PROSPECTUS
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HEMISPHERx BIOPHARMA, INC.
2,770 SHARES OF COMMON STOCK
2,427,275 SHARES OF COMMON STOCK UNDERLYING SERIES D PREFERRED STOCK
890,543 SHARES OF COMMON STOCK UNDERLYING
COMMON STOCK PURCHASE WARRANTS
This Prospectus relates to the possible resale of up to 2,770 shares of the
common stock, $.001 par value (the "Common Stock") of Hemispherx Biopharma, Inc.
(the "Company") currently outstanding, 2,427,275 shares of Common Stock
underlying the Company's Series D Preferred Stock, $.01 par value (the
"Preferred Stock") and up to 890,543 additional shares of Common Stock
underlying certain outstanding Common Stock Purchase Warrants (the "Warrants").
The Warrants represent the right of the registered holder to purchase one share
of Common Stock at an average weighted exercise price of $4.56.
The Company will not receive any proceeds from possible resales by the
Selling Securityholders of their respective shares of Common Stock of the
Company. The Company has agreed to indemnify certain of the Selling
Securityholders against certain liabilities, including certain liabilities under
the Securities Act of 1933, as amended (the "Securities Act"), or contribute to
payments which such Selling Securityholders may be required to make in respect
thereof. The Company will receive gross proceeds of up to $4,064,900 upon
exercise of the Warrants. There can be no assurance that any of the Warrants
will be exercised.
The Selling Securityholders may sell their shares of Common Stock from time
to time, in market transactions, in negotiated transactions, through the writing
of options, or a combination of such methods of sale, at fixed prices which may
be changed, at market prices prevailing at the time of sale, at prices related
to such prevailing market prices or at negotiated prices. The Selling
Securityholders may effect such transactions by selling their shares of Common
Stock to or through broker-dealers, and such broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the
Selling Securityholders and/or the purchasers of such shares of Common Stock for
whom such broker-dealer may act as agents or to whom they may sell as
principals, or both (which compensation as to a particular broker-dealer might
be in excess of customary commissions). The Company has agreed to bear all
expenses in connection with the registration of the shares of Common Stock to
which this Prospectus relates.
The Company's Common Stock and Class A Redeemable Warrants (the "Class A
Warrants") are quoted on the Nasdaq SmallCap Market System ("Nasdaq") under the
symbols HEMX and HEMXW, respectively. On September 9, 1996 the last sale price
of the Common Stock and Class A Warrants as reported on Nasdaq was $3.625 and
$1.25, respectively.
THESE SECURITIES ARE HIGHLY SPECULATIVE. THEY INVOLVE A HIGH DEGREE OF RISK.
THEY SHOULD BE PURCHASED ONLY BY PERSONS WHO CAN AFFORD TO SUSTAIN A TOTAL LOSS
OF THEIR ENTIRE INVESTMENT (SEE "RISK FACTORS" - PAGE 7)
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION, OR ANY STATE SECURITIES COMMISSION, NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this Prospectus is September 16, 1996
<PAGE>
ADDITIONAL INFORMATION
With respect to the securities offered hereby, the Company has filed with
the principal office of the Securities and Exchange Commission (the
"Commission") in Washington, D.C., a Registration Statement on Form S-1 under
the Securities Act. For purposes hereof, the term "Registration Statement" means
the original Registration Statement and any and all amendments thereto. This
Prospectus does not contain all of the information set forth in the Registration
Statement and the exhibits thereto, to which reference hereby is made. Each
statement made in this Prospectus concerning a document filed as an exhibit to
the Registration Statement is not necessarily complete and is qualified in its
entirety by reference to such exhibit for a complete statement of its
provisions. The Company is subject to the informational requirements of the
Securities Exchange Act of 1934 (the "Exchange Act") and in accordance therewith
files reports and other information with the Commission. Any interested party
may inspect the Registration Statement and its exhibits and other reports and
information filed by the Company with the Commission without charge, or obtain a
copy of all or any portion thereof, at prescribed rates, at the public reference
facilities of the Commission at its principal office at Judiciary Plaza, 450
Fifth Street, N.W., Room 1024, Washington, D.C. 20549. The Registration
Statement and exhibits may also be inspected at the Commission's regional
offices at Northwestern Atrium Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661-2511, and at 7 World Trade Center, Suite 1300, New York,
New York 10048.
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PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information and the Consolidated Financial Statements and Notes thereto
appearing elsewhere or incorporated by reference elsewhere in this Prospectus,
including information under "Risk Factors". See "Glossary of Terms" for the
definition of certain terms used in this Prospectus.
THE COMPANY
Hemispherx Biopharma, Inc. ("HEM" or the "Company") (formerly HEM
Pharmaceuticals Corp.) is a pharmaceutical company using nucleic acid
technologies to develop therapeutic products for the treatment of viral diseases
and certain cancers. Nucleic acid compounds represent a potentially new class of
pharmaceutical products that are designed to act at the molecular level for the
treatment of human disease. The Company's drug technology utilizes specially
configured ribonucleic acid ("RNA"). The Company's double stranded RNA drug
product, trademarked Ampligen(R), which is administered intravenously, is in
human clinical development for various therapeutic indications. Based on the
results of pre-clinical studies and clinical trials, the Company believes that
Ampligen may have broad-spectrum anti-viral and anti-cancer activities. Over 300
patients have received Ampligen in clinical trials authorized by the U.S. Food
and Drug Administration ("FDA") at over twenty clinical trial sites across the
United States, representing the administration of more than 40,000 doses of this
drug. Ampligen is being developed clinically for use in treating three
anti-viral indications: chronic Hepatitis B virus ("HBV") infection (Phase I/II
clinical trial), human immunodeficiency virus ("HIV") associated disorders
(Phase II), and myalgic encephalomyelitis, also known as chronic fatigue
syndrome ("ME/CFS") (Phase II/III). The Company's business strategy is designed
around seeking the required regulatory approvals which will allow the
progressive introduction of Ampligen for HIV followed by HBV and ME/CFS in the
U.S., Canada, Europe and Japan. There can be no assurance that Ampligen will
receive regulatory approval for any of such disorders. Ampligen has received
Orphan Drug designation from the FDA for four indications (AIDS, renal cell
carcinoma, chronic fatigue syndrome and invasive malignant melanoma), the latter
two of which were obtained in December 1993. The Company is also developing a
second generation RNA drug technology, termed Oragen compounds, which the
Company believes offers the potential for broad spectrum antiviral activity by
oral administration.
The World Health Organization ("WHO") estimates that there are
approximately 300 million chronic carriers of HBV worldwide. More than 40% of
the persistently infected persons who survive to adulthood will die from
cirrhosis, hepatocellular carcinoma (liver cancer), or some other consequence of
their infection. In the U.S. alone, there are an estimated 1.25 million
carriers. HBV is one of several viruses that cause human hepatitis, or
inflammation of the liver. The Company has been conducting a Phase I/II clinical
trial of Ampligen in the U.S. for the treatment of chronic HBV infection at
Stanford University and the University of Pennsylvania. A significant reduction
in viral components and improvement in liver function was noted during the
course of the Phase I/II clinical trial to date and the drug has been generally
well tolerated. At present, interferon-alpha is the only approved product for
the treatment of this disease; however, 60% to 75% of patients with chronic HBV
ultimately fail to respond to interferon-alpha. The global sales of interferon
are presently estimated at more than $1 billion, largely because of its use in
liver infections.
The Centers for Disease Control ("CDC") has estimated that approximately
one million people in the U.S. are infected with HIV, excluding patients who
have progressed to fully symptomatic AIDS. The WHO has estimated that 30 to 40
million people will be infected with HIV worldwide by the year 2000. The Company
is in Phase II clinical testing of Ampligen in the U.S. for the treatment of
symptomatic HIV infection.
ME/CFS is a condition recently recognized by the CDC and characterized by
unexplained fatigue or chronic illness for six months or longer for which no
cause has been identified after a thorough medical work-up. Although the CDC is
presently conducting studies to more exactly determine the rate of incidence of
ME/CFS, the CDC's latest estimate of the prevalence rate of this disease in the
U.S. is in excess of 200 per 100,000 population. In November 1992, the Company
received approval from the Health Protection Branch ("HPB") of Canada's
Department of Health and Welfare, the federal drug regulatory agency in Canada,
to conduct an open-label clinical trial of Ampligen in patients with severely
debilitating ME/CFS. In this clinical trial, the HPB has authorized the Company
to charge patients for the cost of the Ampligen administered. The Company is
presently receiving limited revenues from sales of Ampligen in Belgium under a
similar cost recovery program. The Company has also received authorization in
1993 from the FDA, in the U.S., and the HPB, in Canada, to initiate a Phase
II/III clinical trial of Ampligen in patients with ME/CFS. The Company is
unaware of any investigational new drugs which are currently at comparable
stages of clinical development for ME/CFS.
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The Company also has clinical experience with Ampligen in patients with
certain cancers, including renal cell carcinoma (kidney cancer) and metastatic
malignant melanoma. Based on estimates prepared by the American Cancer Society,
the Company anticipates that approximately 25,000 new cases of renal cell
carcinoma will be diagnosed in the U.S. in 1996. In March and June, 1993,
respectively, the Company was authorized by the FDA, in the U.S., and the HPB,
in Canada, to initiate a Phase II/III clinical trial of Ampligen in renal cell
carcinoma patients. In late 1993, the HPB authorized the Company to proceed with
an open-label clinical trial of Ampligen for renal cell carcinoma in Canada. The
HPB has authorized the Company to charge patients for the cost of the Ampligen
administered in this clinical trial. The Company has not initiated these
programs to date because of limited resources and a shift in the Company's
clinical priorities. The Company does not believe that approvals for these
studies will be withdrawn as a result of the delay since the approvals were not
conditioned upon a particular commencement date. Based on estimates prepared by
the American Cancer Society, the Company anticipates that approximately 34,000
new cases of malignant melanoma will be diagnosed in the U.S. in 1996. Data from
the American Cancer Society and the World Health Organization indicate that both
the incidence and mortality from malignant melanoma are rising steadily among
white populations throughout the world. In the past decade, the incidence of
melanoma has increased faster than that of any other cancer except lung cancer
in women.
In November 1995, the Company sold 5,313,000 Units through an initial
public offering. Each Unit consists of one share of Common Stock and one Class A
Warrant.
In September 1995, the Company entered into an agreement with Rivex Pharma,
Inc., a Canadian-based pharmaceutical company ("Rivex"), pursuant to which Rivex
will provide various services in connection with the exclusive distribution of
Ampligen in Canada on an emergency drug release basis. Under the terms of this
agreement, the Company will supply and Rivex will purchase as much Ampligen as
necessary to satisfy Rivex's customers at a mutually agreed upon cost. In
return, Rivex will retain the exclusive right to distribute Ampligen in Canada.
In October 1994, the Company entered into an agreement with Bioclones
Proprietary Limited ("Bioclones"), a biopharmaceutical company which is
associated with The South African Breweries Limited ("SAB" and, together with
Bioclones, "SAB/Bioclones") with respect to codevelopment of various RNA drugs,
including Ampligen, for which the Company has previously obtained international
patent protection. The licensing agreement, as amended (the "SAB Agreement")
provides that the Company will provide SAB/Bioclones with an exclusive
manufacturing and marketing license for certain Southern hemisphere countries
(including certain countries in South America) as well as the United Kingdom,
Ireland, Africa, Australia, Tasmania, New Zealand and certain other countries
and territories. In exchange for these marketing and distribution rights, the
SAB Agreement provides for: (a) a $3 million cash payment to the Company,
payable in installments upon the occurrence of certain milestones, including the
transfer of certain technical documents which have already been transferred; (b)
the formation and issuance to the Company of 24.9% of the capital stock of a
company which is developing and operating a new manufacturing facility for RNA
drugs constructed by SAB/Bioclones; and (c) royalties on all sales of the
Company's product in the licensed territories after the first $50 million of
sales. In addition, SAB/Bioclones has agreed to use reasonable efforts to pursue
the marketing approval of Ampligen for HBV in Australia, South Africa, Brazil,
and the United Kingdom, as well as to perform (at its own expense) a phase III
study of Ampligen for chronic HBV infection in South Africa, which clinical
study is to be performed pursuant to U.S. FDA good clinical practice and good
laboratory practice ("GLP") guidelines and standards. SAB/Bioclones will be
granted a right of first refusal to manufacture and supply to the Company the
drug product required for not less than one-third of its world-wide sales of
Ampligen (after deducting SAB/Bioclones-related sales). To date, the Company has
received approximately $3,000,000 pursuant to the SAB Agreement.
In September 1994, the Company formed three subsidiaries and granted
licenses to the subsidiaries for the purpose of developing its technology for
ultimate sale into certain non-pharmaceutical specialty consumer markets, such
as the tobacco market, the market for skincare products and the market for
diagnostic devices. The Company intends to issue equity in one of such
subsidiaries and has granted options to certain of its officers and directors.
See "Business Subsidiary Companies." No assurance can be given that any of these
companies will be able to complete testing in these areas, develop any products
or successfully produce and market any products in the targeted specialty
consumer markets.
The Company's corporate headquarters are located at 1617 JFK Boulevard,
Philadelphia, Pennsylvania 19103. The Company's telephone number is (215)
988-0080.
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As of July 15, 1996
Securities Outstanding (1)(2)(3)(4) Common Stock 9,470,675
Series D Preferred Stock 6,000
Units 6,110,917
Risk Factors: AN INVESTMENT IN THE COMPANY'S SECURITIES
INVOLVES A HIGH DEGREE OF RISK. FOR A
DISCUSSION OF CERTAIN RISK FACTORS
EFFECTING THE COMPANY, SEE "RISK FACTORS".
Nasdaq Symbols
for Common Stock HEMX
for Warrants HEMXW
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(1) Excludes: (i) 460,798 shares of Common Stock reserved for issuance pursuant
to the Company's 1990 Stock Option Plan under which options to purchase
228,502 shares have been granted; (ii) 92,160 shares of Common Stock
reserved for issuance pursuant to the Company's 1992 Stock Option Plan
under which no options or other rights to purchase shares have been
granted; (iii) 138,240 shares of Common Stock reserved for issuance
pursuant to the Company's 1993 Employee Stock Purchase Plan pursuant to
which no rights to purchase shares have been granted; (iv) 556 shares of
Common Stock reserved for issuance pursuant to options granted prior to
1990; (v) 1,663,797 shares of Common Stock reserved for issuance pursuant
to certain outstanding warrants with an average weighted exercise price of
$3.70; (vi) 2,080,000 warrants to purchase Common Stock of the Company
issued to officers, directors and consultants of the Company in reliance
upon Rule 701 of the Securities Act, at an exercise price of $3.50 per
share (the "Rule 701 Warrants"); and (vii) 2,750,000 warrants to purchase
Common Stock at an exercise price of $1.75 per share issued in accordance
with the terms of the 1995 Standby Financing Agreement. See "Management's
Discussion and Analysis of Financial Condition and Results of Operations,"
"Management--1992 Stock Option Plan," "--1990 Stock Option Plan" and
"--Employee Stock Purchase Plan," "Description of Securities--Warrants"
(2) Does not include 195,833 shares of Common Stock and 1,000,000 Class A
Warrants contained in the Bridge Units issuable upon exercise of the
Bridgeholder Option issued in connection with the Bridge Loans.
