Filed Pursuant to Rule 424(b)(3) under the Securities Act of 1933, as amended,
in connection with Registration Statement No. 333-108278
PROSPECTUS
IMMTECH INTERNATIONAL, INC.
[LOGO]
2,081,598 Shares
Common Stock
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This is a public offering of 2,081,598 shares of our common stock. We may
from time to time offer and sell, subject to American Stock Exchange LLC
("AMEX") rules, up to 750,000 shares of common stock for our own account and the
stockholders named under the caption "Selling Stockholders" may from time to
time offer and sell up to an additional 1,331,598 shares of common stock. By
this post-effective Amendment No. 4, the Company is registering for Selling
Stockholders an additional 550,000 shares of common stock, of which 100,000 are
outstanding and 450,000 are underlying warrants. Of the 450,000 shares
underlying warrants, 100,000 are exercisable at $6.00 per share, 100,000 are
exercisable at $6.08 per share, 125,000 are exercisable at $10.00 per share and
125,000 are exercisable at $15.00 per share. The shares may be sold in
transactions occurring either on or off the AMEX at prevailing market prices or
at negotiated prices. Sales may be made through brokers or through dealers, who
are expected to receive customary commissions or discounts. We will receive no
proceeds from the sale of shares sold by selling stockholders under this
prospectus.
Our common stock is traded on the AMEX under the symbol "IMM". The last
reported sale of our common stock on the AMEX on April 22, 2004 was $18.60.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
CONSIDER CAREFULLY THE RISK FACTORS BEGINNING ON PAGE S-1 OF THIS PROSPECTUS
BEFORE PURCHASING ANY OF THE COMMON STOCK OFFERED.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this prospectus is April 23, 2004
TABLE OF CONTENTS
RISK FACTORS .............................................................. 1
ABOUT THIS PROSPECTUS ..................................................... 14
WHERE YOU CAN FIND MORE INFORMATION;INCORPORATION OF DOCUMENTS BY
REFERENCE ................................................................. 15
FORWARD-LOOKING STATEMENTS ................................................ 16
THE COMPANY ............................................................... 17
USE OF PROCEEDS ........................................................... 18
SELLING STOCKHOLDERS ...................................................... 18
DESCRIPTION OF CAPITAL STOCK .............................................. 22
PLAN OF DISTRIBUTION ...................................................... 22
LEGAL MATTERS ............................................................. 24
EXPERTS ................................................................... 24
INTERESTS OF NAMED EXPERTS AND COUNSEL .................................... 24
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES ............................................................... 25
GLOSSARY .................................................................. 26
RISK FACTORS
An investment in the shares offered by this prospectus involves a high
degree of risk. In addition to the other information contained in this
prospectus, the following risk factors should be considered carefully in
evaluating our business before purchasing the shares.
There is no assurance that we will successfully develop a commercially viable
product; our most advanced product candidate is in Phase II human clinical
trials.
We are at an early stage of human clinical, and in some cases
pre-clinical, development activities required for drug approval and
commercialization. Since our formation in October 1984, we have engaged in
research and development programs, expanding our network of scientists and
scientific advisors, licensing technology agreements and advancing the
commercialization of the dication technology platform. We have generated no
revenue from product sales and do not have any products currently available for
sale, and none are expected to be commercially available for sale until after
March 31, 2005, if at all. There can be no assurance that the research we fund
and manage will lead to commercially viable products. Our most advanced programs
are in the Phase II human clinical testing stage using our lead compound DB289
for several indications including trypanosomiasis and malaria and must undergo
substantial additional regulatory review prior to commercialization.
We have a history of losses and an accumulated deficit; our future profitability
is uncertain.
We have experienced significant operating losses since our inception and
we expect to incur additional operating losses as we continue research and
development, clinical trial and commercialization efforts. As of December 31,
2003, we had an accumulated deficit of approximately $54,286,000. Losses from
operations were $4,693,000 and $10,712,000, respectively, for the fiscal year
ended March 31, 2003 and the nine-month period ended December 31, 2003.
We will need substantial additional funds in future years to continue our
research and development; if financing is not available, we may be required to
reduce spending for our research programs, cease operations or pursue other
financing alternatives.
Our operations to date have consumed substantial amounts of cash. Negative
cash flow from operations is expected to continue in the foreseeable future.
Without substantial additional financing, we may be required to reduce some or
all of our research programs or cease operations. Our cash requirements may vary
materially from those now planned because of results of research and
development, results of pre-clinical and clinical testing, responses to our
grant requests, relationships with strategic partners, changes in the focus and
direction of our research and development programs, competitive and
technological advances, the Food and Drug Administration ("FDA") and foreign
regulatory process and other factors. In any of these circumstances, we may
require substantially more funds than we currently have available or currently
intend to raise to continue our business. We may seek to satisfy future funding
requirements through public or private offerings of securities, by collaborative
or other arrangements with pharmaceutical or biotechnology companies, issuance
of debt or from other
sources. Additional financing may not be available when needed or may not be
available on acceptable terms. If adequate financing is not available, we may
not be able to continue as a going concern or may be required to delay, scale
back or eliminate certain research and development programs, relinquish rights
to certain technologies or product candidates, forego desired opportunities or
license third parties to commercialize our products or technologies that we
would otherwise seek to develop internally. To the extent we raise additional
capital by issuing equity securities, ownership dilution to existing
stockholders will result.
We receive funding primarily from charitable grants, research and
development programs and from sales of our equity securities. To date we have
directed most of such funds not used for general and administrative overhead
toward our research and development and commercialization programs (including
preparation of test results for submission to regulatory agencies for product
approval). Until one or more of our product candidates is approved for sale, our
funding is limited to funds received from testing and research agreements,
licensing of our technology and potential fees associated with interim leasing
of our properties while we develop them for product manufacture.
We do not have employment contracts with any employees other than our CEO, T.
Stephen Thompson; some of our proprietary intellectual property is developed by
scientists that are not employed by us.
We have an employment agreement with our CEO, T. Stephen Thompson that
renews annually in April of each year unless 30 day prior notice is given by
either party to the other. Mr. Thompson renewed his employment with the company
this year and has not expressed any indication that he desires to leave the
company or retire. All other company employees are "at will" and may leave at
any time, however, none have as of this date, expressed any intention to do so.
We do not have "key-man" life insurance policies on any of our executives,
including Mr. Thompson.
Most of the financial aspects of the company, including investor
relations, intellectual property control and corporate governance, are under the
direct supervision of Cecilia Chan and Gary Parks. Together with Mr. Thompson,
Ms. Chan and Mr. Parks hold institutional knowledge and business savvy that they
utilize to assist the company to forge new relationships and exploit new
business opportunities without diminishing or undermining existing programs and
obligations. Neither Ms. Chan nor Mr. Parks have employment contracts with the
company, however, neither has indicated any intention to retire or leave the
company.
Our business depends to a significant degree on the continuing
contributions of our key management, scientific and technical personnel, as well
as on the continued discoveries of scientists, researchers and specialists at
The University of North Carolina at Chapel Hill ("UNC"), Georgia State
University, Duke University and Auburn University (collectively, the "Scientific
Consortium") and other research groups that assist in the development of our
product candidates. Substantial amounts of our proprietary intellectual property
is developed by scientists who are employed by the universities that comprise
the Scientific Consortium and other research groups. We do not have control
over, knowledge of, or access to those employment arrangements. We have not been
advised by any of the key members of our company, the scientific research groups
or of the Scientific Consortium of their intention to leave their employ or the
program.
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There can be no assurance that the loss of certain members of management
or the scientists, researchers and technicians from the Scientific Consortium
universities would not materially adversely affect our business.
Additional research grants needed to fund our operations may not be available
or, if available, not on terms acceptable to the company.
We have funded our product development and operations as of December 31,
2003 through a combination of sales of equity and revenue generated from
research agreements funded by grants. As of December 31, 2003, our accumulated
deficit is approximately $54,286,000 of which approximately $10,641,000 was
funded either directly or indirectly with grant funds and payments from research
and testing agreements.
In March 2001 we entered into a clinical research subcontract with UNC,
funded by a $15.1 million grant from The Bill & Melinda Gates Foundation ("The
Gates Foundation") to UNC for the study of African sleeping sickness and
Leishmaniasis, under which UNC is to pay to us $9.8 million in installments over
a period not to exceed five years based on our achieving certain milestones. We
entered into a second subcontract with UNC under which we are to receive over
$2.4 million based on a separate $2.7 million grant from the Gates Foundation to
UNC to accelerate the African sleeping sickness study. We will continue to apply
for new grants to support continuing research and development of our dication
platform technology and other product candidates. The process of obtaining
grants is extremely competitive and there can be no assurance that any of our
grant applications will be acted upon favorably. Some charitable organizations
may request licenses to our proprietary information or may impose price
restrictions on the products we develop with grant funds. We may not be able to
negotiate terms that are acceptable to us with such organizations. In the event
we are unable to raise sufficient funds to advance our product developments with
grant funds we may seek to raise additional capital with the issuance of debt or
equity securities. There can be no assurance that we will be able to place or
sell debt or equity securities on terms acceptable to the company and, if we
sell equity, existing stockholders may suffer dilution (see Risk Factors, this
section, entitled "Shares eligible for future sale may adversely affect our
ability to sell equity securities," and "Our outstanding options and warrants
may adversely affect our ability to consummate future equity financings due to
the dilution potential to future investors").
