s3a.htm
As
filed with the Securities and Exchange Commission on September 7,
2007
Registration
Statement No. 333-144391
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Pre-Effective
Amendment No. 1 to
FORM
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
IMMTECH
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in charter)
|
Delaware
(State
or other jurisdiction of incorporation or organization)
|
39-1523370
(I.R.S.
Employer Identification Number)
|
One
North End Avenue
New
York, NY 10282
(212)
791-2911
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal executive offices)
Eric
L. Sorkin
Chief
Executive Officer
Immtech
Pharmaceuticals, Inc.
One
North End Avenue
New
York, NY 10282
(212)
791-2911
(Name,
address, including zip code, and telephone number, including area code, of
agent
for service)
Copy
To:
Michael
L. Zuppone, Esq.
Paul,
Hastings, Janofsky & Walker LLP
75
East 55th Street
New
York, New York 10022
(212)
318-6000
Approximate
date of commencement of proposed sale to the public:
From
time to time 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:
|_|
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, as
amended, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box: |X|
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. |_|
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. |_|
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. |_|
If
this
Form is a post-effective amendment to a registration statement filed pursuant
to
General Instruction I.D. filed to register addition securities or additional
class or securities pursuant to Rule 413(b) under the Securities Act, check
the
following box. |_|
CALCULATION
OF REGISTRATION FEE
|
Title
of each class of securities to be registered
|
Proposed
maximum
aggregate
offering price(1)
(2)
|
Amount
of
registration
fee)(3)
|
|
Common
Stock, par value $0.01 per share
|
$50,000,000
|
$1,535
|
|
(1)
Such indeterminate number of shares of Common Stock as may from time
to
time be issued at indeterminate prices.
(2)
Estimated solely for the purpose of calculating the registration
fee
pursuant to Rule 457(c) of the Securities Act of 1933.
(3)
Previously paid.
|
The
registrant hereby amends this registration statement on such date or dates
as
may be necessary to delay its effective date until the registrant files a
further amendment, which specifically states that this registration statement
will thereafter become effective in accordance with Section 8(a) of the
Securities Act or until this registration statement becomes effective on such
date as the Securities and Exchange Commission, acting pursuant to Section
8(a)
of the Securities Act, may determine.
The
information in this prospectus is not complete and may be changed. We
may not sell these securities 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 September 6, 2007
|
PRELIMINARY
PROSPECTUS
|
IMMTECH
PHARMACEUTICALS, INC.
|
|
$50,000,000
Common
Stock
We
may,
from time to time, offer up to $50,000,000 in shares of our common stock
(“Common Stock”).
Our
Common Stock is traded on the AMEX under the symbol “IMM”. The last
reported sale of our Common Stock on the AMEX on September 5, 2007 was
$8.06.
When
we
offer our Common Stock, we will provide specific terms of the offering in
supplements to this prospectus. The Common Stock offered by this prospectus
and
any prospectus supplement may be offered directly or to or through one or more
underwriters, dealers or agents, or directly to purchasers, on a continuous
or
delayed basis. If any underwriters are involved in the sale of any Common Stock
offered by this prospectus and any prospectus supplement, their names, and
any
applicable purchase price, fee, commission or discount arrangement between
or
among them, will be set forth, or will be calculable from the information set
forth, in the applicable prospectus supplement.
You
should read this prospectus and any prospectus supplement carefully before
you
invest in any of our securities.
INVESTING
IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD CONSIDER
CAREFULLY THE RISK FACTORS BEGINNING ON PAGE 2 OF THIS PROSPECTUS BEFORE
PURCHASING ANY OF THE COMMON STOCK OFFERED.
This
prospectus may not be used to offer or sell any securities unless accompanied
by
a prospectus supplement.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION
HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR
ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The
date of this prospectus
is ,
2007
TABLE
OF CONTENTS
|
SUMMARY
|
1
|
|
RISK
FACTORS
|
2
|
|
USE
OF PROCEEDS
|
12
|
|
PLAN
OF DISTRIBUTION
|
12
|
|
DESCRIPTION
OF CAPITAL STOCK
|
13
|
|
LEGAL
MATTERS
|
15
|
|
EXPERTS
|
15
|
|
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
|
15
|
|
WHERE
YOU CAN FIND MORE INFORMATION
|
16
|
|
FORWARD-LOOKING
STATEMENTS
|
16
|
|
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
17
|
|
GLOSSARY
|
18
|
In
this
prospectus, unless the context specifically indicates otherwise, “Immtech,” “the
Company,” “we,” “us” and “our” refer to Immtech Pharmaceuticals,
Inc.
No
person
has been authorized to give any information or make any representations in
connection with this offering other than those contained in this prospectus
and,
if given or made, such information or representations must not be relied
upon as
having been authorized by us. This prospectus does not constitute an offer
to
sell or a solicitation of any offer to buy any of the securities offered
hereby
by anyone in any jurisdiction in which it is unlawful to make such offer
or
solicitation. Neither the delivery of this prospectus nor any sale made
hereunder shall, under any circumstances, create any implication that the
information contained herein is correct as of any time subsequent to the
date of
the prospectus.
SUMMARY
The
following summary provides an overview of certain information about our company
and the offering and may not contain all the information that may be important
to you. This summary is qualified in its entirety by and should be read together
with the information contained in other parts of this prospectus. You should
carefully read this entire prospectus before making a decision about whether
to
invest in our Common Stock.
Our
Company
We
are a
pharmaceutical company advancing the development and commercialization of drugs
to treat infectious diseases. We are clinically testing treatments for malaria,
Pneumocystis pneumonia, or PCP, and trypanosomiasis, or African sleeping
sickness, and are developing treatments for fungal infections, bacterial
infections and hepatitis C. We have a worldwide, exclusive license to
commercialize a pharmaceutical platform from which a pipeline of products may
be
developed to target large, global markets.
Our
strategy is to develop drugs effective against infectious diseases utilizing
a
large library of well-defined compounds. Infectious diseases in the global
population have increased significantly during the past 20 years and are the
most common cause of death worldwide according to the World Health Organization
(“WHO”). Relatively few new drugs for treatment of infectious diseases have been
brought to market during this period. New antimicrobials are needed to overcome
the problems of multi-drug resistance and the increasing number of new pathogens
that are causing global health problems.
Since
our
formation in October 1984, we have engaged in pharmaceutical research and drug
development, expanding our scientific capabilities and collaborative network,
developing technology licensing agreements and advancing the commercialization
of our proprietary technologies, including the development of aromatic cationic
compounds commencing in 1998. In addition to our internal resources, we use
the
expertise and resources of strategic partners and third parties in a number
of
areas, including (i) discovery research, (ii) pre-clinical and human clinical
trials and (iii) manufacture of pharmaceutical drugs.
