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Filing
Table of Contents
As filed with the Securities and Exchange Commission on
May 1, 2006
Registration Statement
No. 333-
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form S-3
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT OF
1933
ADVENTRX Pharmaceuticals,
Inc.
(Exact name of Registrant as
specified in its charter)
Delaware | 84-1318182 | |
(State or other jurisdiction
of incorporation or organization) |
(I.R.S. Employer Identification Number) |
6725 Mesa Ridge Road,
Suite 100
San Diego, California
92121
(Address, including zip code,
and telephone number,
including area code, of
Registrants principal executive offices)
Carrie E. Carlander
Chief Financial
Officer
ADVENTRX Pharmaceuticals,
Inc.
6725 Mesa Ridge Road,
Suite 100
San Diego, California
92121
(858) 552-0866
facsimile:
(858) 552-0867
(Name, address, including zip
code, and telephone number,
including area code, of agent
for service)
Copies of all communications
to:
Venrice R.
Palmer, Esq.
Charles Lee, Esq.
John H. Kim, Esq.
Bingham McCutchen LLP
Three Embarcadero
Center
San Francisco, California
94111
phone:
(415) 393-2000
facsimile:
(415) 393-2286
email:
venrice.palmer@bingham.com
john.kim@bingham.com
Approximate date of commencement of proposed sale to the
public: as soon as practicable after the
effective date of this registration statement.
If the only securities being registered on this form are being
offered pursuant to dividend or interest reinvestment plans,
please check the following
box. o
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933, other than
securities offered only in connection with dividend or interest
reinvestment plans, check the following
box: þ
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
please check the following box and list the Securities Act
registration statement number of the earlier effective
registration statement for the same
offering: o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering: o
If this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that
shall become effective upon filing with the Commission pursuant
to Rule 462(e) under the Securities Act, check the
following box. o
If this Form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities
Act, check the following box. o
CALCULATION OF REGISTRATION
FEE
Proposed Maximum |
Amount of |
|||||
Title of Each Class of |
Aggregate |
Registration |
||||
Securities to be Registered(1) | Offering Price (2) | Fee | ||||
Common stock, par value
$0.001 per share
|
$100,000,000 | $10,700 | ||||
(1) | In addition to the common stock set forth in the table, the amount to be registered includes an indeterminate number of shares issuable pursuant to stock splits and stock dividends in accordance with Securities Act Rule 416(b). | |
(2) | We are registering hereunder such indeterminate number of shares of common stock as shall have an aggregate initial offering price not to exceed $100,000,000. The registration fee has been calculated pursuant to Rule 457(o) under the Securities Act of 1933. |
The Registrant hereby amends this Registration Statement on
such date or dates as may be necessary to delay its effective
date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall
thereafter become effective in accordance with section 8(a)
of the Securities Act of 1933, or until the Registration
Statement shall become effective on such date as the Securities
and Exchange Commission, acting pursuant to said
section 8(a), may determine.
Table of Contents
The
information in this prospectus is not complete and may be
changed. No securities may be sold until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not
permitted. |
SUBJECT TO COMPLETION
DATED: ,
2006
PROSPECTUS
$100,000,000
Common Stock
ADVENTRX Pharmaceuticals,
Inc.
6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
(858) 558-0866
ADVENTRX Pharmaceuticals, Inc. (the Company) is
offering an aggregate of up to $100,000,000 of its common stock.
We may sell the shares covered by this prospectus from time to
time in transactions on the American Stock Exchange LLC, in the
over-the-counter
market or in negotiated transactions. We may sell directly, or
through agents or dealers designated from time to time, at fixed
prices, at prevailing market prices at the time of sale, at
varying prices determined at the time of sale or at negotiated
prices.
Our common stock is listed on the American Stock Exchange LLC
under the symbol ANX. On April 28, 2006, the
last reported sale price of our common stock on the American
Stock Exchange LLC was $4.88 per share.
Investing In Our Common Stock Involves Risks. See Risk
Factors Beginning On Page 7.
Neither the Securities and Exchange Commission nor any state
securities regulator has approved or disapproved the shares of
common stock covered by this prospectus, or determined if this
prospectus is truthful or complete. Any representation to the
contrary is a criminal offense.
The date of this prospectus
is ,
2006
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Important
Information About This Prospectus
This prospectus is part of a shelf registration
statement that we filed with the SEC. By using a shelf
registration statement, we may sell our common stock, as
described in this prospectus, from time to time in one or more
offerings. Each time we sell our common stock, we will provide a
supplement to this prospectus that contains specific information
about the terms of that offering. The supplement may also add,
update or change information contained in this prospectus.
Before purchasing any of our common stock, you should carefully
read both this prospectus and any supplement, together with the
additional information incorporated into this prospectus or
described under the heading Where You Can Find More
Information.
You should rely only on the information contained or
incorporated by reference in this prospectus and any prospectus
supplement. We have not authorized any other person to provide
you with different information. If anyone provides you with
different or inconsistent information, you should not rely on
it. We will not make an offer to sell our common stock in any
jurisdiction where the offer or sale is not permitted. The
information in this prospectus and any prospectus supplement is
accurate as of the date on the front cover of this prospectus or
any prospectus supplement, and the information in documents we
file with the SEC and incorporate by reference into this
prospectus or any prospectus supplement, is accurate as of the
date on those documents.
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EXHIBIT 5.1 | ||||||||
EXHIBIT 23.1 | ||||||||
EXHIBIT 23.2 |
In this prospectus, ADVENTRX, the
company, we, us, and
our refer to ADVENTRX Pharmaceuticals, Inc.
Special
Note Regarding Forward-Looking Statements
Some of the statements under Our Company, Risk
Factors and elsewhere in this prospectus constitute
forward-looking statements. These statements involve known and
unknown risks, uncertainties, and other factors that may cause
our actual results to be materially different from projected
results expressed or implied by the forward-looking statements.
These factors include, among others, those listed under
Risk Factors and elsewhere in this prospectus.
In some cases, you can identify forward-looking statements by
terms such as may, will,
should, expects, plans,
anticipates, believes,
estimates, predicts,
potential, or continue or similar terms.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance, or
achievements. Our actual results could differ materially from
those expressed or implied by these forward-looking statements
as a result of various factors, including the risk factors
described under the heading Risk Factors and
elsewhere in this prospectus. We undertake no obligation to
update publicly any forward-looking statements for any reason,
except as required by law, even as new information becomes
available or other events occur in the future.
Where You
Can Find More Information About Us
We file annual, quarterly and current reports, proxy statements
and other information with the Securities and Exchange
Commission. You may read and copy any document we file with the
Commission at the Public Reference Room at the Commission, 100 F
Street, N.E., Washington, D.C. 20549. Please call
1-800-SEC-0330
for further information concerning the Public Reference Room.
The Commission also makes these documents and other information
available on its website at http://www.sec.gov. We also maintain
a website at http://www.adventrx.com. The material on our
website is not a part of this prospectus or any prospectus
supplement.
We have filed with the Commission a registration statement under
the Securities Act on
Form S-3
relating to the common stock offered by this prospectus. This
prospectus and any prospectus supplement constitute a part of
the registration statement but do not contain all of the
information set forth in the registration statement and its
exhibits. For further information, we refer you to the
registration statement and its exhibits.