None of our product candidates have been approved for sale by any regulatory
agency; approval is required before we can sell drug products commercially.
All of our product candidates, including DB289 and DB075, require
additional clinical testing, regulatory approval and development of marketing
and distribution channels, all of which are expected to require substantial
additional investment prior to commercialization. There can be no assurance that
any of our product candidates will be successfully developed, prove to be safe
and effective in human clinical trials, meet applicable regulatory standards, be
capable of being produced in commercial quantities at acceptable costs, be
eligible for third party reimbursement from governmental or private insurers, be
successfully marketed or achieve market acceptance. If we are unable to
commercialize our product candidates in a timely manner we may be required to
seek additional funding, reduce or cancel some or all of our development
programs, sell or license some of our proprietary information or cease
operations.
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There are substantial uncertainties related to clinical trials that may result
in the extension, modification or termination of one or more of our programs.
In order to obtain required regulatory approvals for the commercial sale
of our product candidates, we must demonstrate through human clinical trials
that our product candidates are safe and effective for their intended uses.
Prior to conducting human clinical trials we must obtain governmental approvals
from the host nation, approval from the U.S. to export our product candidate to
the test site and qualify a sufficient number of volunteer patients that meet
our trial criteria. If we do not obtain required governmental consents or if we
do not enroll a sufficient number of patients in a timely manner or at all, our
trial expenses could increase, results may be delayed or the trial may be
cancelled.
We may find, at any stage of our research and development, that product
candidates that appeared promising in earlier clinical trials do not demonstrate
safety or effectiveness in later clinical trials and therefore do not receive
regulatory approvals. Despite the positive results of our pre-clinical testing
and human clinical trials those results may not be predictive of the results of
later clinical trials and large-scale testing. Companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in various
stages of clinical trials, even after promising results had been obtained in
early-stage human clinical trials.
Completion of the clinical trials may be delayed by many factors,
including slower than anticipated patient enrollment, difficulty in securing
sufficient supplies of clinical trial materials or adverse events occurring
during clinical trials. For instance, once we obtain permission to run a test,
there are strict criteria regulating who we can test. In the case of our malaria
product candidate, we may encounter difficulties in finding potential patients
because our initial regimen requires patients to first fail other treatment
programs in order to be eligible for our treatment. In a second case, we were
forced to cancel a human clinical trial and relocate due to political
insurrection in our host nation.
Completion of testing, studies and trials may take several years, and the
length of time varies substantially with the type, complexity, novelty and
intended use of the product. Delays or rejections may be based upon many
factors, including changes in regulatory policy during the period of product
development. No assurance can be given that any of our development programs will
be successfully completed, that any Investigational New Drug ("IND") application
filed with the FDA (or any foreign equivalent filed with the appropriate foreign
authorities) will become effective, that additional clinical trials will be
allowed by the FDA or other regulatory authorities, or that clinical trials will
commence as planned. There have been delays in our testing and development
schedules due to funding and patient enrollment difficulties and there can be no
assurance that our future testing and development schedules will be met.
We do not have pharmaceutical manufacturing capability, which could impair our
ability to develop commercially viable products at reasonable costs.
Our ability to commercialize product candidates will depend in part upon
our ability to have manufactured the product candidates, either directly or
through third parties, at a competitive cost and in accordance with FDA and
other regulatory requirements. We currently lack facilities and personnel to
manufacture our product candidates. There can be no assurance
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that we will be able to acquire such resources, either directly or through third
parties, at reasonable costs, if we develop commercially viable products.
We intend to commence construction of a pharmaceutical manufacturing
facility in the People's Republic of China ("PRC") with our subsidiary Immtech
Hong Kong Limited. We have recently acquired a building in which to construct
the facility, however, operation of such a facility is subject to various
governmental approvals, which may be difficult or impossible to obtain. There
can be no guarantee that products manufactured at this facility will be accepted
in the countries where we desire to sell our future products.
We are dependent on third-party relationships for critical aspects of our
business; problems that develop in these relationships may increase costs and/or
diminish our ability to develop our product candidates.
We use the expertise and resources of strategic partners and third parties
in a number of key areas, including (i) research and development, (ii)
pre-clinical and human clinical trials and (iii) manufacture of pharmaceutical
drugs. We have licensing and exclusive commercialization rights to a dicationic
pharmaceutical platform and are developing drugs intended for commercial use
based on that platform. This strategy creates risks by placing critical aspects
of our business in the hands of third parties, whom we may not be able to
control. If these third parties do not perform in a timely and satisfactory
manner, we may incur costs and delays as we seek alternate sources of such
products and services, if available. Such costs and delays may have a material
adverse effect on our business if the delays jeopardize our licensing
arrangements by causing us to become non-compliant with certain license
agreements.
We may seek additional third-party relationships in certain areas,
particularly in clinical testing, marketing, manufacturing and other areas where
pharmaceutical and biotechnology company collaborators will enable us to develop
particular products or geographic markets that are otherwise beyond our current
resources and/or capabilities. There is no assurance that we will be able to
obtain any such collaboration or any other research and development,
manufacturing or clinical trial arrangements. Our inability to obtain and
maintain satisfactory relationships with third parties may have a material
adverse effect on our business by slowing our ability to develop new products,
requiring us to expand our internal capabilities, increasing our overhead and
expenses, hampering future growth opportunities or causing us to delay or
terminate effected programs.
We are uncertain about the ability to protect or obtain necessary patents and
protect our proprietary information; our ability to develop our product
candidates would be compromised without adequate intellectual property
protection.
We have spent and continue to spend considerable funds to develop our
product candidates and we are relying on the potential to exploit commercially
without competition the results of our product development. Much of our
intellectual property is licensed to us under various agreements including the
Consortium Agreement. It is the primary responsibility of the discoverer to
develop his, her or its invention confidentially, insure that the invention is
unique, and to obtain patent protection. In most cases, our role is to reimburse
patent related costs after we decide to develop any such invention. We therefore
rely on the inventors to insure that technology licensed to us is adequately
protected. Without adequate protection for our
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intellectual property we believe our ability to realize profits on our future
commercialized product would be diminished. Without protection, competitors
might be able to copy our work and compete with our products without having
invested in the development.
There can be no assurance that any particular patent will be granted or
that issued patents will provide us, directly or through licenses, with the
intellectual property protection contemplated. Patents and licenses of patents
can be challenged, invalidated or circumvented. It is also possible that
competitors will develop similar products simultaneously. Our breach of any
license agreement or the failure to obtain a license to any technology or
process which may be required to develop or commercialize one or more of our
product candidates may have a material adverse effect on our business including
the need for additional capital to develop alternate technology, the potential
that competitors may gain unfair advantage and lessen our expectation of
potential future revenues.
The pharmaceutical and biotechnology fields are characterized by a large
number of patent filings, and a substantial number of patents have already been
issued to other pharmaceutical and biotechnology companies. Third parties may
have filed applications for, or may have been issued, certain patents and may
obtain additional patents and proprietary rights related to products or
processes competitive with or similar to those that we are attempting to develop
and commercialize. We may not be aware of all of the patents potentially adverse
to our interests that may have been issued to others. No assurance can be given
that patents do not exist, have not been filed or could not be filed or issued,
which contain claims relating to or competitive with our technology, product
candidates or processes. If patents have been or are issued to others containing
preclusive or conflicting claims, then we may be required to obtain licenses to
one or more of such patents or to develop or obtain alternative technology.
There can be no assurance that the licenses or alternative technology that might
be required for such alternative processes or products would be available on
commercially acceptable terms, or at all.
Because of the substantial length of time and expense associated with
bringing new drug products to market through the development and regulatory
approval process, the pharmaceutical and biotechnology industries place
considerable importance on patent and trade secret protection for new
technologies, products and processes. Since patent applications in the United
States are confidential until patents are issued and since publication of
discoveries in the scientific or patent literature often lag behind actual
discoveries, we cannot be certain that we (or our licensors) were the first to
make the inventions covered by pending patent applications or that we (or our
licensors) were the first to file patent applications for such inventions. The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions and, therefore, the
breadth of claims allowed in pharmaceutical and biotechnology patents, or their
enforceability, cannot be predicted. There can be no assurance that any patents
under pending patent applications or any further patent applications will be
issued. Furthermore, there can be no assurance that the scope of any patent
protection will exclude competitors or provide us competitive advantages, that
any of our (or our licensors') patents that have been issued or may be issued
will be held valid if subsequently challenged, or that others, including
competitors or current or former employers of our employees, advisors and
consultants, will not claim rights in, or ownership to, our (or our licensors')
patents and other proprietary rights. There can be no assurance that others will
not independently develop substantially equivalent proprietary information or
otherwise obtain access to our proprietary
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information, or that others may not be issued patents that may require us to
obtain a license for, and pay significant fees or royalties for, such
proprietary information.
