Final Prospectus
Filed
pursuant to Rule 424(b)(3)
File
No. 333-115471
PROSPECTUS
CALLISTO
PHARMACEUTICALS, INC.
5,605,431
Shares of Common Stock
The
selling stockholders named in this prospectus are offering to sell up to
5,605,431 shares of common stock of Callisto Pharmaceuticals, Inc. which are
currently issued and outstanding and were previously issued by us to the selling
stockholders in private transactions. We will not receive any proceeds from
the
resale of shares of our common stock.
Our
common stock currently trades on the American Stock Exchange under the symbol
"KAL." On June 29, 2005, the last reported sale price for our common stock
on
the American Stock Exchange was $1.00 per share.
The
securities offered in this prospectus involve a high degree of risk. See "Risk
Factors" beginning on page 5 of this prospectus to read about factors you should
consider before buying shares of our common stock.
The
selling stockholders are offering these shares of common stock. The selling
stockholders may sell all or a portion of these shares from time to time in
market transactions through any market on which our common stock is then traded,
in negotiated transactions or otherwise, and at prices and on terms that will
be
determined by the then prevailing market price or at negotiated prices directly
or through a broker or brokers, who may act as agent or as principal or by
a
combination of such methods of sale. The selling stockholders will receive
all
proceeds from the sale of the common stock. For additional information on the
methods of sale, you should refer to the section entitled "Plan of
Distribution."
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined whether this
prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
The
date of this Prospectus is July 6, 2005
TABLE
OF CONTENTS
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You
may only rely on the information contained in this prospectus or that we have
referred you to. We have not authorized anyone to provide you with different
information. This prospectus does not constitute an offer to sell or a
solicitation of an offer to buy any securities other than the common stock
offered by this prospectus. This prospectus does not constitute an offer to
sell
or a solicitation of an offer to buy any common stock in any circumstances
in
which such offer or solicitation is unlawful. Neither the delivery of this
prospectus nor any sale made in connection with this prospectus shall, under
any
circumstances, create any implication that there has been no change in our
affairs since the date of this prospectus or that the information contained
by
reference to this prospectus is correct as of any time after its date.
This
prospectus is part of a registration statement that we filed on Form S-3 with
the Securities and Exchange Commission or SEC. This prospectus does not contain
all of the information in the registration statement and the exhibits and
schedules that were filed with the registration statement. You should refer
to
the registration statement for additional information about us and the common
stock being offered in this prospectus. Statements made in this prospectus
regarding the contents of any contract, agreement or other document that is
filed as an exhibit to the registration statement or any document incorporated
by reference into the registration statement are not necessarily complete,
and
you should review the referenced document itself for a complete understanding
of
its terms.
We
file annual, quarterly and special reports, proxy statements and other
information with the SEC. You may read and copy any document that we file at
the
SEC’s public reference facilities located at 450 Fifth Street, NW, Room 1024,
Washington, DC 20549, and at the SEC's regional offices at 500 West Madison
Street, Suite 1400, Chicago, Illinois 60661 and Woolworth Building, 233 Broadway
New York, New York. Copies of all or any part of the registration statement
may
be obtained from the SEC upon payment of the prescribed fee. Information
regarding the operation of the public reference rooms may be obtained by calling
the SEC at 1-800-SEC-0330. Our SEC filings are also available to you free of
charge at the SEC’s web site at http://www.sec.gov.
The
SEC allows us to 'incorporate by reference' the information into this
prospectus. This means that we can disclose important information to you by
referring you to another document filed separately with the SEC. The information
that we incorporate by reference is considered to be part of this prospectus.
Because we are incorporating by reference our future filings with the SEC,
this
prospectus is continually updated and those future filings may modify or
supersede some or all of the information included or incorporated in this
prospectus. This means that you must look at all of the SEC filings that we
incorporate by reference to determine if any of the statements in this
prospectus or in any document previously incorporated by reference have been
modified or superseded. This prospectus incorporates by reference the documents
listed below and any future filings we will make with the SEC under Sections
13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934 until the
selling stockholders sell all of our common stock registered under this
prospectus.
· our
annual report on Form 10-K/A for the fiscal year ended December 31,
2004;
· our
quarterly report on Form 10-Q filed on May 16, 2005;
· our
current reports on Form 8-K filed on February 3, 2005, February 7, 2005,
February 14, 2005, March 15, 2005, March 30, 2005 and April 8, 2005;
and
· the
description of our common stock contained in Item 1 of our Registration
Statement on Form 8-A, dated October 22, 2004.
The
information about us contained in this prospectus should be read together with
the information in the documents incorporated by reference. You may request
a
copy of any or all of these filings, at no cost, by writing or telephoning
us at
Callisto Pharmaceuticals, Inc., 420 Lexington Avenue, Suite 1609, New York,
New
York 10170, Telephone: (212) 297-0010
This
summary highlights information contained elsewhere in this prospectus. You
should read the entire prospectus carefully, including, the section entitled
"Risk Factors" before deciding to invest in our common stock. Callisto
Pharmaceuticals, Inc. is referred to throughout this prospectus as "Callisto,"
"we" or "us."
We
are a biopharmaceutical company focused on the development of drugs to treat
relapsed (failure of prior therapy) acute leukemia, multiple myeloma (an
incurable blood cancer that invades and proliferates in bone marrow), other
cancers and osteolytic bone disease (bone disease caused by white blood cells).
Our lead drug candidate, Annamycin, a drug from the anthracycline family
(chemotherapy drugs which are also antibiotics), earlier completed a Phase
I/IIa
trial in leukemia patients who had residual leukemic cells (refractory) in
their
bodies. Annamycin, originally developed by scientists at The University of
Texas
M.D. Anderson Cancer Center to address the clinical limitations associated
with
anthracycline drugs such as Adriamycin (doxorubicin) to treat cancer, is planned
to begin a trial at The University of Texas M.D. Anderson Cancer Center in
adult
relapsed acute lymphocytic leukemia (ALL) patients in mid-2005 which will
include an initial evaluation of a small number of patients (2 cohorts totaling
approximately 6 patients) in a Phase I/IIa trial that will be rolled into a
larger Phase IIb trial. We also expect to commence two additional trials of
Annamycin in 2005, a single agent trial in pediatric relapsed ALL patients
and
in combination with Ara-C (cytosine arabinoside) in relapsed acute myeloid
leukemia (AML) patients.
Our
second drug candidate, Atiprimod, is an orally available drug with
antiproliferative and antiangiogenic activity. Atiprimod commenced a Phase
I/IIa
clinical trial in relapsed multiple myeloma patients on May 26, 2004. These
are
patients that no longer respond to chemotherapy, and are in advanced stages
of
the disease. The Phase I/IIa clinical trial is currently being enrolled at
four
sites, The University of Texas M.D. Anderson Cancer Center (Houston, TX), the
Dana-Farber Cancer Institute (Boston, MA), the St. Vincent's Comprehensive
Cancer Center (New York, NY) and the Roswell Park Cancer Institute (Buffalo,
NY).
On
January 6, 2004, we announced that the Office of Orphan Products Development
of
the United States Food and Drug Administration (FDA) granted orphan drug
designation to Atiprimod for the treatment of multiple myeloma.
Recent
Developments
On
March 9, 2005 we sold and issued in a private placement an aggregate 1,985,791
shares of common stock at a per share price of $1.52, for aggregate gross
proceeds of approximately $3.02 million. Because this transaction was completed
with certain existing institutional shareholders and certain members of our
management we paid no fees to selling agents and have agreed to file a
registration statement covering resale of the shares within 30 days of the
closing.
On
March 15, 2005 we announced a second Phase I/IIa clinical trial of Atiprimod
in
advanced cancer patients. The new trial is entitled: “An Open Label Study of the
Safety and Efficacy of Atiprimod Treatment for Patients with Advanced Cancer”.
The trial protocol received IRB approval on February 22, 2005 at The University
of Texas M.D. Anderson Cancer Center. Site initiation was completed on March
3,
2005, and patient screening and dosing began in April, 2005.
History
In
March 2002, Callisto Pharmaceuticals, Inc. ("Old Callisto") purchased 99.7%
of
the outstanding common shares of Webtronics, Inc., ("Webtronics") a public
company for $400,000. Webtronics was incorporated in Florida on February 2,
2001
and had limited operations at December 31, 2002.
