Unassociated Document
Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-170140
PROSPECTUS
SUPPLEMENT
(To
Prospectus dated October 26, 2010)
SENESCO
TECHNOLOGIES, INC.
$5,500,000
Common
Stock
We have
entered into a sales agreement with McNicoll Lewis & Vlak relating to shares
of our common stock offered by this prospectus supplement and the accompanying
prospectus. In accordance with the terms of the sales agreement, we may offer
and sell shares of our common stock, $0.01 par value per share, having an
aggregate offering price of up to $5.5 million from time to time through
McNicoll Lewis & Vlak acting as agent.
Our
common stock is listed on the NYSE Amex Exchange (the “NYSE Amex”) under the
symbol “SNT.” The last reported sale price of our common stock on the NYSE Amex
on December 16, 2010 was $0.29 per share.
Sales of
our common stock, if any, under this prospectus supplement and the accompanying
prospectus may be made in sales deemed to be “at-the-market” equity offerings as
defined in Rule 415 promulgated under the Securities Act of 1933, as
amended, including sales made directly on or through the NYSE Amex, the existing
trading market for our common stock, sales made to or through a market maker
other than on an exchange or otherwise, and/or any other method permitted by
law. McNicoll Lewis & Vlak will act as sales agent on a best efforts basis.
There is no arrangement for funds to be received in any escrow, trust or similar
arrangement.
McNicoll
Lewis & Vlak will be entitled to compensation at a commission rate of up to
6% of the gross sales price per share sold, depending on the sales price per
share. In connection with the sale of the common stock on our behalf, McNicoll
Lewis & Vlak may be deemed to be an “underwriter” within the meaning of the
Securities Act of 1933, as amended, and the compensation of McNicoll Lewis &
Vlak may be deemed to be underwriting commissions or discounts.
As of
December 8, 2010, the aggregate market value of our outstanding common stock
held by non-affiliates was approximately $16,876,841, based on 68,355,099 shares
of outstanding common stock, of which approximately 15,614,972 shares were held
by affiliates, and a price of $0.32 per share, which was the last reported sale
price of our common stock on the NYSE Amex on December 8, 2010. As of
the date of this prospectus supplement, we have not offered any securities
pursuant to General Instruction I.B.6. of Form S-3 during the prior
12 calendar month period that ends on, and includes, the date of this prospectus
supplement.
Before
buying shares of our common stock, you should carefully consider the risk
factors described in “Risk Factors“ beginning on page S-4 of this prospectus
supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus
supplement and the accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
The date
of this prospectus supplement is December 22, 2010.
TABLE
OF CONTENTS
PROSPECTUS
SUPPLEMENT
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Page
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ABOUT
THIS PROSPECTUS SUPPLEMENT
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S-1
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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S-2
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PROSPECTUS
SUPPLEMENT SUMMARY
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S-3
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THE
OFFERING
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S-3
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RISK
FACTORS
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S-4
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USE
OF PROCEEDS
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S-14
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DILUTION
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S-15
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PLAN
OF DISTRIBUTION
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S-16
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LEGAL
MATTERS
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S-16
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EXPERTS
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S-17
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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S-17
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PROSPECTUS
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Page
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
SENESCO TECHNOLOGIES, INC
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1
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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13
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RISK
FACTORS
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13
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DESCRIPTION
OF THE SECURITIES WE MAY OFFER
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24
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WARRANTS
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24
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PREFERRED
STOCK
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27
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COMMON
STOCK
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29
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BOOK-ENTRY
PROCEDURES AND SETTLEMENT
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30
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USE
OF PROCEEDS
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32
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PLAN
OF DISTRIBUTION
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32
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WHERE
YOU CAN FIND MORE INFORMATION; INCORPORATION OF DOCUMENTS BY
REFERENCE
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34
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LEGAL
MATTERS
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35
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EXPERTS
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35
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ABOUT
THIS PROSPECTUS SUPPLEMENT
Unless
expressly stated otherwise, all references in this prospectus supplement and the
accompanying prospectus to “the Company,” “Senesco,” “we,” “us,” “our,” or
similar references mean Senesco Technologies, Inc. and its subsidiary on a
consolidated basis.
This
document is in two parts. The first part is this prospectus supplement, which
describes the terms of this offering of our common stock and supplements
information contained in the accompanying prospectus and the documents
incorporated by reference into the accompanying prospectus. The second part is
the accompanying prospectus, which gives more general information about us and
the shares of capital stock we may offer from time to time under our shelf
registration statement. To the extent there is a conflict between the
information contained in this prospectus supplement, on the one hand, and the
information contained in the accompanying prospectus or any document
incorporated by reference therein, on the other hand, the information in this
prospectus supplement shall control.
We have
not authorized any dealer, salesperson or other person to give any information
or to make any representation other than those contained or incorporated by
reference in this prospectus supplement, the accompanying prospectus and any
related free writing prospectus. You should not rely upon any information or
representation not contained or incorporated by reference in this prospectus
supplement, the accompanying prospectus or any free writing prospectus that we
may authorize to be provided to you. This prospectus supplement, the
accompanying prospectus and any related free writing prospectus do not
constitute an offer to sell or the solicitation of an offer to buy common stock,
nor do this prospectus supplement, the accompanying prospectus and any related
free writing prospectus constitute an offer to sell or the solicitation of an
offer to buy common stock in any jurisdiction to any person to whom it is
unlawful to make such offer or solicitation in such jurisdiction. You should not
assume that the information contained in this prospectus supplement, the
accompanying prospectus and any related free writing prospectus is accurate on
any date subsequent to the date set forth on the front of the document or that
any information we have incorporated by reference is correct on any date
subsequent to the date of the document incorporated by reference, even though
this prospectus supplement, the accompanying prospectus and any related free
writing prospectus is delivered or common stock is sold on a later
date.
We
further note that the representations, warranties and covenants made by us in
any agreement that is filed as an exhibit to any document that is incorporated
by reference into the accompanying prospectus were made solely for the benefit
of the parties to such agreement, including, in some cases, for the purpose of
allocating risk among the parties to such agreements, and should not be deemed
to be a representation, warranty or covenant to you. Moreover, such
representations, warranties or covenants were accurate only as of the date when
made. Accordingly, such representations, warranties and covenants should not be
relied on as accurately representing the current state of our
affairs.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained in this prospectus supplement and in the documents
incorporated by reference herein constitute “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995. All
statements other than statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements frequently, but not
always, use the words “may”, “intends”, “plans”, “believes”, “anticipates” or
“expects” or similar words and may include statements concerning our strategies,
goals and plans. All forward-looking statements are management’s present
expectations of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. In particular, our
statements regarding the anticipated growth in the markets for our technologies,
the continued advancement of our research, the approval of our patent
applications, the possibility of governmental approval in order to sell or offer
for sale to the general public a genetically engineered plant or plant product,
the successful implementation of our commercialization strategy, including the
success of our agricultural partners and the successful implementation of the
Rahan Joint Collaboration, statements relating to our patent applications, the
anticipated long term growth of our business, the results of our preclinical
studies, if any, our ability to comply with the continued listing standards of
the NYSE Amex, and the timing of the projects and trends in future operating
performance are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties, including, but not
limited to, our limited operating history, our need for additional
capital to fund our operations until we are able to generate a profit, the
current economic environment, our dependence on a single principal technology,
our outsourcing of our research and development activities, our significant
future capital needs, our dependence on our patents and proprietary rights and
the enforcement of these rights, the potential for our competitors or third
parties to allege that we are infringing upon their intellectual property
rights, the potential that our security measures may not adequately protect our
unpatented technology, potential difficulty in managing our growth and expanding
our operations, our lack of marketing or sales history and dependence on
third-party marketing partners, our potential future dependence on joint
ventures and strategic alliances to develop and market our technology, the
intense competition in the human health and agricultural biotechnology
industries, the various government regulations that our business is subject to,
the potential that our preclinical studies and clinical trials of our human
health applications may be unsuccessful, any inability to license from third
parties their proprietary technologies or processes which we use in connection
with the development of our technology, the length, expense and uncertainty
associated with clinical trials for our human health technology, the
potential that, even if we receive regulatory approval, consumers may not accept
products containing our technology, our dependence on key personnel, the
potential that certain provisions of our charter, by-laws and Delaware law could
make a takeover difficult, increasing political and social turmoil, the
potential that our management and other affiliates, due to their significant
control of our common stock have the ability to significantly influence our
actions, the potential that a significant portion of our total outstanding
shares of common stock may be sold in the market in the near future, the limited
trading market of our common stock, the potential that our common stock may be
delisted from the NYSE Amex Exchange, fluctuations in the market price of our
common stock, our dividend policy and potential for our stockholders to be
diluted.
The
following documents, among others, describe these assumptions, risks,
uncertainties, and other factors. You should read and interpret any
forward-looking statements together with these documents:
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the
risk factors contained in any prospectus supplement under the caption
“Risk Factors”;
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our
most recent annual report on Form 10-K, including the sections entitled
“Business”, “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of
Operations”;
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our
quarterly reports on Form 10-Q; and
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In light
of these assumptions, risks and uncertainties, the results and events discussed
in the forward-looking statements contained in this prospectus, any prospectus
supplement or in any document incorporated by reference in this prospectus might
not occur. Investors are cautioned not to place undue reliance on the
forward-looking statements, which speak only of the date of this prospectus, the
date of any prospectus supplement or the date of the document incorporated by
reference in this prospectus. We are not under any obligation, and we expressly
disclaim any obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or otherwise, except as
may be required by applicable law. All subsequent forward-looking statements
attributable to us are expressly qualified in their entirety by the cautionary
statements contained or referred to in this section.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights selected information contained elsewhere or incorporated by
reference in this prospectus supplement and the accompanying prospectus. The
summary may not contain all the information that you should consider before
investing in our common stock. you should read the entire prospectus supplement
and the accompanying prospectus carefully, including “Risk Factors” contained in
this prospectus supplement and the documents incorporated by reference in the
accompanying prospectus, before making an investment decision. This prospectus
supplement may add to, update or change information in the accompanying
prospectus.
THE
OFFERING
Common
stock offered by us pursuant to this prospectus supplement
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Shares
having an aggregate offering price of up to $5.5 million. (1)
(2)
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Manner
of offering
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“At-the-market”
offering that may be made from time to time through our agent, McNicoll
Lewis & Vlak. See “Plan of Distribution” on
page S-16.
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Use
of proceeds
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We
intend to use the net proceeds from this offering for working capital and
other general corporate purposes. See “Use of Proceeds” on page
S-14.
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NYSE
Amex symbol
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“SNT”
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Risk
factors
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This
investment involves a high degree of risk. See “Risk Factors” beginning on
page S-4 of this prospectus supplement as well as the other information
included in or incorporated by reference in this prospectus supplement and
the accompanying prospectus for a discussion of risks you should consider
carefully before making an investment
decision.
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(1)
Pursuant to the Securities Purchase Agreement (the “Purchase Agreement”) dated
as of March 26, 2010 by and among Senesco Technologies, Inc. and the purchasers
set forth on the signature pages thereto (the “Purchasers”), Senesco issued in a
private placement, an aggregate of approximately 10,297 shares of Senesco 10%
Series A Convertible Preferred Stock, par value $0.01 per share (the “Series A
Preferred Stock”), initially convertible into approximately 32,178,125 shares of
Senesco common stock, and (ii) immediately exercisable warrants to purchase up
to approximately 32,178,125 shares of common stock for an aggregate offering
price of approximately $10,297,000. Pursuant to the terms of the
Purchase Agreement, the Purchasers collectively have the right to participate in
an amount up to 100% of any subsequent issuance by Senesco or any of its
subsidiaries of common stock or common stock equivalents for cash consideration,
indebtedness or a combination thereof (the “Preemptive Right”). Such
Preemptive Right exists until such time as the Purchasers no longer hold any
shares of the Series A Preferred Stock. The aggregate shares offered
pursuant to this prospectus supplement would be reduced to the extent any of the
Purchasers exercise their Preemptive Right, and any purchases upon exercise of
such Preemptive Right would be in the open market at prevailing market prices at
the time of sale.
(2)
Pursuant to the terms of the Series A Preferred Stock and Senesco’s 10% Series B
Convertible Preferred Stock, par value $0.01 per share (the “Series B Preferred
Stock”, and together with the Series A Preferred Stock, the “Preferred Stock”),
in the event Senesco issues common stock or common stock equivalents at a per
share price of less than $0.32, the current conversion price of the Preferred
Stock, the conversion price of the Preferred Stock shall be reduced to an amount
equal to the per share purchase price for such subsequent
issuance. Therefore, if any shares offered pursuant to this
prospectus supplement are sold at a per share purchase price of less than $0.32
per share, the anti-dilution provisions of the Preferred Stock will be
triggered, and the conversion price for the Preferred Stock shall be reduced in
accordance with the terms of such Preferred Stock.
RISK
FACTORS
Before
making an investment decision, you should carefully consider the risks described
in this prospectus supplement, together with all of the other information
incorporated by reference into this prospectus supplement and the accompanying
prospectus, including from our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q. The following risks are presented as
of the date of this prospectus supplement and we expect that these will be
updated from time to time in our periodic and current reports filed with the
SEC, which will be incorporated herein by reference. Please refer to these
subsequent reports for additional information relating to the risks associated
with investing in our common stock.
Our
business, financial condition or results of operations could be materially
adversely affected by any of these risks. The trading price of our securities
could decline due to any of these risks, and you may lose part or all of your
investment. This prospectus supplement, the accompanying prospectus and the
incorporated documents also contain forward-looking statements that involve
risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors,
including the risks mentioned below. Forward-looking statements included in this
prospectus supplement are based on information available to us on the date
hereof, and all forward-looking statements in documents incorporated by
reference are based on information available to us as of the date of such
documents. We disclaim any intent to update any forward-looking
statements.
Risks Related to Our
Business
We have a limited operating history
and have incurred substantial losses and expect to incur future
losses.
We are a
development stage biotechnology company with a limited operating history and
limited assets and capital. We have incurred losses each year since inception
and had an accumulated deficit of $53,863,041 at September 30, 2010. We
have generated minimal revenues by licensing our technology for certain crops to
companies willing to share in our development costs. In addition, our technology
may not be ready for commercialization for several years. We expect to continue
to incur losses for the next several years because we anticipate that our
expenditures on research and development and administrative activities will
significantly exceed our revenues during that period. We cannot predict when, if
ever, we will become profitable.
We
may need additional capital to fund our operations until we are able to generate
a profit.
Our
operations to date have required significant cash expenditures. Our
future capital requirements will depend on the results of our research and
development activities, preclinical and clinical studies, and competitive and
technological advances.
We will
need to obtain more funding in the future through collaborations or other
arrangements with research institutions and corporate partners, or public and
private offerings of our securities, including debt or equity
financing. We may not be able to obtain adequate funds for our
operations from these sources when needed or on acceptable terms. Future
collaborations or similar arrangements may require us to license valuable
intellectual property to, or to share substantial economic benefits with, our
collaborators. If we raise additional capital by issuing additional
equity or securities convertible into equity, our stockholders may experience
dilution and our share price may decline. Any debt financing may
result in restrictions on our spending.
If we are
unable to raise additional funds, we will need to do one or more of the
following:
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delay,
scale-back or eliminate some or all of our research and product
development programs;
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provide
licenses to third parties to develop and commercialize products or
technologies that we would otherwise seek to develop and commercialize
ourselves;
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seek
strategic alliances or business
combinations;
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attempt
to sell our company;
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We
believe that at the projected rate of spending we should have sufficient cash to
maintain our present operations for at least the next twelve (12) months from
September 30, 2010.
We
may be adversely affected by the current economic environment.
Our
ability to obtain financing, invest in and grow our business, and meet our
financial obligations depends on our operating and financial performance, which
in turn is subject to numerous factors. In addition to factors
specific to our business, prevailing economic conditions and financial, business
and other factors beyond our control can also affect our business and ability to
raise capital. We cannot anticipate all of the ways in which the
current economic climate and financial market conditions could adversely impact
our business.
We depend on a single principal
technology and, if our technology is not commercially successful, we will have
no alternative source of revenue.
Our
primary business is the development and licensing of technology to identify,
isolate, characterize and promote or silence genes which control the death of
cells in humans and plants. Our future revenue and profitability critically
depend upon our ability, or our licensees’ ability, to successfully develop
apoptosis and senescence gene technology and later license or market such
technology. We have conducted experiments on certain crops with
favorable results and have conducted certain preliminary cell-line and animal
experiments, which have provided us with data upon which we have designed
additional research programs. However, we cannot give any assurance that our
technology will be commercially successful or economically viable for any crops
or human health applications.
In
addition, no assurance can be given that adverse consequences might not result
from the use of our technology such as the development of negative effects on
humans or plants or reduced benefits in terms of crop yield or
protection. Our failure to obtain market acceptance of our technology
or of our current or potential licensees to successfully commercialize such
technology would have a material adverse effect on our business.
We
outsource all of our research and development activities and, if we are
unsuccessful in maintaining our alliances with these third parties, our research
and development efforts may be delayed or curtailed.
We rely
on third parties to perform all of our research and development
activities. Our research and development efforts take place at the
University of Waterloo in Ontario, Canada, where our technology was discovered,
at the Mayo Clinic, at other commercial research facilities and with our
commercial partners. At this time, we do not have the internal
capabilities to perform our own research and development activities.
Accordingly, the failure of third-party research partners to perform under
agreements entered into with us, or our failure to renew important research
agreements with these third parties, may delay or curtail our research and
development efforts.
We
have significant future capital needs and may be unable to raise capital when
needed, which could force us to delay or reduce our research and development
efforts.
As of
September 30, 2010, we had cash of $6,290,995 and working capital of
$3,841,940. Using our available reserves as of September 30, 2010, we
believe that we can operate according to our current business plan for at least
the next twelve (12) months from September 30, 2010. To date, we have
generated minimal revenues and anticipate that our operating costs will exceed
any revenues generated over the next several years. Therefore, we
will be required to raise additional capital in the future in order to operate
in accordance with our current business plan, and this funding may not be
available on favorable terms, if at all. If we are unable to raise
additional funds, we will need to do one or more of the following:
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delay,
scale back or eliminate some or all of our research and development
programs;
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provide
a license to third parties to develop and commercialize our technology
that we would otherwise seek to develop and commercialize
ourselves;
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seek
strategic alliances or business
combinations;
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attempt
to sell our company;
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In
addition, in connection with any funding, if we need to issue more equity
securities than our certificate of incorporation currently authorizes, or more
than 20% of the shares of our common stock outstanding, we may need stockholder
approval. If stockholder approval is not obtained or if adequate
funds are not available, we may be required to curtail operations significantly
or to obtain funds through arrangements with collaborative partners or others
that may require us to relinquish rights to certain of our technologies, product
candidates, products or potential markets. Investors may experience
dilution in their investment from future offerings of our common
stock. For example, if we raise additional capital by issuing equity
securities, such an issuance would reduce the percentage ownership of existing
stockholders. In addition, assuming the exercise of all options and
warrants outstanding and the conversion of the preferred stock into common
stock, as of September 30, 2010, we had 68,746,396 shares of common stock
authorized but unissued and unreserved, which may be issued from time to time by
our board of directors without stockholder approval. Furthermore, we
may need to issue securities that have rights, preferences and privileges senior
to our common stock. Failure to obtain financing on acceptable terms
would have a material adverse effect on our liquidity.
Since our
inception, we have financed all of our operations through private equity and
debt financings. Our future capital requirements depend on numerous factors,
including:
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the
scope of our research and
development;
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our
ability to attract business partners willing to share in our development
costs;
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our
ability to successfully commercialize our
technology;
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competing
technological and market
developments;
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our
ability to enter into collaborative arrangements for the development,
regulatory approval and commercialization of other products;
and
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the
cost of filing, prosecuting, defending and enforcing patent claims and
other intellectual property rights.
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Our
business depends upon our patents and proprietary rights and the enforcement of
these rights. Our failure to obtain and maintain patent protection
may increase competition and reduce demand for our technology.
As a
result of the substantial length of time and expense associated with developing
products and bringing them to the marketplace in the biotechnology and
agricultural industries, obtaining and maintaining patent and trade secret
protection for technologies, products and processes is of vital
importance. Our success will depend in part on several factors,
including, without limitation:
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our
ability to obtain patent protection for our technologies and
processes;
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our
ability to preserve our trade secrets;
and
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our
ability to operate without infringing the proprietary rights of other
parties both in the United States and in foreign
countries.