We
intend
to continue to work with our scientific and foundation alliances to
validate and commercialize our technology platform. We believe we will
be
permitted to sell drugs in niche markets as we further target
multi-billion dollar markets by developing drugs to treat fungal, bacterial
and
viral infections. Our leading oral drug candidate is pafuramidine maleate,
or
pafuramidine, which is also known as DB289. Pafuramidine is in two Phase
III
trials, one to treat PCP and another to treat African sleeping sickness.
Each of
these trials have been given a Special Protocol Assessment by the United
States
Food and Drug Administration, or the FDA. Because we demonstrated to the
FDA
pafuramidine’s potential to provide improvement over currently available
alternative therapies, the FDA also granted fast track designation to
pafuramidine for treatment of African sleeping sickness. The development
of
pafuramidine to treat African sleeping sickness is
sponsored through grants to the scientific consortium with which we
collaborate. The consortium is led by the University of North Carolina
at Chapel
Hill (UNC-CH) and is sponsored by the Bill and Melinda Gates
Foundation. Orphan drug designation has been given to
pafuramidine for treatment of African sleeping sickness and malaria and
may
allow for accelerated FDA review. However, there is no guarantee that orphan
drug designation will result in faster product development or impact the
likelihood and timing of product approval. In addition to the phase III
trials,
we also have two phase II trials targeting malaria treatment and malaria
prevention.
Immtech
holds an exclusive worldwide license to develop and commercialize a broad
platform of aromatic cationic compounds. These drugs have
demonstrated broad activity against a number of infectious organisms that
cause
fungal, parasitic, bacterial and viral diseases.
An
aromatic cationic compound is a molecule that has at least one positively
charged end and one benzene ring in its structure. Immtech’s library of
compounds includes many aromatic dications. Although the mechanism of action
of
these compounds is not completely understood, it is thought that their
ability
to bind to segments of deoxyribonucleic acid, or DNA, interferes with the
activity of enzymes needed for microbial growth and development. The composition
of dications, with positive charges on the ends and links of different
length,
shape, flexibility and curvature, allows for compound-specific binding
to DNA or
to other receptors.
No
significant research work was done on cationic compounds until the National
Institute of Health began supporting work done by scientists from the UNC-CH
led
consortium. The library of compounds to which Immtech
has
worldwide exclusive right represents a new generation of cationic compounds.
Additionally, scientists from the UNC-CH led consortium developed a proprietary
prodrug technology which could make the compounds orally available.
About
Immtech
A
predecessor of our company was incorporated under the laws of the State of
Wisconsin on October 15, 1984, and subsequently merged into the current Delaware
corporation on April 1, 1993. Our executive offices are located at One North
End
Avenue, New York, New York 10282, telephone number (212)791-2911 or toll-free
(877) 898-8093.
RISK
FACTORS
An
investment in our Common Stock involves a high degree of risk. You should
carefully consider the information contained in the sections titled “Business”
and “Risk Factors” in Part I of our Annual Report on Form 10-K and the
risks described below, together with the other information contained in, or
incorporated by reference into, this prospectus, before you decide whether
to
buy our Common Stock. If any of the events described in these risks actually
occurs, the market price of our Common Stock could decline, and you may lose
all
or part of the money you paid to buy our Common Stock.
There
is no assurance that we will successfully develop a commercially viable
product. Our most advanced and first drug candidate, pafuramidine, is
in Phase III pivotal clinical trials for two
indications.
We
are in
various stages of human clinical trials, and in some cases preclinical
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, since
obtaining the rights thereto in 1997, advancing the commercialization of the
aromatic cation technology platform that is the basis for our first drug
candidate, pafuramidine. We have generated no revenue from product
sales, do not have any products currently available for sale, and none are
expected to be commercially available for sale until after March 31, 2008,
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 clinical testing using pafuramidine, our first drug candidate,
for several indications including Phase III clinical studies of PCP and African
sleeping sickness and malaria prophylaxis and malaria treatment and must undergo
substantial additional regulatory review prior to
commercialization.
We
have a history of losses and an accumulated deficit and, as a result, 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 June 30, 2007, we
had an accumulated deficit of approximately
$103.3 million. Losses from operations were approximately
$15.7 million and $11.7 million for the fiscal years ended
March 31, 2006 and March 31, 2007, respectively and were approximately
$2.7 million and $2.8 million for the fiscal quarters ended June 30,
2006 and June 30, 2007, respectively.
We
need substantial additional funds, currently and in future years, to continue
our research and development. If such financing is not available, we
may be required to pursue other financing alternatives, reduce spending for
our
research programs or cease operations.
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 preclinical
and clinical testing, responses to our grant requests, relationships with
strategic partners, changes in the focus and direction of our research and
development programs, delays in the enrollment and completion of our clinical
trials, competitive and technological advances, FDA and foreign regulatory
approval processes and other factors. In any of these circumstances,
we may require substantially more funds than we currently have available or
intend to raise to continue our business. We may seek to satisfy
future funding requirements through public or private offerings of equity
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 drug candidates, forego
desired opportunities or license third parties to commercialize our products
or
technologies that we would otherwise seek to pursue internally. To
the extent we raise additional capital by issuing equity securities, ownership
dilution to existing stockholders may result.
We
receive funding primarily from research and development programs, fees
associated with licensing of our technology, grants and from sales of 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 submissions to regulatory
agencies). Until one or more of our drug candidates is approved for
sale, our funding is limited to funds from research and development programs,
fees associated with licensing of our technology, grants and proceeds from
sales
of equity or debt securities.
We
do not have employment contracts with most of our
employees.
All
of
our employees are “at will” and may leave at any time. None of our
executive officers has as of this date, expressed any intention to retire or
leave our employ. We do not have “key-man” life insurance policies on
any of our executives.
Most
of
our business’ financial aspects, including investor relations, intellectual
property control and corporate governance, are under the supervision of Eric
L.
Sorkin, Cecilia Chan and Gary Parks. Together, Mr. Sorkin,
Ms. Chan and Mr. Parks hold institutional knowledge and business acumen
that they utilize to assist us to forge new relationships and foster new
business opportunities without diminishing or undermining existing programs
and
obligations.
A
substantial portion of our proprietary intellectual property is developed by
scientists who are not employed by us.
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 UNC-CH, Georgia State
University, Duke University, and Auburn University, and other research groups
that form part of our Scientific Consortium and assist in the development of
our
drug candidates. A substantial portion of our proprietary
intellectual property is developed by scientists who are employed by our partner
universities 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 our key employees, key members of the scientific research
groups or other research groups that form part of our Scientific Consortium
of
their intention to leave their employ with these parties or the programs they
conduct.
