RISK
FACTORS
An
investment in our securities involves a high degree of
risk. Prospective investors should carefully consider the risks and
uncertainties described below before deciding whether to invest in our
securities together with all of the other information contained or incorporated
by reference in this prospectus. You should also consider the risks,
uncertainties and assumptions discussed under Item 1A, “Risk Factors,” in
our Annual Report on Form 10-K for the fiscal year ended December 31, 2009
(as updated in our Quarterly Reports on Form 10-Q) which are incorporated herein
by reference, and may be amended, supplemented or superseded from time to time
by other reports we file with the SEC in the future and any prospectus
supplement related to a particular offering. The risks and uncertainties we have
described are not the only ones we face. The occurrence of any of the risks
described below could have a material adverse effect on our business, financial
condition and/or results of operations, and the trading price of our common
stock may decline and investors may lose all or part of their investment. We
cannot guarantee that we will successfully address these risks or other unknown
risks that may affect our business.
In
evaluating us, our business and any investment in our business, readers should
carefully consider the following factors.
Since
inception in 2003 and through September 30, 2010, we have raised approximately
$10,815,000 in capital. During this same period, we have recorded
accumulated losses totaling $12,766,728. As of September 30, 2010, we
had working capital of $3,768,257 and stockholders’ equity of $1,969,210. Our
net losses for the two most recent fiscal years ended December 31, 2008 and 2009
have been $3,326,261 and $5,132,827, respectively. Since inception, we have
generated no revenue. We intend to develop our drug compounds through
Phase I/II then 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. Even if
we succeed in developing one or more product candidates, we expect to incur
substantial losses for the foreseeable future and may never become
profitable.
We also
expect to experience negative cash flow for the foreseeable future as we fund
our operating losses and capital expenditures. As a result, we will need to
generate significant revenues in order to achieve and maintain profitability. We
may not be able to generate these revenues or achieve profitability in the
future. Our failure to achieve or maintain profitability could negatively impact
the value of our securities.
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 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, license, commercialize, market, sell and derive material
revenues from our proposed products in development.
We
currently have no product revenues and will need to raise additional capital to
operate our business.
To date,
we have generated no product revenues
.
Until, and unless, we
receive approval from the FDA and other regulatory authorities for our product
candidates, we cannot sell our drugs and will not have product revenues.
Currently, our only product candidates are G-202 and G-115 and none of these
products are approved for sale by the FDA. Therefore, for the foreseeable
future, we will have to fund all of our operations and capital expenditures from
cash on hand and, potentially future offerings. Currently, we believe we have
cash on hand to fund our operations until September 30,
2011. However, changes may occur that would consume our available
capital before that time, including changes in and progress of our development
activities, acquisitions of additional product candidates and changes in
regulation. Accordingly, we will need additional capital to fund our continuing
operations. Since we do not generate any revenue, the most likely sources of
such additional capital include private placements of our equity securities,
including our common stock, debt financing or funds from a potential strategic
licensing or collaboration transaction involving the rights to one or more of
our product candidates. To the extent that we raise additional capital by
issuing equity securities, our stockholders will likely experience dilution,
which may be significant depending on the number of shares we may issue and the
price per share. If we raise additional funds through collaborations and
licensing arrangements, it may be necessary to relinquish some rights to our
technologies, product candidates or products, or grant licenses on terms that
are not favorable to us. If we raise additional funds by incurring
debt, we could incur significant interest expense and become subject to
covenants in the related transaction documentation that could affect the manner
in which we conduct our business.
However,
we have no committed sources of additional capital and our access to capital
funding is always uncertain. This uncertainty is exacerbated due to the current
global economic turmoil, which has severely restricted access to the U.S. and
international capital markets, particularly for biopharmaceutical and
biotechnology companies. Accordingly, despite our ability to secure adequate
capital in the past, there is no assurance that additional equity or debt
financing will be available to us when needed, on acceptable terms or even at
all. If we fail to obtain the necessary additional capital when needed, we may
be forced to significantly curtail our planned research and development
activities, which will cause a delay in our drug development
programs.
