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Hemispherx's common stock and class A warrants are listed on the
American Stock Exchange under the symbols HEB and HEB/WS, respectively. The
reported last sale price on the American Stock Exchange on September 1, 1999 was
$6.1875 and $2.50, respectively.
The mailing address of our principal executive offices is 1617 JFK
Boulevard, Philadelphia, Pennsylvania 19103, and the telephone number is (215)
988-0080.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined that
this prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
The date of this prospectus is ____________, 1999
Prospectus Summary
Because this is a summary, it may not contain all information that may
be important to you. You should read this entire prospectus, including the
information incorporated by reference and the financial data and related notes,
before making an investment decision. When used in this prospectus, the terms
"we," "our" and "us" refer to Hemispherx and not to the selling stockholders.
Hemispherx
Hemispherx is a pharmaceutical company that is using genetic
technologies to develop therapeutic products for the treatment of viral diseases
and certain cancers. Ampligen, our lead compound, is in advanced human clinical
development for various therapeutic indications. We have clinically evaluated
Ampligen in over 400 patients for different therapeutic indications. These
clinical studies show that the drug acts as an antiviral agent against a large
number of different viruses, including myalgic encephalomyelitis, also known as
chronic fatigue syndrome, HIV infection and hepatitis B, as well as a treatment
for certain cancers. Clinical trials conducted in the early 1990's indicate that
Ampligen may have potential in the treatment of metastatic renal cell cancer and
malignant melanoma. Ampligen appears to stimulate the immune system and is
generally well tolerated. We are currently conducting Phase III human clinical
trials for the therapeutic treatment of chronic fatigue syndrome. Phase III
trials are the final drug testing phase for approval by the U.S. Food and Drug
Administration.
We will continue our research and clinical efforts for the next several
years. We expect significant benefits as a result of certain revenues expected
from various cost recovery treatment programs, notably in Canada, Belgium and
the United States. Cost recovery treatment programs allow us to charge patients
for the cost of Ampligen even though the drug has yet to be approved by the Food
and Drug Administration. We are also pursuing similar programs in other
countries, especially within the European Union where our resources have been
substantially increased in order to pursue regulatory approvals. Over the years,
we have secured more than 25 issued U.S. patents and over 300 derivative
international filings. Nine additional U.S. patent filings are pending along
with their international counterparts.
We require substantial resources to conduct the time-consuming
research, preclinical development, and clinical trials necessary to bring
pharmaceutical products to market and establish commercial production and
marketing capabilities. Accordingly, we may need to raise additional funds
through additional equity or debt financing, collaborative arrangements with
corporate partners, off balance sheet financing or from other sources in order
to complete the necessary clinical trials and the regulatory approval processes
and begin commercializing our products.
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Manufacturing
In 1994, we entered into an agreement with Bioclones, Ltd., a
subsidiary of South African Breweries, Ltd., to co-develop various genetic
drugs, including Ampligen. The Bioclones agreement provided for the formation of
Ribotech, Ltd. Ribotech was formed in 1994 to produce the raw materials for
manufacturing Ampligen. Hemispherx and Bioclones jointly own Ribotech. Ribotech
presently has the capacity to produce the materials required to treat
approximately 2,000 patients per year. We are planning to develop a new
production plant. This new facility will have the capacity to produce the
materials needed to treat up to 50,000 patients.
In the third quarter of 1998, we informed the Food and Drug
Administration of our intention to switch certain patients from the labor
intensive freeze-dried dosage form of Ampligen to the more convenient
ready-to-infuse liquid formulation for the treatment of patients in clinical
trials. We manufacture the liquid product more efficiently and the process
allows greater production volumes, although we will continue to produce the
freeze-dried product for further clinical development. We have initiated efforts
to identify and locate additional liquid formulation capacity in the U.S. and
Europe, since we anticipate that additional production capacity will be needed
in the future.
Product Development
In the second quarter of 1998, we commenced a Phase III clinical study
of Ampligen for the treatment of chronic fatigue syndrome. We plan to enroll up
to 230 patients with severely debilitating chronic fatigue syndrome. Chronic
fatigue syndrome patients who are not eligible for the Phase III trial in the
United States may seek treatment under the chronic fatigue syndrome cost
recovery treatment program now authorized by the Food and Drug Administration.
Treatment with cost recovery has been ongoing since mid-1997 under the auspices
of the Food and Drug Administration. Under this protocol, the enrolled patients
pay for the Ampligen administered, which totals about $7,400 for a 24 week
treatment course. Patients are also treated for chronic fatigue syndrome in
Belgium, Austria and Canada under similar chronic fatigue cost recovery
treatment programs.
Distribution/Marketing
In February 1998, we entered into an agreement with Kimberly Home
Health Care, Inc. which operates under the name Olsten Health Services. Olsten
Health Services will serve as a distributor of our products to U.S. patients
enrolled in the chronic fatigue syndrome cost recovery program and will maintain
an Ampligen inventory for use in treating these patients. In addition, Olsten
Health Services will initially provide up to $500,000 of support for other
clinical program efforts including identification of the potential medical and
economic benefits
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to patients receiving Ampligen. Olsten Health Services is able to deliver
treatment and services to chronic disease patients including infusion services,
home nursing and other medical services through a national network of more than
500 locations.
We formed a wholly owned subsidiary in Europe, Hemispherx Biopharma
Europe NV/SA. This subsidiary is presently based in Antwerp and is pursuing
chronic fatigue clinical tests, related clinical treatments and new drug
marketing approval in Belgium and other European countries. In December 1998, we
filed final drug marketing approval documents for the European Union, consisting
of 15 countries, for Ampligen's use for treatment of patients with chronic
fatigue syndrome. In January 1999, we were notified that the filing was complete
and the review process had started. The review process by the European Medical
Evaluation Agency has produced ongoing discussions. At this time we have no
specific indication as to the timing or outcome of their review process.
Subsidiary Spin-Off
We are considering distributing to our shareholders at least 80% of the
issued and outstanding shares of common stock of Core Biotech Corp. We would
distribute the Core Biotech shares to each of the holders of our common stock as
of a record date set by us. The timetable for this potential spin-off has not
been determined.
After the proposed spin-off, Core Biotech would use genetic
technologies, including Ampligen and other products, to develop therapeutic
products for the treatment of viral hepatitis diseases. We would license or
sublicense to Core Biotech the technology for the products that will be used by
Core Biotech.
In connection with the proposed spin-off, we would enter into several
agreements with Core Biotech, including, but not limited to,
(a) a separation and distribution agreement which will separate
our hepatitis technology from us, including some assets and
liabilities, and distribute Core Biotech common stock to our
shareholders;
(b) a tax allocation agreement allocating tax liabilities that
relate to the planned spin-off and to periods prior to the
spin-off date;
(c) a services agreement providing for allocation of
responsibilities with respect to various services to be
provided by us to Core Biotech;
(d) an employee benefits agreement;
(e) a technology license agreement; and |