We rely on technology developed by others and shared with collaborators to
develop our product candidates.
We rely on trade secrets, know-how and technological advancement to
maintain our competitive position. Although we use confidentiality agreements
and employee proprietary information and invention assignment agreements to
protect our trade secrets and other unpatented know-how, these agreements may be
breached by the other party thereto or may otherwise be of limited effectiveness
or enforceability.
We are licensed to commercialize technology from a dication platform
developed by a Scientific Consortium, comprised primarily of scientists employed
by universities in an academic setting. The academic world is improved by the
sharing of information. As a business, however, the sharing of information
whether through publication of research, academic lectures or general
intellectual discourse among contemporaries is not conducive to protection of
proprietary information. Our proprietary information may fall into the
possession of unintended parties without our knowledge through customary
academic information sharing.
At times we may enter into confidentiality agreements with other
companies, allowing them to test our compounds for potential future licensing,
in return for milestone and royalty payments should any discoveries result from
the use of our proprietary information. We cannot be assured that such parties
will honor these confidentiality agreements subjecting our intellectual property
to unintended disclosure.
The pharmaceutical and biotechnology industries have experienced extensive
litigation regarding patent and other intellectual property rights. We could
incur substantial costs in defending suits that may be brought against us (or
our licensors) claiming infringement of the rights of others or in asserting our
(or our licensors') patent rights in a suit against another party. We may also
be required to participate in interference proceedings declared by the U.S.
Patent and Trademark Office or similar foreign agency for the purpose of
determining the priority of inventions in connection with our (or our
licensors') patent applications.
Adverse determinations in litigation or interference proceedings could
require us to seek licenses (which may not be available on commercially
reasonable terms) or subject us to significant liabilities to third parties, and
could therefore have a material adverse effect on our business by increasing our
expenses and having an adverse effect on our business. Even if we prevail in an
interference proceeding or a lawsuit, substantial resources, including the time
and attention of our officers, would be required.
Confidentiality agreements may not adequately protect our intellectual property.
We require our employees, consultants and third-parties with whom we share
proprietary information to execute confidentiality agreements upon the
commencement of their relationship with us. The agreements generally provide
that trade secrets and all inventions conceived by the individual and all
confidential information developed or made known to the individual during the
term of the relationship will be our exclusive property and will be kept
confidential and not
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disclosed to third parties except in specified circumstances. There can be no
assurance, however, that these agreements will provide meaningful protection for
our proprietary information in the event of unauthorized use or disclosure of
such information. If our unpatented proprietary information is publicly
disclosed before we have been granted patent protection, our competitors could
be unjustly enrichened and we could lose the ability to profitably develop
products from such information.
Our industry has significant competition; our product candidates may become
obsolete prior to commercialization due to alternative technologies.
The pharmaceutical and biotechnology fields are characterized by extensive
research efforts and rapid technological progress. Competition from other
pharmaceutical and biotechnology companies and research and academic
institutions is intense and other companies are engaged in research and product
development for treatment of the same diseases that we target. New developments
in pharmaceutical and biotechnology fields are expected to continue at a rapid
pace in both industry and academia. There can be no assurance that research and
discoveries by others will not render some or all of our programs or products
non-competitive or obsolete.
We are aware of other companies and institutions dedicated to the
development of therapeutics similar to those we are developing, including
Aventis Pharmaceuticals, Inc., Hoffman-LaRoche Ltd., Sanofi-Synthelabo Inc.,
Pfizer Inc., and Bayer Corporation. Many of our existing or potential
competitors have substantially greater financial and technical resources than we
do and therefore may be in a better position to develop, manufacture and market
pharmaceutical products. Many of these competitors are also more experienced
performing pre-clinical testing and human clinical trials and obtaining
regulatory approvals. The current or future existence of competitive products
may also adversely affect the marketability of our product candidates.
In the event some or all of our programs are rendered non-competitive or
obsolete, we do not currently have alternative strategies to develop new product
lines or financial resources to pursue such a course of action.
There is no assurance that we will receive FDA or corollary foreign approval for
any of our product candidates for any indication; we are subject to government
regulation for the commercialization of our product candidates.
We have not made application to the U.S. FDA or any other regulatory
agency to sell commercially or label any of our product candidates. We or our
test collaborators have received licenses from the FDA to export DB289 for
testing purposes and have been approved to conduct human clinical trials for
various indications in each of the Democratic Republic of Congo, Angola,
Thailand and Peru.
All new pharmaceutical drugs and biologics, including our product
candidates, are subject to extensive and rigorous regulation by the federal
government, principally the FDA under the Federal Food, Drug and Cosmetic Act
("FDCA") and other laws including, in the case of biologics, the Public Health
Services Act, and by state, local and foreign governments. Such regulations
govern, among other things, the development, testing, manufacture, labeling,
storage,
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pre-market clearance or approval, advertising, promotion, sale and distribution
of pharmaceutical drugs and biologics. If drug products or biologics are
marketed abroad, they are subject to extensive regulation by foreign
governments. Failure to comply with applicable regulatory requirements may
subject us to administrative or judicially imposed sanctions such as civil
penalties, criminal prosecution, injunctions, product seizure or detention,
product recalls, total or partial suspension of production and FDA refusal to
approve pending applications.
Each of our product candidates must be approved for each indication for
which we believe it to be viable. We have not yet determined from which
regulatory bodies we will seek approval for our product candidates or for which
indications. Once determined, the approval process is subject to those agencies'
policies and acceptance of those agencies' approvals, if obtained, in the
countries where we intend to market our product candidates.
We have not received regulatory approval in the United States or any foreign
jurisdiction for the commercial sale of any of our product candidates.
The process of obtaining FDA and other required regulatory approvals,
including foreign approvals, often takes many years and varies substantially
based upon the type, complexity and novelty of the products involved and the
indications being studied. Furthermore, the approval process is extremely
expensive and uncertain. There can be no assurance that our product candidates
will be approved for commercial sale in the United States by the FDA or
regulatory agencies in foreign countries. The regulatory review process can take
many years and we will need to raise additional funds to complete the regulatory
review process for our current product candidates. Therefore, the failure to
receive FDA approval would have a material adverse effect on our business by
precluding us from marketing and selling such products in the United States and
preventing us from representing to other nations that the U.S. FDA has approved
our products to facilitate accelerated review procedures in those nations and
therefore negatively impacting our ability to generate future revenues. Even if
regulatory approval of a product is granted, there can be no assurance that we
will be able to obtain the labeling claims (a labeling claim is a product's
description and its FDA permitted uses) necessary or desirable for the promotion
of such product. FDA regulations prohibit the marketing or promotion of a drug
for unapproved indications. Furthermore, regulatory marketing approval may
entail ongoing requirements for post-marketing studies if regulatory approval is
obtained; we will then be subject to ongoing FDA obligations and continued
regulatory review. In particular, we, or our third party manufacturers, will be
required to adhere to Good Manufacturing Practices ("GMP"), which require us (or
our third party manufacturers) to manufacture products and maintain records in a
prescribed manner with respect to manufacturing, testing and quality control.
Further, we (or our third party manufacturers) must pass a manufacturing
facilities pre-approval inspection by the FDA or corollary agency before
obtaining marketing approval. Failure to comply with applicable regulatory
requirements may result in penalties, such as restrictions on a product's
marketing or withdrawal of the product from the market. In addition,
identification of certain side effects after a drug is on the market or the
occurrence of manufacturing problems could cause subsequent withdrawal of
approval, reformulation of the drug, additional pre-clinical testing or clinical
trials and changes in labeling of the product.
Prior to the submission of an application for FDA approval, our
pharmaceutical drugs and biologics undergo rigorous pre-clinical and clinical
testing, which may take several years and the
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expenditure of substantial financial and other resources. Before commencing
clinical trials in humans in the United States, we must submit to the FDA and
receive clearance of an IND. There can be no assurance that submission of an IND
for future clinical testing of any of our product candidates under development
or other future product candidates would result in FDA permission to commence
clinical trials or that we will be able to obtain the necessary approvals for
future clinical testing in any foreign jurisdiction. Further, there can be no
assurance that if such testing of product candidates under development is
completed, any such drug compounds will be accepted for formal review by the FDA
or any foreign regulatory body or approved by the FDA for marketing in the
United States or by any such foreign regulatory bodies for marketing in foreign
jurisdictions.
