ) | (3,326,261 | ) | |||||||||||||
| Balance, December 31, 2008 | 12,486,718 | $ | 1,249 | $ | 4,922,174 | $ | (4,768,246 | ) | $ | 155,177 | ||||||||||
See accompanying notes to financial statements.
56
GENSPERA, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2008 AND 2007
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO DECEMBER 31, 2008
| Cumulative Period | ||||||||||||
| from November 21, 2003 | ||||||||||||
| (date of inception) to | ||||||||||||
| Years ended December 31, | December 31, | |||||||||||
| 2008 | 2007 | 2008 | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net loss | $ | (3,326,261 | ) | $ | (691,199 | ) | $ | (4,768,246 | ) | |||
| Adjustments to reconcile net loss to net | ||||||||||||
| cash used in operating activities: | ||||||||||||
| Amortization | 11,511 | - | 11,511 | |||||||||
| Stock based compensation | 363,743 | 391,582 | 845,689 | |||||||||
| Contributed services | 50,000 | 220,000 | 774,000 | |||||||||
| Amortization of debt discount | 9,629 | - | 9,629 | |||||||||
| Increase in accounts payable and accrued expenses | 241,401 | 1,589 | 260,075 | |||||||||
| Cash used in operating activities | (2,649,977 | ) | (78,028 | ) | (2,867,342 | ) | ||||||
| Cash flows from investing activities: | ||||||||||||
| Acquisition of intangibles | (184,168 | ) | - | (184,168 | ) | |||||||
| Cash used in investing activities | (184,168 | ) | - | (184,168 | ) | |||||||
| Cash flows from financing activities: | ||||||||||||
| Proceeds from sale of common stock and warrants | 2,778,000 | 652,700 | 3,430,800 | |||||||||
| Proceeds from convertible notes - stockholder | - | - | 155,000 | |||||||||
| Cash provided by financing activities | 2,778,000 | 652,700 | 3,585,800 | |||||||||
| Net increase (decrease) in cash | (56,145 | ) | 574,672 | 534,290 | ||||||||
| Cash, beginning of period | 590,435 | 15,763 | - | |||||||||
| Cash, end of period | $ | 534,290 | $ | 590,435 | $ | 534,290 | ||||||
| Supplemental cash flow information: | ||||||||||||
| Cash paid for interest | $ | - | $ | - | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||||||
| Non-cash financial activities: | ||||||||||||
| Accrued interest paid with common stock | $ | 15,859 | $ | - | ||||||||
| Convertible note issued as payment of placement fees | 163,600 | - | ||||||||||
| Fair value of warrants issued with convertible debt recorded | ||||||||||||
| as debt discount | 20,675 | - | ||||||||||
See accompanying notes to financial statements.
57
GENSPERA, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2008 AND 2007
AND FOR THE PERIOD FROM NOVEMBER 21, 2003
(INCEPTION) TO DECEMBER 31, 2008
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES
A summary of the significant accounting policies applied in the preparation of the accompanying financial statements follows.
Business and Basis of Presentation
GenSpera Inc. (“we”, “us”, “ our company “, “our”, “GenSpera” or the “Company” ) was formed under the laws of the State of Delaware in 2003. We are a development stage company, as defined by Statement of Financial Accounting Standards (“SFAS”) No. 7. GenSpera, Inc. is a pharmaceutical company focused on the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. Our operations are based in San Antonio, Texas.
To date, we have generated no sales revenues, have incurred significant expenses and have sustained losses. Consequently, our operations are subject to all the risks inherent in the establishment of a new business enterprise. For the period from inception on November 21, 2003 through December 31, 2008, we have accumulated losses of $4,768,246.
Going Concern
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements during years ended December 31, 2008 and 2007 the Company incurred losses of $3,326,261 and $691,199 respectively. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
In order to address our capital requirements, we intend to seek to raise additional cash for working capital purposes through the public or private sales of debt or equity securities, the procurement of advances on contracts or licenses, funding from joint-venture or strategic partners, debt financing or short-term loans, or a combination of the foregoing. We may also seek to satisfy indebtedness without any cash outlay through the private issuance of debt or equity securities. There can be no assurance the Company will be successful in its effort to secure additional equity financing.
If operations and cash flows continue to improve through these efforts, management believes that the Company can continue to operate. However, no assurance can be given that management's actions will result in profitable operations or the resolution of its liquidity issues.
The accompanying financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Although these estimates are based on management's best knowledge of current events and actions the Company may undertake in the future, actual results may differ from those estimates.
Research and Development
Research and development costs include expenses incurred by the Company for research and development of therapeutic agents for the treatment of cancer and are charged to operations as incurred. Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, and compensation and consulting costs.
58
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
GenSpera incurred research and development expenses of $2,432,991, $294,440 and $3,424,407 for the years ended December 31, 2008 and 2007, and from November 21, 2003 (inception) through December 31, 2008, respectively.
Cash Equivalents
For purposes of the statements of cash flows, we consider all highly liquid debt instruments purchased with a maturity date of three months or less to be cash equivalents. We maintain our cash in bank deposit accounts which, at times, may exceed insured limits. We have not experienced any losses in our accounts.
Concentrations of Credit Risk
Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and cash equivalents. The Company places its cash and temporary cash investments with credit quality institutions. At times, such investments may be in excess of applicable government mandated insurance limits. At December 31, 2008, deposits exceeded current insurance limits by approximately $284,000.
Fair Value of Financial Instruments
SFAS No. 107, "Disclosures About Fair Value of Financial Instruments," requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.
Intangible Assets
Intangible assets consist of 5 issued patents and 3 patent applications pending worldwide (see Note 4). These patents and patent applications cover the intellectual property underlying our technology. The assets are recorded at cost. The patents are being amortized on the straight line basis over their estimated useful lives of twelve years.
Loss Per Share
We use SFAS No. 128, “Earnings Per Share” for calculating the basic and diluted loss per share. We compute basic loss per share by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. There were 3,713,598 common share equivalents at December 31, 2008 and 339,600 at December 31, 2007. For the years ended December 31, 2008 and 2007, these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share.
Income Taxes
We have adopted the provisions of SFAS No. 109 "Accounting for Income Taxes"("SFAS 109"). SFAS 109 requires recognition of deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax liabilities and assets are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The Company has incurred losses that can be carried forward to offset future earnings if conditions of the Internal Revenue Codes are met. A valuation allowance is recorded to reduce a deferred tax asset to that portion that is expected to more likely than not be realized.
In July 2006, the FASB issued FIN 48, "Accounting for Uncertainty in Income Taxes-an interpretation of FASB Statement No. 109" ("FIN 48"). FIN 48 clarifies the recognition threshold and measurement of a tax position taken on a tax return. FIN 48 is effective for fiscal years beginning after December 15, 2006. FIN 48 also requires expanded disclosure with respect to the uncertainty in income taxes. The adoption of FIN 48 did not have any effect on the Company’s financial position or results of operations.