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As of
September 30, 2010, we have been issued twenty one (21) patents by the PTO and
fifty-seven (57) patents from foreign countries. We have also filed
numerous patent applications for our technology in the United States and in
several foreign countries, which technology is vital to our primary business, as
well as several continuations in part on these patent
applications. Our success depends in part upon the grant of patents
from our pending patent applications.
Although
we believe that our technology is unique and that it will not violate or
infringe upon the proprietary rights of any third party, we cannot assure you
that these claims will not be made or if made, could be successfully defended
against. If we do not obtain and maintain patent protection, we may
face increased competition in the United States and internationally, which would
have a material adverse effect on our business.
Since
patent applications in the United States are maintained in secrecy until patents
are issued, and since publication of discoveries in the scientific and patent
literature tend to lag behind actual discoveries by several months, we cannot be
certain that we were the first creator of the inventions covered by our pending
patent applications or that we were the first to file patent applications for
these inventions.
In
addition, among other things, we cannot assure you that:
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our
patent applications will result in the issuance of
patents;
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any
patents issued or licensed to us will be free from challenge and if
challenged, would be held to be
valid;
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any
patents issued or licensed to us will provide commercially significant
protection for our technology, products and
processes;
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other
companies will not independently develop substantially equivalent
proprietary information which is not covered by our patent
rights;
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other
companies will not obtain access to our
know-how;
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other
companies will not be granted patents that may prevent the
commercialization of our technology;
or
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we
will not incur licensing fees and the payment of significant other fees or
royalties to third parties for the use of their intellectual property in
order to enable us to conduct our
business.
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Our
competitors may allege that we are infringing upon their intellectual property
rights, forcing us to incur substantial costs and expenses in resulting
litigation, the outcome of which would be uncertain.
Patent
law is still evolving relative to the scope and enforceability of claims in the
fields in which we operate. We are like most biotechnology companies
in that our patent protection is highly uncertain and involves complex legal and
technical questions for which legal principles are not yet firmly
established. In addition, if issued, our patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products, or provide us with any competitive
advantage.
The PTO
and the courts have not established a consistent policy regarding the breadth of
claims allowed in biotechnology patents. The allowance of broader
claims may increase the incidence and cost of patent interference proceedings
and the risk of infringement litigation. On the other hand, the
allowance of narrower claims may limit the scope and value of our proprietary
rights.
The laws
of some foreign countries do not protect proprietary rights to the same extent
as the laws of the United States, and many companies have encountered
significant problems and costs in protecting their proprietary rights in these
foreign countries.
We could
become involved in infringement actions to enforce and/or protect our
patents. Regardless of the outcome, patent litigation is expensive
and time consuming and would distract our management from other
activities. Some of our competitors may be able to sustain the costs
of complex patent litigation more effectively than we could because they have
substantially greater resources. Uncertainties resulting from the
initiation and continuation of any patent litigation could limit our ability to
continue our operations.
If
our technology infringes the intellectual property of our competitors or other
third parties, we may be required to pay license fees or damages.
If any
relevant claims of third-party patents that are adverse to us are upheld as
valid and enforceable, we could be prevented from commercializing our technology
or could be required to obtain licenses from the owners of such
patents. We cannot assure you that such licenses would be available
or, if available, would be on acceptable terms. Some licenses may be
non-exclusive and, therefore, our competitors may have access to the same
technology licensed to us. In addition, if any parties successfully
claim that the creation or use of our technology infringes upon their
intellectual property rights, we may be forced to pay damages, including treble
damages.
Our
security measures may not adequately protect our unpatented technology and, if
we are unable to protect the confidentiality of our proprietary information and
know-how, the value of our technology may be adversely affected.
Our
success depends upon know-how, unpatentable trade secrets, and the skills,
knowledge and experience of our scientific and technical
personnel. As a result, all employees agreed to a confidentiality
provision in their employment agreement that prohibited the disclosure of
confidential information to anyone outside of our company, during the term of
employment and for 5 years thereafter. The employment agreements have
since been terminated, but the period of confidentiality is still in
effect. We also require all employees to disclose and assign to us
the rights to their ideas, developments, discoveries and
inventions. We also attempt to enter into similar agreements with our
consultants, advisors and research collaborators. We cannot assure
you that adequate protection for our trade secrets, know-how or other
proprietary information against unauthorized use or disclosure will be
available.
We
occasionally provide information to research collaborators in academic
institutions and request that the collaborators conduct certain
tests. We cannot assure you that the academic institutions will not
assert intellectual property rights in the results of the tests conducted by the
research collaborators, or that the academic institutions will grant licenses
under such intellectual property rights to us on acceptable terms, if at
all. If the assertion of intellectual property rights by an academic
institution is substantiated, and the academic institution does not grant
intellectual property rights to us, these events could limit our ability to
commercialize our technology.
As
we evolve from a company primarily involved in the research and development of
our technology into one that is also involved in the commercialization of our
technology, we may have difficulty managing our growth and expanding our
operations.
As our
business grows, we may need to add employees and enhance our management, systems
and procedures. We may need to successfully integrate our internal
operations with the operations of our marketing partners, manufacturers,
distributors and suppliers to produce and market commercially viable
products. We may also need to manage additional relationships with
various collaborative partners, suppliers and other
organizations. Although we do not presently conduct research and
development activities in-house, we may undertake those activities in the
future. Expanding our business may place a significant burden on our
management and operations. We may not be able to implement
improvements to our management information and control systems in an efficient
and timely manner and we may discover deficiencies in our existing systems and
controls. Our failure to effectively respond to such changes may make
it difficult for us to manage our growth and expand our operations.
We
have no marketing or sales history and depend on third-party marketing
partners. Any failure of these parties to perform would delay or
limit our commercialization efforts.
We have
no history of marketing, distributing or selling biotechnology products and we
are relying on our ability to successfully establish marketing partners or other
arrangements with third parties to market, distribute and sell a commercially
viable product both here and abroad. Our business plan envisions
creating strategic alliances to access needed commercialization and marketing
expertise. We may not be able to attract qualified sub-licensees,
distributors or marketing partners, and even if qualified, these marketing
partners may not be able to successfully market agricultural products or human
health applications developed with our technology. If our current or
potential future marketing partners fail to provide adequate levels of sales,
our commercialization efforts will be delayed or limited and we may not be able
to generate revenue.
We
will depend on joint ventures and strategic alliances to develop and market our
technology and, if these arrangements are not successful, our technology may not
be developed and the expenses to commercialize our technology will
increase.
In its
current state of development, our technology is not ready to be marketed to
consumers. We intend to follow a multi-faceted commercialization
strategy that involves the licensing of our technology to business partners for
the purpose of further technological development, marketing and
distribution. We have and are seeking business partners who will
share the burden of our development costs while our technology is still being
developed, and who will pay us royalties when they market and distribute
products incorporating our technology upon commercialization. The
establishment of joint ventures and strategic alliances may create future
competitors, especially in certain regions abroad where we do not pursue patent
protection. If we fail to establish beneficial business partners and
strategic alliances, our growth will suffer and the continued development of our
technology may be harmed.
Competition
in the human health and agricultural biotechnology industries is intense and
technology is changing rapidly. If our competitors market their
technology faster than we do, we may not be able to generate revenues from the
commercialization of our technology.
Many
human health and agricultural biotechnology companies are engaged in research
and development activities relating to apoptosis and senescence. The
market for plant protection and yield enhancement products is intensely
competitive, rapidly changing and undergoing consolidation. We may be
unable to compete successfully against our current and future competitors, which
may result in price reductions, reduced margins and the inability to achieve
market acceptance for products containing our technology. Our
competitors in the field of plant senescence gene technology are companies that
develop and produce transgenic plants and include major international
agricultural companies, specialized biotechnology companies, research and
academic institutions and, potentially, our joint venture and strategic alliance
partners. These companies include: Mendel Biotechnology, Inc.,
Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG,
among others. Some of our competitors that are involved in apoptosis
research include: Amgen Inc.; Centocor, Inc.; Genzyme Corporation;
OSI Pharmaceuticals, Inc.; Novartis AG; Introgen Therapeutics, Inc.; Genta
Incorporated; and Vertex Pharmaceuticals, Inc. Many of these
competitors have substantially greater financial, marketing, sales, distribution
and technical resources than us and have more experience in research and
development, clinical trials, regulatory matters, manufacturing and
marketing. We anticipate increased competition in the future as new
companies enter the market and new technologies become available. Our
technology may be rendered obsolete or uneconomical by technological advances or
entirely different approaches developed by one or more of our competitors, which
will prevent or limit our ability to generate revenues from the
commercialization of our technology.
Our
business is subject to various government regulations and, if we or our
licensees are unable to obtain regulatory approval, we may not be able to
continue our operations.
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies:
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the
USDA regulates the import, field testing and interstate movement of
specific types of genetic engineering that may be used in the creation of
transgenic plants;
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the
EPA regulates activity related to the invention of plant pesticides and
herbicides, which may include certain kinds of transgenic plants;
and
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the
FDA regulates foods derived from new plant
varieties.
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The FDA
requires that transgenic plants meet the same standards for safety that are
required for all other plants and foods in general. Except in the
case of additives that significantly alter a food’s structure, the FDA does not
require any additional standards or specific approval for genetically engineered
foods, but expects transgenic plant developers to consult the FDA before
introducing a new food into the marketplace.
Use of
our technology, if developed for human health applications, will also be subject
to FDA regulation. The FDA must approve any drug or biologic product
before it can be marketed in the United States. In addition, prior to
being sold outside of the U.S., any products resulting from the application of
our human health technology must be approved by the regulatory agencies of
foreign governments. Prior to filing a new drug application or
biologics license application with the FDA, we would have to perform extensive
clinical trials, and prior to beginning any clinical trial, we would need to
perform extensive preclinical testing which could take several years and may
require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
governmental regulatory agency. However, we are planning on performing clinical
trials, which would be subject to FDA approval. Additionally,
federal, state and foreign regulations relating to crop protection products and
human health applications developed through biotechnology are subject to public
concerns and political circumstances, and, as a result, regulations have changed
and may change substantially in the future. Accordingly, we may
become subject to governmental regulations or approvals or become subject to
licensing requirements in connection with our research and development efforts.
We may also be required to obtain such licensing or approval from the
governmental regulatory agencies described above, or from state agencies, prior
to the commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
Preclinical
studies of our human health applications may be unsuccessful, which could delay
or prevent regulatory approval.
Preclinical
studies may reveal that our human health technology is ineffective or harmful,
and/or may be unsuccessful in demonstrating efficacy and safety of our human
health technology, which would significantly limit the possibility of obtaining
regulatory approval for any drug or biologic product manufactured with our
technology. The FDA requires submission of extensive preclinical,
clinical and manufacturing data to assess the efficacy and safety of potential
products. We are currently in the process of conducting preclinical toxicology
studies for our multiple myeloma product candidate. Any delay in this
toxicology study, or any potential negative findings in this toxicology study,
will delay our ability to file an IND for our multiple myeloma product
candidate. Furthermore, the success of preliminary studies does not
ensure commercial success, and later-stage clinical trials may fail to confirm
the results of the preliminary studies.
Our
success will depend on the success of our clinical trials that have not yet
begun.
It may
take several years to complete the clinical trials of a product, and failure of
one or more of our clinical trials can occur at any stage of
testing. We believe that the development of our product candidate
involves significant risks at each stage of testing. If clinical
trial difficulties and failures arise, our product candidate may never be
approved for sale or become commercially viable.
There are
a number of difficulties and risks associated with clinical
trials. These difficulties and risks may result in the failure to
receive regulatory approval to sell our product candidate or the inability to
commercialize our product candidate. The possibility exists
that:
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we
may discover that the product candidate does not exhibit the expected
therapeutic results in humans, may cause harmful side effects or have
other unexpected characteristics that may delay or preclude regulatory
approval or limit commercial use if
approved;
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the
results from early clinical trials may not be statistically significant or
predictive of results that will be obtained from expanded advanced
clinical trials;
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institutional
review boards or regulators, including the FDA, may hold, suspend or
terminate our clinical research or the clinical trials of our product
candidate for various reasons, including noncompliance with regulatory
requirements or if, in their opinion, the participating subjects are being
exposed to unacceptable health
risks;
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subjects
may drop out of our clinical
trials;
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our
preclinical studies or clinical trials may produce negative, inconsistent
or inconclusive results, and we may decide, or regulators may require us,
to conduct additional preclinical studies or clinical trials;
and
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the
cost of our clinical trials may be greater than we currently
anticipate.
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Clinical
trials for our human health technology will be lengthy and expensive and their
outcome is uncertain.
Before
obtaining regulatory approval for the commercial sales of any product containing
our technology, we must demonstrate through clinical testing that our technology
and any product containing our technology is safe and effective for use in
humans. Conducting clinical trials is a time-consuming, expensive and
uncertain process and typically requires years to complete. In our
industry, the results from preclinical studies and early clinical trials often
are not predictive of results obtained in later-stage clinical
trials. Some products and technologies that have shown promising
results in preclinical studies or early clinical trials subsequently fail to
establish sufficient safety and efficacy data necessary to obtain regulatory
approval. At any time during clinical trials, we or the FDA might
delay or halt any clinical trial for various reasons, including:
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occurrence
of unacceptable toxicities or side
effects;
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ineffectiveness
of the product candidate;
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negative
or inconclusive results from the clinical trials, or results that
necessitate additional studies or clinical
trials;
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delays
in obtaining or maintaining required approvals from institutions, review
boards or other reviewing entities at clinical
sites;
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delays
in patient enrollment; or
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insufficient
funding or a reprioritization of financial or other
resources.
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Any
failure or substantial delay in successfully completing clinical trials and
obtaining regulatory approval for our product candidates could severely harm our
business.
If
our clinical trials for our product candidates are delayed, we would be unable
to commercialize our product candidates on a timely basis, which would
materially harm our business.
Planned
clinical trials may not begin on time or may need to be restructured after they
have begun. Clinical trials can be delayed for a variety of reasons,
including delays related to:
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obtaining
an effective investigational new drug application, or IND, or regulatory
approval to commence a clinical
trial;
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negotiating
acceptable clinical trial agreement terms with prospective trial
sites;
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obtaining
institutional review board approval to conduct a clinical trial at a
prospective site;
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recruiting
qualified subjects to participate in clinical
trials;
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competition
in recruiting clinical
investigators;
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shortage
or lack of availability of supplies of drugs for clinical
trials;
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the
need to repeat clinical trials as a result of inconclusive results or
poorly executed testing;
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the
placement of a clinical hold on a
study;
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the
failure of third parties conducting and overseeing the operations of our
clinical trials to perform their contractual or regulatory obligations in
a timely fashion; and
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exposure
of clinical trial subjects to unexpected and unacceptable health risks or
noncompliance with regulatory requirements, which may result in suspension
of the trial.
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We
believe that our product candidate has significant milestone to reach, including
the successful completion of clinical trials, before
commercialization. If we have significant delays in or termination of
clinical trials, our financial results and the commercial prospects for our
product candidates or any other products that we may develop will be adversely
impacted. In addition, our product development costs would increase
and our ability to generate revenue could be impaired.
Any
inability to license from third parties their proprietary technologies or
processes which we use in connection with the development of our technology may
impair our business.
Other
companies, universities and research institutions have or may obtain patents
that could limit our ability to use our technology in a product candidate or
impair our competitive position. As a result, we would have to obtain
licenses from other parties before we could continue using our technology in a
product candidate. Any necessary licenses may not be available on
commercially acceptable terms, if at all. If we do not obtain
required licenses, we may not be able to develop our technology into a product
candidate or we may encounter significant delays in development while we
redesign methods that are found to infringe on the patents held by
others.
Even
if we receive regulatory approval, consumers may not accept products containing
our technology, which will prevent us from being profitable since we have no
other source of revenue.
We cannot
guarantee that consumers will accept products containing our
technology. Recently, there has been consumer concern and consumer
advocate activism with respect to genetically-engineered agricultural consumer
products. The adverse consequences from heightened consumer concern
in this regard could affect the markets for agricultural products developed with
our technology and could also result in increased government regulation in
response to that concern. If the public or potential customers perceive our
technology to be genetic modification or genetic engineering, agricultural
products grown with our technology may not gain market
acceptance.
We
depend on our key personnel and, if we are not able to attract and retain
qualified scientific and business personnel, we may not be able to grow our
business or develop and commercialize our technology.
We are
highly dependent on our scientific advisors, consultants and third-party
research partners. Our success will also depend in part on the
continued service of our key employees and our ability to identify, hire and
retain additional qualified personnel in an intensely competitive
market. Although we have a research agreement with Dr. John Thompson,
this agreement may be terminated upon short or no
notice. Additionally, we do not have employment agreements with our
key employees. We do not maintain key person life insurance on any
member of management. The failure to attract and retain key personnel
could limit our growth and hinder our research and development
efforts.
Certain
provisions of our charter, by-laws and Delaware law could make a takeover
difficult.
Certain
provisions of our certificate of incorporation and by-laws could make it more
difficult for a third party to acquire control of us, even if the change in
control would be beneficial to stockholders. Our certificate of
incorporation authorizes our board of directors to issue, without stockholder
approval, except as may be required by the rules of the NYSE Amex Exchange,
5,000,000 shares of preferred stock with voting, conversion and other rights and
preferences that could adversely affect the voting power or other rights of the
holders of our common stock. Similarly, our by-laws do not restrict
our board of directors from issuing preferred stock without stockholder
approval.
In
addition, we are subject to the Business Combination Act of the Delaware General
Corporation Law which, subject to certain exceptions, restricts certain
transactions and business combinations between a corporation and a stockholder
owning 15% or more of the corporation’s outstanding voting stock for a period of
three years from the date such stockholder becomes a 15% owner. These
provisions may have the effect of delaying or preventing a change of control of
us without action by our stockholders and, therefore, could adversely affect the
value of our common stock.
Furthermore,
in the event of our merger or consolidation with or into another corporation, or
the sale of all or substantially all of our assets in which the successor
corporation does not assume our outstanding equity awards or issue equivalent
equity awards, our current equity plans require the accelerated vesting of such
outstanding equity awards.
Risks Related to Our Common
Stock
We
currently meet the NYSE Amex Exchange continued listing
standards. However, if our common stock is delisted from the NYSE
Amex Exchange, we may not be able to list on any other stock exchange, and our
common stock may be subject to the “penny stock” regulations which may affect
the ability of our stockholders to sell their shares.
The NYSE
Amex Exchange requires us to meet minimum financial requirements in order to
maintain our listing. Although we have met the $6,000,000 minimum net
worth continued listing requirement of the NYSE Amex Exchange and have received
notice from the NYSE that we are back in compliance with their continued listing
requirement, we previously did not meet the $6,000,000 minimum net worth
continued listing requirement of the NYSE Amex Exchange. However, we remain
subject to periodic review by NYSE Staff. Failure to remain in compliance with
the continued listing standards could result in our company being delisted from
the NYSE Amex Exchange. If we are delisted from the NYSE Amex
Exchange, our common stock likely will become a “penny stock.” In
general, regulations of the SEC define a “penny stock” to be an equity security
that is not listed on a national securities exchange and that has a market price
of less than $5.00 per share or with an exercise price of less than $5.00 per
share, subject to certain exceptions. If our common stock becomes a
penny stock, additional sales practice requirements would be imposed on
broker-dealers that sell such securities to persons other than certain qualified
investors. For transactions involving a penny stock, unless exempt, a
broker-dealer must make a special suitability determination for the purchaser
and receive the purchaser’s written consent to the transaction prior to the
sale. In addition, the rules on penny stocks require delivery, prior
to and after any penny stock transaction, of disclosures required by the
SEC.
If our
stock is not accepted for listing on the NYSE Amex Exchange, we will make every
possible effort to have it listed on the Over the Counter Bulletin Board, or the
OTC Bulletin Board. If our common stock were to be traded on the OTC
Bulletin Board, the Securities Exchange Act of 1934, as amended, and related
Securities and Exchange Commission (SEC) rules would impose additional sales
practice requirements on broker-dealers that sell our
securities. These rules may adversely affect the ability of
stockholders to sell our common stock and otherwise negatively affect the
liquidity, trading market and price of our common stock.