If a product is regulated as a biologic, the FDA will require the
submission and approval of both a Product License Application ("PLA") and an
Establishment License Application ("ELA") before commercial marketing can
commence. The PLA must include detailed information about the biologic, its
manufacture and the results of product development, pre-clinical studies and
clinical trials. The FDA's time to review PLAs and ELAs averages two to five
years. The FDA may ultimately decide that the PLA and ELA do not satisfy the
regulatory criteria for approval and deny approval or require additional
clinical studies. Future federal, state, local or foreign legislation or
administrative acts could also prevent or delay regulatory approval of our
pharmaceutical drug and biologic candidates. We anticipate filing a NDA with the
FDA for compassionate use of DB289 as a treatment for trypanosomiasis in
sub-Sahara Africa in calendar year 2005.
Our most advanced programs are developing products intended for sale in
countries that may not have established pharmaceutical regulatory agencies.
Some of the intended markets for our treatment of African sleeping
sickness and malaria are in countries without developed pharmaceutical
regulatory agencies. We plan in such cases to try first to obtain regulatory
approval from a recognized pharmaceutical regulatory agency such as the U.S. FDA
or one or more European agencies and then to apply to the targeted country for
recognition of the foreign approval. Because the countries where we intend
market to market treatments for African sleeping sickness and malaria are not
obligated to accept foreign regulatory approvals and because those countries do
not have standards of their own for us to rely upon, we may be required to
provide additional documentation or complete additional testing prior to
distributing our products in those countries.
There is uncertainty regarding the availability of health care reimbursement for
purchasers of our anticipated products; health care reform may negatively impact
the ability of prospective purchasers of our anticipated products to pay for
such products.
Our ability to commercialize any of our product candidates will depend in
part on the extent to which reimbursement for the costs of the resulting drug or
biologic will be available from government health administration authorities,
private health insurers, charities and others. Many of our product candidates,
including treatments for trypanosomiasis, malaria and tuberculosis, would be in
the greatest demand in developing nations, many of which do not maintain
comprehensive health care systems with the financial resources to pay for such
drugs. We do not know to what extent governments, private charities,
international organizations and others would contribute toward bringing newly
developed drugs to developing nations. Even
-10-
among drugs sold in developed countries, significant uncertainty exists as to
the reimbursement status of newly approved health care products. There can be no
assurance of the availability of third-party insurance reimbursement coverage
enabling us to establish and maintain price levels sufficient for realization of
a profit on our investment in developing pharmaceutical drugs and biologics.
Government and other third-party payers are increasingly attempting to contain
health care costs by limiting both coverage and the level of reimbursement for
new drug or biologic products approved for marketing by the FDA and by refusing,
in some cases, to provide any coverage for uses of approved products for disease
indications for which the FDA has not granted marketing approval. If adequate
coverage and reimbursement levels are not provided by government and third-party
payers for uses of our anticipated products, the market acceptance of these
products would be adversely affected.
Health care reform proposals are continually introduced in Congress and in
various state legislatures and there is no guarantee that such proposals will
not be introduced in the future. We cannot predict when any proposed reforms
will be implemented, if ever, or the effect of any implemented reforms on our
business. Implemented reforms may have a material adverse effect on our business
by reducing or eliminating the availability of third-party reimbursement for our
anticipated products or by limiting price levels at which we are able to sell
such products. If reimbursement is not available for our products, health care
providers may prescribe alternative remedies if available. Patients, if they
cannot afford our products, may do without. In addition, if we are able to
commercialize products in overseas markets, then our ability to achieve success
in such markets may depend, in part, on the health care financing and
reimbursement policies of such countries. We cannot predict changes in health
care systems in foreign countries, and therefore, do not know the effects on our
business of possible changes.
Shares eligible for future sale may adversely affect our ability to sell equity
securities.
Sales of our common stock (including the issuance of shares upon
conversion of preferred stock) in the public market could materially and
adversely affect the market price of shares because prior sales have been
executed at or below our current market price. We have outstanding four series
of preferred stock that convert to common stock at prices equivalent to $4.42,
$4.00, $4.42 and $9.00, respectively, for our series A, series B, series C and
series D convertible preferred stock. Our obligation to convert the preferred
stock upon demand by the holders may depress the price of our common stock and
also make it more difficult for us to sell equity securities or equity-related
securities in the future at a time and price that we deem appropriate.
As of March 19, 2004, we had 9,834,986 shares of common stock outstanding,
plus (1) 80,800 shares of series A convertible preferred stock, convertible into
approximately 457,013 shares of common stock at the conversion rate of 1:5.656,
(2) 19,925 shares of series B Convertible Preferred stock convertible into
approximately 124,531 shares of common stock at the conversion rate of 1:6.25,
(3) 72,304 shares of series C convertible preferred stock convertible into
approximately 408,954 shares of common stock at the conversion rate of 1:5.656,
(4) 200,000 shares of series D convertible preferred stock convertible into
approximately 555,540 shares of common stock at the conversion rate of 1:2.778,
(5) 955,374 options to purchase shares of common stock with a weighted-average
exercise price of $8.58 per share and (6) 2,787,712 warrants to purchase shares
of common stock with a weighted-average
-11-
exercise price of $7.10. Of the shares outstanding, 6,888,199 shares of common
stock are freely tradable without restriction. All of the remaining 2,946,787
shares are restricted from resale, except pursuant to certain exceptions under
the Securities Act of 1933, as amended (the "Securities Act").
Our outstanding options and warrants may adversely affect our ability to
consummate future equity financings due to the dilution potential to future
investors.
We have outstanding options and warrants for the purchase of shares of our
common stock with exercise prices currently below market which may adversely
affect our ability to consummate future equity financings. The holders of such
warrants and options may exercise them at a time when we would otherwise be able
to obtain additional equity capital on more favorable terms. To the extent any
such options and warrants are exercised, the outstanding shares of our common
stock will be diluted.
As of March 19, 2004, we have outstanding vested options to purchase
616,615 shares of common stock at a weighted-average exercise price of $6.47 and
vested warrants to purchase 2,787,712 shares of common stock with a
weighted-average price of $7.12.
Due to the number of shares of common stock we are obligated to sell
pursuant to outstanding options and warrants described above, potential
investors may not purchase our future equity offerings at market price because
of the potential dilution such investors may suffer as a result of the exercise
of the outstanding options and warrants.
The market price of our common stock has experienced significant volatility.
The securities markets from time to time experience significant price and
volume fluctuations unrelated to the operating performance of particular
companies. In addition, the market prices of the common stock of many publicly
traded pharmaceutical and biotechnology companies have been and can be expected
to be especially volatile. Our common stock price in the 52-week period ended
March 19, 2004 had a low of $4.15 and high of $32.51. Announcements of
technological innovations or new products by us or our competitors, developments
or disputes concerning patents or proprietary rights, publicity regarding actual
or potential clinical trial results relating to products under development by us
or our competitors, regulatory developments in both the United States and
foreign countries, delays in our testing and development schedules, public
concern as to the safety of pharmaceutical drugs or biologics and economic and
other external factors, as well as period-to-period fluctuations in our
financial results, may have a significant impact on the market price of our
common stock. The realization of any of the risks described in these "Risk
Factors" may have a significant adverse impact on such market prices.
We routinely pay vendors in stock as consideration for their services; this may
result in shareholder dilution, additional costs and difficulty retaining
certain vendors.
In order for us to preserve our cash resources, we often pay vendors in
shares or options to purchase shares of our common stock rather than cash.
Payments for services in stock may materially adversely affect our shareholders
by diluting the value of outstanding shares of our common stock. In addition, in
situations where we have agreed to register the shares issued to a
-12-
vendor, this will generally cause us to incur additional expenses associated
with such registration. Paying vendors in shares or options to purchase shares
of common stock may also limit our ability to contract with the vendor of our
choice should that vendor decline payment in stock.
We do not intend to pay dividends on our common stock. Until such time as we pay
cash dividends our stockholders must rely on increases in our stock price for
appreciation.
We have never declared or paid dividends on our common stock. We intend to
retain future earnings to develop and commercialize our products and therefor we
do not intend to pay cash dividends in the foreseeable future. Until such time
as we determine to pay cash dividends on our common stock, our stockholders must
rely on increases in our common stock's market price for appreciation.
There are limitations on the liability of our directors, and we may have to
indemnify our officers and directors in certain instances.