(3) Does not include 6,110,917 shares of Common Stock issuable upon the
exercise of the Class A Warrants contained in the Units at an exercise
price of $4.00 per share.
(4) Does not include 2,427,275 shares of Common Stock reserved for issuance
upon conversion of the Preferred Stock.
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SUMMARY FINANCIAL INFORMATION
(in thousands, except share and per share data)
The data set forth below should be read in conjunction with the
Consolidated Financial Statements, related Notes and other financial information
included or incorporated by reference elsewhere in this Prospectus.
<TABLE>
<CAPTION>
Six Months Ended
December 31, June 30,
---------------------------------------------------------- ----------------------
(unaudited)
1991 1992 1993 1994 1995 1995 1996
---- ---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C> <C>
Consolidated Statements
of Operations Data:
Revenues
Research and Development $ -- $ -- $ 48 $ 76 $ 66 $ 33 $ 18
License fee -- -- -- 100 2,900 1,000 --
------ ------ ------ ------ ------ ------ ------
Total Revenues -- -- 48 176 2,966 1,033 18
Cost and expenses:
Research and development 6,181 4,734 2,119 1,638 1,029 533 694
General and administrative 2,469 2,825 3,347 2,618 2,880 1,274 1,236
------ ------ ------ ------ ------ ------ ------
Total costs and expenses 8,650 7,559 5,466 4,256 3,909 1,807 1,930
Debt conversion expenses -- -- (1,215) (10) (149) (149) --
Net interest income (expense) 172 (322) (1.069) (1,043) (748) (449) 166
------ ------ ------ ------ ------ ------ ------
Net loss $(8,478) $(7,881) $(7,702) $(5,133) $(1,840) $(1,372) $(1,746)
====== ====== ====== ====== ====== ====== ======
Net loss per share -- -- -- $ (.44)(1) $ (.13)(1) $ (.11)(1) $ (.11)
Weighted average
number of shares outstanding
used in computing
net loss per share -- -- -- 11,536,276(1) 14,199,701(1) 13,047,506(1) 15,581,592
</TABLE>
December 31, 1995 June 30, 1996
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Consolidated Balance Sheet Data: (Unaudited)
Current assets ............................. $11,354 $2,625
Current liabilities ........................ 8,279 1,366
Total assets ............................... 12,700 4,043
Long-term obligations ...................... 0 0
Accumulated deficit ........................ (43,544) (45,291)
Stockholders' equity ....................... 4,421 2,678
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(1) Computed on a proforma basis described in Note 3 to the Consolidated
Financial Statements.
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RISK FACTORS
AN INVESTMENT IN THE SECURITIES OFFERED HEREBY IS HIGHLY SPECULATIVE,
INVOLVES A HIGH DEGREE OF RISK AND SHOULD BE MADE ONLY BY INVESTORS WHO CAN
AFFORD THE LOSS OF THEIR ENTIRE INVESTMENT. PROSPECTIVE PURCHASERS, PRIOR TO
MAKING AN INVESTMENT DECISION, SHOULD CAREFULLY CONSIDER, ALONG WITH OTHER
MATTERS REFERRED TO HEREIN, THE FOLLOWING RISK FACTORS:
Dependence on Ampligen; Non-Exclusive Right to Manufacture of Ampligen;
Expiration of Patents.
The Company's principal development efforts are currently focused on
Ampligen. While most clinical trials of Ampligen have to date produced favorable
results, additional trials sponsored by the Company are planned, and no
assurance can be given that the drug will ultimately be demonstrated to be safe
or efficacious. In addition, while Ampligen has been authorized for use in
clinical trials in the United States and other countries, no assurance can be
given that additional clinical trials approvals will be authorized in the United
States or in other countries in a timely fashion or at all or that such clinical
trials will be completed by the Company. The Company has never commercially
introduced a product, and no assurance can be given that commercialization of
Ampligen in any countries where Ampligen may be approved will prove successful.
In addition, the Company does not have exclusive rights to manufacture Ampligen.
Competitors of the Company are currently able to manufacture Ampligen. The
Company believes, however, that its extensive patent estate may hinder such
competitors from testing and developing Ampligen for particular indications
since the Company has patented the use of Ampligen for many disease indications.
The Company further believes that the available market for non-patented disease
indications for Ampligen which might be available to competitors is minimal
since the Company believes, based on laboratory tests, that Ampligen may not be
effective against such disease indications; however, no assurances can be given.
Willful infringement of the Company's patents by a competitor could result in
significant monetary damages to the Company in the event that such infringement
was not enjoined by a court of law. Nevertheless, in the event that the
Company's patent protection is not adequate for all relevant disease
indications, competitors might be able to test, develop and commercialize
Ampligen. Additionally, as a result of the Company's dependence on Ampligen, the
failure to demonstrate the drug's safety and efficacy in planned clinical
trials, to conduct the planned clinical trials, to obtain additional approvals
for the drug or to successfully commercialize the drug would have a materially
adverse effect on the Company.
No Assurance of Regulatory Approval; Government Regulation.
The Company's research, preclinical development, clinical trials, and the
manufacturing and marketing of its products are subject to extensive regulation
by numerous governmental authorities in the U.S. and other countries, including,
but not limited to, the Food and Drug Administration ("FDA") in the U.S. and the
Health Protection Branch of Canada's Department of Health and Welfare ("HPB"), a
federal regulatory agency in Canada. None of the Company's products has been
approved for commercial sale by the FDA, the HPB or any other foreign regulatory
authority and the Company does not expect to achieve profitable operations
unless Ampligen receives FDA approval and is commercialized successfully. In
order to obtain FDA approval of a new drug product for an indication, the
Company must demonstrate to the satisfaction of the FDA that such product is
safe and effective for its intended uses and that the Company is capable of
manufacturing the product to the applicable regulatory standards. The process of
obtaining FDA and other required regulatory approvals (including those of the
HPB) is rigorous and lengthy and has required and will continue to require the
expenditure of substantial resources. There can be no assurance that the Company
will be able to obtain the necessary regulatory approvals. Unsatisfactory
clinical trial results, clinical trials not conducted in accordance with
applicable protocol requirements and/or delays in obtaining regulatory approvals
would prevent the marketing of products developed by the Company, and pending
the receipt of such approvals, the Company will not receive product revenues or
royalties.
Pharmaceutical products and their manufacture are subject to continued
review following regulatory approval, and later discovery of previously unknown
problems may result in the imposition of restrictions on such products or their
manufacture, including withdrawal of the products from the market. Failure to
comply with applicable regulatory requirements could, among other things, result
in fines, suspension of regulatory approvals, operating restrictions and
criminal prosecution. The Company cannot predict the extent to which current or
future government regulations might have a materially adverse effect on the
production, marketing and sale of the Company's products. Such regulations may
delay or prevent clinical trials, regulatory approval, and the manufacture or
marketing of the Company's potential products. In addition, such regulation may
7
<PAGE>
impose costly procedures upon the Company's activities or furnish a competitive
advantage to other companies more experienced in regulatory affairs than the
Company and may deplete the Company's liquidity and capital resources.
Additional Financing Requirements.
The development of the Company's products has required and will continue to
require the commitment of substantial resources to conduct the time-consuming
research, preclinical development, and clinical trials that are necessary to
bring pharmaceutical products to market and to establish commercial-sale
production and marketing capabilities. Based on its current operating plan, the
Company anticipates that projected cash flow from operations and currently
available financing arrangements will be sufficient to meet the Company's
capital requirements for approximately 18 months from the date of this
Prospectus. It is not expected that the Company's current cash flow will be
sufficient to enable the Company to complete the necessary clinical trials or
regulatory approval process for Ampligen for any indication or, if any such
approval were obtained, to begin manufacturing or marketing Ampligen on a
commercial basis. Accordingly, the Company may need to raise substantial
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 its products. If adequate funds are
not available from operations, as is anticipated, and if the Company is not able
to secure additional sources of financing on acceptable terms, the Company's
business will be materially adversely affected. In addition, certain officers,
directors and shareholders have entered into a 1995 Standby Financing Agreement
pursuant to which they have agreed to provide funding up to $5,500,000 to the
Company in the event that existing and additional financing is insufficient to
cover the cash needs of the Company through December 1, 1996.
Moreover, because of the Company's long-term capital requirements, it may
seek to access the public equity market whenever conditions are favorable, even
if it does not have an immediate need for additional capital at that time. There
can be no assurance that any additional funding will be available to the Company
on terms acceptable to the Company, if at all. Any additional funding may result
in significant dilution and could involve the issuance of securities with rights
which are senior to those of existing stockholders. The Company may also need
additional funding earlier than anticipated, and the Company's cash requirements
in general may vary materially from those now planned, for reasons including,
but not limited to, changes in the Company's research and development programs,
clinical trials, competitive and technological advances, the regulatory process,
and higher than anticipated expenses and lower than anticipated revenues from
certain of the Company's clinical trials as to which cost recovery from
participants has been approved.
Uncertainty Regarding Patents and Proprietary Rights.
The Company's success will depend, in large part, on its ability to obtain
patent protection for its products and to obtain and preserve proprietary
information and trade secrets. The Company does not have exclusive rights to the
manufacture of Ampligen. Consequently, the Company's ability to obtain exclusive
rights for the commercial sale of Ampligen is subject to the Company's
acquisition of enforceable patents covering the use of the drug for a particular
indication. The Company has been issued certain patents on the use of Ampligen
alone and Ampligen in combination with certain other drugs for the treatment of
human immunodeficiency virus ("HIV"). The Company has also been issued a patent
on the use of Ampligen in combination with certain other drugs for the treatment
of chronic Hepatitis B virus ("HBV") and chronic Hepatitis C virus ("HCV") and a
patent which affords protection on the use of Ampligen in patients with myalgic
encephalomyetis, also know as chronic fatigue syndrome ("ME/CFS"). To date, the
Company has not been issued any patents in the U.S. for the use of Ampligen as
monotherapy for HBV or for any of the cancers which the Company has sought to
target. The Company's applications for U.S. patents for the use of Ampligen as
monotherapy for HBV and in the treatment of renal cell carcinoma and lung cancer
are currently pending, although no assurances can be given that any of such
applications will be approved. No assurances can be given that competitors will
not seek and obtain patents regarding the use of Ampligen in combination with
various other agents (including AZT) for a particular target indication prior to
the Company. Although the Company's license to manufacture Ampligen is
non-exclusive, the Company believes that the existence of the Company's
treatment indication patents precludes a competitor from selling an identical or
similar product for the same treatment indication without infringing upon the
Company's issued patents. No assurance can be given, however, that the Company's
patent protection will be adequate to prevent the entry into the market of
competitors for all of the Company's treatment indications.
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<PAGE>
The Company has been unable to secure Orphan Drug designation from the FDA
for treatment of HBV in the U.S. In the event that the Company is unable to
obtain adequate patent protection for the indication, it would be unable to
maintain a competitive advantage over other drug manufacturers which could enter
the market immediately.
The patent position of biotechnology and pharmaceutical firms is highly
uncertain and involves complex legal and factual questions. To date, no
consistent policy has emerged regarding the breadth of protection afforded by
pharmaceutical and biotechnology patents. Accordingly, there can be no assurance
that patent applications relating to the Company's products or technology will
result in patents being issued or that, if issued, such patents will afford
meaningful protection against competitors with similar technology. It is
generally anticipated that there may be significant litigation in the industry
regarding patent and other intellectual property rights and that such litigation
could consume substantial resources of the Company. No assurance can be given
that the Company's patents will provide competitive advantages for its products
or will not be successfully challenged or circumvented by its competitors. No
assurance can be given that patents do not exist or could not be filed which
would have a materially adverse effect on the Company's ability to market its
products or to obtain or maintain any competitive position the Company may
achieve with respect to its products. The Company's patents also may not prevent
others from developing competitive products using related technology. Other
companies obtaining patents covering products or processes useful to the Company
may bring infringement actions against the Company. There can be no assurance
that the Company will have the financial resources necessary to enforce patent
rights it may hold. As a result, the Company may be required to obtain licenses
from others to develop, manufacture or market its products. There can be no
assurance that the Company would be able to obtain any such licenses on
commercially reasonable terms, if at all. The Company licenses certain patents
and proprietary information from third parties, some of which patents and
proprietary information may have been developed with government grants under
circumstances where the government maintained certain rights with respect to the
patents/information developed. No assurances can be given that such third
parties will adequately enforce any rights they may have or that the rights, if
any, retained by the government will not adversely affect the value of the
Company's license. Certain of the Company's know-how and technology is not
patentable, particularly the procedures for the manufacture of the Company's
drug product which are carried out according to standard operating procedure
manuals. To protect its rights, the Company has since 1991 required employees
and consultants to enter into confidentiality agreements with the Company. There
can be no assurance that these agreements will not be breached, that the Company
would have adequate and enforceable remedies for any breach, or that any trade
secrets of the Company will not otherwise become known or be independently
developed by competitors.
Disputes and Legal Proceedings Related to Patent Rights.
The Company's ownership of one of its patents for the use of Ampligen for
the treatment of HIV is the subject of a dispute. Vanderbilt University has
advised the Company of its position that employees of the University were the
inventors of the patent at issue. The Company does not believe the University's
position to have merit, and if the University filed a claim against the Company,
the Company would vigorously defend against such an action. If such a claim were
filed and if such a claim were found to have merit, the loss of the patent at
issue would not have a materially adverse effect on the Company's long range
business since the University would be able to limit or prevent only the
Company's use of Ampligen in combination with AZT in the treatment of HIV. In
the event that the University obtained ownership of the disputed patent, the
University could license a third entity to sell Ampligen for a specific
combinational treatment. However, without the Company's consent, the Company
believes that the commercialization process by a third party would require
substantial expenditure to repeat clinical trials and establish a new
manufacturing protocol acceptable to regulatory agencies and would require a
license from the Company for the use of Ampligen as a component of the
combinational requirement. Furthermore, the loss of this patent would not affect
the Company's ability to market Ampligen as a monotherapy for HIV which
treatment the Company has tested and expects to continue to develop.
In July 1994, Temple University advised the Company that it was in breach
of a certain licensing agreement for certain ribonucleic acid ("RNA") drug
compounds termed Oragen compounds at the preclinical stage of product
development. In November 1994, in an action captioned HEM Pharmaceuticals Corp.
v. Temple University of the Commonwealth System of Higher Education, the Company
filed suit against Temple in the Superior Court of the State of Delaware, New
Castle County seeking a declaratory judgment that the licensing agreement was
unlawfully terminated by Temple and remains in full force and effect and seeking
monetary damages estimated to be in excess of $10 million for Temple's alleged
9
<PAGE>
breach of its obligations of good faith and fair dealing and certain terms of
the Temple Agreement. In January 1995, Temple filed a separate litigation
against the Company in the Court of Common Pleas of Philadelphia County seeking
declaratory judgment that the Temple Agreement was lawfully terminated as of
July 1, 1994, together with an award of costs, including attorney fees. The
Court of Common Pleas has stayed further proceedings in that litigation pending
the outcome of the Company's Superior Court case. If the Company were to lose
its claim, the Company would lose its investment to date in certain Oragen
compounds acquired pursuant to the Temple Agreement. While not yet tested on
humans these Oragen compounds have the potential and theoretical advantage of
having an Ampligen-like effect upon oral administration. No assurance can be
given that as a result of such loss, Temple or its new licensee, if any, would
not become competitors of the Company or that the termination of the licensing
agreement will not have a materially adverse effect on the Company's long range
business or financial condition.