We
believe that the listing of our common stock on a recognized national trading
market, such as the NYSE Amex Exchange, is an important part of our business and
strategy. Such a listing helps our stockholders by providing a
readily available trading market with current quotations. Without
that, stockholders may have a difficult time getting a quote for the sale or
purchase of our stock, the sale or purchase of our stock would likely be made
more difficult and the trading volume and liquidity of our stock would likely
decline. The absence of such a listing may adversely affect the
acceptance of our common stock as currency or the value accorded it by other
parties. In that regard, the absence of a listing on a recognized
national trading market will also affect our ability to benefit from the use of
our operations and expansion plans, including for use in licensing agreements,
joint ventures, the development of strategic relationships and acquisitions,
which are critical to our business and strategy and none of which is currently
the subject of any agreement, arrangement or understanding, with respect to any
future financing or strategic relationship we may undertake. A
delisting from the NYSE Amex Exchange could result in negative publicity and
could negatively impact our ability to raise capital in the future.
Our
management and other affiliates have significant control of our common stock and
could significantly influence our actions in a manner that conflicts with our
interests and the interests of other stockholders.
As of
September 30, 2010, our executive officers, directors and affiliated entities
together beneficially own approximately 45.0% of the outstanding shares of our
common stock, assuming the exercise of options and warrants which are currently
exercisable or will become exercisable within 60 days of September 30, 2010,
held by these stockholders. As a result, these stockholders, acting
together, will be able to exercise significant influence over matters requiring
approval by our stockholders, including the election of directors, and may not
always act in the best interests of other stockholders. Such a
concentration of ownership may have the effect of delaying or preventing a
change in control of us, including transactions in which our stockholders might
otherwise receive a premium for their shares over then current market
prices.
A
significant portion of our total outstanding shares of common stock may be sold
in the market in the near future, which could cause the market price of our
common stock to drop significantly.
As of
September 30, 2010, we had 64,302,322 shares of our common stock issued and
outstanding and 6,052 shares of convertible preferred stock outstanding which
can convert into 18,912,500 shares of common stock. Approximately
34,164,431 shares of such shares are registered pursuant to registration
statements on Form S-3 and 49,050,391 of which are either eligible to be sold
under SEC Rule 144 or are in the public float. In addition, we have
registered 35,890,007 shares of our common stock underlying warrants previously
issued on Form S-3 registration statements and we registered 11,137,200 shares
of our common stock underlying options granted or to be granted under our stock
option plan. Consequently, sales of substantial amounts of our common
stock in the public market, or the perception that such sales could occur, may
have a material adverse effect on our stock price.
Our
common stock has a limited trading market, which could limit your ability to
resell your shares of common stock at or above your purchase price.
Our
common stock is quoted on the NYSE Amex Exchange and currently has a limited
trading market. The NYSE Amex Exchange requires us to meet minimum
financial requirements in order to maintain our listing. Currently,
we meet the continued listing requirements of the NYSE Amex
Exchange. However, if we do not continue to meet the continued
listing standards, we could be delisted. We cannot assure you that an
active trading market will develop or, if developed, will be
maintained. As a result, our stockholders may find it difficult to
dispose of shares of our common stock and, as a result, may suffer a loss of all
or a substantial portion of their investment.
The
market price of our common stock may fluctuate and may drop below the price you
paid.
We cannot
assure you that you will be able to resell the shares of our common stock at or
above your purchase price. The market price of our common stock may
fluctuate significantly in response to a number of factors, some of which are
beyond our control. These factors include:
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quarterly
variations in operating results;
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the
progress or perceived progress of our research and development
efforts;
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changes
in accounting treatments or
principles;
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announcements
by us or our competitors of new technology, product and service offerings,
significant contracts, acquisitions or strategic
relationships;
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additions
or departures of key personnel;
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future
offerings or resales of our common stock or other
securities;
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stock
market price and volume fluctuations of publicly-traded companies in
general and development companies in particular;
and
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general
political, economic and market
conditions.
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For
example, during the year ended June 30, 2010, our common stock traded between
$0.25 per share and $0.83 per share.
Because
we do not intend to pay, and have not paid, any cash dividends on our shares of
common stock, our stockholders will not be able to receive a return on their
shares unless the value of our common stock appreciates and they sell their
shares.
We have
never paid or declared any cash dividends on our common stock, and we intend to
retain any future earnings to finance the development and expansion of our
business. We do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Therefore, our stockholders
will not be able to receive a return on their investment unless the value of our
common stock appreciates and they sell their shares.
Our
stockholders may experience substantial dilution as a result of the conversion
of convertible preferred stock, the exercise of options and warrants to purchase
our common stock, or due to anti-dilution provisions relating to any on the
foregoing.
As of
September 30, 2010, we have outstanding 6,052 shares of convertible preferred
stock which may convert into 18,912,500 shares of our common stock and warrants
to purchase 55,471,226 shares of our common stock. In addition, as of
September 30, 2010, we have reserved 15,204,884 shares of our common stock for
issuance upon the exercise of options granted or available to be granted
pursuant to our stock option plan, all of which may be granted in the
future. The conversion of the convertible preferred stock and the exercise
of these options and warrants will result in dilution to our existing
stockholders and could have a material adverse effect on our stock price. The
conversion price of the convertible preferred stock and certain warrants are
also subject to certain anti-dilution adjustments.
USE
OF PROCEEDS
Except as
described in any free writing prospectus that we may authorize to be provided to
you, we currently intend to use the net proceeds from the sale of the securities
offered by us hereunder for working capital and other general corporate
purposes.
We have
not determined the amounts we plan to spend on any of the areas listed above or
the timing of these expenditures. As a result, our management will have broad
discretion to allocate the net proceeds from this offering. Pending application
of the net proceeds as described above, we expect to invest the net proceeds in
short-term, interest-bearing, investment-grade securities pursuant to our
investment policy.
DILUTION
Our net
tangible book value as of September 30, 2010 was $2,547,826 million, or $ 0.04
per share of common stock. Net tangible book value per share is calculated by
subtracting our total liabilities from our total tangible assets, which is total
assets less intangible assets, and dividing this amount by the number of shares
of common stock outstanding. After giving effect to the sale of our common stock
in the aggregate amount of $5.5 million at an assumed offering price of $0.29
per share, the last reported sale price of our common stock on the NYSE Amex on
December 16, 2010, and after deducting estimated offering commissions and
expenses payable by us, our net tangible book value as of September 30, 2010
would have been $7,617,826 million, or $0.091 per share of common stock. This
represents an immediate increase in the net tangible book value of $0.051 per
share to our existing stockholders and an immediate and substantial dilution in
net tangible book value of $0.199 per share to new investors. The following
table illustrates this per share dilution:
Assumed
offering price per share
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$ |
0.29 |
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Net
tangible book value per share as of September 30, 2010
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$ |
2,547,826 |
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Increase
per share attributable to new investors
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$ |
5,070,000 |
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As-adjusted
net tangible book value per share after this offering
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$ |
7,617,826 |
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Net
dilution per share to new investors
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$ |
0.199 |
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The table
above assumes for illustrative purposes that an aggregate of 18,965,517 shares
of our common stock are sold at a price of $0.29 per share, the last reported
sale price of our common stock on the NYSE Amex on December 16, 2010, for
aggregate gross proceeds of $5.5 million. The shares sold in this offering, if
any, will be sold from time to time at various prices. An increase of $0.05 per
share in the price at which the shares are sold from the assumed offering price
of $0.29 per share shown in the table above, assuming all of our common stock in
the aggregate amount of $5.5 million is sold at that price, would increase our
adjusted net tangible book value per share after the offering to $0.095 per
share and would decrease the dilution in net tangible book value per share to
new investors in this offering to $0.195 per share, after deducting commissions
and estimated aggregate offering expenses payable by us. A decrease of $0.05 per
share in the price at which the shares are sold from the assumed offering price
of $0.29 per share shown in the table above, assuming all of our common stock in
the aggregate amount of $6.0 million is sold at that price, would decrease our
adjusted net tangible book value per share after the offering to $0.087 per
share and would increase the dilution in net tangible book value per share to
new investors in this offering to $0.203 per share, after deducting commissions
and estimated aggregate offering expenses payable by us. This information is
supplied for illustrative purposes only.
The
calculations above are based upon 64,302,322 shares of common stock outstanding
as of September 30, 2010 and exclude:
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18,912,500
shares of common stock issuable upon the conversion of 6,052 shares of
convertible preferred stock;
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55,471,226
shares of common stock underlying outstanding
warrants;
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7,269,172
shares of common stock underlying options issued;
and
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7,935,712
shares of common stock underlying options reserved but
unissued.
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PLAN
OF DISTRIBUTION
We have
entered into a At the Market Issuance Agreement with McNicoll Lewis & Vlak,
or MLV, under which we may issue and sell our common stock having aggregate
sales proceeds of up to $5.5 million from time to time through MLV acting as
agent. The form of the sales agreement will be filed as an exhibit to a report
filed under the Exchange Act and incorporated by reference in this prospectus
supplement. The sales, if any, of shares made under the sales agreement will be
made on the NYSE Amex by means of ordinary brokers’ transactions at market
prices. We may instruct MLV not to sell common stock if the sales cannot be
effected at or above the price designated by us from time to time. We or MLV may
suspend the offering of common stock upon notice and subject to other
conditions. As an agent, MLV will not engage in any transactions that stabilize
the price of our common stock.
Pursuant
to a requirement of the Financial Industry Regulatory Authority, or FINRA, the
maximum commission or discount to be received by any FINRA member or independent
broker/dealer may not be greater than 8% of the gross proceeds received by the
offeror for the sale of any securities being registered pursuant to SEC Rule 415
under the Securities Act of 1933, as amended. We will pay MLV commissions for
its services in acting as agent in the sale of common stock. MLV will be
entitled to compensation at a commission rate of up to 6% of the gross sales
price per share sold, depending on the sales price per share. We estimate that
the total expenses for the offering, excluding compensation payable to MLV under
the terms of the sales agreement, will be approximately $100,000.
Settlement
for sales of common stock will occur on the third business day following the
date on which any sales are made, or on some other date that is agreed upon by
us and MLV in connection with a particular transaction, in return for payment of
the net proceeds to us. There is no arrangement for funds to be received in an
escrow, trust or similar arrangement.
MLV will
act as sales agent on a reasonable efforts basis. In connection with the sale of
the common stock on our behalf, MLV may, and will with respect to sales effected
in an “at the market offering,” be deemed to be an “underwriter” within the
meaning of the Securities Act and the compensation of MLV may be deemed to be
underwriting commissions or discounts. We have agreed to provide indemnification
and contribution to MLV against certain civil liabilities, including liabilities
under the Securities Act. We have also agreed to reimburse MLV for certain other
specified expenses. We also have agreed to reimburse a portion of MLV’s expenses
in connection with the offering, up to an aggregate amount of
$25,000
The
offering pursuant to the sales agreement will terminate upon the earlier of
(i) the sale of all common shares subject to the agreement, or
(ii) termination of the sales agreement as permitted therein.
MLV,
formed in July 2009 and registered as a broker-dealer in January 2010, is an
independent full service investment bank and institutional broker dealer located
in New York. Its banking and research divisions focus on the energy,
infrastructure, healthcare, and life sciences sectors. It has served as agent or
co-agent for approximately 15 publicly filed at-the-market offerings of equity
securities since registering as a broker-dealer. MLV has no relationship with us
other than its current role as a sales agent for our at-the-market offering of
common stock. MLV and its affiliates may in the future provide
various investment banking, commercial banking and other financial services for
us and our affiliates, for which services they may in the future receive
customary fees. To the extent required by Regulation M, MLV will not engage
in any market making activities involving our common stock while the offering is
ongoing under this prospectus supplement.
LEGAL
MATTERS
The
validity of the shares of common stock being offered has been passed upon for us
by Morgan, Lewis & Bockius LLP, Princeton, New Jersey. MLV is being
represented in connection with this offering by Holme, Roberts & Owen LLP,
Denver, Colorado.
EXPERTS
McGladrey
& Pullen, LLP, independent registered public accounting firm, has audited
our consolidated financial statements included in our Annual Report on
Form 10-K for the year ended June 30, 2010, as set forth in their report,
which is incorporated by reference in this prospectus supplement and elsewhere
in the registration statement. Our financial statements are incorporated by
reference in reliance on McGladrey & Pullen, LLP’s report, given on their
authority as experts in accounting and auditing.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
This
prospectus supplement is part of a registration statement on Form S-3 that we
filed with the SEC. The registration statement that contains this prospectus
supplement, including the exhibits to the registration statement, contains
additional information about us and the securities offered by this prospectus
supplement.
We file
annual, quarterly and special reports, proxy statements and other information
with the SEC. You may read and copy any document we file with the SEC at the
SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for further information on the Public
Reference Room. The SEC maintains an Internet site that contains reports, proxy
and information statements, and other information regarding issuers that file
electronically with the SEC, including Senesco Technologies, Inc. The SEC’s
Internet site can be found at
http://www.sec.gov.
PROSPECTUS
$25,000,000
WARRANTS
PREFERRED
STOCK
COMMON
STOCK
Senesco
Technologies, Inc. may from time to time offer to sell warrants, preferred stock
and/or common stock, separately or together in one or more combinations. The
warrants and preferred stock may be convertible into or exercisable or
exchangeable for common stock or preferred stock or other securities of Senesco
Technologies, Inc. or any other party identified in the applicable prospectus
supplement.
Our
common stock is traded on the NYSE Amex under the symbol “SNT”. The last
reported sale of our common stock on the NYSE Amex on October 25, 2010 was
$0.2312 per share. Our principal offices are located at 303 George
Street, Suite 420, New Brunswick, New Jersey 08901. Our telephone number is
(732) 296-8400.
The total
amount of warrants, preferred stock and common stock will have an initial
aggregate offering price of up to $25,000,000, or the equivalent amount in other
currencies, currency units or composite currencies.
The
securities covered by this prospectus may be offered and sold to or through one
or more underwriters, dealers and agents, or directly to purchasers, on a
continuous or delayed basis.
This
prospectus describes some of the general terms that may apply to these
securities and the general manner in which they may be offered. The specific
terms of any securities to be offered, and the specific manner in which they may
be offered, will be described in one or more supplements to this
prospectus.
The
aggregate market value of our outstanding common equity held by non-affiliates
on October 25, 2010 was approximately $12,045,105. We have not issued any
securities pursuant to Instruction I.B.6 of Form S-3 during the 12 calendar
month period that ends on and includes the date hereof.
INVESTING
IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. RISKS ASSOCIATED WITH AN
INVESTMENT IN OUR SECURITIES WILL BE DESCRIBED IN THE APPLICABLE PROSPECTUS
SUPPLEMENT AND CERTAIN OF OUR FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION, AS DESCRIBED UNDER THE SECTION ENTITLED “RISK FACTORS” ON PAGE 13 OF
THIS PROSPECTUS. THE PROSPECTUS SUPPLEMENT APPLICABLE TO EACH TYPE OR
SERIES OF SECURITIES WE OFFER MAY CONTAIN A DISCUSSION OF ADDITIONAL RISKS
APPLICABLE TO AN INVESTMENT IN US AND THE PARTICULAR TYPE OF SECURITIES WE ARE
OFFERING UNDER THAT PROSPECTUS SUPPLEMENT.
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 ,
2010
EXPLANATORY
NOTE
The
prospectus contained herein relates to the general description of warrants,
preferred stock and common stock issuable by Senesco Technologies,
Inc.
To the
extent required, the information in the prospectus, including financial
information, will be updated at the time of each offering. Upon each such
offering, a prospectus supplement to the base prospectus will be
filed.
TABLE
OF CONTENTS
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Page
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
SENESCO TECHNOLOGIES, INC
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1
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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13
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RISK
FACTORS
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13
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DESCRIPTION
OF THE SECURITIES WE MAY OFFER
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24
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WARRANTS
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24
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PREFERRED
STOCK
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27
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COMMON
STOCK
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29
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BOOK-ENTRY
PROCEDURES AND SETTLEMENT
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30
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USE
OF PROCEEDS
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32
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PLAN
OF DISTRIBUTION
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32
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WHERE
YOU CAN FIND MORE INFORMATION; INCORPORATION OF DOCUMENTS BY
REFERENCE
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34
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LEGAL
MATTERS
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35
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EXPERTS
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35
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You
should rely only on the information provided in this prospectus and the
prospectus supplement, as well as the information incorporated by reference. We
have not authorized anyone to provide you with different information. We are not
making an offer of these securities in any jurisdiction where the offer is not
permitted. You should not assume that the information in this prospectus, the
prospectus supplement or any documents incorporated by reference is accurate as
of any date other than the date of the applicable document.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with
the U.S. Securities and Exchange Commission, referred to herein as the SEC,
using a “shelf” registration process. Under a shelf registration
process, we may issue, in one or more offerings, any combination of senior or
subordinated warrants, preferred stock or common stock, collectively referred to
herein as the securities, up to a total dollar amount of
$25,000,000.
Each time
we sell these securities we will provide you with a prospectus supplement
containing specific information about the terms of each such
sale. This prospectus may not be used to sell any of the securities
unless accompanied by a prospectus supplement. The prospectus
supplement also may add, update or change information in this prospectus. If
there is any inconsistency between the information in the prospectus and the
prospectus supplement, you should rely on the information in the prospectus
supplement. You should read both this prospectus and any prospectus
supplement together with additional information described under the heading
“Where You Can Find More Information; Incorporation of Documents by Reference”
beginning on page 34 of this prospectus.
Unless
otherwise indicated or unless the context otherwise requires, all references in
this prospectus to “we,” “us,” or similar references mean Senesco Technologies,
Inc. and our subsidiaries.
You
should rely only on the information contained in this prospectus or in a
prospectus supplement or amendment. We have not authorized anyone to provide you
with information different from that contained or incorporated by reference in
this prospectus. We may offer to sell, and seek offers to buy these securities
only in jurisdictions where offers and sales are permitted. The information
contained in this prospectus or a prospectus supplement or amendment or
incorporated herein by reference is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or of any sale
of securities.
ABOUT
SENESCO TECHNOLOGIES, INC.
GENERAL
Our
Business
The
primary business of Senesco Technologies, Inc., a Delaware corporation
incorporated in 1999, and its wholly-owned subsidiary, Senesco, Inc., a New
Jersey corporation incorporated in 1998, collectively referred to as “Senesco,”
“we,” “us” or “our,” is to utilize our patented and patent-pending genes,
primarily eucaryotic translation initiation Factor 5A, or Factor 5A, and
deoxyhypusine synthase, or DHS, and related technologies for inhibition in human
health applications to develop novel approaches to treat inflammatory diseases
and cancer.
In
agricultural applications we are developing and licensing Factor 5A, DHS and
Lipase to enhance the quality and productivity of fruits, flowers, and
vegetables and agronomic crops through the control of cell death, referred to
herein as senescence, and growth in plants.
Human
Health Applications
We
believe that our gene technology could have broad applicability in the human
health field, by either inducing or inhibiting apoptosis. Inducing
apoptosis may be useful in treating certain forms of cancer because the
cancerous cells have failed to initiate apoptosis on their own due to damaged or
inhibited apoptotic pathways. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis.
We have
commenced preclinical in-vivo and in-vitro research to
determine the ability of Factor 5A to regulate key execution genes,
pro-inflammatory cytokines, receptors, and transcription factors, which are
implicated in numerous apoptotic diseases.