On
April 30, 2003, pursuant to an Agreement and Plan of Merger dated March 10,
2003, as amended April 4, 2003, Synergy Acquisition Corp., a wholly-owned
subsidiary of Webtronics merged into Synergy Pharmaceuticals Inc. ("Synergy")
and Callisto Acquisition Corp., a wholly-owned subsidiary of Webtronics merged
into Old Callisto (collectively, the "Merger"). As a result of the Merger,
Old
Callisto and Synergy became wholly-owned subsidiaries of Webtronics. In the
Merger Webtronics issued 17,318,994 shares of its common stock in exchange
for
outstanding Old Callisto common stock and an additional 4,395,684 shares in
exchange for outstanding Synergy common stock. Old Callisto changed its name
to
Callisto Research Labs, LLC ("Callisto Research") and Webtronics changed its
name to Callisto Pharmaceuticals, Inc. and changed its state of incorporation
from Florida to Delaware. Subsequently, 171,818 shares of common stock issued
to
former Synergy shareholders were returned to us under the terms of certain
indemnification agreements.
Our
principal executive office is located at 420 Lexington Avenue, Suite 1609,
New
York, New York 10170 and our telephone number is (212) 297-0010.
An
investment in our shares involves a high degree of risk. Before making an
investment decision, you should carefully consider all of the risks described
in
this prospectus. If any of the risks discussed in this prospectus actually
occur, our business, financial condition and results of operations could be
materially and adversely affected. If this were to happen, the price of our
shares could decline significantly and you may lose all or a part of your
investment. Our forward-looking statements in this prospectus are subject to
the
following risks and uncertainties. Our actual results could differ materially
from those anticipated by our forward-looking statements as a result of the
risk
factors below. See "Forward-Looking Statements."
Risks
Related to Our Business
We
are at an early stage of development as a company, currently have no source
of
revenue and may never become profitable.
We
are a development stage biopharmaceutical company. Currently, we have no
products approved for commercial sale and, to date, we have not generated any
revenue. Our ability to generate revenue depends heavily on:
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demonstration
in Phase I/IIa and Phase IIb clinical trials that our two product
candidates, Atiprimod for the treatment of relapsed multiple myeloma
and
Annamycin for the treatment of relapsed acute leukemia, respectively,
are
safe and effective;
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the
successful development of our other product
candidates;
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our
ability to seek and obtain regulatory approvals, including with respect
to
the indications we are seeking;
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the
successful commercialization of our product candidates;
and
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market
acceptance of our products.
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All
of our existing product candidates will require extensive additional clinical
evaluation, regulatory review, significant marketing efforts and substantial
investment before they could provide us with any revenue. For example, Atiprimod
for the treatment of multiple myeloma entered Phase I/IIa clinical trials in
May
2004 and Annamycin for the treatment of acute leukemia is expected to enter
clinical trials in mid-2005. Our other product candidates are in preclinical
development. As a result, if we do not successfully develop and commercialize
Atiprimod or Annamycin, we will be unable to generate any revenue for many
years, if at all. We do not anticipate that we will generate revenue for several
years, at the earliest, or that we will achieve profitability for at least
several years after generating material revenue, if at all. If we are unable
to
generate revenue, we will not become profitable, and we may be unable to
continue our operations.
We
have incurred significant losses since inception and anticipate that we will
incur continued losses for the foreseeable future.
As
of March 31, 2005 and December 31, 2004, we had an accumulated deficit of
$35,955,328 and $33,361,197, respectively. We have incurred losses in each
year
since our inception in 1996. We incurred a net loss of $2,594,131 for the three
months ended March 31, 2005 and $7,543,467 and $13,106,247 for the years ended
December 31, 2004 and 2003, respectively. These
losses, among other things, have had and will continue to have an adverse effect
on our stockholders' equity and working capital. We expect to incur significant
and increasing operating losses for the next several years as we expand our
research and development, continue our clinical trials of Atiprimod for the
treatment of multiple myeloma, initiate our clinical trials of Annamycin for
the
treatment of acute leukemias, acquire or license technologies, advance our
other
product candidates into clinical development, seek regulatory approval and,
if
we receive FDA approval, commercialize our products. Because of the numerous
risks and uncertainties associated with our product development efforts, we
are
unable to predict the extent of any future losses or when we will become
profitable, if at all. If we are unable to achieve and then maintain
profitability, the market value of our common stock will likely decline.
We
will need to raise substantial additional capital to fund our operations, and
our failure to obtain funding when needed may force us to delay, reduce or
eliminate our product development programs or collaboration efforts.
Our
operations have consumed substantial amounts of cash since inception. We expect
to continue to spend substantial amounts to:
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complete
the clinical development of our two lead product candidates, Atiprimod
for
the treatment of multiple myeloma and Annamycin for the treatment
of acute
leukemias;
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continue
the development of our other product
candidates;
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finance
our general and administrative
expenses;
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prepare
regulatory approval applications and seek approvals for Atiprimod
and
Annamycin and our other product
candidates;
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license
or acquire additional technologies;
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launch
and commercialize our product candidates, if any such product candidates
receive regulatory approval; and
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develop
and implement sales, marketing and distribution
capabilities.
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In
2004, our cash used in operations increased significantly over 2003 and we
expect that our cash used in operations will increase significantly for the
next
several years. Over the past 12 months, we have spent approximately $4.7 million
or approximately $400,000 per month. We
expect that our existing capital resources will be sufficient to fund our
operations for at least the next 12 months. We will be required to raise
additional capital to complete the development and commercialization of our
current product candidates. Our future funding requirements will depend on
many
factors, including, but not limited to:
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the
rate of progress and cost of our clinical trials and other development
activities;
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any
future decisions we may make about the scope and prioritization of
the
programs we pursue;
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the
costs of filing, prosecuting, defending and enforcing any patent
claims
and other intellectual property
rights;
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the
costs and timing of regulatory
approval;
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the
costs of establishing sales, marketing and distribution
capabilities;
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the
effect of competing technological and market
developments;
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the
terms and timing of any collaborative, licensing and other arrangements
that we may establish; and
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general
market conditions for offerings from biopharmaceutical
companies.
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To
date, our sources of cash have been primarily limited to the sale of our equity
securities. We cannot be certain that additional funding will be available
on
acceptable terms, or at all. To the extent that we raise additional funds by
issuing equity securities, our stockholders may experience significant dilution.
Any debt financing, if available, may involve restrictive covenants that impact
our ability to conduct our business. If we are unable to raise additional
capital when required or on acceptable terms, we may have to significantly
delay, scale back or discontinue the development and/or commercialization of
one
or more of our product candidates. We also may be required to:
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seek
collaborators for our product candidates at an earlier stage than
otherwise would be desirable and on terms that are less favorable
than
might otherwise be available; and
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relinquish,
license or otherwise dispose of rights to technologies, product candidates
or products that we would otherwise seek to develop or commercialize
ourselves on unfavorable terms.
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If
our agreements with AnorMED Inc. or The University of Texas M.D. Anderson Cancer
Center terminate, our business would be adversely affected.
Our
business is dependent on rights we have licensed from AnorMED Inc. and The
University of Texas M.D. Anderson Cancer Center. Under the terms of the AnorMED
license agreement, we are obligated to make a maintenance fee payment of
$200,000 on January 1 of each year for the term of the license agreement.
Pursuant to the license agreement, failure to pay the maintenance fee is a
material breach of the agreement. We do not anticipate failing to pay the
maintenance fee, however in the event we cannot pay the maintenance fee, AnorMED
may terminate the license agreement and we would not be able to further develop
and commercialize Atiprimod which would have an adverse effect on our business.
Under the terms of the The University of Texas M.D. Anderson Cancer Center
license agreement, we are required to make certain good faith expenditures
towards the clinical development of at least one licensed product within the
two
year period after March 2005. In addition, at any time after 5 years from August
12, 2004, The University of Texas M.D. Anderson Cancer Center has the right
to
terminate the license if we fail to provide evidence within 90 days of written
notice that we have commercialized or we are actively and effectively attempting
to commercialize Annamycin. If we fail to fulfill these obligations or other
material obligations, The University of Texas M.D. Anderson Cancer Center
license agreement may be terminated and our business would be adversely
affected.