History of Losses; Future Profitability Uncertain.
The Company began operations in 1966 and has reported net profit only from
1985 through 1987. Since 1987, the Company has incurred substantial operating
losses and as of March 31, 1996, the Company's accumulated deficit was
approximately $44 million. The Company has not generated significant revenues
from its products and could incur substantial and increased losses over the next
several years. Such losses may fluctuate significantly from quarter to quarter.
There can be no assurance that the Company will ever achieve significant
revenues from product sales or become profitable. The Company's ability to
achieve profitable operations is dependent, in large part, on successfully
developing products, obtaining regulatory approvals on a timely basis, and
making the transition from a research and development firm to an organization
producing commercial products or entering into joint ventures or other licensing
arrangements. No assurance can be given that the Company's product development
efforts will be successfully completed, required regulatory approvals will be
obtained, any products will be manufactured and marketed successfully, or
profitability will be achieved.
No Assurance of Successful Product Development.
The development of new pharmaceutical products is subject to a number of
significant risks. Potential products that appear to be promising at an early
stage of research or development may not reach the market for a number of
reasons. Potential products may be found to be ineffective or to have adverse
side effects, fail to receive necessary regulatory clearances, be difficult to
manufacture on a commercial scale, be uneconomical to market or be precluded
from commercialization by proprietary rights of third parties. The Company's
products are in various stages of clinical and pre-clinical development; each
will need to progress through further clinical studies and appropriate
regulatory approval processes before any such products can be marketed. Ampligen
is not expected to be generally available for commercial sale for any indication
for at least the next several years, if at all. Generally, only a small
percentage of potential therapeutic products are eventually approved by the FDA
for commercial sale. The transition from limited production of pre-clinical and
clinical research quantities to production of commercial quantities of the
Company's products will involve distinct management and technical challenges and
will require additional management and technical personnel and capital to the
extent such manufacturing is not handled by third parties. There can be no
assurance that the Company's efforts will be successful or that any given
product will be determined to be safe and effective, capable of being
manufactured economically in commercial quantities or successfully marketed.
Limited Manufacturing Experience and Capacity.
Ampligen is currently produced only in limited quantities for use in its
clinical trials. To be successful, the Company's products must be manufactured
in commercial quantities in compliance with regulatory requirements and at
acceptable costs. Although the Company has entered into an agreement with
Bioclones Proprietary, Ltd. ("Bioclones"), a biopharmaceutical company which is
associated with South African Breweries, Ltd. (together with Bioclones,
"SAB")(the "SAB Agreement") which provides for the construction of a new
commercial manufacturing facility by a company which is 24.9% owned by the
Company, no assurance can be given as to the timing of such construction, and
therefore the Company may continue to be dependent on third parties for a
considerable portion of the manufacturing and production process. A pilot
facility in South Africa is being expanded to provide a limited supply of
Ampligen raw material. While the Company believes that construction of the
commercial facility will begin in 1997, the construction is dependent upon the
10
<PAGE>
regulatory status of Ampligen in various global markets, and no assurance can be
given with respect to when, and if, construction will occur. To the extent the
Company is involved in the production process, the Company's current facilities
are not adequate for the production of its proposed products for large-scale
commercialization, and the Company currently does not have adequate personnel to
conduct commercial-scale manufacturing. The Company intends to utilize
third-party facilities if and when the need arises or, if it is unable to do so,
to build or acquire commercial-scale manufacturing facilities. The Company will
need to comply with regulatory requirements for such facilities, including those
of the FDA and HPB pertaining to Good Manufacturing Practices ("GMP")
regulations. There can be no assurance that such facilities can be used, built,
or acquired on commercially acceptable terms, that such facilities, if used,
built, or acquired, will be adequate for the Company's long-term needs.
Moreover, there is no assurance that successful manufacture of a drug on a
limited scale basis for investigational use will lead to a successful transition
to commercial, large-scale production. Small changes in methods of manufacture
may affect the chemical structure of Ampligen and other such RNA drugs, as well
as their safety and efficacy. Changes in methods of manufacture, including
commercial scale-up, can, among other things, require new clinical studies and
affect orphan drug status, particularly, market exclusivity rights, if any,
under the Orphan Drug Act.
Lack of Marketing Experience and Capacity.
The Company currently has limited marketing or sales capability and does
not expect to establish a significant direct sales capability for at least the
next several years. To the extent that the Company determines not, or is unable,
to enter into marketing agreements or third party distribution agreements for
its products, significant additional resources will be required to develop a
sales force and distribution organization. Pursuant to the SAB Agreement, the
corporate partner will be responsible for fielding an adequate sales force in
South America, Africa, United Kingdom, Australia and New Zealand. Nevertheless,
there can be no assurance that the Company will be able to establish such
arrangements, under the SAB Agreement or otherwise, on terms acceptable to the
Company, if at all, or that the cost of establishing such arrangements will not
exceed any product revenues, or that such arrangements will be successful. To
the extent that the Company enters into co-marketing or other licensing
arrangements, any revenues received by the Company will be dependent on the
efforts of third parties, and there can be no assurance that such efforts will
be successful.
Rapid Technological Change and Substantial Competition.
The pharmaceutical and biotechnology industries are subject to rapid and
substantial technological change. Technological competition from pharmaceutical
and biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase. Most of
these entities have significantly greater research and development capabilities
than the Company, as well as substantial marketing, financial and managerial
resources, and represent significant competition for the Company. Acquisition
of, or investments in, competing companies by large pharmaceutical companies
could increase such competitors' financial, marketing and other resources. There
can be no assurance that developments by others will not render the Company's
products or technologies obsolete or noncompetitive or that the Company will be
able to keep pace with technological developments. Competitors have developed or
are in the process of developing technologies that are, or in the future may be,
the basis for competitive products. Some of these products may have an entirely
different approach or means of accomplishing similar therapeutic effects to
products being developed by the Company. These competing products may be more
effective and less costly than the Company's products. In addition, conventional
drug therapy, surgery and other more familiar treatments will offer competition
to the Company's products. Furthermore, many of the Company's competitors have
significantly greater experience than the Company in pre-clinical testing and
human clinical trials of pharmaceutical products and in obtaining FDA, HPB and
other regulatory approvals of products. Accordingly, the Company's competitors
may succeed in obtaining FDA and HPB product approvals more rapidly than the
Company. If any of the Company's products receive regulatory approvals for any
indication and the Company commences commercial sales of its products, it will
also be competing with respect to manufacturing efficiency and marketing
capabilities, areas in which it has no experience. The Company's competitors may
possess or obtain patent protection or other intellectual property rights that
prevent, limit or otherwise adversely affect the Company's ability to develop or
exploit its products.
Dependence upon Qualified and Key Personnel.
Because of the specialized nature of the Company's business, the Company's
success will depend, among other things, on its ability to attract and retain
qualified management and scientific personnel. Competition for such personnel is
11
<PAGE>
intense. There can be no assurance that the Company will be able to continue to
attract or retain such persons. The Company currently depends upon the services
of Dr. William A. Carter, its President, Chief Executive Officer and Chairman of
the Board, Robert E. Peterson, its Chief Financial Officer and Dr. Carol A.
Smith, the Company's Director of Manufacturing and Process Development. Certain
key individuals upon whom the Company currently depends, including but not
limited to the Company's Medical Director, Dr. David Strayer, are not employees
of the Company, but instead are employees of an institution with whom the
Company has a collaborative at will arrangement. R. Douglas Hulse, Chief
Operating Officer, is an employee of The Sage Group and serves in his position
under a written agreement. In addition, Dr. Smith and Mr. Peterson do not have
written employment agreements with the Company. The continued availability to
the Company of the services of these individuals is subject to the policies of
the institution which employs them; any change in such policies may have an
adverse effect upon the Company's continued retention of the services of these
individuals. While the Company has an employment agreement with Dr. William A.
Carter, and has secured key man life insurance in the amount of $2 million on
the life of Dr. Carter, the loss of Dr. Carter or other key personnel or of the
services of such employees of collaborators or the failure to recruit additional
personnel as needed could have a materially adverse effect on the Company's
ability to achieve its objectives.
Dependence on Third Parties.
The Company's strategy for research, development and commercialization is
to rely in part upon collaborative arrangements with third parties in
appropriate circumstances. The Company's strategy has led it to enter into
various arrangements with universities, research groups, licensors and others.
The Company is dependent on a number of important arrangements with third
parties. In particular, the Company utilizes the services of employees of and
regularly makes use of certain equipment and facilities at Hahnemann University
and has obtained certain of its technology for Oragen products through a license
with Temple University, which agreement is alleged by Temple to be terminated
and which is the subject of a suit filed by the Company in November 1994. There
can be no assurance that the Company will be able to negotiate additional third
party arrangements or continue any existing arrangements on terms acceptable to
the Company, if at all, or that key researchers upon whom the Company is
dependent will continue to be associated with such universities and/or to work
on the Company's products. The loss of any such existing arrangement or key
researcher could have a materially adverse effect on the Company. The Company
may seek a significant portion of its future capital requirements from
arrangements with pharmaceutical companies or others pursuant to arrangements
under which, among other things, the Company would receive payment for certain
research and development activities in exchange for future royalty payments.
There can be no assurance that any such arrangements will be established on a
basis acceptable to the Company, if at all, or if established, will be
scientifically or commercially successful. The failure to achieve such
arrangements on satisfactory terms could have a materially adverse effect on the
Company. The Company is dependent upon certain third party suppliers for key
components of its proposed products and for substantially all of the production
process. The failure to continue arrangements with such third parties or obtain
satisfactory substitute arrangements could have a materially adverse effect on
the Company.
Impact of Potential Nasdaq Delisting on Marketability of Securities;
Broker-Dealer Sales of the Company's Securities.
The Company's Common Stock and Class A Warrants trade on Nasdaq. The NASD
has rules which establish criteria for the initial and continued listing of
securities on Nasdaq. Under the rules for initial listing, a company must have
at least $4,000,000 in total assets, at least $2,000,000 in total stockholders'
equity, and a minimum bid price of $3.00 per share. For continued listing on
Nasdaq, a company must maintain at least $2,000,000 in total assets, at least
$1,000,000 in shareholders' equity, and a minimum bid price of $1.00 per share.
The Company currently has approximately $5,079,000 in total assets and
approximately $3,750,000 in total shareholders' equity.
If the Company were to continue to incur operating losses, it might be
unable to maintain the standards for continued listing and the listed securities
could be subject to delisting from Nasdaq. If the Company's securities are
delisted, trading in the delisted securities could thereafter be conducted on
the NASD Bulletin Board or in the over-the-counter market in what is commonly
referred to as the "pink sheets." If this were to occur, an investor would find
it more difficult to dispose of the Company's securities or to obtain accurate
quotations as to the price of the Company's securities and it could have an
adverse effect on the coverage of news concerning the Company. In addition, if
the Company's securities were delisted, they would be subject to a rule that
imposes additional sales practice requirements on broker-dealers who sell such
12
<PAGE>
securities to persons other than established customers and accredited investors
(accredited investors are generally persons having net worth in excess of
$1,000,000 or annual income exceeding $200,000, or $300,000 together with a
spouse). For transactions covered by this rule, the broker-dealer must make a
special suitability determination for the purchaser and must have received the
purchaser's written consent to the transaction prior to sale, as well as
disclosing certain information concerning the risks of purchasing low-priced
securities on the market for such securities. Consequently, delisting, if it
occurred, would adversely affect the ability of broker-dealers to sell the
Company's securities and would make subsequent financing more difficult.
In order for the Company's securities to be included for trading on Nasdaq,
there must exist market makers and specialists, respectively, to support trading
in such securities. As of the date of this Prospectus, several brokerage firms,
sufficient to satisfy the requirements of Nasdaq are engaged in market making
activities with respect to the securities. There is no obligation on the part of
the brokerage firm to continue to act as market makers. In the event that the
market makers and specialists cease to function as such, public trading in the
securities will be adversely affected or may cease entirely.
Product Liability Exposure.
The Company faces an inherent business risk of exposure to product
liability claims in the event that the use of its products results in adverse
effects. Such liability might result from claims made directly by patients,
hospitals, clinics or other consumers, or by pharmaceutical companies or others
manufacturing such products on behalf of the Company. While the Company will
continue to attempt to take appropriate precautions, there can be no assurance
that it will avoid significant product liability exposure. The Company does not
currently maintain any product liability insurance coverage; accordingly, a
significant uninsured risk exists with respect to product liability claims
arising out of the Company's human clinical trials. The Company plans to obtain
product liability insurance coverage for its product distribution in Canada.
Uncertainty of Health Care Reimbursement and Potential Legislation.
The Company's ability to successfully commercialize its products will
depend, in part, on the extent to which reimbursement for the cost of such
products and related treatment will be available from government health
administration authorities, private health coverage insurers and other
organizations. Significant uncertainty exists as to the reimbursement status of
newly approved health care products, and from time to time legislation is
proposed which, if adopted, could further restrict the prices charged by and/or
amounts reimbursable to manufacturers of pharmaceutical products. The Company
cannot predict what, if any, legislation will ultimately be adopted or the
impact of such legislation on the Company. Reimbursement from government
agencies may become more restricted in the future. The Company also understands
that there is increasing political pressure in Canada to limit health care
costs; no assurances can be given that the legislative or regulatory results, if
any, of such pressure will not have an adverse impact on the Company.
Furthermore, there can be no assurance that third party insurance companies will
allow the Company to charge and receive payments for its products sufficient to
realize an appropriate return on its investment in product development. The
Company's potential products represent a new mode of therapy, and the Company
expects that the costs associated with purchasing and administering its products
will be substantial. There can be no assurance that the Company's proposed
products, if successfully developed, will be considered cost effective to
third-party payors, that reimbursement will be available or, if available, that
the timing and amount of such payors' reimbursement will not adversely affect
the Company's ability to sell its products on a profitable basis.
Legal Proceedings
In February 1991, Vanderbilt University advised the Company of its position
that University employees were the inventors of an issued U.S. patent regarding
the use of Ampligen in combination with various other agents (including AZT) for
the treatment of HIV infection. See Risk Factors - "Disputes and Legal
Proceedings Related to Patent Rights".
The Company is the plaintiff in an action captioned HEM Pharmaceuticals
Corp. v. Temple University of the Commonwealth System of Higher Education, in
which the Company is seeking a declaratory judgment that the Company's licensing
agreement with Temple University was unlawfully terminated by Temple. Temple has
filed a motion to dismiss this lawsuit upon the grounds of lack of personal
jurisdiction and forum non-conviens. In January 1995, Temple filed a separate
litigation against the Company seeking declaratory judgment that the Temple
13
<PAGE>
Agreement was lawfully terminated as of July 1, 1994, together with an award of
costs, including attorney fees. See Risk Factors "Disputes and Legal Proceedings
Related to Patent Rights".