Our certificate of incorporation limits, to the maximum extent permitted
under Delaware law, the personal liability of our directors for monetary damages
for breach of their fiduciary duties as directors. Our bylaws provide that we
will indemnify our officers and directors and may indemnify our employees and
other agents to the fullest extent permitted by law. We have entered into
indemnification agreements with our officers and directors containing provisions
that are in some respects broader than the specific indemnification provisions
under Delaware law. The indemnification agreements may require us, among other
things, to indemnify such officers and directors against certain liabilities
that may arise by reason of their status or service as directors or officers
(other than liabilities arising from willful misconduct of a culpable nature),
to advance their expenses incurred as a result of any proceeding against them as
to which they could be indemnified and to obtain directors' and officers'
insurance. Section 145 of the Delaware General Corporation Law provides that a
corporation may indemnify a director, officer, employee or agent made or
threatened to be made a party to an action by reason of the fact that he or she
was a director, officer, employee or agent of the corporation or was serving at
the request of the corporation, against expenses actually and reasonably
incurred in connection with such action if he or she acted in good faith and in
a manner he or she reasonably believed to be in, or not opposed to, the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Delaware law does not permit a corporation to eliminate a director's duty of
care and the provisions of our certificate of incorporation have no effect on
the availability of equitable remedies, such as injunction or rescission, for a
director's breach of the duty of care.
We believe that our limitation of director liability assists us to attract
and retain qualified directors. However, in the event a director or the board
commits an act that may legally be indemnified under Delaware law, the company
will be responsible to pay for such director(s) legal defense and potentially
any damages resulting therefrom. Furthermore, the limitation on director
liability may reduce the likelihood of derivative litigation against directors,
and may discourage or deter stockholders from instituting litigation against
directors for breach of their fiduciary duties, even though such an action, if
successful, might benefit the company and its stockholders. Given the difficult
environment and potential for incurring liabilities currently facing directors
of publicly-held corporations, we believe that director indemnification is in
the
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best interests of the company and its stockholders, because it enhances our
ability to retain highly qualified directors and reduce a possible deterrent to
entrepreneurial decision-making.
Nevertheless, limitations of director liability may be viewed as limiting
the rights of stockholders, and the broad scope of the indemnification
provisions contained in our certificate of incorporation and bylaws could result
in increased expense to the company. The board of directors believes, however,
that these provisions will provide a better balancing of the legal obligations
of, and protections for, directors and will contribute positively to the quality
and stability of our corporate governance. The board of directors has concluded
that the benefit to stockholders of improved corporate governance outweighs any
possible adverse effects on stockholders of reducing the exposure of directors
to liability and broadened indemnification rights.
Product liability exposure may expose us to significant liability.
We do not have pharmaceutical products for sale and we therefor do not
carry product liability insurance. However, if we do commercialize drug products
we will face risk of exposure to product liability and other claims and lawsuits
in the event that the development or use of our technology or prospective
products is alleged to have resulted in adverse effects. We may not be able to
avoid significant liability exposure. We may not have sufficient insurance
coverage and we may not be able to obtain sufficient coverage at a reasonable
cost. An inability to obtain product liability insurance at acceptable cost or
to otherwise protect against potential product liability claims could prevent or
inhibit the commercialization of our products. A product liability claim could
hurt our financial performance. Even if we avoid liability exposure, significant
costs could be incurred, potentially damaging our financial performance. We do
carry commercial general liability insurance and clinical trials insurance which
covers our human clinical trial activities.
ABOUT THIS PROSPECTUS
This document is called a prospectus and is part of a registration
statement on Form S-3 that we filed with the SEC. Under this prospectus, we may
from time to time sell any combination of the securities described in this
prospectus in one or more offerings. The company's offerings may total up to
750,000 shares. In addition, the selling stockholders also may from time to time
collectively offer up to 1,331,598 shares of our common stock plus any
additional shares paid to selling stockholders as dividends on the preferred
shares that are convertible into the common stock registered hereunder.
You should rely only on the information contained or incorporated by
reference in this prospectus. 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 are not making, nor will
we make, an offer to sell the common stock in any jurisdiction where the offer
or sale is not permitted. You should assume that the information appearing in
this prospectus is current only as of the date on its cover. Our business,
financial condition, results of operations and prospects may have changed since
that date. You should read this prospectus together with the additional
information described under the heading "Where You Can Find More Information"
below.
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WHERE YOU CAN FIND MORE INFORMATION;
INCORPORATION OF DOCUMENTS BY REFERENCE
We file annual, quarterly and current reports, proxy statements and other
documents with the Securities and Exchange Commission (the "SEC"), under the
Securities Exchange Act of 1934, as amended (the "Exchange Act"). You may read
and copy any materials that we file with the SEC at the SEC's Public Reference
Room at 450 Fifth Street, N.W., Washington, D.C. 20549, at 233 Broadway, 16th
Floor, New York, New York 10279 and at Northwest Atrium Center, 5000 West
Madison Street, Suite 1400, Chicago, Illinois 60661-2511. You may obtain
information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our reports, proxy statements and other documents filed
electronically with the SEC are available at the website maintained by the SEC
at http://www.sec.gov. We also make available free of charge on or through our
Internet website, http://www.immtech-international.com, our annual, quarterly
and current reports, and, if applicable, amendments to those reports, filed or
furnished pursuant to Section 13(a) of the Exchange Act, as soon as reasonably
practicable after we electronically file such reports with the SEC. Information
on our website is not a part of this report.
We have filed with the SEC a registration statement on Form S-3 under the
Securities Act with respect to the shares. This prospectus, which constitutes a
part of that registration statement, does not contain all the information
contained in that registration statement and its exhibits. For further
information with respect to the company and the shares, you should consult the
registration statement and its exhibits. The registration statement and any of
its amendments, including exhibits filed as a part of the registration statement
or an amendment to the registration statement, are available for inspection and
copying through the SEC's public reference rooms listed above.
The SEC allows us to "incorporate by reference" in this prospectus the
information that we file with them, which means we can disclose important
information to you by referring you to other documents that contain that
information. The information we incorporate by reference is considered to be
part of this prospectus and information we later file with the SEC will
automatically update and supersede the information in this prospectus. The
following documents filed by us with the SEC pursuant to Section 13 of the
Exchange Act (File No. 000-25669) and any future filings under Sections 13(a),
13(c), 14 or 15(d) of the Exchange Act made before the termination of the
offering are incorporated by reference herein:
(i) our Amended Annual Report on Form 10-K/A for the fiscal year ended
March 31, 2003, filed with the SEC on October 15, 2003;
(ii) our Quarterly Reports on Form 10-Q for the fiscal quarters ended
June 30, 2003, September 30, 2003, and December 31, 2003, filed
with the SEC on August 14, 2003, November 14, 2003 and February 17,
2004, respectively;
(iii) the description of our common stock contained in our registration
statement filed with the SEC via Edgar under Section 12 of the
Exchange Act on April 29, 1999, including any amendments or reports
filed for the purpose of updating such description;
-15-
(iv) our definitive proxy statement pursuant to Section 14(A) of the
Exchange Act for our 2003 Annual Meeting of the Shareholders filed
with the SEC on December 12, 2003;
(v) all other reports filed pursuant to Section 13(a) or 15(d) of the
Exchange Act since the end of the fiscal year covered by the Annual
Report referenced in (i) above;
(vi) our Form 8-A pursuant to Section 12(b) of the Exchange Act filed
with the SEC on August 6, 2003;
(vii) our registration statement on Form SB-2/A filed with the SEC on
February 11, 1999; and
(viii) our certificate of incorporation, as amended, filed as Exhibit 3.1
to the above referenced registration statement on Form SB-2/A.
All documents filed by the company pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act subsequent to the date of this registration
statement and prior to the filing of a post-effective amendment indicating that
all securities offered hereby have been sold or deregistering all securities
then remaining unsold are expressly incorporated by reference into this
prospectus and to be a part of this prospectus from the date of filing of such
documents.
Statements made in this prospectus, or in any documents incorporated by
reference in this prospectus as to the contents of any contract or other
document are materially complete. For additional information we refer you to the
copy of the contract or other document filed as an exhibit to the registration
statement of which this prospectus is a part or as an exhibit to the documents
incorporated by reference.
We will provide to you a copy of any document incorporated by reference in
this prospectus and any exhibits specifically incorporated by reference in those
documents at no cost. You may request copies by contacting us at the following
address or telephone numbers: Corporate Secretary, Immtech International, Inc.,
150 Fairway Drive, Suite 150, Vernon Hills, Illinois, 60061, Telephone No.:
(847) 573-0033 or toll free (877) 898-8038.
Any statement incorporated or deemed incorporated herein by reference will
be deemed to be modified or superseded for the purpose of the registration
statement and this prospectus to the extent that a statement contained in this
prospectus or in any subsequently filed document modifies or supersedes such
statement. Any such statement so modified or superseded will not be deemed,
except as so modified or superseded, to constitute a part of the registration
statement or this prospectus.