There
can
be no assurance that the loss of certain members of management or the
scientists, researchers and technicians from the universities or other members
of our Scientific Consortium would not materially adversely affect our
business.
Additional
research grants to fund our operations may not be available or, if available,
not on terms acceptable to us.
We
have
funded our product development and operations as of June 30, 2007 through a
combination of sales of equity instruments and revenue generated from research
agreements and grants. As of June 30, 2007, our accumulated deficit
was approximately $103.3 million, net of approximately $25.9 million,
which was funded either directly or indirectly with grant funds and payments
from research and testing agreements.
In
November 2000, The Bill & Melinda Gates Foundation awarded a
$15.1
million grant to UNC-CH to develop new drugs to treat African sleeping sickness
and Leishmaniasis, a parasite that infects humans and can cause severe liver
damage or disfiguring skin disease. On March 29, 2001, we
entered into a clinical research subcontract with UNC-CH, whereby we were to
receive up to $9.8 million, subject to certain terms and conditions, over the
succeeding five year period, to conduct certain clinical and research studies
related to the grant from the Foundation. In April 2003, the
Foundation increased the grant to UNC-CH by approximately $2.7 million for
the
expansion of Phase IIb/III clinical trials to treat African sleeping sickness
and to improve manufacturing processes. As of March 31, 2006, we had
received, pursuant to the clinical research subcontract, inclusive of our
portion of the increase of the grant from the Foundation, a total amount of
funding of approximately $11.7 million. On March 28, 2006, the
Foundation increased the grant to UNC-CH by an approximate additional $22.6
million. $13.6 million of the additional grant is budgeted to be paid
to us over five years under the clinical research subcontract, which
was
amended
and restated. On May 24, 2006, we received the first payment of
approximately $5.6 million of the five year $13.6 million contract.
We
will
continue to apply for new grants to support continuing research and development
of our proprietary aromatic cation technology platform and other drug
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 directly or indirectly
provide funding to us may require licenses to our proprietary information or
may
impose price restrictions on the products we develop with their
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 such grant funds
we
may seek to raise additional capital with the issuance of equity or debt
securities. There can be no assurance that we will be able to place
or sell equity or debt securities on terms acceptable to us and, if we sell
equity, existing stockholders may suffer dilution.
None
of our drug candidates have been approved for sale by any regulatory
agency. Such approval is required before we can sell drug products
commercially.
Our
first
drug candidate, pafuramidine, requires 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 drug
candidates will be successfully developed, demonstrated to be safe and effective
in human clinical trials, meet applicable regulatory standards, be approved
by
regulatory authorities, 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 drug 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.
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 drug
candidates, we must demonstrate through human clinical trials that our drug
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 United States to export our drug candidate to
the
test site (if the test site is not in the United States) 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 and commercialization, that
drug 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
preclinical 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 or late-stage human
clinical trials or even after initial regulatory approval and commercialization
of the approved product.
Completion
of human clinical trials may be delayed by many factors, including slower than
anticipated patient enrollment, participant retention and follow up, difficulty
in securing sufficient supplies of clinical trial materials or other adverse
events occurring during clinical trials. For instance, once we obtain
permission to run a human trial, there are strict criteria regulating who we
can
enroll in the trial. In the case of African sleeping sickness, we are
subject to civil unrest in sub-Sahara Africa where local rebels could close
clinics and dramatically reduce enrollment or follow up rates, and make it
difficult to conduct trials. Political instability and the minimal
infrastructure in the African countries where we conduct our African sleeping
sickness trials may cause delays in enrollment and difficulty in the completion
of trials.
Completion
of preclinical and clinical studies, and development of the chemistry,
manufacturing and quality controls of the drug candidate 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 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 the aforementioned conditions and funding
and
patient enrollment difficulties and there can be no assurance that our future
testing and development schedules will be met.
We
do not currently have pharmaceutical manufacturing and distribution capability,
which could impair our ability to develop commercially viable products at
reasonable costs.
Our
ability to commercialize drug candidates will depend in part upon our ability
to
have manufactured or developed the capability to manufacture our drug candidates
and to distribute those goods, 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 or distribute our drug candidates. There can be no
assurance 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
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 drug
candidates.
We
use
the expertise and resources of strategic partners and third parties in a number
of key areas, including (i) discovery research, (ii) preclinical and
human clinical trials, (iii) product development, and (iv) manufacture
of pharmaceutical drugs. We have a worldwide license and exclusive
commercialization rights to a proprietary aromatic cation technology 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, manufacturing, marketing, distribution 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,
clinical trial, manufacturing, marketing or distribution
relationships. 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 affected
programs.
We
are uncertain about our ability to protect or obtain necessary patents and
protect our proprietary information. Our ability to develop and
commercialize drug candidates would be compromised without adequate intellectual
property protection.
We
have
spent and continue to spend considerable funds to develop our drug 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. 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 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 (issued to us directly or through licenses) will provide us with the
intellectual property protection contemplated by such
patents. Patents and licenses of patents can be challenged,
invalidated or circumvented. Patent litigation is expensive and
time-consuming and the outcome cannot be predicted. 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 drug 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, drug candidates, product uses 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 filed in the United States are
confidential for eighteen months after filing and some are confidential until
their date of issue as a patent 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
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 drug candidates, which puts our proprietary information at risk of
unauthorized disclosure.
We
rely
on trade secrets, know-how and technological advancement to maintain our
competitive position. Although we use license agreements,
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 proprietary aromatic cation
technology platform developed by our research partners, comprised primarily
of
scientists employed by universities in our Scientific Consortium. 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 technology 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 United States 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, which could
result in unauthorized disclosure or use of our proprietary
information.
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 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 enriched and we
could lose the ability to profitably develop products from such
information.
Our
industry has significant competition; our drug candidates may become obsolete
prior to commercialization due to alternative technologies, thereby rendering
our development efforts obsolete or non-competitive.
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 to treat 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. 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 preclinical 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 drug 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
the
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 drug candidates for any indication. We are subject to
government regulation for the commercialization of our drug
candidates.
We
have
not made application to the FDA or any other regulatory agency to sell
commercially or label any of our drug candidates. We or our
collaborators have received licenses from the FDA to export pafuramidine for
testing purposes and have previously been approved to conduct human clinical
trials for various indications in each of the United States, Germany, France,
the Democratic Republic of Congo, Angola, Sudan, Thailand, Argentina, Chile,
Colombia, Mexico, Peru, South Africa, and the United Kingdom.