Certain
preclinical human health results to date include:
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Performing efficacy,
toxicological and dose-finding studies in mice for our potential multiple
myeloma drug candidate, SNS-01-T. SNS-01-T is a
nano-encapsulated combination therapy of Factor 5A and an siRNA against
Factor 5A. Our efficacy study in severe combined
immune-deficient (“SCID”) mice with subcutaneous human multiple myeloma
tumors tested SNS-01-T dosages ranging from 0.15 mg/kg to 1.5
mg/kg. In these studies, mice treated with a dose of either
0.75 mg/kg or 1.5 mg/kg both showed a 91% reduction in tumor volume and a
decrease in tumor weight of 87% and 95%, respectively. For mice
that received smaller doses of either 0.38 mg/kg or 0.15 mg/kg, there was
also a reduction in tumor volume (73% and 61%, respectively) and weight
(74% and 36%, respectively). All of the treated mice,
regardless of dose, survived. This therapeutic dose range study
provided the basis for an 8-day maximum tolerated dose study in which
normal mice received two intravenous doses of increasing amounts of
SNS-01-T (from 2.2 mg/kg). Body weight, organ weight and serum
levels of liver enzymes were used as clinical indices to assess
toxicity. A dose between 2.2 mg/kg and 2.9 mg/kg was well
tolerated with respect to these clinical indices, and the survival rate at
2.9 mg/kg was 80%. Those mice receiving above 2.9 mg/kg of
SNS-01-T showed evidence of morbidity and up to 80%
mortality. The 2.9 mg/kg threshold, twice the upper end of the
proposed therapeutic dose range, was therefore determined to be the
maximum tolerated dose in
mice;
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Demonstrated significant tumor
regression and diminished rate of tumor growth of multiple myeloma tumors
in SCID mice treated with Factor 5A technology encapsulated in
nanoparticles;
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Increased median survival by
approximately 250% in a tumor model of mice injected with melanoma cancer
cells;
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Induced apoptosis in both human
cancer cell lines derived from tumors and in lung tumors in
mice;
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Induced apoptosis of cancer cells
in a human multiple myeloma cell line in the presence of
IL-6;
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Measured VEGF reduction in mouse
lung tumors as a result of treatment with our
genes;
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Decreased ICAM and activation of
NFkB in cancer cells employing siRNA against Factor
5A;
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Increased the survival rate in
H1N1 mouse influenza survival studies from 14% in untreated mice to 52% in
mice treated with our siRNA against Factor 5A. Additionally,
the treated mice reversed the weight loss typically seen in infected mice
and had other reduced indicators of disease severity as measured by blood
glucose and liver enzymes;
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Increased the survival, while
maintaining functionality, of mouse pancreatic islet cells isolated for
transplantation, using intraperitoneal administration of our
technology. Initial animal studies have shown that our
technology administered prior to harvesting beta islet cells from a mouse,
has a significant impact not only on the survival of the beta islet cells,
but also on the retention of the cells’ functionality when compared to the
untreated beta islet cells. Additional studies have shown that
the treated beta islet cells survive a pro-inflammatory cytokine
challenge, while maintaining their functionality with respect to insulin
production. These further studies also revealed Factor-5A’s
involvement in the modulation of inducible nitric oxide synthase (iNOS),
an important indicator of inflammation;
and
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Increased the survival rate of
mice in a lethal challenge sepsis model. Additionally, a broad
spectrum of systemic pro-inflammatory cytokines were down-regulated, while
not effecting the anti-inflammatory cytokine
IL-10.
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Accelerating
Apoptosis
The data
from our pre-clinical studies indicate that the up-regulation of Factor 5A
induces cell death in cancer cells through both the p53 (intrinsic) and cell
death receptor (extrinsic) apoptotic pathways. Tumors arise when abnormal cells
fail to undergo apoptosis due to an inability to activate their apoptotic
pathways. Just as the Factor 5A gene appears to facilitate expression of the
entire suite of genes required for programmed cell death in plants, the Factor
5A gene appears to regulate expression of a suite of genes required for
programmed cell death in human cells. Because the Factor 5A gene appears to
function at the initiation point of the apoptotic pathways, both intrinsic and
extrinsic, we believe that our gene technology has potential application as a
means of combating a broad range of cancers. Based on the results
obtained through our in-vitro studies, we have
found that up-regulating Factor 5A results in: (i) the up-regulation of p53;
(ii) increased inflammatory cytokine production; (iii) increased cell death
receptor formation; and (iv) increased caspase activity. These
features, coupled with a simultaneous down-regulation Bcl-2, result in apoptosis
of cancer cells. In addition, our in-vitro studies have shown
that the up-regulation of Factor 5A also down-regulates VEGF, a growth factor
which allows tumors to develop additional vascularization needed for growth
beyond a small mass of cells.
Inhibiting
Apoptosis
Our
preclinical studies indicate that down-regulation of our proprietary Factor 5A
gene may have potential application as a means for controlling the effects of a
broad range of diseases that are attributable to premature cell death, ischemia,
or inflammation. Such inflammatory diseases include glaucoma, heart disease, and
other certain inflammatory diseases such as Crohn’s disease, sepsis and diabetic
retinopathy. We have performed preclinical research of certain
inflammatory diseases. Using small inhibitory RNA’s, or siRNA’s, against Factor
5A to inhibit its expression, the results of our studies have indicated a
reduction in pro-inflammatory cytokine formation and the formation of receptors
for LPS, interferon-gamma and TNF-alpha. Our studies have also
indicated that by inhibiting Factor 5A, iNOS, MAPK, NFkB, JAK1 and ICAM are
downregulated, which decreases the inflammatory cytokines formed through these
pathways. Additionally, a mouse study has indicated that our siRNA is comparable
to a steroid and to a prescription anti-TNF drug in its ability to reduce
cytokine response to LPS. Other mouse studies have also indicated
that the siRNA against Factor 5A (i) protects thymocyte cells from apoptosis and
decreases formation of MPO, TNF-a, MIP-1alpha, and IL-1 in the lungs of mice
challenged with LPS and (ii) increases the survival rate in which sepsis was
induced by a lethal injection of LPS and (iii) reduces blood serum levels of
inflammatory proteins, such as IL-1, IL-2, IL-6, IL-12, TNF-a, IFNg and
MIP-1alpha, while not effecting IL-10, an anti-inflammatory
cytokine. Other experiments utilizing siRNA to Factor 5A include
inhibition of or apoptosis during the processing of mouse pancreatic beta islet
cells for transplantation, and the inhibition of early inflammatory changes
associated with type-1 diabetes in an in-vivo rat model.
Proteins
required for cell death include p53, interleukins, TNF-a and other cytokines and
caspases. Expression of these cell death proteins is required for the
execution of apoptosis. Based on our studies, we believe that
down-regulating Factor 5A by treatment with siRNA inhibits the expression of
p53, a major cell death transcription factor that in turn controls the formation
of a suite of other cell death proteins. In addition, we believe
that the down-regulation of Factor 5A up-regulates Bcl-2, a suppressor of
apoptosis.
Human
Health Target Markets
We
believe that our gene technology may have broad applicability in the human
health field, by either accelerating or inhibiting
apoptosis. Accelerating apoptosis may be useful in treating certain
forms of cancer because the body’s immune system is not able to force cancerous
cells to undergo apoptosis. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis, including diabetes, diabetic retinopathy and
lung inflammation, among others.
We are
advancing our research in multiple myeloma with the goal of initiating a Phase I
clinical trial, and may select additional human health indications to bring into
clinical trials. We believe that the success of our future operations will
likely depend on our ability to transform our research and development
activities into a commercially feasible technology.
Human
Health Research Program
Our human
health research program, which has consisted of pre-clinical in-vitro and in-vivo experiments designed
to assess the role and method of action of the Factor 5A genes in human
diseases, is being performed by approximately nine (9) third party researchers,
at our direction, at Mayo Clinic, our contract research organization (Cato
Research) and the University of Waterloo. Additionally, we outsource
certain projects, such as our pivotal toxicity studies, to other third party
research organizations.
Our
research and development expenses incurred on human health applications were
approximately 79% of our total research and development expenses for the year
ended June 30, 2010. Our research and development expenses incurred
on human health applications were approximately 74% of our total research and
development expenses for the year ended June 30, 2009. Our research
and development expenses incurred on human health applications were
approximately 56% of our total research and development expenses for the year
ended June 30, 2008. Since inception, the proportion of our research
and development expenses on human health applications has increased, as compared
to our research and development expenses on agricultural
applications. This change is primarily due to the fact that our
research focus on human health has increased and some of our research costs for
plant applications have shifted to our license partners.
Our
planned future research and development initiatives for human health
include:
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Multiple Myeloma. Our
objective is to advance our technology for the potential treatment of
multiple myeloma with the goal of initiating a clinical
trial. In connection with the potential clinical trial, we have
engaged a clinical research organization, or CRO, to assist us through the
process. We have also determined the delivery system for our
technology, contracted for the supply of pharmaceutical grade materials to
be used in toxicology and human studies, performed certain toxicology
studies, and have contracted with a third party laboratory to conduct
additional toxicology studies. Together with the assistance of
our CRO, we will have additional toxicology studies performed with the
goal of filing an investigational new drug application, or IND
application, with the U.S. Food and Drug Administration, or FDA, for their
review and consideration in order to initiate a clinical
trial. We estimate that it will take approximately six (6)
months from June 30, 2010 to complete these
objectives.
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Other. We may continue
to look at other disease states in order to determine the role of Factor
5A.
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In order
to pursue the above research initiatives, as well as other research initiatives
that may arise, we completed a private placement of convertible preferred stock
and warrants on April 1, 2010 and June 2, 2010. However, it may be
necessary for us to raise a significant amount of additional working capital in
the future. If we are unable to raise the necessary funds, we may be
required to significantly curtail the future development of some of our research
initiatives and we will be unable to pursue other possible research
initiatives.
We may
further expand our research and development program beyond the initiatives
listed above to include other research centers.
Human
Health Suppliers
The
materials for our SNT-01T therapeutic for multiple myeloma consists of three
parts: Factor 5A plasmid, siRNA against Factor 5A, and a
nano-particle. We have entered into supply agreements for the
components as follows:
On June
27, 2008, the Company entered into a supply agreement with VGXI, Inc. (“VGXI”)
under which VGXI will supply the Company with the plasmid portion of the
Company’s combination therapy consisting of the Factor 5A gene and siRNA against
Factor 5A (the “Plasmid Product”). The agreement has an
initial term that commences on the date of the agreement and runs for a period
of five (5) years. The agreement shall, upon mutual agreement, renew
for consecutive one (1) year periods thereafter. The Company’s
financial obligation under the agreement is dependent upon the amount of Plasmid
Product ordered by the Company.
On June
30, 2008, the Company entered into a supply agreement with POLYPLUS under which
POLYPLUS will supply the Company with its “in vivo-jetPEI” (the “Product”),
which is used for systemic delivery of the Company’s combination therapy of
siRNA against Factor 5A and a plasmid of the Factor 5A gene. The
agreement has an initial term which commences on the date of the agreement and
runs until the eighth anniversary of the first sale of the
Product. The agreement shall automatically renew for consecutive one
(1) year periods thereafter, except if terminated by either party upon six (6)
months written notice prior to the initial or any subsequent renewal
term. The Company’s financial obligation under the agreement is
dependent upon the amount of Product ordered by the Company.
On
September 4, 2008, the Company entered into a supply agreement with AVECIA under
which AVECIA will supply the Company with the siRNA portion of the Company’s
combination therapy consisting of the Factor 5A gene and siRNA against Factor 5A
(the “Plasmid Product”). The agreement has a term which commences on
the date of the agreement and terminates on the later of the completion of all
services to be provided under the agreement or 30 days following delivery of the
final shipment of product.
Human
Health Competition
Our
competitors in human health that are presently attempting to distribute their
technology have generally utilized one of the following distribution
channels:
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Entering into strategic
alliances, including licensing technology to major marketing and
distribution partners; or
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Developing in-house production
and marketing capabilities.
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In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
There are
many large companies and development stage companies working in the field of
apoptosis research including: Amgen Inc., Centocor, Inc., Genzyme Corporation,
OSI Pharmaceuticals, Inc., Novartis AG, Introgen Therapeutics, Inc., Genta,
Incorporated, and Vertex Pharmaceuticals, Inc., amongst others.
We do not
currently have any commercialized products, and therefore, it is difficult to
assess our competitive position in the market. However, we believe
that if we are able to develop and commercialize a product or products under our
patents to our Factor 5A platform technology, we will have a competitive
position in the markets in which we will operate.
Agricultural
Applications
Our
agricultural research focuses on the discovery and development of certain gene
technologies, which are designed to confer positive traits on fruits, flowers,
vegetables, forestry species and agronomic crops. To date, we have
isolated and characterized the senescence-induced Lipase gene, DHS, and Factor
5A in certain species of plants. Our goal is to modulate the expression of these
genes in order to achieve such traits as extended shelf life, increased biomass,
increased yield and increased resistance to environmental stresses and disease,
thereby demonstrating proof of concept in each category of crop.
Certain
agricultural results to date include:
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longer shelf life of perishable
produce;
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increased biomass and seed
yield;
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greater tolerance to
environmental stresses, such as drought and soil
salinity;
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|
greater tolerance to certain
fungal and bacterial
pathogens;
|
|
·
|
more efficient use of fertilizer;
and
|
|
·
|
advancement to field trials in
banana, and trees.
|
The
technology presently utilized by the industry for increasing the shelf life in
certain flowers, fruits and vegetables relies primarily on reducing ethylene
biosynthesis, and therefore only has application to the crops that are
ethylene-sensitive. Because Factor 5A, DHS and Lipase are already
present in all plant cells, our technology may be incorporated into crops by
using either conventional breeding methods (non-genetically modified) or
biotechnology techniques.
We have
licensed this technology to various strategic partners and have entered into a
joint collaboration. We may continue to license this technology, as
opportunities present themselves, to additional strategic partners and/or enter
into additional joint collaborations or ventures. Our commercial
partners have licensed our technology for use in turfgrass, canola, corn,
soybean, cotton, banana, alfalfa, rice and certain species of trees and bedding
plants, and we have obtained proof of concept for enhanced post harvest shelf
life, seed yield, biomass, and resistance to disease in several of these plant
species.
We have
ongoing field trials of certain trees and bananas with our respective
partners. The initial field trials conducted with ArborGen over a
five year period in certain species of trees have concluded and the trees have
been harvested for wood quality assessment. Preliminary data from our
joint field trials show significantly enhanced growth rates in some of the trees
relative to controls. Selected trees from the field trials were
harvested and their wood chemistry and density was assessed. There
were no differences in key economic characteristics of wood, such as lignin,
cellulose and specific gravity, between the trees with the enhanced growth
attributes and untreated control trees, which indicates that the faster growth
does not result in lower wood quality. Additional field trials for
enhanced growth rates and other traits are currently being performed with
ArborGen.
To date,
banana field trials have indicated that our technology extends the shelf life of
banana fruit by 100%. In addition to the post harvest shelf life
benefits, an additional field trial generated encouraging disease tolerance data
specific to Black Sigatoka (Black Leaf Streak Disease), for banana plants.
Additional field trials for banana plants are ongoing for the combined traits of
disease resistance and shelf life extension.
Commercialization
by our partners may require a combination of traits in a crop, such as both post
harvest shelf life and disease resistance, or other traits. Our
near-term research and development initiatives include modulating the expression
of DHS and Factor 5A genes in these plants and then propagation and phenotype
testing of such plants.
Our
ongoing research and development initiatives for agriculture include assisting
our license and joint collaboration partners to:
|
·
|
further develop and implement the
DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass,
bedding plants, rice, alfalfa, corn, soybean and trees;
and
|
|
·
|
test the resultant crops for new
beneficial traits such as increased yield, increased tolerance to
environmental stress, disease resistance and more efficient use of
fertilizer.
|
Agricultural
Target Markets
In order
to address the complexities associated with marketing and distribution in the
worldwide market, we have adopted a multi-faceted commercialization strategy, in
which we have entered into and plan to enter into, as the opportunities present
themselves, additional licensing agreements or other strategic relationships
with a variety of companies or other entities on a crop-by-crop
basis. We anticipate revenues from these relationships in the form of
licensing fees, royalties, usage fees, or the sharing of gross
profits. In addition, we anticipate payments from certain of our
partners upon their achievement of certain research and development
benchmarks. This commercialization strategy allows us to generate
revenue at various stages of product development, while ensuring that our
technology is incorporated into a wide variety of crops. Our optimal
partners combine the technological expertise to incorporate our technology into
their product line along with the ability to successfully market the enhanced
final product, thereby eliminating the need for us to develop and maintain a
sales force.
Because
the agricultural market is dominated by privately held companies or subsidiaries
of foreign owned companies, market size and market share data for the crops
under our license and development agreements is not readily
available. Additionally, because we have entered into confidentiality
agreements with our license and development partners, we are unable to report
the specific financial terms of the agreements as well as any market size and
market share data that our partners may have disclosed to us regarding their
companies.
Agricultural
Development and License Agreements
Through
June 30, 2010, we have entered into eight (8) license agreements and one (1)
joint collaboration with established agricultural biotechnology companies and an
established ethanol company.
On August
6, 2007, we entered into a license agreement with Monsanto Company for the
development and commercialization of corn and soy. Under the terms of
the agreement, we received an upfront payment, are entitled to royalty payments
in the low single digits and potential milestone payments upon achievement of
certain development milestones. The agreement contains standard
termination provisions, and the term of the agreement runs until the expiration
of the patents licensed under the agreement (2019 in the United States and 2025
outside the United States).
On
December 21, 2006, we entered into a license agreement with Arborgen, LLC
regarding the growth and development of trees (other than edible fruit and nut
production). Under the terms of the agreement, we received three
fixed payments and are entitled to royalty payments in the mid single
digits. The agreement contains standard termination provisions, and
the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
On March
8, 2004, we entered into a development and license agreement with The Scotts
Company for the development and commercialization of garden plants, potted
plants and turf grass (excluding forage grasses). Under the terms of
the agreement, we are entitled to certain benchmark payments upon various
anniversaries of the date of execution as well as upon achievement of certain
commercial milestones. We are also entitled to royalty payments in
the low to mid single digits. The agreement contains standard
termination provisions, and the term of the agreement runs until the expiration
of the patents licenses under the agreement (2019 in the United States and 2024
outside of the United States).
On July
17, 2007, we entered into a license agreement with Bayer CropScience AG for the
development and commercialization of rice. Under the terms of the
agreement, we are entitled to royalty payments of a dollar value per unit and
potential milestone payments upon the achievement of certain development
milestones. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
On August
30, 2007, we entered into a license agreement with Bayer CropScience AG for the
development and commercialization of cotton. Under the terms of the
agreement, we are entitled to royalty payments in the low to mid single digits
and potential milestone payments upon the achievement of certain development
milestones. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
On
November 8, 2006, we entered into a license agreement with Bayer CropScience
GmbH for the development and commercialization of Brassica. Under the
terms of the agreement, we are entitled to receive potential milestone payments
upon the achievement of certain development and commercialization milestones and
a share of Bayer’s income related to our license. The agreement
contains standard termination provisions, and the term of the agreement runs
until the expiration of the patents licensed under the agreement (2019 in the
United States and 2024 outside the United States).
On
October 14, 2004, we entered into a development and license agreement with Broin
and Associates, Inc. for the development and commercialization of certain inputs
in connection with the manufacturing process for ethanol. Under the
terms of the agreement, we are entitled to payments based on the usage of our
intellectual property at Broin’s facilities. The agreement contains
standard termination provisions, and the term of the agreement runs until the
expiration of the patents licensed under the agreement (2019 in the United
States and 2021 outside the United States).
On
September 14, 2002, we entered into a development and license agreement with
Cal/West Seeds for the development and commercialization of alfalfa, medicago
species. Under the terms of the agreement, we are entitled to
potential milestone payments upon the achievement of certain development and
commercialization milestones and a dollar amount of royalties based upon
production. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2021 outside the United
States).
On May
14, 1999, we entered into an agreement with Rahan Meristem, an Israeli
partnership that is engaged in the worldwide marketing of tissue culture
plants. The purpose of the agreement is to develop enhanced banana
plants which will result in banana fruit with improved consumer and
grower-driven traits. The program has been performed as a joint
collaboration whereby we pay for 50% of the research costs of the program and
upon successful commercialization of banana fruit, we will receive 50% of the
profits, as defined by the agreement.
Agricultural
Research Program
Our
agricultural research and development is performed by four (4) researchers, at
our direction, at the University of Waterloo, where the technology was
developed. Additional agricultural research and development is
performed by our license or joint collaboration partners.
The
discoverer of our technology, John E. Thompson, Ph.D., is the Associate Vice
President, Research and former Dean of Science at the University of Waterloo in
Ontario, Canada, and is our Executive Vice President and Chief Scientific
Officer. Dr. Thompson is also one of our directors and owns 1.8% of
the outstanding shares of our common stock, $0.01 par value, as of June 30,
2010.
On
September 1, 1998, we entered into, and have extended through November 30, 2010,
a research and development agreement with the University of Waterloo and Dr.
Thompson as the principal inventor. The Research and Development
Agreement provides that the University of Waterloo will perform research and
development under our direction, and we will pay for the cost of this work and
make certain payments to the University of Waterloo. In return for
payments made under the Research and Development Agreements, we have all rights
to the intellectual property derived from the research.
Agricultural
Competition
Our
competitors in both human health and agriculture that are presently attempting
to distribute their technology have generally utilized one of the following
distribution channels:
|
·
|
licensing technology to major
marketing and distribution
partners;
|
|
·
|
entering into strategic
alliances; or
|
|
·
|
developing in-house production
and marketing capabilities.
|
In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
Our
competitors in the field of delaying plant senescence are companies that develop
and produce transformed plants with a variety of enhanced
traits. Such companies include: Mendel Biotechnology; Renessen LLC;
Exelixis Plant Sciences, Inc.; and Syngenta International AG; among
others.