The Commission allows us to incorporate by reference
the information we file with it, which means that we can
disclose certain information to you by referring you to another
document we have filed with the Commission. We may furnish other
information to the Commission which is not considered to be
filed and is therefore not incorporated by reference
into or otherwise a part of this prospectus, unless we indicate
to the contrary. The information incorporated by reference is an
important part of this prospectus and information that we file
later with
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the Commission will automatically update this prospectus and
replace any outdated information. We incorporate by reference
the following:
(a) the section entitled Description of
Registrants Securities contained in the
Registrants Registration Statement on
Form 8-A
(file
No. 001-32157)
filed with the Commission on April 27, 2004;
(b) our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2005 filed with the
Commission on March 16, 2006;
(c) our Current Report on
Form 8-K
filed with the Commission on January 30, 2006;
(d) our Current Report on
Form 8-K
filed with the Commission on January 31, 2006;
(e) our Current Report on
Form 8-K
filed with the Commission on February 6, 2006;
(f) our Current Report on
Form 8-K
filed with the Commission on February 15, 2006;
(g) our Current Report on
Form 8-K
filed with the Commission on March 1, 2006;
(h) our Current Report on
Form 8-K
filed with the Commission on March 20, 2006
(Items 4.02, 8.01 and 9.01), as amended by Amendment
No. 1 filed with the Commission on March 27, 2006;
(i) our Current Report on
Form 8-K
filed with the Commission on March 20, 2006
(Items 8.01 and 9.01);
(j) our Current Report on
Form 8-K
filed with the Commission on April 6, 2006;
(k) our Current Report on
Form 8-K
filed with the Commission on April 11, 2006 as
amended by Amendment No. 1; and
(l) any future filings we make with the Commission under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act after the date of the initial registration statement and
prior to effectiveness of the registration statement, and until
we file a post-effective amendment which indicates the
termination of the offering of the securities made by this
prospectus.
You may request a copy of these filings, at no cost, by writing
or telephoning:
Carrie E. Carlander
Chief Financial Officer
ADVENTRX Pharmaceuticals, Inc.
6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
(858) 552-0866
We will provide exhibits to these filings at no cost only if
they are specifically incorporated into those filings.
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Our
Company
We are a biopharmaceutical research and development company
focused on introducing new technologies for anticancer and
antiviral treatments that improve the performance and safety of
existing drugs by addressing significant problems such as drug
metabolism, toxicity, bioavailability and resistance. We do not
manufacture, market, sell or distribute any product. Pursuant to
license agreements with University of Southern California and SD
Pharmaceuticals, Inc., we have rights to drug candidates in
varying stages of development. Our current drug candidates are
CoFactor, ANX-530, Selone and Thiovir. All of these drug
candidates are described in our Annual Report on
Form 10-KSB
for the fiscal year ended December 31, 2005.
On May 30, 2003, we merged our wholly-owned subsidiary,
Biokeys, Inc., into the Company and changed our name from
Biokeys Pharmaceuticals, Inc. to ADVENTRX Pharmaceuticals, Inc.
The merger had no effect on our financial statements.
In July 2004, we formed a wholly-owned subsidiary, ADVENTRX
(Europe) Ltd., in the United Kingdom for the purpose of
conducting drug trials in the European Union.
We have incurred net losses since our inception. As of
December 31, 2005, our accumulated deficit was
approximately $59,964,840 . We expect to incur substantial and
increasing losses for the next several years as we continue
development and possible commercialization of new products.
To date, we have funded our operations primarily through sales
of equity securities.
Our business is subject to significant risks, including risks
inherent in our ongoing clinical trials, the regulatory approval
processes, the results of our research and development efforts,
commercialization, and competition from other pharmaceutical
companies.
Recent
Developments
On April 7, 2006, we entered into an Agreement and Plan of
Merger (the Merger Agreement) among the Company, SD
Pharmaceuticals, Inc., a Delaware corporation (SDP),
Speed Acquisition, Inc., a Delaware corporation and a
wholly-owned subsidiary of the Company (Merger Sub),
Paul Marangos and Andrew X. Chen, each as stockholders of SDP
and Paul Marangos, as an individual acting as the stockholder
representative. Pursuant to the Merger Agreement, we will
acquire SDP through the merger of Merger Sub into SDP and SDP
will continue as the surviving corporation and as a wholly-owned
subsidiary of the Company (the Merger).
Upon the closing of the transaction on April 26, 2006,
ADVENTRX acquired certain U.S. and ex-U.S. intellectual
property rights to eight oncology and infectious disease product
candidates, including certain ex-US rights to SDP-012 (ANX-530,
vinorelbine emulsion). In October 2005, ADVENTRX announced it
had licensed US development and marketing rights to SDP-012
(ANX-530) from SD Pharma. Certain product candidates that
ADVENTRX acquired as a result of the merger are based on a
nano-emulsion technology for both soluble and insoluble
parenteral drugs. The nano-emulsion technology was developed by
Dr. Andrew Chen and is designed to enable the delivery of vein
irritating or difficult to dissolve drugs without
excipient-induced adverse effects. Many of the product
candidates are based on currently approved drugs and may qualify
for the 505(b)(2) regulatory process. Certain product candidates
obtained in the transaction are being evaluated by ADVENTRX as
possible out-licensing opportunities.
The SD Pharma product portfolio consists of five anticancer and
three anti-infective therapies which are listed below:
| SDP-013 A non-allergenic, non cremophor-containing emulsion formulation of paclitaxel (Taxoltm) designed to eliminate the need for immunosuppressant premedication, which is recommended for paclitaxel therapy to reduce the incidence and severity of severe hypersensitivity reaction. Paclitaxel is approved to treat breast, ovarian and non-small cell lung cancers. Taxoltm worldwide sales were approximately $750 million in 2005. (Source: Bristol-Myers Squibb). | |
| SDP-014 A novel docetaxel (Taxoteretm) formulation not containing polysorbate 80 or other detergents, intended to eliminate the need for multiday immunosuppressant premedication, which is recommended for |
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docetaxel therapy to reduce the incidence and severity of allergic reaction. Taxoteretm is approved to treat breast, non-small cell lung, prostate and gastric cancers. Worldwide Taxoteretm sales were approximately $1.6 billion in 2005. (Source: Sanofi-Aventis) |
| SDP-012 (vinorelbine emulsion) A novel emulsion formulation of vinorelbine tartrate designed to reduce vein irritation associated with the drug. Vinorelbine is approved to treat non-small cell lung cancer. According to IMS Health, worldwide sales of vinorelbine in 2005 were over $150 million. | |
| SDP-111 A novel formulation of beta-elemene, a small molecule anticancer agent belonging to the triterpene family and currently approved in China for a variety of cancers. | |
| SDP-112 An emulsion formulation of alpha-tocopheryl succinate, a form of vitamin E which has been shown to selectively facilitate apoptosis, or cell death, in cancer cells. | |
| SDP-015 A proprietary intravenous formulation of an approved antibiotic in the macrolide family known as clarithromycin. Clarithromycin is approved for mild to moderate bacterial infections such as in community-acquired pneumonia. Only oral formulations of clarithromycin are currently available in the US. | |
| SDP-011 A broad spectrum intranasal/topical anti-viral gel intended for use in cold and flu and other viral indications as an over-the-counter (OTC) product. | |
| SDP-016 A novel formulation of vancomycin, a parenteral glycopeptide antibiotic approved to treat gram-positive bacterial infections. SDP-016 is designed to reduce the vein irritation and phlebitis associated with the IV-delivered drug. |
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Risk
Factors
Readers and prospective investors in our securities should
carefully consider the following risk factors as well as the
other information contained or incorporated by reference in this
report. The risks and uncertainties described below are not the
only ones facing us. Additional risks and uncertainties that
management is not aware of or focused on or that management
currently deems immaterial may also impair our business
operations. This report is qualified in its entirety by these
risk factors.