FORWARD-LOOKING STATEMENTS
Certain statements contained in this prospectus and in the documents
incorporated by reference in this prospectus constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. All statements other than statements of historical fact may be deemed
to be forward-looking statements. Forward-looking statements frequently, but not
always, use the words "intends," "plans," "believes," "anticipates" or
-16-
"expects" or similar words and may include statements concerning our strategies,
goals and plans. Forward-looking statements involve a number of significant
risks and uncertainties that could cause our actual results or achievements or
other events to differ materially from those reflected in such forward-looking
statements. Such factors include, among others described in the prospectus, the
following: (i) we are in an early stage of product development, (ii) our
technology is in the research and development stage and therefore its potential
benefits for human therapy are unproven, (iii) the possibility that favorable
relationships with collaborators cannot be established or, if established, will
be abandoned by the collaborators before completion of product development, (iv)
the possibility that we or our collaborators will not successfully develop any
marketable products, (v) the possibility that advances by competitors will cause
our product candidates not to be viable, (vi) uncertainties as to the
requirement that a drug product may not be found to be safe and effective after
extensive clinical trials and the possibility that the results of such trials,
if completed, will not establish the safety or efficacy of our drug product
candidates, (vii) risks relating to requirements for approvals by governmental
agencies, such as the Food and Drug Administration, before products can be
marketed and the possibility that such approvals will not be obtained in a
timely manner or at all or will be conditioned in a manner that would impair our
ability to market our product candidates successfully, (viii) the risk that our
patents could be invalidated or narrowed in scope by judicial actions or that
our technology could infringe upon the patent or other intellectual property
rights of third parties, (ix) the possibility that we will not be able to raise
adequate capital to fund our operations through the process of commercializing a
successful product or that future financing will be completed on unfavorable
terms, (x) the possibility that any products successfully developed by us will
not achieve market acceptance and (xi) other risks and uncertainties that may
not be described herein. We undertake no obligation except as required by
securities law to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise in this prospectus.
THE COMPANY
AN INVESTMENT IN THE SECURITIES OFFERED BY THIS PROSPECTUS INVOLVES A HIGH
DEGREE OF RISK. PROSPECTIVE INVESTORS SHOULD CONSIDER CAREFULLY THE INFORMATION
PROVIDED UNDER "RISK FACTORS" BEGINNING ON PAGE S-1. A GLOSSARY WHICH DEFINES
VARIOUS TERMS USED IN THIS PROSPECTUS BEGINS ON PAGE S-26.
We are a pharmaceutical company focused on the development and
commercialization of oral drugs to treat infectious diseases. The company has
development programs that include fungal infections, malaria, tuberculosis,
hepatitis C, Pneumocystis carinii pneumonia ("PCP") and tropical medicine
diseases, including African sleeping sickness (a parasitic disease also known as
trypanosomiasis) and leishmaniasis (a parasitic disease that destroys the
liver). We hold worldwide patents, patent applications, licenses and rights to
license worldwide patents, patent applications and technologies from a
scientific consortium and exclusive rights to commercialize products from those
patents and licenses that are integral to our business.
Since our formation in October 1984, we have engaged in research and
development programs, expanding our network of scientists and scientific
advisors, licensing technology agreements and advancing the commercialization of
the dication technology platform. We use
-17-
the expertise and resources of strategic partners and third parties in a number
of areas, including (i) research and development, (ii) pre-clinical and human
clinical trials and (iii) manufacture of pharmaceutical drugs. We have licensing
and exclusive commercialization rights to a dicationic pharmaceutical platform
and are developing drugs intended for commercial use based on that platform.
Dication pharmaceutical drugs work by blocking life-sustaining enzymes from
binding to key sites in the "minor groove" of an organism's deoxyribonucleic
acid ("DNA"), killing the infectious organisms that cause fungal, parasitic,
bacterial and viral diseases. The key site on an organism's DNA is an area where
enzymes interact with the infectious organism's DNA as part of their normal life
cycle. Structurally, dications are chemical molecules that have two positively
charged ends held together by a chemical linker. The composition of the
dications, with positive charges on both ends (shaped like molecular barbells),
allows dications to bind (similar to a band-aid) to the negatively charged key
sites of an infectious organism's DNA. The bound dications block life sustaining
enzymes from attaching to the DNA's key sites, thereby killing the infectious
organism.
The dication technology is the result of a research program developed by
scientists at UNC, Georgia State University, Duke University and Auburn
University (collectively, the "Scientific Consortium"). We entered into an
agreement with the Scientific Consortium, dated January 15, 1997, as amended,
and a License Agreement, dated as of January 28, 2002 (collectively, the
"Consortium Agreement"), to commercialize product candidates resulting from the
Scientific Consortium's research, including the dication technology.
USE OF PROCEEDS
We intend to use the proceeds of the sale of shares under this prospectus
by the company for general corporate purposes, including research and
development and commercialization efforts. We will not receive any of the
proceeds from the sale of the shares offered by the selling stockholders under
this prospectus.
SELLING STOCKHOLDERS
The selling stockholders other than Gabriele Group LLC ("Gabriele"), Mr.
John Vaccaro ("Mr. Vaccaro"), Fulcrum Holdings of Australia, Inc. ("Fulcrum")
and China Harvest International Ltd. ("China Harvest"), listed below acquired
our series C stock in private placements between June 6-9, 2003. Such selling
stockholders have the right to acquire shares (i) upon conversion of the series
C stock or (ii) upon issuance of common stock as stock dividends to holders of
series C stock, granted to them in connection with their participation in the
private placements. No period of time has been fixed within which the shares
registered under this prospectus may be offered or sold. Our obligation to keep
the registration statement of which this prospectus is a part effective expires
as to 667,144 shares on June 6, 2004, 41,854 shares on June 9, 2004, 70,000 on
July 31, 2004, and 2,600 shares on November 12, 2004 or sooner if all selling
stockholders' shares are sold.
Between June 6-9, 2003, the selling stockholders purchased in the
aggregate 125,352 shares of our series C stock for gross proceeds to us of
$3,133,800. We completed our offering of series C stock as of June 9, 2003.
Subject to adjustment for dilution protection, each share of series C stock is
convertible into 5.6561 shares of common stock, 708,998 shares in the
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aggregate. The series C stock earns an 8% per annum dividend payable
semi-annually each April 15th and October 15th, in cash or common stock at the
company's option for so long as any series C stock remains outstanding. If
common stock is to be used to pay the series C stock dividend, such common stock
is to be valued at the 10-day volume-weighted average closing-bid price
immediately prior to the date of payment. We agreed to use reasonable efforts to
register the resale by the selling stockholders of the shares of common stock
issuable upon conversion of the series C stock within 180 days after the date of
purchase of the series C stock, and to keep such registration effective for the
lesser of one year or until all of such shares are sold.
On July 31, 2002, we entered into a one-year agreement with Gabriele to
provide to us management consulting services, strategic planning, public
relations and promotions. We issued to Gabriele 40,000 shares of our common
stock and three warrants, each to purchase 10,000 shares of our common stock
exercisable at $6.00 per share; the warrants vest when the market price of our
common stock meets or exceeds $10, $15 and $20 for a period of 20 consecutive
trading days, respectively, or if the valuation of our common stock in a merger
or acquisition meets or exceeds $10, $15 and $20 per share, respectively.
On April 26, 1999, we entered into a consulting arrangement with Mr.
Vaccaro for services to be provided to assist the company to list its common
stock on to the NASDAQ SmallCap Market. For his services, Mr. Vaccaro was
granted a warrant to purchase 2,600 shares of common stock exercisable at $16.00
per share of common stock upon such listing.
On March 21, 2003, we entered into an investor relations agreement with
Fulcrum for financial consulting services and public relations management to be
provided over a 12-month period. Pursuant to this agreement we issued, among
other things, warrants to purchase 350,000 shares of common stock from the
Company. Warrants to purchase 100,000 shares are exercisable at $6.00 per share;
warrants to purchase 125,000 shares are exercisable at $10.00 per share; and
warrants to purchase an additional 125,000 shares are exercisable at $15.00 per
share. The warrants are fully vested and may be exercised until the earliest of
March 21, 2005, the effective date of a sale, merger or other combination of the
Company.
On July 25, 2003, we entered into a consulting agreement with Fulcrum to
identify and negotiate with stock exchanges to list our common stock and to
assist us to prepare applications to list our common stock on stock exchanges.
Pursuant to this agreement and upon the listing of our common stock on the
American Stock Exchange on August 11, 2003, we issued to Fulcrum 100,000 shares
of our common stock.
On July 16, 2003, we entered into an agreement with China Harvest for
services to assist the Company in obtaining regulatory approval to conduct
clinical trials in China. Pursuant to this agreement, we granted China Harvest a
warrant to purchase 600,000 shares of our common stock at $6.08 per share. These
warrants are fully vested and have an exercise period of five years. We are
registering hereunder 100,000 of the 600,000 shares of common stock underlying
the abovementioned warrants.