All
new
pharmaceutical drugs, including our drug candidates, are subject to extensive
and rigorous regulation by the federal government, principally the FDA under
the
FFDCA and other laws and by applicable state, local and foreign
governments. Such regulations govern, among other things, the
development, testing, manufacturing, labeling, storage, pre-market clearance
or
approval, advertising, promotion, sale and distribution of pharmaceutical
drugs. If drug products 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 drug candidates must be approved for each indication for which we believe
it
to be viable. We have not yet determined from which regulatory
agencies we will seek approval for our drug candidates or indications for
which
approval will be sought. 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 drug
candidates.
We
have not received regulatory approval in the United States or any foreign
jurisdiction for the commercial sale of any of our drug
candidates.
On
November 21, 2006, the FDA granted
orphan drug designation for pafuramidine to treat PCP, and on June 18, 2007,
the
FDA granted orphan drug designation for pafuramidine to treat malaria. This
provides Immtech with financial and regulatory benefits during the development
course of pafuramidine, including opportunity to apply for government grants
for
conducting clinical trials, waiver of the Prescription Drug User’s Fee for
submission of the NDA for pafuramidine for PCP and malaria, tax credits, and
a
seven-year market exclusivity upon final FDA approval for each use.
On
April 23, 2004, the FDA granted fast-track designation for pafuramidine for
treatment of African sleeping sickness. Fast-track designation means,
among other things, that the FDA may accept initial late-stage data from us,
rather than waiting for the entire Phase III pivotal clinical trial data to
be submitted together, for consideration of approval to market the
drug. There is, however, no guarantee that fast-track designation
will result in faster product development or licensing approval or that our
drug
candidates will be approved at all.
The
process of obtaining FDA or other 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 drug 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 drug candidates. The failure to
receive FDA or other governmental approval would have a material adverse effect
on our business by precluding us from marketing and selling such products and
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 also 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, 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 preclinical testing or clinical
trials and changes in labeling of the product.
Prior
to
the submission of an application for FDA or other regulatory approvals, our
pharmaceutical drugs undergo rigorous preclinical and clinical testing, which
may take several years and the 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 drug candidates under development or other future
drug candidates will 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 drug candidates under development is
completed, any such drug compounds will be accepted for formal review by the
FDA
or any foreign regulatory agency or approved by the FDA for marketing in the
United States or by any such foreign regulatory agencies for marketing in
foreign jurisdictions.
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 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 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 to
prospective 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 drug candidates will depend in part on
the
extent to which reimbursement for the costs of the resulting drug will be
available from government health administration authorities, private health
insurers, non-governmental organizations and others. Many of our drug
candidates, including treatments for human African sleep sickness, malaria
and
TB, 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 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. 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 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.
Healthcare
reform proposals are regularly introduced in the United States 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 our
preferred stock (the “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
five series of Preferred Stock that convert to our Common Stock at prices
equivalent to $4.42, $4.00, $4.42, $9.00 and $7.04, respectively, for our
series A convertible preferred stock (“Series A Preferred Stock”),
series B convertible preferred stock (“Series B Preferred Stock”),
series C convertible preferred stock (“Series C Preferred Stock”),
series D convertible preferred stock (“Series D Preferred Stock”) and
series E convertible preferred stock (“Series E Preferred Stock”) (subject
to adjustment for stock splits, stock dividends and similar dilutive
events). Our obligation to convert our 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
August 29, 2007 we had 15,410,847 shares of Common Stock outstanding, plus
(1) 54,500 shares of Series A Preferred Stock, convertible into
approximately 308,257 shares of Common Stock at the conversion rate of 1:5.6561,
(2) 13,464 shares of Series B Preferred Stock convertible into
approximately 84,150 shares of Common Stock at the conversion rate of 1:6.25,
(3) 45,536 shares of Series C Preferred Stock convertible into
approximately 257,556 shares of Common Stock at the conversion rate of 1:5.6561,
(4) 115,200 shares of Series D Preferred Stock convertible into
approximately 320,003 shares of Common Stock at the conversion rate of 1:2.7778,
(5) 108,200 shares of Series E Preferred Stock convertible into
approximately 384,234 shares of Common Stock at the conversion rate of 1:3.5511,
(6) 1,875,158 options to purchase shares of Common Stock with a
weighted-average exercise price of $8.73 per share, and (7) 2,323,610
warrants to purchase shares of Common Stock with a weighted-average exercise
price of $8.06. Of the shares outstanding,
14,565,563 shares of Common Stock are freely tradable
without restriction. All of the remaining 845,284 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 value of our outstanding
shares of our Common Stock may be diluted.
As
of
August 29, 2007, we have outstanding vested options to purchase 1,411,271
shares of Common Stock at a weighted-average exercise price of $9.16 and vested
warrants to purchase 2,303,610 shares of Common Stock with a weighted-average
price of $8.05.
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 companies have been and can be expected to be
especially volatile. Our Common Stock price in the 52-week period
ended (i) March 31, 2007 had a high of $9.60 and a low of $4.50 and (ii) August
29, 2007 had a high of $9.60 and a low of $4.80. 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 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
may pay vendors in stock as consideration for their services. This
may result in stockholder dilution, additional costs and difficulty retaining
certain vendors.
In
order
for us to preserve our cash resources, we have previously paid and may in the
future pay vendors in shares, warrants or options to purchase shares of our
Common Stock rather than cash. Payments for services in stock may
materially and adversely affect our stockholders 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 vendor, this will
generally cause us to incur additional expenses associated with such
registration. Paying vendors in shares, warrants 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 therefore
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.
If
we do not effectively manage our growth, our resources, systems and controls
may
be strained and our operating results may suffer.
We
have
recently added to our workforce and we plan to continue to increase the size
of
our workforce and scope of our operations as we continue our drug development
programs and clinical trials and move towards commercialization of our
products. This growth of our operations will place a significant
strain on our management personnel, systems and resources. We may
need to implement new and upgraded operational and financial systems, procedures
and controls, including the improvement of our accounting and other internal
management systems. These endeavors will require substantial
management effort and skill, and we may require additional personnel and
internal
processes to manage these efforts. If we are unable to effectively
manage our expanding operations, our revenue and operating results could be
materially and adversely affected.
