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PROSPECTUS SUPPLEMENT NO. 4
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Filed pursuant to Rule 424(b)(5) |
(To Prospectus dated June 4, 2009)
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Registration Statement No. 333-159376 |
ADVENTRX Pharmaceuticals, Inc.
15,676 Shares of 3.73344597664961% Series E Convertible Preferred Stock
Warrants to Purchase 10,282, 041 Shares of Common Stock
51,410,206 Shares of Common Stock Underlying the Preferred Stock and Warrants
We are offering 15,676 shares of our 3.73344597664961% Series E convertible preferred stock,
$0.001 par value per share, and warrants to purchase up to 10,282,041 shares of our common stock to
purchasers in this offering. We are also offering an aggregate of 51,410,206 shares of our common
stock issuable upon conversion of the convertible preferred stock and exercise of the warrants. The
convertible preferred stock and warrants will be sold in units, with each unit consisting of one
share of convertible preferred stock and a warrant to purchase approximately 655.91 shares of
common stock. Subject to certain ownership limitations, the convertible preferred stock is
convertible at any time at the option of the holder into shares of our common stock at a conversion
ratio determined by dividing the stated value of the convertible preferred stock by a conversion
price of $0.38115 per share and will accrue a 3.73344597664961% dividend until January 7, 2015. In
the event the convertible preferred stock is converted at any time prior to January 7, 2015, we
will pay the holder of such converted convertible preferred stock an amount equal to the total
dividend that would accrue on such convertible preferred stock, less any dividend payments
previously made with respect to such shares. The warrants are exercisable at any time after their
date of issuance and on or before the 30-month anniversary of their initial exercise date at an
exercise price of $0.3499 per share of common stock. Each unit will be sold at a negotiated price
of $1,000. Units will not be issued or certificated. The shares of convertible preferred stock and
warrants are immediately separable and will be issued separately.
We will place 18.6672%, or approximately $2,926,274, of the gross proceeds in an escrow
account, which amounts will be released to make the dividend and other payments due on the
convertible preferred stock.
Our common stock is listed on the NYSE Amex (formerly, the American Stock Exchange) under the
symbol ANX. The last reported sale price of our common stock on December 31, 2009 was $0.3499 per
share. We do not intend to list the preferred stock or warrants on any national securities
exchange.
This investment involves a high degree of risk. You should carefully review the risks and
uncertainties described under the heading Risk Factors beginning on page S-3 of this prospectus
supplement.
Rodman & Renshaw, LLC is acting as our placement agent in connection with this offering.
The placement agent is not purchasing or selling any of these securities nor is it required to sell
any specific number or dollar amount of securities, but has agreed to use its reasonable best
efforts to sell the securities offered by this prospectus supplement. We may increase the dollar
value of securities we offer under the registration statement(s) of which this prospectus
supplement and the accompanying prospectus form a part by up to $3,901,311. In consideration for
its services, we have agreed to pay the placement agent the cash fees set forth in the table below,
which shows the cash fees we would pay without and with such increase, and to issue 30-month
warrants to the placement agent to purchase up to an aggregate of 2,056,408 shares (or 2,492,457
shares if we effect the increase) of our common stock at an exercise price of $0.4765 per share.
These warrants are not covered by this prospectus supplement.
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Maximum Amount |
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Maximum Amount |
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Per Unit |
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(without increase) |
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(with increase) |
Public offering price |
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$ |
1,000 |
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$ |
15,676,000 |
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$ |
19,000,000 |
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Placement agent fees |
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$ |
70 |
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$ |
1,097,320 |
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$ |
1,330,000 |
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Proceeds, before expenses, to ADVENTRX Pharmaceuticals, Inc. |
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$ |
930 |
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$ |
14,578,680 |
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$ |
17,670,000 |
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We expect delivery of the units being sold in this offering to be made to purchasers on or
about January 7, 2010, against payment of immediately available funds. Because there is no minimum
offering amount required as a condition to closing this offering, the actual public offering price,
placement agent fees, and proceeds to us, if any, are not presently determinable and may be
substantially less than the maximum amounts set forth above.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities, or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
Rodman & Renshaw, LLC
The date of this prospectus supplement is January 3, 2010.
TABLE OF CONTENTS
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Prospectus Supplement |
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Page |
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S-ii |
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S-1 |
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S-3 |
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S-23 |
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S-24 |
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S-25 |
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S-26 |
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S-28 |
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S-29 |
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S-31 |
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S-31 |
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S-31 |
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Prospectus |
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Page |
ABOUT THIS PROSPECTUS |
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ii |
SUMMARY |
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1 |
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RISK FACTORS |
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4 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
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26 |
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USE OF PROCEEDS |
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27 |
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DESCRIPTION OF COMMON STOCK AND PREFERRED STOCK |
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28 |
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DESCRIPTION OF DEBT SECURITIES |
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31 |
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DESCRIPTION OF WARRANTS |
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40 |
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DESCRIPTION OF UNITS |
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41 |
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PLAN OF DISTRIBUTION |
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43 |
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LEGAL MATTERS |
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45 |
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EXPERTS |
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45 |
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WHERE YOU CAN FIND ADDITIONAL INFORMATION |
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45 |
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE |
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45 |
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S-i
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying prospectus are part of a shelf registration
statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC, using
a shelf registration process. This prospectus supplement describes the specific terms of this
offering. The accompanying prospectus, including the documents incorporated by reference, provides
general information about us, some of which, such as the section therein entitled Plan of
Distribution, may not apply to this offering. Generally, when we refer to this prospectus, we are
referring to both parts of this document, this prospectus supplement and the accompanying
prospectus, combined.
We urge you to carefully read this prospectus supplement, the accompanying prospectus and the
documents incorporated herein and therein, before buying any of the securities being offered under
this prospectus supplement. These documents contain information you should consider when making
your investment decision.
You should rely only on the information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus. We have not, and the placement agent has
not, authorized anyone to provide you with different information. If anyone provides you with
different or inconsistent information, you should not rely on it. This prospectus supplement may
add, update or change information contained in the accompanying prospectus. To the extent any
information in this prospectus supplement is inconsistent with the accompanying prospectus, you
should rely on the information in this prospectus supplement. The information in this prospectus
supplement will be deemed to modify or supersede those made in the accompanying prospectus and the
documents incorporated by reference therein, except for those documents incorporated by reference
therein which we file with the SEC after the date hereof.
You should not assume that the information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus is accurate on any date subsequent to the
date set forth on the front cover of this prospectus supplement and the accompanying prospectus or
on any date subsequent to the date of the document incorporated by reference, as applicable. Our
business, financial condition, results of operations and prospects may have changed since those
dates.
We are offering to sell, and seeking offers to buy, the securities described in this
prospectus supplement only in jurisdictions where offers and sales are permitted. The distribution
of this prospectus supplement and the offering of the securities in certain jurisdictions may be
restricted by law. Persons outside the United States who come into possession of this prospectus
supplement must inform themselves about, and observe any restrictions relating to, the offering of
the securities and the distribution of this prospectus supplement outside the United States. This
prospectus supplement does not constitute, and may not be used in connection with, an offer to
sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement by
any person in any jurisdiction in which it is unlawful for such person to make such an offer or
solicitation.
We are not making any representation to you regarding the legality of an investment in the
units, the convertible preferred stock and warrants comprising the units or the underlying common
stock by you under applicable law. You should consult with your own legal advisors as to the legal,
tax, business, financial and related aspect of a purchase of these securities.
S-ii
SUMMARY
This summary highlights selected information about us and this offering and does not contain
all of the information that you need to consider in making your investment decision. You should
carefully read this entire prospectus supplement and the accompanying prospectus, including the
risks and uncertainties discussed under the heading Risk Factors beginning on page S-3 of this
prospectus supplement, and the information incorporated by reference, including our financial
statements, before making an investment decision. When used in this prospectus supplement, the
terms ADVENTRX, we, us, our and the Company refer to ADVENTRX Pharmaceuticals, Inc. and
its consolidated subsidiaries, unless otherwise indicated or the context otherwise requires.
About ADVENTRX Pharmaceuticals, Inc.
We are a development-stage specialty pharmaceutical company focused on in-licensing,
developing and commercializing proprietary product candidates for the treatment of cancer. We seek
to improve the performance of existing drugs by addressing limitations associated principally with
their safety and use. We have not yet marketed or sold any products or generated any significant
revenue. We have devoted substantially all of our resources to research and development or to
acquisition of our product candidates. We have not yet marketed or sold any products or generated
any significant revenue. Our lead product candidates, ANX-530 and ANX-514, are novel emulsion
formulations of currently marketed chemotherapy drugs. We submitted a New Drug Application, or NDA,
for ANX-530 to the United States Food and Drug Administration, or FDA, in December 2009. In
addition, we continue to evaluate the data from our recently-completed bioequivalence study of
ANX-514 and we plan to seek a meeting with the FDA to discuss the results.
Our business was incorporated in Delaware in December 1995. In October 2000, we merged our
wholly-owned subsidiary, Biokeys Acquisition Corp., with and into Biokeys, Inc. and changed our
name to Biokeys Pharmaceuticals, Inc. In May 2003, we merged Biokeys, Inc., our wholly-owned
subsidiary, with and into us and changed our name to ADVENTRX Pharmaceuticals, Inc. In July 2004,
we formed a wholly-owned subsidiary, ADVENTRX (Europe) Ltd., in the United Kingdom primarily to
facilitate conducting clinical trials in the European Union and to obtain favorable pricing for
discussions with the European Medicines Agency. In April 2006, we acquired SD Pharmaceuticals, Inc.
as a wholly-owned subsidiary. Our executive offices are located at 6725 Mesa Ridge Road, Suite 100,
San Diego, California 92121, and our telephone number is (858) 552-0866. Our corporate website is
located at www.adventrx.com. We make available free of charge through our Internet website our
annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and
amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the SEC. Information on our website does
not constitute part of this prospectus supplement or any other prospectus supplement.
S-1
The Offering
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Convertible preferred stock offered by us:
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Up to 15,676 shares of convertible preferred
stock; |
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Up to 41,128,165 shares of common stock issuable upon conversion of the convertible preferred stock; |
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Warrants to purchase up to 10,282,041 shares of
common stock; and |
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Up to 10,282,041 shares of common stock issuable
upon exercise of the warrants. |
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Common stock to be outstanding after this offering:
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205,285,265 shares of common stock, or 256,695,471 shares
of common stock if the convertible preferred stock and
warrants offered hereby are converted and exercised in
full. |
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Make-whole Payment:
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In the event that the convertible preferred stock is
converted at any time prior to January 7, 2015, we will
pay to the holder an amount equal to $186.67 per $1,000
in stated value of the shares of convertible preferred
stock converted, less any dividend payments previously
made with respect to such shares. |
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Escrow:
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An amount of the gross proceeds of the offering equal to
the aggregate potential make-whole payment will be
deposited with a third party, as escrow agent, to be held
until January 7, 2015. Amounts in the escrow account will
be released to pay dividends and any make-whole payments
with respect to convertible preferred stock converted
during the escrow period. |
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Use of proceeds:
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We currently intend to use the net proceeds from this
offering to fund activities relating to the commercial
launch of ANX-530, including acquiring or developing
sales, marketing and distribution capabilities and the
associated regulatory compliance infrastructure, and to
continue the development of ANX-514 in the United States,
and for general corporate purposes. Please see Use of
Proceeds below. |
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NYSE Amex Symbol:
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ANX |
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Risk Factors:
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See Risk Factors below for a discussion of factors that
you should carefully read and consider before investing
in our securities. |
The number of shares of our common stock that will be outstanding immediately after the
offering is based on 205,285,265 shares outstanding as of December 31, 2009, and excludes:
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5,859,000 shares of common stock issuable upon the exercise of outstanding stock
options issued under our equity incentive plans prior to this offering, at a weighted
average exercise price of $0.80 per share; |
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14,383,656 shares of common stock available for future issuance under our 2008
Omnibus Incentive Plan; |
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23,658,733 shares of common stock issuable upon the exercise of outstanding warrants
issued prior to this offering, at a weighted average exercise price of $1.13 per share; |
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12,462,285 shares of common stock issuable upon the exercise of the warrants to be
issued to the purchasers in this offering, at an exercise price of $0.3499 per share,
which amount assumes we increase the dollar value of securities in this offering by a
total of $3,901,311; and |
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2,492,457 shares of common stock issuable upon exercise of warrants to be issued to
the placement agent in connection with this offering, which are not covered by this
prospectus supplement, at an exercise price of $0.4765 per share, which amount assumes
we increase the dollar value of securities in this offering by a total of $3,901,311. |
S-2
RISK FACTORS
Investing in our securities involves a high degree of risk. You should carefully consider the
risk factors discussed below, together with all the other information contained or incorporated by
reference in this prospectus supplement and the accompanying prospectus, and in our filings under
the Securities Exchange Act of 1934, as amended, or the Exchange Act, before deciding whether to
purchase any of the securities being offered by this prospectus supplement. Each of the risk
factors could adversely affect our business, operating results and financial condition, as well as
adversely affect the value of an investment in our securities, and the occurrence of any of these
risks might cause you to lose all or part of your investment.
RISKS RELATED TO OUR BUSINESS
Risks Related to Our Capital Requirements, Operations and Ability to Continue as a Going Concern
We have incurred losses since our inception, we expect our operating expenses to continue to exceed
our revenues for the foreseeable future and we may never generate revenues sufficient to achieve
profitability.
We are a development stage company and have not generated sustainable revenues from operations or
been profitable since inception, and it is possible we will never achieve profitability. We have
devoted our resources to developing a new generation of therapeutic products, but such products
cannot be marketed until the regulatory process is completed and governmental approvals have been
obtained. Accordingly, there is no current source of revenues from operations, much less profits,
to sustain our present activities, and no revenues from operations will likely be available until,
and unless, our product candidates are approved by the U.S. Food and Drug Administration, or FDA,
or other regulatory agencies and successfully marketed, either by us or a partner, an outcome which
we are not able to guarantee.
Our financial resources are limited, we will require substantial additional funding to continue our
business, and, if we are unable to raise sufficient additional capital, we may cease operating as a
going concern and liquidate our assets.
We have experienced significant operating losses in funding the development of our product
candidates, accumulating net losses totaling approximately $146.7 million as of September 30, 2009,
and we expect to continue to incur substantial operating losses for the foreseeable future, even if
we or a future partner of ours is successful in advancing our product candidates to market. As of
September 30, 2009, we had approximately $3.1 million in cash and cash equivalents and we do not
expect to generate cash flows from sales of our products unless and until our products are approved
for marketing, the timing of which we cannot predict accurately. We anticipate that our cash and
cash equivalents as of September 30, 2009, together with the net proceeds from the equity financing
we completed on October 9, 2009, will be sufficient to permit us to conduct our business through
December 31, 2010. However, we will need substantial additional funds to commercialize ANX-530,
including acquiring or developing sales, marketing and distribution capabilities and the associated
regulatory compliance infrastructure, and to continue the development of ANX-514. In addition, we
may incur substantial costs in connection with evaluating and negotiating future capital-raising
and/or strategic or partnering transactions, the effect of which may be to shorten the period
through which our operating funds will sustain us. We cannot currently predict the extent of these
costs. Even if we incur costs in pursuing, evaluating and negotiating particular capital-raising
and/or strategic or partnering transactions, our efforts may not prove successful.
Our independent auditors report for the year ended December 31, 2008 includes an explanatory
paragraph stating that our recurring losses from operations and negative cash flows raise
substantial doubt about our ability to continue as a going concern. If we are unable to obtain
additional financing or consummate a strategic transaction on commercially reasonable terms, our
business, financial condition and results of operations will be materially and adversely affected
and we may be unable to continue as a going concern. If we are unable to continue as a going
concern, we may have to seek protection under the provisions of the U.S. Bankruptcy Code or
liquidate our assets and dissolve our company. In either case, we may receive less than the value
at which our assets are carried on our financial statements. Based on our current working capital
and estimated costs of implementing an orderly liquidation of our assets, we do not expect that
there will be material cash available for distribution to our stockholders.
Even following the offering described in this prospectus supplement, we may need to raise
additional capital to execute our business plans. Our future expenditures on our programs are
subject to many uncertainties, including whether our product candidates will be developed with a
partner or independently. Our future capital requirements will depend on, and could increase
significantly as a result of, many factors, including:
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the costs of seeking regulatory approval for our lead product candidates, ANX-530 and
ANX-514, including any bioequivalence or clinical studies, process development, scale-up
and other manufacturing activities, or other work required to achieve such approval, as
well as the timing of such activities and approval; |
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the timing and terms of any collaborative, licensing and other strategic arrangements
that we may establish; |
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the cost related to establishing or contracting for sales and marketing capabilities and
other commercial capabilities;
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S-3
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the scope, prioritization and number of development and/or commercialization programs we
pursue and the rate of progress and costs with respect to such programs; |
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the extent to which we will need to rebuild our workforce, which currently consists of
two full-time employees, and the cost involved in hiring, training and incentivizing new
employees; |
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the extent to which we invest in or acquire new technologies, products or businesses; |
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the effect of competing technological and market developments; and |
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the cost involved in establishing, enforcing or defending patent claims and other
intellectual property rights. |
Even if we sell the maximum amount of units offered by this prospectus supplement, including any
potential increase to the offering, we may seek additional funding through public or private sales
of our equity securities, debt financings, collaborations, licensing arrangements or other
strategic transactions. However, we may not be able to obtain sufficient additional funding on
satisfactory terms, if at all. We believe global economic conditions, including the recent credit
crisis, have adversely impacted our ability to raise additional capital and may continue to do so.
In addition, we have been evaluating and continue to evaluate strategic options, including the sale
or exclusive license of one or more of our product candidate programs, a strategic business merger
and similar transactions. However, to date, discussions with potential strategic transaction
partners have been unsuccessful, protracted or on terms that we determined were unacceptable.
Our ability to raise capital may be limited by applicable laws and regulations.
Although we have an effective shelf registration statement, we may not be able to use that
registration statement to raise substantial additional capital, if any. Under current SEC
regulations, we will not be eligible to use a registration statement on Form S-3 for primary
offerings of our common stock or securities convertible into our common stock unless our common
stock is listed and registered on a national securities exchange or unless the aggregate market
value of our common stock held by non-affiliates reaches $75 million or more. The NYSE Amex will
review the appropriateness of continued listing of any issuer that falls below the exchanges
continued listing standards and may, in its discretion, at any time, and without notice, suspend
dealings in, or may remove any security from, listing privileges. The NYSE Amex will normally
consider suspending dealings in, or removing from the list, securities of an issuer which has
stockholders equity of less than $6.0 million if such issuer has sustained losses from continuing
operations and/or net losses in its five most recent fiscal years. On June 1, 2009, we received
notice from the NYSE Amex staff that, based on their review of our Form 10-Q for the period ended
March 31, 2009, we are not in compliance with certain stockholders equity continued listing
standards. Specifically, the NYSE Amex staff noted that we are not in compliance with Section
1003(a)(ii) of the NYSE Amex Company Guide because we reported stockholders equity of less than
$4,000,000 and losses from continuing operations and net losses in three of our four most recent
fiscal years, or with Section 1003(a)(iii) of the Company Guide because we reported stockholders
equity of less than $6,000,000 and losses from continuing operations and net losses in our five
most recent fiscal years. In addition, the NYSE Amex staff notified us, in accordance with Section
1003(f)(v) of the Company Guide, that it deems it appropriate for us to effect a reverse stock
split of our common stock to address our low selling price per share, and that if a reverse stock
split is not completed within a reasonable amount of time after June 1, 2009, the NYSE Amex may
consider suspending dealings in, or removing from the list, our common stock. On July 1, 2009, we
submitted a plan to attempt to resolve our listing deficiencies and regain compliance with the
continued listing requirements. On July 31, 2009, the NYSE Amex staff notified us that it
determined that the plan we submitted makes a reasonable demonstration of our ability to regain
compliance with the NYSE Amexs continued listing standards and determined to grant us an
extension, until December 1, 2010, for us to regain compliance with the NYSE Amexs continued
listing standards. See the risk factor below headed, We are currently not in compliance with
NYSE Amex continuing listing standards and are at risk of being delisted from the NYSE Amex
equities market, for additional information regarding the risk of our common stock being delisted
from the NYSE Amex. If our common stock were delisted from the NYSE Amex, our ability to raise
capital on terms and conditions we deem acceptable, if at all, may be materially impaired.
Currently, we do not anticipate being eligible to register and list our common stock on any other
national securities exchange.
In addition, even if we maintain our listing with the NYSE Amex, under current SEC regulations, at
any time during which the aggregate market value of our common stock held by non-affiliates, or
public float, is less than $75.0 million (calculated as set forth in Form S-3 and SEC rules and
regulations), the amount we can raise through primary offerings of our securities in any
twelve-month period using a registration statement on Form S-3 will be limited to an aggregate of
one-third of our public float; however, the market value of all securities sold by us under our
Form S-3 registration statement in the past 12 months will be subtracted from that amount to
determine any future amount we can raise using our Form S-3 registration statement. While, as of
the date hereof, our public float exceeds $75.0 million (calculated as set forth in Form S-3 and
SEC rules and regulations), SEC rules and regulations require that we periodically re-evaluate the
value of our public float. If, at a re-evaluation data, our public float is less than $75.0
million (calculated as set forth in Form S-3 and SEC rules and regulations), the amount we could
raise through primary offerings of our securities in any twelve-month period using a registration
statement on Form S-3 again will be limited to an aggregate of one-third of our public float as
described above. Alternative means of raising capital through sales of our securities, including
through the use of a Form S-1 registration statement, may be more costly and time-consuming.
S-4
In addition, our ability to timely raise sufficient capital may be limited by the requirements of
the NYSE Amex relating to stockholder approval for transactions involving the issuance of our
common stock or securities convertible into our common stock. For instance, the NYSE Amex requires
that we obtain stockholder approval of any transaction involving the sale, issuance or potential
issuance by us of our common stock (or securities convertible into our common stock) at a price
less than the greater of book or market value, which (together with sales by our officers,
directors and principal stockholders) equals 20% or more of our presently outstanding common stock,
unless the transaction is deemed a public offering by the NYSE Amex staff. Based on our
outstanding common stock as of December 31, 2009 and a closing price of $0.3499, which was the
closing price of our common stock on December 31, 2009, we could not raise more than approximately
$14.4 million without stockholder approval, unless the transaction is deemed a public offering or
does not involve the sale, issuance or potential issuance by us of our common stock (or securities
convertible into our common stock) at a price less than the greater of book or market value.
However, certain prior sales by us may be aggregated to any offering we may propose in the
near-term, further limiting the amount we could raise in any future offering that is not deemed a
public offering by the NYSE Amex and would involve the sale, issuance or potential issuance by us
of our common stock (or securities convertible into our common stock) at a price less than the
greater of book or market value.
Obtaining stockholder approval is a costly and time-consuming process. If we are required to obtain
stockholder approval, we would expect to spend substantial additional money and resources. In
addition, seeking stockholder approval would delay our receipt of otherwise available capital,
which may materially and adversely affect our ability to continue as a going concern, and there is
no guarantee our stockholders would ultimately approve a proposed transaction. A public offering
under the NYSE Amex rules typically involves broadly announcing the proposed transaction, which
often times has the effect of depressing the issuers stock price. Accordingly, the price at which
we could sell our securities in a public offering may be less and the dilution existing
stockholders experience may in turn be greater than if we were able to raise capital through other
means.
Raising additional capital may cause dilution to our existing stockholders, require us to
relinquish proprietary rights or restrict our operations.
We may raise additional capital at any time and may do so through one or more financing
alternatives, including public or private sales of our equity securities, debt financings,
collaborations, licensing arrangements or other strategic transactions. Each of these financing
alternatives carries certain risks. Raising capital through the issuance of common stock may
depress the market price of our stock and may substantially dilute our existing stockholders. If we
instead seek to raise capital through strategic transactions, such as licensing arrangements or
sales of one or more of our technologies or product candidates, we may be required to relinquish
valuable rights. For example, any licensing arrangement would likely require us to share a
significant portion of any revenues generated by our licensed technologies with our licensees.
Additionally, the development of any product candidates licensed or sold to third parties will no
longer be in our control and thus we may not realize the full value of any such product candidates.
Debt financings could involve covenants that restrict our operations. These restrictive covenants
may include limitations on additional borrowing and specific restrictions on the use of our assets,
as well as prohibitions on our ability to create liens or make investments and may, among other
things, preclude us from making distributions to stockholders (either by paying dividends or
redeeming stock) and taking other actions beneficial to our stockholders. In addition, investors
could impose more one-sided investment terms and conditions on companies that have or are perceived
to have limited remaining funds or limited ability to raise additional funds. As we continue to use
our cash and cash equivalents to fund our operations, it will likely become increasingly difficult
to raise additional capital on commercially reasonable terms, or at all.
If we are unable to raise sufficient additional capital, we may be forced to reduce or abandon
on-going and/or planned development and/or commercialization activities, partner our product
candidates or products at inopportune times or pursue less-expensive but higher-risk development
paths, which we have done in the past.
Even following the offering described in this prospectus supplement, we may need to raise
additional capital in order to execute our business plans. If we are not able to raise adequate
funds to continue our operations at levels we believe would enable us to capitalize on our assets,
we may have to abandon some or all of them or attempt to continue our development and
commercialization efforts by entering into arrangements with partners or others that, if available
at all, may not be on favorable terms and may require us to relinquish some or all of our rights to
our product candidates or the financial benefits thereof, or we may determine to liquidate our
assets and may receive less than the value at which our assets are carried on our financial
statements.
To conserve funds, we may pursue less expensive but higher-risk development paths. For instance, in
the past, we limited our ANX-530 manufacturing activities to the minimum we felt was sufficient to
support our development and commercialization goals, in particular, with respect to ANX-530. While
we successfully completed certain key manufacturing activities with respect to ANX-530, without
extensive manufacturing experience, we may lack the information necessary to increase the scale of
our existing processes and may be unable to manufacture successfully at commercial-scale. If we are
unable to scale our manufacturing processes, we may be unable to effectively commercialize our
products, if approved.
If we are unable to raise sufficient additional capital, we may seek to merge with or be acquired
by another company and that transaction may adversely affect our business and the value of our
securities.
If we are unable to raise sufficient additional capital, we may seek to merge with another company
with a stronger cash position, complementary work force or product candidate portfolio or for other
reasons. We believe the market price for our common stock may
S-5
not accurately reflect the value of our business. While we will continue to seek to maximize the
value of our business to our stockholders, the most attractive option for doing so may require us
to consummate a transaction involving an exchange of our common stock with that of another company.
There are numerous risks associated with merging or being acquired. These risks include, among
others, incorrectly assessing the quality of a prospective acquirer or merger-partner, encountering
greater than anticipated costs in integrating businesses, facing resistance from employees and
being unable to profitably deploy the assets of the new entity. The operations, financial
condition, and prospects of the post-transaction entity depend in part on our and our
acquirer/merger-partners ability to successfully integrate the operations related to our product
candidates, business and technologies. We may be unable to integrate operations successfully or to
achieve expected cost savings and any cost savings which are realized may be offset by losses in
revenues or other charges to operations. As a result, our stockholders may not realize the full
value of their investment.
If we fail to maintain registration of the shares of common stock issued or issuable pursuant to
the exercise of warrants we issued in our July 2005 private placement, we will be required to pay
the holders of those securities liquidated damages, which could be material in amount.
The terms of the securities purchase agreement that we entered into in connection with our July
2005 private placement require us to pay liquidated damages to the purchasers of those securities
in the event any shares issued or issuable pursuant to the exercise of warrants we issued in the
private placement cannot be resold pursuant to our registration statement on Form S-3 (No.
333-127857) filed with and declared effective by the SEC on September 2, 2005. We refer to this as
a maintenance failure. For each 30-day period or portion thereof during which a maintenance failure
remains uncured, we are obligated to pay each purchaser an amount in cash equal to 1% of the
purchasers aggregate purchase price for any shares of common stock or shares of common stock
issuable upon exercise of warrants then held by the purchaser (prorated for any period less than a
month), increasing by an additional 1% with regard to each additional 30-day period or portion
thereof until the maintenance failure is cured. There is no cap with respect to the total amount of
these liquidated damages. The aggregate gross proceeds from our July 2005 private placement were
approximately $20 million. We are required to maintain the registration statement until the earlier
of the date (i) all of the securities issued in our July 2005 private placement have been resold
and (ii) each purchaser can resell the securities pursuant to Rule 144 under the Securities Act of
1933, as amended, without regard to the adequate current public information, volume, manner of sale
or notice filing restrictions. The amount of these liquidated damages could be substantial and
could have a material adverse effect on our financial condition.
For additional information, see Note 11 of the Notes to Consolidated Financial Statements,
Registration Payment Arrangement, of our annual report on Form 10-K for the year ended December
31, 2008.
We may be unable to retain the services of key personnel, and, even if we are successful in raising
additional funds, we may not be successful in rebuilding our workforce to carry out the development
and commercialization activities necessary for our product candidates.
We have only two full-time employees and we depend on the services of these employees to continue
our business. We do not have a chief executive officer or chief financial officer. Our Chief
Business Officer and Senior Vice President currently is acting as our interim principal executive
officer and our General Counsel, Secretary and Vice President, Legal currently is acting as our
interim principal financial and accounting officer. To the extent we are successful in raising
additional funds to continue to advance our product candidates, we will need to expand our
financial, regulatory, research and development, manufacturing, commercial, quality, compliance and
other resources in order to manage our operations, submit applications to and respond to inquiries
from the FDA, commercialize ANX-530, should it be approved, and continue the development of
ANX-514. We do not expect that our current management and personnel, systems and facilities will be
adequate to support these activities.
The success of our business will depend, in part, on our ability to attract and retain highly
qualified management, scientific and other personnel, and on our ability to develop and maintain
important relationships with respected service providers and industry-leading consultants and
advisors. Competition for these types of personnel and relationships is intense from numerous
pharmaceutical and biotechnology companies, universities and other research institutions,
particularly in the San Diego, California area. In connection with the cost-cutting measures we
implemented in October 2008, January 2009 and March 2009, we eliminated, among others, our
scientific staff and our manufacturing and regulatory personnel, who had a deep background in our
product candidates and our research and development programs. Recruiting and retaining employees,
including senior-level personnel, with relevant product development experience in cancer and
process development experience with emulsified cytotoxic drugs may be costly and time-consuming.
Depending on the net proceeds to us from the offering described in this prospectus supplement, our
ability to provide competitive compensation to our officers and employees may also be adversely
affected by our limited capital resources and anticipated need to raise substantial additional
capital to continue our business. We cannot ensure that we will be able to retain existing
employees or attract and retain additional skilled personnel on acceptable terms as a result of
these factors and, accordingly, we may not achieve our development and commercialization goals.
We have significant incentive and may, under certain circumstances, have significant severance and
other obligations under agreements with our current officers.
S-6
In July 2009, we adopted a 2009 mid-year incentive plan and a retention and severance plan, both of
which apply to Mr. Culley and Mr. Keran, our two remaining employees. Under the incentive plan,
each of Mr. Culley and Mr. Keran are eligible for incentive awards based upon the achievement of
corporate performance objectives in effect at the end of 2009. Awards generally will be paid in
cash. The potential award of each of Mr. Culley and Mr. Keran will be based 100% on our
achievement of corporate objectives and the target award amount for each of them is $150,000. The
target amount of each award may be increased or decreased by multiplying the target amount by a
corporate performance multiplier, as will be determined by the compensation committee of our board
of directors in the first quarter of 2010. Award multipliers will range from zero to 1.5. Payment
of awards under the incentive plan will be made after December 31, 2009 and on or before March 14,
2010. Under the retention plan, if the employment of either of our two remaining employees
terminates at any time as a result of an involuntary termination, and such employee delivers and
does not revoke a general release of claims, which will also confirm any post-termination
obligations and/or restrictions applicable to such employee, such employee will be entitled to an
amount equal to twelve (12) months of such employees then-current base salary, less applicable
withholdings, and an amount equal to the estimated cost of continuing such employees health care
coverage and the coverage of such employees dependents who are covered at the time of the
involuntary termination under the Consolidated Omnibus Budget Reconciliation Act of 1985, as
amended, for a period equal to twelve (12) months. These severance benefits will be paid in a
lump-sum on the date the general release of claims becomes effective. Our aggregate contractual
obligation under the retention plan, including applicable payroll and employer taxes, is
approximately $650,000.