59
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
Stock-Based Compensation
We account for our share-based compensation under the provisions of FASB Statement No. 123(R), “Share-Based Payment”, (“FAS 123R”). We adopted FAS 123R as of January 1, 2006, using the modified prospective application method. Prior to January 1, 2006 we applied the provisions of FAS 123, “Accounting for Stock-Based Compensation”.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No.157, Fair Value Measurements (“SFAS 157”). SFAS 157 defines fair value to be the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and emphasizes that fair value is a market-based measurement, not an entity-specific measurement. It establishes a fair value hierarchy and expands disclosures about fair value measurements in both interim and annual periods. SFAS 157 is effective for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years. The Company adopted SFAS 157 on January 1, 2008 which did not have a material impact on its consolidated financial position and results of operations. The Company also adopted the deferral provisions of the Financial Accounting Standards Board Staff Position No. 157-2, which delays the effective date of SFAS No. 157 for all nonrecurring fair value measurements of non-financial assets and liabilities until fiscal years beginning after November 15, 2008.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. SFAS No. 157 also expands disclosures about instruments measured at fair value and establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
Level 1 — Quoted prices for identical assets and liabilities in active markets;
Level 2 — Quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and
Level 3 — Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The Company designates cash equivalents as Level 1. As of December 31, 2008 and 2007, the Company did not have any cash equivalents, therefore there were no assets measured at fair value.
In February 2007, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 159, The Fair Value Option for Financial Assets and Financial Liabilities-Including an Amendment of FASB Statement No. 115 (“SFAS 159”). SFAS 159 permits entities to measure eligible assets and liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS 159 is effective for fiscal years beginning after November 15, 2007. The Company adopted SFAS 159 on January 1, 2008 and did not elect the fair value option which did not have a material impact on its financial position and results of operations.
In December 2007, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 141R, Business Combinations , and Statement of Financial Accounting Standards No. 160, Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 .. These new standards significantly change the accounting for and reporting of business combination transactions and noncontrolling interests (previously referred to as minority interests) in consolidated financial statements. Both standards are effective for fiscal years beginning on or after December 15, 2008, with early adoption prohibited. These Statements are effective for the Company beginning on January 1, 2009. The Company is currently evaluating the provisions of FAS 141(R) and FAS 160.
In March 2008, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 161, Disclosures About Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 . This new standard enhances the disclosure requirements related to derivative instruments and hedging activities required by FASB Statement No. 133 .. This standard is effective for fiscal years and interim periods beginning after November 15, 2008, with early adoption encouraged. The Company adopted the required provisions of SFAS 161 on January 1, 2008 and the adoption did not have a significant impact on its financial position and results of operations.
60
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES (cont’d)
In June 2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock. EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions. Instruments not indexed to their own stock fail to meet the scope exception of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities, paragraph 11(a), and should be classified as a liability and marked-to-market. The statement is effective for fiscal years beginning after December 15, 2008 and is to be applied to outstanding instruments upon adoption with the cumulative effect of the change in accounting principle recognized as an adjustment to the opening balance of retained earnings. The Company has assessed its outstanding equity-linked financial instruments and has concluded that effective January 1, 2009, warrants issued during 2008 with a fair value of $734,617 on December 31, 2008 will need to be reclassified from equity to a liability. The cumulative effect of the change in accounting principle on January 1, 2009 will be a $290,455 increase to the deficit accumulated during development stage.
NOTE 2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY
We are authorized to issue 80,000,000 shares of common stock with a par value of $.0001 per share and 10,000,000 shares of preferred stock with a par value of $.0001 per share.
Our Chief Executive Officer has provided his services without compensation from inception through November 2007. We have recorded compensation expense for these contributed services, with the corresponding credit to additional paid-in capital. For the year ended December 31, 2007, we have recorded compensation expense of $220,000. Our Chief Operating Officer provided his services without compensation for the second quarter of 2008. We have recorded compensation expense for these contributed services in the amount of $50,000, with the corresponding credit to additional paid-in capital. For the period from November 21, 2003 to December 31, 2008, compensation expense for contributed services aggregated $774,000.
On January 1, 2008, we granted a total of 1,000,000 common stock warrants to consultants for financial services. The warrants have an exercise price of $0.50 per share. The warrants vested upon grant. We have recorded an expense of $89,680 during 2008 related to the fair value of the warrants that vested during that period, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 3.2%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the warrants of .25 years. The warrants were exercised during March and we received proceeds of $500,000.
On January 7, 2008, we granted 100,000 shares of common stock, valued at $50,000, to a director as payment for services. The shares were vested upon grant.
On February 1, 2008, we granted a total of 240,000 common stock options to members of our Scientific Advisory Board. The options have an exercise price of $0.50 per share. The options vest in equal installments quarterly over a period of three years commencing March 31, 2008, and lapse if unexercised on January 31, 2018. We have recorded an expense of $35,643 during 2008 related to the fair value of the options that vested during that period, using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 2.2%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 111%; and (4) an expected life of the options of 2 years.
On February 11, 2008, we granted a total of 100,000 common stock options to a consultant for investor relation services. The options have an exercise price of $0.50 per share and expire if unexercised on February 11, 2013. The options vest 20,000 upon grant and 80,000 upon the attainment of certain financial milestones. Any options not vesting by June 30, 2008 terminate on that date. Of the 80,000 options subject to the attainment of financial milestones, 64,000 vested on June 30, 2008 and the balance were terminated. We have recorded an expense of $21,906 during 2008 related to the fair value of the options that vested during that period, using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 2.7%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 97%; and (4) an expected life of the options of 2 years.
On February 11, 2008, we granted a total of 20,000 common stock options to a consultant for professional services. The options have an exercise price of $0.50 per share. The options vest in equal installments quarterly over a period of one year commencing March 31, 2008, and lapse if unexercised on February 11, 2018. We have recorded an expense of $8,910 during 2008 related to the fair value of the options that vested during that period, using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 2.2%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 111%; and (4) an expected life of the options of 2 years.
61
NOTE 2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY (cont’d)
On March 6, 2008, we granted a total of 1,000,000 common stock warrants to consultants for financial services. The warrants have an exercise price of $1.00 per share. The warrants vested upon grant and expire if unexercised on March 6, 2011. We have recorded an expense of $76,338 during 2008 related to the fair value of the warrants that vested during that period, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 2%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the warrants of 1 year.