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 come primarily from the sale of our
securities. We have expended and will continue to expend substantial
amounts of cash in the development, 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 and for general working
capital needs. We anticipate that we will require an additional $7 million in
addition to $2.25 million in operating costs to take our lead drug through Phase
II clinical evaluations, which is currently anticipated to occur in the fourth
quarter of 2012.
As of
September 30, 2010, we had cash on hand of approximately $3,901,000 which we
anticipate will fund our operations through September of
2011. Presently, the Company has an average monthly cash burn rate of
$298,000. Assuming monies are available from future financings, we will expend
an additional $225,000 per month through the first three quarters of
2011 in the development of G-115.
Accordingly,
we will need to raise additional capital to fund anticipated operating expenses
after October of 2011. In the event we are not able to secure financing, 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.
We cannot
assure you that financing whether from external sources or related parties, will
be available if needed. 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.
Raising
needed capital 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.
We
may not be able to commercially develop our technologies.
We have
concentrated our research and development on our pro-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 the
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 could
harm our ability to generate revenues, operate profitably or remain a viable
business.
Inability to
complete pre-clinical and clinical testing and trials will impair our
viability.
In the
first quarter of 2010, we commenced our first clinical trials of G-202 at the
University of Wisconsin, Carbone Cancer Center in Madison Wisconsin and at the
Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins
University. Although we have commenced our clinical 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
our clinical trials 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.
Future
financing 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.
We
depend on Craig A. Dionne, PhD, our Chief Executive Officer, and Russell
Richerson, PhD, our Chief Operating Officer, for our continued
operations.
We only
have 2 full time employees. The loss of either Craig A. Dionne, PhD,
our Chief Executive Officer, or Russell Richerson, PhD, our Chief Operating
Officer, would be detrimental to us. Although we have entered into employment
agreements with Messrs. Dionne and Richerson, there can be no assurance that
these individuals will continue to provide services to us. A voluntary or
involuntary termination of employment by Messrs. Dionne or Richerson could have
a materially adverse effect on our business. Further, as part of
their employment agreements, Messrs. Dionne and Richerson agreed to not compete
with us for a certain amount of time following the termination of their
employment. Once the applicable time of these provisions expires,
Messrs. Dionne and Richerson may be employed by a competitor of ours in the
future.
We
may be required to make significant payments to members of our management in the
event their employment with us is terminated or if we experience a change of
control.
We are a
party to employment agreements with each of Craig Dionne, our President and
Chief Executive Officer and Russell Richerson, our Chief Operating
Officer. In the event we terminate the employment of any of these
executives, we experience a change in control, or in certain cases, if such
executives terminate their employment with us, such executives will be entitled
to receive certain severance and related payments. Additionally, in
such instance, certain securities held by Messrs. Dionne and Richerson will
become immediately vested and exercisable. Upon the occurrence of any
such event, our obligation to make such payments could significantly impact our
working capital and accordingly, our ability to execute our business plan which
could have a materially adverse effect to our business. Also, these
provisions may discourage potential takeover attempts.
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, may 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
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 and Ipsen, 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.
We
are dependent upon third-parties to develop our product candidates, and such
parties are, to some extent, outside of our control.
We depend
upon independent investigators and collaborators, such as universities and
medical institutions, to conduct our pre-clinical and clinical trials under
agreements with us. These collaborators are not our employees and we cannot
control the amount or timing of resources that they devote to our programs.
These investigators may not assign as great a priority to our programs or pursue
them as diligently as we would if we were undertaking such programs ourselves.
If outside collaborators fail to devote sufficient time and resources to our
drug-development programs, or if their performance is substandard, the approval
of our FDA applications, if any, and our introduction of new drugs, if any, will
be delayed. These collaborators may also have relationships with other
commercial entities, some of whom may compete with us. If our collaborators
assist our competitors at our expense, our competitive position would be
harmed.