We believe these plans are necessary to incentivize and retain these key employees and reinforce
their dedication to us during a period when they would otherwise likely seek alternative
employment. Our contractual responsibility for our current and any future incentive and/or
severance obligations may cause us to cease or curtail our operations at an earlier date than would
otherwise be the case if we were not required to satisfy these obligations. In addition, part or
all of the proceeds from a future capital raising transaction may be used to satisfy these
obligations.
The use of our net operating loss carryforwards may be limited.
Net operating loss carryforwards may expire and not be used. As of December 31, 2008, we had
generated federal net operating loss carryforwards of approximately $90.4 million and state net
operating loss carryforwards of approximately $41.4 million. Federal net operating loss
carryforwards have a 20-year carryforward period and begin to expire in 2020. State net operating
loss carryforwards have a ten year carry forward period and begin to expire in 2012.
Pursuant to Section 382 of the Internal Revenue Code, annual use of our net operating loss
carryforwards may be limited in the event a cumulative change in ownership of more than 50 percent
occurs within a three-year period. We determined that, as of January 1, 2009, no such ownership
change had occurred. However, recent and potential future financing events, including this
offering, may cause changes in ownership under Section 382, which could cause our net operating
loss carryforwards to be subject to limitations and restrictions. If a change in ownership were to
occur, our net operating loss carryforwards could be eliminated or restricted. Inability to fully
utilize our net operating loss carryforwards could have an adverse impact on our financial position
and results of operations.
If we fail to maintain an effective system of internal control over financial reporting, we may not
be able to accurately report our financial results. As a result, current and potential investors
could lose confidence in our financial reporting, which could harm our business and have an adverse
effect on our stock price.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to annually furnish a
report by our management on our internal control over financial reporting. Such report must
contain, among other matters, an assessment by our principal executive officer and our principal
financial officer on the effectiveness of our internal control over financial reporting, including
a statement as to whether or not our internal control over financial reporting is effective as of
the end of our fiscal year. This assessment must include disclosure of any material weakness in our
internal control over financial reporting identified by management. In addition, under current SEC
rules, we will be required to obtain an attestation from our independent registered public
accounting firm as to our internal control over financial reporting for our annual report on Form
10-K for our fiscal year ending December 31, 2009. Performing the system and process documentation
and evaluation needed to comply with Section 404 is both costly and challenging. We have in the
past discovered, and may in the future discover, areas of internal controls that need improvement.
For example, during the fourth quarter of 2008, we discovered that we did not correctly apply
generally accepted accounting principles as they related to accounting for warrant liability
because our accounting staff did not have adequate training or expertise, and determined that we
had a material weakness in our internal control over financial reporting as of December 31, 2007. A
material weakness is a deficiency, or a combination of deficiencies, in internal control over
financial reporting, such that there is a reasonable possibility that a material misstatement of
our annual or interim financial statements will not be prevented or detected on a timely basis. For
a detailed description of this material weakness and our remediation of this material weakness, see
Part II Item 9A(T) Controls and Procedures of our annual report on Form 10-K for the year
ended December 31, 2008. If additional material weaknesses are identified in our internal control
over financial reporting, neither our management nor our independent registered public accounting
firm will be able to assert that our internal control over financial reporting and/or our
disclosure controls and procedures are effective, and we could be required to further implement
expensive and time-consuming remedial measures. We cannot be certain that any measures we take will
ensure that we implement and maintain adequate internal control over financial reporting and that
we will remediate the material weakness. As a result of recent reductions in our workforce and
other personnel departures, we have experienced substantial turnover in our personnel responsible
for performing activities related to our internal control over financial reporting. We have used
third-party contractors to maintain effective internal control over financial reporting during this
turn-over.
S-7
However, if we fail to maintain effective internal control over financial reporting and/or
disclosure controls and procedures we could lose investor confidence in the accuracy and
completeness of our financial reports, which could have a material adverse effect on our stock
price.
Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic
event.
Our corporate headquarters are located at a single business park in San Diego, California.
Important documents and records, including copies of our regulatory documents and other records for
our product candidates, are located at our facilities and we depend on our facilities for the
continued operation of our business. Natural disasters and other catastrophic events, such as
wildfires and other fires, earthquakes and extended power interruptions, which have impacted San
Diego businesses in the past, and terrorist attacks, drought or flood, could significantly disrupt
our operations and result in additional, unplanned expense. As a small company, we have limited
capability to establish and maintain a comprehensive disaster recovery program and, accordingly, we
do not have a formal business continuity or disaster recovery plan, and any natural disaster or
catastrophic event could delay our development and commercialization efforts. Even though we
believe we carry commercially reasonable insurance, we might suffer losses that exceed the coverage
available under these insurance policies. In addition, we are not insured against terrorist attacks
or earthquakes.
Risks Related to Drug Development and Commercialization
Further testing of and/or validation of manufacturing processes with respect to our product
candidates is required and regulatory approval may be delayed or denied, which would limit or
prevent us from marketing our product candidates and significantly impair our ability to generate
revenues.
Human pharmaceutical products generally are subject to rigorous preclinical testing and clinical
trials and other approval procedures mandated by the FDA and foreign regulatory authorities.
Various federal and foreign statutes and regulations also govern or influence the manufacturing,
safety, labeling, storage, record keeping and marketing of pharmaceutical products. The process of
obtaining these approvals and the subsequent compliance with appropriate U.S. and foreign statutes
and regulations is time-consuming and requires the expenditure of substantial resources. In
addition, these requirements and processes vary widely from country to country.
To varying degrees based on the regulatory plan for each product candidate, the effect of
government regulation and the need for FDA and other regulatory agency approval will delay
commercialization of our product candidates, impose costly procedures upon our activities, and put
us at a disadvantage relative to larger companies with which we compete. There can be no assurance
that FDA or other regulatory approval for any product candidates developed by us will be granted on
a timely basis, or at all. Even though the FDA has confirmed the appropriateness of a Section
505(b)(2) regulatory path for ANX-530 and ANX-514, the FDAs views may change. If the FDA requires
the longer-term regulatory approval pathway associated with traditional drug development for
ANX-530 and ANX-514, we may determine that the associated time and cost is not financially
justifiable and, as a result, discontinue those programs. If we discontinue the development of one
or both of these product candidates, our business and stock price may suffer.
In connection with any NDA that we file under Section 505(b)(2) of the Federal Food, Drug and
Cosmetic Act, or FDCA, we may be required to notify third parties that we have certified to the FDA
that any patents listed for the approved drug in the FDAs Orange Book publication are invalid or
will not be infringed by the manufacture, use or sale of our drug. If the third-party files a
patent infringement lawsuit against us within 45 days of its receipt of notice of our
certification, the FDA is automatically prevented from approving our NDA until, subject to certain
adjustments, the earliest of 30 months, expiration of the patent, settlement of the lawsuit or a
decision in the infringement case that is favorable to us. Accordingly, we may invest significant
time and expense in the development of our product candidates, including ANX-530 and ANX-514, only
to be subject to significant delay and patent litigation before our products may be commercialized.
We may not achieve our projected development and commercialization goals in the time frames we
announce. Delays in the commencement or completion of pre/non-clinical testing, bioequivalence or
clinical trials or manufacturing, regulatory or launch activities could result in increased costs
to us and delay or limit our ability to generate revenues.
We set goals for and make public statements regarding our estimates of the timing of the
accomplishment of objectives material to successful development and commercialization of our
product candidates. The actual timing of these events can vary dramatically due to any number of
factors, including delays or failures in our pre/non-clinical testing, bioequivalence and clinical
trials and manufacturing, regulatory and launch activities and the uncertainties inherent in the
regulatory approval process. While our regulatory strategy for ANX-530 and ANX-514 has been to
demonstrate the pharmacokinetic equivalence of each to the currently approved reference product in
small, bioequivalence trials in humans, we may determine to conduct clinical studies to support
uses in new indications or other label changes or for other reasons.
We conduct pre/non-clinical activities in the course of our development programs, including in
connection with the manufacture of our product candidates, and in response to requests by
regulatory authorities, as well as for other reasons. Delays in our pre/non-clinical activities
could occur for a number of reasons, including:
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delays in reaching agreement on acceptable terms with prospective contract research
organizations, or CROs, and contract manufacturing organizations, or CMOs, the terms of
which can be subject to extensive negotiation and may vary significantly among different
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failures on the part of our CROs and CMOs in developing procedures and protocols or
otherwise conducting activities on timeframes requested by us; |
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changes in regulatory requirements or other standards or guidance relating to
preclinical testing, including testing of pharmaceutical products in animals; |
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a lack of availability of animals that are suitable for the types of studies we plan to
conduct; |
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a lack of availability of capacity at our CMOs, or of the component materials, including
the active pharmaceutical ingredient, or API, or related materials, including vials and
stoppers, necessary to manufacture our product candidates or products; and |
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unforeseen results of preclinical or nonclinical testing that require us to amend study
or test designs or delay future testing or bioequivalence or clinical trials and related
regulatory filings. |
In addition, we do not know whether planned bioequivalence or clinical trials will commence on time
or be completed on schedule, if at all. The commencement and completion of trials can be delayed
for a variety of reasons, including delays related to:
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obtaining regulatory approval to commence a trial; |
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identifying appropriate trial sites and reaching agreement on acceptable terms with
prospective CROs, trial sites and investigators, the terms of which can be subject to
extensive negotiation and may vary significantly among different CROs, trial sites and
investigators; |
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manufacturing sufficient quantities of a product candidate; |
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obtaining institutional review board, or IRB, approval to conduct a trial at a
prospective site; |
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recruiting and enrolling patients to participate in trials for a variety of reasons,
including competition from other clinical trials for the same indication as our product
candidates and the perception that the design of a trial or the proposed treatment regimen
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retaining patients who have initiated a trial but may be prone to withdraw due to side
effects from the therapy, lack of efficacy or personal issues, or who are lost to further
follow-up. |
For example, in October 2007, we announced results of our phase 2b clinical trial of ANX-510, or
CoFactor, for the first-line treatment of metastatic colorectal cancer, which demonstrated that the
CoFactor/5-FU arm did not demonstrate statistically significant improved safety in the trials
primary endpoint. In November 2007, we announced that we would discontinue enrolling patients in
our phase 3 clinical trial of CoFactor for the first-line treatment of metastatic colorectal cancer
and, in October 2008, we announced that we had discontinued active work on all product candidates
other than ANX-530 and ANX-514, including CoFactor. In addition, in May 2009, we announced that we
did not meet the primary endpoint in our bioequivalence study of ANX-514, resulting in additional
uncertainty around the cost and timeline to obtaining FDA approval for that product candidate.
In addition, a trial may be suspended or terminated by us, the FDA or other regulatory authorities
due to a number of factors, including:
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failure to conduct the trial in accordance with regulatory requirements or the trials
protocol; |
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inspection of trial operations or trial sites by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold; |
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unforeseen safety issues; or |
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lack of adequate funding to continue the trial. |
Additionally, changes in regulatory requirements and guidance relating to clinical trials may occur
and we may need to amend clinical trial protocols to reflect these changes. Amendments may require
us to resubmit our clinical trial protocols to IRBs for reexamination or renegotiate terms with
CROs, trial sites and clinical investigators, all of which may impact the costs, timing or
successful completion of a clinical trial.
S-9
There can be no assurance that our preclinical and nonclinical testing and bioequivalence and/or
clinical trials will commence or be
completed, that we will make regulatory submissions or receive regulatory approvals as planned or
that we will be able to adhere to our current schedule for the development or commercialization of
any of our product candidates. If we experience delays in completion of, or if we terminate, our
bioequivalence or clinical trials or preclinical and nonclinical testing, the commercial prospects
for our product candidates will be harmed, and our ability to generate product revenues will be
delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or
completion of bioequivalence or clinical trials or preclinical and nonclinical testing may also
ultimately lead to the denial of regulatory approval of a product candidate. Even if we are able to
ultimately commercialize our product candidates, other therapies for the same indications may have
been introduced to the market and established a competitive advantage.
Positive results in our preclinical testing and/or bioequivalence trials do not ensure that future
bioequivalence or clinical trials will be successful or that our product candidates will receive
the regulatory approvals necessary for their commercialization.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we
must demonstrate through preclinical testing and bioequivalence or clinical trials that each
product is safe and effective for use in each target indication. Success in preclinical testing
and/or bioequivalence trials does not ensure that subsequent or large-scale trials will be
successful. Additionally, throughout development, we must provide adequate assurance to the FDA and
other regulatory authorities that we can consistently produce our product candidates in conformance
with current good manufacturing practices, or cGMP, and other regulatory standards. Bioequivalence
and clinical trial results are frequently susceptible to varying interpretations and regulatory
authorities may disagree on what are appropriate methods for analyzing data, which may delay, limit
or prevent regulatory approvals. For instance, with respect to our bioequivalence trial of ANX-530,
the FDA may perform its pharmacokinetic equivalence analysis based on a patient population other
than the population on which we based our analysis, which may result in the FDA determining that
ANX-530 and Navelbine® are not bioequivalent, requiring that we evaluate additional patients,
re-perform the study or take other remedial action. In addition, the FDA may inquire regarding the
manufacturing source, in-process and product release specifications and overall uniformity of
reference product used in the bioequivalence trial of ANX-530, particularly since it was conducted
at sites in multiple countries, and we may be unable to provide documentation satisfactory to the
FDA with respect to such reference product, which may result in the FDA requiring that we evaluate
additional patients, re-perform the study or take other remedial measures. Further, the ANX-530
bioequivalence trial was open-label, meaning physician-investigators, as well as patients, may have
been aware of which drug was being administered. There is a risk of investigator bias in reporting
adverse events as a result of the studys open-label nature, including bias that increased the
reporting of adverse events associated with Navelbine and/or that decreased the reporting of
adverse events associated with ANX-530. With respect to ANX-514, despite positive preclinical
testing that indicated pharmacokinetic equivalence between ANX-514 and the reference product, our
bioequivalence trial of ANX-514 did not demonstrate pharmacokinetic equivalence between ANX-514 and
the reference product based on benchmark regulatory standards.
The length of time necessary to complete bioequivalence or clinical trials and manufacturing
development work and to submit an application for marketing approval for a final decision by a
regulatory authority varies significantly and may be difficult to predict. In addition, delays or
rejections may be encountered based upon changes in FDA policy for drug approval during the period
of product development and FDA regulatory review of each submitted NDA. There is a significant risk
that any of our product candidates could fail to show satisfactory results in human trials, as was
the case in our bioequivalence study of ANX-514, or manufacturing development, and, as a result, we
may not continue their development. A failure to obtain requisite regulatory approvals or to obtain
approvals of the scope requested will delay or preclude us from marketing our products or limit the
commercial use of the products, and would have a material adverse effect on our business, financial
condition and results of operations.
If any of our product candidates for which we receive regulatory approval do not achieve broad
market acceptance (including as a result of failing to differentiate our products from competitor
products or as a result of failing to obtain reimbursement rates for our products that are
competitive from the healthcare providers perspective), the revenues we generate from their sales
will be limited and our business may not be profitable.
Our success will depend in substantial part on the extent to which our products for which we obtain
marketing approval from the FDA and comparable foreign regulatory authorities are accepted by the
medical community and reimbursed by third-party payors, including government payors. The degree of
market acceptance will depend upon a number of factors, including, among other things:
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our products perceived advantages over existing treatment methods (including relative
convenience and ease of administration and prevalence and severity of any adverse side
effects); |
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claims or other information (including limitations or warnings) in our products
approved labeling; |
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reimbursement and coverage policies of government and other third-party payors; |
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pricing and cost-effectiveness; |
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in the U.S., the ability of group purchasing organizations, or GPOs (including
distributors and other network providers), to sell our products to their constituencies; |
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the establishment and demonstration in the medical community of the safety and efficacy
of our products and our ability to provide acceptable evidence of safety and efficacy; |
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availability of alternative treatments; and |
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the prevalence of off-label substitution of chemically equivalent products. |
We cannot predict whether physicians, patients, healthcare insurers or maintenance organizations,
or the medical community in general, will accept or utilize any of our products. If our products
are approved but do not achieve an adequate level of acceptance by these parties, we may not
generate sufficient revenues from these products to become or remain profitable. In addition, our
efforts to educate the medical community and third-party payors regarding the benefits of our
products may require significant resources and may never be successful.
Under our Section 505(b)(2) regulatory strategy for ANX-530 and ANX-514, because we anticipate
submitting NDAs based on pharmacokinetic data, our ability to differentiate our products from
competitor products will be limited unless the FDA allows us to include certain data in our
products labels. Even if our products demonstrate clinical or pharmacoeconomic benefits, we may be
unable to market our products based on these benefits.
If we fail to obtain a unique Healthcare Common Procedure Coding System, or HCPCS, product code for
ANX-530, it is unlikely we will be able to sell that product at a price that exceeds its
manufacturing, marketing and distribution costs. Even if we obtain separate HCPCS codes for our
products, if our products are perceived to provide little or no advantage relative to competitive
products or for other reasons, we may be required to price our products at levels that do not cover
our costs to manufacture, market and distribute the products or provide any profit, or to price our
products at levels at which they are not competitive.
We do not have manufacturing capabilities and are dependent on single source manufacturers and
suppliers for certain of our product candidates and their component materials, and the loss of any
of these manufacturers or suppliers, or their failure to provide us with an adequate supply of
products or component materials on commercially acceptable terms, or at all, could harm our
business.
We do not have any manufacturing capability. We rely on third-party manufacturers and component
materials suppliers for the manufacture of our product candidates for bioequivalence or clinical
trial purposes and we anticipate establishing relationships with third-party manufacturers and
component materials suppliers for the commercial production of our products. Currently we do not
have any commercial supply agreements or commitments with our third-party manufacturers or
component suppliers, and we cannot ensure that we will be able to establish relationships with
these parties on commercially acceptable terms, or at all. If we fail to establish and maintain
such relationships, we expect it would have a material and adverse effect on our operations. Even
if we successfully establish relationships with third-party manufacturers and component suppliers
on commercially acceptable terms, our manufacturers and suppliers may not perform as agreed or may
terminate their agreements with us. Because many of our single source suppliers provide
manufacturing services to a number of other pharmaceutical companies, our suppliers may experience
capacity constraints or choose to prioritize one or more of their other customers over us. Any
significant problem that our single source manufacturers or suppliers experience could delay or
interrupt the supply to us of bioequivalence or clinical trial materials or products until the
manufacturer or supplier cures the problem or until we locate an alternative source of supply, if
an alternative source is available, and any such delay or interruption could materially and
adversely affect our development and commercial activities and operations.
For instance, ANX-530 is an emulsified cytotoxic product that must be aseptically-filled. There are
a limited number of CMOs capable and willing to manufacture this type of product at the commercial
scale at which we anticipate requiring in accordance with our marketing plans for ANX-530, which
will make identifying and establishing short- or long-term relationships with willing manufacturers
more difficult and provide them with substantial leverage over us in any negotiations. Furthermore,
certain of the component materials of ANX-530 are available only from a particular supplier, and
currently we do not have any short- or long-term agreements for the supply of those materials.
Even if we successfully establish a long-term relationship with our current CMO for ANX-530 on
commercially acceptable terms, our CMO may be unable to successfully and consistently manufacture
ANX-530 at commercial scale. We and this manufacturer have limited experience manufacturing
ANX-530. Because data from a single bioequivalence trial of ANX-530 may be sufficient to support an
NDA for ANX-530, our and our current contract manufacturers ability to gain experience
manufacturing ANX-530, in particular at various scales, has been limited. If our current CMO is
unable to manufacture ANX-530 successfully and consistently at commercial scale and within
established parameters, we may be unable to validate our manufacturing process, even if the FDA
otherwise would approve our NDA, and therefore unable to sell ANX-530. Our current CMO has
similarly limited experience with ANX-514.
All manufacturers of our products and product candidates must comply with cGMP requirements
enforced by the FDA through its facilities inspection program, as well as applicable requirements
of foreign regulatory authorities. These requirements include quality control, quality assurance
and the maintenance of records and documentation. Manufacturers of our products and product
candidates may be unable to comply with these cGMP requirements and with other FDA, state and
foreign regulatory requirements. While we or our representatives generally monitor and audit our
manufacturers systems, we have little control over our manufacturers ongoing
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compliance with these regulations and standards. A failure to comply with these requirements may
result in fines and civil penalties, suspension of production, suspension or delay in product
approval, product seizure or recall, or withdrawal of product approval.
Furthermore, the manufacture of pharmaceutical products requires significant expertise and capital
investment, including the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter difficulties in production, particularly
in scaling up initial production. These problems include difficulties with production costs and
yields, quality control, including stability of the product candidate and quality assurance testing
and shortages of qualified personnel.
If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with
their contractual obligations, our ability to provide product candidates to patients in our future
bioequivalence or clinical trials may be jeopardized. Any delay or interruption in the supply of
supplies could delay the completion of our future trials, increase the costs associated with
maintaining our development programs and, depending upon the period of delay, require us to
commence new trials at significant additional expense or terminate the trials completely. We cannot
ensure that manufacturing or quality control problems will not arise in connection with the
manufacture of our products or product candidates, or that third-party manufacturers will be able
to maintain the necessary governmental licenses and approvals to continue manufacturing such
products or product candidates. Any of the above factors could cause us to delay or suspend
anticipated or on-going trials, regulatory submissions, required approvals or commercialization of
our product candidates, entail higher costs or result in our being unable to effectively
commercialize our products. Our dependence upon third parties for the manufacture of our products
and product candidates may adversely affect our future costs and our ability to develop and
commercialize our products and product candidates on a timely and competitive basis.
If any of our product candidates should be approved, any problems or delays experienced in their
manufacturing processes may impair our ability to provide commercial quantities of the products,
which would limit our ability to sell the products and would adversely affect our business. It
could take significant time to redesign our manufacturing processes or identify alternative
suppliers in response to problems we may encounter as we manufacture our products, if such
alternative processes and suppliers are available at all. Even if we are able to identify
alternative suppliers, they may be unwilling to manufacture our products on commercially reasonable
terms. Neither ANX-530 nor ANX-514 have been manufactured at the scales we believe will be
necessary to maximize their commercial value to us and, accordingly, we may encounter difficulties
in production while scaling-up initial production and may not be successful at all in scaling-up
initial production.
Any new supplier of products or component materials, including API, would be required to qualify
under applicable regulatory requirements and would need to have sufficient rights under applicable
intellectual property laws to the method of manufacturing such products or ingredients. The FDA may
require us to conduct additional bioequivalence or clinical trials, collect stability data and
provide additional information concerning any new supplier, or change in a validated manufacturing
process, before we could distribute products from that supplier or revised process. Obtaining the
necessary FDA approvals or other qualifications under applicable regulatory requirements and
ensuring non-infringement of third-party intellectual property rights could result in a significant
interruption of supply and could require the new supplier to bear significant additional costs
which may be passed on to us. For instance, with respect to ANX-530, the form of API used in the
manufacture of ANX-530 for purposes of our bioequivalence study of ANX-530 will not be the same
form of API used in the manufacture of ANX-530 for purposes of process validation batches or
commercial supply. To ensure the comparability of the ANX-530 used in the bioequivalence study and
the ANX-530 intended for commercial sale, FDA may require that we evaluate both forms of ANX-530 in
additional patients, re-perform the bioequivalence study or take other remedial actions. We may
have insufficient quantities of both forms of ANX-530 and could incur substantial cost and delay in
acquiring such quantities, in addition to the time and expense associated with conducting the
evaluation, re-performing the study or taking other remedial measures.
We rely in part on third parties to conduct our preclinical and nonclinical testing and
bioequivalence and clinical studies and other aspects of our development programs and if those
third parties do not satisfactorily perform their contractual obligations or meet anticipated
deadlines, the development of our product candidates could be adversely affected.
We do not employ personnel or possess the facilities necessary to conduct the activities associated
with our programs, particularly since we implemented severe cost-cutting measures in late 2008 and
early 2009. We engage consultants, advisors, CROs, CMOs and others to design and conduct
preclinical and nonclinical tests and bioequivalence and clinical studies in connection with the
research and development of our product candidates. As a result, many important aspects of our
product candidates development are outside our direct control. There can be no assurance that such
third parties will perform all of their obligations under arrangements with us or will perform
those obligations satisfactorily.
The CROs with which we contract for execution of our bioequivalence and clinical studies play a
significant role in the conduct of the studies and subsequent collection and analysis of data, and
we will likely depend on these and other CROs and clinical investigators to conduct our future
bioequivalence or clinical or studies or assist with our analysis of completed bioequivalence
studies. Individuals working at the CROs with which we contract, as well as investigators at the
sites at which our studies are conducted, are not our employees, and we cannot control the amount
or timing of resources that they devote to our programs. If these CROs fail to devote sufficient
time and resources to our studies, or if their performance is substandard, it will delay the
approval of our applications to regulatory agencies and the introduction of our products. Failure
of these CROs to meet their obligations could adversely affect development of our product
candidates. Moreover, these CROs may have relationships with other commercial entities, some of
which may compete with us. If they assist our competitors at our expense, it could harm our
competitive position.
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For instance, we lack the internal capabilities to fully analyze the data from our bioequivalence
study of ANX-514 and will rely on multiple third-party consultants to help us interpret and
understand the data. Because of the impact different analyses of the data may have on our business,
we believe an employee likely would approach the data and analysis in a substantially more
rigorous, thoughtful and creative manner than a consultant or contractor.
We currently have no sales or marketing capability and our failure to develop these and related
capabilities internally or contract with third parties to perform these activities successfully
could delay and/or limit our ability to generate revenues in the event one or more of our product
candidates obtains regulatory approval.
We currently do not have sales, marketing or commercialization personnel. We have limited business
development personnel. To commercialize our products, including ANX-530, we will have to acquire or
develop sales, marketing and distribution capabilities, or rely on marketing partners or other
arrangements with third parties for the marketing, distribution and sale of our products. There is
no guarantee that we will be able to establish marketing, distribution or sales capabilities or
make arrangements with third parties to perform those activities on terms satisfactory to us, or
that any internal capabilities or third party arrangements will be cost-effective. The acquisition
or development of a sales and distribution and associated regulatory compliance infrastructure will
require substantial resources, which may divert the attention of our management and key personnel
and negatively impact our product development efforts.
In addition, any third parties with which we establish marketing, distribution or sales
arrangements may have significant control over important aspects of the commercialization of our
products, including market identification, marketing methods, pricing, composition of sales force
and promotional activities. If we retain third-party service providers to perform functions related
to the sale and distribution of our products, key aspects of those functions that would be out of
our direct control could include warehousing and inventory management, distribution, contract
administration and chargeback processing, accounts receivable management and call center
management. In this event, we would place substantial reliance on third-party providers to perform
services for us, including entrusting our inventories of products to their care and handling. If
these third-party service providers fail to comply with applicable laws and regulations, fail to
meet expected deadlines, or otherwise do not carry out their contractual duties to us, or encounter
natural or other disasters at their facilitates, our ability to deliver product to meet commercial
demand could be significantly impaired. In addition, we may use third parties to perform various
other services for us relating to sample accountability and regulatory monitoring, including
adverse event reporting, safety database management and other product maintenance services. If the
quality or accuracy of the data maintained by these service providers is insufficient, our ability
to continue to market our products could be jeopardized or we could be subject to regulatory
sanctions. We do not currently have the internal capacity to perform these important commercial
functions, and we may not be able to maintain commercial arrangements for these services on
reasonable terms, or at all. Even if we are successful in establishing and maintaining these
arrangement, there can be no assurance that we will be able to control the amount and timing of
resources that any third party may devote to our products or prevent any third party from pursuing
alternative technologies or products that could result in the development of products that compete
with, or the withdrawal of support for, our products.
If we receive regulatory approval for one or more of our product candidates, we may face
competition from generic products, which could exert downward pressure on the pricing and market
share of our products and limit our ability to generate revenues.
Many of the currently marketed and anticipated products against which our product candidates may
compete are, or we anticipate will be, available as generics. For instance, ANX-530 will compete
against Navelbine, for which generic equivalents are already available. ANX-514 will compete
against Taxotere®. We anticipate that ANX-514 will also compete against other formulations of
docetaxel and that generic Taxotere will enter the market in November 2013 or May 2014 (depending
on whether a period of pediatric exclusivity is granted in the future). Even if we obtain unique
HCPCS codes for our products, the existence of generic products could make it more difficult for
our branded products, including ANX-530 and ANX-514, to gain or maintain market share and could
cause prices for our products to drop, each of which could adversely affect our business.
We may also face competition for our products from lower priced products from foreign countries
that have placed price controls on pharmaceutical products. Proposed federal legislative changes
may expand consumers ability to import lower priced versions of our and competing products from
Canada. Further, several states and local governments have implemented importation schemes for
their citizens, and, in the absence of federal action to curtail such activities, we expect other
states and local governments to launch importation efforts. The importation of foreign products
that compete with our own products could negatively impact our business and prospects.
Even if we receive regulatory approval in the U.S. for ANX-530 and/or ANX-514, we will likely
depend on a limited number of group purchasing organizations for retail distribution of these
products, and if we subsequently lose any significant GPO relationship, our business could be
harmed.
Our current U.S. commercialization strategy for our lead emulsion formulations initially involves
marketing and selling these products through a limited number of GPOs. Even if we are successful in
securing relationships with these entities, the subsequent loss of any one or more of these GPO
accounts or a material reduction in their participation could harm our business, financial
condition or results of operations. In addition, we may face pricing pressure from these GPOs.
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Even if we receive regulatory approval for one or more of our product candidates, they may still
face future development and regulatory difficulties that could materially and adversely affect our
business, financial condition and results of operations and cause our stock price to decline.
Even if initial regulatory approval is obtained, the FDA or a foreign regulatory agency may still
impose significant restrictions on a products indicated uses or marketing or impose ongoing
requirements for potentially costly post-approval studies or marketing surveillance programs. Our
product candidates will also be subject to ongoing FDA requirements related to the labeling,
packaging, storage, advertising, promotion, record-keeping and submission of safety and other
post-market information on the product. For instance, in September 2007, amendments to the FDCA
were signed into law. These amendments significantly strengthen the FDAs regulatory authority over
drugs, including new controls over the post-approval monitoring of drugs. The FDA may now require
changes to approved drug labels, require post-approval clinical trials and impose distribution and
use restrictions on certain drugs. In addition, approved products, manufacturers and manufacturers
facilities are subject to continuing regulatory review and periodic inspections. If previously
unknown problems with a product are discovered, such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is manufactured, the FDA may impose
restrictions on that product or us, including requiring withdrawal of the product from the market.
If we or a CMO of ours fail to comply with applicable regulatory requirements, a regulatory agency
may:
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issue warning letters or untitled letters; |
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impose civil or criminal penalties; |
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suspend or withdraw regulatory approval; |
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suspend or terminate any ongoing bioequivalence or clinical trials; |
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refuse to approve pending applications or supplements to approved applications; |
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impose restrictions or affirmative obligations on our or our CMOs operations, including
costly new manufacturing requirements; |
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close the facilities of a CMO; or |
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seize or detain products or require a product recall. |
Even if one or more of our product candidates receive regulatory approval in the U.S., we may never
receive approval or commercialize our products outside of the U.S., which would limit our ability
to realize the full market potential of our product candidates.
In order to market any products outside of the U.S., we must establish and comply with numerous and
varying regulatory requirements of other countries regarding safety and efficacy. Approval
procedures vary among countries and can involve additional product testing and validation and
additional administrative review periods. The time required to obtain approval in other countries
might differ from that required to obtain FDA approval. In particular, other countries may not have
a comparable regulatory procedure as is available under Section 505(b)(2) of FDCA. Even if a
country did have a comparable procedure, that country may require a more robust data package than
the pharmacokinetic data package that we intend to submit in support of NDAs for ANX-530 and
ANX-514. The regulatory approval process in other countries may include all of the risks detailed
above regarding FDA approval in the U.S., as well as other risks. Regulatory approval in one
country does not ensure regulatory approval in another, but a failure or delay in obtaining
regulatory approval in one country may have a negative effect on the regulatory process in others.
Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such
approval could have the same adverse effects detailed above regarding FDA approval in the U.S. As
described above, such effects include the risks that our product candidates may not be approved for
all indications requested, which could limit the uses of our product candidates and have an adverse
effect on product sales, and that such approval may be subject to limitations on the indicated uses
for which the product may be marketed or require costly, post-marketing follow-up studies.