While the Company intends to vigorously prosecute or defend against all of
the litigation described above, no assurance can be given as to the ultimate
outcome or the Company's costs in bringing or defending this litigation, and
with regard to the Temple litigation, no assurance can be given that an outcome
adverse to the Company will not have a materially adverse effect on the
Company's business or financial condition.
Hazardous Materials.
The Company's business involves the controlled use of hazardous materials,
carcinogenic chemicals and various radioactive compounds. Although the Company
believes that its safety procedures for handling and disposing of such materials
comply in all material respects with the standards prescribed by applicable
regulations, the risk of accidental contamination or injury from these materials
cannot be completely eliminated. In the event of such an accident or the failure
to comply with applicable regulations, the Company could be held liable for any
damages that result, and any such liability could be significant. The Company
does not maintain insurance coverage against such liabilities. The Company is
also subject to a variety of laws and regulations relating to occupational
health and safety, environmental protection, hazardous substance control, and
waste management and disposal. The failure to comply with any of such
regulations could subject the Company to, among other things, third party damage
claims, civil penalties and criminal liability.
Control of the Company by Certain Officers, Directors and Current
Stockholders.
The officers, directors and current 5% stockholders of the Company
beneficially own approximately 32.5% of the outstanding shares of Common Stock.
Pursuant to certain irrevocable proxies, Dr. William A. Carter, President and
Chief Executive Officer of the Company, has the power to control the vote of
21.1% of the outstanding shares of Common Stock. As a result of such ownership
or voting power these persons, should they vote as a bloc, may be able to
effectively control all matters requiring approval by the stockholders of the
Company, including the election of directors.
Possible Volatility of Stock Price.
The stock market in general and biotechnology and pharmaceutical stocks in
particular have from time to time experienced significant price and volume
fluctuations that may be unrelated to the operating performance of particular
companies. The market price of the Securities, like the stock prices of many
publicly traded biotechnology and smaller pharmaceutical companies, may be
highly volatile. Announcements of technological innovations, regulatory matters
or new commercial products by the Company or its competitors, developments or
disputes concerning patent or proprietary rights, publicity regarding actual or
potential medical results relating to products under development by the Company
or its competitors, regulatory developments in both the U.S. and foreign
countries, public concern as to the safety of pharmaceutical products, economic
and other external factors, and period-to-period fluctuations in financial
results, may have a significant impact on the market price of the Securities.
Shares Eligible for Future Sale; Registration Rights.
Of the 15,587,842 (32,750,313 upon the exercise of the outstanding Class A
Warrants, other warrants, stock options and conversion of Preferred Stock)
shares of Common Stock issued and outstanding as of the date of this Prospectus
a significant number of such shares are "restricted securities" as that term is
defined under Rule 144 promulgated under the Securities Act. William A. Carter,
the Company's President, Chief Executive Officer and Chairman, has agreed not to
sell or transfer his securities for a period of 36 months following commencing
November 2, 1995. The purchasers of the Bridge Loans who hold the Bridgeholder
Options and the holder of 5,898 shares of Common Stock have agreed (with certain
exceptions) not to sell or transfer their securities for a period of 13 months
commencing November 2, 1995. The Tisch/Tsai Entities have agreed with the
Company (with certain exceptions including the transfer to immediate family
members or related entities) not to sell or transfer their securities for a
period of 18 months commencing November 2, 1995. In addition, Canaan Venture
Limited Partnership and Canaan Venture Offshore Limited Partnership C.V. (the
"Canaan Entities"), Michael Dubilier, a principal stockholder of the Company,
and three other stockholders holding an aggregate of 1,253,227 shares of Common
Stock have agreed not to sell or transfer their securities for a period of 18
months commencing November 2, 1995. These agreements are subject to early
termination in the event of the early release of other securityholders of the
Company from lock-up agreements by the Company. The holders of the remainder of
14
<PAGE>
the Company's securities are subject to agreements with the Company which
prohibit the sale or transfer of such securities for a period of 24 months
commencing November 2, 1995, without the Company's consent ("Lock Up
Agreements"). As of October 25, 1995, the holders of approximately 10% of the
Company's securities had not executed lock up agreements. The restricted
securities may be sold without registration pursuant to Rule 144, under certain
circumstances. In addition, the Company has issued warrants to purchase
2,080,000 shares of Common Stock (the "Rule 701 Warrants") in reliance upon the
provisions of Rule 701 of the Securities Act, pursuant to which, in certain
circumstances, such Rule 701 Warrants may be sold. The holders of these
securities are subject to Lock Up Agreements with the Company for a period of 24
months. The sale, or availability for sale, of substantial amounts of the
Company's securities in the public market subsequent to this Prospectus,
including the securities held by those stockholders who have not executed
24-month Lock Up Agreements and the Securities issued pursuant to Rule 144, Rule
701 or otherwise, could adversely affect the market price of the Common Stock
and could impair the Company's ability to raise additional capital through the
sale of its equity securities or debt financing. The availability of Rule 144
and Rule 701 to the holders of restricted securities of the Company would be
conditioned on, among other factors, the availability of certain public
information concerning the Company.
Adverse Consequences Associated with Substantial Shares of Common Stock
Reserved for Issuance Pursuant to Outstanding Warrants, Options and Conversion
of the Preferred Stock.
The Company has reserved an aggregate of up to 17,162,407 shares of Common
Stock for issuance upon exercise of the Class A Warrants, warrants, stock
options and upon conversion of the Preferred Stock. Holders of these warrants,
options and Preferred Stock are likely to exercise and convert them when, in all
likelihood, the Company could obtain additional capital on terms more favorable
than those provided by such convertible securities. Furthermore, while the
convertible securities are outstanding, they may adversely affect the terms on
which the Company could obtain additional capital. Should a significant portion
of such convertible securities be exercised, the resulting increase in the
amount of the Common Stock in the public market may have the effect of reducing
the market price thereof.
Conflicts of Interest.
All of the members of the Company's Scientific Advisory Board are employed
other than by the Company and may have commitments to or consulting or advisory
contracts with other entities (which may include competitors of the Company)
that may limit their availability to the Company. While each member of the
Company's Scientific Advisory Board does execute a non-disclosure and
non-competition agreement with respect to proprietary data that he or she
receives from the Company, there can be no assurance that these agreements will
absolutely protect the Company from the results of such data being revealed,
accidentally or otherwise, by a member of its Scientific Advisory Board.
Absence of Dividends.
The Company intends to retain future earnings, if any, to provide funds for
the operations of its business and, accordingly, does not anticipate paying any
dividends on its Common Stock in the reasonably foreseeable future.
15
<PAGE>
CAPITALIZATION
The following table sets forth the capitalization of the Company at June
30, 1996. This table should be read in conjunction with the Consolidated
Financial Statements and related Notes appearing elsewhere in this Prospectus.
June 30, 1996
-------------
(in thousands except share data)
(unaudited)
Notes Payable and Stockholder Loans
(including accrued related interest) ............................... $ 0
Stockholders' equity (deficit):
Common Stock, $.001 par value, 50,000,000 shares authorized;
15,581,592 issued and outstanding ................................ 16
Additional paid-in capital ......................................... 47,953
Accumulated deficit ................................................ (45,291)
Total stockholders' equity ......................................... 2,678
Total capitalization ............................................... 2,678
(1) Assumes no exercise of (i) outstanding options to purchase an aggregate of
228,502 shares of Common Stock or of options to purchase 392,624 shares of
Common Stock which may be granted under the Company's stock option and
stock purchase plans; (ii) outstanding warrants to purchase shares of
Common Stock and Bridgeholders Options to purchase Bridge Units consisting
of 195,833 shares of Common Stock and 1,000,000 Class A Warrants; or (iii)
5,313,000 Class A Warrants included in the Units; (iv) other warrants to
purchase Common Stock totaling 6,493,797 shares; or (v) 1,504,000 warrants
to purchase Common Stock issued in connection with the Company's initial
public offering ("IPO") and subsequent financing. See "Management--1990
Stock Option Plan," "--1992 Stock Option Plan and "--Employee Stock
Purchase Plan, "Descriptions of Securities--Class A Redeemable Warrants .
16
<PAGE>
SELECTED FINANCIAL DATA
(in thousands, except share and per share data)
The selected financial data should be read in conjunction with the
Consolidated Financial Statements as of December 31, 1995 and 1994 and for each
of the years in the three year period ended December 31, 1995, the related notes
and the independent auditors' report. The consolidated statements of operations
data for the years ended December 31, 1991 and 1992, and the consolidated
balance sheet data at December 31, 1991, 1992 and 1993 are derived from audited
Consolidated Financial Statements not included in this Prospectus. Selected
financial data for the six months ended June 30, 1995 and 1996 are derived from
unaudited condensed consolidated financial statements included in this
Prospectus. The unaudited condensed consolidated financial statements, in the
opinion of management, include all adjustments, consisting of normal recurring
adjustments, which the Company considers necessary to present fairly the
financial position of the Company at June 30, 1996 and the results of operations
and cash flows for the six months ended June 30, 1995 and 1996. The results of
operations for the six months ended June 30, 1996 are not necessarily indicative
of results that may be expected for the full fiscal year ending December 31,
1996.
<TABLE>
<CAPTION>
Six Months Ended
December 31, June 30,
---------------------------------------------------------- ------------------
(unaudited)
1991 1992 1993 1994 1995 1995 1996
---- ---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C> <C>
Consolidated Statements
of Operations Data:
Revenues
Research and Development .... $ -- $ -- $ 48 $ 76 $ 66 $ 33 $ 18
License fee ................. -- -- -- 100 2,900 1,000 --
------ ------ ------ ------ ------ ------ ------
Total Revenues ................ -- -- 48 176 2,966 1,033 18
Cost and expenses:
Research and development .... 6,181 4,734 2,119 1,638 1,029 533 694
General and administrative .. 2,469 2,825 3,347 2,618 2,880 1,274 1,236
------ ------ ------ ------ ------ ------ ------
Total costs and expenses .... 8,650 7,559 5,466 4,256 3,909 1,807 1,930
Debt conversion expenses .... -- -- (1,215) (10) (149) (149) --
Net interest income (expense) . 172 (322) (1.069) (1,043) (748) (449) 166
------ ------ ------ ------ ------ ------ ------
Net loss ...................... $(8,478) $(7,881) $(7,702) $(5,133) $(1,840) $(1,372) $(1,746)
====== ====== ====== ====== ====== ====== ======
Net loss per share ............ -- -- -- $ (.44)(1) $ (.13)(1) $ (.11)(1) $ (.11)
Weighted average
number of shares outstanding
used in computing
net loss per share .......... -- -- -- 11,536,276(1 14,199,701(1) 13,047,506(1) 15,581,592
</TABLE>
(1) Computed on a proforma basis described in Note 3 to the Consolidated
Financial Statements.
<TABLE>
<CAPTION>
December 31, June 30,
---------------------------------------------------------- -----------
(In Thousands) (unaudited)
1991 1992 1993 1994 1995 1995
---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C>
Consolidated Balance Sheet Data:
Current assets ....................... $ 1,316 $ 2,282 $ 6 $ 64 $11,354 $ 2,626
Current liabilities .................. 1,714 2,750 10,599 13,043 8,279 1,306
Total assets ......................... 3,190 4,415 1,9126 1,651 12,700 4,043
Long-term obligations ................ 112 6,950 30 -- -- --
Redeemable preferred stock ........... 2,000 2,536 2,866 3,238 -- --
Accumulated deficit .................. (20,988) (28,869) (36,571) (41,704) (43,544) (45,291)
Stockholders' equity (deficit) ....... $ (637) $ (7,821) $(11,579) $(14,630) $ 4,421 $ 2,678
</TABLE>
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PRICE RANGE OF COMMON STOCK
The Company's Common Stock and Class A Warrants are traded on the National
Association of Securities Dealers Automated Quotation System ("Nasdaq") under
the symbols HEMX and HEMXW, respectively. The Company's Units, each Unit
consisting of one share of Common Stock and one Class A Warrant (the "Units"),
traded on Nasdaq during the period from November 2, 1995 to August 19, 1996, at
which time they were voluntarily delisted. The Company's Common Stock and Class
A Warrants were listed for trading on Nasdaq on July 12, 1996. The following
table sets forth the high and low bid prices for the Company's Units for the
periods indicated as reported by Nasdaq. On September 9, 1996, the high and low
bid price for the Common Stock was $3.625 and $3.5625, respectively. The high
and low bid price for the Class A Warrants on such date was $1.375 and $1.21875,
respectively.
UNIT
1995 High Low
- ----- ----- ----
Quarter ended 12/31 ................... 8 1/2 2
1996
- ----
Quarter ended 3/31 .................... 3 9/16 1 1/2
Quarter ended 6/30 .................... 6 2 11/16
On May 15, 1996, there were approximately 331 holders of record of the
Company's Common Stock. The number of record holders do not include holders
whose securities are held in street name.
DIVIDENDS
The Company does not currently pay dividends on its Common Stock. It is
management's intention not to declare or pay dividends on the Common Stock, but
to retain earnings, if any, for the operation and expansion of the Company's
business.
The holders of its Series D Preferred Shares are entitled to certain
dividend payments upon declaration by the Company's Board.
USE OF PROCEEDS
The Company intends to utilize the proceeds received from the exercise of
the 890,543 Warrants, estimated to be $4,064,900 if all Warrants are exercised
in full, for general corporate and working capital purposes. There can be no
assurance that any of the Warrants will be exercised. The foregoing represents
the Company's best estimate of its use of proceeds generated from the possible
exercise of Warrants based upon the current state of its business operations,
its current plans and current economic and industry conditions. Any changes in
the use of proceeds will be made at the sole discretion of the Board of
Directors of the Company.
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with
the Consolidated Financial Statements and related notes contained elsewhere in
this Prospectus.
GENERAL
Hemispherx Biopharma, Inc. and subsidiaries (the "Company"), formerly known
as HEM Pharmaceuticals Corp., is a pharmaceutical company using nucleic acid
technologies to develop therapeutic products for the treatment of viral diseases
and certain cancers. The Company's drug technology uses specially-configured
ribonucleic acid (RNA). the Company's double- stranded RNA drug product,
trademarked Ampligen, is in human clinical development for various therapeutic
indications. The efficacy and safety of Ampligen is being developed clinically
for three anti-viral indications: myalgic encephalomyelitis, also known as
chronic fatigue syndrome (ME/CFS)(Phase II clinical trial completed and Phase
II/III clinical trial authorized); human immunodeficiency virus associated
disorders (Phase II clinical trial authorized); and chronic hepatitis B virus
infection (HBV)(Phase I/II clinical trial in process). The Company also has
clinical experience with Ampligen in patients with certain cancers including
renal cell carcinoma (kidney cancer) and metastatic malignant melanoma.
The Consolidated Financial Statements include the financial statements of
Hemispherx Biopharma, Inc. and its three wholly-owned subsidiaries, BioPro
Corp., BioAegean Corp. and Core BioTech Corp. which were incorporated in
September 1994 for the purpose of developing technology for ultimate sale into
certain non-pharmaceutical specialty consumer markets. All significant
intercompany balances and transactions have been eliminated in consolidation.