Clinical
trials involve a lengthy and expensive process with an uncertain outcome, and
results of earlier studies and trials may not be predictive of future trial
results.
In
order to receive regulatory approval for the commercialization of our product
candidates, we must conduct, at our own expense, extensive clinical trials
to
demonstrate safety and efficacy of these product candidates. Clinical testing
is
expensive, can take many years to complete and its outcome is uncertain. Failure
can occur at any time during the clinical trial process.
The
results of preclinical studies and early clinical trials of our product
candidates do not necessarily predict the results of later-stage clinical
trials. Product candidates in later stages of clinical trials may fail to show
the desired safety and efficacy traits despite having progressed through initial
clinical testing. The data collected from clinical trials of our product
candidates may not be sufficient to support the submission of a new drug
application or to obtain regulatory approval in the United States or elsewhere.
Because of the uncertainties associated with drug development and regulatory
approval, we cannot determine if or when we will have an approved product for
commercialization or achieve sales or profits.
Delays
in clinical testing could result in increased costs to us and delay our ability
to generate revenue.
While
to date there have no delays in our clinical trials, enrollment in our Atiprimod
Phase I/IIa trial in multiple myeloma was slower than anticipated due to limited
availability of relapsed multiple myeloma patients. In
the future, we may experience delays in clinical testing of our product
candidates. We do not know whether planned clinical trials will begin on time,
will need to be redesigned or will be completed on schedule,
if
at all. Clinical trials can be delayed for a variety of reasons, including
delays in obtaining regulatory approval to commence a trial, in reaching
agreement on acceptable clinical trial terms with prospective sites, in
obtaining institutional review board approval to conduct a trial at a
prospective site, in recruiting patients to participate in a trial or in
obtaining sufficient supplies of clinical trial materials. Many factors affect
patient enrollment, including the size of the patient population, the proximity
of patients to clinical sites, the eligibility criteria for the trial, competing
clinical trials and new drugs approved for the conditions we are investigating.
Prescribing physicians will also have to decide to use our product candidates
over existing drugs that have established safety and efficacy profiles. Any
delays in completing our clinical trials will increase our costs, slow down
our
product development and approval process and delay our ability to generate
revenue.
We
may be required to suspend or discontinue clinical trials due to unexpected
side
effects or other safety risks that could preclude approval of our product
candidates.
Our
clinical trials may be suspended at any time for a number of reasons. For
example, we may voluntarily suspend or terminate our clinical trials if at
any
time we believe that they present an unacceptable risk to the clinical trial
patients. In addition, regulatory agencies may order the temporary or permanent
discontinuation of our clinical trials at any time if they believe that the
clinical trials are not being conducted in accordance with applicable regulatory
requirements or that they present an unacceptable safety risk to the clinical
trial patients.
Administering
any product candidates to humans may produce undesirable side effects. These
side effects could interrupt, delay or halt clinical trials of our product
candidates and could result in the FDA or other regulatory authorities denying
further development or approval of our product candidates for any or all
targeted indications. Ultimately, some or all of our product candidates may
prove to be unsafe for human use. Moreover, we could be subject to significant
liability if any volunteer or patient suffers, or appears to suffer, adverse
health effects as a result of participating in our clinical trials.
If
we are unable to satisfy regulatory requirements, we may not be able to
commercialize our product candidates.
We
need FDA approval prior to marketing our product candidates in the United States
of America. We commenced in May 2004 a Phase I/IIa trial of Atiprimod for the
treatment of multiple myeloma. We expect to commence a Phase I/IIa clinical
trial of Annamycin for the treatment of acute leukemias in mid-2005. If we
fail
to obtain FDA approval to market our product candidates, we will be unable
to
sell our product candidates in the United States of America and we will not
generate any revenue.
This
regulatory review and approval process, which includes evaluation of preclinical
studies and clinical trials of a product candidate as well as the evaluation
of
our manufacturing process and our contract manufacturers' facilities, is
lengthy, expensive and uncertain. To receive approval, we must, among other
things, demonstrate with substantial evidence from well-controlled clinical
trials that the product candidate is both safe and effective for each indication
where approval is sought. Satisfaction of these requirements typically takes
several years and the time needed to satisfy them may vary substantially, based
on the type, complexity and novelty of the pharmaceutical product. We cannot
predict if or when we might submit for regulatory review any of our product
candidates currently under development. Any approvals we may obtain may not
cover all of the clinical indications for which we are seeking approval. Also,
an approval might contain significant limitations in the form of narrow
indications, warnings, precautions, or contra-indications with respect to
conditions of use.
The
FDA has substantial discretion in the approval process and may either refuse
to
file our application for substantive review or may form the opinion after review
of our data that our application is insufficient to allow approval of our
product candidates. If the FDA does not file or approve our application, it
may
require that we conduct additional clinical, preclinical or manufacturing
validation studies and submit that data before it will reconsider our
application. Depending on the extent of these or any other studies, approval
of
any applications that we submit may be delayed by several years, or may require
us to expend more resources than we have available. It is also possible that
additional studies, if performed and completed, may not be considered sufficient
by the FDA to make our applications approvable. If any of these outcomes occur,
we may be forced to abandon our applications for approval, which might cause
us
to cease operations.
We
will also be subject to a wide variety of foreign regulations governing the
development, manufacture and marketing of our products. Whether or not FDA
approval has been obtained, approval of a product by the comparable regulatory
authorities of foreign countries must still be obtained prior to manufacturing
or marketing the product in those countries. The approval process varies from
country to country and the time needed to secure approval may be longer or
shorter than that required for FDA approval. We cannot assure you that clinical
trials conducted in one country will be accepted by other countries or that
approval in one country will result in approval in any other country.
If
our product candidates are unable to compete effectively with marketed cancer
drugs, our commercial opportunity will be reduced or eliminated.
We
face competition from established pharmaceutical and biotechnology companies,
as
well as from academic institutions, government agencies and private and public
research institutions. Many of our competitors have significantly greater
financial resources and expertise in research and development, manufacturing,
preclinical testing, conducting clinical trials, obtaining regulatory approvals
and marketing approved products than we do. Smaller or early-stage companies
may
also prove to be significant competitors, particularly through collaborative
arrangements with large, established companies. Our commercial opportunity
will
be reduced or eliminated if our competitors develop and commercialize cancer
drugs that are safer, more effective, have fewer side effects or are less
expensive than our product candidates. These third parties compete with us
in
recruiting and retaining qualified scientific and management personnel,
establishing clinical trial sites and patient registration for clinical trials,
as well as in acquiring technologies and technology licenses complementary
to
our programs or advantageous to our business.
We
expect that our ability to compete effectively will depend upon our ability
to:
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successfully
and rapidly complete clinical trials and submit for and obtain all
requisite regulatory approvals in a cost-effective
manner;
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maintain
a proprietary position for our products and manufacturing processes
and
other related product technology;
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attract
and retain key personnel;
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develop
relationships with physicians prescribing these products;
and
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build
an adequate sales and marketing infrastructure for our product
candidates.
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Because
we will be competing against significantly larger companies with established
track records, we will have to demonstrate to physicians that, based on
experience, clinical data, side-effect profiles and other factors, our products
are preferable to existing cancer drugs. If we are unable to compete effectively
in the cancer drug market and differentiate our products from currently marketed
cancer drugs, we may never generate meaningful revenue.
Numerous
pharmaceutical and biotechnology companies have developed anthracycline drugs
used to treat acute leukemias similar to our compound, Annamycin. These
compounds include Adriamycin® and Ellence® which are marketed by Pfizer and
Cerubidine® which is marketed by Boehringer Ingelheim. These drugs have been
approved by the FDA and are currently being marketed as opposed to Annamycin
which is in clinical development. Atiprimod, our drug candidate for relapsed
multiple myeloma, works through a different mechanism of action than Velcade
which is currently marketed by Millenium Pharmaceuticals and other drugs in
development, such as Celgene Corporation’s Revlimid.
We
currently have no sales and marketing organization. If we are unable to
establish a direct sales force in the United States to promote our products,
the
commercial opportunity for our products may be diminished.