Our product candidates may cause undesirable side effects or have other properties that could delay
or prevent their regulatory approval or commercialization.
Undesirable side effects caused by our product candidates could interrupt, delay or halt
bioequivalence or clinical trials and could result in the denial of regulatory approval by the FDA
or other regulatory authorities for any or all indications, and in turn prevent us from
commercializing our product candidates and generating revenues from their sale.
In addition, if any of our product candidates receive marketing approval and we or others later
identify undesirable side effects caused by the product or the reference product:
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regulatory authorities may require the addition of labeling statements, such as a black
box warning or a contraindication; |
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regulatory authorities may withdraw their approval of the product; |
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we may be required to change the way the product is administered, conduct additional
clinical trials or change the labeling of the product; and |
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our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the
affected product or could substantially increase the costs and expenses of commercializing the
product, which in turn could delay or prevent us from generating significant revenues from its
sale.
Risks Related to Our Intellectual Property
Our success will depend on patents and other protection we obtain on our product candidates and
proprietary technology.
Our success will depend in part on our ability to:
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obtain and maintain patent protection with respect to our products; |
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prevent third parties from infringing upon our proprietary rights; |
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maintain trade secrets; |
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operate without infringing upon the patents and proprietary rights of others; and |
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obtain appropriate licenses to patents or proprietary rights held by third parties if
infringement would otherwise occur, both in the U.S. and in foreign countries. |
The patent and intellectual property positions of specialty pharmaceutical companies, including
ours, are uncertain and involve complex legal and factual questions. There is no guarantee that we
have or will develop or obtain the rights to products or processes that are patentable, that
patents will issue from any pending applications or that claims allowed will be sufficient to
protect the technology we develop or have developed or that is used by us, our CMOs or our other
service providers. In addition, we cannot be certain that patents issued to us will not be
challenged, invalidated, infringed or circumvented, including by our competitors, or that the
rights granted thereunder will provide competitive advantages to us.
Furthermore, patent applications in the U.S. are confidential for a period of time until they are
published, and publication of discoveries in scientific or patent literature typically lags actual
discoveries by several months. As a result, we cannot be certain that the inventors listed in any
patent or patent application owned by us were the first to conceive of the inventions covered by
such patents and patent applications or that such inventors were the first to file patent
applications for such inventions.
We may also rely on unpatented trade secrets and know-how and continuing technological innovation
to develop and maintain our competitive position, which we seek to protect, in part, by
confidentiality agreements with employees, consultants, collaborators and others. We also have
invention or patent assignment agreements with our employees and certain consultants. There can be
no assurance, however, that binding agreements will not be breached, that we will have adequate
remedies for any breach, or that trade secrets will not otherwise become known or be independently
discovered by competitors. In addition, there can be no assurance that inventions relevant to us
will not be developed by a person not bound by an invention assignment agreement with us.
Exclusivity for our emulsion-formulation product candidates may be limited because of the nature of
patent protection available for these candidates.
While the patent applications covering our emulsion-formulation product candidates, including
ANX-530 and ANX-514, include product claims, they cover only specific formulations of the
underlying chemical entity, or API, and not the API itself. Such product claims are not as strong
as claims covering new APIs, which are widely viewed as the strongest form of intellectual property
protection for pharmaceutical products, as they apply without regard to how the API is formulated
or the method in which the API is used. A competitor may modify our formulations and obtain
regulatory approval for products with the same API as our products. Such competitive products may
not infringe the patents we hold covering our specific formulations of the API.
If we are sued for infringing the proprietary rights of third parties, it will be costly and time
consuming, and an unfavorable outcome would have an adverse effect on our business.
Our commercial success depends on our ability and the ability of our CMOs and component suppliers
to develop, manufacture, market and sell our products and product candidates and use our
proprietary technologies without infringing the proprietary rights of third parties. Numerous U.S.
and foreign issued patents and pending patent applications, which are owned by third parties, exist
in the fields in which we are or may be developing products. As the biotechnology and
pharmaceutical industry expands and more patents are issued, the risk increases that our products
and product candidates may give rise to claims that our products or product candidates
S-15
infringe the rights of others. Because patent applications can take many years to publish and
issue, there may be currently pending applications, unknown to us, that may later result in issued
patents that our products, product candidates or technologies infringe, or that the process of
manufacturing our products or any of their respective component materials, or the component
materials themselves, infringe.
We or our CMOs or component material suppliers may be exposed to, or threatened with, future
litigation by third parties having patent or other intellectual property rights alleging that our
products, product candidates and/or technologies infringe their intellectual property rights or
that the process of manufacturing our products or any of their respective component materials, or
the component materials themselves, infringe their intellectual property rights. If one of these
patents was found to cover our products, product candidates, technologies or their uses, or any of
the underlying manufacturing processes or components, we could be required to pay damages and could
be unable to commercialize our products or use our technologies or methods unless we are able to
obtain a license to the patent or intellectual property right. A license may not be available to us
on acceptable terms, if at all. In addition, during litigation, a patent holder could obtain a
preliminary injunction or other equitable remedy that could prohibit us from making, using or
selling our products, technologies or methods.
In connection with any NDA that we file under Section 505(b)(2) of the FDCA, we may be required to
notify third parties that we have certified to the FDA that any patents listed for the approved
drug in the FDAs Orange Book publication are invalid or will not be infringed by the manufacture,
use or sale of our drug. If the third-party files a patent infringement lawsuit against us within
45 days of its receipt of notice of our certification, the FDA is automatically prevented from
approving our Section 505(b)(2) NDA until, subject to certain adjustments, the earliest of
30 months, expiration of the patent, settlement of the lawsuit or a decision in the infringement
case that is favorable to us. Accordingly, we may invest significant time and expense in the
development of our product candidates, including ANX-514, only to be subject to significant delay
and patent litigation before our product candidates may be commercialized.
There is a substantial amount of litigation involving patent and other intellectual property rights
in the biotechnology and pharmaceutical industries generally. If a third party claims that we or
our CMOs or component material suppliers infringe its intellectual property rights, we may face a
number of issues, including, but not limited to:
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infringement and other intellectual property claims which, with or without merit, may be
expensive and time consuming to litigate and may divert our managements attention from our
core business; |
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substantial damages for infringement, including treble damages and attorneys fees,
which we may have to pay if a court decides that the product at issue infringes on or
violates the third partys rights; |
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a court prohibiting us from selling or licensing the product unless the third party
licenses its product rights to us, which it may not be required to do; |
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if a license is available from the third party, we may have to pay substantial
royalties, fees and/or grant cross-licenses to our products; and |
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redesigning our products or processes so they do not infringe, which may not be possible
or may require substantial funds and time. |
No assurance can be given that patents do not exist, have not been filed, or could not be filed or
issued, which contain claims covering our products, technology or methods or those of our CMOs or
component material suppliers. Because of the number of patents issued and patent applications filed
in our field, we believe there is a risk that third parties may allege they have patent rights
encompassing our products, technology or methods or those of our CMOs or component material
suppliers.
In addition, it may be necessary for us to enforce patents under which we have rights, or to
determine the scope, validity and unenforceability of other parties proprietary rights, which may
affect our rights. There can be no assurance that our patents would be held valid by a court or
administrative body or that an alleged infringer would be found to be infringing. The uncertainty
resulting from the mere institution and continuation of any technology-related litigation or
interference proceeding could have a material and adverse effect on us.
RISKS RELATED TO OUR INDUSTRY
We expect intense competition in the marketplace for all of our product candidates.
The industry in which we operate is highly competitive and rapidly changing. If successfully
developed and approved, all of our products will likely compete with existing and new products and
therapies and our competitors may succeed in commercializing products more rapidly or effectively
than us, which would have a material and adverse effect on our results of operations and financial
condition. In addition, there are numerous companies with a focus in oncology and/or that are
pursuing the development of pharmaceuticals that target the same diseases as are targeted by the
products being developed by us or that focus on reformulating currently approved drugs. We
anticipate that we will face intense and increasing competition in the future as new products enter
the
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market and advanced technologies become available. There is no assurance that existing products or
new products developed by competitors will not be more effective, or more effectively marketed and
sold, than those we may market and sell. Competitive products may render our products and product
candidates obsolete or noncompetitive.
For instance, numerous companies are focused on reformulating currently approved chemotherapeutic
agents. In particular, the taxanes, the class of drugs of which Taxotere is a member, have
experienced substantial commercial success, in part as a result of their effectiveness in treating
a wide variety of cancers, which has generated significant interest in reformulating Taxotere and
other taxanes. In addition to our approach of emulsifying docetaxel, other companies are pursuing
alternative delivery vehicles, including the use of albumin nanoparticles, prodrugs,
polyglutamates, analogs, co-solvents, liposomes and microspheres. Many of these or similar
approaches could be applied to vinorelbine. Relative to our formulations, formulations based on one
or more of these other methods may result in greater efficacy or safety, provide better drug
delivery to tumor sites or otherwise increase benefits to patients and healthcare providers.
In particular, ANX-530 and ANX-514, if approved, may compete against Navelbine and Taxotere,
respectively, as well as their generic equivalents and other formulations of vinorelbine and
docetaxel. In addition to Navelbine, currently there are at least 6 generic versions of vinorelbine
on the market. In addition, there is an oral formulation of vinorelbine approved for use in the
European Union, or EU, against which we would compete if our emulsion formulation of vinorelbine
were approved for use in the EU. In the U.S., in May 2010 (but subject to any period of pediatric
exclusivity that may be granted in the future), patent protection ends for docetaxel and, in
November 2013 (but subject to any period of pediatric exclusivity that may be granted in the
future), patent protection ends for Taxotere. We are aware of two leading generics companies that
each have developed or acquired a formulation of docetaxel and have certified that, after May 2010,
their respective formulations of docetaxel will not infringe any unexpired Taxotere patents.
Under our current regulatory strategy, because we anticipate submitting Section 505(b)(2) NDAs with
only bioequivalence data, the ability to differentiate our products from competitor products will
be limited. Even if we believe our products demonstrate clinical or pharmacoeconomic benefits, we
may be unable to market our products based on these benefits. If our products fail to obtain unique
HCPCS codes, we may be required to price our products at levels that do not cover our costs to
manufacture, market and distribute the products or provide any profit, or to price our products at
levels at which they are not competitive.
Companies likely to have products that will compete with our product candidates have significantly
greater financial, technical and human resources and are better equipped to develop, manufacture,
market and distribute products. Many of these companies have extensive experience in preclinical
testing and clinical trials, obtaining FDA and other regulatory approvals and manufacturing and
marketing products and have products that have been approved or are in late-stage development and
operate large, well-funded research and development programs.
Smaller companies may also prove to be significant competitors, particularly through collaborative
arrangements with large pharmaceutical and biotechnology companies. Furthermore, academic
institutions, government agencies and other public and private research organizations are becoming
increasingly aware of the commercial value of their inventions and are actively seeking to
commercialize the technology they have developed.
We are subject to uncertainty relating to healthcare reform measures and reimbursement policies
that, if not favorable to our products, could hinder or prevent our products commercial success.
Our ability to commercialize our products successfully will depend in part on the extent to which
reimbursement for the costs of such products and related treatments will be available from
government health administration authorities, private health insurers and other third-party payors.
Significant uncertainty exists as to the reimbursement status of newly approved medical products.
The continuing efforts of the government, insurance companies, managed care organizations and other
payors of healthcare services to contain or reduce costs of healthcare may adversely effect:
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our ability to set a price we believe is fair for our products; |
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our ability to generate revenues or achieve or maintain profitability; |
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the future revenues and profitability of our potential customers, suppliers and
collaborators; and |
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the availability to us of capital. |
If we are successful in obtaining FDA approval for ANX-530, we will compete with Navelbine and
several generic versions of Navelbine. Our ability to commercialize ANX-530 will depend in part on
the extent to which governmental authorities, private health insurers and other organizations
establish appropriate coverage and reimbursement levels for the cost of our products and related
treatments. These payors are increasingly attempting to contain healthcare costs by limiting both
coverage and the level of reimbursement, particularly for new therapeutic products or if there is a
perception that the target indication of the new product is well-served by existing drugs or other
treatments. Accordingly, even if coverage and reimbursement are provided, market acceptance of our
products would be adversely affected if the amount of coverage and/or reimbursement available for
the use of our products proved to be unprofitable for healthcare providers or less profitable than
alternative treatments.
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There have been federal and state proposals to subject the pricing of healthcare goods and services
to government control and to make other changes to the U.S. healthcare system. While we cannot
predict the outcome of current or future legislation, we anticipate, particularly given President
Obamas focus on healthcare reform, that Congress and state legislatures will introduce initiatives
directed at lowering the total cost of healthcare. In addition, in certain foreign markets, the
pricing of drugs is subject to government control and reimbursement may in some cases be
unavailable or insufficient. It is uncertain if future legislative proposals, whether domestic or
abroad, will be adopted that might affect our product candidates or what actions federal, state, or
private payors for healthcare treatment and services may take in response to any such healthcare
reform proposals or legislation. Any such healthcare reforms could have a material and adverse
effect on the marketability of any products for which we ultimately receive FDA or other regulatory
agency approval.
We face potential product liability exposure and, if successful claims are brought against us, we
may incur substantial liability for a product or product candidate and may have to limit its
commercialization. In the future, we anticipate that we will need to obtain additional or increased
product liability insurance coverage and it is uncertain that such increased or additional
insurance coverage can be obtained on commercially reasonable terms.
Our business (in particular, the use of our product candidates in clinical trials and the sale of
our products for which we obtain marketing approval) will expose us to product liability risks.
Product liability claims might be brought against us by patients, health care providers,
pharmaceutical companies or others selling our products. If we cannot successfully defend ourselves
against these claims, we will incur substantial liabilities. Regardless of merit or eventual
outcome, liability claims may result in:
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decreased demand for our products or product candidates; |
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impairment of our business reputation; |
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withdrawal of bioequivalence or clinical trial participants; |
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costs of related litigation; |
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substantial monetary awards to patients or other claimants; |
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loss of revenues; and |
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the inability to commercialize our products and product candidates. |
We maintain limited product liability insurance for our bioequivalence and clinical trials, but our
insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses
or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and, in
the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us against losses.
We intend to expand our insurance coverage to include the sale of commercial products if we obtain
marketing approval of any of our product candidates, but we may be unable to obtain product
liability insurance on commercially acceptable terms or may not be able to maintain such insurance
at a reasonable cost or in sufficient amounts to protect us against potential losses. Large
judgments have been awarded in class action lawsuits based on drugs that had unanticipated side
effects. A successful product liability claim or series of claims brought against us could cause
our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash
and adversely affect our business.
RISKS RELATED TO OUR COMMON STOCK
We currently are not in compliance with NYSE Amex continuing listing standards and are at risk of
being delisted from the NYSE Amex equities market.
Our common stock currently trades on the NYSE Amex. NYSE Amex will normally consider suspending
dealings in, or removing from the list, securities of an issuer which has stockholders equity of
less than $6.0 million if such issuer has sustained losses from continuing operations and/or net
losses in its five most recent fiscal years. As of September 30, 2009, our stockholders equity was
approximately $1.6 million and we have incurred annual net losses since inception. In addition,
NYSE Amex will normally consider suspending dealings in, or removing from the list, securities
selling for a substantial period of time at a low price per share if the issuer fails to effect a
reverse split of such stock within a reasonable time after being notified that the NYSE Amex deems
such action to be appropriate under the circumstances. Since October 1, 2007 through the date
hereof, the closing price of a share of our common stock has been less than $1.00.
On June 1, 2009, we received notice from the NYSE Amex staff that, based on their review of our
Form 10-Q for the period ended March 31, 2009, we are not in compliance with certain stockholders
equity continued listing standards. Specifically, the NYSE Amex staff noted that we are not in
compliance with Section 1003(a)(ii) of the NYSE Amex Company Guide because we reported
stockholders equity of less than $4,000,000 and losses from continuing operations and net losses
in three of our four most recent
S-18
fiscal years, or with Section 1003(a)(iii) of the Company Guide because we reported stockholders
equity of less than $6,000,000 and losses from continuing operations and net losses in our five
most recent fiscal years. In addition, the NYSE Amex staff notified us, in accordance with Section
1003(f)(v) of the Company Guide, that it deems it appropriate for us to effect a reverse stock
split of our common stock to address its low selling price per share, and that if a reverse stock
split is not completed within a reasonable amount of time after June 1, 2009, the NYSE Amex may
consider suspending dealings in, or removing from the list, our common stock.
To maintain the listing of our common stock on the NYSE Amex, the NYSE Amex required us to submit a
plan by July 1, 2009, advising the exchange of the actions we have taken, or will take, to regain
compliance with Sections 1003(a)(ii) and (iii) of the Company Guide by December 1, 2010. On July 1,
2009, we submitted a plan to attempt to resolve our listing deficiencies and regain compliance with
the continued listing requirements. On July 31, 2009, the NYSE Amex staff notified us that it
determined that the plan we submitted makes a reasonable demonstration of our ability to regain
compliance with the NYSE Amexs continued listing standards and determined to grant us an
extension, until December 1, 2010, for us to regain compliance with the NYSE Amexs continued
listing standards. During this extension period, we will be subject to periodic review to
determine whether we are making progress consistent with our plan. If we do not show progress
consistent with our plan, the NYSE Amex staff will review the circumstances and may immediately
commence delisting proceedings.
The delisting of our common stock from the NYSE Amex likely would reduce the trading volume and
liquidity in our common stock and may lead to further decreases in the trading price of our common
stock. The delisting of our common stock may also materially impair our stockholders ability to
buy and sell shares of our common stock. In addition, the delisting of our common stock could
significantly impair our ability to raise capital, which is critical to the continuation of our
business.
If our common stock were delisted and determined to be a penny stock, a broker-dealer may find it
more difficult to trade our common stock and an investor may find it more difficult to acquire or
dispose of our common stock in the secondary market.
If our common stock were removed from listing with the NYSE Amex, it may be subject to the
so-called penny stock rules. The SEC has adopted regulations that define a penny stock to be
any equity security that has a market price per share of less than $5.00, subject to certain
exceptions, such as any securities listed on a national securities exchange. For any transaction
involving a penny stock, unless exempt, the rules impose additional sales practice requirements
on broker-dealers, subject to certain exceptions. If our common stock were delisted and determined
to be a penny stock, a broker-dealer may find it more difficult to trade our common stock and an
investor may find it more difficult to acquire or dispose of our common stock on the secondary
market. Investors in penny stocks should be prepared for the possibility that they may lose their
whole investment.
The market price of our common stock has been and is likely to continue to be highly volatile.
On October 1, 2007, the market price for our common stock dropped almost 80% following our
announcement of the results of our phase 2b clinical trial of CoFactor for the first-line treatment
of metastatic colorectal cancer. In addition, the market price for our common stock has
historically been highly volatile, and the market for our common stock has from time to time
experienced significant price and volume fluctuations that are unrelated to our operating
performance. The market price of our common stock may fluctuate significantly in response to a
number of factors, including:
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the level of our financial resources and ability to continue as a going concern; |
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announcements of entry into or consummation of a financing or strategic transaction; |
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any decision by us to liquidate our assets and wind-up operations; |
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changes in the regulatory status of our product candidates, including results of our
bioequivalence and clinical trials and other research and development programs; |
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FDA or international regulatory actions and regulatory developments in the U.S. and
foreign countries; |
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announcements of new products or technologies, commercial relationships or other events
(including bioequivalence and clinical trial results and regulatory events and actions) by
us or our competitors; |
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market conditions in the pharmaceutical, biopharmaceutical specialty pharmaceutical and
biotechnology sectors; |
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developments concerning intellectual property rights generally or those of us or our
competitors; |
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litigation or public concern about the safety of our products or product candidates; |
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changes in securities analysts estimates of our financial performance or deviations in
our business and the trading price of our common stock from the estimates of securities
analysts; |
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events affecting any future collaborations, commercial agreements and grants; |
S-19
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fluctuations in stock market prices and trading volumes of similar companies; |
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders or pursuant to shelf or resale registration
statements that register shares of our common stock that may be sold by certain of our
current or future stockholders; |
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discussion of us or our stock price by the financial and scientific press and in online
investor communities; |
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commencement of delisting proceedings by the NYSE Amex; |
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additions or departures of key personnel; and |
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changes in third party reimbursement policies. |
As evidenced by the October 1, 2007 decline, the realization of any of the foregoing could have a
dramatic and adverse impact on the market price of our common stock. In addition, class action
litigation has often been instituted against companies whose securities have experienced periods of
volatility in market price. Moreover, regulatory entities often undertake investigations of
investor transactions in securities that experience volatility following an announcement of a
significant event or condition. Any such litigation brought against us or investigation involving
our investors could result in substantial costs and a diversion of managements attention and
resources, which could hurt our business, operating results and financial condition.
Sales of substantial amounts of our common stock or the perception that such sales may occur could
cause the market price of our common stock to drop significantly, even if our business is
performing well.
The market price of our common stock could decline as a result of sales by, or the perceived
possibility of sales by, us or our existing stockholders of shares of our common stock. These sales
might also make it more difficult for us to sell equity securities at a time and price that we deem
appropriate. In addition, this shelf registration statement and our resale registration statements
on Form S-3 register a significant number of shares of our common stock, and securities convertible
into our common stock, that may be sold by us or certain of our stockholders, which may increase
the likelihood of sales by, or the perception of an increased likelihood of sales by, us or our
existing stockholders of shares of our common stock.
Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of
us, which may be beneficial to our stockholders, more difficult, which could depress our stock
price. Alternatively, prohibitions on anti-takeover provisions in our charter documents may
restrict us from acting in the best interests of our stockholders.
We are incorporated in Delaware. Certain anti-takeover provisions of Delaware law and our charter
documents as currently in effect may make a change in control of our company more difficult, even
if a change in control would be beneficial to our stockholders. Our bylaws limit who may call a
special meeting of stockholders and establish advance notice requirements for nomination of
individuals for election to our board of directors or for proposing matters that can be acted upon
at stockholders meetings. Delaware law also prohibits corporations from engaging in a business
combination with any holders of 15% or more of their capital stock until the holder has held the
stock for three years unless, among other possibilities, the board of directors approves the
transaction. Our board of directors may use these provisions to prevent changes in the management
and control of our company. Also, under applicable Delaware law, our board of directors may adopt
additional anti-takeover measures in the future. In addition, provisions of certain compensatory
contracts with our management, such as equity award agreements with our executive officers, may
have an anti-takeover effect by resulting in accelerated vesting of outstanding equity securities
held by these officers. In particular, in the event of a change in control, the vesting of options
we granted in July 2009 to our remaining executives will accelerate with respect to fifty percent
of the then unvested shares on the day prior to the date of the change in control and, subject to
the respective executives continuous service, with respect to the remaining fifty percent of the
then unvested shares on the one year anniversary of the date of the change in control. As a result,
if an acquirer desired to retain the services of one or both of our remaining executives following
an acquisition, it may be required to provide additional incentive to them, which could increase
the cost of the acquisition to the acquirer and may deter or affect the terms of the acquisition or
potential acquisition.
In connection with a July 2005 private placement, we agreed with the investors in that transaction
that we would not implement certain additional measures that would have an anti-takeover effect. As
a result, under our amended and restated certificate of incorporation, we are prohibited from
dividing our board of directors into classes and adopting or approving any rights plan, poison
pill or other similar plan or device. A classified board of directors could serve to protect our
stockholders against unfair treatment in takeover situations, by making it more difficult and
time-consuming for a potential acquirer to take control of our board of directors. A company may
also adopt a classified board of directors to ensure stability in the board of directors and
thereby improve long-term planning, which may benefit stockholders. A poison pill or similar plan
or device may encourage potential acquirers to discuss their intentions with the board of directors
of a company and avoid the time, expense and distraction of a hostile take-over. Any benefit to us
and our stockholders from instituting a classified board or adopting or approving a poison pill
or similar plan or device in these and other circumstances is unavailable.
S-20
Because we do not expect to pay dividends with respect to our common stock in the foreseeable
future, you must rely on stock appreciation for any return on your investment.
We have paid no cash dividends on any of our common stock to date, and we currently intend to
retain our future earnings, if any, to fund the development and growth of our business. As a
result, with respect to our common stock, we do not expect to pay any cash dividends in the
foreseeable future, and payment of cash dividends, if any, will also depend on our financial
condition, results of operations, capital requirements and other factors and will be at the
discretion of our board of directors. Furthermore, we are subject to various laws and regulations
that may restrict our ability to pay dividends and we may in the future become subject to
contractual restrictions on, or prohibitions against, the payment of dividends. Accordingly, the
success of your investment in our common stock will likely depend entirely upon any future
appreciation and there is no guarantee that our common stock will appreciate in value.
RISKS RELATED TO THIS OFFERING
Since we have broad discretion in how we use the proceeds from this offering, we may use the
proceeds in ways with which you disagree.
Although we describe under the heading Use of Proceeds in this prospectus supplement our
currently intended use of the net proceeds from this offering, we cannot estimate the allocation of
the net proceeds from this offering among those uses and we reserve the right to change the use of
proceeds as a result of certain contingencies, including any future partnering or strategic
transaction opportunity. Accordingly, our management will have significant flexibility in applying
the net proceeds from this offering. You will be relying on the judgment of our management and our
board of directors with regard to the use of these net proceeds, and you will not have the
opportunity, as part of your investment decision, to assess whether the proceeds are being used
appropriately. It is possible that the net proceeds will be used in a way that does not improve our
operating results or enhance the value of our common stock. In addition, if we are unable to obtain
additional capital or complete a strategic transaction on a timely basis, net proceeds from this
offering may be used for expenses related to seeking protection under the provisions of the U.S.
Bankruptcy Code or conducting an orderly liquidation of our assets and winding up of our corporate
affairs. In either case, you could lose part or all of your investment.
Investors in this offering will pay a much higher price than the book value of our stock.
The public offering price of the securities offered hereby is likely to be substantially higher
than the book value per share of our common stock. Investors purchasing securities in this offering
may, therefore, incur immediate dilution in net tangible book value per share of the common stock
issuable upon conversion or exercise of the securities purchased in this offering. See Dilution
below for a more detailed discussion of the dilution you will incur in this offering.
Provisions of the Delaware General Corporation Law may prohibit us from making dividend payments
with respect to our Series E convertible preferred stock or make-whole payments that may be due to
the holders of our Series E convertible preferred stock.
We are incorporated in the State of Delaware and are subject to the provisions of the Delaware
General Corporation Law (the DGCL). Section 170 of the DGCL provides, among other things, that a
Delaware corporation may declare and pay dividends upon shares of its capital stock out of its
surplus, as defined in and computed in accordance with Sections 154 and 244 of the DGCL. As of the
date hereof, we have sufficient surplus to make dividend payments with respect to the Series E
convertible preferred stock offered by this prospectus supplement, as well as sufficient surplus to
make the make-whole payments that may be due to the holders of our Series E convertible preferred
stock, should such make-whole payments be deemed a dividend under the DGCL. However, our surplus
will decrease as we spend our capital on operational activities, unless our spending is offset by
capital-raising transactions. If our surplus is less than then-due dividend payments, including
make-whole payments if they are deemed a dividend under the DGCL, we will be prohibited by the DGCL
from making the dividend or make-whole payment, which may constitute a violation of our certificate
of incorporation or a breach of our contractual obligations to the holders of our Series E
convertible preferred stock.
If third parties bring claims against us, the proceeds held in escrow may be reduced and we may not
be able to make dividend payments with respect to our Series E convertible preferred stock or
make-whole payments that may be due to the holders of our Series E convertible preferred stock.
Our placing of a portion of the proceeds from this offering in escrow may not protect those funds
from third party claims against us. We cannot assure you that we will be able to prevent third
parties, including other lenders or holders of our debt, from making claims against the escrow
account. Additionally, if we are forced to file a bankruptcy case or an involuntary bankruptcy case
is filed against us which is not dismissed, the proceeds held in our escrow account may be subject
to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to claims of
third parties with priority over the claims of the holders of our Series E convertible preferred
stock. To the extent bankruptcy claims deplete the amounts held in escrow, we cannot assure that we
will able to make dividend payments with respect to our Series E convertible preferred stock or
make-whole payments that may be due to the holders of our Series E convertible preferred stock.
S-21
There is no public market for the convertible preferred stock or the warrants being offered by this
prospectus supplement.
There is no established trading market for the convertible preferred stock or the warrants being
offered by this prospectus supplement and we do not expect a market to develop. In addition, we do
not intend to apply to list the convertible preferred stock or the warrants on any securities
exchange or automated quotation system. Without an active market, the liquidity of the convertible
preferred stock and the warrants will be limited.
S-22
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying prospectus, including the documents that we
incorporate herein and therein by reference, include forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. All statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements, including, but not limited to,
statements regarding business strategy, expectations and plans, our objectives for future
operations, including product development, and our future financial position. When used in this
report, the words believe, may, could, will, estimate, continue, anticipate,
intend, expect, indicate and similar expressions are intended to identify forward-looking
statements.
We base these forward-looking statements on our current expectations and projections about
future events and trends that we believe may affect our financial condition, results of operations,
business strategy, short-term and long-term business operations and objectives, and financial
needs, including our ability to consummate a strategic transaction or otherwise satisfy our
immediate need for additional capital. These forward-looking statements are subject to risks and
uncertainties that could cause our actual results to differ materially from those reflected in the
forward-looking statements. Factors that could cause or contribute to such differences include, but
are not limited to: the risk that we will pursue development activities at levels or on timelines,
or will incur unexpected expenses, that shortens the period through which our operating funds will
sustain us; the risk that ADVENTRX will be unable to raise sufficient additional capital to
commercialize ANX-530, if an ANX-530 NDA is submitted and approved, or to continue the development
of ANX-514; the risk that ADVENTRX will be unable to raise sufficient additional capital on a
timely basis to continue as a going concern; the risk that ADVENTRX will seek protection under the
provisions of the U.S. Bankruptcy Code; the risk that changes made in transferring the
manufacturing process for ANX-530 may result in a lack of comparability between the commercial
product and the material used in clinical trials, and that FDA may require ADVENTRX to perform
additional non-clinical or clinical studies; the potential for regulatory authorities to require
additional preclinical work and/or clinical activities to support regulatory filings, including
prior to the submission or the approval of an NDA for ANX-530 and/or ANX-514, which activities may
increase the cost and timeline to NDA submission or approval and negatively impact our ability to
raise additional capital and/or complete a strategic or partnering transaction; the risk the FDA
will determine that ANX-530 and Navelbine and/or ANX-514 and Taxotere are not bioequivalent,
including as a result of performing pharmacokinetic equivalence analysis based on a patient
population other than the population on which we based our analysis or determining that increased
docetaxel blood-levels during and immediately following infusion are clinically relevant; the risk
of investigator bias in reporting adverse events as a result of the open-label nature of the
ANX-530 bioequivalence study, including bias that increased the reporting of adverse events
associated with Navelbine and/or that decreased the reporting of adverse events associated with
ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing
ANX-530 and ANX-514, including validating commercial manufacturing processes and manufacturers, as
well as suppliers, and the potential for automatic injunctions regarding FDA approval of ANX-514;
the risk that the performance of third parties on whom we rely to conduct our studies or evaluate
the data, including clinical investigators, expert data monitoring committees, contract
laboratories and contract research organizations, may be substandard, or they may fail to perform
as expected; the risk that our significantly reduced workforce and leadership by officers who do
not have substantial previous experience in executive leadership roles will negatively impact our
ability to raise capital or maintain effective disclosure controls and procedures or internal
control over financial reporting; the risk that our common stock will be delisted by the NYSE Amex,
including as a result of failing to maintain sufficient stockholders equity or a sufficient stock
price; the risk that we will trigger a maintenance failure under that certain Rights Agreement,
dated July 27, 2005, as amended, and be required to pay liquidated damages, including as a result
of losing our eligibility to use Form S-3 if our common stock is delisted from the NYSE Amex; and
other risks and uncertainties discussed under the heading Risk Factors in this prospectus
supplement, the accompanying prospectus and in other reports and documents we file with the SEC.
Any forward-looking statement speaks only as of the date on which it is made and, except as
required by law, we do not intend to update any forward-looking statements publicly to reflect
events or circumstances after the date on which such statement is made or to update the reasons
actual results could differ materially from those anticipated in the forward-looking statements,
even if new information becomes available in the future. You should not place undue reliance on
any forward-looking statement.