During March 2008, we granted to each of three new members of our board of directors, as compensation for serving on our board of directors, options to purchase 100,000 common shares at $0.50 per share, reflecting the fair market value of the shares as of that date. The options vest 50,000 each upon grant with the balance vesting quarterly over a period of two years commencing March 31, 2008, and lapse if unexercised on April 1, 2018. The 300,000 options have been valued at $72,208 at the date of grant using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 2%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 100%; and (4) an expected life of the options of 2 years. We have recorded an expense of $52,652 during 2008 based on the options that vested during that period. On September 30, 2008 one of the directors resigned from the board, but will continue to perform services as a consultant. His remaining options, totaling 31,250 options, will be valued and recorded as compensation as they vest. During the fourth quarter of 2008, 6,250 options vested. We have recorded an expense of $4,203 related to the fair value of these options, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.9%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 144%; and (4) an expected life of the options of 2 years.
On March 7, 2008, we issued 31,718 shares of common stock to our president and chief executive officer as payment of accrued interest in the amount of $15,859. Of this amount, $14,800 had been accrued at December 31, 2007.
During July and August of 2008, we sold an aggregate of 2,320,000 units resulting in gross proceeds of $2,320,000 or $1.00 per unit. Net cash received was $2,278,000. Each unit consists of 1 share of common stock and ½ common stock purchase warrant. The warrants have a term of 5 years and an exercise price of $2.00 per share subject to certain anti-dilution adjustments. The fair value of the warrants has been recorded as permanent equity since the warrants are exercisable into unregistered shares of our common stock and do not contain any net cash settlement provisions. The warrants are also callable by the Company in the event the Company’s shares are publically traded in the future and certain price and volume conditions are met.
TR Winston & Company, LLC (“TR Winston”) acted as the Company’s placement agent with respect to the transaction. Pursuant to a placement agent agreement with TR Winston we agreed to the following compensation: (i) cash fee equal to 8% of gross proceeds raised, including any payments made to the Company upon the exercise of the warrants; (ii) the issuance of a warrant to purchase 8% of all securities issued; and (iii) payment of legal expenses totaling $20,000. As an accommodation to the Company, TR Winston agreed to receive a convertible debenture and warrants to purchase an additional 81,800 common shares in lieu of $163,600 of its cash fee.
On October 16, 2008, we granted a total of 50,000 common stock warrants to a consultant for marketing services. The warrants have an exercise price of $2.00 per share and expire if unexercised on October 16, 2013. The warrants vested upon grant. We have recorded an expense of $17,238 during 2008 related to the fair value of the options, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 2.9%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 111%; and (4) an expected life of the options of 2 years.
On October 16, 2008, we granted a total of 15,000 common stock options to a director as compensation for serving on a special committee. The options have an exercise price of $1.00 per share and expire if unexercised on October 16, 2018. The options vested upon grant. We have recorded an expense of $7,173 during 2008 related to the fair value of the options, using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 2.9%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 111%; and (4) an expected life of the options of 2 years.
On June 7, 2004, we granted a total of 750,000 common stock options to members of our Scientific Advisory Board. The options vested over a four year period on December 31 of each year. On May 15, 2007 our board approved a resolution to accelerate the vesting of the remaining 187,500 unvested options. At that time, all of the options were exercised and we received proceeds of $1,200. We have recorded compensation expense of $24,082 for the nine months ended September 30, 2007 related to the fair value of the options that vested during that period, using the Black-Scholes method based on the following assumption ranges: (1) risk free interest rate of 3% - 4.9%; (2) dividend yield of 0%; (3) estimated volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the options of .5 - 3 years.
62
NOTE 2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY (cont’d)
On November 10, 2006, we granted a total of 150,000 common stock options to employees and advisors. The options vested upon grant. All of these options were exercised during 2007 and we received proceeds of $1,500.
During 2007, we issued an aggregate of 735,000 shares of common stock, valued at $367,500, as compensation for consulting and financial and legal advisory services.
During November 2007, we sold an aggregate of 1,300,000 common shares in a private placement at $0.50 per share, for proceeds of $650,000.
NOTE 3 -CONVERTIBLE NOTES PAYABLE
We have executed five convertible notes with our president and chief executive officer pursuant to which we have borrowed an aggregate of $155,000. The notes bear an interest rate of 4.2% and mature at various dates through December 6, 2011. Interest accrued through February 29, 2008 was $15,859. On March 7, 2008 we issued 31,718 shares of common stock as payment of this amount. Accrued interest at December 31, 2008 was $5,399. The notes and accrued interest are convertible, at the option of the holder, into shares of our common stock at a conversion price of $0.50 per share.
As an accommodation to the Company, TR Winston & Company, LLC, our placement agent, agreed to receive a convertible debenture in the principal amount of $163,600 plus warrants to purchase an additional 81,800 common shares in lieu of $163,600 of its cash fee. The convertible debenture accrues interest at 5% per annum and has a maturity date of July 14, 2010 (extended from July 14, 2009 – see Note 7, Subsequent Events). It is convertible into the shares of the Company’s common stock, at the sole discretion of the holder, at $1.00 per share subject to certain anti-dilution adjustments.
In accordance with Emerging Issues Task Force (“EITF”) No.00-27, “ Application of EITF Issue No. 98-5, ‘Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Rates’, to Certain Convertible Instruments ”, a portion of the proceeds were allocated to the warrants based on their relative fair value, which totaled $20,675 using the Black Scholes option pricing model. This amount has been recorded as a debt discount and will be amortized over the term of the debenture. We determined that there was no beneficial conversion feature attributable to the convertible debenture since the effective conversion price was greater than the value of our common shares on the date of issuance. The assumptions used in the Black Scholes model are as follows: (1) dividend yield of 0%; (2) expected volatility of 100%, (3) risk-free interest rate of 2.9%, and (4) expected life of 2 year.