We
currently have no sales and marketing organization. If any of our product
candidates are approved by the FDA, we intend to market that product directly
to
hospitals in the United States of America through our own sales force. We will
incur significant additional expenses and commit significant additional
management resources to establish this sales force. We may not be able to
establish these capabilities despite these additional expenditures. We will
also
have to compete with other pharmaceutical and biotechnology companies to
recruit, hire and train sales and marketing personnel. If we elect to rely
on
third parties to sell our product candidates in the United States, we may
receive less revenue than if we sold our products directly. In addition, we
may
have little or no control over the sales efforts of those third parties. In
the
event we are unable to develop our own sales force or collaborate with a third
party to sell our product candidates, we may not be able to commercialize our
product candidates which would negatively impact our ability to generate
revenue.
We
may need others to market and commercialize our product candidates in
international markets.
In
the future, if appropriate regulatory approvals are obtained, we intend to
commercialize our product candidates in international markets. However, we
have
not decided how to commercialize our product candidates in those markets. We
may
decide to build our own sales force or sell our products through third parties.
Currently, we do not have any plans to enter international markets. If we decide
to sell our product candidates in international markets through a third party,
we may not be able to enter into any marketing arrangements on favorable terms
or at all. In addition, these arrangements could result in lower levels of
income to us than if we marketed our product candidates entirely on our own.
If
we are unable to enter into a marketing arrangement for our product candidates
in international markets, we may not be able to develop an effective
international sales force to successfully commercialize those products in
international markets. If we fail to enter into marketing arrangements for
our
products and are unable to develop an effective international sales force,
our
ability to generate revenue would be limited.
If
our relationship with our contract manufacturer forAnnamycin terminates, or
their facilities are damaged or destroyed, we may be unable to develop or
commercialize Annamycin.
Currently,
Antibioticos S.p.A. is our sole supplier of Annamycin for our clinical trials.
If our relationship with this contract manufacturer, or any other contract
manufacturer we might use, terminates or if any of their facilities are damaged
for any reason, including fire, flood, earthquake or other similar event, we
may
be unable to obtain supply of Annamycin. If any of these events were to occur,
we may need to find alternative manufacturers or manufacturing facilities.
The
number of contract manufacturers with the expertise, required regulatory
approvals and facilities to manufacture Annamycin on a commercial scale is
extremely limited, and it would take a significant amount of time to arrange
for
alternative manufacturers. If we need to change to other commercial
manufacturers, the FDA and comparable foreign regulators must approve these
manufacturers’ facilities and processes prior to our use, which would require
new testing and compliance inspections. In addition, we may not have the
intellectual property rights, or may have to share intellectual property rights,
to any improvements in the current manufacturing processes or any new
manufacturing processes for Annamycin. Any of these factors could cause us
to
delay or suspend clinical trials, regulatory submissions, required approvals
or
commercialization of Annamycin, entail higher costs, and could result in our
being unable to commercialize Annamycin successfully. Furthermore, if our
contract manufacturers fail to deliver the required commercial quantities of
bulk drug substance or finished product on a timely basis and at commercially
reasonable prices, and we were unable to find one or more replacement
manufacturers capable of production at a substantially equivalent cost, in
substantially equivalent volumes and quality, and on a timely basis, we would
likely be unable to meet demand for Annamycin and we would lose potential
revenue.
If
the FDA does not approve our contract manufacturers' facilities, we may be
unable to develop or commercialize our product candidates.
We
rely on third-party contract manufacturers to manufacture our product
candidates, and currently have no plans to develop our own manufacturing
facility. The facilities used by our contract manufacturers to manufacture
our
product candidates must be approved by the FDA. If the FDA does not approve
these facilities for the manufacture of our product, we may need to fund
additional modifications to our manufacturing
process,
conduct additional validation studies, or find alternative manufacturing
facilities, any of which would result in significant cost to us as well as
a
delay of up to several years in obtaining approval for and manufacturing of
our
product candidates. In addition, our contract manufacturers will be subject
to
ongoing periodic unannounced inspection by the FDA and corresponding state
agencies for compliance with good manufacturing practices regulations, or cGMPs,
and similar foreign standards. These regulations cover all aspects of the
manufacturing, testing, quality control and record keeping relating to our
product candidates. We do not have control over our contract manufacturers'
compliance with these regulations and standards. Failure by our contract
manufacturers to comply with applicable regulations could result in sanctions
being imposed on us, including fines, injunctions, civil penalties, failure
of
the government to grant market approval of drugs, delays, suspension or
withdrawals of approvals, operating restrictions and criminal prosecutions,
any
of which could significantly and adversely affect our business. In addition,
we
have no control over our contract manufacturers' ability to maintain adequate
quality control, quality assurance and qualified personnel. Failure by our
contract manufacturers to comply with or maintain any of these standards could
adversely affect the development of our product candidates and our business.
If
product liability lawsuits are successfully brought against us, we may incur
substantial liabilities and may be required to limit commercialization of our
product candidates.
We
face an inherent risk of product liability lawsuits related to the testing
of
our product candidates, and will face an even greater risk if we sell our
product candidates commercially. Currently, we are not aware of any anticipated
product liability claims with respect to our product candidates. In the future,
an individual may bring a liability claim against us if one of our product
candidates causes, or merely appears to have caused, an injury. If we cannot
successfully defend ourselves against the product liability claim, we may incur
substantial liabilities. Regardless of merit or eventual outcome, liability
claims may result in:
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decreased
demand for our product candidates;
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injury
to our reputation;
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withdrawal
of clinical trial participants;
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costs
of related litigation;
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substantial
monetary awards to patients;
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the
inability to commercialize our product
candidates.
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We
have "clinical trial" liability insurance with a $3,000,000 annual aggregate
limit for up to 40 patients participating in our Atiprimod and prospective
Annamycin clinical trials. We
intend to expand our insurance coverage to include the sale of commercial
products if marketing approval is obtained for our product candidates. Our
current insurance coverage may prove insufficient to cover any liability claims
brought against us. In addition, because of the increasing costs of insurance
coverage, we may not be able to maintain insurance coverage at a reasonable
cost
or obtain insurance coverage that will be adequate to satisfy any liability
that
may arise.
Even
if we receive regulatory approval for our product candidates, we will be subject
to ongoing significant regulatory obligations and oversight.
If
we receive regulatory approval to sell our product candidates, the FDA and
foreign regulatory authorities may, nevertheless, impose significant
restrictions on the indicated uses or marketing of such products, or impose
ongoing requirements for post-approval studies. Following any regulatory
approval of our product candidates, we will be subject to continuing regulatory
obligations, such as safety reporting requirements, and additional
post-marketing obligations, including regulatory oversight of the promotion
and
marketing of our products. If we become aware of previously unknown problems
with any of our product candidates here or overseas or our contract
manufacturers' facilities, a regulatory agency may impose restrictions on our
products, our contract manufacturers or on us, including requiring us to
reformulate our products, conduct additional clinical trials, make changes
in
the labeling of our products, implement changes to or obtain re-approvals of
our
contract manufacturers' facilities or withdraw the product from the market.
In
addition, we may experience a significant drop in the sales of the affected
products, our reputation in the marketplace may suffer and we may become the
target of lawsuits, including class action suits. Moreover, if we fail to comply
with applicable regulatory requirements, we may be subject to fines, suspension
or withdrawal of regulatory approvals, product recalls, seizure of products,
operating restrictions and criminal prosecution. Any of these events could
harm
or prevent sales of the affected products or could substantially increase the
costs and expenses of commercializing and marketing these products.
We
rely on third parties to conduct our clinical trials. If these third parties
do
not successfully carry out their contractual duties or meet expected deadlines,
we may not be able to seek or obtain regulatory approval for, or commercialize
our product candidates.
We
have agreements with third-party contract research organizations, or CROs,
to
provide monitors and to manage data for our clinical programs. We and our CROs
are required to comply with current Good Clinical Practices, or GCPs,
regulations and guidelines enforced by the FDA for all of our products in
clinical development. The FDA enforces GCPs through periodic inspections of
trial sponsors, principal investigators and trial sites. In the future, if
we or
our CROs fail to comply with applicable GCPs, the clinical data generated in
our
clinical trials may be deemed unreliable and the FDA may require us to perform
additional clinical trials before approving our marketing applications. We
cannot assure you that, upon inspection, the FDA will determine that any of
our
clinical trials for products in clinical development comply with GCPs. In
addition, our clinical trials must be conducted with product produced under
cGMP
regulations, and will require a large number of test subjects. Our failure
to
comply with these regulations may require us to repeat clinical trials, which
would delay the regulatory approval process.