S-23
USE OF PROCEEDS
We estimate that the net proceeds to us from the sale of the securities offered under this
prospectus supplement, after deducting the placement agents fees and our estimated offering
expenses, but before deducting our dividend and related payment obligations, and excluding the
proceeds, if any, from exercise of the warrants issued in this offering, will be approximately
$14.5 million, if we sell the maximum number of units. We may increase the dollar value of
securities offered under the registration statement(s) of which this prospectus supplement and the
accompanying prospectus form a part. In this event, we estimate that the net proceeds to us from
the sale of the securities offered under this prospectus supplement, after deducting the placement
agents fees and our estimated offering expenses, but before deducting our dividend and related
payment obligations, and excluding the proceeds, if any, from exercise of the warrants issued in
this offering, will be approximately $17.6 million, if we sell the maximum number of units
available for such increase. Because there is no minimum offering amount required as a condition
to closing in this offering, we may sell less than all of the securities offered hereby, which may
significantly reduce the amount of proceeds received by us.
We currently intend to use the majority of the net proceeds from this offering to fund
activities relating to the commercial launch of ANX-530, including acquiring or developing sales,
marketing and distribution capabilities and the associated regulatory compliance infrastructure,
and to continue the development of ANX-514 in the United States, and for general corporate
purposes. At this time we cannot estimate the allocation of the net proceeds of this offering
among these anticipated uses. The amounts and timing of the expenditures may vary significantly
depending on numerous factors, including the net proceeds to us from the sales of the securities
offered under this prospectus supplement and our need for and ability to raise additional capital
to launch ANX-530 in the U.S., should it be approved, and continue the development of ANX-514. We
reserve the right to change the use of proceeds as a result of certain contingencies, such as those
discussed above and any future opportunities to evaluate, negotiate and complete one or more
strategic or partnering transactions. Accordingly, our management will have broad discretion in the
application of the net proceeds of this offering. Pending use of the net proceeds, we intend to
invest the net proceeds in short-term, interest-bearing, investment-grade securities.
S-24
DIVIDEND POLICY
We have never declared or paid any cash dividends on our common stock and do not anticipate
declaring or paying any cash dividends on our common stock in the foreseeable future. Our 5% Series
B Convertible Preferred Stock would have accrued cumulative dividends at a rate of 5% per annum
until July 6, 2014, payable on a quarterly basis beginning on October 1, 2009, our 5% Series C
Convertible Preferred Stock would have accrued cumulative dividends at a rate of 5% per annum until
February 10, 2012, payable on a quarterly basis beginning on October 1, 2009 and our 4.25660%
Series D Convertible Preferred Stock would have accrued cumulative dividends at a rate of 4.25660%
per annum until October 9, 2020, payable on a quarterly basis beginning January 1, 2010. However,
all of the shares of the 5% Series B Convertible Preferred Stock, the 5% Series C Convertible
Preferred Stock and the 4.25660% Series D Convertible Preferred Stock were converted into common
stock prior to the initial dividend payment date. Pursuant to the terms of the 5% Series B
Convertible Preferred Stock, the 5% Series C Convertible Preferred Stock and the 4.25660% Series D
Convertible Preferred Stock, in connection with these conversions, we paid an amount equal to $250
per $1,000 stated value of such converted shares of 5% Series B Convertible Preferred Stock, or an
aggregate of $340,250, we paid an amount equal to $125 per $1,000 stated value of such converted
shares of the 5% Series C Convertible Preferred Stock, or an aggregate of $115,250, and we paid an
amount equal to $468.23 per $1,000 stated value of such converted shares of 4.25660% Series D
Convertible Preferred Stock, or an aggregate of $5,283,000, in each case in lieu of our dividend
obligations. Such payments may be deemed dividends under the DGCL. Except for dividends, or amounts
that may be deemed dividends, payable on our 3.73344597664961% Series E convertible Preferred stock
offered hereby, we expect to retain all available funds and any future earnings to support
operations and fund the development and growth of our business. Our board of directors will
determine whether we pay and the amount of future dividends (including cash dividends), if any.
S-25
DILUTION
If you invest in the units being offered by this prospectus supplement, you will suffer
immediate and substantial dilution in the net tangible book value per share of common stock. Our
net tangible book value as of September 30, 2009 was approximately $1.6 million, or approximately
$0.01 per share of common stock. Net tangible book value per share is determined by dividing our
net tangible book value, which consists of our total tangible assets less total liabilities, by the
number of shares of our common stock outstanding on that date.
Dilution in net tangible book value per share represents the difference between the amount per
share of common stock underlying the convertible preferred stock paid by purchasers in this
offering and the net tangible book value per share of our common stock immediately after this
offering. Without taking into account any other changes in the net tangible book value after
September 30, 2009 other than to give effect to:
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our receipt of the proceeds from the sale of 11,283 shares of units, or 60,000,000
shares of common stock issuable upon conversion of the convertible preferred stock
comprising the units at an effective acquisition price of $0.18805 per share of common
stock, in our financing that closed on October 9, 2009, less the placement agents fees
and our estimated offering expenses, but before deducting our dividend and related
payment obligations, and |
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our receipt of the estimated proceeds from the sale of 15,676 units in this offering
at an offering price of $1,000 per unit, or 41,128,165 shares of common stock issuable
upon conversion of the convertible preferred stock comprising the units at an effective
acquisition price of $0.38115 per share of common stock, less the estimated placement
agents fees and our estimated offering expenses, but before deducting our dividend and
related payment obligations, |
our net tangible book value as of September 30, 2009, after giving effect to the items above, would
have been approximately $26.5 million, or approximately $0.12 per share of common stock. This
represents an immediate increase of approximately $0.11 in net tangible book value per share to our
existing stockholders and an immediate dilution of approximately $0.26 per share to purchasers of
units in this offering. The following table illustrates this per share dilution.
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Public offering price per share of common stock underlying convertible preferred stock |
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$ |
0.38115 |
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Net tangible book value per share as of September 30, 2009 |
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$ |
0.01 |
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Increase in net tangible book value per share attributable to offering closed October 9, 2009 |
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$ |
0.06 |
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Increase in net tangible book value per share attributable to this offering |
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$ |
0.05 |
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Pro forma net tangible book value per share as of September 30, 2009, after giving effect to the
offering closed October 9, 2009 |
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$ |
0.07 |
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Pro forma net tangible book value per share as of September 30, 2009, after giving effect to this
offering |
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$ |
0.12 |
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Dilution in net tangible book value per share to new investors in this offering |
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$ |
(0.26115 |
) |
We may increase the dollar value of securities we offer under the registration statement(s) of
which this prospectus supplement and the accompanying prospectus form a part by up to $3,901,311.
After giving effect to our receipt of the estimated proceeds from the sale of 19,000 units, which
reflects the maximum number of units we could sell under the registration statement(s) of which
this prospectus supplement and the accompanying prospectus form a part after such increase, at an
offering price of $1,000 per unit, or 49,849,141 shares of common stock issuable upon conversion of
the convertible preferred stock comprising the units at an effective acquisition price of $0.38115
per share of common stock, less the estimated placement agents fees and our estimated offering
expenses, but before deducting our dividend and related payment obligations, our net tangible book
value as of September 30, 2009, after giving effect to the items above, would have been
approximately $29.7 million, or approximately $0.13 per share of common stock. This represents an
immediate increase of approximately $0.12 in net tangible book value per share to our existing
stockholders and an immediate dilution of approximately $0.25 per share to purchasers of units in
this offering.
The above is based on 124,885,267 shares of our common stock outstanding as of September 30,
2009 (as adjusted for 60,000,000 shares of common stock issued upon conversion of the convertible
preferred stock issued in our offering that closed on October 9, 2009 and 41,128,165 shares (or
49,849,141 shares if we effect the increase) of common stock to be issued upon conversion of the
convertible preferred stock to be issued in this offering), and excludes, as of that date:
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5,859,000 shares of common stock issuable upon the exercise of outstanding stock
options issued under our equity incentive plans prior to this offering, at a weighted
average exercise price of $0.80 per share; |
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14,383,656 shares of common stock available for future issuance under our 2008
Omnibus Incentive Plan;
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S-26
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20,658,33 shares of common stock issuable upon the exercise of outstanding warrants,
at a weighted average exercise price of $1.26 per share; |
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19,800,000 shares of common stock issued or issuable upon the exercise of
outstanding warrants issued to the purchasers in the offering the closed October 9,
2009, at an exercise price of $0.1468; |
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3,600,000 shares of common stock issuable upon the exercise of outstanding warrants
issued to the placement agent in connection with the offering that closed October 9,
2009, at an exercise price of $0.235 per share |
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12,462,285 shares of common stock issuable upon the exercise of the warrants to be
issued to the purchasers in this offering, at an exercise price of $0.3499 per share,
which amount assumes we increase the dollar value of securities in this offering by a
total of $3,901,311; and |
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2,492,457 shares of common stock issuable upon exercise of warrants to be issued to
the placement agent in connection with this offering, which are not covered by this
prospectus supplement, at an exercise price of $0.4765 per share, which amount assumes
we increase the dollar value of securities in this offering by a total of $3,901,311. |
To the extent that any options or warrants are exercised, new options or other equity awards
are issued under our 2008 Omnibus Incentive Plan, or we otherwise issue additional shares of common
stock in the future, there will be further dilution to new investors.
S-27
DESCRIPTION OF SECURITIES WE ARE OFFERING
The convertible preferred stock and the warrants being offered in this offering will be issued
pursuant to a securities purchase agreement between each of the investors and us. We urge you to
review the securities purchase agreement, the certificate of designation authorizing the
convertible preferred stock and the form of warrant, which we will file as exhibits to a Current
Report on Form 8-K filed with the SEC in connection with this offering, for a complete description
of the terms and conditions applicable to the convertible preferred stock and the warrants. The
following brief summary of the material terms and provisions of the convertible preferred stock and
the warrants is subject to, and qualified in its entirety by, the certificate of designation
authorizing the convertible preferred stock and the form of warrant. This prospectus supplement
also relates to the offering of the shares of our common stock upon the conversion or exercise, if
any, of the convertible preferred stock or the warrants issued to the investors in this offering.
The warrants we are issuing to the placement agent in connection with this offering to purchase up
to an aggregate of 2,492,457 shares of our common stock are not covered by this prospectus
supplement, which amount assumes we increase the dollar value of securities in this offering by a
total of $3,901,311.
Convertible Preferred Stock
We will authorize the convertible preferred stock by filing a certificate of designation with
the Secretary of State of the State of Delaware. The certificate of designation may be authorized
by our board of directors without approval by our stockholders.
The convertible preferred stock will be convertible at the option of the holder at any time
into shares of our common stock at a conversion ratio determined by dividing the stated value of
the convertible preferred stock, or $1,000, by a conversion price of $0.38115 per share. The
conversion price of the convertible preferred stock will be subject to adjustment in the case of
stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
The convertible preferred stock will be subject to automatic conversion into shares of common stock
upon the occurrence of a change in control of our company and we may become obligated to redeem the
convertible preferred stock upon the occurrence of certain triggering events, including the
material breach by us of certain contractual obligations to the holders of the convertible
preferred stock, the occurrence of a change in control of our company, the occurrence of certain
insolvency events relating to our company or the failure of our common stock to continue to be
listed or quoted for trading on one or more specified United States securities exchanges. Subject
to limited exceptions, a holder of the convertible preferred stock will not have the right to
convert any portion of its convertible preferred stock if the holder, together with its affiliates,
would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding
immediately after giving effect to its conversion.
The convertible preferred stock is entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value of $1,000 per share) of 3.73344597664961% per annum
until January 7, 2015, payable quarterly beginning April 1, 2010. If the convertible preferred
stock is converted any time prior to January 7, 2015, we will pay the holder of the converted
shares an amount equal to $186.67 per $1,000 in stated value (subject to adjustment) of the shares
of convertible preferred stock converted, less dividends paid with respect to such converted
preferred shares before the relevant conversion date.
Except as required by law, holders of the convertible preferred stock are not entitled to
voting rights, except that the affirmative vote of the holders of a majority of the outstanding
shares of convertible preferred stock is required to take certain actions that may adversely affect
the rights or preferences of the holders of convertible preferred stock.
The securities purchase agreement pursuant to which the convertible preferred stock will be
issued and the certificate of designation authorizing the preferred stock includes certain
agreements and covenants for the benefit of the holders of convertible preferred stock, including
restrictions on our ability to amend our certificate of incorporation or bylaws, pay cash dividends
or distributions with respect to our common stock or other junior securities, repurchase shares of
common stock or other junior securities, issue additional equity securities for a period of 90-days
after the closing of the offering and incur indebtedness.
Warrants
The warrants will provide for an exercise price of $0.3499 per share and will be exercisable
at the option of the holder at any time after the date of issuance, which will be the closing date
of this offering, through and including the date that is the 30-month anniversary of the initial
exercise date. Subject to limited exceptions, a warrant holder will not have the right to exercise
any portion of the warrant if the holder, together with its affiliates, would beneficially own in
excess of 4.9% of the number of shares of our common stock outstanding immediately after the
exercise. The exercise price of the warrants, and in some cases the number of shares issuable upon
exercise of the warrants, will be subject to adjustment in the event of stock splits, stock
dividends, combinations and similar events affecting our common stock. In addition, in the event we
consummate a merger or consolidation with or into another person or other reorganization event in
which our common stock is converted or exchanged for securities, cash or other property, or we
sell, lease, license or otherwise dispose of all or substantially all of our assets or we or
another person acquire 50% or more of our outstanding common stock, then following such event, the
holders of the warrants will be entitled to receive upon exercise of the warrants the same kind and
amount of securities, cash or property which the holders would have received had they exercised the
warrants immediately prior to such fundamental transaction. Any successor to us or surviving entity
shall assume the obligations
S-28
under the warrants.
The warrant holders must surrender payment in cash of the aggregate exercise price of the
shares being acquired upon exercise of the warrants. If, however, we are unable to offer and sell
the shares underlying these warrants pursuant to this prospectus supplement due to the
ineffectiveness of the registration statement of which this prospectus supplement is a part, then
the warrants may only be exercised on a net or cashless basis. No fractional shares of common
stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we
will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise
price.
We do not intend to list the convertible preferred stock or the warrants on any securities
exchange or automated quotation system.
PLAN OF DISTRIBUTION
We have entered into an engagement letter agreement, dated January 3, 2010, with Rodman &
Renshaw, LLC. Subject to the terms and conditions set forth in the agreement, Rodman & Renshaw has
agreed to act as our placement agent in connection with this offering. The placement agent is not
purchasing or selling any securities being offered by this prospectus supplement or the
accompanying prospectus, nor is it required to arrange for the purchase or sale of any specific
number or dollar amount of the units, but has agreed to use its reasonable best efforts to arrange
for the sale of all of the units in this offering.
There is no requirement that any minimum number of units or dollar amount of units be sold in
this offering and there can be no assurance that we will sell all or any of the units being
offered.
Our agreement with the placement agent provides that the obligations of the placement agent
and the investors are subject to certain conditions precedent, including, among other things, the
absence of any material change in our business and receipt of a customary written legal opinion.
We currently anticipate that the closing of this offering will take place on or about January
7, 2010. On the scheduled closing date, the following will occur:
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we will receive funds in the amount of the aggregate purchase price; |
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the placement agent will receive the placement agent fees and compensation warrants
to purchase shares of our common stock in accordance with the terms of the engagement
letter agreement; and |
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we will deliver the units to the investors. |
We have agreed to pay the placement agent an aggregate fee equal to 7.0% of the gross proceeds
of the sale of the units in this offering. We have also agreed to grant compensation warrants to
the placement agent to purchase that number of our shares of common stock equal to 5.0% of the
number of shares of common stock underlying the convertible preferred stock sold by us in this
offering, or up to an aggregate of 2,492,457 shares (which amount assumes we increase the dollar
value of securities in this offering by a total of $3,901,311), at an exercise price of $0.4765 per
share. In compliance with the guidelines of FINRA, under no circumstances will the fee, commission
or discount received by the placement agent or any other FINRA member or independent broker-dealer
exceed 8.0% of the gross proceeds to us in this offering or any other offering in the United States
pursuant the accompanying prospectus.
The compensation warrants will be substantially on the same terms as the warrants offered
hereby, except that they will comply with FINRA Rule 5110(g) in that for a period of six months
after their date of issuance (which shall not be earlier than the closing date of this offering),
neither the compensation warrants nor any shares issued upon exercise of the compensation warrants
shall be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging,
short sale, derivative, put, or call transaction that would result in the effective economic
disposition of the securities by any person, except the transfer of any security:
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by operation of law or by reason of reorganization of us; |
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to any FINRA member firm participating in this offering and the officers or partners
thereof, if all securities so transferred remain subject to the lock-up restriction
described above for the remainder of the time period; |
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if the aggregate amount of our securities held by Rodman & Renshaw or related persons
do not exceed 1% of the securities being offered; |
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that is beneficially owned on a pro-rata basis by all equity owners of an investment
fund, provided that no participating member manages or otherwise directs investments by
the fund, and participating members in the aggregate do not own
more than 10% of the equity in the fund; or |
S-29
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the exercise or conversion of any security, if all securities received remain subject
to the lock-up restriction set forth above for the remainder of the time period. |
The following table shows the per unit and total fees we will pay to the placement agent in
connection with the sale of the units offered pursuant to this prospectus supplement and the
accompanying prospectus, assuming the purchase of all of the units being offered hereby. Because
there is no minimum offering amount required as a condition to closing in this offering, the actual
total offering fees, if any, are not presently determinable and may be substantially less than the
maximum amount set forth below.
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Per unit placement agent fees |
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$ |
70 |
|
Maximum offering total |
|
$ |
1,097,320 |
|
Maximum offering total
(following increase to dollar value of securities we
may offer under the registration statement(s) of
which this prospectus supplement and the accompanying
prospectus form a part) |
|
$ |
1,330,000 |
|
The placement agent proposes to arrange for the sale to one or more purchasers of the units
offered pursuant to this prospectus supplement and the accompanying prospectus directly through a
securities purchase agreement between the purchasers and us.
The purchase price per unit and the exercise price for the warrants were determined based on
negotiations with the purchasers and discussions with the placement agent.
We have agreed to indemnify the placement agent and its affiliates against certain liabilities
relating to or arising out of its activities under the engagement letter agreement. We have also
agreed to contribute to payments the placement agent may be required to make in respect of such
liabilities.
A copy of the engagement letter agreement will be included as an exhibit to a Current Report
on Form 8-K filed with the SEC in connection with this offering.
The placement agent has informed us that it will not engage in over-allotment, stabilizing
transactions or syndicate covering transactions in connection with this offering.
The transfer agent for our common stock is American Stock Transfer & Trust Company. We will
act as transfer agent for the shares of convertible preferred stock and the warrants being offered
hereby.
Our common stock is traded on the NYSE Amex under the symbol ANX. Neither the convertible
preferred stock nor the warrants being offered hereby are expected to be eligible for trading on
any market.
S-30
LEGAL MATTERS
The validity of the issuance of the securities being offered hereby will be passed upon for us by
DLA Piper LLP (US), San Diego, California.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and current reports, proxy statements and other information
electronically with the SEC. You may read and copy these reports, proxy statements and other
information at the SECs public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public
reference room. You can request copies of these documents by writing to the SEC and paying a fee
for the copying costs. The SEC also maintains an Internet site that contains reports, proxy and
information statements, and other information regarding issuers that file electronically with the
SEC, including us. The SECs Internet site can be found at http://www.sec.gov. In addition, we
make available on or through our Internet site copies of these reports as soon as reasonably
practicable after we electronically file or furnish them to the SEC. Our Internet site can be
found at http://www.adventrx.com.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
We are allowed to incorporate by reference information contained in documents that we file
with the SEC. This means that we can disclose important information to you by referring you to
those documents and that the information in this prospectus supplement and the accompanying
prospectus is not complete. You should read the information incorporated by reference for more
detail. We incorporate by reference in two ways. First, we list below certain documents that we
have already filed with the SEC. The information in these documents is considered part of this
prospectus supplement. Second, the information in documents that we file in the future will update
and supersede the current information in, and be incorporated by reference in, this prospectus
supplement.
We incorporate by reference the documents listed below and any filings we make with the SEC
pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus
supplement until the termination of this offering (in each case, except for the information
furnished under Item 2.02 or Item 7.01 in any current report on Form 8-K and Form 8-K/A):
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our annual report on Form 10-K for the year ended December 31, 2008 filed with the
SEC on March 27, 2009 (File No. 001-32157- 09708145); |
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the information specifically incorporated by reference into our annual report on
Form 10-K for the year ended December 31, 2008 from our definitive proxy statement on
Schedule 14A filed with the SEC on April 30, 2009 (File No. 001-32157-09781242); |
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our quarterly report on Form 10-Q for the quarterly period ended March 31, 2009 filed
with the SEC on May 15, 2009 (File No. 001-32157-09829059); |
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our quarterly report on Form 10-Q for the quarterly period ended June 30, 2009 filed
with the SEC on August 12, 2009 (File No. 001-32157-091007525); |
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our quarterly report on Form 10-Q for the quarterly period ended September 30, 2009
filed with the SEC on November 10, 2009 (File No. 001-32157-091172685); |
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our current reports on Form 8-K filed with the SEC on January 2, 2009 (File No.
001-32157-09501628); January 5, 2009 (File No. 001-32157-09505346); January 8, 2009
(File No. 001-32157-09516181); February 2, 2009 (File No. 001-32157-09561715); February
5, 2009 (File No. 001-32157-09573163); February 10, 2009 (File No. 001-32157-09583495);
March 20, 2009 (File No. 001-32157-09696365); March 25, 2009 (File No.
001-32157-09702853); March 25, 2009 (File No. 001-32157-09702857); May 7, 2009 (File No.
001-32157-09806033); June 2, 2009 (File No. 001-32157-09868487); June 8, 2009 (File No.
001-32157-09878961); June 29, 2009 (File No. 001-32157-09914471); June 30, 2009 (File
No. 001-32157-09917820); July 22, 2009 (File No. 001-32157-09957353); July 24, 2009
(File No. 001-32157- 09962569); August 4, 2009 (File No. 001-32157-09983616); August 5,
2009 (File No. 001-32157-09989205); August 20, 2009 (File No. 001-32157-091025631);
August 28, 2009 (File No. 001-32157-091043396); September 1, 2009 (File No.
001-32157-091049161); October 13, 2009 (File No. 001-32157-091115090); October 19, 2009
(File No. 001-32157-091126027); and December 24, 2009 (File No. 001-32157-091260100);
and |
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the description of our common stock contained in our registration statement on Form
8-A filed with the SEC on April 27, 2004 (File No. 001-32157-041020580). |
We will provide each person, including any beneficial owner, to whom this prospectus
supplement and the accompanying prospectus is delivered, a copy of any or all of the documents
incorporated by reference in this prospectus supplement and the
S-31
accompanying prospectus but not delivered with this prospectus supplement and the accompanying
prospectus upon written or oral request at no cost to the requester. Requests should be directed
to: ADVENTRX Pharmaceuticals, Inc., 6725 Mesa Ridge Road, Suite 100, San Diego, California 92121,
Attn: Investor Relations, telephone: (858) 552-0866.
This prospectus supplement is part of a registration statement on Form S-3 that we have filed
and/or will file with the SEC. That registration statement(s) contains more information than this
prospectus supplement regarding us and our common stock, including certain exhibits and schedules.
You can obtain a copy of the registration statement from the SEC at the address listed above or
from the SECs Internet website.
You should rely only on the information in and incorporated by reference into this prospectus
supplement and the accompanying prospectus. We have not authorized anyone else to provide you with
different information. You should not assume that the information in this prospectus supplement or
the accompanying prospectus is accurate as of any date other than the date on the front cover of
these documents.
S-32
PROSPECTUS
$25,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
ADVENTRX PHARMACEUTICALS, INC.
We may, from time to time in one or more offerings, offer and sell up to $25,000,000 in the
aggregate of common stock, preferred stock, debt securities, warrants to purchase common stock,
preferred stock or debt securities, or any combination of the foregoing, either individually or as
units comprised of one or more of the other securities.
This prospectus provides a general description of the securities we may offer. We will
provide the specific terms of the securities offered in one or more supplements to this prospectus.
We may also authorize one or more free writing prospectuses to be provided to you in connection
with these offerings. You should read carefully this prospectus, the applicable prospectus
supplement and any related free writing prospectus, as well as any documents incorporated by
reference before you invest in any of our securities. This prospectus may not be used to offer or
sell any securities unless accompanied by the applicable prospectus supplement
Our common stock is listed on the NYSE Amex (formerly, the American Stock Exchange) under the
symbol ANX.
As of May 20, 2009, the aggregate market value of our outstanding common stock held by
non-affiliates was approximately $10,689,066, based on 90,252,572 shares of outstanding common
stock, of which 8,656,648 shares are held by affiliates, and a price of $0.1310 per share, which
was the last reported sale price of our common stock on the NYSE Amex on May 20, 2009. As of the
date of this prospectus, 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.
Investing in our securities involves risk. You should carefully review the risks and
uncertainties described under the heading Risk Factors beginning on page 4 of this prospectus and
contained in the applicable prospectus supplement and any related free writing prospectus.
We will sell these securities directly to investors, through agents designated from time to
time or to or through underwriters or dealers. For additional information on the methods of sale,
you should refer to the section entitled Plan of Distribution in this prospectus. If any
underwriters are involved in the sale of any securities with respect to which this prospectus is
being delivered, the names of such underwriters and any applicable commissions or discounts will be
set forth in a prospectus supplement. The price to the public of such securities and the net
proceeds we expect to receive from such sale will also be set forth in a 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 is truthful or
complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is June 4, 2009.
TABLE OF CONTENTS
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i
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or the SEC, using a shelf registration process. Under this shelf
registration process, we may from time to time sell common stock, preferred stock, debt securities
or warrants to purchase common stock, preferred stock or debt securities, or any combination of the
foregoing, either individually or as units comprised of one or more of the other securities, in one
or more offerings up to a total dollar amount of $25,000,000. We have provided to you in this
prospectus a general description of the securities we may offer. Each time we sell securities
under this shelf registration, we will, to the extent required by law, provide a prospectus
supplement that will contain specific information about the terms of that offering. We may also
authorize one or more free writing prospectuses to be provided to you that may contain material
information relating to these offerings. The prospectus supplement and any related free writing
prospectus that we may authorize to be provided to you may also add, update or change information
contained in this prospectus or in any documents that we have incorporated by reference into this
prospectus. To the extent there is a conflict between the information contained in this prospectus
and the prospectus supplement or any related free writing prospectus, you should rely on the
information in the prospectus supplement or the related free writing prospectus; provided that if
any statement in one of these documents is inconsistent with a statement in another document having
a later date for example, a document incorporated by reference in this prospectus or any
prospectus supplement or any related free writing prospectus the statement in the document
having the later date modifies or supersedes the earlier statement.
We have not authorized any dealer, agent or other person to give any information or to make
any representation other than those contained or incorporated by reference in this prospectus and
any accompanying prospectus supplement. You must not rely upon any information or representation
not contained or incorporated by reference in this prospectus or an accompanying prospectus
supplement. This prospectus and the accompanying prospectus supplement, if any, do not constitute
an offer to sell or the solicitation of an offer to buy any securities other than the registered
securities to which they relate, nor do this prospectus and the accompanying prospectus supplement
constitute an offer to sell or the solicitation of an offer to buy securities 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, any applicable prospectus
supplement or 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 (as our
business, financial condition, results of operations and prospects may have changed since that
date), even though this prospectus, any applicable prospectus supplement or any related free
writing prospectus is delivered or securities are sold on a later date.
As permitted by the rules and regulations of the SEC, the registration statement, of which
this prospectus forms a part, includes additional information not contained in this prospectus.
You may read the registration statement and the other reports we file with the SEC at the SECs web
site or at the SECs offices described below under the heading Where You Can Find Additional
Information.
ii
SUMMARY
This summary highlights selected information from this prospectus and does not contain all of
the information that you need to consider in making your investment decision. You should carefully
read the entire prospectus, including the risks of investing discussed under Risk Factors
beginning on page 4, the information incorporated by reference, including our financial statements,
and the exhibits to the registration statement of which this prospectus is a part. When used in
this prospectus, the terms ADVENTRX, we, our, us or the Company refer to ADVENTRX
Pharmaceuticals, Inc. and its consolidated subsidiaries, unless otherwise indicated or as the
context otherwise requires.
About ADVENTRX Pharmaceuticals, Inc.
We are a development-stage biopharmaceutical company whose fundamental business is focused on
in-licensing, developing and commercializing proprietary product candidates for the treatment of
cancer. We seek to improve the performance and commercial potential of existing treatments by
addressing limitations associated principally with their safety and use. We have devoted
substantially all of our resources to research and development or to acquisition of our product
candidates. We have not yet marketed or sold any products or generated any significant revenue. Our
lead product candidates, ANX-530 and ANX-514, are novel emulsion formulations of currently marketed
chemotherapy drugs. However, due to our immediate need to raise additional capital to continue our
business, we have discontinued substantially all of our development activities and fundamental
business operations to conserve cash while we pursue financing alternatives, evaluate strategic
options, including the sale or exclusive license of one or more of our product candidate programs,
a strategic business merger and other similar transactions, and consider whether to liquidate our
assets, wind-up our operations and distribute any remaining cash to our stockholders.
Our business was incorporated in Delaware in December 1995. In October 2000, we merged our
wholly-owned subsidiary, Biokeys Acquisition Corp., with and into Biokeys, Inc. and changed our
name to Biokeys Pharmaceuticals, Inc. In May 2003, we merged Biokeys, Inc., our wholly-owned
subsidiary, with and into us and changed our name to ADVENTRX Pharmaceuticals, Inc. In July 2004,
we formed a wholly-owned subsidiary, ADVENTRX (Europe) Ltd., in the United Kingdom primarily to
facilitate conducting clinical trials in the European Union and to obtain favorable pricing for
discussions with the European Medicines Agency. In April 2006, we acquired SD Pharmaceuticals, Inc.
as a wholly-owned subsidiary. Our executive offices are located at 6725 Mesa Ridge Road, Suite 100,
San Diego, California 92121, and our telephone number is (858) 552-0866. Our corporate website is
located at www.adventrx.com. We make available free of charge through our Internet website our
annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and
amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the SEC. Information on our website does
not constitute part of this prospectus or any prospectus supplement.
The Securities We May Offer
We may offer shares of our common stock and preferred stock, various series of debt securities
and warrants to purchase any of such securities, either individually or in units, with a total
value of up to $25,000,000 from time to time under this prospectus, together with any applicable
prospectus supplement and related free writing prospectus, at prices and on terms to be determined
by market conditions at the time of offering. If we issue any debt securities at a discount from
their original stated principal amount, then, for purposes of calculating the total dollar amount
of all securities issued under this prospectus, we will treat the initial offering price of the
debt securities as the total original principal amount of the debt securities. Each time we offer
securities under this prospectus, we will provide offerees with a prospectus supplement that will
describe the specific amounts, prices and other important terms of the securities being offered,
including, to the extent applicable:
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maturity, if applicable; |
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original issue discount, if any; |
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rates and times of payment of interest or dividends, if any; |
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redemption, conversion, exchange or sinking fund terms, if any; |
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conversion or exchange prices or rates, if any, and, if applicable, any provisions
for changes to or adjustments in the conversion or exchange prices or rates and in the
securities or other property receivable upon conversion or exchange; |
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ranking; |
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restrictive covenants, if any; |
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voting or other rights, if any; and |
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important United States federal income tax considerations. |
A prospectus supplement and any related free writing prospectus that we may authorize to be
provided to you may also add, update or change information contained in this prospectus or in
documents we have incorporated by reference. However, no prospectus supplement or free writing
prospectus will offer a security that is not registered and described in this prospectus at the
time of the effectiveness of the registration statement of which this prospectus is a part.
We may sell the securities to or through underwriters, dealers or agents or directly to
purchasers. We, as well as any agents acting on our behalf, reserve the sole right to accept and
to reject in whole or in part any proposed purchase of securities. Each prospectus supplement will
set forth the names of any underwriters, dealers or agents involved in the sale of securities
described in that prospectus supplement and any applicable fee, commission or discount arrangements
with them, details regarding any over-allotment option granted to them, and net proceeds to us.
The following is a summary of the securities we may offer with this prospectus.
Common Stock
We currently have authorized 200,000,000 shares of common stock, par value $0.001 per share.