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.
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 the Mediterranean Sea.
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 affected.
Our
current manufacturing process requires acetonitrile.
The
current manufacturing process for our compounds requires the common solvent
acetonitrile. Beginning in late 2008, there was a worldwide shortage of
acetonitrile for a variety of reasons. We observed that during that period of
time the available supply of acetonitrile was 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 if an
acetonitrile shortage was to reoccur. In an extreme case this situation could
adversely affect our ability to manufacture our compounds 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:
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our demonstration to the medical
community of the clinical efficacy and safety of our proposed
products;
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our ability to create products
that are superior to alternatives currently on the
market;
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our ability to establish in the
medical community the potential advantage of our treatments over
alternative treatment methods;
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the reimbursement policies of
government and third-party
payors.
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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 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, 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
skin. 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.
The
synthesis of 12ADT must be conducted in special facilities.
There are
a limited number of manufacturing facilities qualified to handle and manufacture
therapeutic toxic agents and compounds. This limits the potential number of
possible manufacturing sites for our therapeutic compounds derived from
Thapsia
garganica
. No assurances can be provided that these
facilities 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, our business and future prospects will be adversely
affected.
Our
therapeutic compounds have not been subjected to large scale manufacturing
procedures.
To date,
G-202 and G-115 have 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 and G-115 will work at a larger scale adequate for
commercial needs. In the event our therapeutic compounds cannot be
manufactured in sufficient quantities, our future prospects could be
significantly impacted.
We
face product liability risks and may not be able to obtain adequate insurance to
protect us against losses.
We
currently have no products that have been approved for commercial sale. However,
the current and future use of our product candidates by us in clinical trials,
and the sale of any approved products in the future, may expose us to liability
claims. These claims might be made directly by consumers or healthcare providers
or indirectly by pharmaceutical companies, or others selling such products. We
may experience financial losses in the future due to product liability claims.
We have obtained limited general commercial liability insurance coverage for our
clinical trials. However, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts to protect us against all
losses. If a successful product liability claim or series of claims is brought
against us for uninsured liabilities or in excess of insured liabilities, our
assets may not be sufficient to cover such claims and our business operations
could be impaired.
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 if issued, our
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 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.
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. Although we began the G-202 Phase I clinical trial on
January 19, 2010, we cannot assure you that we will successfully complete the
trial. 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. 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 Our Common Stock
There
is no well established public market for our securities.
On
September 18, 2009, our common shares began quotation on the Over-the-Counter
Bulletin Board (“OTCBB”) and Pinksheets. The shares were initially
sporadic traded and as a result, we did not consider that a public market for
our securities existed. Commencing in the first quarter of 2010, our
common shares began trading regularly but with limited
volume. Accordingly, although technically a limited public
market for our securities now exists, it is still relatively
illiquid. Any prospective investor in our common stock should
consider the limited market when making an investment decision as our securities
are still relatively illiquid. No assurances can be given
that the trading volume of our common shares will increase or that a liquid
public market will ever materialize. Additionally, due to the
limited trading volume, it may be difficult for an investor to sell
shares.
Our
stock price may be particularly volatile because we are a drug development
company.
The
market prices for securities of biotechnology companies in general, and
early-stage drug development companies in particular, have been highly volatile
and may continue to be highly volatile in the future. The following factors, in
addition to other risk factors described in this section, may have a significant
impact on the market price of our common stock:
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the development status of our
drug candidates, particularly the results of our clinical trials of
G-202;
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market conditions or trends
related to the biotechnology and pharmaceutical industries, or the market
in general;
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announcements of technological
innovations, new commercial products, or other material events by our
competitors or us;
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disputes or other developments
concerning our proprietary
rights;
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changes in, or failure to meet,
securities analysts’ or investors’ expectations of our financial
performance;
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additions or departures of key
personnel;
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discussions of our business,
products, financial performance, prospects, or stock price by the
financial and scientific press and online investor communities such as
chat rooms;
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public concern as to, and
legislative action with respect to, testing or other research areas of
biopharmaceutical companies, the pricing and availability of prescription
drugs, or the safety of
drugs;
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regulatory developments in the
United States or foreign countries;
and
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economic and political
factors.