Our
continuing obligations as a public company under the laws, regulations and
standards relating to corporate governance and public disclosure, including
the
Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”) and related regulations, are
likely to increase our expenses and administrative burden. Changes in
the laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act and related regulations implemented
by the SEC and self-regulatory organizations (e.g. the AMEX), are creating
uncertainty for public companies, increasing legal and financial compliance
costs and making some activities more time consuming. These laws,
regulations and standards are subject to varying interpretations, and, as a
result, their application in practice may evolve over time as new guidance
is
provided by regulatory and governing bodies. This could result in
continuing uncertainty regarding compliance matters and higher costs
necessitated by ongoing revisions to disclosure and governance
practices. We have and expect to continue to invest resources to
comply with evolving laws, regulations and standards, and this investment may
result in increased general and administrative expenses and a diversion of
management’s time and attention from the business of the Company to compliance
activities. If our efforts to comply with new laws, regulations and
standards differ from the conduct expected by regulatory or governing bodies,
those authorities may initiate legal proceedings against us and our business
may
be harmed.
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, directors, employees and other agents
to
the fullest extent permitted by law. These provisions may be in some
respects broader than the specific indemnification provisions under Delaware
law. The indemnification provisions may require us, among other
things, to (i) indemnify such persons against certain liabilities that may
arise by reason of their status with or service to the Company (other than
liabilities arising from willful misconduct of a culpable nature),
(ii) advance expenses incurred as a result of any proceeding against such
persons as to which they could be indemnified and (iii) 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 officer and director liability assists us to
attract and retain qualified officers and directors. However, in the
event an officer, a director or our board of directors commits an act that
may
legally be indemnified under Delaware law, we will be responsible to pay for
such officer(s) or 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 us and our stockholders. Given the
difficult environment and potential for incurring liabilities currently facing
directors of publicly-held corporations, we believe that director
indemnification is in our and our stockholders’
best interests because it enhances our ability to attract and 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
expenses. Our 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. Our 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.
We
are exposed to potential risks from recent legislation requiring companies
to
evaluate controls under Section 404 of the Sarbanes-Oxley
Act.
The
Sarbanes-Oxley Act requires that we maintain effective internal controls over
financial reporting and disclosure controls and procedures. Among
other things, we must perform system and process evaluation and testing of
our
internal controls over financial reporting to allow management to report on,
and
our independent registered public accounting firm to attest to, our internal
controls over financial reporting, as required by Section 404 of the
Sarbanes-Oxley Act. Compliance with Section 404 requires
substantial accounting expense and significant management
efforts. Our testing, or the subsequent review by our independent
registered public accounting firm, may reveal deficiencies in our internal
controls that would require us to remediate in a timely manner so as to be
able
to comply with the requirements of Section 404 each year. If we
are not able to comply with the requirements of Section 404 in a timely
manner each year, we could be subject to sanctions or investigations by the
SEC,
the AMEX or other regulatory authorities that would require additional financial
and management resources and could adversely affect the market price of our
Common Stock.
Product
liability exposure may expose us to significant liability.
We
do not
have pharmaceutical products for sale and we therefore 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 trial insurance
which covers our human clinical trial activities.
USE
OF PROCEEDS
We
will receive all of the net proceeds
from the sale by us of our securities registered under the registration
statement of which this prospectus is a part. Unless otherwise specified in
the
applicable prospectus supplement, we intend to use the net proceeds for general
corporate purposes, including clinical trials, research and development
expenses, general and administrative expenses, and for working capital and
other
general corporate purposes.
PLAN
OF DISTRIBUTION
We
may
sell our Common Stock to one or more underwriters for public offering and sale
by them and may also sell our Common Stock to investors directly or through
agents. We will name any underwriter or agent involved in the offer and sale
of
our Common Stock in the applicable prospectus supplement. We have reserved
the
right to sell or exchange our Common Stock directly to investors on our own
behalf in those jurisdictions where we are authorized to do so.
We
may
distribute our Common Stock from time to time in one or more
transactions:
|
·
|
at
a fixed price or prices which may be
changed;
|
|
·
|
at
prices related to such prevailing market prices;
or
|
We may also, from time to time, authorize dealers, acting
as our agents, to
offer and sell our Common Stock upon the terms and conditions set forth in
the
applicable prospectus supplement. In connection with the sale of our Common
Stock, we or the purchasers of our Common Stock for whom the underwriters may
act as agents may compensate underwriters in the form of underwriting discounts
or commissions. Underwriters may sell our Common Stock to or through dealers,
and those 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 agent. Unless otherwise indicated in a prospectus
supplement, an agent will be acting on a best efforts basis and a dealer
will
purchase our Common Stock as a principal, and may then resell our Common Stock
at varying prices to be determined by the dealer.
In
connection with the sale of the Common Stock or interests therein, we may
enter
into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the Common Stock in the course
of
hedging the positions they assume. We may also sell shares of the Common
Stock
short and deliver these securities to close out their short positions, or
loan
or pledge the Common Stock to broker-dealers that in turn may sell these
securities. We may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or
more
derivative securities which require the delivery to such broker-dealer or
other
financial institution of shares offered by this prospectus, which shares
such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
We
will
describe in the applicable prospectus supplement any compensation we pay to
underwriters or agents in connection with the offering of our Common Stock,
and
any discounts, concessions or commissions allowed by underwriters to
participating dealers. Dealers and agents participating in the distribution
of
our Common Stock may be deemed to be underwriters, and any discounts and
commissions received by them and any profit realized by them on resale of our
Common Stock may be deemed to be underwriting discounts and commissions. We
may
enter into agreements to indemnify underwriters, dealers and agents against
certain civil liabilities, including liabilities under the Securities Act,
and
to reimburse these persons for certain expenses.
To
facilitate the offering of our Common Stock, certain persons participating
in
the offering may engage in transactions that stabilize, maintain, or otherwise
affect the price of our Common Stock. This may include over-allotments or short
sales of our Common Stock, which involve the sale by persons participating
in
the offering of more of our Common Stock than we sold to them. In these
circumstances, these persons would cover such over-allotments or short positions
by making purchases in the open market or by exercising their over-allotment
option, if any. In addition, these persons may stabilize or maintain the price
of our Common Stock by bidding for or purchasing our Common Stock in the open
market or by imposing penalty bids, whereby selling concessions allowed to
dealers participating in the offering may be reclaimed if our Common Stock
sold
by them are repurchased in connection with stabilization transactions. The
effect of these transactions may be to stabilize or maintain the market price
of
our Common Stock at a level above that which might otherwise prevail in the
open
market. These transactions, if commenced, may be discontinued at any
time.
Certain
of the underwriters, dealers or agents and their associates may engage in
transactions with and perform services for us in the ordinary course of their
business for which they receive compensation.
Any
Common Stock sold pursuant to a prospectus supplement will be eligible for
listing and trading on the American Stock Exchange, subject to official notice
of issuance.