We may offer shares of our common stock either alone or underlying other registered securities
convertible into or exercisable for our common stock. Holders of our common stock are entitled to
such dividends as our board of directors may declare from time to time out of legally available
funds, subject to the preferential rights of the holders of any shares of our preferred stock that
are outstanding or that we may issue in the future. Currently, we do not pay any dividends. Each
holder of our common stock is entitled to one vote per share. In this prospectus, we provide a
general description of, among other things, the rights and restrictions that apply to holders of
our common stock.
Preferred Stock
We currently have authorized 1,000,000 shares of preferred stock, par value $0.001 per share,
none of which are outstanding. Under our certificate of incorporation, our board of directors has
the authority to issue shares of our preferred stock in one or more series and to fix or alter the
rights, preferences, privileges and restrictions granted to or imposed upon any series of preferred
stock. The particular terms of each class or series of preferred stock, including redemption
privileges, liquidation preferences, voting rights, dividend rights and/or conversion rights, will
be more fully described in the applicable prospectus supplement relating to the preferred stock
offered thereby.
The rights, preferences, privileges and restrictions granted to or imposed upon any series of
preferred stock that we offer and sell under this prospectus and applicable prospectus supplements
will be set forth in a certificate of designation relating to the series. We will incorporate by
reference into the registration statement of which this prospectus is a part the form of any
certificate of designation that describes the terms of the series of preferred stock we are
offering before the issuance of shares of that series of preferred stock. You should read to read
any
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prospectus supplement and any free writing prospectus that we may authorize to be provided to
you related to the series of preferred stock being offered, as well as the complete certificate of
designation that contains the terms of the applicable series of preferred stock.
Debt Securities
We may offer general debt obligations, which may be secured or unsecured, senior or
subordinated and convertible into shares of our common stock. In this prospectus, we refer to the
senior debt securities and the subordinated debt securities together as the debt securities. We
may issue debt securities under a note purchase agreement or under an indenture to be entered
between us and a trustee; a form of the indenture is included as an exhibit to the registration
statement of which this prospectus is a part. The indenture does not limit the amount of
securities that may be issued under it and provides that debt securities may be issued in one or
more series. The senior debt securities will have the same rank as all of our other indebtedness
that is not subordinated. The subordinated debt securities will be subordinated to our senior debt
on terms set forth in the applicable prospectus supplement. In addition, the subordinated debt
securities will be effectively subordinated to creditors and preferred stockholders of our
subsidiaries. Our board of directors will determine the terms of each series of debt securities
being offered. This prospectus contains only general terms and provisions of the debt securities.
The applicable prospectus supplement will describe the particular terms of the debt securities
offered thereby. You should read any prospectus supplement and any free writing prospectus that we
may authorize to be provided to you related to the series of debt securities being offered, as well
as the complete note agreements and/or indentures that contain the terms of the debt securities.
Forms of indentures have been filed as exhibits to the registration statement of which this
prospectus is a part, and supplemental indentures and forms of debt securities containing the terms
of debt securities being offered will be incorporated by reference into the registration statement
of which this prospectus is a part from reports we file with the SEC.
Warrants
We may offer warrants for the purchase of shares of our common stock or preferred stock or of
debt securities. We may issue the warrants by themselves or together with preferred stock, common
stock or debt securities, and the warrants may be attached to or separate from any offered
securities. Each series of warrants will be issued under a separate warrant agreement to be
entered into between us and the investors or a warrant agent. Our board of directors will
determine the terms of the warrants. This prospectus contains only general terms and provisions of
the warrants. The applicable prospectus supplement will describe the particular terms of the
warrants being offered thereby. You should read any prospectus supplement and any free writing
prospectus that we may authorize to be provided to you related to the series of warrants being
offered, as well as the complete warrant agreements that contain the terms of the warrants.
Specific warrant agreements will contain additional important terms and provisions and will be
incorporated by reference into the registration statement of which this prospectus is a part from
reports we file with the SEC.
Units
We may offer units consisting of our common stock or preferred stock, debt securities and/or
warrants to purchase any of these securities in one or more series. We may evidence each series of
units by unit certificates that we will issue under a separate agreement. We may enter into unit
agreements with a unit agent. Each unit agent will be a bank or trust company that we select. We
will indicate the name and address of the unit agent in the applicable prospectus supplement
relating to a particular series of units. This prospectus contains only a summary of certain
general features of the units. The applicable prospectus supplement will describe the particular
features of the units being offered thereby. You should read any prospectus supplement and any free
writing prospectus that we may authorize to be provided to you related to the series of units being
offered, as well as the complete unit agreements that contain the terms of the units. Specific unit
agreements will contain additional important terms and provisions and will be incorporated by
reference into the registration statement of which this prospectus is a part from reports we file
with the SEC.
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RISK FACTORS
Investing in our securities involves a high degree of risk. You should carefully consider the
risk factors discussed below, together with all the other information contained or incorporated by
reference in this prospectus, as may be updated by our subsequent filings under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and the risk factors and other information
contained in any applicable prospectus supplement and in any related free writing prospectus in
connection with a specific offering, and in the documents incorporated herein or therein before
deciding whether to purchase any of the securities being registered pursuant to the registration
statement of which this prospectus is a part. Each of the risk factors could adversely affect our
business, operating results and financial condition, as well as adversely affect the value of an
investment in our securities, and the occurrence of any of these risks might cause you to lose all
or part of your investment.
RISKS RELATED TO OUR BUSINESS
Risks Related to Our Financial Performance, Operations and Ability to Continue as a Going Concern
We have incurred losses since our inception, we expect our operating expenses to continue to exceed
our revenues for the foreseeable future and we may never generate revenues sufficient to achieve
profitability.
We are a development stage company and have not generated sustainable revenues from operations or
been profitable since inception, and it is possible we will never achieve profitability. We have
devoted our resources to developing a new generation of therapeutic products, but such products
cannot be marketed until the regulatory process is completed and governmental approvals have been
obtained. Accordingly, there is no current source of revenues from operations, much less profits,
to sustain our present activities, and no revenues from operations will likely be available until,
and unless, our product candidates are approved by the U.S. Food and Drug Administration, or FDA,
or other regulatory agencies and successfully marketed, either by us or a partner, an outcome which
we are not able to guarantee.
Our financial resources are limited, we will require substantial additional funding to continue our
business, and, if we are unable to raise sufficient additional capital, we may cease operating as a
going concern and liquidate our assets.
We have experienced significant operating losses in funding the development of our product
candidates, accumulating operating losses totaling approximately $141.7 million as of March 31,
2009, and we expect to continue to incur substantial operating losses for the foreseeable future,
even if we or a future partner of ours is successful in advancing our product candidates to market.
As of March 31, 2009, we had approximately $5.3 million in cash and cash equivalents and $2.8
million in working capital and we do not expect to generate positive net cash flows for the
foreseeable future. While we have discontinued substantially all of our development activities and
fundamental business operations, we expect to incur substantial costs in connection with
evaluating, negotiating and consummating capital-raising and/or strategic transactions or
liquidating our assets and winding-up our operations. We cannot currently predict the extent of
these costs. Even if we incur costs in pursuing, evaluating and negotiating particular
capital-raising and/or strategic transactions, our efforts may not prove successful. Accordingly,
we do not believe we can provide a reasonable estimate of the rate of utilization of our cash
resources in the near term. However, excluding the potentially significant costs associated with
evaluating, negotiating and consummating capital-raising and/or strategic transactions or
liquidating our assets and winding-up our operations, we anticipate that our cash and cash
equivalents as of March 31, 2009 will be sufficient to permit us to conduct our business through at
least September 30, 2009. We will need to raise substantial additional capital to continue our
business after this period.
Our independent auditors report for the year ended December 31, 2008 includes an explanatory
paragraph stating that our recurring losses from operations and negative cash flows raise
substantial doubt about our ability to continue as a going concern. If we are unable to obtain
additional financing or consummate a strategic transaction on commercially reasonable terms, our
business, financial condition and results of operations will be materially and adversely affected
and we may be unable to continue as a going concern. If we are unable to continue as a going
concern, we may have to liquidate our assets and may receive less than the value at which those
assets are carried on our financial statements. Based on our current working capital and estimated
costs of implementing an orderly liquidation of our assets, we do not expect that there will be
material cash available for distribution to our stockholders.
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We have been evaluating and continue to evaluate strategic options, including the sale or exclusive
license of one or more of our product candidate programs, a strategic business merger and similar
transactions. However, discussions with potential strategic transaction partners have been
unsuccessful, protracted or on terms that we determined were unacceptable. We intend to seek
funding during the second quarter of 2009 in order to continue our business and resume certain of
our development activities and fundamental business operations, including activities related to
submitting a new drug application, or NDA, to obtain approval of the FDA for marketing ANX-530 in
the United States, or U.S. Our future expenditures on our programs are subject to many
uncertainties, including whether our product candidates will be developed with a partner or
independently. Our future capital requirements will depend on, and could increase significantly as
a result of, many factors, including:
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the costs of seeking regulatory approval for our lead product candidates, ANX-530 and
ANX-514, including any bioequivalence or clinical studies, process development, scale-up
and other manufacturing activities, or other work required to achieve such approval, as
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the timing and terms of any collaborative, licensing and other strategic arrangements
that we may establish; |
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the cost related to establishing or contracting for sales and marketing capabilities and
other commercial capabilities; |
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the scope, prioritization and number of development and/or commercialization programs we
pursue and the rate of progress and costs with respect to such programs; |
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the extent to which we will need to rebuild our workforce, which currently consists of
three full-time employees, and the cost involved in hiring, training and incentivizing new
employees; |
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the extent to which we invest in or acquire new technologies, products or businesses; |
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the effect of competing technological and market developments; and |
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the cost involved in establishing, enforcing or defending patent claims and other
intellectual property rights. |
We intend to seek additional funding through public or private sales of our equity securities, debt
financings, collaborations, licensing arrangements or other strategic transactions. However, we may
not be able to obtain sufficient additional funding on satisfactory terms, if at all. We believe
global economic conditions, including the credit crisis, have adversely impacted our ability to
raise additional capital and may continue to do so.
Our ability to raise capital may be limited by applicable laws and regulations.
Under current SEC regulations, we will not be eligible to use a registration statement on Form S-3
for primary offerings of our common stock or securities convertible into our common stock unless
our common stock is listed and registered on a national securities exchange. The NYSE Amex will
review the appropriateness of continued listing of any issuer that falls below the exchanges
continued listing standards and may, in its discretion, at any time, and without notice, suspend
dealings in, or may remove any security from, listing privileges. The NYSE Amex will normally
consider suspending dealings in, or removing from the list, securities of an issuer which has
stockholders equity of less than $6.0 million if such issuer has sustained losses from continuing
operations and/or net losses in its five most recent fiscal years. As of March 31, 2009, we do not
meet this continued listing standard. As of May 20, 2009, we have not received any
notice from the NYSE Amex of its intention to suspend dealings in, or remove from listing, our
common stock. However, we may receive such notice at any time. If our common stock were delisted
from the NYSE Amex, our ability to raise capital on terms and conditions we deem acceptable, if at
all, may be materially impaired. Currently, we do not anticipate being eligible to register and
list our common stock on any other national securities exchange.
In addition, even if we maintain our listing with the NYSE Amex, under current SEC regulations, at
any time during
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which the aggregate market value of our common stock held by non-affiliates, or public float, is
less than $75.0 million (calculated as set forth in Form S-3 and SEC rules and regulations), the
amount we can raise through primary offerings of our securities in any twelve-month period using a
registration statement on Form S-3 will be limited to an aggregate of one-third of our public
float. As of May 20, 2009, our public float was
approximately 81.6 million shares, the value of
which was approximately $10.7 million based upon the closing price of our common stock of
$0.1310
on such date. As of May 20, 2009, the value of one-third of our public float calculated on the
same basis was approximately $3.6 million. Alternative means of raising capital through sales of
our securities, including through the use of a Form S-1 registration statement, may be more costly
and time-consuming.
Even if we maintain our listing with the NYSE Amex, our ability to timely raise sufficient capital
may be limited by the exchanges requirements relating to stockholder approval for transactions
involving the issuance of our common stock or securities convertible into our common stock. For
instance, the NYSE Amex requires that we obtain stockholder approval of any transaction involving
the sale, issuance or potential issuance by us of our common stock (or securities convertible into
our common stock) at a price less than the greater of book or market value, which (together with
sales by our officers, directors and principal stockholders) equals 20% or more of our presently
outstanding common stock, unless the transaction is deemed a public offering by the NYSE Amex
staff. Based on our outstanding common stock and closing price as of
May 20, 2009, we could not
raise more than approximately $2.4 million without stockholder approval, unless the transaction is
deemed a public offering or does not involve the sale, issuance or potential issuance by us of our
common stock (or securities convertible into our common stock) at a price less than the greater of
book or market value.
Obtaining stockholder approval is a costly and time-consuming process. If we are required to obtain
stockholder approval, we would expect to spend substantial additional money and resources. In
addition, seeking stockholder approval would delay our receipt of otherwise available capital,
which may materially and adversely affect our ability to continue as a going concern, and there is
no guarantee our stockholders would ultimately approve a proposed transaction. A public offering
under NYSE Amex rules typically involves broadly announcing the proposed transaction, which often
times has the effect of depressing the issuers stock price. Accordingly, the price at which we
could sell our securities in a public offering may be less and the dilution existing stockholders
experience may in turn be greater than if we were able to raise capital through other means.
Raising additional capital may cause dilution to our existing stockholders, require us to
relinquish proprietary rights or restrict our operations.
We may raise additional capital at any time and may do so through one or more financing
alternatives, including public or private sales of our equity securities, debt financings,
collaborations, licensing arrangements or other strategic transactions. Each of these financing
alternatives carries certain risks. Raising capital through the issuance of common stock may
depress the market price of our stock and may substantially dilute our existing stockholders. If we
instead seek to raise capital through strategic transactions, such as licensing arrangements or
sales of one or more of our technologies or product candidates, we may be required to relinquish
valuable rights. For example, any licensing arrangement would likely require us to share a
significant portion of any revenues generated by our licensed technologies with our licensees.
Additionally, the development of any product candidates licensed or sold to third parties will no
longer be in our control and thus we may not realize the full value of any such product candidates.
Debt financings could involve covenants that restrict our operations. These restrictive covenants
may include limitations on additional borrowing and specific restrictions on the use of our assets,
as well as prohibitions on our ability to create liens or make investments and may, among other
things, preclude us from making distributions to stockholders (either by paying dividends or
redeeming stock) and taking other actions beneficial to our stockholders. In addition, investors
could impose more one-sided investment terms and conditions on companies that have or are perceived
to have limited remaining funds or limited ability to raise additional funds. As we continue to use
our cash and cash equivalents to fund our operations, it will likely become increasingly difficult
to raise additional capital on commercially reasonable terms, or at all.
If we are unable to raise sufficient additional capital, we may be not be able to resume our
development programs or we may be forced to partner product candidates at inopportune times or
pursue less-expensive but higher-risk development paths.
Currently, we have suspended substantially all of our development activities and fundamental
business operations and we have reduced our workforce to three full-time employees in order to
provide additional time to consummate
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a strategic transaction or otherwise obtain financing. If we are not able to raise adequate funds
to resume our development programs and operations at levels we believe would enable us to
capitalize on our assets, we may have to abandon some or all of them altogether or attempt to
continue our development and commercialization efforts by entering into arrangements with partners
or others that, if available at all, may not be on favorable terms and may require us to relinquish
some or all of our rights to our product candidates or the financial benefits thereof or we may
determine to liquidate our assets and may receive less than the value at which those assets are
carried on our financial statements.
To conserve funds, we may pursue less expensive but higher-risk development paths. For instance, we
may limit our process development activities to the minimum we feel is sufficient to support our
development and commercialization goals, in particular, with respect to ANX-530. Process
development helps define the various parameters and specifications for manufacturing products at
commercial-scale. Without comprehensive process development activities, we may lack the information
necessary to develop an accurate validation plan to support an NDA and may be unable to
successfully manufacture at commercial scale. If we are unable to validate the manufacturing
processes included in an NDA, we may be required to amend the NDA, which could result in
substantial delays in commercializing the subject drug, as well as call into question our ability
to ultimately obtain marketing approval for that drug. In addition, we would expect to spend
significant funds undertaking the activities necessary to support an amendment to an NDA.
We may seek to merge with or be acquired by another company and that transaction may adversely
affect our business and the value of our securities.
Because of our limited ability to raise funds, including for the reasons noted above, we may seek
to merge with another company with a stronger cash position, complementary work force or product
candidate portfolio or for other reasons. We believe the market price for our common stock may not
accurately reflect the value of our business. While we will continue to seek to maximize the value
of our business to our stockholders, the most attractive option for doing so may require us to
consummate a transaction involving an exchange of our common stock with that of another company.
There are numerous risks associated with merging or being acquired. These risks include, among
others, incorrectly assessing the quality of a prospective acquirer or merger-partner, encountering
greater than anticipated costs in integrating businesses, facing resistance from employees and
being unable to profitably deploy the assets of the new entity. The operations, financial
condition, and prospects of the post-transaction entity depend in part on our and our
acquirer/merger-partners ability to successfully integrate the operations related to our product
candidates, business and technologies. We may be unable to integrate operations successfully or to
achieve expected cost savings and any cost savings which are realized may be offset by losses in
revenues or other charges to operations. As a result, our stockholders may not realize the full
value of their investment.
If we fail to maintain registration of the shares of common stock issued or issuable pursuant to
the exercise of warrants we issued in our July 2005 private placement, we will be required to pay
the holders of those securities liquidated damages, which could be material in amount.
The terms of the securities purchase agreement that we entered into in connection with our July
2005 private placement require us to pay liquidated damages to the purchasers of those securities
in the event any shares issued or issuable pursuant to the exercise of warrants we issued in the
private placement cannot be resold pursuant to our registration statement on Form S-3 (No.
333-127857) filed with and declared effective by the SEC on September 2, 2005. We refer to this as
a maintenance failure. For each 30-day period or portion thereof during which a maintenance failure
remains uncured, we are obligated to pay each purchaser an amount in cash equal to 1% of the
purchasers aggregate purchase price for any shares of common stock or shares of common stock
issuable upon exercise of warrants then held by the purchaser (pro rated for any period less than a
month), increasing by an additional 1% with regard to each additional 30-day period or portion
thereof until the maintenance failure is cured. There is no cap with respect to the total amount of
these liquidated damages. The aggregate gross proceeds from our July 2005 private placement were
approximately $20 million. We are required to maintain the registration statement until the earlier
of the date (i) all of the securities issued in our July 2005 private placement have been resold
and (ii) each purchaser can resell the securities pursuant to Rule 144 under the Securities Act of
1933, as amended, without regard to the adequate current public information, volume, manner of sale
or notice filing restrictions. The amount of these liquidated damages could be substantial and
could have a material adverse effect on our financial condition.
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For additional information, see Note 11 of the Notes to Consolidated Financial Statements,
Registration Payment Arrangement, of our annual report on Form 10-K for the year ended December
31, 2008.
We may be unable to retain the services of key personnel, and, even if we are successful in raising
additional funds to continue our business and resume development and commercialization of our
product candidates, we may not be successful in rebuilding our workforce to carry out those
activities.
As of May 20, 2009, we had only three full-time employees and we depend on the services of
certain of these employees to continue our business. We do not have a chief executive officer or
chief financial officer. Our Chief Business Officer and Senior Vice President is currently acting
as our interim principal executive officer and a member of our board of directors is currently
acting as our interim principal financial and accounting officer. To the extent we are successful
in raising additional funds to continue our business and resume our development and
commercialization activities, we may need to expand our managerial, financial, regulatory, research
and development, manufacturing, commercial, quality, compliance and other resources in order to
manage our operations, submit applications to and respond to inquiries from the FDA and, if
approved, commercialize our products. We do not expect that our current management and personnel,
systems and facilities will be adequate to support these activities.
The success of our business will depend, in part, on our ability to attract and retain highly
qualified management, scientific and other personnel, and on our ability to develop and maintain
important relationships with respected service providers and industry-leading consultants and
advisors. Competition for these types of personnel and relationships is intense from numerous
pharmaceutical and biotechnology companies, universities and other research institutions,
particularly in the San Diego, California area. In connection with the cost-cutting measures we
implemented in October 2008, January 2009 and March 2009, we eliminated, among others, our
scientific staff and our manufacturing and regulatory personnel, who had a deep background in our
product candidates and our research and development programs. Recruiting and retaining employees,
including senior-level personnel, with relevant product development experience in cancer and
process development experience with emulsified cytotoxic drugs may be costly and time-consuming.
We have historically provided incentive compensation to our officers and employees in part through
grants of stock options and, more recently, restricted stock units under our equity compensation
plans. Decreases in the trading price of our common stock, however, have substantially reduced the
value of equity compensation awards made to our officers and employees in prior years and such
awards may not provide adequate compensation to retain such individuals. Our ability to provide
competitive compensation to our officers and employees may also be adversely affected by our
limited capital resources and anticipated need to raise substantial additional capital to continue
our business. We cannot ensure that we will be able to retain existing employees or attract and
retain additional skilled personnel on acceptable terms as a result of these factors and,
accordingly, we may not achieve our development and commercialization goals.
We have significant incentive and may, under certain circumstances, have significant severance and
other obligations under agreements with certain of our current officers.
In January 2009, we entered into incentive and retention agreements with each of our current
officers that, except in the event of a termination for cause, effectively guarantee their
respective salaries through specified dates (either June 30, 2009 or September 30, 2009). Our
aggregate contractual obligation under these agreements, determined as of May 20, 2009, was
approximately $225,000. We believe these agreements were necessary to incentivize and retain these
key employees and reinforce their dedication to us during a period when they would otherwise likely
seek alternative employment. In addition, we may determine to enter into new incentive and
retention and/or severance agreements with our current officers under which we may agree to
effectively guarantee their respective salaries through specified extended dates and/or provide for
cash severance payments and/or the continuation of health insurance and other benefits upon
termination by us without cause or involuntary termination by the officer for good reason, which
may or may not be conditioned upon a change in control. Our contractual responsibility for our
current and any future incentive and/or severance obligations may cause us to cease or curtail our
operations at an earlier date than would otherwise be the case if we were not required to satisfy
these obligations. In addition, part or all of the proceeds from a future capital raising
transaction may be used to satisfy these obligations.
The use of our net operating loss carryforwards may be limited.
Net operating loss carryforwards may expire and not be used. As of December 31, 2008, we had
generated federal
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net operating loss carryforwards of approximately $90.4 million and state net operating loss
carryforwards of approximately $41.4 million. Federal net operating loss carryforwards have a
20-year carryforward period and begin to expire in 2020. State net operating loss carryforwards
have a ten year carry forward period and begin to expire in 2012.
Pursuant to Section 382 of the Internal Revenue Code, annual use of our net operating loss
carryforwards may be limited in the event a cumulative change in ownership of more than 50 percent
occurs within a three-year period. We determined that, as of January 1, 2009, no such ownership
change had occurred. However, future financing events may cause changes in ownership under Section 382, which
could cause our net operating loss carryforwards to be subject to limitations and restrictions. If
a change in ownership were to occur, our net operating loss carryforwards could be eliminated or
restricted.
If we fail to maintain an effective system of internal control over financial reporting, we may not
be able to accurately report our financial results. As a result, current and potential investors
could lose confidence in our financial reporting, which could harm our business and have an adverse
effect on our stock price.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to annually furnish a
report by our management on our internal control over financial reporting. Such report must
contain, among other matters, an assessment by our principal executive officer and our principal
financial officer on the effectiveness of our internal control over financial reporting, including
a statement as to whether or not our internal control over financial reporting is effective as of
the end of our fiscal year. This assessment must include disclosure of any material weakness in our
internal control over financial reporting identified by management. In addition, under current SEC
rules, we will be required to obtain an attestation from our independent registered public
accounting firm as to our internal control over financial reporting for our annual report on Form
10-K for our fiscal year ending December 31, 2009. Performing the system and process documentation
and evaluation needed to comply with Section 404 is both costly and challenging. We have in the
past discovered, and may in the future discover, areas of internal controls that need improvement.
For example, during the fourth quarter of 2008, we discovered that we did not correctly apply
generally accepted accounting principles as they related to accounting for warrant liability
because our accounting staff did not have adequate training or expertise, and determined that we
had a material weakness in our internal control over financial reporting as of December 31, 2007.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over
financial reporting, such that there is a reasonable possibility that a material misstatement of
our annual or interim financial statements will not be prevented or detected on a timely basis. For
a detailed description of this material weakness and our remediation of this material weakness, see
Part II Item 9A(T) Controls and Procedures of our annual report on Form 10-K for the year
ended December 31, 2008. If additional material weaknesses are identified in our internal control
over financial reporting, neither our management nor our independent registered public accounting
firm will be able to assert that our internal control over financial reporting and/or our
disclosure controls and procedures are effective, and we could be required to further implement
expensive and time-consuming remedial measures. We cannot be certain that any measures we take will
ensure that we implement and maintain adequate internal control over financial reporting and that
we will remediate the material weakness. As a result of recent reductions in our workforce and
other personnel departures, we have experienced substantial turnover in our personnel responsible
for performing activities related to our internal control over financial reporting. We have used
third-party contractors to maintain effective internal control over financial reporting during this
turn-over. However, if we fail to maintain effective internal control over financial reporting
and/or disclosure controls and procedures we could lose investor confidence in the accuracy and
completeness of our financial reports, which could have a material adverse effect on our stock
price.
Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic
event.
Our corporate headquarters are located at a single business park in San Diego, California.
Important documents and records, including copies of our laboratory books and records for our
product candidates, are located at our facilities and we depend on our facilities for the continued
operation of our business. Natural disasters and other catastrophic events, such as wildfires and
other fires, earthquakes and extended power interruptions, which have impacted San Diego businesses
in the past, and terrorist attacks, drought or flood, could significantly disrupt our operations
and result in additional, unplanned expense. As a small company, we have limited capability to
establish and maintain a comprehensive disaster recovery program and, accordingly, we do not have a
formal business continuity or disaster recovery plan, and any natural disaster or catastrophic
event could delay our development and commercialization
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efforts. Even though we believe we carry commercially reasonable insurance, we might suffer losses
that exceed the coverage available under these insurance policies. In addition, we are not insured
against terrorist attacks or earthquakes.
Risks Related to Drug Development and Commercialization
Further testing of and/or validation of manufacturing processes with respect to our product
candidates is required and regulatory approval may be delayed or denied, which would limit or
prevent us from marketing our product candidates and significantly impair our ability to generate
revenues.
Human pharmaceutical products generally are subject to rigorous preclinical testing and clinical
trials and other approval procedures mandated by the FDA and foreign regulatory authorities.
Various federal and foreign statutes and regulations also govern or influence the manufacturing,
safety, labeling, storage, record keeping and marketing of pharmaceutical products. The process of
obtaining these approvals and the subsequent compliance with appropriate U.S. and foreign statutes
and regulations is time-consuming and requires the expenditure of substantial resources. In
addition, these requirements and processes vary widely from country to country.
To varying degrees based on the regulatory plan for each product candidate, the effect of
government regulation and the need for FDA and other regulatory agency approval will delay
commercialization of our product candidates, impose costly procedures upon our activities, and put
us at a disadvantage relative to larger companies with which we compete. There can be no assurance
that FDA or other regulatory approval for any product candidates developed by us will be granted on
a timely basis, or at all. Even though the FDA has confirmed the appropriateness of a Section
505(b)(2) regulatory path for ANX-530 and ANX-514, the FDAs views may change. If the FDA requires
the longer-term regulatory approval pathway associated with traditional drug development for
ANX-530 and ANX-514, we may determine that the associated time and cost is not financially
justifiable and, as a result, discontinue those programs. If we discontinue the development of one
or both of these product candidates, our business and stock price may suffer.
In connection with any NDA that we file under Section 505(b)(2) of the Federal Food, Drug and
Cosmetic Act, or FDCA, we may be required to notify third parties that we have certified to the FDA
that any patents listed for the approved drug in the FDAs Orange Book publication are invalid or
will not be infringed by the manufacture, use or sale of our drug. If the third-party files a
patent infringement lawsuit against us within 45 days of its receipt of notice of our
certification, the FDA is automatically prevented from approving our Section 505(b)(2) NDA until,
subject to certain adjustments, the earliest of 30 months, expiration of the patent, settlement of
the lawsuit or a decision in the infringement case that is favorable to us. Accordingly, we may
invest significant time and expense in the development of our product candidates, including ANX-530
and ANX-514, only to be subject to significant delay and patent litigation before our products may
be commercialized.
We may not achieve our projected development and commercialization goals in the time frames we
announce. Delays in the commencement or completion of pre/non-clinical testing, bioequivalence or
clinical trials or manufacturing, regulatory or launch activities could result in increased costs
to us and delay or limit our ability to generate revenues.
We set goals for and make public statements regarding our estimates of the timing of the
accomplishment of objectives material to successful development and commercialization of our
product candidates. The actual timing of these events can vary dramatically due to any number of
factors, including delays or failures in our pre/non-clinical testing, bioequivalence and clinical
trials and manufacturing, regulatory and launch activities and the uncertainties inherent in the
regulatory approval process. While our regulatory strategy for ANX-530 and ANX-514 has been to
demonstrate the pharmacokinetic equivalence of each to the currently approved reference product in
small, bioequivalence trials in humans, we or our partner may determine to conduct clinical studies
to support uses in new indications or other label changes or for other reasons.
We conduct pre/non-clinical activities in the course of our development programs, including in
connection with the manufacture of our product candidates, and in response to requests by
regulatory authorities, as well as for other reasons. Delays in our pre/non-clinical activities
could occur for a number of reasons, including:
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delays in reaching agreement on acceptable terms with prospective contract research
organizations, or CROs, and contract manufacturing organizations, or CMOs, the terms of
which can be subject to extensive negotiation and may vary significantly among different
CROs and CMOs; |
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failures on the part of our CROs and CMOs in developing procedures and protocols or
otherwise conducting activities on timeframes requested by us; |
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changes in regulatory requirements or other standards or guidance relating to
preclinical testing, including testing of pharmaceutical products in animals; |
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a lack of availability of animals that are suitable for the types of studies we plan to
conduct; |
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a lack of availability of capacity at our CMOs, or of the component materials, including
the active pharmaceutical ingredient, or API, or related materials, including vials and
stoppers, necessary to manufacture our product candidates or products; and |
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unforeseen results of preclinical or nonclinical testing that require us to amend study
or test designs or delay future testing or bioequivalence or clinical trials and related
regulatory filings. |
In addition, we do not know whether planned bioequivalence or clinical trials will commence on time
or be completed on schedule, if at all. The commencement and completion of trials can be delayed
for a variety of reasons, including delays related to:
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obtaining regulatory approval to commence a trial; |
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identifying appropriate trial sites and reaching agreement on acceptable terms with
prospective CROs, trial sites and investigators, the terms of which can be subject to
extensive negotiation and may vary significantly among different CROs, trial sites and
investigators; |
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manufacturing sufficient quantities of a product candidate; |
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obtaining institutional review board, or IRB, approval to conduct a trial at a
prospective site; |
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recruiting and enrolling patients to participate in trials for a variety of reasons,
including competition from other clinical trials for the same indication as our product
candidates and the perception that the design of a trial or the proposed treatment regimen
is less beneficial to patients than available alternatives; and |
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retaining patients who have initiated a trial but may be prone to withdraw due to side
effects from the therapy, lack of efficacy or personal issues, or who are lost to further
follow-up. |
For example, in October 2007, we announced results of our phase 2b clinical trial of ANX-510, or
CoFactor, for the first-line treatment of metastatic colorectal cancer, which demonstrated that the
CoFactor/5-FU arm did not demonstrate statistically significant improved safety in the trials
primary endpoint. In November 2007, we announced that we would discontinue enrolling patients in
our phase 3 clinical trial of CoFactor for the first-line treatment of metastatic colorectal cancer
and, in October 2008, we announced that we had discontinued active work on all product candidates
other than ANX-530 and ANX-514, including CoFactor. In addition, in May 2009, we announced that we
did not meet the primary endpoint in our bioequivalence study of ANX-514, resulting in additional
uncertainty around the cost and timeline to obtaining FDA approval for that product candidate.