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In the
past, following periods of volatility in the market price of a particular
company’s securities, securities class action litigation has often been brought
against that company. We may become subject to this type of litigation, which is
often extremely expensive and diverts management’s attention.
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 SEC 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 requires a company’s management to assess the company’s
internal control over financial reporting annually and include a report on such
assessment in our annual report filed with the SEC. Section 404(b) is
not applicable to smaller reporting companies. Presently we qualify
as a smaller reporting company under Section 404(b) and, accordingly, our
independent registered public accounting firm is not required to audit the
design and operating effectiveness of our internal controls and management's
assessment of the design and the operating effectiveness of such internal
controls. In the event we cease to qualify as a smaller reporting
company, we will be required to expand substantial capital in connection with
compliance.
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.
Compliance
with changing regulation of corporate governance and public disclosure will
result in additional expenses and will divert time and attention away from
revenue generating activities.
Changing
laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002 and related SEC
regulations, have created uncertainty for public companies and significantly
increased the costs and risks associated with accessing the public markets and
public reporting. For example, on January 30th, 2009, the SEC adopted rules
requiring companies to provide their financial statements in interactive data
format using the eXtensible Business Reporting Language, or XBRL. We will have
to comply with these rules by June 15th, 2011. Our management team will need to
invest significant management time and financial resources to comply with both
existing and evolving standards for public companies, which will lead to
increased general and administrative expenses and a diversion of management time
and attention from potential future revenue generating activities to compliance
activities which could have an adverse effect on our business.
Our
common stock may be considered a “penny stock,” and thereby be subject to
additional sale and trading regulations that may make it more difficult to
sell.
Our
common stock, which currently trades on the OTCBB, may be considered to be a
“penny stock” if it does not qualify for one of the exemptions from the
definition of “penny stock” under Section 3a51-1 of the Securities Exchange Act
for 1934, as amended (the “Exchange Act”). Our common stock may be a
“penny stock” if it meets one or more of the following conditions (i) the stock
trades at a price less than $5.00 per share; (ii) it is NOT traded on a
“recognized” national exchange; (iii) it is NOT quoted on the Nasdaq Capital
Market, or even if so, has a price less than $5.00 per share; or (iv) is issued
by a company that has been in business less than three years with net tangible
assets less than $5 million.
The
principal result or effect of being designated a “penny stock” is that
securities broker-dealers participating in sales of our common stock will be
subject to the “penny stock” regulations set forth in Rules 15-2 through 15g-9
promulgated under the Exchange Act. For example, Rule 15g-2 requires
broker-dealers dealing in penny stocks to provide potential investors with a
document disclosing the risks of penny stocks and to obtain a manually signed
and dated written receipt of the document at least two business days before
effecting any transaction in a penny stock for the investor’s
account. Moreover, Rule 15g-9 requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any penny stock to that investor. This procedure requires the
broker-dealer to (i) obtain from the investor information concerning his or her
financial situation, investment experience and investment objectives; (ii)
reasonably determine, based on that information, that transactions in penny
stocks are suitable for the investor and that the investor has sufficient
knowledge and experience as to be reasonably capable of evaluating the risks of
penny stock transactions; (iii) provide the investor with a written statement
setting forth the basis on which the broker-dealer made the determination in
(ii) above; and (iv) receive a signed and dated copy of such statement from the
investor, confirming that it accurately reflects the investor’s financial
situation, investment experience and investment
objectives. Compliance with these requirements may make it more
difficult and time consuming for holders of our common stock to resell their
shares to third parties or to otherwise dispose of them in the market or
otherwise.