The following table sets forth for each selling stockholder (i) the number
of shares being registered by this prospectus, (ii) the number of shares and
percent of class beneficially owned at the date of filing, and (iii) the number
of shares and percent of class that the selling stockholder
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would beneficially own if all shares registered hereunder were sold, assuming no
other shares were purchased. No selling stockholder has been an officer,
director or employee of Immtech for the past three years. Because the selling
stockholders may offer all, some or none of their shares, we cannot provide a
definitive estimate of the number of shares each will hold after such
registration. This prospectus is filed at our expense.
Percent of
Shares Class
Percent of Remaining Remaining
Class of if all if all
Shares Shares Shares Shares
Series C Shares of Beneficially Shares Beneficially Registered Registered
Name Stock Common Owned Registered Owned(1) are Sold are Sold
--------------------------------------- -------- --------- ------------ ---------- ------------ ---------- ----------
Fulcrum Holdings of Australia, Inc. 0 550,000 551,000 450,000 4.6% 101,000 1.02%
China Harvest International Ltd. 0 600,000 600,000 100,000 6.15% 500,000 5.08%
Gabriele Group LLC 0 70,000 70,000 70,000 * % 0 * %
Vivienne Lee 9,200 52,036 202,602 52,036 2.0% 150,566 * %
Ma Fa On 0 36,199 64,751 36,199 * % 28,552 * %
Tao Wai Ling 0 32,805 33,072 32,805 * % 267 * %
Cheung Ming Tak 0 32,805 66,311 32,805 * % 33,506 * %
Cheung Shuk Kwan 4,800 27,149 120,847 27,149 1.2% 93,698 * %
Monet Capital Fund I, LP 4,800 27,149 120,847 27,149 1.2% 93,698 * %
Tsang Wai Ping Alfred 0 24,887 79,598 24,887 * % 54,711 * %
Sanford Goldfarb 0 22,624 24,949 22,624 * % 2,325 * %
Lau Chu 4,000 22,624 102,528 22,624 1.0% 79,904 * %
Cheung Yuk Chor Dickie 0 22,624 137,886 22,624 1.4% 90,262 * %
Donald H. Wong 3,400 19,231 53,885 19,231 * % 34,654 * %
Chan Chee Wing 3,200 18,100 115,684 18,100 1.2% 97,589 * %
Tefa Capital, Inc. 3,200 18,100 18,225 18,100 * % 125 * %
Liu Yuk Tong and Wong Gum Wing Caroline 3,000 16,968 103,672 16,968 1.0% 86,704 * %
Val Busler 0 15,837 15,837 15,837 * % 0 * %
Li Lo Kwong 2,600 14,706 25,694 14,706 * % 0 * %
Jerry Sorkin 2,600 14,706 17,808 14,706 * % 3,102 * %
Lau Kin Yip 2,400 13,575 13,669 13,575 * % 94 * %
Ho Siu Man 0 11,991 12,087 11,991 * % 96 * %
Lau Mei Yin Amy 0 11,765 23,214 11,765 * % 11,449 * %
Shum Kit Ching 0 11,765 11,859 11,765 * % 94 * %
Fukoku Asset Management Ltd. 2,000 11,312 64,552 11,312 * % 53,246 * %
John R. Harrington and
John R. Harrington, Jr. Trust 3,800 21,493 134,630 21,493 1.4% 113,137 * %
Hui Chin Ki 0 11,312 26,584 11,312 * % 15,272 * %
Mao Frank Tsao Yu 0 11,312 11,471 11,312 * % 159 * %
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Percent of
Shares Class
Percent of Remaining Remaining
Class of if all if all
Shares Shares Shares Shares
Series C Shares of Beneficially Shares Beneficially Registered Registered
Name Stock Common Owned Registered Owned(1) are Sold are Sold
--------------------------------------- -------- --------- ------------ ---------- ------------ ---------- ----------
Richard M. Schaeffer 2,000 11,312 11,390 11,312 * % 78 * %
Wingpearl Investments Ltd. 2,000 11,312 11,390 11,312 * % 78 * %
Mak Wah 0 10,860 10,974 10,860 * % 87 * %
John J. Orlando 1,800 10,181 25,902 10,181 * % 15,721 * %
Target Profits Securities Limited 1,768 10,000 30,069 10,000 * % 20,069 * %
Chan Yu Ching 1,768 10,000 10,069 10,000 * % 69 * %
Wong Hon Fai Jones 1,768 10,000 16,220 10,000 * % 6,220 * %
John Neal 0 10,000 10,164 10,000 * % 164 * %
Lee Hon Kit Raymond 1,600 9,050 24,647 9,050 * % 15,597 * %
Ho Cho Chuen 1,600 9,050 9,112 9,050 * % 62 * %
Li Wai Yin 0 9,050 9,176 9,050 * % 126 * %
Thomas J. Krupp II 0 6,787 6,852 6,787 * % 65 * %
Raymond Carbone 0 5,656 6,750 5,656 * % 1,094 * %
Richard H. Harrington 1,000 5,656 15,695 5,656 * % 10,039 * %
Scott Hess 1,000 5,656 12,491 5,656 * % 6,835 * %
John Ketcham 1,000 5,656 9,695 5,656 * % 4,039 * %
Michael Strada 1,000 5,656 5,695 5,656 * % 39 * %
Chan Pui Ling Juliana 0 4,525 6,588 4,525 * % 2,063 * %
Dwight B. Crane 800 4,525 31,844 4,525 * % 27,319 * %
James M. Florsheim Trust Account #1 800 4,525 11,402 4,525 * % 6,877 * %
Sum Lan Hing 0 2,715 2,735 2,715 * % 20 * %
John A. Vaccaro 0 2,600 2,600 2,600 * % 0 * %
John J. Coonan 400 2,262 4,631 2,262 * % 2,369 * %
Yeung Lai 0 2,262 5,317 2,262 * % 3,055 * %
Stephen Carter 400 2,262 3,788 2,262 * % 1,526 * %
Ho Mei Yee 400 2,262 2,277 2,262 * % 15 * %
Lam Yuk Ying 0 2,262 2,293 2,262 * % 31 * %
Michael Dundas 400 2,262 2,277 2,262 * % 15 * %
Lau Wai Wah Richard 400 2,262 2,277 2,262 * % 15 * %
Lo Mo On 400 2,262 8,321 2,262 * % 6,059 * %
Salvatore Picciallo 400 2,262 2,277 2,262 * % 15 * %
Michael Volpe 400 2,262 7,235 2,262 * % 4,973 * %
Martin Boyle 200 1,131 8,057 1,131 * % 6,926 * %
-------- --------- ------------ ----------
Totals 72,304 1,931,598 3,153,472 1,331,598
(1) The corresponding percentages are the quotient of (x) the number of shares
beneficially owned and (y) the sum of the 9,834,986 shares of common stock
outstanding, the number shares of common stock issuable upon conversion of
series A stock, series B stock, series C stock and series D stock and such
holder's options and warrants exercisable within 60 days of the date of
March 19, 2004.
* Less than 1.00%.
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DESCRIPTION OF CAPITAL STOCK
General
The following are the material terms of our common stock. You should refer
to the applicable provisions of Delaware law, our certificate of incorporation
as amended and our bylaws for additional information. See "Where You Can Find
More Information."
Under our certificate of incorporation, as amended, our authorized capital
stock consists of:
30,000,000 shares of common stock; and
5,000,000 shares of preferred stock, par value $0.01 per share.
As of March 19, 2004, we had 9,834,986 shares of common stock outstanding
(not including 457,013 shares of common stock reserved for conversion of series
A stock, 124,531 shares of common stock reserved for conversion of series B
stock, 408,954 shares of common stock reserved for conversion of series C stock,
555,540 shares of common stock reserved for the conversion of series D stock,
955,374 shares of common stock reserved for exercise of outstanding options and
2,787,712 shares of common stock reserved for exercise of outstanding warrants
held by certain investors). Of the shares of common stock outstanding, 6,888,199
shares of common stock are freely tradable without restriction. All of the
remaining 2,946,787 shares are restricted from resale except pursuant to certain
exceptions under the Securities Act. All of the common stock underlying the
outstanding series C stock is registered by this prospectus.
Common Stock
Our common stock is traded on the American Stock Exchange LLC ("AMEX")
under the symbol "IMM." Each share of our common stock entitles the holder to
one vote on all matters on which holders are permitted to vote. There is no
cumulative voting for election of directors. Accordingly, the holders of a
majority of the shares voted can elect all of the nominees for director.
Subject to preferences that may be applicable to any outstanding series of
preferred stock, the holders of our common stock are entitled to dividends when,
and if, declared by the board of directors out of funds legally available for
that purpose. Upon liquidation, dissolution or winding up, subject to
preferences that may be applicable to any outstanding series of preferred stock,
the holders of our common stock are entitled to a pro rata share in any
distribution to stockholders. Our common stock has no preemptive or conversion
rights or other subscription rights. There are no redemption or sinking fund
provisions applicable to our common stock. All outstanding shares of our common
stock are fully paid and non-assessable.