We do not
currently have any commercialized products, and therefore, it is difficult to
assess our competitive position in the market. However, we believe
that if we or our licensee’s are able to develop and commercialize a product or
products using our technology, we will have a competitive position in the
markets in which we or our licensee’s operate.
Agricultural
Development Program
Generally,
projects with our licensees and joint venture partner begin by transforming seed
or germplasm to incorporate our technology. Those seeds or germplasm
are then grown in our partners’ greenhouses. After successful
greenhouse trials, our partners will transfer the plants to the field for field
trials. After completion of successful field trials, our partners may
have to apply for and receive regulatory approval prior to initiation of any
commercialization activities.
Generally,
the approximate time to complete each sequential development step is as
follows:
Seed
Transformation
|
|
approximately
1 to 2 years
|
Greenhouse
|
|
approximately
1 to 2 years
|
Field
Trials
|
|
approximately
2 to 5 years
|
The
actual amount of time spent on each development phase depends on the crop, its
growth cycle and the success of the transformation achieving the desired
results. As such, the amount of time for each phase of development
could vary, or the time frames may change.
The
development of our technology with Poet is different than our other licenses in
that we are modifying certain production inputs for ethanol. That
process involves modifying the inputs, testing such inputs in Poet’s production
process and if successful, implementing such inputs in Poet’s production process
on a plant by plant basis.
The
status of each of our projects with our partners is as follows:
Project
|
|
Partner
|
|
Status
|
Banana
|
|
Rahan
Meristem
|
|
|
-
Shelf Life
|
|
|
|
Field
trials
|
-
Disease Resistance
|
|
|
|
Field
trials
|
Trees
|
|
Arborgen
|
|
|
-
Growth
|
|
|
|
Field
trials
|
Alfalfa
|
|
Cal/West
|
|
Greenhouse
|
Corn
|
|
Monsanto
|
|
Proof
of concept ongoing
|
Cotton
|
|
Bayer
|
|
Seed
transformation
|
Canola
|
|
Bayer
|
|
Seed
transformation
|
Rice
|
|
Bayer
|
|
Proof
of concept ongoing
|
Soybean
|
|
Monsanto
|
|
Proof
of concept ongoing
|
Turfgrass
|
|
The
Scotts Company
|
|
Greenhouse
|
Ethanol
|
|
Poet
|
|
Modify
inputs
|
Commercialization
by our partners may require a combination of traits in a crop, such as both
shelf life and disease resistance, or other traits.
Based
upon our commercialization strategy, we anticipate that there may be a
significant period of time before plants enhanced using our technology reach
consumers. Thus, we have not begun to actively market our technology
directly to consumers, but rather, we have sought to establish ourselves within
the industry through presentations at industry conferences, our website and
direct communication with prospective licensees.
Consistent
with our commercialization strategy, we intend to attract other companies
interested in strategic partnerships or licensing our technology, which may
result in additional license fees, revenues from contract research, royalty fees
and other related revenues. Successful future operations will depend
on our ability to transform our research and development activities into a
commercially feasible technology.
Intellectual
Property
We have
twenty-one (21) issued patents from the United States Patent and Trademark
Office, or PTO, and fifty-seven (57) issued patents from foreign countries,
fifty-three (53) of which are for the use of our technology in agricultural
applications and twenty-five (25) of which relate to human health
applications.
In
addition to our seventy-eight (78) patents, we have a wide variety of patent
applications, including divisional applications and continuations-in-part, in
process with the PTO and internationally. We intend to continue our
strategy of enhancing these new patent applications through the addition of data
as it is collected.
Our
agricultural patents are generally set to expire in 2019 in the United States
and 2025 outside the United States. Our core human health technology
patents are set to expire in 2021 in the United States and 2025 outside the
United States, and our patents related to multiple myeloma are set to expire,
both in and outside the United States in 2026. To the extent our
patents have different expiration dates abroad than in the United States, we are
currently developing a strategy to extend the United States expiration dates to
the foreign expiration dates.
Government
Regulation
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies: (i) the U.S. Department of Agriculture regulates the
import, field-testing and interstate movement of specific types of genetic
engineering that may be used in the creation of transformed plants; (ii) the
Environmental Protection Agency regulates activity related to the invention of
plant pesticides and herbicides, which may include certain kinds of transformed
plants; and (iii) the FDA regulates foods derived from new plant
varieties. The FDA requires that transformed plants meet the same
standards for safety that are required for all other plants and foods in
general. Except in the case of additives that significantly alter a
food’s structure, the FDA does not require any additional standards or specific
approval for genetically engineered foods but expects transformed plant
developers to consult the FDA before introducing a new food into the market
place.
In
addition, our ongoing preclinical research with cell lines and lab animal models
of human disease is not currently subject to the FDA requirements that govern
clinical trials. However, use of our technology, if developed for
human health applications, will also be subject to FDA
regulation. Generally, the FDA must approve any drug or biologic
product before it can be marketed in the United States. In addition,
prior to being sold outside of the U.S., any products resulting from the
application of our human health technology must be approved by the regulatory
agencies of foreign governments. Prior to filing a new drug
application or biologics license application with the FDA, we would have to
perform extensive clinical trials, and prior to beginning any clinical trial, we
need to perform extensive preclinical testing which could take several years and
may require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
government regulatory agency. However, we are planning on performing
clinical trials, which would be subject to FDA
approval. Additionally, federal, state and foreign regulations
relating to crop protection products and human health applications developed
through biotechnology are subject to public concerns and political
circumstances, and, as a result, regulations have changed and may change
substantially in the future. Accordingly, we may become subject to
governmental regulations or approvals or become subject to licensing
requirements in connection with our research and development efforts. We may
also be required to obtain such licensing or approval from the governmental
regulatory agencies described above, or from state agencies, prior to the
commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
Liquidity
and Capital Resources
Overview
As of
June 30, 2010, our cash balance totaled $8,026,296, and we had working capital
of $6,001,970. As of June 30, 2010, we had a federal tax loss
carryforward of approximately $41,466,000 and a state tax loss carry-forward of
approximately $34,101,000 to offset future taxable income. We cannot assure you
that we will be able to take advantage of any or all of such tax loss
carryforwards, if at all, in future fiscal years.
Contractual
Obligations
The
following table lists our cash contractual obligations as of June 30,
2010:
|
|
Payments
Due by Period
|
|
Contractual
Obligations
|
|
Total
|
|
|
Less
than
1
year
|
|
|
1 -
3 years
|
|
|
3 -
5 years
|
|
|
More
than
5
years
|
|
Research
and Development Agreements (1)
|
|
$
|
911,401
|
|
|
$
|
911,401
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Facility,
Rent and Operating Leases (2)
|
|
$
|
73,568
|
|
|
$
|
73,568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Employment,
Consulting and Scientific Advisory Board Agreements (3)
|
|
$
|
224,542
|
|
|
$
|
217,042
|
|
|
$
|
7,500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
Contractual Cash Obligations
|
|
$
|
1,209,511
|
|
|
$
|
1,202,011
|
|
|
$
|
7,500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
(1)
|
Certain
of our research and development agreements disclosed herein provide that
payment is to be made in Canadian dollars and, therefore, the contractual
obligations are subject to fluctuations in the exchange
rate.
|
(2)
|
The lease for our office space in
New Brunswick, New Jersey is subject to certain escalations for our
proportionate share of increases in the building’s operating
costs.
|
(3)
|
Certain of our consulting
agreements provide for automatic renewal, which is not reflected in the
table, unless terminated earlier by the parties to the respective
agreements.
|
We expect
our capital requirements to increase significantly over the next several years
as we commence new research and development efforts, increase our business and
administrative infrastructure and embark on developing in-house business
capabilities and facilities. Our future liquidity and capital funding
requirements will depend on numerous factors, including, but not limited to, the
levels and costs of our research and development initiatives and the cost and
timing of the expansion of our business development and administrative
staff.
Effective
September 1, 2010, we extended our research and development agreement with the
University of Waterloo for an additional three-month period through November 30,
2010, in the amount of CAD $164,200 or approximately USD $164,200, which is not
included in the above table of contractual obligations. Research and development
expenses under this agreement aggregated $672,693 for the year ended June 30,
2010, USD $653,104 for the year ended June 30, 2009, USD $730,960 for the year
ended June 30, 2008 and USD $5,953,061 for the cumulative period from inception
through June 30, 2010. Total research and development expenses aggregated
$2,637,407 for the year ended June 30, 2010, $2,353,962 for the year ended June
30, 2009, $1,767,741 for the year ended June 30, 2008 and $14,948,964 for the
cumulative period from inception through June 30, 2010.
Capital
Resources
Since
inception, we have generated revenues of $1,590,000 in connection with the
initial fees and milestone payments received under our license and development
agreements. We have not been profitable since inception, we will
continue to incur additional operating losses in the future, and we will require
additional financing to continue the development and subsequent
commercialization of our technology. While we do not expect to
generate significant revenues from the licensing of our technology for several
years, we may enter into additional licensing or other agreements with marketing
and distribution partners that may result in additional license fees, receive
revenues from contract research, or other related revenue.
License
Agreements
On July
17, 2007 we entered into a license agreement with Bayer CropScience AG for the
development and commercialization of cotton. Under the terms of the
license agreement, we received an upfront payment, will receive milestone
payments upon the achievement of certain development milestones, and
additionally, upon commercialization, a royalty on net sales.
On
August 6, 2007 we entered into a license agreement with Monsanto for the
development and commercialization of corn and soy. Under the terms of
the license agreement, we received an upfront payment, will receive milestone
payments upon the achievement of certain development milestones, and
additionally, upon commercialization, a royalty on net sales.
On
September 11, 2007 we entered into a license agreement with Bayer CropScience AG
for the development and commercialization of rice. Under the terms of
the agreement, we received an upfront payment, will receive milestone payments
upon the achievement of certain development milestones, and additionally, upon
commercialization, a royalty on net sales.
Financing
On April
1, 2010, we entered into securities purchase agreements with non-affiliated and
affiliated investors for the issuance of 10% convertible preferred stock and
warrants and received aggregate gross proceeds of $11,497,000.
On July
9, 2009, we entered into securities purchase agreements with Partlet Holdings
Ltd., for the issuance of common stock and warrants and received gross proceeds
of $1,000,000.
On July
29, 2009, we entered into securities purchase agreements with each of Robert
Forbes, Timothy Forbes and certain insiders and affiliates for the issuance of
common stock and warrants and received gross proceeds of $530,000.
On July
29, 2009, we entered into a securities purchase agreement with Cato Holding
Company for the issuance of common stock and warrants in exchange for amounts
owed by us to Cato Research Ltd. in the amount of
$175,000.
We
anticipate that, based upon our current cash balance, we will be able to fund
our operations for at least the next twelve (12) months from June 30,
2010. Over the next twelve months from June 30, 2010, we plan to fund
our research and development and commercialization activities by:
|
·
|
utilizing our current cash
balance and investments,
|
|
·
|
achieving some of the milestones
set forth in our current licensing
agreements,
|
|
·
|
through the execution of
additional licensing agreements for our technology,
and
|
|
·
|
through the placement of equity
or debt instruments.
|
We cannot
assure you that we will be able to raise money through any of the foregoing
transactions, or on favorable terms, if at all.
EMPLOYEES
As of
October 25, 2010, we had 4 total employees, all of whom were full-time
employees.
CORPORATE
INFORMATION
We were
incorporated in Delaware in 1999. Our principal business address is
303 George Street, Suite 420, New Brunswick, New Jersey, 08901, and our
telephone number is (732) 296-8400. We maintain a website at
“http://www.senesco.com” (this is not a hyperlink; you must visit this website
through an Internet browser). Our website and the information contained therein
or connected thereto are not incorporated into this prospectus.
AVAILABLE
INFORMATION
We file
annual, quarterly and current reports, proxy statements and other information
with the Securities and Exchange Commission, or the Commission. You may read and
copy any document we file with the Commission at the Commission’s public
reference rooms at 100 F Street, N.E., Washington, D.C. 20549. Please call the
Commission at 1-800-SEC-0330 for further information on the public reference
room. Our Commission filings are also available to the public from the
Commission’s Website at “http://www.sec.gov.” We make available free of charge
our annual, quarterly and current reports, proxy statements and other
information upon request. To request such materials, please send an e-mail to
jbrooks@senesco.com or contact Joel Brooks, our Chief Financial Officer, at 303
George Street, Suite 420, New Brunswick, New Jersey, 08901 or at (732)
296-8400.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained in this prospectus, any prospectus supplement and in the
documents incorporated by reference herein constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995. All statements other than statements of historical fact may be deemed
to be forward-looking statements. Forward-looking statements frequently, but not
always, use the words “may”, “intends”, “plans”, “believes”, “anticipates” or
“expects” or similar words and may include statements concerning our strategies,
goals and plans. All forward-looking statements are management’s present
expectations of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. In particular, our
statements regarding the anticipated growth in the markets for our technologies,
the continued advancement of our research, the approval of our patent
applications, the possibility of governmental approval in order to sell or offer
for sale to the general public a genetically engineered plant or plant product,
the successful implementation of our commercialization strategy, including the
success of our agricultural partners and the successful implementation of the
Rahan Joint Collaboration, statements relating to our patent applications, the
anticipated long term growth of our business, the results of our preclinical
studies, if any, our ability to comply with the continued listing standards of
the NYSE Amex, and the timing of the projects and trends in future operating
performance are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties, including, but not
limited to, our limited operating history, our need for additional
capital to fund our operations until we are able to generate a profit, the
current economic environment, our dependence on a single principal technology,
our outsourcing of our research and development activities, our significant
future capital needs, our dependence on our patents and proprietary rights and
the enforcement of these rights, the potential for our competitors or third
parties to allege that we are infringing upon their intellectual property
rights, the potential that our security measures may not adequately protect our
unpatented technology, potential difficulty in managing our growth and expanding
our operations, our lack of marketing or sales history and dependence on
third-party marketing partners, our potential future dependence on joint
ventures and strategic alliances to develop and market our technology, the
intense competition in the human health and agricultural biotechnology
industries, the various government regulations that our business is subject to,
the potential that our preclinical studies and clinical trials of our human
health applications may be unsuccessful, any inability to license from third
parties their proprietary technologies or processes which we use in connection
with the development of our technology, the length, expense and uncertainty
associated with clinical trials for our human health technology, the
potential that, even if we receive regulatory approval, consumers may not accept
products containing our technology, our dependence on key personnel, the
potential that certain provisions of our charter, by-laws and Delaware law could
make a takeover difficult, increasing political and social turmoil, the
potential that our management and other affiliates, due to their significant
control of our common stock have the ability to significantly influence our
actions, the potential that a significant portion of our total outstanding
shares of common stock may be sold in the market in the near future, the limited
trading market of our common stock, the potential that our common stock may be
delisted from the NYSE Amex Exchange, fluctuations in the market price of our
common stock, our dividend policy and potential for our stockholders to be
diluted.
The
following documents, among others, describe these assumptions, risks,
uncertainties, and other factors. You should read and interpret any
forward-looking statements together with these documents:
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the risk factors contained in any
prospectus supplement under the caption “Risk
Factors”;
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our most recent annual report on
Form 10-K, including the sections entitled “Business”, “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results
of Operations”;
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our quarterly reports on Form
10-Q; and
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In light
of these assumptions, risks and uncertainties, the results and events discussed
in the forward-looking statements contained in this prospectus, any prospectus
supplement or in any document incorporated by reference in this prospectus might
not occur. Investors are cautioned not to place undue reliance on the
forward-looking statements, which speak only of the date of this prospectus, the
date of any prospectus supplement or the date of the document incorporated by
reference in this prospectus. We are not under any obligation, and we expressly
disclaim any obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or otherwise, except as
may be required by applicable law. All subsequent forward-looking statements
attributable to us are expressly qualified in their entirety by the cautionary
statements contained or referred to in this section.
RISK
FACTORS
This
Registration Statement contains forward-looking statements that involve risks
and uncertainties. Our actual results could differ materially from those
discussed in this Registration Statement. Factors that could cause or contribute
to these differences include, but are not limited to, those discussed below,
elsewhere in this Registration Statement, and in any documents incorporated in
this Registration Statement by reference.
Risks Related to Our
Business
We have a limited operating history
and have incurred substantial losses and expect to incur future
losses.
We are a
development stage biotechnology company with a limited operating history and
limited assets and capital. We have incurred losses each year since inception
and had an accumulated deficit of $50,841,159 at June 30, 2010. We have
generated minimal revenues by licensing our technology for certain crops to
companies willing to share in our development costs. In addition, our technology
may not be ready for commercialization for several years. We expect to continue
to incur losses for the next several years because we anticipate that our
expenditures on research and development and administrative activities will
significantly exceed our revenues during that period. We cannot predict when, if
ever, we will become profitable.
We
may need additional capital to fund our operations until we are able to generate
a profit.
Our
operations to date have required significant cash expenditures. Our
future capital requirements will depend on the results of our research and
development activities, preclinical and clinical studies, and competitive and
technological advances.
We will
need to obtain more funding in the future through collaborations or other
arrangements with research institutions and corporate partners, or public and
private offerings of our securities, including debt or equity
financing. We may not be able to obtain adequate funds for our
operations from these sources when needed or on acceptable terms. Future
collaborations or similar arrangements may require us to license valuable
intellectual property to, or to share substantial economic benefits with, our
collaborators. If we raise additional capital by issuing additional
equity or securities convertible into equity, our stockholders may experience
dilution and our share price may decline. Any debt financing may
result in restrictions on our spending.
If we are
unable to raise additional funds, we will need to do one or more of the
following:
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delay, scale-back or eliminate
some or all of our research and product development
programs;
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provide licenses to third parties
to develop and commercialize products or technologies that we would
otherwise seek to develop and commercialize
ourselves;
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seek strategic alliances or
business combinations;
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attempt to sell our
company;
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We
believe that at the projected rate of spending we should have sufficient cash to
maintain our present operations for at least the next twelve (12)
months.
We
may be adversely affected by the current economic environment.
Our
ability to obtain financing, invest in and grow our business, and meet our
financial obligations depends on our operating and financial performance, which
in turn is subject to numerous factors. In addition to factors
specific to our business, prevailing economic conditions and financial, business
and other factors beyond our control can also affect our business and ability to
raise capital. We cannot anticipate all of the ways in which the
current economic climate and financial market conditions could adversely impact
our business.
We depend on a single principal
technology and, if our technology is not commercially successful, we will have
no alternative source of revenue.
Our
primary business is the development and licensing of technology to identify,
isolate, characterize and promote or silence genes which control the death of
cells in humans and plants. Our future revenue and profitability critically
depend upon our ability, or our licensees’ ability, to successfully develop
apoptosis and senescence gene technology and later license or market such
technology. We have conducted experiments on certain crops with
favorable results and have conducted certain preliminary cell-line and animal
experiments, which have provided us with data upon which we have designed
additional research programs. However, we cannot give any assurance that our
technology will be commercially successful or economically viable for any crops
or human health applications.
In
addition, no assurance can be given that adverse consequences might not result
from the use of our technology such as the development of negative effects on
humans or plants or reduced benefits in terms of crop yield or
protection. Our failure to obtain market acceptance of our technology
or of our current or potential licensees to successfully commercialize such
technology would have a material adverse effect on our
business.
We
outsource all of our research and development activities and, if we are
unsuccessful in maintaining our alliances with these third parties, our research
and development efforts may be delayed or curtailed.
We rely
on third parties to perform all of our research and development
activities. Our research and development efforts take place at the
University of Waterloo in Ontario, Canada, where our technology was discovered,
at the Mayo Clinic, at other commercial research facilities and with our
commercial partners. At this time, we do not have the internal
capabilities to perform our own research and development activities.
Accordingly, the failure of third-party research partners to perform under
agreements entered into with us, or our failure to renew important research
agreements with these third parties, may delay or curtail our research and
development efforts.
We
have significant future capital needs and may be unable to raise capital when
needed, which could force us to delay or reduce our research and development
efforts.