Principal amounts of the notes mature as follows:
| Years ended December 31, | ||||
| 2009 | $ | 50,000 | ||
| 2010 | 198,600 | |||
| 2011 | 70,000 | |||
| $ | 318,600 | |||
NOTE 4 – INTELLECTUAL PROPERTY
We have acquired know-how, pre-clinical data, development data and related patent portfolios for a series of technologies that relate to targeted, potentially curative treatments for a variety of human cancers. We currently own 5 issued patents and 3 patent applications pending worldwide. The previous owner of the intellectual property, John Hopkins University, agreed to assign the patents underlying the technology to our co-founders (the “Assignee Co-Founders”) in return for their assumption of future patent fees and costs, and patent attorney fees and costs, associated with all of the assigned technology. In exchange for us continuing to pay for these future costs, the Assignee Co-Founders entered into world-wide, exclusive option agreements with us. In April 2008, upon the reimbursement of approximately $122,778 in previously-paid patent costs, fees and expenses to John Hopkins University, the Assignee Co-Founders assigned to GenSpera all right, title, and interest in and to the intellectual property, and GenSpera subsequently recorded these assignments in the United States Patent & Trademark Office. By virtue of the April 2008 assignments, GenSpera has no further financial obligations to the Assignee Co-Founders or to John Hopkins University with regard to the assigned intellectual property. These reimbursement costs were required to be paid by the Assignee Co-Founders to Johns Hopkins University. As part of our agreements with the Assignee Co-Founders, we have provided these reimbursement costs directly to the Assignee Co-Founders specifically for reimbursement to Johns Hopkins University. Because these payments have been made by us to the
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NOTE 4 – INTELLECTUAL PROPERTY (cont’d)
Assignee Co-Founders, this may trigger a taxable event such that the Assignee Co-Founders may be required to pay Federal and state taxes (if any) based upon our payment of the reimbursement costs to the Assignee Co-Founders. Therefore, as part of our agreements with the Assignee Co-Founders, we have further provided additional funds to cover applicable Federal and state taxes (if any) associated with the reimbursement payments. Under our agreement with the Assignee Co-Founders, we will not be required to make any other future payments, including fees, milestone or royalty fees, to either Johns Hopkins University or the Assignee Co-Founders.
On March 10, 2008, we paid an aggregate of $184,167 to acquire the 5 issued patents and 3 patent applications pending worldwide described above. Amortization expense recorded during the period ended December 31, 2008 was $11,511.
Amortization expense for each on the next five fiscal years is estimated to be $15,348 per year.
NOTE 5- STOCK OPTIONS AND WARRANTS
We have one equity incentive plan, our 2007 Equity Compensation Plan (“2007 Plan”). Our 2007 Plan is administered by a committee of non-employee directors who are appointed by our board of directors (“Committee”). The purpose of our 2007 Plan is to advance the interests of GenSpera and our stockholders by attracting, retaining and rewarding persons performing services for us and to motivate such persons to contribute to our growth and profitability.
Under our 2007 Plan, we may grant stock options and restricted stock to employees, directors and consultants. Our 2007 Plan authorizes the issuance of up to 1,500,000 shares of our common stock for the foregoing awards. The exercise price of Nonqualified Stock Options shall not be less than 85% of the fair market value per share on the date of grant. The exercise price per share for Incentive Stock Option grants must be no less than 100% of the fair market value per share on the date of grant. The exercise price per share for an incentive stock option grant to an employee who, at the time of grant, owns stock representing more than 10% of the voting power of all classes of stock of GenSpera or any parent or subsidiary, must be no less than 110% of the fair market value per share on the date of grant.
Generally, the option exercise price may be paid in cash, by check, by cashless exercise, by net exercise or by tender or attestation of ownership of shares having a fair market value not less than the exercise price and that either (A) have been owned by the optionee for more than six months and not used for another exercise by tender or attestation, or (B) were not acquired, directly or indirectly, from us.
At the time an award is granted, the Committee must fix the period within which the award may be exercised and determine any conditions that must be satisfied before the award may be exercised. Notwithstanding, options shall vest over a period of not more than five years and at a rate of not less than 20% per year. The Committee may accelerate the exercisability of any or all outstanding options at any time for any reason. The maximum term of an option granted under our 2007 Plan is ten years.
Our 2007 Plan provides that in the event of our merger with or into another corporation, the sale of substantially all of our assets, or the sale or exchange of more than 50% of our voting stock, each outstanding award shall be assumed or an equivalent award substituted by the surviving, continuing, successor or purchasing corporation or a parent thereof. The Committee may also deem an award assumed if the award confers the right to the award-holder to receive, for each share of stock subject to an award immediately prior to the change in control, the consideration that a stockholder is entitled on the effective date of the change in control. Upon a change in control, all outstanding options shall automatically accelerate and become fully exercisable and all restrictions and conditions on all outstanding restricted stock grants shall immediately lapse.
The Committee may at any time amend, suspend or terminate our 2007 Plan. Notwithstanding the forgoing, the Committee shall not amend the Plan without shareholder approval if such approval is required by section 422 of the Internal Revenue Code or section 162(m) therein.
Transactions involving our stock options are summarized as follows:
| 2008 | 2007 | |||||||||||||||
| Number | Weighted Average Exercise Price | Number | Weighted Average Exercise Price | |||||||||||||
| Outstanding at beginning of the period | — | $ | — | 900,000 | $ | 0.003 | ||||||||||
| Granted during the period | 675,000 | 0.51 | — | — | ||||||||||||
| Exercised during the period | — | — | (900,000 | ) | 0.003 | |||||||||||
| Terminated during the period | (16,000 | ) | 0.50 | — | — | |||||||||||
| Outstanding at end of the period | 659,000 | $ | 0.51 | — | $ | — | ||||||||||
| Exercisable at end of the period | 424,000 | $ | 0.52 | — | $ | — | ||||||||||
The intrinsic value of options exercised during 2007 was approximately $114,000.
At December 31, 2008 employee options outstanding totaled 215,000 with a weighted average exercise price of $0.53. These options had an intrinsic value of $74,000 and a remaining contractual term of 9.3 years. Of these options, 165,000 are exercisable at December 31, 2008, with an intrinsic value of $55,500 and a remaining weighted average contractual term of 9.3 years. Compensation cost related to the unvested employee options not yet recognized is $12,036 at December 31, 2008. This amount will be recognized during 2009.
The weighted average remaining life of the options is 8.6 years.
Transactions involving our stock warrants are summarized as follows:
| 2008 | 2007 | |||||||||||||||
| Number | Weighted Average Exercise Price | Number | Weighted Average Exercise Price | |||||||||||||
| Outstanding at beginning of the period | — | $ | — | — | $ | — | ||||||||||
| Granted during the period | 3,570,200 | 1.30 | — | — | ||||||||||||
| Exercised during the period | (1,000,000 | ) | 0.50 | — | — | |||||||||||
| Terminated during the period | — | — | — | — | ||||||||||||
| Outstanding at end of the period | 2,570,200 | $ | 1.61 | — | $ | — | ||||||||||
| Exercisable at end of the period | 2,570,200 | $ | 1.61 | — | $ | — | ||||||||||
The weighted average remaining life of the warrants is 3.6 years.
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NOTE 6 - INCOME TAXES
During the year ended December 31, 2007, we adopted Financial Accounting Standards Board (FASB) Interpretation No. 48, "Accounting for Uncertainty in Income Taxes" (FIN 48), which supplements SFAS No. 109, "Accounting for Income Taxes," by defining the confidence level that a tax position must meet in order to be recognized in the financial statements. The Interpretation requires that the tax effects of a position be recognized only if it is "more-likely-than-not" to be sustained based solely on its technical merits as of the reporting date. The more-likely-than-not threshold represents a positive assertion by management that a company is entitled to the economic benefits of a tax position. If a tax position is not considered more-likely- than-not to be sustained based solely on its technical merits no benefits of the tax position are to be recognized. Moreover, the more-likely-than-not threshold must continue to be met in each reporting period to support continued recognition of a benefit. With the adoption of FIN 48, companies are required to adjust their financial statements to reflect only those tax positions that are more-likely-than-not to be sustained. Any necessary adjustment would be recorded directly to retained earnings and reported as a change in accounting principle.