PLAN OF DISTRIBUTION
The distribution of the shares described in this prospectus may be
effected from time to time in one or more transactions either (a) at a fixed
price or prices, which may be changed, (b) at market prices prevailing at the
time of sale, (c) at prices relating to the prevailing market
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prices or (d) at negotiated prices. We (subject to AMEX rules), and any selling
stockholders, may offer and sell the shares described in this prospectus (i)
through agents, (ii) through one or more underwriters or dealers, (iii) through
a block trade in which the broker or dealer engaged to handle the block trade
will attempt to sell the securities as agent, but may position and resell a
portion of the block as principal to facilitate the transaction, (iv) directly
to one or more purchasers (through a specific bidding or auction process or
otherwise), (v) in "at the market offerings," within the meaning of Rule
415(a)(4) of the Securities Act, (vi) through a combination of any of these
methods of sale, or (vii) at a fixed exchange ratio in return for other of our
securities.
To our knowledge, the selling stockholders have not entered into any
agreements, understandings or arrangements with any underwriters or
broker-dealers regarding the sale of the shares, nor is there an underwriter or
coordinating broker acting in connection with the proposed sales of shares by
the selling stockholders. Any shares covered by this prospectus that qualify for
sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144
rather than pursuant to this prospectus. We will pay all costs and expenses
incurred in connection with the registration of the shares offered by this
prospectus. Any brokerage commissions and similar selling expenses attributable
to the sale of shares by the selling stockholders will be borne by the selling
stockholders.
We have agreed to indemnify the selling stockholders and the selling
stockholders' respective officers, directors, employees and agents, and each
person who controls such selling stockholders, in certain circumstances against
certain liabilities, including liabilities arising under the Securities Act, and
the selling stockholders have agreed to indemnify us and our directors and
officers in certain circumstances against certain liabilities, including
liabilities arising under the Securities Act, in each case in connection with
this offering.
We or the selling stockholders may solicit offers to purchase the shares
directly and we or the selling stockholders may sell the shares directly to
institutional or other investors. We or the selling stockholders may enter into
agreements with agents, underwriters and dealers under which we or the selling
stockholders may agree to indemnify the agents, underwriters and dealers against
certain liabilities, including liabilities under the Securities Act, or to
contribute to payments they may be required to make with respect to these
liabilities. Some of the agents, underwriters or dealers, or their affiliates
may be customers of, engage in transactions with or perform services for us or
the selling stockholders in the ordinary course of business.
If we or any selling stockholders offer and sell shares through an
underwriter or underwriters, then we or the selling stockholders will execute an
underwriting agreement with the underwriter or underwriters. The names of the
specific managing underwriter or underwriters, as well as any other
underwriters, and the terms of the transactions, including compensation of the
underwriters and dealers, which may be in the form of discounts, concessions or
commissions, if any, will be described in a prospectus supplement, if
applicable, which will be used by the underwriters to make resales of the
shares. If the selling stockholders offer and sell the shares through a dealer,
then the selling stockholders or an underwriter will sell the shares to the
dealer, as principal. The dealer may then resell the shares to the public at
varying prices to be determined by the dealer at the time of resale.
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We may engage in at the market offerings of our common stock. An at the
market offering is an offering of our common stock at other than a fixed price
to or through a market maker. Under Rule 415(a)(4) of the Securities Act, the
total value of at the market offerings made under this prospectus may not exceed
10% of the aggregate market value of our common stock held by non-affiliates.
Any underwriter that we engage for an at the market offering would be named in a
post-effective amendment to the registration statement containing this
prospectus. Additional details of our arrangement with the underwriter,
including commissions or fees paid by us and whether the underwriter is acting
as principal or agent, would be described in the related prospectus supplement.
We may grant underwriters who participate in the distribution of the
shares an option to purchase additional shares to cover over-allotments, if any,
in connection with the distribution.
The selling stockholders, dealers acting in connection with the offering
and brokers executing sell orders on behalf of one or more selling stockholders
may be deemed to be "underwriters" within the meaning of the Securities Act. In
addition, any such broker or dealer may be required to deliver a copy of this
prospectus to any person who purchases any of the shares from or through such
broker or dealer.
LEGAL MATTERS
Legal matters in connection with the validity of the shares offered by
this prospectus will be passed upon for the company by Cadwalader, Wickersham &
Taft LLP, New York, New York.
EXPERTS
The financial statements incorporated in this prospectus by reference from
the company's Annual Report on Form 10-K/A have been audited by Deloitte &
Touche LLP, independent auditors, as stated in their report, which is
incorporated herein by reference, and have been so incorporated in reliance upon
the report of such firm given upon their authority as experts in accounting and
auditing.
INTERESTS OF NAMED EXPERTS AND COUNSEL
None.
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DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of the
company pursuant to the foregoing provisions, the company has been advised that
in the opinion of the SEC such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable.
You should rely only on the information contained in this prospectus,
incorporated by reference herein or provided by supplement. We have not
authorized anyone else to provide you with different information. The
information contained in this prospectus is correct only as of the date of this
prospectus, regardless of the time of the delivery of this prospectus or any
sale of these securities.
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GLOSSARY
As used in this prospectus, the following terms have the meanings set
forth below.
AIDS Acquired immune deficiency syndrome, a disease caused by a
virus.
DB289 The designation given to our lead dication.
Dication A chemical molecule with two positively charged ends that are
held together by a chemical linker. Dications bind to the DNA
of infectious organisms.
DNA A type of molecule made up of polymerized deoxyribonucleotides
linked together by phosphate bonds.
ELA Establishment License Application.
FDA U.S. Food and Drug Administration.
FDCA Federal Food, Drug, and Cosmetic Act as Amended.
HCV Hepatitis C virus, or HCV, is one of the viruses that causes
acute and chronic hepatitis. Persons who are chronically
infected with hepatitis C are at an increased risk for the
development of cirrhosis and liver cancer.
HIV HIV is the human immunodeficiency virus most researchers
believe causes AIDS.
IND Investigational New Drug Application, or IND, is a document
required to be filed with the FDA prior to performing clinical
studies on human subjects in the United States.
Leishmaniasis An infection caused by a protozoal parasite that affects the
skin and abdominal organs, causing ulcers or skin disorders
that resemble leprosy.
PCP Pneumocystis carinii pneumonia ("PCP") is a protozoal
infection of the lungs, and most common of the AIDS-associated
diseases.
Phase I Clinical testing in which the safety and pharmacological
profile of a new drug is established in humans.
Phase II Clinical testing in which the effectiveness of a new drug is
established in humans. This includes establishing the dose
amount and frequency required to achieve a therapeutic effect,
the metabolic rate of the administered drug and the toxicity
profile in specific patient populations.
PLA Product License Application.
TB A disease caused by bacteria, Mycobacterium tuberculosis, that
is transmitted by breathing in or eating infected droplets,
usually affecting the lungs, although infection of other organ
systems can occur.
Trypanosomiasis An infection caused by a protozoal parasite and transmitted
usually by insect bites. Also known as African sleeping
sickness.
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====================================== ======================================
TABLE OF CONTENTS
RISK FACTORS .................... 1 IMMTECH INTERNATIONAL,
ABOUT THIS PROSPECTUS ........... 14 INC.
WHERE YOU CAN FIND MORE
INFORMATION; INCORPORATION OF 2,081,598 Shares
DOCUMENTS BY REFERENCE .......... 15 Common Stock
FORWARD-LOOKING STATEMENTS ...... 16
THE COMPANY ..................... 17 ----------------------
USE OF PROCEEDS ................. 18 PROSPECTUS
SELLING STOCKHOLDERS ............ 18 ----------------------
DESCRIPTION OF CAPITAL STOCK .... 22
PLAN OF DISTRIBUTION ............ 22 April 23, 2004
LEGAL MATTERS ................... 24
EXPERTS ......................... 24
INTERESTS OF NAMED EXPERTS AND
COUNSEL ......................... 24
GLOSSARY ........................ 26
ALL DEALERS THAT EFFECT TRANSACTIONS
IN THESE SECURITIES, WHETHER OR NOT
PARTICIPATING IN THIS OFFERING, MAY BE
REQUIRED TO DELIVER A PROSPECTUS UNTIL
THE LATER OF JUNE 5, 2004 OR 40 DAYS
AFTER THE EFFECTIVE DATE OF THIS
PROSPECTUS OR ANY POST-EFFECTIVE
AMENDMENT TO THIS PROSPECTUS. THIS IS
IN ADDITION TO THE DEALERS' OBLIGATION
TO DELIVER A PROSPECTUS WHEN ACTING AS
UNDERWRITERS AND WITH RESPECT TO THEIR
UNSOLD ALLOTMENTS OR SUBSCRIPTIONS.
====================================== ======================================
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