If any of the following risks actually occur, the Companys
financial condition and results of operations could be
materially and adversely affected. If this were to happen, the
value of the Companys securities could decline
significantly, and you could lose all or part of your investment.
We
have a substantial accumulated deficit and limited working
capital.
We had an accumulated deficit of $59,964,840 as of
December 31, 2005. Since we presently have no source of
revenues and are committed to continuing our product research
and development program, significant expenditures and losses
will continue until development of new products is completed and
such products have been clinically tested, approved by the FDA
or other regulatory agencies and successfully marketed. In
addition, we fund our operations primarily through the sale of
equity securities, and have had limited working capital for our
product development and other activities. We do not believe that
debt financing from financial institutions will be available
until at least the time that one of our products is approved for
commercial production.
We
have no current product sales revenues or profits.
We have devoted our resources to developing a new generation of
therapeutic drug products, but such products cannot be marketed
until clinical testing is completed and governmental approvals
have been obtained. Accordingly, there is no current source of
revenues, much less profits, to sustain our present activities,
and no revenues will likely be available until, and unless, the
new products are clinically tested, approved by the FDA or other
regulatory agencies and successfully marketed, either by us or a
marketing partner, an outcome which we are not able to guarantee.
It is
uncertain that we will have access to future
capital.
We do not expect to generate positive cash flow from operations
for at least the next several years. As a result, substantial
additional equity or debt financing for research and development
or clinical development will be required to fund our activities.
Although we have raised equity financing in the past, including
in April 2004 and July 2005, we cannot be certain that we will
be able to continue to obtain such financing on favorable or
satisfactory terms, if at all, or that it will be sufficient to
meet our cash requirements. Any additional equity financing
could result in substantial dilution to stockholders, and debt
financing, if available, would likely involve restrictive
covenants that preclude us from making distributions to
stockholders and taking other actions beneficial to
stockholders. If adequate funds are not available, we may be
required to delay or reduce the scope of our drug development
program or attempt to continue development by entering into
arrangements with collaborative partners or others that may
require us to relinquish some or all of our rights to
proprietary drugs. The inability to adequately and timely fund
our capital requirements would have a material adverse effect on
us.
We are
not certain that we will be successful in the development of our
drug candidates.
The successful development of any new drug is highly uncertain
and is subject to a number of significant risks. Our drug
candidates, all of which are in a development stage, require
significant, time-consuming and costly development, testing and
regulatory clearance. This process typically takes several years
and can require substantially more time. Risks include, among
others, the possibility that a drug candidate will (i) be
found to be ineffective or unacceptably toxic, (ii) have
unacceptable side effects, (iii) fail to receive necessary
regulatory clearances, (iv) not achieve broad market
acceptance, (v) be subject to competition from third
parties who may market equivalent or superior products,
(vi) be affected by third parties holding proprietary
rights that will preclude us from marketing a drug product, or
(vii) not be able to be manufactured by manufacturers in a
timely manner in accordance with required standards of quality.
There can be no assurance that the development of our drug
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candidates will demonstrate the efficacy and safety of our drug
candidates as therapeutic drugs, or, even if demonstrated, that
there will be sufficient advantages to their use over other
drugs or treatments so as to render the drug product
commercially viable. In the past, we have been faced with
limiting the scope
and/or
delaying the launch of preclinical and clinical drug trials due
to limited cash and personnel resources. We have also chosen to
terminate licenses of some drug candidates that were not showing
sufficient promise to justify continued expense and development.
In the event that we are not successful in developing and
commercializing one or more drug candidates, investors are
likely to realize a loss of their entire investment.
We have been delayed at certain times in the past in the
development of our drug products by limited funding. In
addition, if certain of our scientific and technical personnel
resigned at or about the same time, the development of our drug
products would probably be delayed until new personnel were
hired and became familiar with the development programs.
Positive
results in preclinical and clinical trials do not ensure that
future clinical trials will be successful or that drug
candidates will receive all necessary regulatory approvals for
the marketing, distribution or sale of such drug
candidates.
Success in preclinical and clinical trials does not ensure that
large-scale clinical trials will be successful. Clinical results
are frequently susceptible to varying interpretations that may
delay, limit or prevent regulatory approvals. The length of time
necessary to complete clinical trials 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 the past, we have terminated licenses of drug
candidates when our preclinical trials did not support or verify
earlier preclinical data. There is a significant risk that any
of our drug candidates could fail to show satisfactory results
in continued trials, and would not justify further development.
We
will face intense competition from other companies in the
pharmaceutical industry.
We are engaged in a segment of the pharmaceutical industry that
is highly competitive and rapidly changing. If successfully
developed and approved, any of our drug candidates will likely
compete with several existing therapies. CoFactor, our leading
drug candidate, would likely compete against a well-established
product, leucovorin. In addition, there are numerous companies
with a focus in oncology
and/or
anti-viral therapeutics that are pursuing the development of
pharmaceuticals that target the same diseases as are targeted by
the drugs being developed by us. We anticipate that we will face
intense and increasing competition in the future as new products
enter the market and advanced technologies become available. We
cannot assure 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 drugs obsolete or noncompetitive prior
to our recovery of development and commercialization expenses.
Many of our likely competitors such as Merck and Pfizer, will
also have significantly greater financial, technical and human
resources and will likely be better equipped to develop,
manufacture and market products. In addition, many of these
competitors have extensive experience in preclinical testing and
clinical trials, obtaining FDA and other regulatory approvals
and manufacturing and marketing pharmaceutical products. A
number of these competitors also 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. Companies such
as Gilead, Roche and GlaxoSmithKline all have drugs in various
stages of development that could become competitors.
Accordingly, competitors may succeed in commercializing products
more rapidly or effectively than us, which would have a material
adverse effect on us.
There
is no assurance that our products will have market
acceptance.
Our success will depend in substantial part on the extent to
which a drug product, if eventually approved for commercial
distribution, achieves market acceptance. The degree of market
acceptance will depend upon a number
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of factors, including (i) the receipt and scope of
regulatory approvals, (ii) the establishment and
demonstration in the medical community of the safety and
efficacy of a drug product, (iii) the products
potential advantages over existing treatment methods and
(iv) reimbursement policies of government and third party
payors. We cannot predict or guarantee that physicians,
patients, healthcare insurers or maintenance organizations, or
the medical community in general, will accept or utilize any of
our drug products.
The
unavailability of health care reimbursement for any of our
products will likely adversely impact our ability to effectively
market such products and whether health care reimbursement will
be available for any of our products is uncertain.
Our ability to commercialize our technology 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. We cannot guarantee that adequate
third-party insurance coverage will be available for us to
establish and maintain price levels sufficient for realization
of an appropriate return on our investments in developing new
therapies. If we are successful in getting FDA approval for
CoFactor, we will be competing against a generic drug,
leucovorin, which has a lower cost and a long, established
history of reimbursement. Receiving sufficient reimbursement for
purchase costs of CoFactor will be necessary to make it cost
effective and competitive versus the established drug,
leucovorin. Government, private health insurers, and other
third-party payors are increasingly attempting to contain health
care costs by limiting both coverage and the level of
reimbursement for new therapeutic products approved for
marketing by the FDA. Accordingly, even if coverage and
reimbursement are provided by government, private health
insurers, and third-party payors for use of our products, the
market acceptance of these products would be adversely affected
if the amount of reimbursement available for the use of our
therapies proved to be unprofitable for health care providers.