SFAS No. 109 requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statement or tax returns. Under this method, deferred tax liabilities and assets are determined based on the difference between financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Temporary differences between taxable income reported for financial reporting purposes and income tax purposes are insignificant.
Net operating losses for tax purposes of approximately $3,171,000 at December 31, 2008 are available for carryover. The net operating losses will expire from 2013 through 2028. We have provided a 100% valuation allowance for the deferred tax benefits resulting from the net operating loss carryover and our tax credits due to our limited operating history. In addressing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences are deductible. The valuation allowance increased by $1,089,000 and $31,000 during the years ended December 31, 2008 and 2007, respectively. A reconciliation of the statutory Federal income tax rate and the effective income tax rate for the years ended December 31, 2008 and 2007 follows.
Significant components of deferred tax assets and liabilities are as follows:
| 2008 | 2007 | |||||||
| Deferred tax assets: | ||||||||
| Net operating loss carryforward | 1,078,000 | 94,000 | ||||||
| Tax credits | 105,000 | — | ||||||
| Valuation allowance | (1,183,000 | ) | (94,000 | ) | ||||
| Net deferred tax assets | $ | - | $ | - | ||||
| Statutory federal income tax rate | -34 | % | -34 | % | ||||
| State income taxes, net of federal taxes | -0 | % | -7 | % | ||||
| Non-deductible items | 4 | % | 30 | % | ||||
| Tax credits | 3 | % | — | |||||
| Valuation allowance | 27 | % | 11 | % | ||||
| Effective income tax rate | 0 | % | 0 | % | ||||
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NOTE 7 – SUBSEQUENT EVENTS
On February 17, 2009, we entered into a modification with Dr. Dionne with regard to our 4% Convertible Promissory Note issued to Dionne in the amount of $35,000 (“Note”). Pursuant to the modification, Dr. Dionne agreed to extend the maturity date of the Note from December 2, 2008 to December 2, 2009. As consideration for the modification, the Company issued Dr. Dionne a common stock purchase warrant entitling him to purchase 11,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions.
On February 17, 2009, we entered into a modification with TR Winston & Company, LLC (“TRW”) with regard to the Company’s 5% Convertible Debenture issued to TRW in the amount of $163,600. Pursuant to the modification, TRW agreed to extend the maturity date of the debenture from July 14, 2009 to July 14, 2010. As consideration for the modification, the we issued TRW a common stock purchase warrant entitling TRW to purchase 50,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions.
On February 19, 2009, we entered into a Securities Purchase Agreement with a number of accredited investors. Pursuant to the terms of the Securities Purchase Agreement, we sold the investors units aggregating approximately $700,000 “Offering”. The price per unit was $1.50. Each unit consists of: (i) one share of the Company’s common stock; and (ii) one half Common Stock Purchase Warrant. 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.
As a result of offering, the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered. These anti-dilution provisions resulted in the exercise price of these warrants being reduced from $2.00 from $1.50. Additionally, we are obligated to issue holders of these warrants an additional 506,754 warrants, and we are obligated to file a registration statement for the common stock underlying such warrants pursuant to the registration rights agreement entered into in connection with the July and August 2008 financing.
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4,516,120 Shares of Common Stock
Prospectus
July [___], 2009
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth the estimated costs and expenses in connection with the sale and distribution of the securities being registered, other than underwriting discounts and commissions. All expenses incurred will be paid by the Company. All of the amounts shown are estimates except the Securities and Exchange Commission, or SEC, registration fees.
To be Paid by the Registrant | ||||
| SEC registration fees | $ | 316 | ||
| Legal fees and expenses | $ | 30,000 | ||
| Accounting fees and expenses | $ | 10,000 | ||
| Printing and engraving expenses | $ | 5,000 | ||
| Transfer agent’s fees | $ | 2,000 | ||
| Miscellaneous fees and expenses | $ | 5,000 | ||
| Total | $ | 52,316 | ||
Item 14. Indemnification of Directors and Officers.
Section 102 of the Delaware General Corporation Law, as amended, or DGCL, allows a corporation to eliminate the personal liability of directors to a corporation or its stockholders for monetary damages for a breach of a fiduciary duty as a director, except where the director breached his duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase or redemption in violation of Delaware corporate law or obtained an improper personal benefit.
Section 145 of the DGCL provides, among other things, that a corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the corporation’s request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses, including attorneys’ fees, judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with the action, suit or proceeding. The power to indemnify applies if (i) such person is successful on the merits or otherwise in defense of any action, suit or proceeding or (ii) such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, and with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. The power to indemnify applies to actions brought by or in the right of the corporation as well, but only to the extent of defense expenses (including attorneys’ fees but excluding amounts paid in settlement) actually and reasonably incurred and not to any satisfaction of judgment or settlement of the claim itself, and with the further limitation that in such actions no indemnification shall be made in the event of any adjudication of negligence or misconduct in the performance of his duties to the corporation, unless a court believes that in light of all the circumstances indemnification should apply.
Section 174 of the DGCL provides, among other things, that a director who willfully and negligently approves of an unlawful payment of dividends or an unlawful stock purchase or redemption may be held liable for such actions. A director who was either absent when the unlawful actions were approved or dissented at the time, may avoid liability by causing his or her dissent to such actions to be entered in the books containing the minutes of the meetings of the board of directors at the time the action occurred or immediately after the absent director receives notice of the unlawful acts.
Our certificate of incorporation states that, to the fullest extent permitted by the DGCL, no director shall be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as director.
Our bylaws provide that we shall, to the fullest extent authorized by the DGCL, indemnify any person who was or is made a party or threatened to be made a party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she or a person of whom he or she is the legal representative, is or was our director or officer or is or was serving at our request as a director or officer of another corporation, or as a controlling person of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, whether the basis of such proceeding is alleged action in an official capacity as a director or officer, or in any other capacity while serving as a director or officer, against all expenses, liability or loss reasonably incurred or suffered by such person in connection with such action, suit or proceeding. Our bylaws also provide that we may enter into one or more agreements with any director, officer, employee or agent of ours, or any person serving at our request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, including employee benefit plans, that provides for indemnification rights equivalent to or, if our board of directors so determines, greater than, those provided for in such bylaws.
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We maintain a liability insurance policy for our directors and officers, subject to certain exclusions.