If
any of our relationships with these third-party CROs terminate, we may not
be
able to enter into arrangements with alternative CROs. If CROs do not
successfully carry out their contractual duties or obligations or meet expected
deadlines, if they need to be replaced, or if the quality or accuracy of the
clinical data they obtain is compromised due to the failure to adhere to our
clinical protocols, regulatory requirements or for other reasons, our clinical
trials may be extended, delayed or terminated, and we may not be able to obtain
regulatory approval for or successfully commercialize our product candidates.
As
a result, our financial results and the commercial prospects for our product
candidates would be harmed, our costs could increase, and our ability to
generate revenue could be delayed.
If
we fail to attract and keep senior management and key scientific personnel,
we
may be unable to successfully develop our product candidates, conduct our
clinical trials and commercialize our product candidates.
Our
success depends in part on our continued ability to attract, retain and motivate
highly qualified management, clinical and scientific personnel and on our
ability to develop and maintain important relationships with leading academic
institutions, clinicians and scientists. We are highly dependent upon our senior
management and scientific staff, particularly Gary S. Jacob, our Chief Executive
Officer, and Donald Picker, our Executive Vice President, R&D. The loss of
services of Dr. Jacob, Dr. Picker or one or more of our other members of senior
management could delay or prevent the successful completion of our planned
clinical trials or the commercialization of our product candidates.
The
competition for qualified personnel in the biotechnology and pharmaceuticals
field is intense. We will need to hire additional personnel as we expand our
clinical development and commercial activities. We may not be able to attract
and retain quality personnel on acceptable terms given the competition for
such
personnel among biotechnology, pharmaceutical and other companies. We do not
carry "key person" insurance covering any members of our senior management.
If
we fail to acquire and develop other products or product candidates, we may
be
unable to grow our business.
To
date, we have in-licensed or acquired the rights to each of our product
candidates. As part of our growth strategy, in addition to developing our
current product candidates, we intend to license or acquire additional products
and product candidates for development and commercialization. Because we have
limited internal research capabilities, we are dependent upon pharmaceutical
and
biotechnology companies and other researchers to sell or license products to
us.
The success of this strategy depends upon our ability to identify, select and
acquire the right pharmaceutical product candidates and products. We currently
do not have any intentions to acquire another company.
Any
product candidate we license or acquire may require additional development
efforts prior to commercial sale, including extensive clinical testing and
approval by the FDA and applicable foreign regulatory authorities. All product
candidates are prone to the risks of failure inherent in pharmaceutical product
development, including the possibility that the product candidate will not
be
shown to be sufficiently safe and effective for approval by regulatory
authorities. In addition, we cannot assure you that any products that we license
or acquire that are approved will be manufactured or produced economically,
successfully commercialized or widely accepted in the marketplace.
Proposing,
negotiating and implementing an economically viable product acquisition or
license is a lengthy and complex process. Other companies, including those
with
substantially greater financial, marketing and sales resources, may compete
with
us for the acquisition or license of product candidates and approved products.
We may not be able to acquire or license the rights to additional product
candidates and approved products on terms that we find acceptable, or at all.
We
may undertake acquisitions in the future, and any difficulties from integrating
these acquisitions could damage our ability to attain or maintain profitability.
We
may acquire additional businesses, products or product candidates that
complement or augment our existing business. Integrating any newly acquired
business or product could be expensive and time-consuming. We may not be able
to
integrate any acquired business or product successfully or operate any acquired
business profitably. Moreover, we many need to raise additional funds through
public or private debt or equity financing to make acquisitions, which may
result in dilution to stockholders and the incurrence of indebtedness that
may
include restrictive covenants.
We
will need to increase the size of our organization, and we may experience
difficulties in managing growth.
We
are a small company with 5 full-time and 2 part-time employees as of June 1,
2005. To continue our clinical trials and commercialize our product candidates,
we will need to expand our employee base for managerial, operational, financial
and other resources. Future growth will impose significant added
responsibilities on members of management, including the need to identify,
recruit, maintain and integrate additional employees. Over the next 12 months
depending on the progress of our planned clinical trials, we plan to add
approximately four employees who we expect to assist us with our clinical
programs. Our
future financial performance and our ability to commercialize our product
candidates and to compete effectively will depend, in part, on our ability
to
manage any future growth effectively. To that end, we must be able to:
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manage
our development efforts
effectively;
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manage
our clinical trials effectively;
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integrate
additional management, administrative, manufacturing and sales and
marketing personnel;
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maintain
sufficient administrative, accounting and management information
systems
and controls; and
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hire
and train additional qualified
personnel.
|
We
may not be able to accomplish these tasks, and our failure to accomplish any
of
them could harm our financial results.
Reimbursement
may not be available for our product candidates, which could diminish our sales.
Market
acceptance and sales of our product candidates may depend on reimbursement
policies and health care reform measures. The levels at which government
authorities and third-party payors, such as private health insurers and health
maintenance organizations, reimburse patients for the price they pay for our
products could affect whether we are able to commercialize these products.
We
cannot be sure that reimbursement will be available for any of these products.
Also, we cannot be sure that reimbursement amounts will not reduce the demand
for, or the price of, our products. We have not commenced efforts to have our
product candidates reimbursed by government or third party payors. If
reimbursement is not available or is available only to limited levels, we may
not be able to commercialize our products.
In
recent years, officials have made numerous proposals to change the health care
system in the United States. These proposals include measures that would limit
or prohibit payments for certain medical treatments or subject the pricing
of
drugs to government control. In addition, in many foreign countries,
particularly the countries of the European Union, the pricing of prescription
drugs is subject to government control. If our products are or become subject
to
government regulation that limits or prohibits payment for our products, or
that
subject the price of our products to governmental control, we may not be able
to
generate revenue, attain profitability or commercialize our products.
As
a result of legislative proposals and the trend towards managed health care
in
the United States, third-party payers are increasingly attempting to contain
health care costs by limiting both coverage and the level of reimbursement
of
new drugs. They may also refuse to provide any coverage of uses of approved
products for medical indications other than those for which the FDA has granted
market approvals. As a result, significant uncertainty exists as to whether
and
how much third-party payers will reimburse patients for their use of
newly-approved drugs, which in turn will put pressure on the pricing of drugs.
Legislative
or regulatory reform of the healthcare system may affect our ability to sell
our
products profitably.
In
both the United States and certain foreign jurisdictions, there have been a
number of legislative and regulatory proposals to change the healthcare system
in ways that could impact upon our ability to sell our products profitably.
In
recent years, new legislation has been proposed in the United States at the
federal and state levels that would effect major changes in the healthcare
system, either nationally or at the state level.
These
proposals have included prescription drug benefit proposals for Medicare
beneficiaries introduced in Congress. Legislation creating a prescription drug
benefit and making certain changes in Medicaid reimbursement has recently been
enacted by Congress and signed by the President. Given this legislation's recent
enactment, it is still too early to determine its impact on the pharmaceutical
industry and our business. Further federal and state proposals are likely.
The
potential for adoption of these proposals affects or will affect our ability
to
raise capital, obtain additional collaborators and market our products. We
expect to experience pricing pressures in connection with the sale of our
products due to the trend toward managed health care, the increasing influence
of health maintenance organizations and additional legislative proposals. Our
results of operations could be adversely affected by future healthcare reforms.
Risks
Related to our Intellectual Property
It
is difficult and costly to protect our proprietary rights, and we may not be
able to ensure their protection.
Our
commercial success will depend in part on obtaining and maintaining patent
protection and trade secret protection of our product candidates, and the
methods used to manufacture them, as well as successfully defending these
patents against third-party challenges. We will only be able to protect our
product candidates from unauthorized making, using, selling, offering to sell
or
importation by third parties to the extent that we have rights under valid
and
enforceable patents or trade secrets that cover these activities.
As
of June 1, 2005, we own 4 issued United States patents and have licensed rights
to 8 issued United States patents and 78 issued foreign patents, and to 3
pending United States patent applications and 39 pending foreign patent
applications. We do not and have not had any control over the filing or
prosecution of these patents or patent applications. We may file additional
patent applications and extensions. Our issued United States patents we own
and
license primarily are composition of matter and formulation patents related
to
Atiprimod and liposomal Annamycin. Our composition of matter patents for
liposomal Annamycin and Atiprimod expire in 2008 and 2009, respectively. Our
formulation patents for liposomal Annamycin and Atiprimod expire in 2019 and
2018, respectively.