Uncertainties
related to health care reform measures may affect our
success.
There have been some federal and state proposals in the past to
subject the pricing of health care goods and services, including
prescription drugs, to government control and to make other
changes to the U.S. health care system. None of the
proposals seems to have affected any of the drugs in our
programs. However, it is uncertain if future legislative
proposals would be adopted that might affect the drugs in our
programs or what actions federal, state, or private payors for
health care treatment and services may take in response to any
such health care reform proposals or legislation. Any such
health care reforms could have a material adverse effect on the
marketability of any drugs for which we ultimately require FDA
approval.
Further
testing of our drug candidates will be required and there is no
assurance of FDA approval.
The FDA and comparable agencies in foreign countries impose
substantial requirements upon the introduction of medical
products, through lengthy and detailed laboratory and clinical
testing procedures, sampling activities and other costly and
time-consuming procedures. Satisfaction of these requirements
typically takes several years or more and varies substantially
based upon the type, complexity, and novelty of the product.
The effect of government regulation and the need for FDA
approval will delay marketing of new products for a considerable
period of time, impose costly procedures upon our activities,
and provide an advantage to larger companies that compete with
us. There can be no assurance that the FDA or other regulatory
approval for any products developed by us will be granted on a
timely basis or at all. Any such delay in obtaining or failure
to obtain, such approvals would materially and adversely affect
the marketing of any contemplated products and the ability to
earn product revenue. Further, regulation of manufacturing
facilities by state, local, and other authorities is subject to
change. Any additional regulation could result in limitations or
restrictions on our ability to utilize any of our technologies,
thereby adversely affecting our operations.
Human pharmaceutical products 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
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U.S. and foreign statutes and regulations are time-consuming and
require the expenditure of substantial resources. In addition,
these requirements and processes vary widely from country to
country.
Among the uncertainties and risks of the FDA approval process
are the following: (i) the possibility that studies and
clinical trials will fail to prove the safety and efficacy of
the drug, or that any demonstrated efficacy will be so limited
as to significantly reduce or altogether eliminate the
acceptability of the drug in the marketplace, (ii) the
possibility that the costs of development, which can far exceed
the best of estimates, may render commercialization of the drug
marginally profitable or altogether unprofitable, and
(iii) the possibility that the amount of time required for
FDA approval of a drug may extend for years beyond that which is
originally estimated. In addition, the FDA or similar foreign
regulatory authorities may require additional clinical trials,
which could result in increased costs and significant
development delays. Delays or rejections may also be encountered
based upon changes in FDA policy and the establishment of
additional regulations during the period of product development
and FDA review. Similar delays or rejections may be encountered
in other countries.
Our
success will depend on licenses and proprietary rights we
receive from other parties, and on any patents we may
obtain.
Our success will depend in large part on our ability and our
licensors ability to (i) maintain license and patent
protection with respect to their drug products, (ii) defend
patents and licenses once obtained, (iii) maintain trade
secrets, (iv) operate without infringing upon the patents
and proprietary rights of others and (iv) 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. We have obtained licenses to
patents and other proprietary rights from the University of
Southern California.
The patent positions of pharmaceutical companies, including
ours, are uncertain and involve complex legal and factual
questions. There is no guarantee that we or our licensors have
or will develop or obtain the rights to products or processes
that are patentable, that patents will issue from any of the
pending applications or that claims allowed will be sufficient
to protect the technology licensed to us. In addition, we cannot
be certain that any patents issued to or licensed by us will not
be challenged, invalidated, infringed or circumvented, or that
the rights granted thereunder will provide competitive
disadvantages to us.
Litigation, which could result in substantial cost, may also be
necessary to enforce any patents to which we have rights, or to
determine the scope, validity and unenforceability of other
parties proprietary rights, which may affect our rights.
U.S. patents carry a presumption of validity and generally
can be invalidated only through clear and convincing evidence.
There can be no assurance that our licensed patents would be
held valid by a court or administrative body or that an alleged
infringer would be found to be infringing. The mere uncertainty
resulting from the institution and continuation of any
technology-related litigation or interference proceeding could
have a material adverse effect on us pending resolution of the
disputed matters.
We may also rely on unpatented trade secrets and know-how to
maintain our competitive position, which we seek to protect, in
part, by confidentiality agreements with employees, consultants
and others. There can be no assurance that these agreements will
not be breached or terminated, that we will have adequate
remedies for any breach, or that trade secrets will not
otherwise become known or be independently discovered by
competitors.
Our
license agreements can be terminated in the event of a
breach.
The license agreements pursuant to which we license our core
technologies for our potential drug products permit the
licensors, to terminate the agreement under certain
circumstances, such as the failure by us to use our reasonable
best efforts to commercialize the subject drug or the occurrence
of any other uncured material breach by us. The license
agreements also provide that the licensor is primarily
responsible for obtaining patent protection for the technology
licensed, and we are required to reimburse the licensor for the
costs it incurs in performing these activities. The license
agreements also require the payment of specified royalties. Any
inability or failure to observe these terms or pay these costs
or royalties could result in the termination of the applicable
license agreement in certain cases. In the past, we have let
lapse certain licenses for drug candidates when we determined
that the expense and risk of continued development outweighed
the likely benefits of that continued development. The
termination of any license agreement could have a material
adverse effect on us.
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Protecting
our proprietary rights is difficult and costly.
The patent positions of pharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and
factual questions. Accordingly, we cannot predict the breadth of
claims allowed in these companies patents or whether we
may infringe or be infringing these claims. Although we have not
been notified of any patent infringement, nor notified others of
patent infringement, such patent disputes are common and could
preclude the commercialization of our products. Patent
litigation is costly in its own right and could subject us to
significant liabilities to third parties. In addition, an
adverse decision could force us to either obtain third-party
licenses at a material cost or cease using the technology or
product in dispute.
We may
be unable to retain skilled personnel and maintain key
relationships.
The success of our business depends, in large 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 leading research
institutions and consultants and advisors. Competition for these
types of personnel and relationships is intense from numerous
pharmaceutical and biotechnology companies, universities and
other research institutions. We are currently dependent upon our
scientific staff, which has a deep background in our drug
candidates and the ongoing preclinical and clinical trials.
Recruiting and retaining senior employees with relevant drug
development experience in oncology and anti-viral therapeutics
is costly and time-consuming. There can be no assurance that we
will be able to attract and retain such individuals on an
uninterrupted basis and on commercially acceptable terms, and
the failure to do so could have a material adverse effect on us
by significantly delaying one or more of our drug development
programs. The loss of any of our senior executive officers,
including our chief executive officer and chief financial
officer, in particular, could have a material adverse effect on
the company and the market for our common stock, particularly if
such loss was abrupt or unexpected. All of our employees are
employed on an at-will basis under offer letters. We do not have
non-competition agreements with any of our employees.
We
currently have no sales capability, and limited marketing
capability.