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
amended and restated certificate of incorporation our authorized capital stock
consists of:
|
|
·
|
100,000,000
shares of Common Stock, par value $0.01 per share;
and
|
|
|
·
|
5,000,000
shares of Preferred Stock, par value $0.01 per
share.
|
As
of
August 29, 2007, we had 15,410,847 shares of Common Stock outstanding (not
including approximately 308,257 shares of Common Stock upon conversion of Series
A Preferred Stock, 84,150 shares of Common Stock upon conversion of Series
B
Preferred Stock, 257,556 shares of Common Stock upon conversion of Series C
Preferred Stock, 320,003 shares of Common Stock upon conversion of Series D
Preferred Stock, 384,234 shares
of
Common Stock upon conversion of Series E Preferred Stock, 1,875,158 shares
of
Common Stock upon exercise of outstanding options, and 2,323,610 shares of
Common Stock reserved for exercise of outstanding warrants held by certain
investors). Of the shares of Common Stock outstanding, 14,565,563 shares of
Common Stock are freely tradable without restriction. All of the remaining
845,284 shares are restricted from resale except pursuant to certain exceptions
under the Securities Act.
Common
Stock
Our
Common Stock is traded on the 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.
Certain
Provisions of Delaware Law and the Company’s Charter and
Bylaws
The
following paragraphs summarize certain provisions of the Delaware General
Corporation Law, or DGCL, and our certificate of incorporation and bylaws.
The
summary does not purport to be complete and is subject to and qualified in
its
entirety by reference to the DGCL and to our bylaws, copies of which are on
file
with the SEC as exhibits to registration statements previously filed by us.
See
“Where You Can Find More Information.”
Certificate
of Incorporation and By-laws. Pursuant to our certificate of incorporation,
our board of directors may issue additional shares of Common Stock or Preferred
Stock. Any additional issuance of Common Stock could have the effect of impeding
or discouraging the acquisition of control of us by means of a merger, tender
offer, proxy contest or otherwise, including a transaction in which our
stockholders would receive a premium over the market price for their shares,
and
thereby protects the continuity of our management. Specifically, if in the
due
exercise of its fiduciary obligations, the board of directors were to determine
that a takeover proposal was not in our best interest, shares could be issued
by
our board of directors without stockholder approval in one or more transactions
that might prevent or render more difficult or costly the completion of the
takeover by:
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·
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diluting
the voting or other rights of the proposed acquirer or insurgent
stockholder group,
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·
|
putting
a substantial voting block in institutional or other hands that might
undertake to support the incumbent board of directors,
or
|
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|
·
|
effecting
an acquisition that might complicate or preclude the
takeover.
|
Our
bylaws set forth advance notice procedures with regard to stockholder proposals
relating to the nomination of candidates for election as directors or new
business to be presented at meetings of stockholders. These
procedures provide that notice of such stockholder proposals must be timely
given in writing to our secretary prior to the meeting at which the action
is to
be taken. Generally, to be timely, notice must be received at our
principal executive offices not less than 90 days nor more than 120 days prior
to the anniversary date of the prior year’s annual meeting. The
advance notice requirement does not give our board of directors any power to
approve or disapprove stockholder director nominations or proposals by may
have
the effect of precluding consideration of business at a meeting if proper notice
procedures are not followed.
Delaware
Anti-Takeover Law. We are subject to the provisions of Section 203 of the
Delaware General Corporation Law concerning corporate takeovers. This section
prevents many Delaware corporations from engaging in a business combination
with
any interested stockholder, under specified circumstances. For these purposes,
a
business combination includes a merger or sale of more than 10% of our assets,
and an interested stockholder includes a stockholder who owns 15% or more of
our
outstanding voting stock, as well as affiliates and associates of these persons.
Under these provisions, this type of business combination is prohibited for
three years following the date that the stockholder became an interested
stockholder unless:
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·
|
the
transaction in which the stockholder became an interested stockholder
is
approved by the board of directors prior to the date the interested
stockholder attained that status,
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·
|
upon
consummation of the transaction that resulted in the stockholder’s
becoming an interested stockholder, the interested stockholder owned
at
least 85% of the voting stock of the corporation outstanding at the
time
the transaction was commenced, excluding those shares owned by persons
who
are directors and also officers, or
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|
·
|
on
or subsequent to that date, the business combination is approved
by the
board of directors and authorized at an annual or special meeting
of
stockholders by the affirmative vote of at least two-thirds of
the
outstanding voting stock that is not owned by the interested
stockholder.
|
This
statute could prohibit or delay mergers or other takeover or change in
control
attempts and, accordingly, may discourage attempts to acquire us.
Limited
Liability and Indemnification. Our certificate of incorporation eliminates
the personal liability of our directors for monetary damages arising from
a
breach of their fiduciary duty as directors to the fullest extent
permitted
by Delaware law. This limitation does not affect the availability of equitable
remedies, such as injunctive relief or rescission. Our certificate of
incorporation requires us to indemnify our directors and officers to the fullest
extent permitted by Delaware law, including in circumstances in which
indemnification is otherwise discretionary under Delaware law.
Under
Delaware law, we may indemnify our directors or officers or other persons who
were, are or are threatened to be made a named defendant or respondent in a
proceeding because the person is or was our director, officer, employee or
agent, if we determine that the person:
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·
|
conducted
himself or herself in good faith,
|
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·
|
reasonably
believed, in the case of conduct in his or her official capacity
as our
director or officer, that his or her conduct was in our best interests,
and, in all other cases, that his or her conduct was at least not
opposed
to our best interests, and
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·
|
in
the case of any criminal proceeding, had no reasonable cause to believe
that his or her conduct was
unlawful.
|
These
persons may be indemnified against expenses, including attorneys fees,
judgments, fines, including excise taxes, and amounts paid in settlement,
actually and reasonably incurred, by the person in connection with the
proceeding. If the person is found liable to the corporation, no indemnification
shall be made unless the court in which the action was brought determines that
the person is fairly and reasonably entitled to indemnity in an amount that
the
court will establish. Insofar as indemnification for liabilities under the
Securities Act may be permitted to directors, officers or persons controlling
us
pursuant to the above provisions, we have been informed that, in the opinion
of
the SEC, such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
LEGAL
MATTERS
Legal
matters in connection with the validity of the shares offered by this prospectus
will be passed upon for the company by Paul, Hastings, Janofsky & Walker
LLP, New York, New York.