The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions for which important
legal principles remain unresolved. No consistent policy regarding the breadth
of claims allowed in biotechnology patents has emerged to date in the United
States. The biotechnology patent situation outside the United States is even
more uncertain. Changes in either the patent laws or in interpretations of
patent laws in the United States and other countries may diminish the value
of
our intellectual property. Accordingly, we cannot predict the breadth of claims
that may be allowed or enforced in our licensed patents or in third-party
patents.
The
degree of future protection for our proprietary rights is uncertain because
legal means afford only limited protection and may not adequately protect our
rights or permit us to gain or keep our competitive advantage. For example:
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others
may be able to make compounds that are competitive with our product
candidates but that are not covered by the claims of our licensed
patents,
or for which we are not licensed under our license
agreements;
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we
or our licensors might not have been the first to make the inventions
covered by our pending patent application or the pending patent
applications and issued patents of our
licensors;
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we
or our licensors might not have been the first to file patent applications
for these inventions;
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others
may independently develop similar or alternative technologies or
duplicate
any of our technologies;
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it
is possible that our pending patent application or one or more of
the
pending patent applications of our licensors will not result in issued
patents;
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the
issued patents of our licensors may not provide us with any competitive
advantages, or may be held invalid or unenforceable as a result
of legal
challenges by third parties;
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we
may not develop additional proprietary technologies that are patentable;
or
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the
patents of others may have an adverse effect on our
business.
|
We
also may rely on trade secrets to protect our technology, especially where
we do
not believe patent protection is appropriate or obtainable. However, trade
secrets are difficult to protect. While we use reasonable efforts to protect
our
trade secrets, our employees, consultants, contractors, outside scientific
collaborators and other advisors may unintentionally or willfully disclose
our
information to competitors. Enforcing a claim that a third party illegally
obtained and is using our trade secrets is expensive and time consuming, and
the
outcome is unpredictable. In addition, courts outside the United States are
sometimes less willing to protect trade secrets. Moreover, our competitors
may
independently develop equivalent knowledge, methods and know-how.
We
may incur substantial costs as a result of litigation or other proceedings
relating to patent and other intellectual property rights and we may be unable
to protect our rights to, or use, our technology.
If
we choose to go to court to stop someone else from using the inventions claimed
in our licensed patents, that individual or company has the right to ask the
court to rule that these patents are invalid and/or should not be enforced
against that third party. These lawsuits are expensive and would consume time
and other resources even if we were successful in stopping the infringement
of
these patents. In addition, there is a risk that the court will decide that
these patents are not valid and that we do not have the right to stop the other
party from using the inventions. There is also the risk that, even if the
validity of these patents is upheld, the court will refuse to stop the other
party on the ground that such other party's activities do not infringe our
rights to these patents.
Furthermore,
a third party may claim that we are using inventions covered by the third
party's patent rights and may go to court to stop us from engaging in our normal
operations and activities, including making or selling our product candidates.
These lawsuits are costly and could affect our results of operations and divert
the attention of managerial and technical personnel. There is a risk that a
court would decide that we are infringing the third party's patents and would
order us to stop the activities covered by the patents. In addition, there
is a
risk that a court will order us to pay the other party damages for having
violated the other party's patents. The biotechnology industry has produced
a
proliferation of patents, and it is not always clear to industry participants,
including us, which patents cover various types of products or methods of use.
The coverage of patents is subject to interpretation by the courts, and the
interpretation is not always uniform. If we are sued for patent infringement,
we
would need to demonstrate that our products or methods of use either do not
infringe the patent claims of the relevant patent and/or that the patent claims
are invalid, and we may not be able to do this. Proving invalidity, in
particular, is difficult since it requires a showing of clear and convincing
evidence to overcome the presumption of validity enjoyed by issued patents.
Because
some patent applications in the United States of America may be maintained
in
secrecy until the patents are issued, because patent applications in the United
States of America and many foreign jurisdictions are typically not published
until eighteen months after filing, and because publications in the scientific
literature often lag behind actual discoveries, we cannot be certain that others
have not filed patent applications for technology covered by our licensors'
issued patents or our pending applications or our licensors' pending
applications or that we or our licensors were the first to invent the
technology. Our competitors may have filed, and may in the future file, patent
applications covering technology similar to ours. Any such patent application
may have priority over our or our licensors' patent applications and could
further require us to obtain rights to issued patents covering such
technologies. If another party has filed a United States patent application
on
inventions similar to ours, we may have to participate in an interference
proceeding declared by the United States Patent and Trademark Office to
determine priority of invention in the United States. The costs of these
proceedings could be substantial, and it is possible that such efforts would
be
unsuccessful, resulting in a loss of our United States patent position with
respect to such inventions.
Some
of our competitors may be able to sustain the costs of complex patent litigation
more effectively than we can because they have substantially greater resources.
In addition, any uncertainties resulting from the initiation and continuation
of
any litigation could have a material adverse effect on our ability to raise
the
funds necessary to continue our operations.
Risks
Related to our Common Stock
Market
volatility may affect our stock price and the value of your investment.
The
market prices for securities of biopharmaceutical companies in general have
been
highly volatile and may continue to be highly volatile in the future. The
following factors, in addition to other risk factors described in this section,
may have a significant impact on the market price of our common stock:
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announcements
of technological innovations or new products by us or our
competitors;
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announcement
of FDA approval or non-approval of our product candidates or delays
in the
FDA review process;
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actions
taken by regulatory agencies with respect to our product candidates,
clinical trials, manufacturing process or sales and marketing
activities;
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regulatory
developments in the United States of America and foreign
countries;
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the
success of our development efforts and clinical
trials;
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the
success of our efforts to acquire or in-license additional products
or
product candidates;
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any
intellectual property infringement action, or any other litigation,
involving us;
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announcements
concerning our competitors, or the biotechnology or biopharmaceutical
industries in general;
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actual
or anticipated fluctuations in our operating
results;
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changes
in financial estimates or recommendations by securities
analysts;
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sales
of large blocks of our common
stock;
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our
ability to meet the listing requirements of the American Stock
Exchange;
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sales
of our common stock by our executive officers, directors and significant
stockholders; and
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the
loss of any of our key scientific or management
personnel.
|
The
occurrence of one or more of these factors may cause our stock price to decline,
and you may not be able to resell your shares at or above the price you paid
for
your shares. In addition, the stock markets in general, and the markets for
biotechnology and biopharmaceutical stocks in particular, have experienced
extreme volatility that has often been unrelated to the operating performance
of
particular companies. These broad market fluctuations may adversely affect
the
trading price of our common stock.
We
are at risk of securities class action litigation.
In
the past, securities class action litigation has often been brought against
a
company following a decline in the market price of its securities. This risk
is
especially relevant for us because biotechnology and biopharmaceutical companies
have experienced significant stock price volatility in recent years. If we
faced
such litigation, it could result in substantial costs and a diversion of
management's attention and resources, which could harm our business.
We
have not paid cash dividends in the past and do not expect to pay cash dividends
in the future. Any return on investment may be limited to the value of our
stock.
We
have never paid cash dividends on our stock and do not anticipate paying cash
dividends on our stock in the foreseeable future. The payment of cash dividends
on our stock will depend on our earnings, financial condition and other business
and economic factors affecting us at such time as the board of directors may
consider relevant. If we do not pay cash dividends, our stock may be less
valuable because a return on your investment will only occur if our stock price
appreciates.