Item 15. Recent Sales of Unregistered Securities.
The following information is given with regard to unregistered securities sold during the preceding three years including the dates and amounts of securities sold, the persons or class of persons to whom we sold the securities, the consideration received in connection with such sales and, if the securities were issued or sold other than for cash, the description of the transaction and the type and amount of consideration received. The descriptions contained below are a summary and qualified by the agreements, if applicable, included as Exhibits to this Registration Statement. The following securities were issued in private offerings pursuant to the exemption from registration contained in Section 4(2) of the Securities Act and the rules promulgated thereunder:
| · | On June 7, 2004, we granted a total of 750,000 common stock options to members of our Scientific Advisory Board. The options vested over a four year period on December 31 of each year and have an exercise price of $0.0016. |
| · | On September 29, 2004, we issued one of our shareholders a convertible note in the amount of $15,000. The consideration paid by the shareholder was cash. The note accrues interest at 4.2% per annum and is convertible into common shares at $0.50 per share. The note is due and payable on September 28, 2009. |
| · | On December 23, 2005, we issued one of our shareholders a convertible note in the amount of $35,000. The consideration paid by the shareholder was cash. The note accrues interest at 4.2% per annum and is convertible into common shares at $0.50 per share. The note is due and payable on December 22, 2010. |
| · | On May 19, 2006, we issued one of our shareholders a convertible note in the amount of $40,000. The consideration paid by the shareholder was cash. The note accrues interest at 4.2% per annum and is convertible into common shares at $0.50 per share. The note is due and payable on May 18, 2011. |
| · | On November 10, 2006, we granted a total of 150,000 common stock options to employees and advisors. The options vested upon grant, have a term of 10 years and an exercise price of $0.01. All of these options were exercised during 2007. |
| · | On December 6, 2006, we issued one of our shareholders a convertible note in the amount of $30,000. The consideration paid by the shareholder was cash. The note accrues interest at 4.2% per annum and is convertible into common shares at $0.50 per share. The note is due and payable on December 6, 2011. |
| · | In March and June of 2007 we issued a total of 900,000 common shares to employees and advisors in connection with the exercise of the options granted on June 7, 2004 and November 10, 2006. |
| · | During 2007, we issued an aggregate of 735,000 shares of common stock, valued at $367,500, as compensation for consulting and financial and legal advisory services. The compensation cost was based on the fair value of our common stock as determined by the Company’s board of directors. |
| · | During November 2007, we sold an aggregate of 1,300,000 common shares in a private placement to accredited investors at $0.50 per share, for gross proceeds of $650,000. |
| · | On January 1, 2008, we granted a total of 1,000,000 common stock warrants to consultants for financial services. Of this total, 500,000 stock warrants were granted to JD Group, LLC and an additional 500,000 common stock warrants were granted to G. Tyler Runnels or Jasmine Niklas Runnels TTEES The Runnel Family Trust dtd 1-11-20. The warrants have an exercise price of $0.50 per share. The warrants vested upon grant. |
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| · | On January 7, 2008, we granted 100,000 shares of common stock, valued at $50,000, to a former director, Richard P. Burgoon, Jr., as compensation for serving on the board. The shares were vested upon grant. |
| · | On February 1, 2008, we granted a total of 240,000 common stock options to members of our Scientific Advisory Board. Of this total, 60,000 options were granted to each of the following individuals: Dr. John T. Isaacs, Dr. Samuel R. Denmeade, Dr. Soren Brogger Christensen and Dr. Hans Lilja. The options have an exercise price of $0.50 per share. The options vest in equal installments quarterly over a period of three years commencing March 31, 2008, and lapse if unexercised on January 31, 2018. |
| · | On February 11, 2008, we granted a total of 100,000 common stock options to the Verrazano Group, LLC, a consultant, for investor relation services. The options have an exercise price of $0.50 per share and expire if unexercised on February 11, 2013. Subsequent to the issuance, options to purchase 16,000 shares lapsed. |
| · | On February 11, 2008, we granted a total of 20,000 common stock options to a consultant, Robert C. Scherne, CPA, PC for professional services. The options have an exercise price of $0.50 per share. The options vest in equal installments quarterly over a period of one year commencing March 31, 2008, and lapse if unexercised on February 11, 2018. |
| · | On March 6, 2008, we granted a total of 1,000,000 common stock warrants to consultants for financial services. Of this total, 500,000 stock warrants were granted to Pangaea Partners, LLC and an additional 500,000 common stock warrants were granted to High Tide, LLC. The warrants have an exercise price of $1.00 per share. |
| · | On March 7, 2008, we issued 1,000,000 common shares upon the exercise of 1,000,000 common stock warrants at $.50 per share. Five hundred thousand warrants were each exercised by JD Group, LLC and G. Tyler Runnels or Jasmine Niklas Runnels TTEES The Runnel Family Trust dtd 1-11-20. We received gross proceeds of $500,000. |
| · | During March 2008, we granted to our board of directors, as compensation for serving on our board of directors, options to purchase an aggregate of 300,000 common shares at $0.50 per share, reflecting the fair market value of the shares as of that date. Each Director (Scott Ogilvie, Richard P. Burgoon, Jr. and John M. Farah, Jr., Ph.D.) received 50,000 options that vested upon grant with the remaining 50,000 options vesting quarterly over a period of two years commencing March 31, 2008, and lapse if unexercised on April 1, 2018. |
| · | On March 7, 2008, we issued 31,718 shares of common stock to our Chief Executive Officer and President, Craig A. Dionne, Ph.D., as payment of accrued interest in the amount of $15,859. |
| · | During July and August of 2008, we sold an aggregate of 2,320,000 units resulting in gross proceeds of $2,320,000 or $1.00 per unit. Each unit consists of: (i) 1 share of common stock; and (ii) ½ common stock purchase warrant. The warrants have a term of 5 years and an exercise price of $2.00 per shares subject to certain anti-dilution adjustments. The warrants are also callable by the Company in the event the Company’s shares are publically traded in the future and certain price and volume conditions are met. |
TR Winston & Company, LLC acted as the Company’s placement agent with respect to the transaction. Pursuant to a placement agent agreement with TR Winston & Company, LLC we agreed to the following compensation: (i) cash fee equal to 8% of gross proceeds raised, including any payments made to the Company upon the exercise of the warrants; (ii) the issuance of a warrant to purchase 8% of all securities issued; and (iii) payment of legal expenses totaling $20,000. Accordingly, we issued to TR Winston & Company, LLC a warrant to purchase 278,400 common shares of which they assigned 22,500 to Mercer Capital for assisting in the transaction. The warrant has an exercise price per common shares of $2.00 and a term of 5 years.