EXPERTS
The
financial statements and management’s report on the effectiveness of internal
control over financial reporting incorporated in this prospectus by reference
from the Company’s Annual Report on Form 10-K for the year ended March 31, 2007
have been audited by Deloitte & Touche LLP, an independent registered public
accounting firm, as stated in their reports which are incorporated herein by
reference in the registration statement (which reports (1) express an
unqualified opinion on the financial statements and includes an explanatory
paragraph relating to the adoption of Financial Accounting Standards Board
(FASB) Statement No. 123 (revised 2004), Share-Based Payment) and (2) express
an
unqualified opinion on management’s assessment regarding the effectiveness of
internal control over financial reporting), and have been so incorporated in
reliance upon the reports of such firm given upon their authority as experts
in
accounting and auditing.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC
allows us to “incorporate by reference” the information we file with them, which
means that we can disclose important information to you by referring you to
those documents instead of having to repeat the information in this prospectus.
The information incorporated by reference is considered to be part of this
prospectus, and later information that we file with the SEC will automatically
update and supersede this information. We incorporate
by reference the documents listed below and any future filings made with the
SEC
under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act between the date
of this prospectus and the termination of the offering and also between the
date
of the initial registration statement and prior to effectiveness of the
registration statement:
| |
(i) |
our
Annual Report on Form 10-K for the fiscal year ended March 31, 2007,
filed
with the SEC on June 14, 2007, and the exhibits incorporated
therein; |
| |
|
|
| |
(ii) |
our
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2007,
filed with the SEC on August 9, 2007, and the exhibits incorporated
therein; |
| |
|
|
| |
(iii) |
our
Current Report on Form 8-K filed with the SEC on May 31,
2007; |
| |
|
|
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(iv) |
our
Current Report on Form 8-K filed with the SEC on June 12,
2007; |
|
|
(v) |
our
Current Report on Form 8-K filed with the SEC on June 13,
2007; |
| |
|
|
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(vi) |
our
Current Report on Form 8-K filed with the SEC on August 22,
2007; |
| |
|
|
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(vii) |
our
Current Report on Form 8-K filed with the SEC on August 29, 2007;
and, |
| |
|
|
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(viii) |
the
description of our Common Stock contained in our registration statement
on
Form 8-A pursuant to Section 12(b) of the Exchange Act filed with the
SEC
on August 6, 2003. |
This
prospectus is part of a registration statement on Form S-3 we have filed with
the SEC under the Securities Act. This prospectus does not contain all of the
information in the registration statement. We have omitted certain parts of
the
registration statement, as permitted by the rules and regulations of the SEC.
You may inspect and copy the registration statement, including exhibits, at
the
SEC’s public reference room or website. Our statements in this prospectus about
the contents of any contract or other document are not necessarily complete.
You
should refer to the copy of each contract or other document we have filed as
an
exhibit to the registration statement for complete information.
You
may
request a copy of any or all of the information incorporated by reference,
at no
cost, by writing or telephoning us at the following address:
Corporate
Secretary
Immtech
Pharmaceuticals, Inc.
150
Fairway Drive, Suite 150
Vernon
Hills, Illinois, 60061
Telephone
No. (847) 573-0033 or toll free (877) 898-8038
WHERE
YOU CAN FIND MORE INFORMATION
We
file
annual, quarterly and current reports, proxy statements and other information
with the SEC. You may read and copy any document we file at the SEC’s public
reference room located at 100 F Street, N.E., Washington, D.C. 20549. Please
call the SEC at 1-800-SEC-0330 for further information on the public reference
room. Our filings with the SEC are also available to the public at the SEC’s
website at http://www.sec.gov. You may also obtain copies of the
documents at prescribed rates by writing to the SEC’s Public Reference Section
at 100 F Street, N.E., Washington, D.C. 20549. Our website is located at
www.immtechpharma.com. The contents of our website are not part of this
prospectus and should not be relied upon with respect thereto.
FORWARD-LOOKING
STATEMENTS
Certain
statements contained in this
annual report and in the documents incorporated by reference herein constitute
“forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements other than statements
of historical fact may be deemed to be forward-looking
statements. Forward-looking statements frequently, but not always,
use the words “may,” “intends,” “plans,” “believes,” “anticipates” or “expects”
or similar words and may include statements concerning our strategies, goals
and
plans. 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 this
annual report, the following: (i) we are in an early stage of
product development, (ii) the possibility that favorable relationships with
collaborators cannot be established or, if established, will be abandoned by
the
collaborators before completion of product development, (iii) the
possibility that we or our collaborators will not successfully develop any
marketable products, (iv) the possibility that advances by competitors will
cause our drug candidates not to be viable, (v) uncertainties as to the
requirement that a drug product 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 candidates,
(vi) risks relating to requirements for approvals by governmental agencies,
such as the United States Food and Drug Administration (the “FDA”), 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 drug candidates successfully,
(vii) 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, (viii) 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, (ix) the possibility that
any products
successfully
developed by us will not achieve market acceptance and (x) other risks and
uncertainties that may not be described herein. We undertake no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Delaware
General Corporation Law
Under
the
General Corporation Law of the State of Delaware, we can indemnify our directors
and officers against liabilities they may incur in such capacities, including
liabilities under the Securities Act of 1933, as amended (the “Securities Act”).
Our certificate of incorporation provides that, pursuant to Delaware law, our
directors shall not be liable for monetary damages for breach of the directors’
fiduciary duty of care to us and our stockholders. This provision in the
certificate of incorporation does not eliminate the duty of care, and in
appropriate circumstances equitable remedies such as injunctive or other forms
of non-monetary relief will remain available under Delaware law. In addition,
each director will continue to be subject to liability for breach of the
director’s duty of loyalty to us or our stockholders, for acts or omissions not
in good faith or involving intentional misconduct or knowing violations of
law,
for any transaction from which the director directly or indirectly derived
an
improper personal benefit, and for payment of dividends or approval of stock
repurchases or redemptions that are unlawful under Delaware law. The provision
also does not affect a director’s responsibilities under any other law, such as
the federal securities laws or state or federal environmental laws.
Our
bylaws provide for the indemnification of our directors and officers to the
fullest extent permitted by the Delaware General Corporation Law. We are not,
however, required to indemnify any director or officer in connection with any
(a) willful misconduct, (b) willful neglect, or (c) gross negligence toward
or
on behalf of us in the performance of his or her duties as a director or
officer. We are required to advance, prior to the final disposition of any
proceeding, promptly on request, all expenses incurred by any director or
officer in connection with that proceeding on receipt of any undertaking by
or
on behalf of that director or officer to repay those amounts if it should be
determined ultimately that he or she is not entitled to be indemnified under
our
bylaws or otherwise.
Commission
Position on Indemnification
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers and or persons controlling the company
pursuant to the foregoing provisions, we have been informed that in the opinion
of the SEC such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
GLOSSARY
As
used
in this prospectus, the following terms have the meanings set forth
below.
|
Dication
|
A
chemical molecule with two positively charged ends that are held
together
by a chemical linker.
|
|
FDA
|
U.S.