In addition, a trial may be suspended or terminated by us, the FDA or other regulatory authorities
due to a number of factors, including:
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failure to conduct the trial in accordance with regulatory requirements or the trials
protocol; |
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inspection of trial operations or trial sites by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold; |
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unforeseen safety issues; or |
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lack of adequate funding to continue the trial. |
Additionally, changes in regulatory requirements and guidance relating to clinical trials may occur
and we may need to amend clinical trial protocols to reflect these changes. Amendments may require
us to resubmit our clinical trial protocols to institutional review boards, or IRBs, for
reexamination or renegotiate terms with CROs, trial sites and clinical investigators, all of which
may impact the costs, timing or successful completion of a clinical trial.
There can be no assurance that our preclinical and nonclinical testing and bioequivalence and/or
clinical trials will commence or be completed, that we will make regulatory submissions or receive
regulatory approvals as planned or that we will be able to adhere to our current schedule for the
development or commercialization of any of our product candidates. If we experience delays in
completion of, or if we terminate, our bioequivalence or clinical trials or preclinical and
nonclinical testing, the commercial prospects for our product candidates will be harmed, and our
ability to generate product revenues will be delayed. In addition, many of the factors that cause,
or lead to, a delay in the commencement or completion of bioequivalence or clinical trials or
preclinical and nonclinical testing may also ultimately lead to the denial of regulatory approval
of a product candidate. Even if we are able to ultimately commercialize our product candidates,
other therapies for the same indications may have been introduced to the market and established a
competitive advantage.
Positive results in our preclinical testing and/or bioequivalence trials do not ensure that future
bioequivalence or clinical trials will be successful or that our product candidates will receive
the regulatory approvals necessary for their commercialization.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we
must demonstrate through preclinical testing and bioequivalence or clinical trials that each
product is safe and effective for use in each target indication. Success in preclinical testing
and/or bioequivalence trials does not ensure that subsequent or large-scale trials will be
successful. Additionally, throughout development, we must provide adequate assurance to the FDA and
other regulatory authorities that we can consistently produce our product candidates in conformance
with current good manufacturing practices, or cGMP, and other regulatory standards. Bioequivalence
and clinical trial results are frequently susceptible to varying interpretations and regulatory
authorities may disagree on what are appropriate methods for analyzing data, any of which may
delay, limit or prevent regulatory approvals. For instance, with respect to our bioequivalence
trial of ANX-530, the FDA may perform its pharmacokinetic equivalence analysis based a patient
population other than the population on which we based our analysis, which may result in the FDA
determining that ANX-530 and Navelbine® are not bioequivalent, requiring that we evaluate
additional patients, re-perform the study or take other remedial action. In addition, the FDA may
inquire regarding the manufacturing source, in-process and product release specifications and
overall uniformity of reference product used in the bioequivalence trial of ANX-530, particularly
since it was conducted at sites in multiple countries, and we may be unable to provide
documentation satisfactory to the FDA with respect to such reference product, which may result in
the FDA requiring that we evaluate additional patients, re-perform the study or take other remedial
measures. Further, the ANX-530 bioequivalence trial was open-label, meaning
physician-investigators, as well as patients, may have been aware of which drug was being
administered. There is a risk of investigator bias in reporting adverse events as a result of the
studys open-label nature, including bias that increased the reporting of adverse events associated
with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530. With
respect to ANX-514, despite positive preclinical testing that indicated pharmacokinetic equivalence
between ANX-514 and the reference product, our bioequivalence trial of ANX-514 did not demonstrate
pharmacokinetic equivalence between ANX-514 and the reference product based on benchmark regulatory
standards.
The length of time necessary to complete bioequivalence or clinical trials and manufacturing
development work and to submit an application for marketing approval for a final decision by a
regulatory authority varies significantly and may be difficult to predict. In addition, delays or
rejections may be encountered based upon changes in FDA policy for drug approval during the period
of product development and FDA regulatory review of each submitted NDA. There is a significant risk
that any of our product candidates could fail to show satisfactory results in human trials, as was
the case in our bioequivalence study of ANX-514, or manufacturing development, and, as a result, we
may not continue their development. A failure to obtain requisite regulatory approvals or to obtain
approvals of the scope requested will delay or preclude us from marketing our products or limit the
commercial use of the products, and would have a material adverse effect on our business, financial condition and results of
operations.
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If any of our product candidates for which we receive regulatory approval do not achieve broad
market acceptance (including as a result of failing to differentiate our products from competitor
products or as a result of failing to obtain reimbursement rates for our products that are
competitive from the healthcare providers perspective), the revenues we generate from their sales
will be limited and our business may not be profitable.
Our success will depend in substantial part on the extent to which our products for which we obtain
marketing approval from the FDA and comparable foreign regulatory authorities are accepted by the
medical community and reimbursed by third-party payors, including government payors. The degree of
market acceptance will depend upon a number of factors, including, among other things:
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our products perceived advantages over existing treatment methods (including relative
convenience and ease of administration and prevalence and severity of any adverse side
effects); |
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claims or other information (including limitations or warnings) in our products
approved labeling; |
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reimbursement and coverage policies of government and other third-party payors; |
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pricing and cost-effectiveness; |
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in the U.S., the ability of group purchasing organizations, or GPOs (including
distributors and other network providers), to sell our products to their constituencies; |
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the establishment and demonstration in the medical community of the safety and efficacy
of our products and our ability to provide acceptable evidence of safety and efficacy; |
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availability of alternative treatments; and |
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the prevalence of off-label substitution of chemically equivalent products. |
We cannot predict whether physicians, patients, healthcare insurers or maintenance organizations,
or the medical community in general, will accept or utilize any of our products. If our products
are approved but do not achieve an adequate level of acceptance by these parties, we may not
generate sufficient revenues from these products to become or remain profitable. In addition, our
efforts to educate the medical community and third-party payors regarding the benefits of our
products may require significant resources and may never be successful.
Under our Section 505(b)(2) regulatory strategy for ANX-530 and ANX-514, because we anticipate
submitting Section 505(b)(2) NDAs based on pharmacokinetic data, our ability to differentiate our
products from competitor products will be limited unless the FDA allows us to include certain data
in our products labels. Even if our products demonstrate clinical or pharmacoeconomic benefits, we
may be unable to market our products based on these benefits.
If we fail to obtain a unique Healthcare Common Procedure Coding System, or HCPCS, product code for
ANX-530, it is unlikely we will be able to sell that product at a price that exceeds its
manufacturing, marketing and distribution costs. Even if we obtain separate HCPCS codes for our
products, if our products are perceived to provide little or no advantage relative to competitive
products or for other reasons, we may be required to price our products at levels that do not cover
our costs to manufacture, market and distribute the products or provide any profit, or to price our
products at levels at which they are not competitive.
We do not have manufacturing capabilities and are dependent on single source manufacturers and
suppliers for certain of our product candidates and their component materials, and the loss of any
of these manufacturers or suppliers, or their failure to provide us with an adequate supply of
products or component materials on commercially acceptable terms, or at all, could harm our
business.
We do not have any manufacturing capability. We rely on third-party manufacturers and component
materials suppliers for the manufacture of our product candidates for bioequivalence or clinical
trial purposes and we
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anticipate establishing relationships with third-party manufacturers and component materials
suppliers for the commercial production of our products. Currently we do not have any commercial
supply agreements or commitments with our third-party manufacturers or component suppliers, and we
cannot ensure that we will be able to establish relationships with these parties on commercially
acceptable terms, or at all. If we fail to establish and maintain such relationships, we expect it
would have a material and adverse effect on our operations. Even if we successfully establish
relationships with third-party manufacturers and component suppliers on commercially acceptable
terms, our manufacturers and suppliers may not perform as agreed or may terminate their agreements
with us. Because many of our single source suppliers provide manufacturing services to a number of
other pharmaceutical companies, our suppliers may experience capacity constraints or choose to
prioritize one or more of their other customers over us. Any significant problem that our single
source manufacturers or suppliers experience could delay or interrupt the supply to us of
bioequivalence or clinical trial materials or products until the manufacturer or supplier cures the
problem or until we locate an alternative source of supply, if an alternative source is available,
and, as a result, any such delay or interruption could materially and adversely affect our
development and commercial activities and operations.
For instance, ANX-530 is an emulsified cytotoxic product that must be aseptically-filled. There are
a limited number of CMOs capable and willing to manufacture this type of product at the commercial
scale at which we anticipate requiring in accordance with our marketing plans for ANX-530, which
will make identifying and establishing short- or long-term relationships with willing manufacturers
more difficult and provide them with substantial leverage over us in any negotiations. Furthermore,
certain of the component materials of ANX-530 are available only from a particular supplier, and
currently we do not have any short- or long-term agreements for the supply of those materials.
Even if we successfully establish a long-term relationship with our current CMO for ANX-530 on
commercially acceptable terms, our CMO may be unable to successfully and consistently manufacture
ANX-530 at commercial scale. We and this manufacturer have limited experience manufacturing
ANX-530, and the experience we and this manufacturer do have is limited to manufacturing a single
engineering batch. Because data from a single bioequivalence trial of ANX-530 may be sufficient to
support a Section 505(b)(2) NDA, our and our current contract manufacturers ability to gain
experience manufacturing ANX-530, in particular at various scales, has been limited. If our current
CMO is unable to manufacture ANX-530 successfully and consistently at commercial scale and within
established parameters, we may be unable to validate our manufacturing process, even if the FDA
other would approve our NDA, and therefore unable to sell ANX-530. Our current CMO has similarly
limited experience with ANX-514.
All manufacturers of our products and product candidates must comply with cGMP requirements
enforced by the FDA through its facilities inspection program, as well as applicable requirements
of foreign regulatory authorities. These requirements include quality control, quality assurance
and the maintenance of records and documentation. Manufacturers of our products and product
candidates may be unable to comply with these cGMP requirements and with other FDA, state and
foreign regulatory requirements. While we or our representatives generally monitor and audit our
manufacturers systems, we have little control over our manufacturers ongoing compliance with
these regulations and standards. A failure to comply with these requirements may result in fines
and civil penalties, suspension of production, suspension or delay in product approval, product
seizure or recall, or withdrawal of product approval.
Furthermore, the manufacture of pharmaceutical products requires significant expertise and capital
investment, including the development of advanced manufacturing techniques and process controls.
Manufacturers of pharmaceutical products often encounter difficulties in production, particularly
in scaling up initial production. These problems include difficulties with production costs and
yields, quality control, including stability of the product candidate and quality assurance testing
and shortages of qualified personnel.
If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with
their contractual obligations, our ability to provide product candidates to patients in our
bioequivalence or clinical trials may be jeopardized. Any delay or interruption in the supply of
supplies could delay the completion of our trials, increase the costs associated with maintaining
our development programs and, depending upon the period of delay, require us to commence new trials
at significant additional expense or terminate the trials completely. We cannot ensure that
manufacturing or quality control problems will not arise in connection with the manufacture of our
products or product candidates, or that third-party manufacturers will be able to maintain the
necessary governmental licenses
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and approvals to continue manufacturing such products or product candidates. Any of the above
factors could cause us to delay or suspend anticipated or on-going trials, regulatory submissions,
required approvals or commercialization of our product candidates, entail higher costs or result in
our being unable to effectively commercialize our products. Our dependence upon third parties for
the manufacture of our products and product candidates may adversely affect our future costs and
our ability to develop and commercialize our products and product candidates on a timely and
competitive basis.
If any of our product candidates should be approved, any problems or delays experienced in their
manufacturing processes may impair our ability to provide commercial quantities of the products,
which would limit our ability to sell the products and would adversely affect our business. It
could take significant time to redesign our manufacturing processes or identify alternative
suppliers in response to problems we may encounter as we manufacture our products, if such
alternative processes and suppliers are available at all. Even if we are able to identify
alternative suppliers, they may be unwilling to manufacture our products on commercially reasonable
terms. Neither ANX-530 nor ANX-514 have been manufactured at the scales we believe will be
necessary to maximize their commercial value to us and, accordingly, we may encounter difficulties
in production while scaling-up initial production and may not be successful at all in scaling-up
initial production.
Any new supplier of products or component materials, including API, would be required to qualify
under applicable regulatory requirements and would need to have sufficient rights under applicable
intellectual property laws to the method of manufacturing such products or ingredients. The FDA may
require us to conduct additional bioequivalence or clinical trials, collect stability data and
provide additional information concerning any new supplier, or change in a validated manufacturing
process, before we could distribute products from that supplier or revised process. Obtaining the
necessary FDA approvals or other qualifications under applicable regulatory requirements and
ensuring non-infringement of third-party intellectual property rights could result in a significant
interruption of supply and could require the new supplier to bear significant additional costs
which may be passed on to us. For instance, with respect to ANX-530, the form of API used in the
manufacture of ANX-530 for purposes of our bioequivalence study of ANX-530 will not be the same
form of API used in the manufacture of ANX-530 for purposes of process validation batches or
commercial supply. To ensure the comparability of the ANX-530 used in the bioequivalence study and
the ANX-530 intended for commercial sale, FDA may require that we evaluate both forms of ANX-530 in
additional patients, re-perform the bioequivalence study or take other remedial actions. We may
have insufficient quantities of both forms of ANX-530 and could incur substantial cost and delay in
acquiring such quantities, in addition to the time and expense associated with conducting the
evaluation, re-performing the study or taking other remedial measures.
We rely in part on third parties to conduct our preclinical and nonclinical testing and
bioequivalence and clinical studies and other aspects of our development programs and if those
third parties do not satisfactorily perform their contractual obligations or meet anticipated
deadlines, the development of our product candidates could be adversely affected.
We do not employ personnel or possess the facilities necessary to conduct the activities associated
with our programs, particularly since we implemented severe cost-cutting measures in late 2008 and
early 2009. We engage consultants, advisors, CROs, CMOs and others to design and conduct
preclinical and nonclinical tests and bioequivalence and clinical studies in connection with the
research and development of our product candidates. As a result, many important aspects of our
product candidates development are outside our direct control. There can be no assurance that such
third parties will perform all of their obligations under arrangements with us or will perform
those obligations satisfactorily.
The CROs with which we contract for execution of our bioequivalence and clinical studies play a
significant role in the conduct of the studies and subsequent collection and analysis of data, and
we will likely depend on these and other CROs and clinical investigators to conduct our future
bioequivalence or clinical or studies or assist with our on-going bioequivalence studies.
Individuals working at the CROs with which we contract, as well as investigators at the sites at
which our studies are conducted, are not our employees, and we cannot control the amount or timing
of resources that they devote to our programs. If these CROs fail to devote sufficient time and
resources to our studies, or if their performance is substandard, it will delay the approval of our
applications to regulatory agencies and the introduction of our products. Failure of these CROs to
meet their obligations could adversely affect development of our product candidates. Moreover,
these CROs may have relationships with other commercial entities, some of which may compete with
us. If they assist our competitors at our expense, it could harm our competitive position.
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For instance, we lack the internal capabilities to fully analyze the data from our bioequivalence
study of ANX-514 and will rely on multiple third-party consultants to help us interpret and
understand the data. Because of the impact different analyses of the data may have on our business,
we believe an employee likely would approach the data and analysis in a substantially more
rigorous, thoughtful and creative manner than a consultant or contractor.
We currently have no sales or marketing capability and our failure to develop these and related
capabilities internally or contract with third parties to perform these activities successfully
could delay and/or limit our ability to generate revenues in the event one or more of our product
candidates obtains regulatory approval.
We currently do not have sales, marketing or commercialization personnel. We have limited business
development personnel. To commercialize our products, including ANX-530, we will have to acquire or
develop sales, marketing and distribution capabilities, or rely on marketing partners or other
arrangements with third parties for the marketing, distribution and sale of our products. There is
no guarantee that we will be able to establish marketing, distribution or sales capabilities or
make arrangements with third parties to perform those activities on terms satisfactory to us, or
that any internal capabilities or third party arrangements will be cost-effective. The acquisition
or development of a sales and distribution and associated regulatory compliance infrastructure will
require substantial resources, which may divert the attention of our management and key personnel
and negatively impact our product development efforts.
In addition, any third parties with which we establish marketing, distribution or sales
arrangements may have significant control over important aspects of the commercialization of our
products, including market identification, marketing methods, pricing, composition of sales force
and promotional activities. If we retain third-party service providers to perform functions related
to the sale and distribution of our products, key aspects of those functions that would be out of
our direct control could include warehousing and inventory management, distribution, contract
administration and chargeback processing, accounts receivable management and call center
management. In this event, we would place substantial reliance on third-party providers to perform
services for us, including entrusting our inventories of products to their care and handling. If
these third-party service providers fail to comply with applicable laws and regulations, fail to
meet expected deadlines, or otherwise do not carry out their contractual duties to us, or encounter
natural or other disasters at their facilitates, our ability to deliver product to meet commercial
demand could be significantly impaired. In addition, we may use third parties to perform various
other services for us relating to sample accountability and regulatory monitoring, including
adverse event reporting, safety database management and other product maintenance services. If the
quality or accuracy of the data maintained by these service providers is insufficient, our ability
to continue to market our products could be jeopardized or we could be subject to regulatory
sanctions. We do not currently have the internal capacity to perform these important commercial
functions, and we may not be able to maintain commercial arrangements for these services on
reasonable terms, or at all. Even if we are successful in establishing and maintaining these
arrangement, there can be no assurance that we will be able to control the amount and timing of
resources that any third party may devote to our products or prevent any third party from pursuing
alternative technologies or products that could result in the development of products that compete
with, or the withdrawal of support for, our products.
If we receive regulatory approval for one or more of our product candidates, we may face
competition from generic products, which could exert downward pressure on the pricing and market
share of our products and limit our ability to generate revenues.
Many of the currently marketed and anticipated products against which our product candidates may
compete are, or we anticipate will be, available as generics. For instance, ANX-530 will compete
against Navelbine, for which generic equivalents are already available. ANX-514 will compete
against Taxotere®. We anticipate that ANX-514 will also compete against other formulations of
docetaxel and that generic Taxotere will enter the market in November 2013 or May 2014 (depending
on whether a period of pediatric exclusivity is granted in the future). Even if we obtain unique
HCPCS codes for our products, the existence of generic products could make it more difficult for
our branded products, including ANX-530 and ANX-514, to gain or maintain market share and could
cause prices for our products to drop, each of which could adversely affect our business.
We may also face competition for our products from lower priced products from foreign countries
that have placed price controls on pharmaceutical products. Proposed federal legislative changes
may expand consumers ability to import lower priced versions of our and competing products from
Canada. Further, several states and local governments have implemented importation schemes for
their citizens, and, in the absence of federal action to
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curtail such activities, we expect other states and local governments to launch importation
efforts. The importation of foreign products that compete with our own products could negatively
impact our business and prospects.
Even if we receive regulatory approval in the U.S. for ANX-530 and/or ANX-514, we will likely
depend on a limited number of group purchasing organizations for retail distribution of these
products, and if we subsequently lose any significant GPO relationship, our business could be
harmed.
Our current U.S. commercialization strategy for our lead emulsion formulations initially involves
marketing and selling these products through a limited number of GPOs. Even if we are successful in
securing relationships with these entities, the subsequent loss of any one or more of these GPO
accounts or a material reduction in their participation could harm our business, financial
condition or results of operations. In addition, we may face pricing pressure from these GPOs.
Even if we receive regulatory approval for one or more of our product candidates, they may still
face future development and regulatory difficulties that could materially and adversely affect our
business, financial condition and results of operations and cause our stock price to decline.
Even if initial regulatory approval is obtained, the FDA or a foreign regulatory agency may still
impose significant restrictions on a products indicated uses or marketing or impose ongoing
requirements for potentially costly post-approval studies or marketing surveillance programs. Our
product candidates will also be subject to ongoing FDA requirements related to the labeling,
packaging, storage, advertising, promotion, record-keeping and submission of safety and other
post-market information on the product. For instance, in September 2007, amendments to the FDCA
were signed into law. These amendments significantly strengthen the FDAs regulatory authority over
drugs, including new controls over the post-approval monitoring of drugs. The FDA may now require
changes to approved drug labels, require post-approval clinical trials and impose distribution and
use restrictions on certain drugs. In addition, approved products, manufacturers and manufacturers
facilities are subject to continuing regulatory review and periodic inspections. If previously
unknown problems with a product are discovered, such as adverse events of unanticipated severity or
frequency, or problems with the facility where the product is manufactured, the FDA may impose
restrictions on that product or us, including requiring withdrawal of the product from the market.
If we or a CMO of ours fail to comply with applicable regulatory requirements, a regulatory agency
may:
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issue warning letters or untitled letters; |
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impose civil or criminal penalties; |
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suspend or withdraw regulatory approval; |
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suspend or terminate any ongoing bioequivalence or clinical trials; |
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refuse to approve pending applications or supplements to approved applications; |
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impose restrictions or affirmative obligations on our or our CMOs operations, including
costly new manufacturing requirements; |
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close the facilities of a CMO; or |
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seize or detain products or require a product recall. |
Even if one or more of our product candidates receive regulatory approval in the U.S., we may never
receive approval or commercialize our products outside of the U.S., which would limit our ability
to realize the full market potential of our product candidates.
In order to market any products outside of the U.S., we must establish and comply with numerous and
varying regulatory requirements of other countries regarding safety and efficacy. Approval
procedures vary among countries and can involve additional product testing and validation and
additional administrative review periods. The time required to obtain approval in other countries
might differ from that required to obtain FDA approval. In particular, other countries may not have
a comparable regulatory as is available under Section 505(b)(2) of FDCA. Even if a
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country did have a comparable procedure, that country may require a more robust data package than
the pharmacokinetic data package that we intend to submit in support of NDAs for ANX-530 and
ANX-514. The regulatory approval process in other countries may include all of the risks detailed
above regarding FDA approval in the U.S., as well as other risks. Regulatory approval in one
country does not ensure regulatory approval in another, but a failure or delay in obtaining
regulatory approval in one country may have a negative effect on the regulatory process in others.
Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such
approval could have the same adverse effects detailed above regarding FDA approval in the U.S. As
described above, such effects include the risks that our product candidates may not be approved for
all indications requested, which could limit the uses of our product candidates and have an adverse
effect on product sales, and that such approval may be subject to limitations on the indicated uses
for which the product may be marketed or require costly, post-marketing follow-up studies.
Our product candidates may cause undesirable side effects or have other properties that could delay
or prevent their regulatory approval or commercialization.
Undesirable side effects caused by our product candidates could interrupt, delay or halt
bioequivalence or clinical trials and could result in the denial of regulatory approval by the FDA
or other regulatory authorities for any or all indications, and in turn prevent us from
commercializing our product candidates and generating revenues from their sale.
In addition, if any of our product candidates receive marketing approval and we or others later
identify undesirable side effects caused by the product or the reference product:
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regulatory authorities may require the addition of labeling statements, such as a black
box warning or a contraindication; |
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regulatory authorities may withdraw their approval of the product; |
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we may be required to change the way the product is administered, conduct additional
clinical trials or change the labeling of the product; and |
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our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the
affected product or could substantially increase the costs and expenses of commercializing the
product, which in turn could delay or prevent us from generating significant revenues from its
sale.
Risks Related to Our Intellectual Property
Our success will depend on patents and other protection we obtain on our product candidates and
proprietary technology.
Our success will depend in part on our ability to:
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obtain and maintain patent protection with respect to our products; |
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prevent third parties from infringing upon our proprietary rights; |
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maintain trade secrets; |
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operate without infringing upon the patents and proprietary rights of others; and |
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obtain appropriate licenses to patents or proprietary rights held by third parties if
infringement would otherwise occur, both in the U.S. and in foreign countries. |
The patent and intellectual property positions of biopharmaceutical companies, including ours, are
uncertain and involve complex legal and factual questions. There is no guarantee that we have or
will develop or obtain the rights
to products or processes that are patentable, that patents will issue from any pending applications
or that claims
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allowed will be sufficient to protect the technology we develop or have developed or
that is used by us, our CMOs or our other service providers. In addition, we cannot be certain that
patents issued to us will not be challenged, invalidated, infringed or circumvented, including by
our competitors, or that the rights granted thereunder will provide competitive advantages to us.
Furthermore, patent applications in the U.S. are confidential for a period of time until they are
published, and publication of discoveries in scientific or patent literature typically lags actual
discoveries by several months. As a result, we cannot be certain that the inventors listed in any
patent or patent application owned by us were the first to conceive of the inventions covered by
such patents and patent applications or that such inventors were the first to file patent
applications for such inventions.
We may also rely on unpatented trade secrets and know-how and continuing technological innovation
to develop and maintain our competitive position, which we seek to protect, in part, by
confidentiality agreements with employees, consultants, collaborators and others. We also have
invention or patent assignment agreements with our employees and certain consultants. There can be
no assurance, however, that binding agreements will not be breached, that we will have adequate
remedies for any breach, or that trade secrets will not otherwise become known or be independently
discovered by competitors. In addition, there can be no assurance that inventions relevant to us
will not be developed by a person not bound by an invention assignment agreement with us.
Exclusivity for our emulsion-formulation product candidates may be limited because of the nature of
patent protection available for these candidates.
While the patent applications covering our emulsion-formulation product candidates, including
ANX-530 and ANX-514, include product claims, they cover only specific formulations of the
underlying chemical entity, or API, and not the API itself. Such product claims are not as strong
as claims covering new APIs, which are widely viewed as the strongest form of intellectual property
protection for pharmaceutical products, as they apply without regard to how the API is formulated
or the method in which the API is used. A competitor may modify our formulations and obtain
regulatory approval for products with the same API as our products. Such competitive products may
not infringe the patents we hold covering our specific formulations of the API.
If we are sued for infringing the proprietary rights of third parties, it will be costly and time
consuming, and an unfavorable outcome would have an adverse effect on our business.
Our commercial success depends on our ability and the ability of our CMOs and component suppliers
to develop, manufacture, market and sell our products and product candidates and use our
proprietary technologies without infringing the proprietary rights of third parties. Numerous U.S.
and foreign issued patents and pending patent applications, which are owned by third parties, exist
in the fields in which we are or may be developing products. As the biotechnology and
pharmaceutical industry expands and more patents are issued, the risk increases that our products
and product candidates may give rise to claims that our products or product candidates infringe the
rights of others. Because patent applications can take many years to publish and issue, there may
be currently pending applications, unknown to us, that may later result in issued patents that our
products, product candidates or technologies infringe, or that the process of manufacturing our
products or any of their respective component materials, or the component materials themselves,
infringe.
We or our CMOs or component material suppliers may be exposed to, or threatened with, future
litigation by third parties having patent or other intellectual property rights alleging that our
products, product candidates and/or technologies infringe their intellectual property rights or
that the process of manufacturing our products or any of their respective component materials, or
the component materials themselves, infringe their intellectual property rights. If one of these
patents was found to cover our products, product candidates, technologies or their uses, or any of
the underlying manufacturing processes or components, we could be required to pay damages and could
be unable to commercialize our products or use our technologies or methods unless we are able to
obtain a license to the patent or intellectual property right. A license may not be available to us
on acceptable terms, if at all. In addition, during litigation, a patent holder could obtain a
preliminary injunction or other equitable remedy that could prohibit us from making, using or
selling our products, technologies or methods.
In connection with any NDA that we file under Section 505(b)(2) of the FDCA, we may be required to
notify third
parties that we have certified to the FDA that any patents listed for the approved drug in the
FDAs Orange Book
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publication are invalid or will not be infringed by the manufacture, use or sale
of our drug. If the third-party files a patent infringement lawsuit against us within 45 days of
its receipt of notice of our certification, the FDA is automatically prevented from approving our
Section 505(b)(2) NDA until, subject to certain adjustments, the earliest of 30 months, expiration
of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable
to us. Accordingly, we may invest significant time and expense in the development of our product
candidates, including ANX-514, only to be subject to significant delay and patent litigation before
our product candidates may be commercialized.
There is a substantial amount of litigation involving patent and other intellectual property rights
in the biotechnology and pharmaceutical industries generally. If a third party claims that we or
our CMOs or component material suppliers infringe its intellectual property rights, we may face a
number of issues, including, but not limited to:
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infringement and other intellectual property claims which, with or without merit, may be
expensive and time consuming to litigate and may divert our managements attention from our
core business; |
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substantial damages for infringement, including treble damages and attorneys fees,
which we may have to pay if a court decides that the product at issue infringes on or
violates the third partys rights; |
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a court prohibiting us from selling or licensing the product unless the third party
licenses its product rights to us, which it may not be required to do; |
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if a license is available from the third party, we may have to pay substantial
royalties, fees and/or grant cross-licenses to our products; and |
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redesigning our products or processes so they do not infringe, which may not be possible
or may require substantial funds and time. |
No assurance can be given that patents do not exist, have not been filed, or could not be filed or
issued, which contain claims covering our products, technology or methods or those of our CMOs or
component material suppliers. Because of the number of patents issued and patent applications filed
in our field, we believe there is a risk that third parties may allege they have patent rights
encompassing our products, technology or methods or those of our CMOs or component material
suppliers.
In addition, it may be necessary for us to enforce patents under which we have rights, or to
determine the scope, validity and unenforceability of other parties proprietary rights, which may
affect our rights. There can be no assurance that our patents would be held valid by a court or
administrative body or that an alleged infringer would be found to be infringing. The uncertainty
resulting from the mere institution and continuation of any technology-related litigation or
interference proceeding could have a material and adverse effect on us.
RISKS RELATED TO OUR INDUSTRY
We expect intense competition in the marketplace for all of our product candidates.
The industry in which we operate is highly competitive and rapidly changing. If successfully
developed and approved, all of our products will likely compete with existing and new products and
therapies and our competitors may succeed in commercializing products more rapidly or effectively
than us, which would have a material and adverse effect on our results of operations and financial
condition. In addition, there are numerous companies with a focus in oncology and/or that are
pursuing the development of pharmaceuticals that target the same diseases as are targeted by the
products being developed by us or that focus on reformulating currently approved drugs. We
anticipate that we will face intense and increasing competition in the future as new products enter
the market and advanced technologies become available. There is no assurance that existing products
or new products developed by competitors will not be more effective, or more effectively marketed
and sold, than those we may market and sell. Competitive products may render our products and
product candidates obsolete or noncompetitive.
For instance, numerous companies are focused on reformulating currently approved chemotherapeutic
agents. In particular, the taxanes, the class of drugs of which Taxotere is a member, have
experienced substantial commercial
success, in part as a result of their effectiveness in treating a wide variety of cancers, which
has generated significant
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interest in reformulating Taxotere and other taxanes. In addition to our
approach of emulsifying docetaxel, other companies are pursuing alternative delivery vehicles,
including the use of albumin nanoparticles, prodrugs, polyglutamates, analogs, co-solvents,
liposomes and microspheres. Many of these or similar approaches could be applied to vinorelbine.
Relative to our formulations, formulations based on one or more of these other methods may result
in greater efficacy or safety, provide better drug delivery to tumor sites or otherwise increase
benefits to patients and healthcare providers.
In particular, ANX-530 and ANX-514, if approved, may compete against Navelbine and Taxotere,
respectively, as well as their generic equivalents and other formulations of vinorelbine and
docetaxel. In addition to Navelbine, currently there are at least 6 generic versions of vinorelbine
on the market. In addition, there is an oral formulation of vinorelbine approved for use in the
European Union, or EU, against which we would compete if our emulsion formulation of vinorelbine
were approved for use in the EU. In the U.S., in May 2010 (but subject to any period of pediatric
exclusivity that may be granted in the future), patent protection ends for docetaxel and, in
November 2013 (but subject to any period of pediatric exclusivity that may be granted in the
future), patent protection ends for Taxotere. We are aware of two leading generics companies that
each have developed or acquired a formulation of docetaxel and have certified that, after May 2010,
their respective formulations of docetaxel will not infringe any unexpired Taxotere patents.
Under our current regulatory strategy, because we anticipate submitting Section 505(b)(2) NDAs with
only bioequivalence data, the ability to differentiate our products from competitor products will
be limited. Even if we believe our products demonstrate clinical or pharmacoeconomic benefits, we
may be unable to market our products based on these benefits. If our products fail to obtain unique
HCPCS codes, we may be required to price our products at levels that do not cover our costs to
manufacture, market and distribute the products or provide any profit, or to price our products at
levels at which they are not competitive.
Companies likely to have products that will compete with our product candidates have significantly
greater financial, technical and human resources and are better equipped to develop, manufacture,
market and distribute products. Many of these companies have extensive experience in preclinical
testing and clinical trials, obtaining FDA and other regulatory approvals and manufacturing and
marketing products and have products that have been approved or are in late-stage development and
operate large, well-funded research and development programs.