We currently do not have sales personnel. We have limited
marketing and business development personnel. We will have to
develop a sales force, or rely on marketing partners or other
arrangements with third parties for the marketing, distribution
and sale of any drug product which is ready for distribution.
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.
In addition, any third parties with which we may establish
marketing, distribution or sales arrangements may have
significant control over important aspects of the
commercialization of a drug product, including market
identification, marketing methods, pricing, composition of sales
force and promotional activities. 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.
We do
not have manufacturing capabilities and may not be able to
efficiently develop manufacturing capabilities or contract for
such services from third parties on commercially acceptable
terms.
We do not have any manufacturing capacity. When and if required,
we will seek to establish relationships with third-party
manufacturers for the manufacture of clinical trial material and
the commercial production of drug products as we have with our
current manufacturing partners. There can be no assurance that
we will be able to establish relationships with third-party
manufacturers on commercially acceptable terms or that
third-party manufacturers will be able to manufacture a drug
product on a cost-effective basis in commercial quantities under
good manufacturing practices mandated by the FDA or other
regulatory matters.
The dependence upon third parties for the manufacture of
products may adversely affect future costs and the ability to
develop and commercialize a drug product on a timely and
competitive basis. Further, there can be no assurance that
manufacturing or quality control problems will not arise in
connection with the manufacture of our
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drug products or that third party manufacturers will be able to
maintain the necessary governmental licenses and approvals to
continue manufacturing such products. Any failure to establish
relationships with third parties for our manufacturing
requirements on commercially acceptable terms would have a
material adverse effect on us.
We are
dependent in part on third parties for drug development and
research facilities.
We do not possess research and development facilities necessary
to conduct all of our drug development activities. We engage
consultants and independent contract research organizations to
design and conduct clinical trials in connection with the
development of our drugs. As a result, these important aspects
of a drugs development will be outside our direct control.
In addition, 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.
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 will expose us to potential product liability risks
that are inherent in the testing, manufacturing and marketing of
pharmaceutical products. There can be no assurance that product
liability claims will not be asserted against us. We intend to
obtain additional limited product liability insurance for our
clinical trials, directly or through our marketing development
partners or contract research organization (CRO) partners, when
they begin in the U.S. and to expand our insurance coverage if
and when we begin marketing commercial products. However, there
can be no assurance that we will be able to obtain product
liability insurance on commercially acceptable terms or that we
will be able to maintain such insurance at a reasonable cost or
in sufficient amounts to protect against potential losses. A
successful product liability claim or series of claims brought
against us could have a material adverse effect on us.
The
market price of our shares, like that of many biotechnology
companies, is highly volatile.
Market prices for our common stock and the securities of other
medical and biomedical technology companies have been highly
volatile and may continue to be highly volatile in the future.
Factors such as announcements of technological innovations or
new products by us or our competitors, government regulatory
action, litigation, patent or proprietary rights developments,
and market conditions for medical and high technology stocks in
general can have a significant impact on any future market for
our common stock.
If we
cannot satisfy AMEXs listing requirements, it may delist
our common stock and we may not have an active public market for
our common stock. The absence of an active trading market would
likely make the common stock an illiquid
investment.
Our common stock is quoted on the American Stock Exchange. To
continue to be listed, we are required to maintain shareholders
equity of $6,000,000 among other requirements. We do not satisfy
that requirement as of December 31, 2005. The AMEX may
consider delisting our common stock and suspend trading in the
common stock in which case our common stock would likely trade
in the
over-the-counter
market in the so-called pink sheets or, if
available, the OTC Bulletin Board Service. As a
result, an investor would likely find it significantly more
difficult to dispose of, or to obtain accurate quotations as to
the value of, our shares. Our ability to raise capital would
most likely also be impaired due to our ineligibility to file
resale registration statements under the Securities Act.
If our
common stock is delisted, it may become subject to the
SECs penny stock rules and more difficult to
sell.
SEC rules require brokers to provide information to purchasers
of securities traded at less than $5.00 and not traded on a
national securities exchange or quoted on the Nasdaq Stock
Market. If our common stock becomes a penny stock
that is not exempt from these SEC rules, these disclosure
requirements may have the effect of reducing trading activity in
our common stock and making it more difficult for investors to
sell. The rules require a broker-dealer to deliver a
standardized risk disclosure document prepared by the SEC that
provides information
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about penny stocks and the nature and level of risks in the
penny market. The broker must also give bid and offer quotations
and broker and salesperson compensation information to the
customer orally or in writing before or with the confirmation.
The SEC rules also require a broker to make a special written
determination that the penny stock is a suitable investment for
the purchaser and receive the purchasers written agreement
to the transaction before a transaction in a penny stock.
Changes
in laws and regulations that affect the governance of public
companies has increased our operating expenses and will continue
to do so.
Recently enacted changes in the laws and regulations affecting
public companies, including the provisions of the Sarbanes-Oxley
Act of 2002 and the listing requirements for American Stock
Exchange have imposed new duties on us and on our executives,
directors, attorneys and independent accountants. In order to
comply with these new rules, we have hired and expect to hire
additional personnel and use additional outside legal,
accounting and advisory services, which have increased and are
likely to continue increasing our operating expenses. In
particular, we expect to incur additional administrative
expenses as we implement Section 404 of the Sarbanes-Oxley
Act, which requires management to extensively evaluate and
report on, and our independent registered public accounting firm
to attest to, our internal controls. For example, we have
incurred significant expenses, and expect to incur additional
expenses, in connection with the evaluation, implementation,
documentation and testing of our existing and newly implemented
control systems. Management time associated with these
compliance efforts necessarily reduces time available for other
operating activities, which could adversely affect operating
results. If we are unable to achieve full and timely compliance
with these regulatory requirements, we could be required to
incur additional costs, expend additional money and management
time on additional remedial efforts which could adversely affect
our results of operations.
Failure
to implement effective control systems, or failure to complete
our assessment of the effectiveness of our internal control over
financial reporting, may subject us to regulatory sanctions and
could result in a loss of public confidence, which could harm
our operating results.
Pursuant to Section 404 of the Sarbanes-Oxley Act,
beginning with our fiscal year ended December 31, 2005, we
are required to include in our annual report our assessment of
the effectiveness of our internal control over financial
reporting. Furthermore, our independent registered public
accounting firm is required to issue an opinion on whether our
assessment of the effectiveness of our internal control over
financial reporting is fairly stated in all material respects
and separately report on whether it believes we maintained, in
all material respects, effective internal control over financial
reporting as of December 31, 2005.
If we fail to remedy any material weaknesses which are
uncovered, fail to timely complete our assessment, or if our
independent registered public accounting firm cannot timely
attest to our assessment, we could be subject to regulatory
sanctions and a loss of public confidence in our internal
control. In addition, any failure to implement required new or
improved controls, or difficulties encountered in their
implementation, could harm our operating results or cause us to
fail to timely meet our regulatory reporting obligations.
We
have engaged in and may continue to engage in further expansion
through mergers and acquisitions, which could negatively affect
our business and earnings.
We have engaged in and may continue to engage in expansion
through mergers and acquisitions. There are risks associated
with such expansion. These risks include, among others,
incorrectly assessing the asset quality of a prospective merger
partner, encountering greater than anticipated costs in
integrating acquired businesses, facing resistance from
customers or employees, and being unable to profitably deploy
assets acquired in the transaction. Additional country- and
region-specific risks are associated with transactions outside
the United States. To the extent we issue capital stock in
connection with additional transactions, these transactions and
related stock issuances may have a dilutive effect on earnings
per share and share ownership.