As of
June 30, 2010, we had cash of $8,026,296 and working capital of
$6,001,970. Using our available reserves as of June 30, 2010, we
believe that we can operate according to our current business plan for at least
the next twelve (12) months. To date, we have generated minimal
revenues and anticipate that our operating costs will exceed any revenues
generated over the next several years. Therefore, we will be required
to raise additional capital in the future in order to operate in accordance with
our current business plan, and this funding may not be available on favorable
terms, if at all. If we are unable to raise additional funds, we will
need to do one or more of the following:
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delay, scale back or eliminate
some or all of our research and development
programs;
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provide a license to third
parties to develop and commercialize our technology that we would
otherwise seek to develop and commercialize
ourselves;
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seek strategic alliances or
business combinations;
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attempt to sell our
company;
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In
addition, in connection with any funding, if we need to issue more equity
securities than our certificate of incorporation currently authorizes, or more
than 20% of the shares of our common stock outstanding, we may need stockholder
approval. If stockholder approval is not obtained or if adequate
funds are not available, we may be required to curtail operations significantly
or to obtain funds through arrangements with collaborative partners or others
that may require us to relinquish rights to certain of our technologies, product
candidates, products or potential markets. Investors may experience
dilution in their investment from future offerings of our common
stock. For example, if we raise additional capital by issuing equity
securities, such an issuance would reduce the percentage ownership of existing
stockholders. In addition, assuming the exercise of all options and
warrants outstanding and the conversion of the preferred stock into common
stock, as of June 30, 2010, we had 64,783,361 shares of common stock authorized
but unissued and unreserved, which may be issued from time to time by our board
of directors without stockholder approval. Furthermore, we may need
to issue securities that have rights, preferences and privileges senior to our
common stock. Failure to obtain financing on acceptable terms would
have a material adverse effect on our liquidity.
Since our
inception, we have financed all of our operations through private equity and
debt financings. Our future capital requirements depend on numerous factors,
including:
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the scope of our research and
development;
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our ability to attract business
partners willing to share in our development
costs;
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our ability to successfully
commercialize our
technology;
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competing technological and
market developments;
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our ability to enter into
collaborative arrangements for the development, regulatory approval and
commercialization of other products;
and
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the cost of filing, prosecuting,
defending and enforcing patent claims and other intellectual property
rights.
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Our
business depends upon our patents and proprietary rights and the enforcement of
these rights. Our failure to obtain and maintain patent protection
may increase competition and reduce demand for our technology.
As a
result of the substantial length of time and expense associated with developing
products and bringing them to the marketplace in the biotechnology and
agricultural industries, obtaining and maintaining patent and trade secret
protection for technologies, products and processes is of vital
importance. Our success will depend in part on several factors,
including, without limitation:
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our ability to obtain patent
protection for our technologies and
processes;
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our ability to preserve our trade
secrets; and
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our ability to operate without
infringing the proprietary rights of other parties both in the United
States and in foreign
countries.
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As of
June 30, 2010, we have been issued twenty one (21) patents by the PTO and
fifty-seven (57) patents from foreign countries. We have also filed
numerous patent applications for our technology in the United States and in
several foreign countries, which technology is vital to our primary business, as
well as several continuations in part on these patent
applications. Our success depends in part upon the grant of patents
from our pending patent applications.
Although
we believe that our technology is unique and that it will not violate or
infringe upon the proprietary rights of any third party, we cannot assure you
that these claims will not be made or if made, could be successfully defended
against. If we do not obtain and maintain patent protection, we may
face increased competition in the United States and internationally, which would
have a material adverse effect on our business.
Since
patent applications in the United States are maintained in secrecy until patents
are issued, and since publication of discoveries in the scientific and patent
literature tend to lag behind actual discoveries by several months, we cannot be
certain that we were the first creator of the inventions covered by our pending
patent applications or that we were the first to file patent applications for
these inventions.
In
addition, among other things, we cannot assure you that:
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our patent applications will
result in the issuance of
patents;
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any patents issued or licensed to
us will be free from challenge and if challenged, would be held to be
valid;
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any patents issued or licensed to
us will provide commercially significant protection for our technology,
products and processes;
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other companies will not
independently develop substantially equivalent proprietary information
which is not covered by our patent
rights;
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other companies will not obtain
access to our know-how;
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other companies will not be
granted patents that may prevent the commercialization of our technology;
or
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we will not incur licensing fees
and the payment of significant other fees or royalties to third parties
for the use of their intellectual property in order to enable us to
conduct our business.
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Our
competitors may allege that we are infringing upon their intellectual property
rights, forcing us to incur substantial costs and expenses in resulting
litigation, the outcome of which would be uncertain.
Patent
law is still evolving relative to the scope and enforceability of claims in the
fields in which we operate. We are like most biotechnology companies
in that our patent protection is highly uncertain and involves complex legal and
technical questions for which legal principles are not yet firmly
established. In addition, if issued, our patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products, or provide us with any competitive
advantage.
The PTO
and the courts have not established a consistent policy regarding the breadth of
claims allowed in biotechnology patents. The allowance of broader
claims may increase the incidence and cost of patent interference proceedings
and the risk of infringement litigation. On the other hand, the
allowance of narrower claims may limit the scope and value of our proprietary
rights.
The laws
of some foreign countries do not protect proprietary rights to the same extent
as the laws of the United States, and many companies have encountered
significant problems and costs in protecting their proprietary rights in these
foreign countries.
We could
become involved in infringement actions to enforce and/or protect our
patents. Regardless of the outcome, patent litigation is expensive
and time consuming and would distract our management from other
activities. Some of our competitors may be able to sustain the costs
of complex patent litigation more effectively than we could because they have
substantially greater resources. Uncertainties resulting from the
initiation and continuation of any patent litigation could limit our ability to
continue our operations.
If
our technology infringes the intellectual property of our competitors or other
third parties, we may be required to pay license fees or damages.
If any
relevant claims of third-party patents that are adverse to us are upheld as
valid and enforceable, we could be prevented from commercializing our technology
or could be required to obtain licenses from the owners of such
patents. We cannot assure you that such licenses would be available
or, if available, would be on acceptable terms. Some licenses may be
non-exclusive and, therefore, our competitors may have access to the same
technology licensed to us. In addition, if any parties successfully
claim that the creation or use of our technology infringes upon their
intellectual property rights, we may be forced to pay damages, including treble
damages.
Our
security measures may not adequately protect our unpatented technology and, if
we are unable to protect the confidentiality of our proprietary information and
know-how, the value of our technology may be adversely affected.
Our
success depends upon know-how, unpatentable trade secrets, and the skills,
knowledge and experience of our scientific and technical
personnel. As a result, all employees agreed to a confidentiality
provision in their employment agreement that prohibited the disclosure of
confidential information to anyone outside of our company, during the term of
employment and for 5 years thereafter. We also require all employees
to disclose and assign to us the rights to their ideas, developments,
discoveries and inventions. We also attempt to enter into similar
agreements with our consultants, advisors and research
collaborators. We cannot assure you that adequate protection for our
trade secrets, know-how or other proprietary information against unauthorized
use or disclosure will be available.
We
occasionally provide information to research collaborators in academic
institutions and request that the collaborators conduct certain
tests. We cannot assure you that the academic institutions will not
assert intellectual property rights in the results of the tests conducted by the
research collaborators, or that the academic institutions will grant licenses
under such intellectual property rights to us on acceptable terms, if at
all. If the assertion of intellectual property rights by an academic
institution is substantiated, and the academic institution does not grant
intellectual property rights to us, these events could limit our ability to
commercialize our technology.
As
we evolve from a company primarily involved in the research and development of
our technology into one that is also involved in the commercialization of our
technology, we may have difficulty managing our growth and expanding our
operations.
As our
business grows, we may need to add employees and enhance our management, systems
and procedures. We may need to successfully integrate our internal
operations with the operations of our marketing partners, manufacturers,
distributors and suppliers to produce and market commercially viable
products. We may also need to manage additional relationships with
various collaborative partners, suppliers and other
organizations. Although we do not presently conduct research and
development activities in-house, we may undertake those activities in the
future. Expanding our business may place a significant burden on our
management and operations. We may not be able to implement
improvements to our management information and control systems in an efficient
and timely manner and we may discover deficiencies in our existing systems and
controls. Our failure to effectively respond to such changes may make
it difficult for us to manage our growth and expand our
operations.
We
have no marketing or sales history and depend on third-party marketing
partners. Any failure of these parties to perform would delay or
limit our commercialization efforts.
We have
no history of marketing, distributing or selling biotechnology products and we
are relying on our ability to successfully establish marketing partners or other
arrangements with third parties to market, distribute and sell a commercially
viable product both here and abroad. Our business plan envisions
creating strategic alliances to access needed commercialization and marketing
expertise. We may not be able to attract qualified sub-licensees,
distributors or marketing partners, and even if qualified, these marketing
partners may not be able to successfully market agricultural products or human
health applications developed with our technology. If our current or
potential future marketing partners fail to provide adequate levels of sales,
our commercialization efforts will be delayed or limited and we may not be able
to generate revenue.
We
will depend on joint ventures and strategic alliances to develop and market our
technology and, if these arrangements are not successful, our technology may not
be developed and the expenses to commercialize our technology will
increase.
In its
current state of development, our technology is not ready to be marketed to
consumers. We intend to follow a multi-faceted commercialization
strategy that involves the licensing of our technology to business partners for
the purpose of further technological development, marketing and
distribution. We have and are seeking business partners who will
share the burden of our development costs while our technology is still being
developed, and who will pay us royalties when they market and distribute
products incorporating our technology upon commercialization. The
establishment of joint ventures and strategic alliances may create future
competitors, especially in certain regions abroad where we do not pursue patent
protection. If we fail to establish beneficial business partners and
strategic alliances, our growth will suffer and the continued development of our
technology may be harmed.
Competition
in the human health and agricultural biotechnology industries is intense and
technology is changing rapidly. If our competitors market their
technology faster than we do, we may not be able to generate revenues from the
commercialization of our technology.
Many
human health and agricultural biotechnology companies are engaged in research
and development activities relating to apoptosis and senescence. The
market for plant protection and yield enhancement products is intensely
competitive, rapidly changing and undergoing consolidation. We may be
unable to compete successfully against our current and future competitors, which
may result in price reductions, reduced margins and the inability to achieve
market acceptance for products containing our technology. Our
competitors in the field of plant senescence gene technology are companies that
develop and produce transgenic plants and include major international
agricultural companies, specialized biotechnology companies, research and
academic institutions and, potentially, our joint venture and strategic alliance
partners. These companies include: Mendel Biotechnology, Inc.,
Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG,
among others. Some of our competitors that are involved in apoptosis
research include: Amgen Inc.; Centocor, Inc.; Genzyme Corporation;
OSI Pharmaceuticals, Inc.; Novartis AG; Introgen Therapeutics, Inc.; Genta,
Inc.; and Vertex Pharmaceuticals, Inc. Many of these competitors have
substantially greater financial, marketing, sales, distribution and technical
resources than us and have more experience in research and development, clinical
trials, regulatory matters, manufacturing and marketing. We
anticipate increased competition in the future as new companies enter the market
and new technologies become available. Our technology may be rendered
obsolete or uneconomical by technological advances or entirely different
approaches developed by one or more of our competitors, which will prevent or
limit our ability to generate revenues from the commercialization of our
technology.
Our
business is subject to various government regulations and, if we or our
licensees are unable to obtain regulatory approval, we may not be able to
continue our operations.
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies:
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the USDA regulates the import,
field testing and interstate movement of specific types of genetic
engineering that may be used in the creation of transgenic
plants;
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the EPA regulates activity
related to the invention of plant pesticides and herbicides, which may
include certain kinds of transgenic plants;
and
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the FDA regulates foods derived
from new plant
varieties.
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The FDA
requires that transgenic plants meet the same standards for safety that are
required for all other plants and foods in general. Except in the
case of additives that significantly alter a food’s structure, the FDA does not
require any additional standards or specific approval for genetically engineered
foods, but expects transgenic plant developers to consult the FDA before
introducing a new food into the marketplace.
Use of
our technology, if developed for human health applications, will also be subject
to FDA regulation. The FDA must approve any drug or biologic product
before it can be marketed in the United States. In addition, prior to
being sold outside of the U.S., any products resulting from the application of
our human health technology must be approved by the regulatory agencies of
foreign governments. Prior to filing a new drug application or
biologics license application with the FDA, we would have to perform extensive
clinical trials, and prior to beginning any clinical trial, we would need to
perform extensive preclinical testing which could take several years and may
require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
governmental regulatory agency. However, we are planning on performing clinical
trials, which would be subject to FDA approval. Additionally,
federal, state and foreign regulations relating to crop protection products and
human health applications developed through biotechnology are subject to public
concerns and political circumstances, and, as a result, regulations have changed
and may change substantially in the future. Accordingly, we may
become subject to governmental regulations or approvals or become subject to
licensing requirements in connection with our research and development efforts.
We may also be required to obtain such licensing or approval from the
governmental regulatory agencies described above, or from state agencies, prior
to the commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
Preclinical
studies of our human health applications may be unsuccessful, which could delay
or prevent regulatory approval.
Preclinical
studies may reveal that our human health technology is ineffective or harmful,
and/or may be unsuccessful in demonstrating efficacy and safety of our human
health technology, which would significantly limit the possibility of obtaining
regulatory approval for any drug or biologic product manufactured with our
technology. The FDA requires submission of extensive preclinical,
clinical and manufacturing data to assess the efficacy and safety of potential
products. We are currently in the process of conducting preclinical toxicology
studies for our multiple myeloma product candidate. Any delay in this
toxicology study, or any potential negative findings in this toxicology study,
will delay our ability to file an IND for our multiple myeloma product
candidate. Furthermore, the success of preliminary studies does not
ensure commercial success, and later-stage clinical trials may fail to confirm
the results of the preliminary studies.
Our success will
depend on the success of our clinical trials that have not yet
begun.
It may
take several years to complete the clinical trials of a product, and failure of
one or more of our clinical trials can occur at any stage of
testing. We believe that the development of our product candidate
involves significant risks at each stage of testing. If clinical
trial difficulties and failures arise, our product candidate may never be
approved for sale or become commercially viable.
There are
a number of difficulties and risks associated with clinical
trials. These difficulties and risks may result in the failure to
receive regulatory approval to sell our product candidate or the inability to
commercialize our product candidate. The possibility exists
that:
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we may discover that the product
candidate does not exhibit the expected therapeutic results in humans, may
cause harmful side effects or have other unexpected characteristics that
may delay or preclude regulatory approval or limit commercial use if
approved;
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the results from early clinical
trials may not be statistically significant or predictive of results that
will be obtained from expanded advanced clinical
trials;
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institutional review boards or
regulators, including the FDA, may hold, suspend or terminate our clinical
research or the clinical trials of our product candidate for various
reasons, including noncompliance with regulatory requirements or if, in
their opinion, the participating subjects are being exposed to
unacceptable health risks;
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subjects may drop out of our
clinical trials;
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our preclinical studies or
clinical trials may produce negative, inconsistent or inconclusive
results, and we may decide, or regulators may require us, to conduct
additional preclinical studies or clinical trials;
and
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the cost of our clinical trials
may be greater than we currently
anticipate.
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Clinical
trials for our human health technology will be lengthy and expensive and their
outcome is uncertain.
Before
obtaining regulatory approval for the commercial sales of any product containing
our technology, we must demonstrate through clinical testing that our technology
and any product containing our technology is safe and effective for use in
humans. Conducting clinical trials is a time-consuming, expensive and
uncertain process and typically requires years to complete. In our
industry, the results from preclinical studies and early clinical trials often
are not predictive of results obtained in later-stage clinical
trials. Some products and technologies that have shown promising
results in preclinical studies or early clinical trials subsequently fail to
establish sufficient safety and efficacy data necessary to obtain regulatory
approval. At any time during clinical trials we or the FDA might
delay or halt any clinical trial for various reasons, including:
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occurrence of unacceptable
toxicities or side effects;
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ineffectiveness of the product
candidate;
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negative or inconclusive results
from the clinical trials, or results that necessitate additional studies
or clinical trials;
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delays in obtaining or
maintaining required approvals from institutions, review boards or other
reviewing entities at clinical
sites;
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delays in patient enrollment;
or
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insufficient funding or a
reprioritization of financial or other
resources.
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Any
failure or substantial delay in successfully completing clinical trials and
obtaining regulatory approval for our product candidates could severely harm our
business.
If
our clinical trials for our product candidates are delayed, we would be unable
to commercialize our product candidates on a timely basis, which would
materially harm our business.
Planned
clinical trials may not begin on time or may need to be restructured after they
have begun. Clinical trials can be delayed for a variety of reasons,
including delays related to:
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obtaining an effective
investigational new drug application, or IND, or regulatory approval to
commence a clinical trial;
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negotiating acceptable clinical
trial agreement terms with prospective trial
sites;
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obtaining institutional review
board approval to conduct a clinical trial at a prospective
site;
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recruiting qualified subjects to
participate in clinical
trials;
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competition in recruiting
clinical investigators;
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shortage or lack of availability
of supplies of drugs for clinical
trials;
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the need to repeat clinical
trials as a result of inconclusive results or poorly executed
testing;
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the placement of a clinical hold
on a study;
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the failure of third parties
conducting and overseeing the operations of our clinical trials to perform
their contractual or regulatory obligations in a timely fashion;
and
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exposure of clinical trial
subjects to unexpected and unacceptable health risks or noncompliance with
regulatory requirements, which may result in suspension of the
trial.
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We
believe that our product candidate has significant milestones to reach,
including the successful completion of clinical trials, before
commercialization. If we have significant delays in or termination of
clinical trials, our financial results and the commercial prospects for our
product candidates or any other products that we may develop will be adversely
impacted. In addition, our product development costs would increase
and our ability to generate revenue could be impaired.
Any
inability to license from third parties their proprietary technologies or
processes which we use in connection with the development of our technology may
impair our business.
Other
companies, universities and research institutions have or may obtain patents
that could limit our ability to use our technology in a product candidate or
impair our competitive position. As a result, we would have to obtain
licenses from other parties before we could continue using our technology in a
product candidate. Any necessary licenses may not be available on
commercially acceptable terms, if at all. If we do not obtain
required licenses, we may not be able to develop our technology into a product
candidate or we may encounter significant delays in development while we
redesign methods that are found to infringe on the patents held by
others.
Even
if we receive regulatory approval, consumers may not accept products containing
our technology, which will prevent us from being profitable since we have no
other source of revenue.
We cannot
guarantee that consumers will accept products containing our
technology. Recently, there has been consumer concern and consumer
advocate activism with respect to genetically-engineered agricultural consumer
products. The adverse consequences from heightened consumer concern
in this regard could affect the markets for agricultural products developed with
our technology and could also result in increased government regulation in
response to that concern. If the public or potential customers perceive our
technology to be genetic modification or genetic engineering, agricultural
products grown with our technology may not gain market acceptance.
We
depend on our key personnel and, if we are not able to attract and retain
qualified scientific and business personnel, we may not be able to grow our
business or develop and commercialize our technology.
We are
highly dependent on our scientific advisors, consultants and third-party
research partners. Our success will also depend in part on the
continued service of our key employees and our ability to identify, hire and
retain additional qualified personnel in an intensely competitive
market. Although we have a research agreement with Dr. John Thompson,
this agreement may be terminated upon short or no
notice. Additionally, we do not have employment agreements with our
key employees. We do not maintain key person life insurance on any
member of management. The failure to attract and retain key personnel
could limit our growth and hinder our research and development
efforts.
Certain
provisions of our charter, by-laws and Delaware law could make a takeover
difficult.
Certain
provisions of our certificate of incorporation and by-laws could make it more
difficult for a third party to acquire control of us, even if the change in
control would be beneficial to stockholders. Our certificate of
incorporation authorizes our board of directors to issue, without stockholder
approval, except as may be required by the rules of the NYSE Amex Exchange,
5,000,000 shares of preferred stock with voting, conversion and other rights and
preferences that could adversely affect the voting power or other rights of the
holders of our common stock. Similarly, our by-laws do not restrict
our board of directors from issuing preferred stock without stockholder
approval.
In
addition, we are subject to the Business Combination Act of the Delaware General
Corporation Law which, subject to certain exceptions, restricts certain
transactions and business combinations between a corporation and a stockholder
owning 15% or more of the corporation’s outstanding voting stock for a period of
three years from the date such stockholder becomes a 15% owner. These
provisions may have the effect of delaying or preventing a change of control of
us without action by our stockholders and, therefore, could adversely affect the
value of our common stock.
Furthermore,
in the event of our merger or consolidation with or into another corporation, or
the sale of all or substantially all of our assets in which the successor
corporation does not assume our outstanding equity awards or issue equivalent
equity awards, our current equity plans require the accelerated vesting of such
outstanding equity awards.