Smaller companies may also prove to be significant competitors, particularly through collaborative
arrangements with large pharmaceutical and biotechnology companies. Furthermore, academic
institutions, government agencies and other public and private research organizations are becoming
increasingly aware of the commercial value of their inventions and are actively seeking to
commercialize the technology they have developed.
We are subject to uncertainty relating to healthcare reform measures and reimbursement policies
that, if not favorable to our products, could hinder or prevent our products commercial success.
Our ability to commercialize our products successfully will depend in part on the extent to which
reimbursement for the costs of such products and related treatments will be available from
government health administration authorities, private health insurers and other third-party payors.
Significant uncertainty exists as to the reimbursement status of newly approved medical products.
The continuing efforts of the government, insurance companies, managed care organizations and other
payors of healthcare services to contain or reduce costs of healthcare may adversely effect:
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our ability to set a price we believe is fair for our products; |
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our ability to generate revenues or achieve or maintain profitability; |
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the future revenues and profitability of our potential customers, suppliers and
collaborators; and |
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the availability to us of capital. |
If we are successful in obtaining FDA approval for ANX-530, we will compete with Navelbine and
several generic versions of Navelbine. Our ability to commercialize ANX-530 will depend in part on
the extent to which
governmental authorities, private health insurers and other organizations establish appropriate
coverage and
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reimbursement levels for the cost of our products and related treatments. These payors
are increasingly attempting to contain healthcare costs by limiting both coverage and the level of
reimbursement, particularly for new therapeutic products or if there is a perception that the
target indication of the new product is well-served by existing treatments. Accordingly, even if
coverage and reimbursement are provided, market acceptance of our products would be adversely
affected if the amount of coverage and/or reimbursement available for the use of our products
proved to be unprofitable for healthcare providers or less profitable than alternative treatments.
There have been federal and state proposals to subject the pricing of healthcare goods and services
to government control and to make other changes to the U.S. healthcare system. While we cannot
predict the outcome of current or future legislation, we anticipate, particularly given President
Obamas focus on healthcare reform, that Congress and state legislatures will introduce initiatives
directed at lowering the total cost of healthcare. In addition, in certain foreign markets, the
pricing of drugs is subject to government control and reimbursement may in some cases be
unavailable or insufficient. It is uncertain if future legislative proposals, whether domestic or
abroad, will be adopted that might affect our product candidates or what actions federal, state, or
private payors for healthcare treatment and services may take in response to any such healthcare
reform proposals or legislation. Any such healthcare reforms could have a material and adverse
effect on the marketability of any products for which we ultimately receive FDA or other regulatory
agency approval.
We face potential product liability exposure and, if successful claims are brought against us, we
may incur substantial liability for a product or product candidate and may have to limit its
commercialization. In the future, we anticipate that we will need to obtain additional or increased
product liability insurance coverage and it is uncertain that such increased or additional
insurance coverage can be obtained on commercially reasonable terms.
Our business (in particular, the use of our product candidates in clinical trials and the sale of
our products for which we obtain marketing approval) will expose us to product liability risks.
Product liability claims might be brought against us by patients, health care providers,
pharmaceutical companies or others selling our products. If we cannot successfully defend ourselves
against these claims, we will incur substantial liabilities. Regardless of merit or eventual
outcome, liability claims may result in:
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decreased demand for our products or product candidates; |
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impairment of our business reputation; |
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withdrawal of bioequivalence or clinical trial participants; |
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costs of related litigation; |
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substantial monetary awards to patients or other claimants; |
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loss of revenues; and |
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the inability to commercialize our products and product candidates. |
We maintain limited product liability insurance for our bioequivalence and clinical trials, but our
insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses
or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and, in
the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us against losses.
We intend to expand our insurance coverage to include the sale of commercial products if we obtain
marketing approval of any of our product candidates, but we may be unable to obtain product
liability insurance on commercially acceptable terms or may not be able to maintain such insurance
at a reasonable cost or in sufficient amounts to protect us against potential losses. Large
judgments have been awarded in class action lawsuits based on drugs that had unanticipated side
effects. A successful product liability claim or series of claims brought against us could cause
our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash
and adversely affect our business.
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RISKS RELATED TO OUR COMMON STOCK
Our common stock may be delisted from the NYSE Amex if we fail to maintain compliance with
continued listing criteria.
Our common stock currently trades on the NYSE Amex. NYSE Amex will normally consider suspending
dealings in, or removing from the list, securities of an issuer which has stockholders equity of
less than $6.0 million if such issuer has sustained losses from continuing operations and/or net
losses in its five most recent fiscal years. As of March 31, 2009, our stockholders equity was
approximately $3.0 million and we have incurred annual net losses since inception. In addition,
NYSE Amex will normally consider suspending dealings in, or removing from the list, securities
selling for a substantial period of time at a low price per share if the issuer fails to effect a
reverse split of such stock within a reasonable time after being notified that the NYSE Amex deems
such action to be appropriate under the circumstances. While the NYSE Amex does not provide bright
line minimum share price standards for continued listing, we believe that a price less than $1.00
per share for a substantial period of time will be investigated.
Since October 1, 2007 through May 20, 2009, the closing price of a share of our common stock has been less than $1.00.
If we are unable to comply with the NYSE Amexs continued listing standards, including its
stockholders equity and minimum trading price requirements, our common stock may be suspended from
trading on and/or delisted from the NYSE Amex. The delisting of our common stock from the NYSE Amex
is likely to reduce the trading volume and liquidity in our common stock and may lead to further
decreases in the trading price of our common stock. The delisting of our common stock may also
materially impair our stockholders ability to buy and sell shares of our common stock. In
addition, the delisting of our common stock could significantly impair our ability to raise
capital, which is critical to the continuation of our business.
If our common stock were delisted and determined to be a penny stock, a broker-dealer may find it
more difficult to trade our common stock and an investor may find it more difficult to acquire or
dispose of our common stock in the secondary market.
In addition, if our common stock were removed from listing with the NYSE Amex, it may be subject to
the so-called penny stock rules. The SEC has adopted regulations that define a penny stock to
be any equity security that has a market price per share of less than $5.00, subject to certain
exceptions, such as any securities listed on a national securities exchange. For any transaction
involving a penny stock, unless exempt, the rules impose additional sales practice requirements
on broker-dealers, subject to certain exceptions. If our common stock were delisted and determined
to be a penny stock, a broker-dealer may find it more difficult to trade our common stock and an
investor may find it more difficult to acquire or dispose of our common stock on the secondary
market. Investors in penny stocks should be prepared for the possibility that they may lose their
whole investment.
The market price of our common stock has been and is likely to continue to be highly volatile.
On October 1, 2007, the market price for our common stock dropped almost 80% following our
announcement of the results of our phase 2b clinical trial of CoFactor for the first-line treatment
of metastatic colorectal cancer. In addition, the market price for our common stock has
historically been highly volatile, and the market for our common stock has from time to time
experienced significant price and volume fluctuations that are unrelated to our operating
performance. The market price of our common stock may fluctuate significantly in response to a
number of factors, including:
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the level of our financial resources and ability to continue as a going concern; |
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announcements of entry into or consummation of a financing or strategic transaction; |
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any decision by us to liquidate our assets and wind-up operations; |
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changes in the regulatory status of our product candidates, including results of our
bioequivalence and clinical trials and other research and development programs; |
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FDA or international regulatory actions and regulatory developments in the U.S. and
foreign countries; |
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announcements of new products or technologies, commercial relationships or other events
(including bioequivalence and clinical trial results and regulatory events and actions) by
us or our competitors; |
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market conditions in the pharmaceutical, biopharmaceutical and biotechnology sectors; |
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developments concerning intellectual property rights generally or those of us or our
competitors; |
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litigation or public concern about the safety of our products or product candidates; |
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changes in securities analysts estimates of our financial performance or deviations in
our business and the trading price of our common stock from the estimates of securities
analysts; |
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events affecting any future collaborations, commercial agreements and grants; |
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fluctuations in stock market prices and trading volumes of similar companies; |
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders or pursuant to shelf or resale registration
statements that register shares of our common stock that may be sold by certain of our
current or future stockholders; |
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discussion of us or our stock price by the financial and scientific press and in online
investor communities; |
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additions or departures of key personnel; and |
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changes in third party reimbursement policies. |
As evidenced by the October 1, 2007 decline, the realization of any of the foregoing could have a
dramatic and adverse impact on the market price of our common stock. In addition, class action
litigation has often been instituted against companies whose securities have experienced periods of
volatility in market price. Moreover, regulatory entities often undertake investigations of
investor transactions in securities that experience volatility following an announcement of a
significant event or condition. Any such litigation brought against us or investigation involving
our investors could result in substantial costs and a diversion of managements attention and
resources, which could hurt our business, operating results and financial condition.
Sales of substantial amounts of our common stock or the perception that such sales may occur could
cause the market price of our common stock to drop significantly, even if our business is
performing well.
The market price of our common stock could decline as a result of sales by, or the perceived
possibility of sales by, us or our existing stockholders of shares of our common stock. These sales
might also make it more difficult for us to sell equity securities at a time and price that we deem
appropriate. In addition, this shelf registration statement and our resale registration statements
register a significant number of shares of our common stock, and securities convertible into our
common stock, that may be sold by us or certain of our stockholders, which may increase the
likelihood of sales by, or the perception of an increased likelihood of sales by, us or our
existing stockholders of shares of our common stock.
Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of
us, which may be beneficial to our stockholders, more difficult, which could depress our stock
price. Alternatively, prohibitions on anti-takeover provisions in our charter documents may
restrict us from acting in the best interests of our stockholders.
We are incorporated in Delaware. Certain anti-takeover provisions of Delaware law and our charter
documents as currently in effect may make a change in control of our company more difficult, even
if a change in control would be beneficial to our stockholders. Our bylaws limit who may call a
special meeting of stockholders and establish advance notice requirements for nomination of
individuals for election to our board of directors or for proposing matters that can be acted upon
at stockholders meetings. Delaware law also prohibits corporations from engaging in a business
combination with any holders of 15% or more of their capital stock until the holder has held the
stock for three years unless, among other possibilities, the board of directors approves the
transaction. Our board of directors
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may use these provisions to prevent changes in the management and control of our company. Also,
under applicable Delaware law, our board of directors may adopt additional anti-takeover measures
in the future. In addition, provisions of certain compensatory contracts with our management, such
as equity award agreements and retention and incentive agreements with our executive officers, may
have an anti-takeover effect by resulting in accelerated vesting of outstanding equity securities
held by these officers and cash payments upon termination without cause or involuntary termination
following a change in control.
In connection with a July 2005 private placement, we agreed with the investors in that transaction
that we would not implement certain additional measures that would have an anti-takeover effect. As
a result, under our amended and restated certificate of incorporation, we are prohibited from
dividing our board of directors into classes and adopting or approving any rights plan, poison
pill or other similar plan or device. A classified board of directors could serve to protect our
stockholders against unfair treatment in takeover situations, by making it more difficult and
time-consuming for a potential acquirer to take control of our board of directors. A company may
also adopt a classified board of directors to ensure stability in the board of directors and
thereby improve long-term planning, which may benefit stockholders. A poison pill or similar plan
or device may encourage potential acquirers to discuss their intentions with the board of directors
of a company and avoid the time, expense and distraction of a hostile take-over. Any benefit to us
and our stockholders from instituting a classified board or adopting or approving a poison pill
or similar plan or device in these and other circumstances is unavailable.
Because we do not expect to pay dividends in the foreseeable future, you must rely on stock
appreciation for any return on your investment.
We have paid no cash dividends on any of our capital stock to date, and we currently intend to
retain our future earnings, if any, to fund the development and growth of our business. As a
result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash
dividends, if any, will also depend on our financial condition, results of operations, capital
requirements and other factors and will be at the discretion of our board of directors.
Furthermore, we are subject to various laws and regulations that may restrict our ability to pay
dividends and we may in the future become subject to contractual restrictions on, or prohibitions
against, the payment of dividends. Accordingly, the success of your investment in our capital stock
will likely depend entirely upon any future appreciation and there is no guarantee that our capital
stock will appreciate in value.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate herein by reference, includes
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other
than statements of historical fact, are statements that could be deemed forward-looking statements,
including, but not limited to, statements regarding business strategy, expectations and plans, our
objectives for future operations, including product development, and our future financial position.
When used in this report, the words believe, may, could, will, estimate, continue,
anticipate, intend, expect, indicate and similar expressions are intended to identify
forward-looking statements.
We base these forward-looking statements on our current expectations and projections about
future events and trends that we believe may affect our financial condition, results of operations,
business strategy, short-term and long-term business operations and objectives, and financial
needs, including our ability to consummate a strategic transaction or otherwise satisfy our
immediate need for additional capital. These forward-looking statements are subject to risks and
uncertainties that could cause our actual results to differ materially from those reflected in the
forward-looking statements. Factors that could cause or contribute to such differences include, but
are not limited to: the risk that we will liquidate our assets, entirely wind-down our operations
and dissolve; the risk that, based on our current working capital, and the estimated costs
associated with seeking approval for and implementing a plan of liquidation, our remaining capital
available for distribution to our stockholders, if any, will be insignificant; the risk that we
will be unable to consummate a strategic or partnering transaction or otherwise raise sufficient
capital on a timely basis, or at all, to continue as a going concern, including as a result of
negative perceptions of the data from our bioequivalence study of ANX-514; the risk that our recent
cost-containment measures, including the discontinuation of substantially all of our development
activities and fundamental business operations and reduction in force to a small, select number of
full-time employees, will negatively impact our ability to consummate a strategic transaction; the
potential for regulatory authorities to require additional preclinical work and/or clinical
activities to support regulatory filings, including prior to the submission or the approval of a
New Drug Application for ANX-530 and ANX-514, and the impact of increased uncertainty regarding the
need for such activities on strategic, partnering and capital-raising transactions; the risk that
our significantly reduced workforce and leadership by officers who do not have substantial previous
experience in executive leadership roles will negatively impact our ability to attract a strategic
or other partner, raise capital or maintain effective disclosure controls and procedures or
internal control over financial reporting; the risk the FDA will determine that ANX-530 and
Navelbine and/or ANX-514 and Taxotere are not bioequivalent, including as a result of performing
pharmacokinetic equivalence analysis based on a patient population other than the population on
which we based our analysis or determining that increased docetaxel blood-levels during and
immediately following infusion are clinically relevant; the risk of investigator bias in reporting
adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including
bias that increased the reporting of adverse events associated with Navelbine and/or that decreased
the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing,
obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating
commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA
approval of ANX-514; the risk that the performance of third parties on whom we rely to conduct our
studies or evaluate the data, including clinical investigators, expert data monitoring committees,
contract laboratories and contract research organizations, may be substandard, or they may fail to
perform as expected; the risk that our common stock will be delisted by the NYSE Amex (formerly,
the American Stock Exchange), including as a result of failing to maintain sufficient stockholders
equity or a sufficient stock price; the risk that we are unable to file timely required reports
with the SEC; the risk that we will trigger a maint
enance failure under that certain Rights
Agreement, dated July 27, 2005, as amended, and be required to pay liquidated damages, including as
a result of losing our eligibility to use Form S-3 if our common stock is delisted from the NYSE
Amex or we are not timely in our filings with the SEC; and other risks and uncertainties discussed
under the heading Risk Factors in this prospectus and in other reports and documents we file with
the SEC.
Any forward-looking statement speaks only as of the date on which it is made and, except as
required by law, we do not intend to update any forward-looking statements publicly to reflect
events or circumstances after the date on which such statement is made or to update the reasons
actual results could differ materially from those anticipated in the forward-looking statements,
even if new information becomes available in the future. You should not place undue reliance on
any forward-looking statement.
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USE OF PROCEEDS
Except as described in any prospectus supplement and any free writing prospectus in connection
with a specific offering, we currently intend to use the net proceeds from the sale of the
securities offered under this prospectus for general corporate purposes, including working capital.
We may also use the net proceeds to repay any debts and/or invest in or acquire complementary
businesses, products or technologies, although we have no current commitments or agreements with
respect to any such investments or acquisitions as of the date of this prospectus. We have not
determined the amount of net proceeds to be used specifically for the foregoing purposes. As a
result, our management will have broad discretion in the allocation of the net proceeds and
investors will be relying on the judgment of our management regarding the application of the
proceeds of any sale of the securities. Pending use of the net proceeds, we intend to invest the
proceeds in short-term, investment-grade, interest-bearing instruments.
When we offer a particular series of securities, we will describe the intended use of the net
proceeds from that offering in a prospectus supplement. The actual amount of net proceeds we spend
on a particular use will depend on many factors, including, our future capital expenditures, the
amount of cash required by our operations, and our future revenue growth, if any. Therefore, we
will retain broad discretion in the use of the net proceeds.
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DESCRIPTION OF COMMON STOCK AND PREFERRED STOCK
The following description of our common stock and preferred stock, together with any
additional information we include in any applicable prospectus supplement or any related free
writing prospectus, summarizes the material terms and provisions of our common stock and the
preferred stock that we may offer under this prospectus. While the terms we have summarized below
will apply generally to any future common stock or preferred stock that we may offer, we will
describe the particular terms of any class or series of these securities in more detail in the
applicable prospectus supplement. For the complete terms of our common stock and preferred stock,
please refer to our amended and restated certificate of incorporation and our amended and restated
bylaws that are incorporated by reference into the registration statement of which this prospectus
is a part or may be incorporated by reference in this prospectus or any applicable prospectus
supplement. The terms of these securities may also be affected by Delaware General Corporation
Law. The summary below and that contained in any applicable prospectus supplement or any related
free writing prospectus are qualified in their entirety by reference to our amended and restated
certificate of incorporation and our amended and restated amended and restated bylaws.
Common Stock
We are authorized to issue 200,000,000 shares of common stock, par value $0.001 per share, of
which 90,252,572 shares were issued and outstanding as of May 20, 2009. Additional shares of
authorized common stock may be issued, as authorized by our board of directors from time to time,
without stockholder approval, except as may be required by applicable securities exchange
requirements. The holders of common stock possess exclusive voting rights in us, except to the
extent our board of directors specifies voting power with respect to any other class of securities
issued in the future. Each holder of our common stock is entitled to one vote for each share held
of record on each matter submitted to a vote of stockholders, including the election of directors.
Stockholders do not have any right to cumulate votes in the election of directors.
Subject to preferences that may be granted to the holders of preferred stock, each holder of
our common stock is entitled to share ratably in distributions to stockholders and to receive
ratably such dividends as may be declared by our board of directors out of funds legally available
therefor. In the event of our liquidation, dissolution or winding up, the holders of our common
stock will be entitled to receive, after payment of all of our debts and liabilities and of all
sums to which holders of any preferred stock may be entitled, the distribution of any of our
remaining assets. Holders of our common stock have no conversion, exchange, sinking fund,
redemption or appraisal rights (other than such as may be determined by our board of directors in
its sole discretion) and have no preemptive rights to subscribe for any of our securities.
All of the outstanding shares of our common stock are, and the shares of common stock issued
upon the conversion of any securities convertible into our common stock will be, fully paid and
non-assessable. The shares of common stock offered by this prospectus or upon the conversion of
any preferred stock or debt securities or exercise of any warrants offered pursuant to this
prospectus, when issued and paid for, will also be, fully paid and non-assessable.
Securities Exchange Listing
Our common stock is listed on the NYSE Amex under the symbol ANX.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer & Trust
Company.
Preferred Stock
We are authorized to issue 1,000,000 shares of preferred stock, par value $0.001 per share,
none of which are issued and outstanding as of the date of this prospectus. Our board of directors
is authorized to classify or reclassify any unissued portion of our authorized shares of preferred
stock to provide for the issuance of shares of other classes or series, including preferred stock
in one or more series. We may issue preferred stock from time to time in one or more class or
series, with the exact terms of each class or series established by our board of directors. Our
board of directors may issue preferred stock with voting and other rights that could adversely
affect the voting
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power of the holders of our common stock without seeking stockholder approval. Additionally,
the issuance of preferred stock may have the effect of decreasing the market price of the common
stock and may adversely affect the voting power of holders of common stock and reduce the
likelihood that common stockholders will receive dividend payments and payments upon liquidation.
The rights, preferences, privileges and restrictions of the preferred stock of each series
will be fixed by the certificate of designation relating to each series. We will incorporate by
reference into the registration statement of which this prospectus is a part the form of any
certificate of designation that describes the terms of the series of preferred stock we are
offering before the issuance of the related series of preferred stock. The applicable prospectus
supplement will specify the terms of the series of preferred stock we are offering, including, but
not limited to:
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the distinctive designation and the maximum number of shares in the series; |
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the number of shares we are offering and purchase price per share; |
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the liquidation preference, if any; |
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the terms on which dividends, if any, will be paid; |
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the voting rights, if any, on the shares of the series; |
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the terms and conditions, if any, on which the shares of the series shall be convertible
into, or exchangeable for, shares of any other class or classes of capital stock; |
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the terms on which the shares may be redeemed, if at all; |
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any listing of the preferred stock on any securities exchange or market; |
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a discussion of any material or special United States federal income tax considerations
applicable to the preferred stock; and |
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any or all other preferences, rights, restrictions, including restrictions on
transferability, and qualifications of shares of the series. |
The issuance of preferred stock may delay, deter or prevent a change in control.
The description of preferred stock above and the description of the terms of a particular
series of preferred stock in any applicable prospectus supplement are not complete. You should
refer to the applicable certificate of designation for complete information.
The General Corporation Law of the State of Delaware, the state of our incorporation, provides
that the holders of preferred stock will have the right to vote separately as a class on any
proposal involving fundamental changes in the rights of holders of that preferred stock. This right
is in addition to any voting rights that may be provided for in the applicable certificate of
designation.
Anti-Takeover Effects of Provisions of our Charter Documents and Delaware Law
The following is a summary of certain provisions of Delaware law, our amended and restated
certificate of incorporation and our amended and restated bylaws. This summary does not purport to
be complete and is qualified in its entirety by reference to the corporate law of Delaware and our
amended and restated certificate of incorporation and amended and restated bylaws.
Certificate of Incorporation and Bylaws
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Preferred Stock. Under our amended and restated certificate of incorporation, our board of
directors has the power to authorize the issuance of up to 1,000,000 shares of preferred stock, all
of which are currently undesignated, and to determine the price, rights, preferences, privileges
and restrictions, including voting rights, of those shares without further vote or action by our
stockholders. The issuance of preferred stock may:
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delay, defer or prevent a change in control; |
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discourage bids for our common stock at a premium over the market price of our
common stock; |
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adversely affect the voting and other rights of the holders of our common stock; and |
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discourage acquisition proposals or tender offers for our shares and, as a
consequence, inhibit fluctuations in the market price of our shares that could result
from actual or rumored takeover attempts. |
Advance Notice Requirement. Stockholder nominations of individuals for election to our board
of directors and stockholder proposals of other matters to be brought before an annual meeting of
our stockholders must comply with the advance notice procedures set forth in our amended and
restated bylaws. Generally, to be timely, such notice must be received at our principal executive
offices no later than the date specified in our proxy statement released to stockholders in
connection with the preceding years annual meeting of stockholders, which date shall be not
earlier than the 120th day, nor later than the close of business on the 90th day, prior to the
first anniversary of the date of the preceding years annual meeting of stockholders.
Special Meeting Requirements. Our amended and restated bylaws provide that special meetings
of our stockholders may only be called at the request of our board of directors, president (unless
there is a chief executive officer who is not the president, in which case a special meeting may be
called at any time by the chief executive officer and not the president) or chair of the board of
directors. Only such business shall be considered at a special meeting as shall have been stated
in the notice for such meeting.
No Cumulative Voting. Our amended and restated certificate of incorporation does not include
a provision for cumulative voting for directors.
Indemnification. Our amended and restated certificate of incorporation and our bylaws, as
amended, provide that we will indemnify our officers and directors against losses as they incur in
investigations and legal proceedings resulting from their services to us, which may include service
in connection with takeover defense measures.
Delaware Anti-Takeover Statute.
We are subject to Section 203 of the Delaware General Corporation Law, an anti-takeover law.
In general, Section 203 prohibits, with some exceptions, a publicly held Delaware corporation from
engaging in a business combination with any interested stockholder for a period of three years
following the date that stockholder became an interested stockholder, unless:
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prior to that date, the board of directors of the corporation approved either the
business combination or the transaction that resulted in the stockholder becoming an
interested stockholder; |
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upon consummation of the transaction that resulted in the stockholder becoming an
interested stockholder, the interested stockholder owned at least 85% of the voting
stock of the corporation outstanding at the time the transaction commenced, excluding
for purposes of determining the number of shares of voting stock outstanding (but not
the voting stock owned by the interested stockholder) those shares owned by persons who
are directors and officers and by excluding employee stock plans in which employee
participants do not have the right to determine whether shares held subject to the plan
will be tendered in a tender or exchange offer; or |
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on or subsequent to that date, the business combination is approved by the board of
directors of the corporation and authorized at an annual or special meeting of
stockholders, and not by written consent, by the affirmative vote of at least 66-2/3%
of the outstanding voting stock that is not owned by the interested stockholder. |
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Section 203 defines business combination to include any of the following:
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any merger or consolidation involving the corporation and the interested
stockholder; |
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any sale, transfer, pledge or other disposition of 10% or more of the assets of the
corporation involving the interested stockholder; |
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subject to certain exceptions, any transaction that results in the issuance or
transfer by the corporation of any stock of the corporation to the interested
stockholder; |
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any transaction involving the corporation that has the effect of increasing the
proportionate share of the stock of any class or series of the corporation beneficially
owned by the interested stockholder; or |
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the receipt by the interested stockholder of the benefit of any loans, advances,
guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203 defines an interested stockholder as any person who, together with
the persons affiliates and associates, beneficially owns, or within three years prior to the
determination of interested stockholder status did beneficially own, 15% or more of the outstanding
voting stock of the corporation.
The above provisions may deter a hostile takeover or delay a change in control of management
or us.
DESCRIPTION OF DEBT SECURITIES
General
The debt securities that we may issue may constitute debentures, notes, bonds or other
evidences of indebtedness of ADVENTRX Pharmaceuticals, Inc., to be issued in one or more series,
which may include senior debt securities, subordinated debt securities and senior subordinated debt
securities. The particular terms of any series of debt securities we may offer, including the
extent to which the general terms set forth below may be applicable to a particular series, will be
described in a prospectus supplement relating to such series.
Debt securities that we may issue may be issued under a senior indenture between us and a
trustee, or a subordinated indenture between us and a trustee (collectively, the indenture). We
have filed forms of the indentures as exhibits to the registration statement of which this
prospectus is a part. If we enter into any revised indenture or indenture supplement, we will file
a copy of that supplement with the SEC.
THE FOLLOWING DESCRIPTION IS A SUMMARY OF THE MATERIAL PROVISIONS OF THE INDENTURE. IT DOES
NOT RESTATE THE INDENTURE IN ITS ENTIRETY. THE INDENTURE IS GOVERNED BY THE TRUST INDENTURE ACT OF
1939. THE TERMS OF THE DEBT SECURITIES INCLUDE THOSE STATED IN THE INDENTURE AND THOSE MADE PART
OF THE INDENTURE BY REFERENCE TO THE TRUST INDENTURE ACT. WE URGE YOU TO READ THE INDENTURE BECAUSE
IT, AND NOT THIS DESCRIPTION, DEFINES YOUR RIGHTS AS A HOLDER OF THE DEBT SECURITIES.
The indenture contains no covenant or provision which affords debt holders protection in the
event of a highly leveraged transaction.
Information You Will Find in the Prospectus Supplement
The indenture provides that we may issue debt securities from time to time in one or more
series by resolution of our board of directors or by means of a supplemental indenture, and that we
may denominate the debt securities and make them payable in foreign currencies. The indenture does
not limit the aggregate principal amount of debt securities that can be issued thereunder. The
prospectus supplement for a series of debt securities will provide information relating to the
terms of the series of debt securities being offered, which may include:
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the title and denominations of the debt securities of the series; |
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any limit on the aggregate principal amount of the debt securities of the series;
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the date or dates on which the principal and premium, if any, with
respect to the debt securities of the series are payable or the
method of determination thereof; |
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the rate or rates, which may be fixed or variable, at which the
debt securities of the series shall bear interest, if any, or the
method of calculating and/or resetting such rate or rates of
interest; |
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the dates from which such interest shall accrue or the method by
which such dates shall be determined and the basis upon which
interest shall be calculated; |
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the interest payment dates for the series of debt securities or
the method by which such dates will be determined, the terms of
any deferral of interest and any right of ours to extend the
interest payments periods; |
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the place or places where the principal and interest on the series of debt securities will be payable; |
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the terms and conditions upon which debt securities of the series
may be redeemed, in whole or in part, at our option or otherwise; |
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our obligation, if any, to redeem, purchase, or repay debt
securities of the series pursuant to any sinking fund or other
specified event or at the option of the holders and the terms of
any such redemption, purchase, or repayment; |
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the terms, if any, upon which the debt securities of the series
may be convertible into or exchanged for other securities,
including, among other things, the initial conversion or exchange
price or rate and the conversion or exchange period; |
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if the amount of principal, premium, if any, or interest with
respect to the debt securities of the series may be determined
with reference to an index or formula, the manner in which such
amounts will be determined; |
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if any payments on the debt securities of the series are to be
made in a currency or currencies (or by reference to an index or
formula) other than that in which such securities are denominated
or designated to be payable, the currency or currencies (or index
or formula) in which such payments are to be made and the terms
and conditions of such payments; |
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any changes or additions to the provisions of the indenture
dealing with defeasance, including any additional covenants that
may be subject to our covenant defeasance option; |
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the currency or currencies in which payment of the principal and
premium, if any, and interest with respect to debt securities of
the series will be payable, or in which the debt securities of the
series shall be denominated, and the particular provisions
applicable thereto in accordance with the indenture; |
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the portion of the principal amount of debt securities of the
series which will be payable upon declaration of acceleration or
provable in bankruptcy or the method by which such portion or
amount shall be determined; |
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whether the debt securities of the series will be secured or guaranteed and, if so, on what terms; |
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any addition to or change in the events of default with respect to the debt securities of the series; |
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the identity of any trustees, authenticating or paying agents, transfer agents or registrars; |
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the applicability of, and any addition to or change in, the
covenants currently set forth in the indenture;
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the subordination, if any, of the debt securities of the series and terms of the subordination; |
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any other terms of the debt securities of the series; and |
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whether securities of the series shall be issuable as registered
securities or bearer securities (with or without interest
coupons), and any restrictions applicable to the offering, sale or
delivery of such bearer securities and the terms upon which such
bearer securities of a series may be exchanged for registered
securities, and vice versa. |
Holders of debt securities may present debt securities for exchange in the manner, at the
places, and subject to the restrictions set forth in the debt securities, the indenture, and the
prospectus supplement. We will provide these services without charge, other than any tax or other
governmental charge payable in connection therewith, but subject to the limitations provided in the
indenture, any board resolution establishing such debt securities and any applicable indenture
supplement. Debt securities in bearer form and the coupons, if any, appertaining thereto will be
transferable by delivery.
Senior Debt
We may issue senior debt securities under the indenture and any coupons that will constitute
part of our senior debt. Unless otherwise set forth in the applicable indenture supplement or in
any board resolution establishing such debt securities and described in a prospectus supplement,
the senior debt securities will be senior unsecured obligations, ranking equally with all of our
existing and future senior unsecured debt. The senior debt securities will be senior to all of our
subordinated debt and junior to any secured debt we may incur as to the assets securing such debt.
Subordinated Debt
We may issue subordinated debt securities under the indenture and any coupons that will
constitute part of such subordinated debt. These subordinated debt securities will be subordinate
and junior in right of payment, to the extent and in the manner set forth in the indenture and any
applicable indenture supplement, to all of our senior indebtedness.
If this prospectus is being delivered in connection with a series of subordinated debt
securities, the accompanying prospectus supplement or the information incorporated by reference
will set forth the approximate amount of senior indebtedness, if any, outstanding as of the end of
our most recent fiscal quarter.
Senior Subordinated Debt
We may issue senior subordinated debt securities under the indenture and any coupons that will
constitute part of our senior subordinated debt. These senior subordinated debt securities will be,
to the extent and in the manner set forth in the indenture, subordinate and junior in right of
payment to all of our senior indebtedness and senior to our other subordinated debt. See the
discussions above under Senior Debt and Subordinated Debt for a more detailed explanation
of our senior and subordinated indebtedness.