Also, as an accommodation to the Company, TR Winston & Company, LLC agreed to receive a convertible debenture and warrants to purchase an additional 81,800 common shares in lieu of $163,600 of its cash fee. The warrant is in addition to any warrants received as compensation for acting as placement agent. The convertible debenture accrues interest at 5% per annum and has a maturity date of July 14, 2009. It is convertible into the shares of the Company’s common stock, at the sole discretion of the holder, at $1.00 per share subject to certain anti-dilution adjustments. The warrant has the same terms as those issued to investors in the offering.
| · | In October of 2008, we granted warrants to purchase an aggregate of 50,000 common shares to Crystal Research Associates, LLC for marketing services. The warrants have an exercise price of $2.00 per share. |
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| · | In October of 2008, we granted options to purchase an aggregate of 15,000 common shares to our director Scott Ogilvie at an exercise price of $1.00 per share. The options vested on the date of grant and lapse if unexercised on October 16, 2018. |
| · | On February 17, 2009, we entered into a modification with TRW with regard to our 5% Convertible Debenture issued to TRW in the amount of $163,600. Pursuant to the modification, TRW agreed to extend the maturity date of the debenture from July 14, 2009 to July 14, 2010. As consideration for the modification, we issued TRW a common stock purchase warrant entitling TRW to purchase 50,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term and contains certain anti-dilution provisions requiring us to adjust the exercise price and number of shares upon the occurrence of a stock split, stock dividends or stock consolidation. |
| · | On February 17, 2009, we entered into a modification with Craig Dionne, our Chief Executive Officer and Chairman with regard to our 4% Convertible Promissory Note issued to Mr. Dionne in the amount of $35,000. Pursuant to the modification, Mr. Dionne agreed to extend the maturity date of the Note from December 2, 2008 to December 2, 2009. Mr. Dionne had previously deferred repayment of the note. As consideration for the modification, we issued Mr. Dionne a common stock purchase warrant entitling Mr. Dionne to purchase 11,000 shares of our common stock at a per share purchase price of $1.50. The warrant has a five year term and contains certain anti-dilution provisions requiring us to adjust the exercise price and number of shares upon the occurrence of a stock split, stock dividends or stock consolidation. |
| · | On February 19, 2009, we entered into a securities purchase agreement with a number of accredited investors. Pursuant to the terms of the securities purchase agreement, we sold the investors 500,000 units in the aggregate amount of approximately $750,000. The price per unit was $1.50. Each unit consists of: (i) one share of common stock; and (ii) one-half common stock purchase warrant. 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 provisions do not provide for any adjustment in the event of subsequent equity sales or transactions. The warrants are also callable by the Company in the event the Company’s shares are publically traded in the future and certain price and volume conditions are met. |
As a result of offering, the anti-dilution provisions in our warrants issued during the July and August 2008 financing were triggered. These anti-dilution provisions resulted in the exercise price of these warrants being reduced from $2.00 to $1.50. Additionally, we issued holders of these warrants an additional 506,754 additional warrants. We are obligated to file a registration statement for the common stock underlying such warrants pursuant to the registration rights agreement entered into in connection with the July and August 2008 financing.
We also entered into registration rights agreements with the investors granting certain registration rights with regard to the shares and the shares underlying the warrants. The registration rights Agreement provides for penalties to be paid in restricted shares in the event the Company: (i) fails to file a registration statement or have such registration statement declared effective within a certain period of time; or (ii) fails to maintain the registration statement effective until all the securities registered therein are sold or are eligible for resale pursuant to Rule 144 without manner of sale or volume restrictions. Subsequent to the issuance, a majority of the investors agreed to waive the date by which the registration statement needed to be filed. As a result of the waiver, a registration statement covering the shares and shares underlying the warrants must be filed on or before July 31, 2009.
| · | On May 8, 2009, we issued 61,875 common shares to Lyophilization Services of New England, Inc. as payment for services valued at $92,812.50 provided in connection with manufacturing of our first drug compound. The shares were valued at $1.50 per share. |
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| · | In June and July of 2009 we entered into a series of securities purchase agreements with a number of accredited and institutional investors. Pursuant to the terms of the agreements, we offered and sold an aggregate of 2,025,344 units resulting in gross proceeds to us of approximately $3,038,000. The price per unit was $1.50. Each unit consists of: (i) one share of common stock; and (ii) one half common stock purchase warrant. The warrants have a term of five years and entitle the investors to purchase our common shares at a price per share of $3.00. 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 stock dividends and fundamental transactions. The provisions do not provide for any adjustment in the event of subsequent equity sales or transactions. The warrants are also callable in the event our common stock becomes publically traded and certain other conditions, as described in the warrants, are met. The Company incurred a total of $220,050 in fees and expenses incurred in connection with the transaction. Of this amount, $50,000 was paid through the issuance of 33,334 units. We also issued a total of 83,895 additional common stock purchase warrants as compensation to certain finders. The warrants have the same terms as the investor warrants. The securities purchase agreements are substantially similar other than the agreement entered into on June 29, 2009 extended the expiration of most favored nation treatment from 90 days until December 31, 2009. |
The Company also entered in two registration rights Agreements with the investors granting the Investors certain registration rights with regard to the Shares and the shares underlying the Warrants. The Registration Rights Agreement provides for penalties to be paid in restricted shares in the event the Company: (i) fails to file a registration statement or have such registration statement declared effective within a certain period of time; or (ii) fails to maintain the registration statement effective until all the securities registered therein are sold or are eligible for resale pursuant to Rule 144 without manner of sale or volume restrictions. Both Registration Rights Agreements are substantially similar other than the agreement entered into on June 29, 2009 requires the Company to: (i) file a registration statement covering the Shares and common stock underlying the Warrants by July 31, 2009 as compared to 120 days after closing; and (ii) requires the registration statement to be declared effective 150 days after filing as compared to 270 days after filing. Notwithstanding the forgoing, the Company anticipates filing a registration statement covering all the shares and common stock underlying the warrants issued in connection with the June 29 and June 30th closing by July 31, 2009.
| · | On July 10, 2009, we issued Kemmerer Resources Corp. a common stock purchase warrant to purchase 150,000 common shares as reimbursement of due diligence expenses. The warrants have a term of five years and entitle the investors to purchase our common shares at a price per share of $3.00. 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 stock dividends and fundamental transactions. The provisions do not provide for any adjustment in the event of subsequent equity sales or transactions. |
Item 16. Exhibits.
See Exhibit Index beginning on page 75 of this registration statement.
Item 17. Undertakings.