The
Private Securities Litigation Reform Act of 1995 (the "Act") provides a safe
harbor for forward-looking statements made by us or on our behalf. We and our
representatives may from time to time make written or oral statements that
are
"forward-looking," including statements contained in this prospectus and other
filings with the Securities and Exchange Commission, reports to our stockholders
and news releases. All statements that express expectations, estimates,
forecasts or projections are forward-looking statements within the meaning
of
the Act. In addition, other written or oral statements which constitute
forward-looking statements may be made by us or on our behalf. Words such as
"expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates,"
"projects," "forecasts," "may," "should," variations of such words and similar
expressions are intended to identify such forward-looking statements. These
statements are not guarantees of future performance and involve risks,
uncertainties and assumptions which are difficult to predict. Therefore, actual
outcomes and results may differ materially from what is expressed or forecasted
in or suggested by such forward-looking statements. We undertake no obligation
to update publicly any forward-looking statements, whether as a result of new
information, future events or otherwise. Among the important factors on which
such statements are based are assumptions concerning our ability to complete
ongoing clinical trials, results of our clinical trials, the timing of approval
of our products by the United States Food and Drug Administration, our ability
to obtain additional financing, our ability to attract and retain key employees,
our ability to protect intellectual property, and our ability to adapt to
economic, political and regulatory conditions affecting the healthcare industry.
We
will
not receive any of the proceeds from the resale of the shares. All proceeds
from
the sale of these shares will be solely for the accounts of the selling
stockholders.
Under
an initial registration statement filed on May 13, 2004, we registered 6,056,541
shares of common stock that were acquired in a private placement from November
2003 through January 2004 and in April 2004. Since August 12, 2004, 451,110
of
such shares have been sold under such registration statement. The remaining
5,605,431 shares are eligible for resale pursuant to this prospectus. The
following table lists certain information with respect to the selling
stockholders as follows: (i) each selling stockholder's name, (ii) the number
of
outstanding shares of common stock beneficially owned by the selling
stockholders prior to this offering, (iii) the number of shares sold under
the
prior registration statement, (iv) the number of remaining shares to be sold
under this registration statement and (v) the number of shares of common stock
to be beneficially owned by each selling stockholder after the completion of
this offering assuming the sale of all of the shares of the common stock offered
by each selling stockholder. Except as noted, none of the selling stockholders
have had any position, office, or other material relationship with us or any
of
our predecessors or affiliates within the past three years.
The
selling stockholders may sell all, or none of their shares in this offering.
See
"Plan of Distribution."
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Prior
to the Offering
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After
the Offering
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Selling
Stockholder
|
Number
of Shares
|
Number
of Shares Already Sold in Offering
|
Number
of Remaining Shares Offered
|
Number
of Shares
|
Percent
of Shares Beneficially Owned
|
|
Wanda
H. Harrington
|
100,000
|
—
|
100,000
|
—
|
—
|
|
R.
Merrill & Marilyn Hunter Children’s Trust f/b/o Kathryn Leigh
Hunter
|
50,000
|
—
|
50,000
|
—
|
—
|
|
R.
Merrill & Marilyn Hunter Children’s Trust f/b/o Christopher Tyler
Hunter
|
50,000
|
—
|
50,000
|
—
|
—
|
|
R.
Merrill & Marilyn Hunter Children’s Trust f/b/o Matthew Reaves
Hunter
|
50,000
|
—
|
50,000
|
—
|
—
|
|
R.
Merrill & Marilyn Hunter Children’s Trust f/b/o Julianna Marie
Hunter
|
50,000
|
—
|
50,000
|
—
|
—
|
|
R.
Merrill Hunter
|
1,000,000
|
—
|
1,000,000
|
—
|
—
|
|
William
J. Ritger
|
181,666
|
166,666
|
—
|
15,000
|
*
|
|
Robert
Shapiro Revocable Trust u/t/a dtd 4/6/94
|
70,000
|
—
|
70,000
|
—
|
—
|
|
Jonah
Jay Lobell
|
70,000
|
—
|
70,000
|
—
|
—
|
|
Alfonse
Melohn
|
210,000
|
—
|
210,000
|
—
|
—
|
|
WMSBG-Kolel
Damesek Eliezer, Inc.
|
70,000
|
—
|
70,000
|
—
|
—
|
|
Howard
Zuckerman
|
34,667
|
—
|
34,667
|
—
|
—
|
|
John
E.M. McConnaughy, Jr.
|
70,000
|
70,000
|
—
|
—
|
—
|
|
MLC
Management Co.
|
140,000
|
140,000
|
—
|
—
|
—
|
|
Blenton
Management S.A.
|
1,110,099
|
—
|
1,004,099
|
—
|
—
|
|
Howard
Gittis
|
806,000
(2)
|
—
|
400,000
|
406,000
|
1.3 |
|
New
England Partners Capital, L.P.
|
914,402
(3)
|
—
|
200,000
|
714,402
|
2.3 |
|
Black
Flower Ltd.
|
35,000
|
—
|
35,000
|
—
|
—
|
|
Stanley
Neal Tennant
|
100,000
|
—
|
100,000
|
—
|
—
|
|
Keith
C. Alliotts
|
35,000
|
—
|
35,000
|
—
|
—
|
|
Shekhar
Basu
|
44,444
|
—
|
44,444
|
—
|
—
|
|
Greenberg
Healthcare Partners LLC
|
444,444
|
—
|
444,444
|
—
|
—
|
|
Alexandra
Global Master Fund Ltd.
|
250,000
|
—
|
250,000
|
—
|
—
|
|
Punk
Ziegel & Company
|
100,000
|
—
|
100,000
|
—
|
—
|
|
Atlas
Equity I, Ltd.
|
200,000
|
—
|
200,000
|
—
|
—
|
|
BioMed
Venture Partners, L.P.
|
150,000
|
—
|
150,000
|
—
|
—
|
|
|
Prior
to the Offering
|
|
|
After
the Offering
|
| Selling
Stockholder |
Number
of Shares
|
Number
of Shares Already Sold in Offering
|
Number
of Remaining Shares Offered
|
Number
of Shares
|
Percent
of Shares Beneficially Owned
|
|
InvestBio
Partners, L.P.
|
150,000
|
—
|
150,000
|
—
|
—
|
|
Pamela
Kaweske
|
22,222
|
22,222
|
—
|
—
|
—
|
|
Baffles
S.A.
|
22,222
|
—
|
22,222
|
—
|
—
|
|
SEGOES
Trust
|
20,000
|
20,000
|
—
|
—
|
—
|
|
Hytec
International, Ltd.
|
8,889
|
—
|
8,889
|
—
|
—
|
|
Nicholas
DiFalco
|
22,222
|
22,222
|
—
|
—
|
—
|
|
Mark
J. Sklar and Andrea D. Sklar
|
10,000
|
10,000
|
—
|
—
|
—
|
|
W.
Harrison Wellford
|
40,000
|
—
|
40,000
|
—
|
—
|
|
Orion
Biomedical Offshore Fund, LP
|
79,333
|
—
|
79,333
|
—
|
—
|
|
Orion
Biomedical Fund, LP
|
365,111
|
—
|
365,111
|
—
|
—
|
|
Seneca
Capital International Ltd.
|
141,222
|
—
|
141,222
|
—
|
—
|
|
Seneca
Capital L.P.
|
81,000
|
—
|
81,000
|
—
|
—
|
* less
than 1%.
(1)
Mr. Ritger is the President of The Research Works, Inc. which has a contract
with Callisto to provide equity research services. The Research Works, Inc.
received 15,000 shares of common stock for its services.
(2)
Includes 406,000 shares held by the Gittis Family Foundation.
(3)
NEGF II, L.P. owns 714,402 of such shares. NEGF II, L.P. is an affiliate of
New
England Partners Capital, L.P.
(4)
Punk Ziegel & Company LLP acted as placement agent to Callisto in the April
19, 2004 private placement pursuant to an Engagement Letter dated January 22,
2004 and was issued warrants to purchase 101,111 shares of common stock
exercisable at $2.48 per share in addition to a cash placement fee.