Since fiscal 1994 , the Company has focused on negotiating and executing
the South African Breweries (SAB) Agreement, exploring potential partnerships to
pursue additional clinical trials with special emphasis on the HBV disease
indication, restructuring certain of its outstanding debt, conducting the 1994
Common Stock Financing and the Bridge Financing and preparing for its Initial
Public Offering ("IPO"). In 1996 and beyond, the Company expects to add some
additional personnel to augment its general and administrative activities in
support of increased efforts for research and development, production and
regulatory activity.
The Company expects to continue its research and clinical efforts for the
next several years with some benefit of certain revenues from cost recovery
programs, notably in Canada and Belgium. Beginning in October, 1993, limited
revenues were initiated in Belgium from sales under the cost recovery provision
for conducting clinical tests in ME/CFS. Overall, the Company expects to
continue incurring losses over the next several years due to clinical costs
which are only partially offset by revenues and potential licensing fees. Such
losses may fluctuate from quarter to quarter as a result of differences in the
timing of significant expenses incurred and receipt of licensing fees and/or
revenues.
Result of Operations
Six months ended June 30, 1996 versus the six months ended June 30, 1995
The Company reported a net loss of $1,746,137 for the six months ended June
30, 1996 versus a net loss of $1,372,275 for the same period in 1995. Several
factors contributed to the increased loss of $373,862.
Revenues were down $1,014,891 for the six months of 1996 as the results for
the six months ended June 20, 1995 include $1,000,000 of licensing fees recorded
in connection with SAB/Bioclones agreement. Research and development costs
increased by $161,295 in the six months ended June 30, 1996 due primarily to
increased efforts on the Canadian and Belgium clinical programs. General and
administrative expenses of $1,235,566 in the first six months of 1996 reflect
the benefit of a one time gain in the amount of $318,757 resulting from the
forgiveness of certain lease obligations in connection with the restructuring of
the Company's principal office lease. Excluding this one time gain, general and
administrative expense in the first six months of 1996 exceeded related expenses
in the first quarter of 1995 by $279,920. This increase can be attributed to
consulting fees, public relations, printing expenses and director and officer
insurance premiums. All of which more or less are associated with the
administration of a public company. The increase is partially offset by
decreases in rent expense and amortization of patents.
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<PAGE>
Debt conversion costs of $149,384 and interest expense of $451,448 incurred
in 1995 did not recur in 1996 due to the fact that all the associated debt was
converted or repaid in 1995. Interest income increased by $162,655 due to the
earnings on the remaining IPO funds.
Years Ended December 31, 1995 versus 1994
The Company reported revenues of $2,965,910 in 1995 versus $175,758 in
1994. In 1995, the Company received and recognized $2,900,000 in licensing fees
resulting from the SAB/Bioclones agreements as compared to $100,000 in 1994.
Revenues from cost recovery clinical trials were $65,910 in 1995 versus $75,758
in 1994. Net losses of $1,839,840 were incurred in 1995 versus losses of
$5,133,051 in 1994. The year to year improvement of $3,293,211 basically
consists of: (1) $2,790,152 in higher revenues primarily due to the licensing
fees received from the SAB Agreement, (2) $609,107 or 37% in lower research and
development costs as a result of the winddown and completion of certain clinical
trials, (3) higher general and administrative costs of $262,681 or 10% basically
due to increased legal and professional fees associated with various legal
matters and the Company's IPO efforts, (4) $138,884 in higher debt conversion
expense relating to certain debt restructuring that took place in April, 1995,
and (5) lower net interest expense in the amount of $295,517 or 28% due to the
paydown of certain notes from the proceeds of the IPO.
Years ended December 31, 1994 versus 1993
In 1994, the Company's net loss was $5,133,051 as compared to a net loss of
$7,702,050 in 1993. The $2,568,999 improvement resulted from increased revenues
of $127,758, reduced research and development costs of $481,127, reduced general
and administrative costs of $729,714, reduced conversion expense of $1,204,000
and reduced net interest expense of $26,400.
The Company had revenues of $48,000 in 1993 compared to $175,758 in 1994.
In 1994 the Company received $100,000 in licensing fees in accordance with the
terms of the SAB Agreement. Additionally, cost recovery revenues from the
Belgium clinical trials increased by approximately $29,000. Operating expenses
declined 22% in 1994 as compared to 1993, primarily as a result of reduced
research costs and efforts to correspondingly downsize the general and
administrative costs. Research and development costs declined $481,000 or 23%
primarily due to the completion of certain clinical trial efforts. General and
administrative expenses declined approximately $730,000 or 22% as a result of
restructuring and downsizing the Company's overhead to support the needs of the
Company and reduced research and development activity. This restructuring in the
fall of 1993 produced lower wages and salaries, telephone expense, travel and
other expenses in 1994. In addition, in 1993 the Company incurred debt
conversion expenses of $1,214,500 as a result of the conversion of certain debt
to equity.
Liquidity and Capital Resources
Cash and cash equivalents at June 30, 1996 was $2,538,880 compared to
$11,291,167 at December 31, 1995. The December 31, 1995 amount included
$5,818,733 of restricted cash as ordered by the Court in connection with the
Cohn litigation. In February 1996, the Company agreed to repay the Cohn note and
settle the Cohn litigation. In exchange for mutual releases and other
consideration, the Company paid Mr. Cohn $6,450,000 on March 21, 1996. This
figure includes $4,920,000 in principal and $1,530,000 for legal and other
costs. The Company retired much of the outstanding vendor and supplier
obligations from the proceeds from the SAB Agreement, the Bridge Loan and
revenue from sales under the cost recovery programs. In addition, certain
officers, directors and shareholders have entered into the 1995 Standby
Financing Agreement pursuant to which they have agreed to provide funding up to
$5,500,000 to the Company in the event that existing and additional financing is
insufficient to cover the cash needs of the Company through December 31, 1996
Moreover, because of the Company's long-term capital requirements, it may seek
to access the public equity market whenever conditions are favorable, even if it
does not have an immediate need for additional capital at that time. Any
additional funding may result in significant dilution and could involve the
issuance of securities with rights which are senior to those of existing
stockholders. The Company may also need additional funding earlier than
anticipated, and the Company's cash requirements in general may vary materially
from those now planned, for reasons including, but not limited to, changes in
the Company's research and development programs, clinical trials, competitive
and technological advances, the regulatory process, and higher than anticipated
expenses and lower than anticipated revenues form certain of the Company's
clinical trials as to which cost recovery from participants has been approved.
20
<PAGE>
The Company has financed its operations since January 1, 1992 primarily
through the IPO, private placement of equity and debt securities, equipment
lease financing interest income, and revenues from licensing and royalty
agreements. Net cash provided by financing activities from January 1, 1992
through March 31, 1996 totaled $29.7 million, including approximately $16
million in net proceeds from the IPO, $3.3 million in net proceeds from the
private placement of Common Stock and Preferred Stock and $10.6 million from the
private placement of debt securities and warrants. Since December 31, 1993, the
Company has raised approximately $20.2 million in the form of debt securities,
warrants, and the sale of stock. $16 million of the $20.2 million raised since
December 31, 1993 represents approximate net proceeds from the IPO in which the
Company sold 5,313,000 Units, each consisting of one share of Common Stock and
one Class A Warrant. See "Certain Transactions" and "Description of
Securities--Class A Redeemable Warrants."
In February 1995, the Company entered into a settlement agreement with the
Tisch/Tsai Entities to restructure the December 1992 and February 1993
promissory notes in the aggregate principal amount of $2,400,000 and settle
certain threatened claims made by the Tisch/Tsai Entities against the Company.
This debt restructuring consisted of (i) the repayment by the Company of
$1,200,000 in principal, (ii) the issuance of replacement Tisch/Tsai Notes in
the aggregate principal amount of $600,000 to the Tisch/Tsai Entities which
notes were retired on November 2, 1995, (iii) the conversion of $600,000 of
principal into 172,414 shares of Series C Preferred Stock at the rate of $3.48
per share, (iv) the amendment and restatement of certain warrants issued in
connection with the original notes in order to increase the number of shares of
stock issuable thereunder by 64,000 shares and to provide for warrants to
purchase a total of 144,000 shares of Common Stock at an exercise price of $2.00
per share, which warrants are exercisable until December 31, 1997, and (v) the
release by all parties of any claims. The replacement notes were secured by a
pledge of stock by the Company's President, Chairman and Chief Executive
Officer. The Company may have been in default of the Tisch/Tsai Notes due to a
possible default under certain other notes payable by the Company. Because such
other notes have been extended, the Company does not believe that any claim of
default can be made under the Tisch/Tsai Notes.
In March 1995, the Company issued a promissory note to Gerald A. Brauser in
the amount of $200,000, bearing interest at a rate of 12% per year (the
"Original Brauser Note"). In connection with the Original Brauser Note, the
Company agreed to pay attorney fees and miscellaneous expenses of approximately
$12,000. In connection with the Original Brauser Note, the Company issued a
warrant to purchase 50,000 shares of Common Stock at a price of $1.75 per share.
The Original Brauser Note was collateralized by the Company and Bridge Ventures
with the Company's patent estate. In May 1995, the Company restructured the
Original Brauser Note in exchange for the Company issuing to Mr. Brauser (i) a
promissory note, collateralized by the Company's patent estate, in the amount of
$100,000 bearing interest at a rate of 12% per year (the "New Brauser Note"),
(ii) a warrant to purchase 25,000 shares of Common Stock at a price of $1.75 per
share, (iii) 100,000 shares of Common Stock at $.50 per share, and (iv) a Bridge
Loan in the amount of $50,000 as well as a Bridgeholder Option to purchase
33,333 Bridge Units. The New Brauser Note was originally due on the earlier of
June 30, 1995 or the Company's receipt of a certain payment from SAB/Bioclones
but was amended to extend the date on which repayment was due on the earlier of
November 2, 1995 or the closing of the IPO. The notes were retired on November
2, 1995.
The June 30, 1996, cash on hand was $2,538,880 which does not include
$5,475,000 received after June 30, 1996 in connection with the private placement
of Series D Preferred Stock. At June 30, 1996, the Company had accounts payable
and accrued current liabilities of approximately $1,365,000.
Net cash used by the Company for operating activities amounted to
approximately $5,170,638 in 1993, $1,952,145 in 1994, $1,939,219 in 1995 and
$3,667,367 for the six months ended June 30, 1996.
The Company has incurred and will continue to incur substantial research
and development costs and manufacturing costs. In addition, if the Company
receives regulatory clearance for the commercial sale of its products, the
Company will incur substantial expenditures to develop its manufacturing, sales,
marketing and distribution capabilities to the extent such functions are not
supplied by third parties. The Company will require substantial additional funds
for these purposes through additional equity and/or debt financings,
collaborative arrangements with corporate partners or from other sources. No
assurances can be given that such additional funds will be available for the
Company to finance its development on acceptable terms, if at all. If adequate
funds are not available from additional sources of financing, the Company's
business will be materially adversely affected and the Company may not be able
to continue operations. "See Business--Company Strategy" and "Risk Factors."
21
<PAGE>
The Company's future capital requirements will depend on many factors,
including scientific progress in its research, drug discovery and development
programs, the magnitude of these programs, the length and expense of
pre-clinical and clinical trials, the time and costs involved in seeking
regulatory approvals, the costs involved in filing, prosecuting and enforcing
patent claims, competing technological and market developments, changes in the
existing collaborative research relationships, the ability of the Company to
establish product development arrangements, the cost of manufacturing scale-up
and effective commercialization activities and arrangements. The failure by the
Company to obtain regulatory approval for any product will preclude its
commercialization. There can be no assurance that necessary regulatory approvals
will be obtained. See "Risk Factors" and "Business--Government Regulation."
Pursuant to the terms of the SAB Agreement, the Company has received an
aggregate of $3,000,000 through July 10, 1996.
New Accounting Pronouncements
In March 1995, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 121 "Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of"
(Statement 121). Statement 121 provides guidance for recognition and measurement
of impairment of long-lived assets, certain identifiable intangibles and
goodwill related both to assets to be held and used and assets to be disposed
of. The Company is required to adopt Statement 121 for the year ended December
31, 1996. The Company has not yet quantified the impact, if any, of the adoption
of Statement 121 may have on its consolidated financial statements.
In October 1995, the FASB issued Statement 123, "Accounting for Stock-Based
Compensation" (Statement 123). Statement 123 allows companies the option to
retain the current accounting method for recognizing stock-based expense in the
financial statements or to adopt a new accounting method based on the estimated
fair value of employee stock options. Companies that do not adopt the new fair
value based method will be required to provide expanded disclosures in the
footnotes. The Company is required to adopt Statement 123 for the year ended
December 31, 1996. The Company expects to continue applying its current
accounting method and upon adoption will present the required footnote
disclosures.
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<PAGE>
BUSINESS
General
The Company is a pharmaceutical company using nucleic acid technologies to
develop therapeutic products for the treatment of viral diseases and certain
cancers. Nucleic acid compounds represent a potential new class of
pharmaceutical products that are designed to act at the molecular level for the
treatment of human disease. The Company's drug technology utilizes
specially-configured RNA. The Company's double stranded RNA drug product,
trademarked Ampligen, which is administered intravenously, is in human clinical
development for various therapeutic indications. Based on the results of
pre-clinical studies and clinical trials, the Company believes that Ampligen may
have broad-spectrum anti-viral and anti-cancer activities. Over 300 patients
have received Ampligen in clinical trials authorized by the FDA at over twenty
clinical trial sites across the United States, representing the administration
of more than 40,000 doses of this drug.
Ampligen is being developed clinically for three anti-viral indications:
HBV (Phase I/II clinical trial), HIV associated disorders (Phase II), and ME/CFS
(Phase II/III). The Company's business strategy is designed around seeking the
required regulatory approvals which will allow the progressive introduction of
Ampligen for HIV followed by HBV and ME/CFS in the U.S., Canada, Europe and
Japan. There can be no assurance that Ampligen will receive regulatory approval
for any of such disorders. Ampligen has received Orphan Drug designation from
the FDA for four indications (AIDS, renal cell carcinoma, chronic fatigue
syndrome and invasive malignant melanoma). The Company is also developing a
second generation RNA drug technology, termed Oragen compounds, with potential
for broad spectrum antiviral activity by oral administration.
The Company has been issued certain patents on the use of Ampligen alone
and Ampligen in combination with certain other drugs, including AZT, ddI, ddC,
interferon and/or IL-2, for the treatment of HIV. The Company has also been
issued a patent on the use of Ampligen in combination with certain other drugs,
including ddI and ganciclovir, for the treatment of HBV and HCV and a patent
which affords protection on the use of Ampligen in patients with ME/CFS. While
the Company does not have any ownership rights to these other drugs, such drugs
may be readily purchased for combinational treatment regimens and thus, the
Company believes that the lack of such ownership rights will not have a material
adverse effect on the Company; however, no assurance can be given. To date, the
Company has not been issued any patents in the U.S. regarding the use of
Ampligen for treatment of the cancers which the Company has sought to target.
The Company's applications for such patents are currently pending; no assurances
can be given that such applications will be allowed. See "Business--Patent
Rights."