Our earnings, financial condition, and prospects after a merger
or acquisition depend in part on our ability to successfully
integrate the operations of the acquired company. We may be
unable to integrate operations
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successfully or to achieve expected cost savings. Any cost
savings which are realized may be offset by losses in revenues
or other charges to earnings.
Description
Of Capital Stock
Our authorized capital stock consists of 1,000,000 shares
of Preferred Stock, $0.01 par value, and
200,000,000 shares of common stock, $0.001 par value.
Common
Stock
Our common stock is quoted on the American Stock Exchange LLC
under the symbol ANX.
We have never paid cash dividends on any of our securities and
do not currently expect to pay any cash dividends on our
securities in the foreseeable future. There are no restrictions
that limit our ability to pay dividends on our common stock or
that are likely to do so in the future other than restrictions
under the Delaware General Corporation Law and other applicable
law.
As of March 31, 2006, there were 69,128,476 shares of
common stock issued and outstanding which were held of record by
approximately 7,021 stockholders.
The holders of our common stock are entitled to one vote per
share held of record on all matters submitted to a vote of the
stockholders. Our certificate of incorporation does not provide
for cumulative voting in the election of directors. Subject to
preferences that may be applicable to any outstanding preferred
stock, the holders of common stock are entitled to receive
ratably such dividends, if any, as may be declared from time to
time by our Board of Directors out of funds legally available
for that purpose. In the event of our liquidation, dissolution
or winding up, holders of our common stock are entitled to share
ratably in all assets remaining after payment of liabilities,
subject to prior distribution rights of preferred stock, if any,
then outstanding. Holders of our common stock have no preemptive
or other subscription or conversion rights. There are no
redemption or sinking fund provisions applicable to our common
stock.
In the event of our voluntary or involuntary liquidation,
dissolution or winding up, the owners of shares of common stock
will be entitled to share equally in any assets available for
distribution after the payment in full of all debts and
distributions and after the owners of any of our outstanding
preferred stock have received their liquidation preferences in
full.
American Stock Transfer & Trust Company is our stock
transfer agent and it maintains all our stockholder records. If
you have questions regarding ADVENTRX stock you own, stock
transfers, address or name changes, lost stock certificates, or
duplicate mailings, please contact American Stock
Transfer & Trust Transfer Company directly at the
address below. If your shares are held with a stockbroker,
please contact your broker.
American Stock Transfer & Trust Company
59 Maiden Lane, Plaza Level
New York, NY 10038
(800) 937-5449
www.amstock.com
email address - info@amstock.com
Preferred
Stock
Our Board of Directors is authorized, without action by the
stockholders, to issue preferred stock in one or more series and
to fix the rights, preferences, privileges and restrictions
thereof. These rights, preferences and privileges may include
dividend rights, conversion rights, voting rights, terms of
redemption, liquidation preferences, sinking fund terms and the
number of shares constituting any series or the designation of
any series, all or any of which may be greater than the rights
of the common stock.
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Use of
Proceeds
We intend to add the net proceeds from the sale of the common
stock to our general funds to be used to fund research and
development and clinical trials and for general corporate
purposes, which may include investment in subsidiaries, working
capital, capital expenditures, repayment of short-term
borrowings, refinancing of existing long-term debt, acquisitions
and other business opportunities.
Plan Of
Distribution
We may sell the common stock through one or more of the
following ways:
| directly to purchasers; | |
| to or through one or more underwriters or dealers; or | |
| through agents. |
A prospectus supplement with respect to a particular issuance of
securities will set forth the terms of the offering of those
securities, including the following:
| name or names of any underwriters, dealers or agents; | |
| the purchase price of the securities and the estimated amount we will receive; | |
| underwriting discounts and commissions; and | |
| any initial public offering price and any discounts or concessions allowed or reallowed or paid to dealers. |
If we use underwriters in the sale, the underwriters will
acquire the securities for their own account and they may resell
them from time to time in one or more transactions, including
negotiated transactions, at a fixed public offering price or at
varying prices determined at the time of sale. Underwriting
syndicates represented by one or more managing underwriters or
one or more independent firms acting as underwriters may offer
the securities to the public. In connection with the sale of
securities, we may compensate the underwriters in the form of
underwriting discounts or commissions. The purchasers of the
securities for whom the underwriters may act as agent may also
pay them commissions. Underwriters may sell the securities to or
through dealers, and these dealers may receive compensation in
the form of discounts, concessions or commissions from the
underwriters
and/or
commissions from the purchasers for whom they may act as agents.
Unless otherwise set forth in the applicable prospectus
supplement, the obligations of any underwriters to purchase the
securities will be subject to conditions precedent, and the
underwriters will be obligated to purchase all of the securities
if any are purchased.
If we use dealers in the sale of the securities, we will sell
the securities to the dealers as principals. The dealers may
then resell the securities to the public at varying prices to be
determined by the dealer at the time of resale. The applicable
prospectus supplement will name any dealer, who may be deemed to
be an underwriter, as that term is defined in the Securities
Act, involved in the offer or sale of securities, and set forth
any commissions or discounts we grant to the dealer.
If we use agents in the sales of the securities, the agents may
solicit offers to purchase the securities from time to time. Any
of these agents, who may be deemed to be an underwriter, as that
term is defined in the Securities Act, involved in the offer or
sale of the securities will be named, and any commissions
payable by us to such agent set forth, in the applicable
prospectus supplement. Any agent will be acting on a reasonable
efforts basis for the period of its appointment or, if indicated
in the applicable prospectus supplement, on a firm commitment
basis.
We may also sell securities directly to institutional investors
or others who may be deemed to be underwriters within the
meaning of the Securities Act with respect to resales. The terms
of those sales would be described in the prospectus supplement.
If the prospectus supplement so indicates, we will authorize
agents, underwriters or dealers to solicit offers to purchase
securities from us at the public offering price set forth in the
prospectus supplement pursuant to stock purchase or delayed
delivery contracts providing for payment and delivery on a
specified date in the future. The
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contracts will be subject only to those conditions set forth in
the prospectus supplement, and the prospectus supplement will
set forth the commission payable for solicitation of the
contracts.
Agents, dealers and underwriters may be entitled under
agreements with us to indemnification against some civil
liabilities, including liabilities under the Securities Act, or
to contribution with respect to payments which the agents,
dealers or underwriters may be required to make. Agents, dealers
and underwriters or their affiliates may engage in transactions
with, or perform services for, us or our subsidiaries for
customary compensation.
If indicated in the applicable prospectus supplement, one or
more firms may offer and sell securities in connection with a
remarketing upon their purchase, in accordance with their terms,
acting as principals for their own accounts or as our agents.
Any remarketing firm will be identified and the terms of its
agreement, if any, with us will be described in the applicable
prospectus supplement. We may be obligated to indemnify the
remarketing firm against some liabilities, including liabilities
under the Securities Act, and the remarketing firm may engage in
transactions with or perform services for us or our subsidiaries
for customary compensation.
Any underwriter may engage in over-allotment, stabilizing and
syndicate short covering transactions and penalty bids in
accordance with Regulation M under the Securities Exchange
Act of 1934, as amended. Over-allotment involves sales in excess
of the offering size, which creates a short position.