Risks Related to Our Common
Stock
We
currently do not meet the NYSE Amex Exchange continued listing
standards. If our common stock is delisted from the NYSE Amex
Exchange, we may not be able to list on any other stock exchange, and our common
stock may be subject to the “penny stock” regulations which may affect the
ability of our stockholders to sell their shares.
The NYSE
Amex Exchange requires us to meet minimum financial requirements in order to
maintain our listing. Although we currently meet the $6,000,000
minimum net worth continued listing requirement of the NYSE Amex Exchange, we
have not met the $6,000,000 minimum net worth continued listing requirement of
the NYSE Amex Exchange for two consecutive quarters and have received a notice
of noncompliance from the NYSE Amex Exchange. We submitted a plan of
compliance to the NYSE Amex Exchange discussing how we intend to regain
compliance with the continued listing requirements. The NYSE Amex
Exchange has accepted our plan of compliance and granted us an extension until
April 29, 2011 to regain compliance with the NYSE's continued listing
standards. During the extension period, we remain subject to periodic
review by NYSE Staff. Failure to make progress consistent with the plan or to
regain compliance with the continued listing standards by the end of the
extension period could result in our company being delisted from the
NYSE. If we are delisted from the NYSE Amex Exchange, our common
stock likely will become a “penny stock.” In general, regulations of
the SEC define a “penny stock” to be an equity security that is not listed on a
national securities exchange or the NASDAQ Stock Market and that has a market
price of less than $5.00 per share or with an exercise price of less than $5.00
per share, subject to certain exceptions. If our common stock becomes
a penny stock, additional sales practice requirements would be imposed on
broker-dealers that sell such securities to persons other than certain qualified
investors. For transactions involving a penny stock, unless exempt, a
broker-dealer must make a special suitability determination for the purchaser
and receive the purchaser’s written consent to the transaction prior to the
sale. In addition, the rules on penny stocks require delivery, prior
to and after any penny stock transaction, of disclosures required by the
SEC.
If our
stock is not accepted for listing on the NYSE Amex Exchange, we will make every
possible effort to have it listed on the Over the Counter Bulletin Board, or the
OTC Bulletin Board. If our common stock were to be traded on the OTC
Bulletin Board, the Securities Exchange Act of 1934, as amended, and related
Securities and Exchange Commission (SEC) rules would impose additional sales
practice requirements on broker-dealers that sell our
securities. These rules may adversely affect the ability of
stockholders to sell our common stock and otherwise negatively affect the
liquidity, trading market and price of our common stock.
We
believe that the listing of our common stock on a recognized national trading
market, such as the NYSE Amex Exchange, is an important part of our business and
strategy. Such a listing helps our stockholders by providing a
readily available trading market with current quotations. Without
that, stockholders may have a difficult time getting a quote for the sale or
purchase of our stock, the sale or purchase of our stock would likely be made
more difficult and the trading volume and liquidity of our stock would likely
decline. The absence of such a listing may adversely affect the
acceptance of our common stock as currency or the value accorded it by other
parties. In that regard, the absence of a listing on a recognized
national trading market will also affect our ability to benefit from the use of
our operations and expansion plans, including for use in licensing agreements,
joint ventures, the development of strategic relationships and acquisitions,
which are critical to our business and strategy and none of which is currently
the subject of any agreement, arrangement or understanding, with respect to any
future financing or strategic relationship we may undertake. A
delisting from the NYSE Amex Exchange could result in negative publicity and
could negatively impact our ability to raise capital in the
future.
Our
management and other affiliates have significant control of our common stock and
could significantly influence our actions in a manner that conflicts with our
interests and the interests of other stockholders.
As of
June 30, 2010, our executive officers, directors and affiliated entities
together beneficially own approximately 53.3% of the outstanding shares of our
common stock, assuming the exercise of options and warrants which are currently
exercisable or will become exercisable within 60 days of June 30, 2010, held by
these stockholders. As a result, these stockholders, acting together, will
be able to exercise significant influence over matters requiring approval by our
stockholders, including the election of directors, and may not always act in the
best interests of other stockholders. Such a concentration of
ownership may have the effect of delaying or preventing a change in control of
us, including transactions in which our stockholders might otherwise receive a
premium for their shares over then current market prices.
A
significant portion of our total outstanding shares of common stock may be sold
in the market in the near future, which could cause the market price of our
common stock to drop significantly.
As of
June 30, 2010, we had 50,092,204 shares of our common stock issued and
outstanding and 9,235 shares of convertible preferred stock outstanding which
can convert into 28,859,375 shares of common stock. Approximately
34,164,431 shares of such shares are registered pursuant to registration
statements on Form S-3 and 44,787,148 of which are either eligible to be sold
under SEC Rule 144 or are in the public float. In addition, we have
registered 35,890,007 shares of our common stock underlying warrants previously
issued on Form S-3 registration statements and we registered 11,137,200 shares
of our common stock underlying options granted or to be granted under our stock
option plan. Consequently, sales of substantial amounts of our common
stock in the public market, or the perception that such sales could occur, may
have a material adverse effect on our stock price.
Our
common stock has a limited trading market, which could limit your ability to
resell your shares of common stock at or above your purchase price.
Our
common stock is quoted on the NYSE Amex Exchange and currently has a limited
trading market. The NYSE Amex Exchange requires us to meet minimum
financial requirements in order to maintain our listing. Currently,
we do not meet the continued listing requirements of the NYSE Amex
Exchange. As we do not meet the continued listing standards, we could
be delisted. We cannot assure you that an active trading market will
develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and,
as a result, may suffer a loss of all or a substantial portion of their
investment.
The
market price of our common stock may fluctuate and may drop below the price you
paid.
We cannot
assure you that you will be able to resell the shares of our common stock at or
above your purchase price. The market price of our common stock may
fluctuate significantly in response to a number of factors, some of which are
beyond our control. These factors include:
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quarterly variations in operating
results;
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the progress or perceived
progress of our research and development
efforts;
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changes in accounting treatments
or principles;
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announcements by us or our
competitors of new technology, product and service offerings, significant
contracts, acquisitions or strategic
relationships;
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additions or departures of key
personnel;
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future offerings or resales of
our common stock or other
securities;
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stock market price and volume
fluctuations of publicly-traded companies in general and development
companies in particular; and
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general political, economic and
market conditions.
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For
example, during the year ended June 30, 2010, our common stock traded between
$0.25 per share and $0.83 per share.
Because
we do not intend to pay, and have not paid, any cash dividends on our shares of
common stock, our stockholders will not be able to receive a return on their
shares unless the value of our common stock appreciates and they sell their
shares.
We have
never paid or declared any cash dividends on our common stock, and we intend to
retain any future earnings to finance the development and expansion of our
business. We do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Therefore, our stockholders
will not be able to receive a return on their investment unless the value of our
common stock appreciates and they sell their shares.
Our
stockholders may experience substantial dilution as a result of the conversion
of convertible preferred stock, the exercise of options and warrants to purchase
our common stock, or due to anti-dilution provisions relating to any on the
foregoing.
As of
June 30, 2010, we have outstanding 9,235 shares of convertible preferred stock
which may convert into 28,859,375 shares of our common stock and warrants to
purchase 55,171,226 shares of our common stock. In addition, as of June
30, 2010, we have reserved 15,204,884 shares of our common stock for issuance
upon the exercise of options granted or available to be granted pursuant to our
stock option plan, all of which may be granted in the future. The
conversion of the convertible preferred stock and the exercise of these options
and warrants will result in dilution to our existing stockholders and could have
a material adverse effect on our stock price. The conversion price of the
convertible preferred stock and certain warrants are also subject to certain
anti-dilution adjustments.
DESCRIPTION
OF THE SECURITIES WE MAY OFFER
We may
issue, in one or more offerings, any combination of warrants, preferred stock or
common stock.
This
prospectus contains a summary of the general terms of the various securities
that we may offer. The prospectus supplement relating to any particular
securities offered will describe the specific terms of the securities, which may
be in addition to or different from the general terms summarized in this
prospectus. The summary in this prospectus and in any prospectus supplement does
not describe every aspect of the securities and is subject to and qualified in
its entirety by reference to all applicable provisions of the documents relating
to the securities offered. These documents are or will be filed as exhibits to
or incorporated by reference in the registration statement.
In
addition, the prospectus supplement will set forth the terms of the offering,
the initial public offering price and estimated net proceeds to us. Where
applicable, the prospectus supplement will also describe any material United
States federal income tax considerations relating to the securities offered and
indicate whether the securities offered are or will be listed on any securities
exchange.
WARRANTS
Please
note that in this section references to holders mean those who own warrants
registered in their own names, on the books that we or our agent maintain for
this purpose, and not those who own beneficial interests in warrants registered
in street name or in warrants issued in book-entry form through one or more
depositaries. Owners of beneficial interests in the warrants should read the
section below entitled “Book-Entry Procedures and Settlement”.
General
We may
offer warrants separately or together with our equity securities.
We may
issue warrants in such amounts or in as many distinct series as we wish. This
section summarizes terms of the warrants that apply generally to all series.
Most of the financial and other specific terms of your warrant will be described
in the prospectus supplement. Those terms may vary from the terms described
here.
The
warrants of a series will be issued under a separate warrant agreement to be
entered into between us and one or more banks or trust companies, as warrant
agent, as set forth in the prospectus supplement. A form of each warrant
agreement, including a form of warrant certificate representing each warrant,
reflecting the particular terms and provisions of a series of offered warrants,
will be filed with the SEC at the time of the offering and incorporated by
reference in the registration statement of which this prospectus forms a part.
You can obtain a copy of any form of warrant agreement when it has been filed by
following the directions outlined in “Where You Can Find More Information;
Incorporation of Documents by Reference” or by contacting the applicable warrant
agent.
The
following briefly summarizes the material provisions of the warrant agreements
and the warrants. As you read this section, please remember that the specific
terms of your warrant as described in the prospectus supplement will supplement
and, if applicable, may modify or replace the general terms described in this
section. You should read carefully the prospectus supplement and the more
detailed provisions of the warrant agreement and the warrant certificate,
including the defined terms, for provisions that may be important to you. If
there are differences between the prospectus supplement and this prospectus, the
prospectus supplement will control. Thus, the statements made in this section
may not apply to your warrant.
Types
of Warrants
We may
issue equity warrants. An equity warrant is a warrant for the purchase or sale
of our equity securities. We may also issue warrants for the purchase or sale
of, or whose cash value is determined by reference to the performance, level or
value of, one or more of the following: securities of one or more issuers,
including those issued by us and described in this prospectus or equity
securities issued by third parties; a currency or currencies; a commodity or
commodities; and other financial, economic or other measure or instrument,
including the occurrence or non-occurrence of any event or circumstances, or one
or more indices or baskets of these items.
Information
in the Prospectus Supplement
The
prospectus supplement will contain, where applicable, the following information
about the warrants:
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the specific designation and
aggregate number of, and the price at which we will issue, the
warrants;
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the currency or currency unit
with which the warrants may be purchased and in which any payments due to
or from the holder upon exercise must be
made;
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the date on which the right to
exercise the warrants will begin and the date on which that right will
expire or, if you may not continuously exercise the warrants throughout
that period, the specific date or dates on which you may exercise the
warrants;
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whether the exercise price may be
paid in cash, by the exchange of warrants or other securities or both, and
the method of exercising the
warrants;
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whether the warrants will be
settled by delivery of the underlying securities or other property or in
cash;
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whether and under what
circumstances we may cancel the warrants prior to their expiration date,
in which case the holders will be entitled to receive only the applicable
cancellation amount, which may be either a fixed amount or an amount that
varies during the term of the warrants in accordance with a schedule or
formula;
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whether the warrants will be
issued in global or non-global
form;
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the identities of the warrant
agent, any depositaries and any paying, transfer, calculation or other
agents for the warrants;
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any securities exchange or
quotation system on which the warrants or any securities deliverable upon
exercise of the warrants may be
listed;
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whether the warrants are to be
sold separately or with other securities, and if the warrants are to be
sold with the securities of another company or other companies, certain
information regarding such company or companies;
and
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any other terms of the
warrants.
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No holder
of a warrant will, as such, have any rights of a holder of the equity securities
or other warrant property purchasable under or in the warrant, including any
right to receive payment thereunder.
No
Limit on Issuance of Warrants
The
warrant agreements will not limit the number of warrants or other securities
that we may issue.
Modifications
We and
the relevant warrant agent may, without the consent of the holders, amend each
warrant agreement and the terms of each issue of warrants, for the purpose of
curing any ambiguity or of correcting or supplementing any defective or
inconsistent provision, or in any other manner that we may deem necessary or
desirable and that will not adversely affect the interests of the holders of the
outstanding unexercised warrants in any material respect.
We and
the relevant warrant agent also may, with the consent of the holders of at least
a majority in number of the outstanding unexercised warrants affected, modify or
amend the warrant agreement and the terms of the warrants. No such modification
or amendment may, without the consent of each holder of an affected
warrant:
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reduce the amount receivable upon
exercise, cancellation or
expiration;
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shorten the period of time during
which the warrants may be
exercised;
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otherwise materially and
adversely affect the exercise rights of the beneficial owners of the
warrants; or
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reduce the percentage of
outstanding warrants whose holders must consent to modification or
amendment of the applicable warrant agreement or the terms of the
warrants.
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Merger
and Similar Transactions Permitted; No Restrictive Covenants or Events of
Default
The
warrant agreements will not restrict our ability to merge or consolidate with,
or sell our assets to, another firm or to engage in any other transactions. If
at any time there is a merger or consolidation involving us or a sale or other
disposition of all or substantially all of our assets, the successor or assuming
company will be substituted for us, with the same effect as if it had been named
in the warrant agreement and in the warrants. We will be relieved of any further
obligation under the warrant agreement or warrants, and, in the event of any
such merger, consolidation, sale or other disposition, we as the predecessor
corporation may at any time thereafter be dissolved, wound up or
liquidated.
The
warrant agreements will not include any restrictions on our ability to put liens
on our assets, including our interests in our subsidiaries, nor will they
provide for any events of default or remedies upon the occurrence of any events
of default.
Warrant
Agreements Will Not Be Qualified under Trust Indenture Act
No
warrant agreement will be qualified as an indenture, and no warrant agent will
be required to qualify as a trustee, under the Trust Indenture Act. Therefore,
holders of warrants issued under a warrant agreement will not have the
protection of the Trust Indenture Act with respect to their
warrants.
Enforceability
of Rights by Beneficial Owner
Each
warrant agent will act solely as our agent in connection with the issuance and
exercise of the applicable warrants and will not assume any obligation or
relationship of agency or trust for or with any registered holder of or owner of
a beneficial interest in any warrant. A warrant agent will have no duty or
responsibility in case of any default by us under the applicable warrant
agreement or warrant certificate, including any duty or responsibility to
initiate any proceedings at law or otherwise or to make any demand upon
us.
Holders
may, without the consent of the applicable warrant agent, enforce by appropriate
legal action, on their own behalf their right to exercise their
warrants.
Governing
Law
Unless
otherwise stated in the prospectus supplement, the warrants and each warrant
agreement will be governed by New York law.
PREFERRED
STOCK
Our
certificate of incorporation authorizes 5,000,000 shares of preferred stock,
$0.01 par value per share, of which12,000 shares of preferred stock has been
designated as Series A preferred stock and 2,000 shares of preferred stock has
been designated as Series B preferred stock. As of October 25, 2010, 10,297
shares of our Series A preferred stock has been issued and 4,345 shares are
outstanding and 1,200 shares of our Series B preferred stock are issued and
outstanding. The preferred stock may be issued from time to time in
one or more series, with such distinctive serial designations, rights and
preferences as shall be determined by the board of directors.
The
following briefly summarizes the material terms of our preferred stock, other
than pricing and related terms disclosed for a particular issuance in an
accompanying prospectus supplement. You should read the particular terms of any
series of preferred stock we offer which will be described in more detail in the
prospectus supplement prepared for such series, together with the more detailed
provisions of our certificate of incorporation and the certificate of
designations relating to each particular series of preferred stock, for
provisions that may be important to you. The certificate of designations
relating to a particular series of preferred stock offered by way of an
accompanying prospectus supplement will be filed with the SEC at the time of the
offering and incorporated by reference in the registration statement of which
this prospectus forms a part. You can obtain a copy of this document by
following the directions outlined in “Where You Can Find More Information;
Incorporation of Documents by Reference.” The prospectus supplement will also
state whether any of the terms summarized below do not apply to the series of
preferred stock being offered.
General
Under our
certificate of incorporation, our board of directors is authorized to issue
shares of preferred stock in one or more series, and to establish from time to
time a series of preferred stock with the following terms
specified:
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the number of shares to be
included in the series;
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the designation, powers,
preferences and rights of the shares of the series;
and
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the qualifications, limitations
or restrictions of such series, except as otherwise stated in the
certificate of
incorporation.
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Prior to
the issuance of any series of preferred stock, our board of directors will adopt
resolutions creating and designating the series as a series of preferred stock
and the resolutions will be filed in a certificate of designation as an
amendment to the certificate of incorporation. The term board of directors
includes any duly authorized committee.
The
rights of holders of the preferred stock offered may be adversely affected by
the rights of holders of any shares of preferred stock that may be issued in the
future, provided that the future issuances are first approved by the holders of
the class(es) of preferred stock adversely affected. The board of directors may
cause shares of preferred stock to be issued in public or private transactions
for any proper corporate purpose. Examples of proper corporate purposes include
issuances to obtain additional financing in connection with acquisitions or
otherwise, and issuances to our officers, directors and employees pursuant to
benefit plans or otherwise. Shares of preferred stock we issue may have the
effect of rendering more difficult or discouraging an acquisition of us deemed
undesirable by our board of directors.
The
preferred stock will be, when issued, fully paid and nonassessable. Holders of
preferred stock will not have any preemptive or subscription rights to acquire
more of our stock.
We will
name the transfer agent, registrar, dividend disbursing agent and redemption
agent for shares of each series of preferred stock in the prospectus supplement
relating to such series.
Rank
Unless
otherwise specified for a particular series of preferred stock in an
accompanying prospectus supplement, each series will rank on an equal basis with
each other series of preferred stock, and prior to the common stock, as to
dividends and distributions of assets.
Dividends
Holders
of each series of preferred stock will be entitled to receive cash dividends,
when, as and if declared by our board of directors out of funds legally
available for dividends. The rates and dates of payment of dividends will be set
forth in the prospectus supplement relating to each series of preferred stock.
Dividends will be payable to holders of record of preferred stock as they appear
on our books on the record dates fixed by the board of directors. Dividends on
any series of preferred stock may be cumulative or noncumulative.
We may
not declare, pay or set apart for payment dividends on the preferred stock
unless full dividends on any other series of preferred stock that ranks on an
equal or senior basis have been paid or sufficient funds have been set apart for
payment for:
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all prior dividend periods of the
other series of preferred stock that pay dividends on a cumulative basis;
or
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the immediately preceding
dividend period of the other series of preferred stock that pay dividends
on a noncumulative basis.
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Partial
dividends declared on shares of preferred stock and any other series of
preferred stock ranking on an equal basis as to dividends will be declared pro
rata. A pro rata declaration means that the ratio of dividends declared per
share to accrued dividends per share will be the same for both series of
preferred stock.
Similarly,
we may not declare, pay or set apart for payment non-stock dividends or make
other payments on the common stock or any other of our stock ranking junior to
the preferred stock until full dividends on the preferred stock have been paid
or set apart for payment for:
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all prior dividend periods if the
preferred stock pays dividends on a cumulative basis;
or
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the immediately preceding
dividend period if the preferred stock pays dividends on a noncumulative
basis.
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Conversion
and Exchange
The
prospectus supplement for any series of preferred stock will state the terms, if
any, on which shares of that series are convertible into or exchangeable for
shares of our common stock or other securities.
Redemption
If so
specified in the applicable prospectus supplement, a series of preferred stock
may be redeemable at any time, in whole or in part, at our option or at the
option of the holder thereof and may be mandatorily redeemed.
Any
partial redemptions of preferred stock will be made in a way that our board of
directors decides is equitable.
Unless we
default in the payment of the redemption price, dividends will cease to accrue
after the redemption date on shares of preferred stock called for redemption and
all rights of holders of such shares will terminate except for the right to
receive the redemption price.
Liquidation
Preference
Upon our
voluntary or involuntary liquidation, dissolution or winding up, holders of each
series of preferred stock will be entitled to receive distributions upon
liquidation in the amount set forth in the prospectus supplement relating to
such series of preferred stock, plus an amount equal to any accrued and unpaid
dividends. Such distributions will be made before any distribution is made on
any securities ranking junior relating to preferred stock in liquidation,
including common stock.