The WHO estimates that there are approximately 300 million chronic carriers
of HBV worldwide. More than 40% of the persistently infected persons who survive
to adulthood will die from cirrhosis, hepatocellular carcinoma (liver cancer),
or some other consequence of their infection. In the U.S. alone there are an
estimated 1.25 million carriers. HBV is one of the several viruses that cause
human hepatitis or inflammation of the liver. The Company is presently
conducting a Phase I/II clinical trial of Ampligen in the U.S. for the treatment
of chronic HBV infection at Stanford University and the University of
Pennsylvania. A significant reduction in viral components and improvement in
liver function has been noted during the course of the study to date and the
drug has been generally well tolerated. At present, interferon-alpha is the only
approved product for this disease; however, approximately 75% of patients with
chronic HBV ultimately fail to respond to interferon-alpha. The global sales of
interferon are presently estimated at more than $1 billion, largely because of
its use in liver infections.
The CDC has estimated that approximately one million people in the U.S. are
infected with HIV, excluding patients who have progressed to fully symptomatic
AIDS. The WHO has estimated that 30 to 40 million people will be infected with
HIV worldwide by the year 2000. The Company is presently in Phase II of clinical
development of Ampligen in the U.S. for the treatment of symptomatic HIV
infection.
ME/CFS is a condition recently recognized by the CDC and characterized by
unexplained fatigue or chronic illness for six months or longer for which no
cause has been identified after a thorough medical work-up. Although the CDC is
presently conducting studies to determine more exactly the rate of incidence of
ME/CFS, the CDC's latest estimate of the prevalence rate of this disease in the
U.S. is in excess of 200 per 100,000 population. In November 1992, the Company
received approval from the HPB of Canada's Department of Health and Welfare, the
federal drug regulatory agency in Canada, to conduct an open-label clinical
trial of Ampligen in patients with severely debilitating ME/CFS. In this
clinical trial, the HPB has authorized the Company to charge patients for the
cost of the Ampligen administered. The Company is presently receiving limited
23
<PAGE>
revenues from sales in Belgium under a similar cost recovery program. The
Company has also received authorization from the FDA, in the U.S., and the HPB,
in Canada, to initiate a Phase II/III clinical trial of Ampligen in patients
with ME/CFS. The Company is unaware of any investigational new drugs which are
currently at comparable stages of clinical development for ME/CFS.
The Company also has clinical experience with Ampligen in patients with
certain cancers, including renal cell carcinoma (kidney cancer) and metastatic
malignant melanoma. Based on estimates prepared by the American Cancer Society,
the Company anticipates that approximately 25,000 new cases of renal cell
carcinoma will be diagnosed in the U.S. in 1996. In March and June, 1993,
respectively, the Company was authorized by the FDA, in the U.S., and the HPB,
in Canada, to initiate a Phase II/III clinical trial of Ampligen in renal cell
carcinoma patients. Recently, the HPB authorized the Company to proceed with an
open-label clinical trial of Ampligen for renal cell carcinoma in Canada. The
HPB has authorized the Company to charge patients for the cost of the Ampligen
administered in this clinical trial. Based on estimates prepared by the American
Cancer Society, the Company also anticipates that approximately 34,000 new cases
of malignant melanoma will be diagnosed in the U.S. in 1996. Data from the
American Cancer Society and the World Health Organization indicate that both the
incidence and mortality from malignant melanoma are rising steadily among white
populations throughout the world. In the past decade, the incidence of melanoma
has increased faster than that of any other cancer except lung cancer in women.
From its inception in 1966 to the early 1980s, the Company's principal
business was to supply research support via contracts received principally from
the NIH. In the early 1980s, the Company redirected its efforts to the
development of nucleic acid pharmaceutical technology and since that time the
Company has devoted substantially all of its resources to its research, drug
discovery and development programs.
In October 1994, the Company entered into the SAB Agreement with respect to
codevelopment of various RNA drugs, including Ampligen, for which the Company
has previously obtained international patent protection. The SAB Agreement, as
amended, provides that the Company will provide SAB/Bioclones with an exclusive
manufacturing and marketing license for certain Southern hemisphere countries
(including certain countries in South America) as well as the United Kingdom,
Ireland, Africa, Australia, Tasmania, New Zealand, and certain other countries
and territories. In exchange for these marketing and distribution rights, the
SAB Agreement provides for: (a) a $3 million cash payment to the Company,
payable in installments upon the occurrence of certain milestones including the
transfer of certain technical documents, some of which have already been
transferred; (b) the formation and issuance to the Company of 24.9% of the
capital stock of a company which is shall developing and operating a new
manufacturing facility for RNA drugs constructed by SAB/Bioclones, and (c)
royalties on all sales of the Company's products in the licensed territories
after the first $50 million of sales. In addition, SAB/Bioclones agrees to use
its best efforts to pursue the marketing approval of Ampligen for HBV in
Australia, South Africa, Brazil, and the United Kingdom, as well as to perform
(at its own expense) a phase III study of Ampligen in chronic HBV infection in
South Africa, which clinical study is to be performed pursuant to U.S. FDA good
clinical practice and good laboratory practice guidelines and standards.
SAB/Bioclones will be granted a right of first refusal to manufacture and supply
to the Company the drug product required for not less than one-third of its
world-wide sales of Ampligen (after deducting SAB/Bioclones-related sales).
According to its most recent annual report, SAB is a multinational holding
company investing in and taking management responsibility for a portfolio of
business in beer and beverages retailing, hotels and the manufacture of certain
mass market consumer goods, together with strategic investments in businesses
which support its mainstream interests. As of July 10, 1996, the Company had
received $3,000,000 pursuant to the SAB Agreement.
Nucleic Acid Pharmaceuticals
The Company believes that nucleic acid compounds represent a potentially
new class of pharmaceutical products that are designed to act at the molecular
level for the treatment of human disease. There are two forms of nucleic acid:
deoxyribonucleic acid ("DNA") and RNA. DNA is a group of naturally occurring
molecules found in chromosomes, the cell's genetic machinery. RNA is a group of
naturally occurring informational molecules which orchestrate a cell's behavior
and which regulate the action of groups of cells, including the cells which
comprise the body's immune system. RNA directs the production of proteins and
regulates certain cell activities including the activation of otherwise dormant
cellular defenses against viruses and tumors. To date, the Company has focused
its efforts on developing two classes of RNA pharmaceuticals, Ampligen, a high
molecular weight double stranded intravenous drug, and Oragen, low molecular
weight double or single stranded drugs intended for oral administration.
24
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Company Strategy
The Company's business strategy is designed around seeking the required
regulatory approvals which will allow the progressive introduction of Ampligen
for HIV followed by HBV and ME/CFS in the U.S., Canada, Europe and Japan and the
Southern hemisphere countries including South Africa, Australia and countries in
South America. Within the next year, the Company expects to receive limited
revenues through cost-recovery from patients who become enrolled in a clinical
trial of Ampligen for severely debilitating ME/CFS in Canada (authorized by the
HPB) and a clinical trial of Ampligen for renal cell carcinoma in Canada
(authorized by the HPB) and has begun to receive revenues from a clinical trial
of Ampligen for ME/CFS in Belgium (authorized by the Belgian Minister of
Health). See "Business--Ampligen." To date, the Company has not granted the
right to market any of the Company's drug products to any third party other than
SAB/Bioclones, Rivex and certain commercial rights to its subsidiaries. See
"Business--General," "--Marketing" and "--Subsidiary Companies."
As part of its development strategy, the Company has initiated clinical
trials of Ampligen in the U.S. and Belgium and has been authorized to conduct
clinical trials in Canada and Ireland. Ampligen is being tested in Phase II
trials in Belgium for ME/CFS, with the active drug administration phase ongoing.
In the U.S., the Company is evaluating and monitoring the duration of the drug
benefit period in certain HIV patients who completed a Phase II trial as well as
monitoring the drug benefit period in certain patients who previously received
Ampligen in a Phase I/II trial in HBV diseases. The Company expects that the
monitoring will help the Company to determine and evaluate the duration of the
potential drug benefit period. In connection with the foreign trials, the
Company has received export authorization from the FDA to ship Ampligen to
Belgium (for ME/CFS) and Canada (for ME/CFS and renal cell carcinoma) for
clinical trials which the Company either has initiated or plans to initiate in
those countries for ME/CFS in 1995, 1996 or 1997. In Japan, there is a high
incidence of chronic HBV. Based on data obtained from the clinical testing of
Ampligen as a possible therapy for HBV, the Company anticipates focusing its
efforts in Japan on the implementation of clinical trials of Ampligen for
chronic HBV. The Company's current strategy is to seek a partnering arrangement
with a Japanese entity and, subject to seeking and obtaining necessary
approvals, to conduct trials in Japan through such an arrangement.
As indicated above, the HPB has approved the Company's application to
conduct an open-label clinical trial of Ampligen at specified sites in Canada
for up to 200 patients with severely debilitating ME/CFS. Clinical sites are
presently being pursued. The HPB has also recently approved the Company's
application to conduct an open-label clinical trial of Ampligen at specified
sites in Canada for up to 200 patients with renal cell carcinoma (kidney
cancer). In these clinical trials, the HPB has authorized the Company to require
participants to pay the Company for the cost of the Ampligen administered. The
Company understands that patients may not be reimbursed for these costs by any
Canadian authority or from any private insurer. Due to the inability of patients
to receive reimbursement, the Company may not be able to charge a sufficient
price for the Ampligen used in such tests. The Company cannot promote
participation in the trial or sale of Ampligen through advertisements to the
general public.
Subject to obtaining the necessary regulatory approvals for the sale of
Ampligen in the home infusion (non-hospital) segment of the U.S. market and
favorable results of clinical trials, which cannot be assured, (see
"Business--Government Regulation"), the Company may utilize a service provider
to execute the direct marketing activities, conduct physical distribution of its
products, and handle billing and collections. The Company believes that this
approach may facilitate the generation of revenues without incurring the
substantial product launch costs associated with the employment of a direct
sales force. Furthermore, this approach will enable the Company to retain many
options for future marketing strategies. The Company does not currently
anticipate devoting substantial resources to the development of an in-house
sales force.
In Europe, the Company plans to adopt a country-by-country and, in certain
cases, an indication-by-indication, marketing strategy due to the heterogeneity
of governmental regulations and alternative distribution systems in these areas.
The Company anticipates that it will adopt an indication-by-indication marketing
strategy in Japan. The marketing alternatives the Company intends to consider
include joint venture arrangements with pharmaceutical companies and the
co-marketing of the Company's products on a selective basis.
Pursuant to the SAB Agreement, the Company has granted SAB/Bioclones an
exclusive marketing license for certain Southern hemisphere countries (including
countries in South America) as well as the United Kingdom, Ireland, Africa,
Australia, Tasmania, New Zealand and certain other countries and territories. In
addition, SAB has agreed to use its best efforts to pursue the necessary
approval to market Ampligen for HBV in Australia, South Africa, Brazil, and the
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United Kingdom, as well as to perform a phase III study of Ampligen in chronic
HBV infection in South Africa. See "Business--General."
The Company's current facilities and staff are not adequate to support the
manufacture and production of Ampligen for large-scale commercialization and, to
the extent the Company receives the necessary regulatory approvals, it will be
required to significantly increase its quality control, packaging, marketing and
distribution capabilities in order to sell the approved product commercially.
The Company plans to utilize third-party facilities or, if it is unable to do
so, build or acquire commercial-scale manufacturing facilities as the need
arises. The Company has entered into the SAB Agreement, which provides for the
issuance to the Company of 24.9% of the capital stock of a company which is
developing and operating a new manufacturing facility financed by SAB/Bioclones.
The Company expects that manufacturing at this new facility will commence in
1996, on a limited scale, with commercial production in 1997, although no
assurances can be given that this will occur.
Based on its current operating plan, the Company anticipates that the net
proceeds of its recent financings and interest thereon, together with
anticipated cost recovery revenues, will be sufficient to meet the Company's
capital requirements for approximately 18 months from the date of this
Prospectus. See "Use of Proceeds" and "Risk Factors--Additional Financing
Requirements, Lack of Liquidity, Uncertainty of Additional Funding and
Independent Auditors' Report with Explanatory Paragraph."
Ampligen
Ampligen is a high molecular weight RNA drug which is administered
intravenously. Based on the results of clinical trials to date, the Company
believes that Ampligen may have the potential to address significant medical
needs where current treatment methods are inadequate or non-existent. The
following table summarizes the primary indications and the current clinical
trial regulatory status of Ampligen in the U.S.
FDA-AUTHORIZED
INDICATION THERAPEUTIC TARGETS CLINICAL TRIALS*
- ---------- ------------------- ----------------
Antiviral Chronic HBV (hepatitis B virus) Phase I/II(1)
HIV Phase II(2)
ME/CFS (chronic fatigue syndrome) Phase II/III(3)
Anti-Cancer Renal Cell Carcinoma Phase II/III(4)
Melanoma (skin cancer) Phase II(5)
- ------------
* The foregoing chart is qualified in its entirety by reference to more
detailed information included elsewhere in this Prospectus. See
"Business--Government Regulation" for a description of the FDA regulatory
approval process.
(1) A Phase I/II study was authorized by the FDA. This study has been partially
enrolled with patients, and the Company expects the results of this study
of Ampligen in HBV to be available in 1996.
(2) A FDA-authorized Phase I and two Phase II clinical trials of Ampligen for
HIV infection have been completed; one Phase II trial studied Ampligen as
monotherapy and the second used Ampligen in combination with AZT. A Phase
II/III study utilizing Ampligen in a population of largely asymptomatic HIV
carriers has been presented to the FDA but is not yet authorized. The
Company is also discussing a double-blinded placebo-controlled Phase III
study with the FDA in a population of HIV patients currently taking a
variety of anti-HIV drugs. The Company is also discussing an open label
safety trial with the FDA in a similar population.
(3) The Company has completed a Phase I/II study and a second Phase II clinical
trial of Ampligen in ME/CFS under FDA authorizations. The FDA has also
authorized the Company's Phase II/III study in ME/CFS which the Company may
consider initiating in North America in 1996 or 1997.
(4) A FDA-authorized Phase I/II study of Ampligen in cancer including patients
with renal cell carcinoma has been completed. The Company has received
authorization from the FDA to initiate a Phase II/III study of Ampligen in
patients with metastatic renal cell carcinoma. At present, the Company does
not anticipate devoting significant Company resources to the funding of
this study, and, accordingly, a date for initiating this study has not been
determined.
(5) Patients with metastatic melanoma have been treated with Ampligen as
monotherapy under a FDA-authorized Phase I/II open-label study of Ampligen
in cancer. The FDA has authorized the Company to conduct a Phase II trial
of Ampligen in melanoma. The Company expects to initiate this trial in
1997.
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The Company has not yet determined when it will seek to commence its
authorized Phase II/III clinical trial for renal cell carcinoma. Although the
Company plans to use a small portion of its available cash for the renal cell
carcinoma and melanoma studies, the Company plans to seek funding under third
party collaborative arrangements for these studies. Decisions regarding the
timing and sources of funding of such trials will be based, in part, on the
Company's progress in conducting clinical trials and seeking regulatory
approvals for other indications. In addition, pursuant to the SAB Agreement, a
controlled Phase II/III clinical trial of Ampligen for treatment of HBV
anticipated to be sufficient for product registration and commercialization in
certain foreign countries is contemplated to begin in 1996 or 1997. No assurance
can be given, however, that the clinical trial will be successfully completed or
that product registration or commercialization will ever occur.