Stabilizing transactions involve bids to purchase the underlying
security so long as the stabilizing bids do not exceed a
specified maximum. Syndicate short covering transactions involve
purchases of securities in the open market after the
distribution has been completed in order to cover syndicate
short positions. Penalty bids permit the underwriters to reclaim
selling concessions from dealers when the securities originally
sold by the dealers are purchased in covering transactions to
cover syndicate short positions. These transactions may cause
the price of the securities sold in an offering to be higher
than it would otherwise be. These transactions, if commenced,
may be discontinued by the underwriters at any time.
The prospectus supplement relating to each offering will set
forth the anticipated date of delivery of the securities.
Legal
Matters
The validity of the issuance of shares of common stock we are
offering under this prospectus will be passed upon for us by
Bingham McCutchen LLP, San Francisco, California.
Experts
Our consolidated balance sheets as of December 31, 2005 and
2004, and the related consolidated statements of operations,
stockholders equity (deficit) and cash flows for each of
the years in the three-year period ended December 31, 2005,
and for the period from June 12, 1996 (date of inception)
through December 31, 2005, and managements assessment
of the effectiveness of internal control over financial
reporting and the effectiveness of our internal control over
financial reporting as of December 31, 2005, have been
incorporated by reference in this prospectus and in the
registration statement in reliance on the reports of J.H. Cohn
LLP, independent registered public accounting firm, given upon
the authority of that firm as experts in accounting and
auditing. The report of J.H. Cohn LLP notes that the
consolidated financial statements for the period from
June 12, 1996 (date of inception) through December 31,
2001, were audited by other auditors. J.H. Cohn LLPs
opinion insofar as it relates to the period from June 12,
1996 to December 31, 2001, is based solely on the report of
such other auditors.
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$
ADVENTRX Pharmaceuticals,
Inc.
COMMON STOCK
PROSPECTUS
,
2006
Table of Contents
PART II
Information
Not Required In Prospectus
Item 14. | Other Expenses Of Issuance And Distribution* |
The estimated expenses in connection with the distribution of
the securities being registered, all of which are to be paid by
us, are as follows:
Securities and Exchange Commission
Registration Fee
|
$ | 10,700 | ||
Legal Fees and Expenses
|
$ | 50,000 | ||
Accounting Fees and Expenses
|
$ | 20,000 | ||
Miscellaneous Fees and Expenses
|
$ | 9,300 | ||
Total
|
$ | 90,000 | ||
* | To be filed by amendment |
Item 15. | Indemnification Of Directors And Officers |
Section 145 of the Delaware General Corporation Law grants
corporations the power to indemnify their directors, officers,
employees and agents in accordance with the provisions thereof.
Article VI of our by-laws provide for indemnification of
our directors, officers, agents and employees to the full extent
permissible under Section 145 of the Delaware General
Corporation Law. Section 102(b)(7) of the Delaware General
Corporation Law authorizes a corporation to eliminate the
liability of directors for breach of fiduciary duty in certain
cases. Article VI of our certificate of incorporation
eliminates such liability to the full extent permitted by
Section 145.
We maintain directors and officers liability
insurance coverage protecting our officers and directors against
certain liabilities.
Item 16. | Exhibits |
An Exhibit Index has been attached as part of this
Registration Statement and is incorporated herein by reference.
Item 17. | Undertakings |
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made pursuant to this registration statement, a
post-effective amendment to this registration statement:
(i) to include any prospectus required by
section 10(a)(3) of the Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement; or
(iii) to include any material information with respect to
the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement;
Provided, however, that paragraphs 1(i), 1(ii) and
(1)(iii) of this section do not apply if the information
required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or
furnished to the Commission by the registrant pursuant to
Section 13 or Section 15(d) of the Securities
II-1
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Exchange Act of 1934 that are incorporated by reference in the
registration statement or is contained in a form of prospectus
filed pursuant to Rule 424(b) that is part of the
registration statement.
(2) That, for the purpose of determining any liability
under the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(3) To remove from registration by means of a
post-effective amendment any of the securities being registered
which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under
the Securities Act of 1933 to any purchaser:
(i) Each prospectus filed by the registrant pursuant to
Rule 424(b)(3) shall be deemed to be part of the
registration statement as of the date the filed prospectus was
deemed part of and included in the registration statement; and
(ii) Each prospectus required to be filed pursuant to
Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration
statement in reliance on Rule 430B relating to an offering
made pursuant to Rule 415(a)(1)(i), (vii), or (x) for
the purpose of providing the information required by
section 10(a) of the Securities Act of 1933 shall be deemed
to be part of and included in the registration statement as of
the earlier of the date such form of prospectus is first used
after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As
provided in Rule 430B, for liability purposes of the issuer
and any person that is at that date an underwriter, such date
shall be deemed to be a new effective date of the registration
statement relating to the securities in the registration
statement to which that prospectus relates, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof. Provided, however, that no statement
made in a registration statement or prospectus that is part of
the registration statement or made in a document incorporated or
deemed incorporated by reference into the registration statement
or prospectus that is part of the registration statement will,
as to a purchaser with a time of contract of sale prior to such
effective date, supersede or modify any statement that was made
in the registration statement or prospectus that was part of the
registration statement or made in any such document immediately
prior to such effective date.
(5) That, for the purpose of determining liability of the
registrant under the Securities Act of 1933 to any purchaser in
the initial distribution of the securities: The undersigned
registrant undertakes that in a primary offering of securities
of the undersigned registrant pursuant to this registration
statement, regardless of the underwriting method used to sell
the securities to the purchaser, if the securities are offered
or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to
the purchaser and will be considered to offer or sell such
securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the
undersigned registrant relating to the offering required to be
filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned registrant or used
or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus
relating to the offering containing material information about
the undersigned registrant or its securities provided by or on
behalf of the undersigned registrant; and
(iv) Any other communication that is an offer in the
offering made by the undersigned registrant to the purchaser.
(6) That, for purposes of determining any liability under
the Securities Act of 1933, each filing of the registrants
annual report pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 that is incorporated by
reference in the registration statement shall be deemed to be a
new registration statement
II-2
Table of Contents
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(7) Insofar as indemnification for liabilities arising
under the Securities Act of 1933 may be permitted to directors,
officers and controlling persons of the registrant pursuant to
the foregoing provisions described in Item 15 above, or
otherwise, the registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act and
is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final
adjudication of such issue.
II-3
Table of Contents
Signatures
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe
that it meets all of the requirements for filing on a
Form S-3
and has duly caused this Registration Statement to be signed on
its behalf by the undersigned, thereunto duly authorized, in the
City of San Diego, State of California, on May 1, 2006.
ADVENTRX Pharmaceuticals, Inc.
By: | /s/ Carrie E. Carlander |
Name: Carrie E. Carlander
Title: | Chief Financial Officer |
KNOWN ALL MEN BY THESE PRESENTS, that each person whose
signature appears below does hereby constitute and appoint Evan
M. Levine and Carrie E. Carlander, and each of them, with full
power to act without the other, his or her true and lawful
attorney-in-fact
and agent for him or her and in his or her name, place and
stead, in any and all capacities, to sign any and all amendments
to this Registration Statement including without limitation any
registration statement for the same offering that is to be
effective upon filing pursuant to Rule 462(b) under the
Securities Act of 1933, as amended, and to file the same, with
all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, granting
unto said
attorneys-in-fact
and agents, and each of them, full power and authority to do and
perform each and every act and thing requisite and necessary to
be done in and about the premises in order to effectuate the
same, as fully, for all intents and purposes, as he could or
might do in person, hereby ratifying and confirming all that
said
attorneys-in-fact
and agents, or any of them, may lawfully do or cause to be done
by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons
in the capacities and on the dates indicated.