If the
liquidation amounts payable relating to the preferred stock of any series and
any other securities ranking on a parity regarding liquidation rights are not
paid in full, the holders of the preferred stock of such series and such other
securities will share in any such distribution of our available assets on a
ratable basis in proportion to the full liquidation preferences. Holders of such
series of preferred stock will not be entitled to any other amounts from us
after they have received their full liquidation
preference.
Voting
Rights
The
holders of shares of our preferred stock will have no voting rights,
except:
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as otherwise stated in the
prospectus supplement;
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as otherwise stated in the
certificate of designations establishing such series;
and
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as required by applicable
law.
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COMMON
STOCK
Under our
certificate of incorporation, as amended to date, we are authorized to issue up
to 250,000,000 shares of common stock, $0.01 par value per share. At
October 25, 2010, approximately 67,713,178 shares of common stock were
issued and outstanding. The following description of our common stock,
certificate of incorporation and bylaws are only summaries, and we encourage you
to review complete copies of these documents. You can obtain copies of these
documents by following the directions outlined in “Where You Can Find More
Information; Incorporation of Documents by Reference”.
Dividends,
Voting Rights and Liquidation
Each
stockholder of record is entitled to one vote for each outstanding share of our
common stock owned by that stockholder on every matter properly submitted to the
stockholders for their vote. After satisfaction of the dividend rights of
holders of any preferred stock, holders of common stock are entitled to any
dividend declared by our board out of funds legally available for that purpose.
After the payment of liquidation preferences to holders of any preferred stock,
holders of common stock are entitled to receive, on a pro rata basis, all our
remaining assets available for distribution to stockholders in the event of our
liquidation, dissolution or winding up. Holders of common stock do not have any
preemptive right to become subscribers or purchasers of additional shares of any
class of our capital stock. The rights, preferences and privileges of holders of
common stock are subject to, and may be injured by, the rights of the holders of
shares of any series of preferred stock that we may designate and issue in the
future.
Transfer
Agent and Registrar
American
Stock Transfer and Trust Company is the transfer agent and registrar for our
common stock.
Delaware
Law and Certain Certificate of Incorporation and By-Law Provisions
The
provisions of Delaware law and of our certificate of incorporation and by-laws
discussed below could discourage or make it more difficult to accomplish a proxy
contest or other change in our management or the acquisition of control by a
holder of a substantial amount of our voting stock. It is possible that these
provisions could make it more difficult to accomplish, or could deter,
transactions that stockholders may otherwise consider to be in their best
interests or the best interests of Senesco.
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Business
Combinations. We are
subject to the provisions of Section 203 of the General Corporation Law of
Delaware. Section 203 prohibits a publicly held Delaware corporation from
engaging in a “business combination” with an “interested stockholder” for
a period of three years after the date of the transaction in which the
person became an interested stockholder, unless the business combination
is approved in a prescribed manner. A “business combination” includes
mergers, asset sales and other transactions resulting in a financial
benefit to the interested stockholder. Subject to specified exceptions, an
“interested stockholder” is a person who, together with affiliates and
associates, owns, or within three years did own, 15% or more of the
corporation’s voting
stock.
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Limitation of
Liability; Indemnification. Our certificate of
incorporation contains provisions permitted under the General Corporation
Law of Delaware relating to the liability of directors. The provisions
eliminate, to the extent legally permissible, a director’s liability for
monetary damages for a breach of fiduciary duty, except in circumstances
involving wrongful acts, such as the breach of a director’s duty of
loyalty or acts or omissions that involve intentional misconduct or a
knowing violation of law. The limitation of liability described above does
not alter the liability of our directors and officers under federal
securities laws. Furthermore, our certificate of incorporation contains
provisions to indemnify our directors and officers to the fullest extent
permitted by the General Corporation Law of Delaware. These provisions do
not limit or eliminate our right or the right of any shareholder of ours
to seek non-monetary relief, such as an injunction or rescission in the
event of a breach by a director or an officer of his duty of care to us.
We believe that these provisions assist us in attracting and retaining
qualified individuals to serve as
directors.
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BOOK-ENTRY
PROCEDURES AND SETTLEMENT
Most
offered securities will be book-entry, or global, securities. Upon issuance, all
book-entry securities will be represented by one or more fully registered global
securities, without coupons. Each global security will be deposited with, or on
behalf of, The Depository Trust Company, or DTC, a securities depository, and
will be registered in the name of DTC or a nominee of DTC. DTC will thus be the
only registered holder of these securities.
Purchasers
of securities may only hold interests in the global securities through DTC if
they are participants in the DTC system. Purchasers may also hold interests
through a securities intermediary — banks, brokerage houses and other
institutions that maintain securities accounts for customers — that has an
account with DTC or its nominee. DTC will maintain accounts showing the security
holdings of its participants, and these participants will in turn maintain
accounts showing the security holdings of their customers. Some of these
customers may themselves be securities intermediaries holding securities for
their customers. Thus, each beneficial owner of a book-entry security will hold
that security indirectly through a hierarchy of intermediaries, with DTC at the
top and the beneficial owner’s own securities intermediary at the
bottom.
The
securities of each beneficial owner of a book-entry security will be evidenced
solely by entries on the books of the beneficial owner’s securities
intermediary. The actual purchaser of the securities will generally not be
entitled to have the securities represented by the global securities registered
in its name and will not be considered the owner under the applicable indenture,
the declaration of trust or other applicable governing documents relating to the
security. In most cases, a beneficial owner will also not be able to obtain a
paper certificate evidencing the holder’s ownership of securities. The
book-entry system for holding securities eliminates the need for physical
movement of certificates. However, the laws of some jurisdictions require some
purchasers of securities to take physical delivery of their securities in
definitive form. These laws may impair the ability to transfer book-entry
securities.
A
beneficial owner of book-entry securities represented by a global security may
exchange the securities for definitive, or paper, securities only
if:
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DTC is unwilling or unable to
continue as depositary for such global security and we do not appoint a
qualified replacement for DTC within 90 days;
or
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we in our sole discretion decide
to allow some or all book-entry securities to be exchangeable for
definitive securities in registered
form.
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Unless we
indicate otherwise, any global security that is exchangeable will be
exchangeable in whole for definitive securities in registered form, with the
same terms and of an equal aggregate principal amount. Definitive securities
will be registered in the name or names of the person or persons specified by
DTC in a written instruction to the registrar of the securities. DTC may base
its written instruction upon directions that it receives from its
participants.
In this
prospectus, for book-entry securities, references to actions taken by security
holders will mean actions taken by DTC upon instructions from its participants,
and references to payments and notices of redemption to security holders will
mean payments and notices of redemption to DTC as the registered holder of the
securities for distribution to participants in accordance with DTC’s
procedures.
DTC is a
limited purpose trust company organized under the laws of the State of New York,
a member of the Federal Reserve System, a clearing corporation within the
meaning of the New York Uniform Commercial Code and a clearing agency registered
under section 17A of the Securities Exchange Act of 1934. The rules applicable
to DTC and its participants are on file with the SEC.
Neither
we nor any trustee or underwriter will have any responsibility or liability for
any aspect of the records relating to, or payments made on account of,
beneficial ownership interest in the book-entry securities or for maintaining,
supervising or reviewing any records relating to the beneficial ownership
interests.
Clearstream
and Euroclear
Links may
be established among DTC, Clearstream Banking, societe anonyme, Luxembourg
(Clearstream Banking SA) and Euroclear (two international clearing systems that
perform functions similar to those that DTC performs in the U.S.), to facilitate
the initial issuance of book-entry securities and cross-market transfers of
book-entry securities associated with secondary market trading.
Although
we understand that DTC, Clearstream Banking SA and Euroclear have agreed to the
procedures provided below in order to facilitate transfers, they are under no
obligation to perform such procedures, and the procedures may be modified or
discontinued at any time.
Clearstream
Banking SA and Euroclear will record the ownership interests of their
participants in much the same way as DTC, and DTC will record the aggregate
ownership of each of the U.S. agents of Clearstream Banking SA and Euroclear, as
participants in DTC.
When
book-entry securities are to be transferred from the account of a DTC
participant to the account of a Clearstream Banking SA participant or a
Euroclear participant, the purchaser must send instructions to Clearstream
Banking SA or Euroclear through a participant at least one business day prior to
settlement. Clearstream Banking SA or Euroclear, as the case may be, will
instruct its U.S. agent to receive book-entry securities against payment. After
settlement, Clearstream Banking SA or Euroclear will credit its participant’s
account. Credit for the book-entry securities will appear on the next day
(European time).
Because
settlement is taking place during New York business hours, DTC participants can
employ their usual procedures for sending book-entry securities to the relevant
U.S. agent acting for the benefit of Clearstream Banking SA or Euroclear
participants. The sale proceeds will be available to the DTC seller on the
settlement date. Thus, to the DTC participant, a cross-market transaction will
settle no differently than a trade between two DTC participants.
When a
Clearstream Banking SA or Euroclear participant wishes to transfer book-entry
securities to a DTC participant, the seller must send instructions to
Clearstream Banking SA or Euroclear through a participant at least one business
day prior to settlement. In these cases, Clearstream Banking SA or Euroclear
will instruct its U.S. agent to transfer the book-entry securities against
payment. The payment will then be reflected in the account of the Clearstream
Banking SA or Euroclear participant the following day, with the proceeds
back-valued to the value date (which would be the preceding day, when settlement
occurs in New York). If settlement is not completed on the intended value date
(i.e., the trade fails), proceeds credited to the Clearstream Banking SA or
Euroclear participant’s account would instead be valued as of the actual
settlement date.
We may
issue, in one or more offerings, any combination of warrants,
preferred stock or common stock.
This
prospectus contains a summary of the general terms of the various securities
that we may offer. The prospectus supplement relating to any particular
securities offered will describe the specific terms of the securities, which may
be in addition to or different from the general terms summarized in this
prospectus. The summary in this prospectus and in any prospectus supplement does
not describe every aspect of the securities and is subject to and qualified in
its entirety by reference to all applicable provisions of the documents relating
to the securities offered. These documents are or will be filed as exhibits to
or incorporated by reference in the registration
statement.
In
addition, the prospectus supplement will set forth the terms of the offering,
the initial public offering price and estimated net proceeds to us. Where
applicable, the prospectus supplement will also describe any material United
States federal income tax considerations relating to the securities offered and
indicate whether the securities offered are or will be listed on any securities
exchange.
USE
OF PROCEEDS
Unless
otherwise set forth in the applicable prospectus supplement, we intend to use
the net proceeds from the sale of the securities we offer by this prospectus for
general corporate purposes, which may include, among other things:
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general corporate purposes,
including additions to working capital and capital
expenditures;
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research and development
activities; and
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the expansion of our business
through internal growth or
acquisitions.
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We may
raise additional funds from time to time through equity or debt financing,
including borrowings under credit facilities, to finance our business and
operations. If required, we will include a more detailed description of the use
of proceeds from any specific offering of securities in the prospectus
supplement relating to that offering.
PLAN
OF DISTRIBUTION
We may
sell our securities from time to time through underwriters, dealers or agents or
directly to purchasers, in one or more transactions at a fixed price or prices,
which may be changed, or at market prices prevailing at the time of sale, at
prices related to such prevailing market prices or at negotiated prices. We may
use these methods in any combination.
By
Underwriters
We may
use an underwriter or underwriters in the offer or sale of our
securities:
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If we use an underwriter or
underwriters, the offered securities will be acquired by the underwriters
for their own account.
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We will include the names of the
specific managing underwriter or underwriters, as well as any other
underwriters, the amounts underwritten by each underwriter, and the terms
of the transactions, including the compensation the underwriters and
dealers will receive, in the prospectus
supplement.
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The underwriters will use this
prospectus and the prospectus supplement to sell our
securities.
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We may
also sell securities pursuant to one or more standby agreements with one or more
underwriters in connection with the call, redemption or exchange of a specified
class or series of any of our outstanding securities. In a standby agreement,
the underwriter or underwriters would agree either:
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to purchase from us up to the
number of shares of common stock that would be issuable upon conversion or
exchange of all the shares of the class or series of our securities at an
agreed price per share of common stock;
or
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to purchase from us up to a
specified dollar amount of offered securities at an agreed price per
offered security, which price may be fixed or may be established by
formula or other method and which may or may not relate to market prices
of our common stock or any other outstanding
security.
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The
underwriter or underwriters may also agree, if applicable, to convert or
exchange any securities of the class or series held or purchased by the
underwriter or underwriters into or for our common stock or other
security.
The
underwriter or underwriters may assist in the solicitation of conversions or
exchanges by holders of the class or series of securities.
By
Dealers
We may
use a dealer to sell our securities.
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If we use a dealer, such person,
as principal, will sell our securities to the
dealer.
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The dealer will then resell our
securities to the public at varying prices that the dealer will determine
at the time it sells our
securities.
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We will include the name of the
dealer and the terms of our transactions with the dealer in the prospectus
supplement.
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By
Agents
We may
designate agents to solicit offers to purchase our securities.
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We will name any agent involved
in offering or selling our securities and any commissions that we will pay
to the agent in the prospectus
supplement.
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Unless indicated otherwise in the
prospectus supplement, our agents will act on a best efforts basis for the
period of their appointment.
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An agent may be deemed to be
underwriters under the Securities Act of any of our securities that they
offer or sell.
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By
Delayed Delivery Contracts
We may
authorize our agents and underwriters to solicit offers by certain institutions
to purchase our securities at the public offering price under delayed delivery
contracts.
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If we use delayed delivery
contracts, we will disclose that we are using them in the prospectus
supplement and will tell you when payment will be demanded and securities
delivered under the delayed delivery
contracts.
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These delayed delivery contracts
will be subject only to the conditions set forth in the prospectus
supplement.
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We will indicate in the
prospectus supplement the commission that underwriters and agents
soliciting purchases of our securities under delayed delivery contracts
will be entitled to receive.
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We may
directly solicit offers to purchase our securities, and we may directly sell our
securities to institutional or other investors, including our affiliates. We
describe the terms of our direct sales in the prospectus supplement. We may also
sell our securities upon the exercise of rights which we may issue.
General
Information
Underwriters,
dealers and agents that participate in the distribution of our securities may be
underwriters as defined in the Securities Act, and any discounts or commissions
they receive and any profit they make on the resale of the offered securities
may be treated as underwriting discounts and commissions under the Securities
Act. Any underwriters or agents will be identified and their compensation
described in a prospectus supplement. We may indemnify agents, underwriters, and
dealers against certain civil liabilities, including liabilities under the
Securities Act, or make contributions to payments they may be required to make
relating to those liabilities. Our agents, underwriters, and dealers, or their
affiliates, may be customers of, engage in transactions with, or perform
services for us in the ordinary course of business.
Each
series of securities offered by this prospectus may be a new issue of securities
with no established trading market. Any underwriters to whom securities offered
by this prospectus are sold by us for public offering and sale may make a market
in the securities offered by this prospectus, but the underwriters will not be
obligated to do so and may discontinue any market making at any time without
notice. No assurance can be given as to the liquidity of the trading market for
any securities offered by this prospectus.
Representatives
of the underwriters through whom our securities are sold for public offering and
sale may engage in over-allotment, stabilizing transactions, syndicate short
covering transactions and penalty bids in accordance with Regulation M under the
Exchange Act. Over-allotment involves syndicate sales in excess of the offering
size, which creates a syndicate short position. Stabilizing transactions permit
bids to purchase the offered securities so long as the stabilizing bids do not
exceed a specified maximum.
Syndicate
covering transactions involve purchases of the offered securities in the open
market after the distribution has been completed in order to cover syndicate
short positions. Penalty bids permit the representative of the underwriters to
reclaim a selling concession from a syndicate member when the offered securities
originally sold by such syndicate member are purchased in a syndicate covering
transaction to cover syndicate short positions. Such stabilizing transactions,
syndicate covering transactions and penalty bids may cause the price of the
offered securities to be higher than it would otherwise be in the absence of
such transactions. These transactions may be effected on a national securities
exchange and, if commenced, may be discontinued at any time. Underwriters,
dealers and agents may be customers of, engage in transactions with or perform
services for, us and our subsidiaries in the ordinary course of
business.
We will
bear all costs, expenses and fees in connection with the registration of the
securities as well as the expense of all commissions and discounts, if any,
attributable to the sales of any of our securities by us.
WHERE
YOU CAN FIND MORE INFORMATION; INCORPORATION OF DOCUMENTS BY
REFERENCE
We file
annual, quarterly and special reports, proxy statements and other information
with the Commission. You may read and copy any document we file at the
Commission’s public reference room at 100 F Street, N.E., Washington, D.C.
20549. Please call the Commission at 1-800-SEC-0330 for further information on
the public reference rooms. Many of the filings we make with the Commission are
also available to the public from the Securities and Exchange Commission’s
Website at “http://www.sec.gov.” We make available free of charge our annual,
quarterly and current reports, proxy statements and other information upon
request. To request such materials, please send an e-mail to jbrooks@senesco.com
or contact Joel Brooks, our Chief Financial Officer, at our address as set forth
below. In addition, our common stock is listed for trading on the NYSE Amex
under the symbol “SNT.” We maintain a Website at “http://www.senesco.com” (this
is not a hyperlink, you must visit this website through an Internet browser).
Our Website and the information contained therein or connected thereto are not
incorporated into this prospectus.
We have
filed with the Commission a Registration Statement (which contains this
prospectus) on Form S-3 under the Securities Act. The registration statement
relates to our offering of the common stock, preferred stock and warrants. This
prospectus does not contain all of the information set forth in the registration
statement and the exhibits and schedules to the registration statement. Please
refer to the registration statement and its exhibits and schedules for further
information with respect to us and our common stock, preferred stock or
warrants. Statements contained in this prospectus as to the contents of any
contract or other document are not necessarily complete and, in each instance,
we refer you to the copy of that contract or document filed as an exhibit to the
Registration Statement. You may read and obtain a copy of the registration
statement and its exhibits and schedules from the Commission, as described in
the preceding paragraph.
The
Commission allows us to “incorporate by reference” the information we file with
them, which means that we can disclose important information to you by referring
you to those documents. The information incorporated by reference is considered
to be part of this prospectus, and information that we file later with the
Commission will automatically update and supersede this information. We
incorporate by reference the documents filed with the Commission listed
below:
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Our Annual Report on Form 10-K
for the year ended June 30, 2010, filed on September 28, as amended on
October 25, 2010;
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The description of our capital
stock contained in our Registration Statement on Form 8-A filed on
May 14, 2002; and
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All documents we have filed with
the Commission pursuant to Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934 after the date of the registration
statement and prior to the effectiveness of the registration statement, as
well as subsequent to the date of this prospectus and prior to the
termination of this offering, shall be deemed to be incorporated by
reference into this prospectus and to be a part of this prospectus from
the date of the filing of the
documents.
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You may
request a copy of these filings, at no cost, by sending an e-mail to
jbrooks@senesco.com and requesting any one or more of such filings or by
contacting Joel Brooks, our Chief Financial Officer at the following address or
telephone number: Senesco Technologies, Inc., 303 George Street, Suite 420, New
Brunswick, New Jersey 08901, Attention: Chief Financial Officer; (732) 296-8400.
Exhibits to the documents will not be sent, unless those exhibits have
specifically been incorporated by reference in this prospectus.
This
prospectus is part of a registration statement we filed with the Commission. You
should rely only on the information contained in this prospectus. We have
authorized no one to provide you with different information. We are not making
an offer of these securities in any state where the offer is not
permitted. You should not assume that the information in this
prospectus is accurate as of any date other than the date on the front of the
document.
LEGAL
MATTERS
Legal
matters with respect to the securities offered hereby are being passed upon for
us by Morgan, Lewis and Bockius LLP, Princeton, New Jersey.
EXPERTS
The
financial statements as of June 30, 2010 and 2009 and for each of the three
years in the period ended June 30, 2010 and for the cumulative period from July
1, 1998 (inception) to June 30, 2010, incorporated by reference in this
prospectus and elsewhere in the registration statement have been audited by
McGladrey & Pullen, LLP, independent registered public accounting firm, as
indicated in their report with respect thereto, and are incorporated by
reference herein in reliance upon the authority of said firm as experts in
accounting and auditing.
$25,000,000
WARRANTS
PREFERRED
STOCK
COMMON
STOCK
October 26,
2010