As
an issuer of “penny stock” the protection provided by the federal securities
laws relating to forward looking statements does not apply to us.
Although
the federal securities law provide a safe harbor for forward-looking statements
made by a public company that files reports under the federal securities laws,
this safe harbor is not available to issuers of penny stocks. As a result, if we
are a penny stock we will not have the benefit of this safe harbor protection in
the event of any legal action based upon an claim that the material provided by
us contained a material misstatement of fact or was misleading in any material
respect because of our failure to include any statements necessary to make the
statements not misleading.
If
securities or industry analysts do not publish research or reports or publish
unfavorable research about our business, the price and trading volume of our
common stock could decline.
The
trading market for our common stock will depend in part on the research and
reports that securities or industry analysts publish about us or our business.
We do not currently have and may never obtain research coverage by securities
and industry analysts. If no securities or industry analysts commence coverage
of us the trading price for our common stock and other securities would be
negatively affected. In the event we obtain securities or industry analyst
coverage, if one or more of the analysts who covers us downgrades our
securities, the price of our securities would likely decline. If one
or more of these analysts ceases to cover us or fails to publish regular reports
on us, interest in the purchase of our securities could decrease, which could
cause the price of our common stock and other securities and their trading
volume to decline.
We
do not intend to pay cash dividends.
We do not
anticipate paying cash dividends in the foreseeable future. Accordingly, 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.
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 September 30, 2010, we have issued and
outstanding 17,604,465 common shares and we have 14,136,170 common shares
reserved for future grants under our equity compensation plans and issuances
upon the exercise of current outstanding options, warrants and convertible
securities. Accordingly, we will be entitled to issue up to 48,259,365
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. Any preferred shares we may issue will 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. The issuance of additional securities may cause
substantial dilution to our shareholders.
Our
Officers and Scientific Advisors beneficially own approximately 37% of our
outstanding common shares.
Our
Officers and Scientific Advisors own approximately 37% 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.
Provisions
in Delaware law and executive employment agreements may prevent or delay a
change of control
We are
subject to the Delaware anti-takeover laws regulating corporate
takeovers. These anti-takeover laws prevent Delaware corporations
from engaging in a merger or sale of more than 10% of its assets with any
stockholder, including all affiliates and associates of the stockholder, who
owns 15% or more of the corporation’s outstanding voting stock, for three years
following the date that the stockholder acquired 15% or more of the
corporation’s assets unless:
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the Board of Directors approved
the transaction in which the stockholder acquired 15% or more of the
corporation’s assets;
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after the transaction in which
the stockholder acquired 15% or more of the corporation’s assets, the
stockholder owned at least 85% of the corporation’s outstanding voting
stock, excluding shares owned by directors, officers and employee stock
plans in which employee participants do not have the right to determine
confidentially whether shares held under the plan will be tendered in a
tender or exchange offer; or
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on or after this date, the merger
or sale is approved by the Board of Directors and the holders of at least
two-thirds of the outstanding voting stock that is not owned by the
stockholder.
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A
Delaware corporation may opt out of the Delaware anti-takeover laws if its
certificate of incorporation or bylaws so provide. We have not opted out of the
provisions of the anti-takeover laws. As such, these laws could prohibit or
delay mergers or other takeover or change of control of GenSpera and may
discourage attempts by other companies to acquire us.
In
addition, employment agreements with certain executive officers provide for the
payment of severance and acceleration of the vesting of options and restricted
stock in the event of termination of the executive officer following a change of
control of GenSpera. These provisions could have the effect of
discouraging potential takeover attempts.
DETERMINATION
OF OFFERING PRICE
The
selling stockholders may sell the common shares issued to them from time-to-time
at prices and at terms then prevailing or at prices related to the then current
market price, or in negotiated transactions.