Signature
|
Title
|
Date
|
||||
/s/ M. Ross Johnson M. Ross Johnson, Ph.D. |
Director, Chairman of the Board | May 1, 2006 | ||||
/s/ Evan M. Levine Evan M. Levine |
Director, Chief Executive Officer and President (Principal Executive Officer) | May 1, 2006 | ||||
/s/ Carrie E.
Carlander Carrie E. Carlander |
Chief Financial Officer, Senior
Vice President, Finance, Treasurer and Secretary (Principal Financial Officer) |
May 1, 2006 | ||||
/s/ Robert A. Daniel Robert A. Daniel |
Controller (Principal Accounting Officer) | May 1, 2006 | ||||
/s/ Michael M.
Goldberg Michael M. Goldberg, M.D. |
Director | May 1, 2006 | ||||
/s/ Mark J. Pykett Mark J. Pykett, V.M.D., Ph.D. |
Director | May 1, 2006 | ||||
/s/ Mark Bagnall Mark Bagnall |
Director | May 1, 2006 | ||||
/s/ Keith Meister Keith Meister |
Director | May 1, 2006 |
II-4
Table of Contents
Exhibit Index
Exhibit |
||||
Number
|
Description
|
|||
3 | .1 | Amended and Restated Certificate of Incorporation(1) | ||
3 | .2 | Amended and Restated Bylaws of the Registrant(2) | ||
4 | .1 | Specimen common stock certificate for shares of Common Stock(3) | ||
5 | .1 | Opinion of Bingham McCutchen LLP | ||
23 | .1 | Consent of J. H. Cohn LLP (as to reports regarding the registrant) | ||
23 | .2 | Consent of J. H. Cohn LLP (as to report regarding SD Pharmaceuticals Inc.) | ||
23 | .3 | Consent of Bingham McCutchen LLP (included in Exhibit 5.1) | ||
24 | Power of Attorney (filed as part of signature page to Registration Statement) |
(1) | Incorporated by reference to exhibit 3.1 to the Registrants Annual Report on Form 10-K for the year ended December 31, 2005. | |
(2) | Incorporated by reference to exhibit 3.6 to the Registrants Registration Statement on Form 10-SB, filed October 2, 2001, as amended. | |
(3) | Incorporated by reference to same-numbered exhibit to the Registrants Registration Statement on Form S-3 filed August 26, 2005 (File No. 333-127857). |
Exhibit 5.1
May 1, 2006
ADVENTRX Pharmaceuticals, Inc.
6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
ADVENTRX Pharmaceuticals, Inc.
6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
Attention:
|
Ms. Carrie E. Carlander | |
Chief Financial Officer |
Registration Statement on Form S-3 of
ADVENTRX Pharmaceuticals, Inc.
ADVENTRX Pharmaceuticals, Inc.
Ladies and Gentlemen:
We have acted as counsel to ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (the Company),
in connection with the registration under the Securities Act of 1933, as amended (the Act), of
shares (the Shares) of the Companys Common Stock, par value $0.001 per share, pursuant to a
Registration Statement on Form S-3 (the Registration Statement) to be filed by the Company with
the Securities and Exchange Commission on or about the date of this opinion.
As to all matters of fact (including factual conclusions and characterizations and descriptions of
purpose, intention or other state of mind) we have entirely relied upon certificates of officers of
the Company, and have assumed, without independent inquiry, the accuracy of those certificates.
As counsel to the Company, in rendering the opinions hereinafter expressed, we have examined and
relied upon originals or copies, certified or otherwise authenticated to our satisfaction, of such
corporate records, agreements, documents and instruments as we have deemed necessary or advisable
for purposes of this opinion, including the following documents and instruments:
A. The Certificate of Incorporation of the Company, as amended, certified by the Delaware Secretary
of State on April 18, 2006.
B. A Certificate of Good Standing of the Company, issued by the Delaware Secretary of State on
April 17, 2006.
ADVENTRX Pharmaceuticals, Inc.
May 1, 2006
Page 2
May 1, 2006
Page 2
C. The By-Laws of the Company, certified by the Secretary of the Company on May 1, 2006.
D. Records of proceedings and actions of the Board of Directors of the Company, certified by the
Secretary of the Company on May 1, 2006.
We have assumed the genuineness of all signatures, the conformity to the originals of all documents
reviewed by us as copies, the authenticity and completeness of all original documents reviewed by
us in original or copy form and the legal competence of each individual executing a document. We
have also assumed that the registration requirements of the Act and all applicable requirements of
state laws regulating the sale of securities will have been duly satisfied.
This opinion is limited solely to the Delaware General Corporation Law and applicable provisions of
the Delaware Constitution, as applied by courts located in Delaware (collectively, the Law) and
the reported judicial decisions interpreting the Law.
Subject to the foregoing, it is our opinion that, following effectiveness of the Registration
Statement, the Shares, when duly authorized and issued against the full payment specified therefor
in accordance with the terms of a definitive purchase, underwriting or similar agreement and any
other necessary agreement pertaining thereto as described in the Registration Statement, which
shall not have a value less than the par value of the Shares, will be legally and validly issued,
fully paid and nonassessable.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and as
an exhibit to any further registration statement to be filed pursuant to Rule 462(b) under the
Securities Act with respect to the Shares, and to the reference to this firm under the heading
Legal Matters in any prospectus
ADVENTRX Pharmaceuticals, Inc.
May 1, 2006
Page 3
May 1, 2006
Page 3
constituting a part of the Registration Statement. In giving our consent, we do not thereby admit
that we are in the category of persons whose consent is required under Section 7 of the Act or the
rules and regulations of the Securities and Exchange Commission thereunder.
Very truly yours,
/s/BINGHAM McCUTCHEN LLP
BINGHAM McCUTCHEN LLP
BINGHAM McCUTCHEN LLP
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in this Registration Statement on Form S-3 of our
reports dated March 10, 2006 on our audits of the consolidated financial statements of ADVENTRX
Pharmaceuticals, Inc. and Subsidiary as of December 31, 2005 and 2004 and for each of the years in
the three-year period ended December 31, 2005 and for the period from June 12, 1996 (date of
inception) to December 31, 2005, and on our audits of the effectiveness of the Companys internal
control over financial reporting and of managements assessment of the Companys internal control
over financial reporting as of December 31, 2005, which reports appear in the Annual Report on Form
10-K of ADVENTRX Pharmaceuticals, Inc. for the year ended December 31, 2005. We also consent to
the reference to our firm under the caption Experts.
/s/ J.H. Cohn LLP
San Diego, California
April 26, 2006
April 26, 2006
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in this Registration Statement on Form S-3 of our
report dated April 14, 2006 on our audits of the financial statements of SD Pharmaceuticals, Inc.
as of December 31, 2005 and 2004 and for the year ended December 31, 2005 and for the period from
June 16, 2004 (date of inception) to December 31, 2004, which report is included in ADVENTRX
Pharmaceuticals, Incs Form 8-K/A filed on May 1, 2006. We also consent to the reference to
our firm under the caption Experts.
/s/ J.H. Cohn LLP
San Diego, California
April 26, 2006
April 26, 2006