Mechanism of Antiviral Action of Ampligen
When a virus enters a healthy human cell, the cell's normal response is to
activate the intracellular enzymes which cause the destruction of viral genetic
information, thereby preventing viral replication. Cells also normally produce
extracellular antiviral factors, called cytokines (such as interferon), which
activate the immune system to attack or scavenge virally infected cells. In
acute viral infections (such as influenza and measles), the presence of the
virus activates these intracellular alarm signals thus triggering the
intracellular and immune system response. Certain viruses associated with
chronic diseases, such as HIV, ME/CFS associated viruses, and HBV, may produce
inhibitory substances which inactivate these natural defenses, and allow the
unchecked proliferation of the virus. A compilation of studies recently
published by the University of Washington suggests that viruses may not be able
to survive unless they can incapacitate these natural defenses.
Although the antiviral mechanism of action of Ampligen is not fully
understood, the Company believes that Ampligen's antiviral mechanism of action
is two-fold. First, the Company believes Ampligen reactivates the inactivated or
dormant antiviral defense system present in various cells. This natural defense
system, termed the ribonuclease L ("RNAse-L") and protein kinase antiviral
pathways, disrupts viral multiplication within human cells, thereby thwarting
further virus-induced cell damage. Second, the Company believes Ampligen
activates components of the immune response, called macrophages and natural
killer cells, which attack or scavenge virally infected cells. This activity is
thought to occur in part by inducing formation of selected cytokines such as
interferon. The Company believes Ampligen causes the production of various
different antiviral or anticancer proteins. Thus, the Company believes that the
administration of Ampligen into the body stimulates the appropriate antiviral
defenses at two levels: first, by activating the intracellular defense system
within various cells of the body; and second, by activating the immune system,
in part by the production of various interferons in their natural form.
The Company believes that the mechanisms of action of most existing
FDA-approved antiviral drugs do not stimulate the production of immune cells to
attack, or scavenge, disease-causing agents such as viruses, in the bloodstream
or attached to the surface of cells. Rather, these drugs appear to directly
inhibit the viruses by interfering with their replication. The Company also
believes that most of these currently available antivirals do not activate the
dormant intracellular defenses described above. See "Business--Competition."
The Company believes that Ampligen may have the ability to elicit a broad
range of host defenses and, consequently, may have the potential to eradicate
certain viral infections. The Company believes that Ampligen therapy may
reactivate the RNAse-L and protein kinase pathways; this activity is believed to
arrest further viral multiplication of certain viruses including retroviruses
(such as HIV), HBV, and ME/CFS associated viruses.
Mechanism of Anti-cancer Activity of Ampligen
Based on preclinical test results, the Company believes that Ampligen may
have an anti-cancer effect at three levels. First, in order for tumor cells to
divide (and thus multiply), the DNA in such cells must unwind. Ampligen triggers
the production of a chemical entity called "bioactive 2-5A" which the Company
believes may inhibit the unwinding of DNA in tumor cells. Second, when the DNA
in tumor cells unwinds, the tumor often spreads to other parts of the body
through a process called metastasis. Selected regions of the tumor cell's DNA,
called oncogenes, produce substances which accelerate tumor spread. The Company
believes that Ampligen may activate pathways, such as the protein kinase pathway
referred to above, which may serve to inhibit certain effects of oncogenes.
Third, the Company believes that Ampligen also induces the formation of various
cytokines, including interferon, interleukins and tumor necrosis factor, each of
which may enhance the ability of circulating immune cells, such as cytotoxic T
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cells and natural killer cells, to scavenge tumor cells. Thus, the Company
believes that Ampligen may have three separate anticancer benefits: (1)
inhibiting the unwinding of DNA in tumor cells; (2) inhibiting the spread of
tumors to other parts of the body; and (3) inducing formation of various
cytokines which may enhance the ability of healthy cells to kill tumor cells.
However, no assurance can be given that Ampligen will have any anti-cancer
effect whatsoever.
Ampligen for Viral Diseases
Chronic Hepatitis B ("HBV")
HBV is one of several viruses that cause human hepatitis, or inflammation
of the liver. Worldwide, an estimated 300 million people are chronic carriers of
HBV. More than 40% of persistently infected persons who survive into adulthood
will die from cirrhosis, hepatocellular carcinoma (liver cancer), or some other
consequence of their infection. In the U.S. alone, there are an estimated 1.25
million carriers. In the mid 1970's, the first HBV vaccine was developed and it
became commercially available in the U.S. in 1981.
Hepatitis B, the form of hepatitis caused by HBV, is a contagious disease
and is transmitted from person to person in several ways including contact with
bodily fluids of an infected person. Perinatal and early childhood transmission
is the predominant mechanism of infection, particularly in lesser developed
countries. Those populations most at risk for infection include health care
workers, housemates of HBV carriers, the sexually active, hemodialysis patients,
the immunodepressed, child care workers, IV drug users, and neonates of HBV
positive mothers.
Common symptoms of HBV include jaundice, fever and the loss of appetite. In
general, infants and young children have milder initial disease than older age
patients. Adults usually develop acute hepatitis after a 4-28 week incubation
period, exhibiting symptoms of fever, nausea, fatigue, headache, jaundice, and
an enlarged and tender liver. Symptoms usually disappear 2-12 weeks after the
onset of jaundice. In rare cases, i.e. in less than 1.5% of patients
hospitalized for acute viral hepatitis, a fatal form of the disease called
fulminant hepatitis occurs.
Approximately 90% of HBV acutely infected adults become free of the HBV
antigen 1-5 years after infection. The remaining approximately 10% become
chronic carriers of HBV, capable of transmitting the disease to other persons.
Chronic carriers can be divided into two groups: (i) chronic active carriers,
and (ii) chronic persistent carriers. Among chronic carriers, about 3 in 10 are
chronic active, exhibiting frequent and often severe symptoms of acute
infection. Chronic active carriers develop significant liver damage, have a high
incidence of hepatocellular carcinoma (liver cancer) and cirrhosis.
Approximately 7 out of 10 chronic carriers are chronic persistent, and are
generally asymptomatic or have very mild and infrequent symptoms of hepatitis.
Chronic persistent carriers do not usually develop significant liver damage,
hepatocellular carcinoma, or cirrhosis.
In the U.S., 300,000 new cases of Hepatitis B occur each year. The reported
incidence of the disease has increased 37% between 1979 and 1989, despite the
introduction and availability of a vaccine in the early 1980's. Of the estimated
1.25 million Americans chronically infected with HBV, there are about 375,000
chronic active carriers, resulting annually in approximately 4,000 deaths from
cirrhosis, and 800 deaths from hepatocellular carcinoma. In China, most of
Africa, Southeast Asia, parts of the Middle East, and the Amazon basin, it is
estimated that 8-15% of the population is chronically infected with HBV. In the
developed countries, such as Western Europe, the U.S., and Australia, chronic
infection rates are generally less that 1% of the population, although some
developed countries--Japan, Italy, and Greece, for example--report chronic
infection rates of 2-7%. In southern Europe, a resistant mutant strain of HBV
has been identified for which current vaccines do not provide immunity.
In late 1991, the Company commenced a Phase I/II study of Ampligen in
HBV-infected individuals in collaboration with investigators at Stanford
University and the University of Pennsylvania. The protocol for this study calls
for a treatment period of six months, and the Company expects the results to be
available in 1996. Subject to completion of and satisfactory results from the
Phase I/II study, the Company anticipates seeking FDA approval for the
initiation of a Phase II/III study for Ampligen for HBV in 1997.
In 1992, the FDA approved the commercial use of recombinant alpha
interferon for the treatment of chronic HBV infection. To the Company's
knowledge, this is the only approved HBV drug in the U.S. Published studies
indicate that 60% to 75% of patients with HBV fail to respond to interferon.
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Among the laboratory markers being monitored in the Company's ongoing Phase
I/II study of Ampligen for HBV is the level of viral DNA. Decreases in viral DNA
levels in clinical evaluations of interferon were found to correlate positively
with clinical improvements as well as improvements in liver function. To date,
eight patients have enrolled in this study. Significant decreases in viral DNA
have been observed in 50% of the patients enrolled in the Company's study with
the patients' DNA levels becoming undetectable during or after Ampligen therapy.
In addition, liver enzymes have been measured as an indication of liver damage
in these patients. There was a significant improvement in liver function with an
approximate 50% or greater decrease in liver enzyme levels in these responding
patients and one additional patient. The liver enzymes returned to normal in two
patients during or after Ampligen therapy. Overall, 63% (5/8) of the chronic HBV
infected patients showed a response to Ampligen therapy.
Ampligen therapy was generally well tolerated. One patient who was
intolerant to IFN-alpha therapy was able to tolerate the full course of Ampligen
therapy at the highest dose given in this study. The Company believes that
Ampligen therapy may convey certain safety advantages over interferon therapy
during prolonged treatment cycles necessary in treating HBV.
The Company has also filed internationally various patent applications
covering hepatitis treatment in conjunction with closely related RNA drugs,
including poly Ao poly U, which is also being developed by a potential
competitor of the Company. The Company has notified the competitor that the
Company believes its patents cover various RNA drugs used in potential treatment
of hepatitis infections.
HIV Infection
HIV infection is characterized by a progressive decline in the patient's
immune system usually resulting in death from overwhelming infections. Fully
symptomatic AIDS is associated with multiple viral infections and the ongoing
destruction of the immune system. At present, each of these viral infections is
generally treated separately, resulting in a "multi-pharmaceutical" treatment
approach for each patient. In studying potential treatments for AIDS, scientists
have employed CD4 cell counts as a surrogate marker to indicate the extent to
which the disease has progressed. Independent studies of the natural course of
HIV disease at the Harvard University School of Public Health have indicated
that stabilization of CD4 levels is associated with reduced short term risk of
death. The Company believes that correction of the underlying deficit in
cellular immunity may result in longer-lasting clinical benefits than currently
approved treatments and also may reduce the need for multi-pharmaceutical
treatments.
In 1986, the Company initiated a Phase II study in ten individuals with HIV
disease, three of whom had fully symptomatic AIDS. This study indicated that
Ampligen treatment appeared to delay the expected immune cell deterioration in
six of the seven HIV patients who had not progressed to AIDS. Although the
Company regards these observations as clinically important, it does not consider
them to be statistically significant due to the small number of cases studied.
In a separate study conducted in Houston, Texas between 1987 and 1989 and
completed at Baylor University in an extension of the Company's first HIV study,
AZT was administered as part of a combination therapy with Ampligen. Patients
who received this combinational therapy experienced a stabilization of CD4 cell
levels for a longer time than was reported for patients receiving either
Ampligen alone or AZT alone. Data obtained at the United States Air Force
Medical Center, Veterans Administration Hospitals and the Walter Reed Army
Institute of Research indicate that responsiveness to foreign antigens injected
under the skin ("skin tests") predicts anticipated life span in patients with
HIV disease. As HIV disease progresses, patients may cease to have a positive
skin test response. The Company's Phase II studies suggest that Ampligen may
have restored the positive skin test response in HIV infected individuals who
had not progressed to AIDS at the time of initiation of Ampligen treatment,
although these preliminary results must be confirmed in subsequent clinical
trials consisting of larger numbers of patients.
In 1987, the Company formed a joint venture with DuPont which sponsored a
multi-center, double-blind placebo-controlled Phase II clinical study of
Ampligen for the treatment of HIV infection. The total patient population of
this study was 330. This study, known as AMP 101, was terminated in 1988 when an
analysis of interim data showed no clinical benefit from Ampligen therapy as
opposed to placebo. After comparing the data from this study with data from
other studies, and additional experimental investigation, the Company concluded
that the activity of the Ampligen administered to the participants in the AMP
101 study was impaired due to a reaction which the Company believed to have been
caused by the packaging of Ampligen in polyvinyl chloride (plastic) bags. Such
plastic bags had not previously been used in the packaging and delivery of
Ampligen used in other clinical trials. On April 13, 1990, a fifteen member
scientific panel assembled by the NIH in order to evaluate whether an NIH grant
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for the clinical testing of Ampligen should be renewed issued its report and
recommendations regarding the renewal of this grant. This report observed that
the Ampligen used in the AMP 101 study had been found by the Company to have
increased content of single strand RNA due to preparation of the drug and the
use of plastic bags. The report further stated that "the promising preliminary
results obtained make further evaluation of the compound alone or in combination
with other agents of great importance to define fully its role as a therapeutic
agent." The joint venture arrangement with DuPont was later terminated as part
of the settlement of a lawsuit brought against the Company by DuPont and an
action against DuPont brought by the Company related to the AMP101 study and
alleged breaches of the joint venture agreement.
In 1991, the NIH, through the National Institute of Allergy and Infectious
Diseases, completed an open-label Phase I/II study of Ampligen involving 39
patients at the University of Pittsburgh treated at different dosages. Of the 24
evaluable patients who received at least 120 mg/m2 of Ampligen for the treatment
of HIV, 14 patients experienced stabilized CD4 levels for at least nine weeks.
The Company has conducted a Phase II clinical trial of Ampligen for HIV
infection. This study, which was initiated in 1990, was a randomized,
controlled, multicenter study evaluating Ampligen therapy in combination with
AZT. The Company filed the results of this study with the FDA in late 1993 along
with a request for approval to initiate a Phase II/III study in 1994. The Phase
II/III study currently being considered by the FDA would utilize Ampligen in a
population of largely asymptomatic HIV carriers. The FDA raised certain issues
with respect to the Phase II clinical trial results, including the laboratory
endpoints used. The Company has presented to the FDA the design of the Phase
II/III study, including identification of appropriate clinical and laboratory
endpoints. See "Business--Government Regulation."
Currently, the principal treatments for HIV are AZT, DDI, DDC, D4T, 3TC and
a new group of compounds termed protease inhibitors, of which three have been
recently approved. In the case of each of these drugs, most patients ultimately
cease to benefit from the drug due to the emergence of new strains of the AIDS
virus. Based on the results obtained to date, an AZT resistant virus has
remained sensitive to Ampligen in various in vitro studies which have been
performed at Hahnemann University. Although no assurances can be given and
additional testing will be necessary to substantiate the Company's belief, the
Company believes that human subjects may be less likely to develop viral
resistance to Ampligen as a result of the drug's perceived mechanism of action.
See "Business--Mechanism of Antiviral Action of Ampligen."
ME/CFS
ME/CFS is characterized by unexplained fatigue or chronic illness for six
months or longer for which no cause has been identified after a thorough medical
workup. Although the etiology of ME/CFS is unknown, a significant segment of the
medical community believes that it may be caused by a virus because the onset of
the condition is usually characterized by flu-like symptoms followed by chronic
tiredness that, in some cases, can continue for years. ME/CFS is also often
accompanied by a disturbance of the patient's immune system, as measured by
lower levels of natural killer cell activity and/or lower lymphocyte counts.
Data reported by a consortium of institutions including Harvard University
and the University of Washington indicate that a majority of those ME/CFS
patients who have been tested have been found to have elevated levels of herpes
virus (HHV-6) as well as brain abnormalities that were noted during magnetic
resonance imaging (known as MRI) testing. Because there may be both viral and
immune components to this disease, the Company believes, although it has not yet
clinically proven, that Ampligen may be well suited as a treatment for ME/CFS.