Insofar as indemnification by the Registrant for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the provisions referenced in Item 15 of this registration statement or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act, and is therefore unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer, or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered hereunder, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes:
| (1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
| (i) | To include any prospectus required by section 10(a)(3) of the Securities Act; |
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| (ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
| (iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
| (2) | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| (3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
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SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of San Antonio, State of Texas, on November 21, 2008.
| GENSPERA, INC. | ||
| By: | ||
/S/ Craig Dionne, PhD | ||
| Craig Dionne, PhD | ||
| Chief Executive Officer | ||
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Craig Dionne and Russell Richerson, and each of them acting alone, with full power of substitution and resubstitution and full power to act without the other, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution for him and in his name, place and stead, in any and all capacities, to sign any and all amendments to this Registration Statement, and all documents in connection therewith (including all post-effective amendments and any subsequent registration statement filed pursuant to Rule 462(b) under the Securities Act), with the SEC, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
| Signature | Title | Date | ||
| /S/ CRAIG DIONNE | Chief Executive Officer, President and Director | July 31, 2009 | ||
| Craig Dionne | (Principal Executive Officer) | |||
| /S/ CRAIG DIONNE | Chief Financial Officer | July 31, 2009 | ||
| Craig Dionne | (Principal Financial and Accounting Officer) | |||
| /S/ JOHN M. FARAH, JR | Director | July 31, 2009 | ||
| John M. Farah, Jr. | ||||
| /S/ SCOTT OGILVIE | Director | July 31, 2009 | ||
| Scott Ogilvie |
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INDEX TO EXHIBITS
| Incorporated by Reference | ||||||||||||
Exhibit No. | Description | Filed Herewith | Form | Exhibit No. | File No. | Filing Date | ||||||
| 3.01 | Amended and Restated Certificate of Incorporation | S-1 | 3.01 | 333-153829 | 10/03/08 | |||||||
| 3.02 | Bylaws | S-1 | 3.02 | 333-153829 | 10/03/08 | |||||||
| 4.01 | Specimen of Common Stock certificate | S-1 | 4.01 | 333-153829 | 10/03/08 | |||||||
| 4.02** | Amended and Restated GenSpera 2007 Equity Compensation Plan adopted on April 20, 2009 | 8-K | 4.01 | 333-153829 | 4/24/09 | |||||||
| 4.03** | GenSpera 2007 Equity Compensation Plan form of Incentive Stock Option Grant | S-1 | 4.03 | 333-153829 | 10/03/08 | |||||||
| 4.04** | GenSpera 2007 Equity Compensation Plan form of Nonqualified Stock Option Grant | S-1 | 4.04 | 333-153829 | 10/03/08 | |||||||
| 4.05 | Form of 4.0% convertible note issued to shareholder | S-1 | 4.05 | 333-153829 | 10/03/08 | |||||||
| 4.06 | Form of Subscription Agreement for November 2007 offering | S-1 | 4.06 | 333-153829 | 10/03/08 | |||||||
| 4.07 | Form of Warrant dated March 6, 2008 issued to consultant for financial consulting services. | S-1 | 4.07 | 333-153829 | 10/03/08 | |||||||
| 4.08 | Form of Securities Purchase Agreement—July and August 2008 private placement | S-1 | 4.08 | 333-153829 | 10/03/08 | |||||||
| 4.09 | Form of Registration Rights Agreement – July and August 2008 private placement | S-1 | 4.09 | 333-153829 | 10/03/08 | |||||||
| 4.10 | Form of Warrant – July and August 2008 private placement | S-1 | 4.10 | 333-153829 | 10/03/08 | |||||||
| 4.11 | Form of insider Lock-Up Agreement – July and August 2008 private placement | S-1 | 4.11 | 333-153829 | 10/03/08 | |||||||
| 4.12 | Form of 5.0% convertible debenture issued to TR Winston & Company, LLC | S-1 | 4.12 | 333-153829 | 10/03/08 | |||||||
| 4.13 | Form of 5.0% convertible debenture modification between TR Winston & Company, LLC and GenSpera, Inc. | 8-K | 10.01 | 333-153829 | 2/20/09 | |||||||
| 4.14 | Form of 4.0% convertible debenture modification between GenSpera, Inc. and shareholder | 8-K | 10.02 | 333-153829 | 2/20/09 | |||||||
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| 4.15 | Form of Common Stock Purchase Warrant issued on 2/17/09 to TR Winston & Company, LLC | 8-K | 10.05 | 333-153829 | 2/20/09 | |||||||
| 4.15 | Form of Common Stock Purchase Warrant issued on 2/17/09 to Craig Dionne | 8-K | 10.06 | 333-153829 | 2/20/09 | |||||||
| 4.16 | Form of Securities Purchase Agreement dated 2/19/09 | 8-K | 10.01 | 333-153829 | 2/20/09 | |||||||
| 4.17 | Form of Common Stock Purchase Warrant dated 2/19/09 | 8-K | 10.02 | 333-153829 | 2/20/09 | |||||||
| 4.18 | Form of Registration Rights Agreement dated 2/19/09 | 8-K | 10.03 | 333-153829 | 2/20/09 | |||||||
| 4.19 | Form of Securities Purchase Agreement dated 6/29/09 | 8-K | 10.01 | 333-153829 | 7/06/09 | |||||||
| 4.20 | Form of Securities Purchase Agreement dated 6/30/09 | 8-K | 10.02 | 333-153829 | 7/06/09 | |||||||
| 4.21 | Form of Common Stock Purchase Warrant dated June of 2009 | 8-K | 10.03 | 333-153829 | 7/06/09 | |||||||
| 4.22 | Form of Registration Rights Agreement dated 6/29/09 | 8-K | 10.04 | 333-153829 | 7/06/09 | |||||||
| 4.20 | Form of Registration Rights Agreement dated 6/30/09 | 8-K | 10.05 | 333-153829 | 7/06/09 | |||||||
| 5.01 | Opinion of Silvestre Law Group, P.C. | * | ||||||||||
| 10.01 | Form of Transactional Fee Agreement between the Company and TR Winston & Company, LLC dated March 17, 2008 | S-1 | 10.01 | 333-153829 | 10/03/08 | |||||||
| 10.02 | Exclusive Supply Agreement between GenSpera and Thapsibiza dated January 22, 2008 | S-1 | 10.02 | 333-153829 | 10/03/08 | |||||||
| 10.03** | Terms of verbal employment agreement with Craig Dionne dated February 11, 2008 | S-1 | 10.03 | 333-153829 | 10/03/08 | |||||||
| 10.04** | Terms of verbal employment agreement with Russell Richerson dated July 1, 2008 | S-1 | 10.04 | 333-153829 | 10/03/08 | |||||||
| 23.01 | Consent of RBSM LLP | * |
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| 23.02 | Consent of Silvestre Law Group, P.C. (contained in opinion filed as Exhibit 5.01 to this registration statement) | * | ||||||||||
| 24.01 | Power of Attorney – Included on the signature page | * |
**Management contracts or compensation plans or arrangements in which directors or executive officers are eligible to participate.
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