Interest Rate
Debt securities that bear interest will do so at a fixed rate or a floating rate. We may
sell, at a discount below the stated principal amount, any debt securities which bear no interest
or which bear interest at a rate that at the time of issuance is below the prevailing market rate.
The relevant prospectus supplement will describe the special United States federal income tax
considerations applicable to:
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any discounted debt securities; and |
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any debt securities issued at par which are treated as having been
issued at a discount for United States federal income tax
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Registered Global Securities
We may issue registered debt securities of a series in the form of one or more fully
registered global securities. We will deposit the registered global security with a depositary or
with a nominee for a depositary identified in the prospectus supplement relating to such series.
The global security or global securities will represent and will be in a denomination or aggregate
denominations equal to the portion of the aggregate principal amount of outstanding registered debt
securities of the series to be represented by the registered global security or securities. Unless
it is exchanged in whole or in part for debt securities in definitive registered form, a registered
global security may not be transferred, except as a whole in three cases:
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by the depositary for the registered global security to a nominee of the depositary; |
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by a nominee of the depositary to the depositary or another nominee of the depositary; and |
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by the depositary or any nominee to a successor of the depositary or a nominee of the successor. |
The prospectus supplement relating to a series of debt securities will describe the specific
terms of the depositary arrangement concerning any portion of that series of debt securities to be
represented by a registered global security. We anticipate that the following provisions will
generally apply to all depositary arrangements.
Upon the issuance of a registered global security, the depositary will credit, on its
book-entry registration and transfer system, the principal amounts of the debt securities
represented by the registered global security to the accounts of persons that have accounts with
the depositary. These persons are referred to as participants. Any underwriters, agents or
debtors participating in the distribution of debt securities represented by the registered global
security will designate the accounts to be credited. Only participants or persons that hold
interests through participants will be able to beneficially own interests in a registered global
security. The depositary for a global security will maintain records of beneficial ownership
interests in a registered global security for participants. Participants or persons that hold
through participants will maintain records of beneficial ownership interests in a global security
for persons other than participants. These records will be the only means to transfer beneficial
ownership in a registered global security.
The laws of some states may require that specified purchasers of securities take physical
delivery of the securities in definitive form. These laws may limit the ability of those persons to
own, transfer or pledge beneficial interests in global securities.
So long as the depositary, or its nominee, is the registered owner of a registered global
security, the depositary or its nominee will be considered the sole owner or holder of the debt
securities represented by the registered global security for all purposes under the indenture.
Except as set forth below, owners of beneficial interests in a registered global security:
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may not have the debt securities represented by a registered
global security registered in their names; |
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will not receive or be entitled to receive physical delivery of
debt securities represented by a registered global security in
definitive form; and |
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will not be considered the owners or holders of debt securities
represented by a registered global security under the indenture. |
Accordingly, each person owning a beneficial interest in a registered global security must
rely on the procedures of the depositary for the registered global security and, if the person is
not a participant, on the procedures of the participant through which the person owns its
interests, to exercise any rights of a holder under the indenture applicable to the registered
global security.
We understand that, under existing industry practices, if we request any action of holders, or
if an owner of a beneficial interest in a registered global security desires to give or take any
action which a holder is entitled to give or take under the indenture, the depositary for the
registered global security would authorize the participants holding
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the relevant beneficial interests to give or take the action, and the participants would
authorize beneficial owners owning through the participants to give or take the action or would
otherwise act upon the instructions of beneficial owners holding through them.
Payment of Interest on and Principal of Registered Global Securities
We will make principal, premium, if any, and interest payments on debt securities represented
by a registered global security registered in the name of a depositary or its nominee to the
depositary or its nominee as the registered owner of the registered global security. None of
ADVENTRX, the trustee, or any paying agent for debt securities represented by a registered global
security will have any responsibility or liability for:
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any aspect of the records relating to, or payments made on account
of, beneficial ownership interests in such registered global
security; |
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maintaining, supervising, or reviewing any records relating to beneficial ownership interests; |
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the payments to beneficial owners of the global security of
amounts paid to the depositary or its nominee; or |
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any other matter relating to the actions and practices of the
depositary, its nominee or any of its participants. |
We expect that the depositary, upon receipt of any payment of principal, premium or interest
in respect of the global security, will immediately credit participants accounts with payments in
amounts proportionate to their beneficial interests in the principal amount of a registered global
security as shown on the depositarys records. We also expect that payments by participants to
owners of beneficial interests in a registered global security held through participants will be
governed by standing instructions and customary practices. This is currently the case with the
securities held for the accounts of customers registered in street name. Such payments will be
the responsibility of participants.
Exchange of Registered Global Securities
We may issue debt securities in definitive form in exchange for the registered global security
if both of the following occur:
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the depositary for any debt securities represented by a registered
global security is at any time unwilling or unable to continue as
depositary or ceases to be a clearing agency registered under the
Exchange Act; and |
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we do not appoint a successor depositary within 90 days. |
In addition, we may, at any time, determine not to have any of the debt securities of a series
represented by one or more registered global securities. In this event, we will issue debt
securities of that series in definitive form in exchange for all of the registered global security
or securities representing those debt securities.
Our Covenants
The indenture includes covenants by us, including among other things that we will make all
payments of principal and interest at the times and places required. The board resolution or
supplemental indenture establishing each series of debt securities may contain additional
covenants, including covenants which could restrict our right to incur additional indebtedness or
liens and to take certain actions with respect to our businesses and assets.
Events of Default
Unless otherwise indicated in the applicable prospectus supplement, the following will be
events of default under the indenture with respect to each series of debt securities issued under
the indenture:
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failure to pay when due any interest on any debt security of that series that continues for 30 days; |
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failure to pay when due the principal of, or premium, if any, on, any debt security of that series; |
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default in the payment of any sinking fund installment with
respect to any debt security of that series when due and payable; |
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failure to perform any other covenant or agreement of ours under
the indenture or the supplemental indenture with respect to that
series or the debt securities of that series, continued for 90
days after written notice to us by the trustee or holders of at
least 25% in aggregate principal amount of the outstanding debt
securities of the series to which the covenant or agreement
relates; |
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certain events of bankruptcy, insolvency or similar proceedings
affecting us and our subsidiaries; and |
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any other event of default specified in any supplemental indenture
under which such series of debt securities is issued. |
Except as to certain events of bankruptcy, insolvency or similar proceedings affecting us and
except as provided in the applicable prospectus supplement, if any event of default shall occur and
be continuing with respect to any series of debt securities under the indenture, either the trustee
or the holders of at least 25% in aggregate principal amount of outstanding debt securities of such
series may accelerate the maturity of all debt securities of such series. Upon certain events of
bankruptcy, insolvency or similar proceedings affecting us, the principal, premium, if any, and
interest on all debt securities of each series shall be immediately due and payable.
After any such acceleration, but before a judgment or decree based on acceleration has been
obtained by the trustee, the holders of a majority in aggregate principal amount of each affected
series of debt securities may waive all defaults with respect to such series and rescind and annul
such acceleration if all events of default, other than the non-payment of accelerated principal,
have been cured, waived or otherwise remedied.
No holder of any debt securities will have any right to institute any proceeding with respect
to the indenture or for any remedy under the indenture, unless such holder shall have previously
given to the trustee written notice of a continuing event of default and the holders of at least
25% in aggregate principal amount of the outstanding debt securities of the relevant series shall
have made written request and offered indemnity satisfactory to the trustee to institute such
proceeding as trustee, and the trustee shall not have received from the holders of a majority in
aggregate principal amount of the outstanding debt securities of such series a direction
inconsistent with such request and shall have failed to institute such proceeding within 60 days.
However, such limitations do not apply to a suit instituted by a holder of a debt security for
enforcement of payment of the principal of and premium, if any, or interest on such debt security
on or after the respective due dates expressed in such debt security.
Supplemental Indentures
We and the trustee may, at any time and from time to time, without prior notice to or consent of
any holders of debt securities after issuance of such debt securities, enter into one or more
supplemental indentures to, among other things:
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add guarantees to or secure any series of debt securities; |
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add any additional Events of Default; |
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provide for the succession of another person pursuant to the provisions of the
indenture relating to consolidations, mergers and sales of assets and the assumption by
such successor of our covenants, agreements, and obligations, or to otherwise comply
with the provisions of the indenture relating to consolidations, mergers, and sales of
assets; |
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surrender any right or power conferred upon us under the indenture or to add to our
covenants further covenants, restrictions, conditions or provisions for the protection
of the holders of all or any series of debt securities; |
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cure any ambiguity or to correct or supplement any provision contained in the
indenture, in any supplemental indenture or in any debt securities that may be
defective or inconsistent with any other provision contained therein, , so long as any
such action does not adversely affect the interests of the holders of debt securities
of any series in any material respect; |
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add or change or eliminate any of the provisions of the indenture to extent as shall
be necessary to permit or facilitate the issuance of debt securities in bear form,
registrable or not registrable as to principal, and with or without interest coupons; |
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add to or change any of the provisions of the indenture to permit the defeasance and
discharge of any series of debt securities pursuant to the indenture; |
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change, or eliminate any of the provisions of the indenture provided that any such
change or elimination shall become effective only when there are no debt securities
outstanding of any series created prior to the execution of such supplemental
indenture; |
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evidence and provide for the acceptance of appointment by a successor or separate
trustee; and |
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establish the form or terms of debt securities of any series and to make any change
that does not adversely affect the interests of the holders of debt securities. |
With the consent of the holders of at least a majority in principal amount of debt securities
of each series affected by such supplemental indenture (each series voting as one class), we and
the trustee may enter into one or more supplemental indentures for the purpose of adding any
provisions to or changing in any manner or eliminating any of the provisions of the indenture or
modifying in any manner the rights of the holders of debt securities of each such series.
Notwithstanding our rights and the rights of the trustee to enter into one or more
supplemental indentures with the consent of the holders of debt securities of the affected series
as described above, no such supplemental indenture to be entered into after issuance of the debt
securities shall, without the consent of the holder of each outstanding debt security of the
affected series, among other things:
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change the final maturity of the principal of, or any installment of interest on, any debt securities; |
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reduce the principal amount of any debt securities or the rate of interest on any debt securities; |
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change the currency in which any debt securities are payable; |
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release any security interest that may have been granted with respect to such debt securities; |
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impair the right of the holders to conduct a proceeding for any remedy available to the trustee; |
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reduce the percentage in principal amount of any series of debt
securities whose holders must consent to an amendment or
supplemental indenture; |
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modify the ranking or priority of the securities; |
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reduce any premium payable upon the redemption of any debt
securities or change the time at which any debt security may be
redeemed; or |
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make any change that adversely affects the relative rights of
holders of subordinated debt securities with respect to senior
debt securities. |
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Satisfaction and Discharge of the Indenture; Defeasance
Except to the extent set forth in a supplemental indenture with respect to any series of debt
securities, we, at our election, may discharge the indenture and the indenture shall generally
cease to be of any further effect with respect to that series of debt securities if (a) we have
delivered to the trustee for cancellation all debt securities of that series (with certain limited
exceptions) or (b) all debt securities of that series not previously delivered to the trustee for
cancellation shall have become due and payable, or are by their terms to become due and payable
within one year or are to be called for redemption within one year, and we have deposited with the
trustee the entire amount sufficient to pay at maturity or upon redemption all such debt
securities.
In addition, we have a legal defeasance option (pursuant to which we may terminate, with
respect to the debt securities of a particular series, all of our obligations under such debt
securities and the indenture with respect to such debt securities) and a covenant defeasance
option (pursuant to which we may terminate, with respect to the debt securities of a particular
series, our obligations with respect to such debt securities under certain specified covenants
contained in the indenture). If we exercise our legal defeasance option with respect to a series
of debt securities, payment of such debt securities may not be accelerated because of an event of
default. If we exercise our covenant defeasance option with respect to a series of debt
securities, payment of such debt securities may not be accelerated because of an event of default
related to the specified covenants.
We may exercise our legal defeasance option or our covenant defeasance option with respect to
the debt securities of a series only if we irrevocably deposit in trust with the trustee cash or
U.S. government obligations (as defined in the indenture) for the payment of principal, premium, if
any, and interest with respect to such debt securities to maturity or redemption, as the case may
be. In addition, to exercise either of our defeasance options, we must comply with certain other
conditions, including the delivery to the trustee of an opinion of counsel to the effect that the
holders of debt securities of such series will not recognize income, gain or loss for Federal
income tax purposes as a result of such defeasance and will be subject to Federal income tax on the
same amounts, in the same manner and at the same times as would have been the case if such
defeasance had not occurred (and, in the case of legal defeasance only, such opinion of counsel
must be based on a ruling from the Internal Revenue Service or other change in applicable Federal
income tax law).
The trustee will hold in trust the cash or U.S. government obligations deposited with it as
described above and will apply the deposited cash and the proceeds from deposited U.S. government
obligations to the payment of principal, premium, if any, and interest with respect to the debt
securities of the defeased series. In the case of subordinated debt securities, the money and U.S.
government obligations held in trust will not be subject to the subordination provisions of the
indenture.
Mergers, Consolidations and Certain Sales of Assets
Under the proposed form of indenture, we may not (1) consolidate with or merge into any other
person or entity or permit any other person or entity to consolidate with or merge into us in a
transaction in which we are not the surviving entity, or (2) transfer, lease or dispose of all or
substantially all of our assets to any other person or entity unless:
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the resulting, surviving or transferee entity shall be a
corporation organized and existing under the laws of the United
States or any state thereof and such resulting, surviving or
transferee entity shall expressly assume, by supplemental
indenture, all of our obligations under the debt securities and
the indenture; |
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immediately after giving effect to such transaction (and treating
any indebtedness which becomes an obligation of the resulting,
surviving or transferee entity as a result of such transaction as
having been incurred by such entity at the time of such
transaction), no default or event of default would occur or be
continuing; and |
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we shall have delivered to the trustee an officers certificate
and an opinion of counsel, each stating that such consolidation,
merger or transfer and such supplemental indenture (if any) comply
with the indenture. |
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Governing Law
The indenture and the debt securities will be governed by the laws of the State of New York.
No Personal Liability of Directors, Officers, Employees and Stockholders
No director, officer, incorporator or stockholder of ADVENTRX , as such, shall have any
liability for any obligations of ADVENTRX under the debt securities or the indenture or for any
claim based on, in respect of, or by reason of, such obligations or their creation, solely by
reason of his, her, or its status as director, officer, incorporator or stockholder of ADVENTRX. By
accepting a debt security, each holder waives and releases all such liability, but only such
liability. The waiver and release are part of the consideration for issuance of the debt
securities. Nevertheless, such waiver may not be effective to waive liabilities under the federal
securities laws and it has been the view of the SEC that such a waiver is against public policy.
Conversion or Exchange Rights
Any debt securities issued under the indenture may be convertible into or exchangeable for
shares of our equity securities. The terms and conditions of such conversion or exchange will be
set forth in the applicable prospectus supplement. Such terms may include, among others, the
following:
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the conversion or exchange price; |
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the conversion or exchange period; |
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provisions regarding our ability or that of the holder to convert or exchange the debt securities; |
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events requiring adjustment to the conversion or exchange price; and |
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provisions affecting conversion or exchange in the event of our redemption of such debt securities. |
Concerning the Trustee
The indenture provides that there may be more than one trustee with respect to one or more
series of debt securities. If there are different trustees for different series of debt
securities, each trustee will be a trustee of a trust under a supplemental indenture separate and
apart from the trust administered by any other trustee under such indenture. Except as otherwise
indicated in this prospectus or any prospectus supplement, any action permitted to be taken by a
trustee may be taken by the trustee only with respect to the one or more series of debt securities
for which it is the trustee under an indenture. Any trustee under the indenture or a supplemental
indenture may resign or be removed with respect to one or more series of debt securities. All
payments of principal of, premium, if any, and interest on, and all registration, transfer,
exchange, authentication and delivery of (including authentication and delivery on original
issuance of the debt securities), the debt securities of a series will be effected by the trustee
with respect to such series at an office designated by the trustee.
The indenture contains limitations on the right of the trustee, should it become a creditor of
ADVENTRX, to obtain payment of claims in certain cases or to realize on certain property received
in respect of any such claim as security or otherwise. If the trustee acquires an interest that
conflicts with any duties with respect to the debt securities, the trustee is required to either
resign or eliminate such conflicting interest to the extent and in the manner provided by the
indenture.
Limitations on Issuance of Bearer Debt Securities
Debt securities in bearer form are subject to special U.S. tax requirements and may not be
offered, sold, or delivered within the United States or its possessions or to a U.S. person, except
in certain transactions permitted by U.S. tax regulations. Investors should consult the relevant
prospectus supplement, in the event that bearer debt securities are issued for special procedures
and restrictions that will apply to such an offering.
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DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of common stock, preferred stock or debt securities.
Warrants may be offered independently or together with common stock, preferred stock or debt
securities offered by any prospectus supplement and may be attached to or separate from those
securities. While the terms we have summarized below will apply generally to any warrants that we
may offer under this prospectus, we will describe in particular the terms of any series of warrants
that we may offer in more detail in the applicable prospectus supplement and any applicable free
writing prospectus. The terms of any warrants offered under a prospectus supplement may differ
from the terms described below.
We will file as exhibits to the registration statement of which this prospectus is a part, or
will incorporate by reference from another report that we file with the SEC, the form of warrant
agreement, which may include a form of warrant certificate, that describes the terms of the of the
particular series of warrants we are offering before the issuance of the related series of
warrants. We may issue the warrants under a warrant agreement that we will enter into with a
warrant agent to be selected by us. The warrant agent will act solely as our agent in connection
with the warrants and will not assume any obligation or relationship of agency or trust for or with
any registered holders of warrants or beneficial owners of warrants. The following summary of
material provisions of the warrants and warrant agreements are subject to, and qualified in their
entirety by reference to, all the provisions of the warrant agreement and warrant certificate
applicable to a particular series of warrants. We urge you to read the applicable prospectus
supplement and any applicable free writing prospectus related to the particular series of warrants
that we sell under this prospectus, as well as the complete warrant agreements and warrant
certificates that contain the terms of the warrants.
The particular terms of any issue of warrants will be described in the prospectus supplement
relating to the issue. Those terms may include:
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the title of such warrants; |
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the aggregate number of such warrants; |
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the price or prices at which such warrants will be issued; |
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the currency or currencies (including composite currencies) in which the price of
such warrants may be payable; |
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the terms of the securities purchasable upon exercise of such warrants and the
procedures and conditions relating to the exercise of such warrants; |
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the price at which the securities purchasable upon exercise of such warrants may be
purchased; |
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the date on which the right to exercise such warrants will commence and the date on
which such right shall expire; |
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any provisions for adjustment of the number or amount of securities receivable upon
exercise of the warrants or the exercise price of the warrants; |
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if applicable, the minimum or maximum amount of such warrants that may be exercised
at any one time; |
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if applicable, the designation and terms of the securities with which such warrants
are issued and the number of such warrants issued with each such security; |
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if applicable, the date on and after which such warrants and the related securities
will be separately transferable; |
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information with respect to book-entry procedures, if any; |
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the terms of any rights to redeem or call the warrants; |
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United States federal income tax consequences of holding or exercising the warrants,
if material; and |
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any other terms of such warrants, including terms, procedures and limitations
relating to the exchange or exercise of such warrants. |
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Each warrant will entitle its holder to purchase the principal amount of debt securities or
the number of shares of preferred stock or common stock at the exercise price set forth in, or
calculable as set forth in, the applicable prospectus supplement. Unless we otherwise specify in
the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time
up to the specified time on the expiration date that we set forth in the applicable prospectus
supplement. After the close of business on the expiration date, unexercised warrants will become
void.
We will specify the place or places where, and the manner in which, warrants may be exercised
in the warrant agreement or warrant certificate and applicable prospectus supplement. Upon receipt
of payment and the warrant certificate properly completed and duly executed at the corporate trust
office of the warrant agent or any other office indicated in the applicable prospectus supplement,
we will, as soon as practicable, issue and deliver the purchased securities. If less than all of
the warrants represented by the warrant certificate are exercised, a new warrant certificate will
be issued for the remaining amount of warrants. If we so indicate in the applicable prospectus
supplement, holders of the warrants may surrender securities as all or part of the exercise price
for warrants.
Prior to the exercise of any warrants to purchase common stock, preferred stock or debt
securities, holders of the warrants will not have any of the rights of holders of the common stock,
preferred stock or debt securities purchasable upon exercise, including (i) in the case of warrants
for the purchase of common stock or preferred stock, the right to vote or to receive any payments
of dividends or payments upon our liquidation, dissolution or winding up on the common stock or
preferred stock purchasable upon exercise, if any; or (ii) in the case of warrants for the purchase
of debt securities, the right to receive payments of principal of, any premium or interest on the
debt securities purchasable upon exercise or to enforce covenants in the applicable indenture.
DESCRIPTION OF UNITS
The following description, together with the additional information we may include in any
applicable prospectus supplement, summarizes the material terms and provisions of the units that we
may offer under this prospectus. While the terms we have summarized below will apply generally to
any units that we may offer under this prospectus, we will describe the particular terms of any
series of units in more detail in the applicable prospectus supplement. The terms of any units
offered under a prospectus supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are set forth in this prospectus or
offer a security that is not registered and described in this prospectus at the time of its
effectiveness.
We will file with the SEC, the form of unit agreement that describes the terms of the series
of units we are offering, and any supplemental agreements, before the issuance of the related
series of units. The following summaries of material terms and provisions of the units are subject
to, and qualified in their entirety by reference to, all the provisions of the unit agreement and
any supplemental agreements applicable to a particular series of units. We urge you to read the
applicable prospectus supplements related to the particular series of units that we sell under this
prospectus, as well as the complete unit agreement and any supplemental agreements that contain the
terms of the units.
General
We may issue units comprised of one or more debt securities, shares of common stock, shares of
preferred stock and warrants in any combination. Each unit will be issued so that the holder of
the unit is also the holder of each security included in the unit. Thus, the holder of a unit will
have the rights and obligations of a holder of each included security. The unit agreement under
which a unit is issued may provide that the securities included in the unit may not be held or
transferred separately, at any time or at any time before a specified date.
We will describe in the applicable prospectus supplement the terms of the series of units,
including, but not limited to:
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the designation and terms of the units and of the securities comprising
the units, including whether and under what circumstances those securities
may be held or transferred separately; |
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any provisions of the governing unit agreement that differ from those
described below; and |
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any provisions for the issuance, payment, settlement, transfer or
exchange of the units or of the securities comprising the units. |
The provisions described in this section, as well as those described under Description of
Common Stock and Preferred Stock, Description of Debt Securities and Description of Warrants
will apply to each unit and to any common stock, preferred stock, debt security or warrant included
in each unit, respectively.
Issuance in Series
We may issue units in such amounts and in numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable unit agreement and will not
assume any obligation or relationship of agency or trust with any holder of any unit. A single
bank or trust company may act as unit agent for more than one series of units. A unit agent will
have no duty or responsibility in case of any default by us under the applicable unit agreement or
unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to
make any demand upon us. Any holder of a unit may, without the consent of the related unit agent
or the holder of any other unit, enforce by appropriate legal action its rights as holder under any
security included in the unit.
We, the unit agents and any of their agents may treat the registered holder of any unit
certificate as an absolute owner of the units evidenced by that certificate for any purpose and as
the person entitled to exercise the rights attaching to the units so requested, despite any notice
to the contrary.
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PLAN OF DISTRIBUTION
We may sell the securities to or through underwriters or dealers, through agents, or directly
to one or more purchasers. A prospectus supplement or supplements (and any related free writing
prospectus that we may authorize to be provided to you) will describe the terms of the offering of
the securities, including, to the extent applicable
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the name or names of any agents or underwriters; |
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the purchase price of the securities being offered and the proceeds we will receive
from the sale; |
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any over-allotment options under which underwriters may purchase additional
securities from us; |
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any agency fees or underwriting discounts and other items constituting agents or
underwriters compensation; |
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any public offering price; |
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any discounts or concessions allowed or reallowed or paid to dealers; and |
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any securities exchanges or markets on which such securities may be listed. |
We may distribute the securities from time to time in one or more transactions at:
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fixed price or prices, which may be changed from time to time; |
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market prices prevailing at the time of sale; |
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prices related to such prevailing market prices; or |
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negotiated prices. |
Agents
We may designate agents who agree to use their reasonable efforts to solicit purchases of our
securities for the period of their appointment or to sell our securities on a continuing basis. We
will name any agent involved in the offering and sale of securities and we will describe any
commissions we will pay the agent in the applicable prospectus supplement.
Underwriters
If we use underwriters for a sale of securities, the underwriters will acquire the securities
for their own account. The underwriters may resell the securities in one or more transactions,
including negotiated transactions, at a fixed public offering price or at varying prices determined
at the time of sale. The obligations of the underwriters to purchase the securities will be
subject to the conditions set forth in the applicable underwriting agreement. Subject to certain
conditions, the underwriters will be obligated to purchase all the securities of the series offered
if they purchase any of the securities of that series. We may change from time to time any public
offering price and any discounts or concessions the underwriters allow or reallow or pay to
dealers. We may use underwriters with whom we have a material relationship. We will describe the
nature of any such relationship in any applicable prospectus supplement naming any such
underwriter. Only underwriters we name in the prospectus supplement are underwriters of the
securities offered by the prospectus supplement.
We may provide agents and underwriters with indemnification against civil liabilities related
to offerings under this prospectus, including liabilities under the Securities Act, or contribution
with respect to payments that the agents or underwriters may make with respect to these
liabilities.
Direct Sales
We may also sell securities directly to one or more purchasers without using underwriters or
agents. Underwriters, dealers and agents that participate in the distribution of the securities
may be underwriters as defined in the Securities Act, and any discounts or commissions they receive
from us and any profit on their resale of the securities may be treated as underwriting discounts
and commissions under the Securities Act. We will identify in
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the applicable prospectus supplement any underwriters, dealers or agents and will describe their
compensation. We may have agreements with the underwriters, dealers and agents to indemnify them
against specified civil liabilities, including liabilities under the Securities Act. Underwriters,
dealers and agents may engage in transactions with or perform services for us in the ordinary
course of their businesses.
Trading Markets and Listing of Securities
Unless otherwise specified in the applicable prospectus supplement, each class or series of
securities will be a new issue with no established trading market, other than our common stock,
which is currently listed on the NYSE Amex. We may elect to list any other class or series of
securities on any exchange or market, but we are not obligated to do so. It is possible that one
or more underwriters may make a market in a class or series of securities, but the underwriters
will not be obligated to do so and may discontinue any market making at any time without notice.
We cannot give any assurance as to the liquidity of the trading market for any of the securities.
Stabilization Activities
Any underwriter may engage in overallotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act.
Overallotment involves sales in excess of the offering size, which create a short position.
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing
bids do not exceed a specified maximum. Short covering transactions involve purchases of the
securities in the open market after the distribution is completed to cover short positions.
Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the
securities originally sold by the dealer are purchased in a covering transaction to cover short
positions. Those activities may cause the price of the securities to be higher than it would
otherwise be. If commenced, the underwriters may discontinue any of these activities at any time.
Passive Market Making
Any underwriters who are qualified market makers on the NYSE Amex may engage in passive market
making transactions in the securities on the NYSE Amex in accordance with Rule 103 of Regulation M,
during the business day prior to the pricing of the offering, before the commencement of offers or
sales of the securities. Passive market makers must comply with applicable volume and price
limitations and must be identified as passive market makers. In general, a passive market maker
must display its bid at a price not in excess of the highest independent bid for such security. If
all independent bids are lowered below the passive market makers bid, however, the passive market
makers bid must then be lowered when certain purchase limits are exceeded.
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LEGAL MATTERS
The validity of the securities being offered by this prospectus will be passed upon for us by
DLA Piper LLP (US), San Diego, California. If the validity of any securities is also passed upon
by counsel any underwriters, dealers or agents, that counsel will be named in the prospectus
supplement relating to that specific offering.
EXPERTS
The consolidated financial statements and schedule of ADVENTRX Pharmaceuticals, Inc. as of
December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders
equity (deficit) and comprehensive loss and cash flows for the years then ended and for the period
from January 1, 2002 through December 31, 2008 have been incorporated by reference herein and in
the registration statement in reliance upon the report of J.H. Cohn LLP, independent registered
public accounting firm, incorporated by reference herein, and upon the authority of said firm as
experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information
electronically with the SEC. You may read and copy these reports, proxy statements and other
information at the SECs public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public
reference room. You can request copies of these documents by writing to the SEC and paying a fee
for the copying costs. The SEC also maintains an Internet site that contains reports, proxy and
information statements, and other information regarding issuers that file electronically with the
SEC, including us. The SECs Internet site can be found at http://www.sec.gov. In addition, we
make available on or through our Internet site copies of these reports as soon as reasonably
practicable after we electronically file or furnish them to the SEC. Our Internet site can be
found at http://www.adventrx.com.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
We are allowed to incorporate by reference information contained in documents that we file
with the SEC. This means that we can disclose important information to you by referring you to
those documents and that the information in this prospectus is not complete. You should read the
information incorporated by reference for more detail. We incorporate by reference in two ways.
First, we list below certain documents that we have already filed with the SEC. The information in
these documents is considered part of this prospectus. Second, the information in documents that we
file in the future will update and supersede the current information in, and be incorporated by
reference in, this prospectus.
We incorporate by reference into this prospectus the documents listed below, any filings we
make with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date
of the initial registration statement of which this prospectus is a part and prior to the
effectiveness of the registration statement, and any filings we make with the SEC pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act from the date of this prospectus until the
termination of this offering (in each case, except for the information furnished under Item 2.02 or
Item 7.01 in any current report on Form 8-K and Form 8-K/A):
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our annual report on Form 10-K for the year ended December 31, 2008 filed with the
SEC on March 27, 2009 (File No. 001-32157- 09708145); |
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the information specifically incorporated by reference into our annual report on
Form 10-K for the year ended December 31, 2008 from our definitive proxy statement on
Schedule 14A filed with the SEC on April 30, 2009 (File No. 001-32157-09781242); |
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our quarterly report on Form 10-Q for the quarterly period
ended March 31, 2009
filed with the SEC on May 15, 2009 (File No. 001-32157-09829059); |
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our current report on Form 8-K filed with the SEC on January 2, 2009 (File No.
001-32157-09501628); |
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our current report on Form 8-K filed with the SEC on January 5, 2009 (File No.
001-32157-09505346); |
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our current report on Form 8-K filed with the SEC on January 8, 2009 (File No.
001-32157-09516181); |
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our current report on Form 8-K filed with the SEC on February 2, 2009 (File No.
001-32157-09561715); |
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our current report on Form 8-K filed with the SEC on February 5, 2009 (File No.
001-32157-09573163); |
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our current report on Form 8-K filed with the SEC on February 10, 2009 (File No.
001-32157-09583495); |
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our current report on Form 8-K filed with the SEC on March 20, 2009 (File No.
001-32157-09696365); |
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our current report on Form 8-K filed with the SEC on March 25, 2009 (File No.
001-32157-09702853); |
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our current report on Form 8-K filed with the SEC on March 25, 2009 (File No.
001-32157-09702857); |
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our current report on Form 8-K filed with the SEC on May 7, 2009 (File No.
001-32157-09806033); and |
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the description of our common stock contained in our registration statement on Form
8-A filed with the SEC on April 27, 2004 (File No. 001-32157-041020580). |
We will provide each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by reference into
this prospectus but not delivered with this prospectus upon written or oral request at no cost to
the requester. Requests should be directed to: ADVENTRX Pharmaceuticals, Inc., 6725 Mesa Ridge
Road, Suite 100, San Diego, California 92121, Attn: Investor Relations, telephone: (858) 552-0866.
This prospectus is part of a registration statement on Form S-3 that we filed with the SEC.
That registration statement contains more information than this prospectus regarding us and our
common stock, including certain exhibits and schedules. You can obtain a copy of the registration
statement from the SEC at the address listed above or from the SECs Internet website.
You should rely only on the information provided in and incorporated by reference into this
prospectus or any prospectus supplement. We have not authorized anyone else to provide you with
different information. You should not assume that the information in this prospectus or any
prospectus supplement is accurate as of any date other than the date on the front cover of these
documents.
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ADVENTRX PHARMACEUTICALS, INC.
$25,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
PROSPECTUS
June 4, 2009