The
selling stockholders, or their pledgees, donees, transferees, or any of their
successors in interest selling shares received from a named selling stockholder
as a gift, partnership distribution or other non-sale-related transfer after
the
date of this prospectus (all of whom may be selling stockholders) may sell
the
common stock offered by this prospectus from time to time on any stock exchange
or automated interdealer quotation system on which the common stock is listed
or
quoted at the time of sale, in the over-the-counter market, in privately
negotiated transactions or otherwise, at fixed prices that may be changed,
at
market prices prevailing at the time of sale, at prices related to prevailing
market prices or at prices otherwise negotiated. The selling stockholders may
sell the common stock by one or more of the following methods, without
limitation:
| |
·
|
Block
trades in which the broker or dealer so engaged will attempt to sell
the
common stock as agent but may position and resell a portion of the
block
as principal to facilitate the transaction;
|
|
| |
|
|
|
| |
·
|
An
exchange distribution in accordance with the rules of any stock exchange
on which the common stock is listed;
|
|
| |
|
|
|
| |
·
|
Ordinary
brokerage transactions and transactions in which the broker solicits
purchases;
|
|
| |
|
|
|
| |
·
|
Privately
negotiated transactions;
|
|
| |
|
|
|
| |
·
|
In
connection with short sales of company shares;
|
|
| |
|
|
|
| |
·
|
Through
the distribution of common stock by any selling stockholder to its
partners, members or stockholders;
|
|
| |
|
|
|
| |
·
|
By
pledge to secure debts of other obligations;
|
|
| |
|
|
|
| |
·
|
In
connection with the writing of non-traded and exchange-traded call
options, in hedge transactions and in settlement of other transactions
in
standardized or over-the-counter options;
|
|
| |
|
|
|
| |
·
|
Purchases
by a broker-dealer as principal and resale by the broker-dealer for
its
account; or
|
|
| |
|
|
|
| |
·
|
In
a combination of any of the above.
|
|
These
transactions may include crosses, which are transactions in which the same
broker acts as an agent on both sides of the trade. The selling stockholders
may
also transfer the common stock by gift. We do not know of any arrangements
by
the selling stockholders for the sale of any of the common stock.
The
selling stockholders may engage brokers and dealers, and any brokers or dealers
may arrange for other brokers or dealers to participate in effecting sales
of
the common stock. These brokers or dealers may act as principals, or as an
agent
of a selling stockholder. Broker-dealers may agree with a selling stockholder
to
sell a specified number of the stocks at a stipulated price per share. If the
broker-dealer is unable to sell common stock acting as agent for a selling
stockholder, it may purchase as principal any unsold shares at the stipulated
price. Broker-dealers who acquire common stock as principals may thereafter
resell the shares from time to time in transactions in any stock exchange or
automated interdealer quotation system on which the common stock is then listed,
at prices and on terms then prevailing at the time of sale, at prices related
to
the then-current market price or in negotiated transactions. Broker-dealers
may
use block transactions and sales to and through broker-dealers, including
transactions of the nature described above. The selling stockholders may also
sell the common stock in accordance with Rule 144 or Rule 144A under the
Securities Act, rather than pursuant to this prospectus. In order to comply
with
the securities laws of some states, if applicable, the shares of common stock
may be sold in these jurisdictions only through registered or licensed brokers
or dealers.
From
time to time, one or more of the selling stockholders may pledge, hypothecate
or
grant a security interest in some or all of the shares owned by them. The
pledgees, secured parties or person to whom the shares have been hypothecated
will, upon foreclosure in the event of default, be deemed to be selling
stockholders. The number of a selling stockholder's shares offered under this
prospectus will decrease as and when it takes such actions. The plan of
distribution for that selling stockholder's shares will otherwise remain
unchanged. In addition, a selling stockholder may, from time to time, sell
the
shares short, and, in those instances, this prospectus may be delivered in
connection with the short sales and the shares offered under this prospectus
may
be used to cover short sales.
To
the extent required under the Securities Act, the aggregate amount of selling
stockholders' shares being offered and the terms of the offering, the names
of
any agents, brokers, dealers or underwriters, any applicable commission and
other material facts with respect to a particular offer will be set forth in
an
accompanying prospectus supplement or a post-effective amendment to the
registration statement of which this prospectus is a part, as appropriate.
Any
underwriters, dealers, brokers or agents participating in the distribution
of
the common stock may receive compensation in the form of underwriting discounts,
concessions, commissions or fees from a selling stockholder and/or purchasers
of
selling stockholders' shares, for whom they may act (which compensation as
to a
particular broker-dealer might be less than or in excess of customary
commissions). Neither we nor any selling stockholder can presently estimate
the
amount of any such compensation.
The
selling stockholders and any underwriters, brokers, dealers or agents that
participate in the distribution of the common stock may be deemed to be
"underwriters" within the meaning of the Securities Act, and any discounts,
concessions, commissions or fees received by them and any profit on the resale
of the securities sold by them may be deemed to be underwriting discounts and
commissions. If a selling stockholder is deemed to be an underwriter, the
selling stockholder may be subject to certain statutory liabilities including,
but not limited to Sections 11, 12 and 17 of the Securities Act and Rule 10b-5
under the Exchange Act. Selling stockholders who are deemed underwriters within
the meaning of the Securities Act will be subject to the prospectus delivery
requirements of the Securities Act. The SEC staff is of a view that selling
stockholders who are registered broker-dealers or affiliates of registered
broker-dealers may be underwriters under the Securities Act. We will not pay
any
compensation or give any discounts or commissions to any underwriter in
connection with the securities being offered by this prospectus. Because
of their affiliation with a broker-dealer, Orion Biomedical Fund, LP, Orion
Biomedical Offshore Fund, LP and Punk Ziegel & Company, each of which are
selling stockholders, is deemed to be an underwriter in connection with the
offering of its respective shares under this prospectus. Each of Orion
Biomedical Fund, LP, Orion Biomedical Offshore Fund, LP and Punk Ziegel &
Company has represented to us that it purchased its respective shares in the
ordinary course of business and at the time of such purchase, had no agreements
or understandings to distribute such shares.
A
selling stockholder may enter into hedging transactions with broker-dealers
and
the broker-dealers may engage in short sales of the common stock in the course
of hedging the positions they assume with that selling stockholder, including,
without limitation, in connection with distributions of the common stock by
those broker-dealers. A selling stockholder may enter into option or other
transactions with broker-dealers, who may then resell or otherwise transfer
those common stock. A selling stockholder may also loan or pledge the common
stock offered hereby to a broker-dealer and the broker-dealer may sell the
common stock offered by this prospectus so loaned or upon a default may sell
or
otherwise transfer the pledged common stock offered by this prospectus.
The
selling stockholders and other persons participating in the sale or distribution
of the common stock will be subject to applicable provisions of the Exchange
Act, and the rules and regulations under the Exchange Act, including Regulation
M. This regulation may limit the timing of purchases and sales of any of the
common stock by the selling stockholders and any other person. The
anti-manipulation rules under the Exchange Act may apply to sales of common
stock in the market and to the activities of the selling stockholders and their
affiliates. Regulation M may restrict the ability of any person engaged in
the
distribution of the common stock to engage in market-making activities with
respect to the particular common stock being distributed for a period of up
to
five business days before the distribution. These restrictions may affect the
marketability of the common stock and the ability of any person or entity to
engage in market-making activities with respect to the common stock.
We
have agreed to indemnify the selling stockholders who participated in our
January 21, 2004 private placement and our April 19, 2004 private placement
(the
"Private Placement Stockholders") and any brokers, dealers and agents who may
be
deemed to be underwriters, if any, of the common stock offered by this
prospectus, against specified liabilities, including liabilities under the
Securities Act. The Private Placement Stockholders have agreed to indemnify
us
against specified liabilities.
The
common stock offered by this prospectus was originally issued to the Private
Placement Stockholders pursuant to an exemption from the registration
requirements of the Securities Act, as amended. We agreed to register the common
stock issued to the Private Placement Stockholders under the Securities Act,
and
to keep the registration statement of which this prospectus is a part effective
until three years after the effective date of
the
registration statement. We have agreed to pay all expenses incident to the
registration of the common stock held by the Private Placement Stockholders
in
connection with this offering, but all selling expenses related to the
securities registered shall be borne by the individual holders of such
securities pro rata on the basis of the number of shares of securities so
registered on their behalf.
We
cannot assure you that the selling stockholders will sell all or any portion
of
the common stock offered by this prospectus. In addition, we cannot assure
you
that a selling stockholder will not transfer the shares of our common stock
by
other means not described in this prospectus.
The
validity of the common stock will be passed upon by Sichenzia Ross Friedman
Ference LLP, New York, New York. Sichenzia Ross Friedman Ference LLP owns an
aggregate of 22,000 shares of Callisto’s common stock.
The
financial statements incorporated by reference in this prospectus have been
audited by BDO Seidman, LLP, an independent registered public accounting firm,
to the extent and for the periods set forth in their report incorporated herein
by reference, and are incorporated herein in reliance upon such report given
upon the authority of said firm as experts in auditing and accounting.
17