Food and Drug Administration.
|
|
FFDCA
|
Federal
Food, Drug, and Cosmetic Act as Amended.
|
|
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.
|
|
NDA
PCP
|
New
Drug Application, or NDA, is a document required to be filed with
the FDA
prior to performing clinical studies on human subjects.
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.
|
|
Phase
III
Scientific
Consortium
|
Commonly
referred to as pivotal studies (however, in certain circumstances,
Phase
II trials can serve as pivotal). When Phase II evaluations
demonstrate that a dose range of the drug has a therapeutic effect
and an
acceptable safety profile, Phase III trials are undertaken in large
patient populations to further evaluate dosage, to provide substantial
evidence of clinical efficacy and to further test for safety in an
expanded and diverse patient population at multiple,
geographically-dispersed clinical trial sites.
University
of North Carolina at Chapel Hill, Georgia State, Duke University
and
Auburn University
|
|
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.
|
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and
Distribution.
The
following table sets forth our estimates of the expenses to be incurred in
connection with the offering of the shares of Common Stock being offered
hereby:
|
SEC
registration fee:
|
|
$ |
1,535
|
|
|
Printing
expenses:
|
|
$ |
500 |
* |
|
Legal
fees and expenses:
|
|
$ |
25,000 |
* |
|
Accounting
fees and expenses:
|
|
$ |
25,000 |
* |
|
Miscellaneous
expenses:
|
|
$ |
1,000 |
* |
|
TOTAL:
|
|
$ |
53,035 |
* |
*
Estimated
Item
15. Indemnification of Directors and Officers.
Under
the
General Corporation Law of the State of Delaware, we can indemnify our directors
and officers against liabilities they may incur in such capacities, including
liabilities under the Securities Act of 1933, as amended (the “Securities Act”).
Our certificate of incorporation provides that, pursuant to Delaware law, our
directors shall not be liable for monetary damages for breach of the directors’
fiduciary duty of care to us and our stockholders. This provision in the
certificate of incorporation does not eliminate the duty of care, and in
appropriate circumstances equitable remedies such as injunctive or other forms
of non-monetary relief will remain available under Delaware law. In addition,
each director will continue to be subject to liability for breach of the
director’s duty of loyalty to us or our stockholders, for acts or omissions not
in good faith or involving intentional misconduct or knowing violations of
law,
for any transaction from which the director directly or indirectly derived
an
improper personal benefit, and for payment of dividends or approval of stock
repurchases or redemptions that are unlawful under Delaware law. The provision
also does not affect a director’s responsibilities under any other law, such as
the federal securities laws or state or federal environmental laws.
Our
bylaws provide for the indemnification of our directors and officers to the
fullest extent permitted by the Delaware General Corporation Law. We are not,
however, required to indemnify any director or officer in connection with any
(a) willful misconduct, (b) willful neglect, or (c) gross negligence toward
or
on behalf of us in the performance of his or her duties as a director or
officer. We are required to advance, prior to the final disposition of any
proceeding, promptly on request, all expenses incurred by any director or
officer in connection with that proceeding on receipt of any undertaking by
or
on behalf of that director or officer to repay those amounts if it should be
determined ultimately that he or she is not entitled to be indemnified under
our
bylaws or otherwise.
Item
16. Exhibits and Financial Statement Schedules.
See
the
Exhibit Index immediately following the Signature Page to this registration
statement.
Item
17. Undertakings.
(a) The
undersigned registrant hereby undertakes:
(1) To
file,
during any period in which offers or sales are being made, 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, as amended.
(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. Notwithstanding
the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Securities and Exchange Commission pursuant to Rule 424(b), if, in the
aggregate, the changes in volume and price represent not more than a 20% change
in the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective registration statement.
(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 (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this
section do not apply if the registration statement is on Form S-3 or Form F-3
and the information required to be included in a post-effective amendment by
those paragraphs is contained in reports filed with or furnished to the
Commission by the registrant pursuant to section 13 or section 15(d) of the
Securities 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:
|
|
(a)
|
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
|
|
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(b)
|
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,
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:
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(a)
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Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424;
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(b)
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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;
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(c)
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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
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(d)
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Any
other communication that is an offer in the offering made by the
undersigned registrant to the
purchaser.
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(b) The
undersigned registrant hereby further undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of
the
registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan’s annual report pursuant to Section 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
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.
(c) 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 provisions described in the foregoing provisions, 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 of 1933 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 of 1933 and will be governed by the final adjudication of such
issue.
(d) The
undersigned registrant hereby undertakes that:
(1) For
purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
(2) For
the purpose of determining any liability under the Securities Act of 1933,
each
post-effective amendment that contains a form of prospectus 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.
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 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
New
York, State of New York, on this 4th day of September
2007.
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IMMTECH
PHARMACEUTICALS,
INC. |
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By:
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/s/
Eric
L. Sorkin |
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Eric
L. Sorkin |
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President
and Chief Executive
Officer |
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| |
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Pursuant
to the requirements of the Securities Act of 1933, this registration statement
was signed by the following persons in the capacities and on the dates
stated.
|
Signatures
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Title
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Date
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| |
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|
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/s/
Eric L.
Sorkin
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President,
Chief Executive Officer and Director
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Eric
L.
Sorkin
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(Principal
Executive Officer)
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/s/
Gary C.
Parks
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Chief
Financial Officer, Treasurer and Secretary
|
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Gary
C.
Parks
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(Principal
Financial and Accounting Officer)
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/s/
Cecilia
Chan
|
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|
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Cecilia
Chan
|
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|
|
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/s/
Judy
Lau
|
|
|
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Judy
Lau
|
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|
|
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| |
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|
|
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/s/
Levi H.K.
Lee
|
|
|
|
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Levi
H.K.
Lee
|
|
|
|
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| |
|
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|
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/s/
Donald F.
Sinex
|
|
|
|
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Donald
F.
Sinex
|
|
|
|
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EXHIBIT
INDEX
|
Exhibit
No.
|
Description
|
|
4.1
|
Form
of Common Stock Certificate (incorporated by reference from our Form
SB-2/A Registration Statement, dated March 30, 1999, File No.
333-64393)
|
|
5.1
|
Opinion
of Paul, Hastings, Janofsky & Walker LLP*
|
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23.1
|
Consent
of Deloitte & Touche LLP *
|
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23.2
|
Consent
of Paul, Hastings, Janofsky & Walker LLP (included in Exhibit 5.1)
*
|
*
Filed
herewith.
23