There are no drugs specifically approved by the FDA for this disorder and
physicians typically prescribe analgesics and anti-inflammatory drugs to combat
the painful symptoms.
In 1989, the Company received FDA authorization to conduct a Phase I/II
study of Ampligen for ME/CFS. In 1991, the Company completed a multicenter,
double-blind, placebo-controlled Phase II clinical trial (the "Phase II ME/CFS
Study") of Ampligen in patients with ME/CFS. The FDA raised certain issues with
respect to this clinical trial. See "Business--Ampligen Safety Profile" for a
discussion of the drug safety issues raised by the FDA.
In 1992, the Company received approval from the HPB, the federal drug
regulatory agency in Canada, to conduct an open-label clinical study at
specified sites to evaluate the activity and safety of Ampligen in up to 200
patients with severely debilitating ME/CFS. The Company has been authorized to
require patients in this clinical study to pay the Company for the Ampligen
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administered. The Company understands that patients may not be reimbursed for
these costs by any Canadian authority or any private insurer. The Company
anticipates that initial patients may be enrolled in this study during 1997. In
October and November 1992, respectively, the Company was authorized by the FDA,
in the U.S., and the HPB, in Canada, to initiate a Phase II/III multicenter,
placebo-controlled, randomized, double blind clinical trial in up to 230
patients in the U.S. and Canada with ME/CFS. In December 1992, the FDA
authorized the export of Ampligen for investigational use for treatment of
ME/CFS patients in Canada. The Company anticipates this study will be initiated
in 1997 at multiple centers in North America.
In February 1993, the Company presented results of its Phase II study of
Ampligen for ME/CFS to an FDA Advisory Committee and these results were
published in early 1994 in Clinical Infectious Diseases, a peer reviewed medical
journal which emphasizes the understanding and potential treatment of infectious
diseases. The results indicated that patients on Ampligen, in contrast to those
receiving a placebo, showed significant improvement in physical capacity as
determined by performance on treadmill testing. The Ampligen treated patient
group also required less pain medication than did the placebo group.
In December 1993, Ampligen was designated as an Orphan Drug by the FDA for
the treatment of Chronic Fatigue Syndrome. See "Business--Government
Regulations."
Ampligen for Cancer
Renal Cell Carcinoma (Kidney Cancer)
Based on estimates prepared by the American Cancer Society, the Company
anticipates that there will be approximately 25,000 new cases of renal cell
carcinoma diagnosed in the U.S. in 1996. Patients with metastatic renal cell
carcinoma show five-year survival rates of only 2%-18%. Treatment of advanced
renal cell carcinoma with metastases with conventional chemotherapy has not
resulted in significant median increases in survival. Biological response
modifiers, or lymphokines, have also been used with limited success to treat
renal cell carcinoma patients. To the Company's knowledge, the only FDA approved
drug for the treatment of renal cell carcinoma is Interleukin-2 ("IL-2"), which
is a biological response modifier. Based on published reports, treatment with
IL-2 results in a reduction in tumor size in approximately 10%-20% of patients.
Increased survival of patients receiving IL-2 therapy has been reported. The FDA
approved IL-2 in 1992 for sale in the treatment of metastatic renal cell
carcinoma.
In 1991, Ampligen was designated as an Orphan Drug by the FDA for the
treatment of renal cell carcinoma. See "Business--Government Regulations." A
Phase I/II clinical trial of Ampligen in cancer patients was initiated in 1983.
Thirteen patients with metastatic renal cell carcinoma received Ampligen at low
doses (10-120 mg.) twice weekly; eighteen patients with metastatic renal cell
carcinoma received Ampligen at high doses (200-500 mg.) twice weekly. Data
analysis from this study indicates that the patients in the high dose group
experienced an increase in median survival versus the low dose group and as
compared to an historical control group of 610 patients. Specifically, the
median survival for the Ampligen high dose group was 20.4 months while the
median survival for the historical control group was 5.5 months. This increase
represents a 370% prolongation of survival in the high dose Ampligen treated
group. The survival of the low dose Ampligen group did not increase compared to
the historical control group. Overall, the Company believes that these results
are encouraging given the substantial inadequacy of current treatment
modalities, and the short life expectancy of many renal cell carcinoma patients.
The Company believes that these results suggest that there may be a correlation
between high dose Ampligen treatment and increased survival in metastatic renal
cell carcinoma patients.
On March 22, 1993, the Company received authorization from the FDA to
initiate an open label, active-controlled, multicenter study of Ampligen in
patients with metastatic renal cell carcinoma. On June 7, 1993, the HPB
authorized the Company to conduct this clinical trial in Canada. At present, the
Company does not anticipate devoting significant Company resources to the
funding of these studies, because the size of the potential market for renal
cell carcinoma is relatively small.
On June 7, 1993, the Company also received approval from the HPB in Canada
to conduct a second open-label clinical study at specified sites to evaluate the
activity and safety of Ampligen in up to 200 patients with renal cell carcinoma.
The Company has been authorized to require patients in this clinical study to
pay the Company for the Ampligen administered. There can be no assurance that
patients will be reimbursed for these costs by any Canadian authority or by any
private insurer. The Company has not initiated this program to date because of
limited resources and a shift in the Company's clinical priorities but
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anticipates that, once resources are available, initial patients will be
enrolled in this study during 1997. The Company does not believe that approvals
for these studies will be withdrawn as a result of the delay since the approvals
were not conditioned upon a particular commencement date.
The Canadian clinical trials have not yet been approved by the ethical
review committees ("ERCs") at the respective clinical sites involved, and the
Company has agreed with the HPB not to proceed with such trials unless such
approvals are obtained. These approvals are required for all drug studies
conducted in Canada. Although the Company believes that it will be able to
secure the approvals of the ERCs, no assurances can be given with respect to
when, or if, these approvals will be obtained. The Company has received
authorization from the FDA to export Ampligen to Canada for investigational use
for treatment of renal cell carcinoma patients in Canada.
Malignant Melanoma
Data from the American Cancer Society and the WHO indicate that both the
incidence and mortality from malignant melanoma are rising steadily among white
populations throughout the world. In the past decade, the incidence of melanoma
has increased faster than that of any other cancer, except lung cancer in women.
In December 1993, Ampligen was designated as an Orphan Drug by the FDA for
the treatment of invasive malignant melanoma. See "Business--Government
Regulations." Patients with metastatic melanoma have been treated with Ampligen
as monotherapy under a Phase I/II open-label study of Ampligen as part of a
broader study of cancer patients at Hahnemann University beginning in 1983 and
Yale University beginning in 1991. Two of the ten patients treated had complete
responses, as substantiated by computerized axial tomography (known as CAT
scans). There was no evidence of clinical benefit among the eight other patients
in this study. The FDA has authorized the Company to conduct a Phase II trial at
the M.D. Anderson Hospital in Houston, Texas. The Company expects to initiate
this trial in 1997.
Ampligen Safety Profile
The Company believes that Ampligen has been generally well tolerated in
more than 15,000 patient treatment weeks with a low incidence of clinical
toxicity, particularly given the life threatening diseases being treated.
Clinical experience with Ampligen now totals 311 patients, of whom 171 patients
have received Ampligen for six months or more. Of these patients, 117 patients
have received Ampligen for one year or more; 63 patients have received Ampligen
for two years or more; and 22 patients have received Ampligen for periods in
excess of three years. A mild flushing reaction has been observed in
approximately 15% of patients treated in the Company's various studies. This
reaction is occasionally accompanied by erythema, a tightness of the chest,
tachycardia, anxiety, shortness of breath, subjective reports of "feeling hot,"
sweating and nausea. The reaction is usually infusion-rate related and may
generally be controlled by slowing the infusion rate. Other adverse side effects
include liver enzyme level elevations, diarrhea, itching, urticaria (swelling of
the skin), bronchospasm, transient hypotension, photophobia, rash, bradycardia,
transient visual disturbances, arrhythmias, decreases in platelets and white
blood cell counts, anemia, dizziness, confusion, elevation of kidney function
tests, occasional temporary hair loss and various flu-like symptoms, including
fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and
vomiting. These flu-like side effects typically subside within several months.
In February 1992, after the conclusion of the Phase II ME/CFS Study and
subsequent to the Company's submission of data from that study to the FDA, the
FDA advised the Company, among other things, of certain concerns regarding the
safety profile of Ampligen. Specifically, the FDA noted that various side
effects of Ampligen had been observed during the Phase II ME/CFS Study,
including severe liver toxicity, severe swelling and itching of extremities,
severe chest pain, severe muscle cramps and severe flu-like symptoms. These
observations were made by the FDA in the context of the FDA's review of the
Company's proposed protocol for a Phase II/III ME/CFS trial.
In July 1992, the Company responded to these concerns by providing an
analysis of the side effects data obtained from the Phase II study and the
treating physicians' views. The Company observed that many of the side effects
described by the FDA were regarded by both the Company and the treating
physicians of those patients as unrelated to Ampligen treatment. The Company
advised the FDA of the Company's view that the data from the Phase II ME/CFS
Study indicated that Ampligen appeared to have a favorable risk/benefit ratio
for ME/CFS. On October 9, 1992, the FDA authorized the Company's proposed Phase
II/III clinical trial for ME/CFS, concluding "that it is reasonably safe for the
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initiation of [the Company's] proposed clinical study." This regulatory action
allows Ampligen to be administered for up to one year to an additional 115
patients (in a 230 patient placebo-controlled trial).
In February 1993, the FDA raised an issue regarding possible side effects
of Ampligen which grew out of the agency's review of an animal study conducted
in 1987 involving beagle dogs. Although the results of this study suggest a
possible association between Ampligen administration and focal epicarditis (a
small localized area of inflammation of the outer lining of the heart), the
study did not establish whether the epicarditis observed was attributable to
Ampligen administration. The meaning of these findings in the beagle dog and how
they relate to human clinical experience is not presently known. Because these
conditions were not observed in any other animal studies or in the clinical
trials conducted in humans over the previous ten years, the Company believes
that these findings may be restricted to the beagle dog. The FDA has requested
that the Company conduct an additional toxicity study of Ampligen in beagle
dogs. The FDA has also asked the Company to revise the informed consent forms
provided to patients upon enrollment in the Company's clinical trials to include
the findings of the 1987 study concerning epicarditis in beagle dogs, as well as
other toxicities observed during the course of the Company's various preclinical
toxicology studies in rabbits, rats, dogs and monkeys. The Company has revised
its informed consent forms in accordance with this request. Finally, the FDA has
also asked the Company to conduct cardiovascular follow-up examinations on
selected patients in accordance with criteria suggested by the FDA. The Company
has complied with this request. These examinations, the results of which were
submitted to the FDA in March, April and May, 1993, showed no evidence of
Ampligen-induced epicarditis in these patients. The Company believes that it has
adequately complied with the FDA's requests for information and believes that
the issues raised by the FDA will not have a material effect on the Company's
efforts to receive approval for Ampligen as a treatment for ME/CFS, although no
assurances can be given.
In connection with the proposed Phase III study on HIV patients under
discussion with the FDA, the Company will complete additional toxicity studies
as required by the FDA.
Oragen Drugs
The Company is in the early pre-clinical stages of developing Oragen drugs,
a nucleic acid technology related to Ampligen. Oragen drugs are low molecular
weight RNA compounds which the Company believes, by virtue of their small size,
have the potential for becoming oral, broad-spectrum treatments for various
viral diseases such as HIV infection and chronic HBV infection. The technology
for these products has been developed in part by the Company and has also been
developed in part by Temple University which has licensed to the Company certain
technology for commercial use on an exclusive basis, subject to certain limited
exceptions. The Company was notified in July 1994 that Temple University
believed the Company was in breach of the licensing agreement and therefore that
the agreement was being terminated. The Company has filed a lawsuit seeking a
declaratory judgement that the agreement remains in full force and effect and
seeking monetary damages. See "Business--Research and Development, Licensing and
Collaboration Agreements," "Business--Legal Proceedings" and "Risk
Factors--Disputes and Legal Proceedings Related to Patent Rights". In the event
that the Company does not prevail in its lawsuit and the agreement is deemed
terminated, the Company would lose its investment to date in certain Oragen
compounds which it acquired pursuant to its licensing agreement. Although the
Company has developed its own Oragen compounds, to which it would maintain its
rights, Temple or its new licensees, if any, could become competitors of the
Company in the event that the Company does not prevail in its lawsuit. To date,
a number of compounds have been developed using this nucleic acid technology by
both the Company and Temple, working both together and separately. No clinical
trials of Oragen drugs have been conducted, and authorization to conduct such
trials cannot be sought or obtained until such time as sufficient pre-clinical
work has been completed.
Initial studies show that these drugs can withstand enzymatic destruction,
an important factor in order for compounds to enter the blood stream in an
intact form. Results from in vitro studies conducted in collaboration with the
National Institute of Allergy and Infectious Diseases indicate that Oragen
products may inhibit HBV infection, and in vitro studies conducted in
collaboration with the National Cancer Institute and the University of Mainz,
Germany, indicate that Oragen products may inhibit HIV infections. One compound,
Oragen 0004, has shown inhibition of HBV multiplication in vitro and another,
Oragen 0044, has demonstrated activity against HIV in in vitro studies performed
by Temple University. These two Oragen compounds have been produced in
quantities which the Company believes are sufficient to perform initial animal
toxicology testing. Recent experiments with mice at the University of Toronto
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indicate that Oragen 0004 may inhibit mouse hepatitis virus, and that Oragen
0004 may be absorbed after oral delivery. There has been no human clinical
testing of Oragen products to date. There can be no assurance that human
clinical testing, if initiated, will yield results consistent with those
achieved in in vitro or animal testing.
The Company believes that Oragen drugs may exert anti-viral activity
through two intracellular mechanisms. First, they may activate the intracellular
"latent" RNAse-L to degrade viral RNA. Second, they may inhibit the HIV
replication enzyme, reverse transcriptase, by binding to a different site on the
enzyme from that bound by conventional anti-HIV compounds such as AZT. The
Company's belief in the potential effects of these compounds is based, in part,
on the collaborative in vitro studies with the National Cancer Institute
referred to above. Certain in vitro experiments performed at Vanderbilt
University indicate that certain human immune cells can be protected from cell
death caused by HIV infection by treatment with Oragen drugs. Under sponsorship
of the National Institute for Allergy and Infectious Diseases, in vitro studies
at Georgetown University also demonstrated that Oragen drugs may inhibit the
replication of human HBV virus. In each of the in vitro studies, no substantial
cell toxicity was observed at concentrations which inhibit the applicable virus.
The Company believes Oragen drugs work at a different stage of the
anti-viral and anti-cancer response chain than Ampligen and therefore may be
effective in disorders where the activity of Ampligen is limited.
The following table shows the Company's past and present pre-clinical
studies of Oragen compounds. Except as otherwise noted, the studies have been
conducted under collaborative arrangements pursuant to which the Company
supplies quantities of the drug to the third party institution for testing, and
that institution assigns all of the commercial rights to the studies to the
Company and funds the research costs. See "Research and Development, Licensing
and Collaboration Agreements."
Potential Market
Target Programs Applications Collaborators
- --------------- ----------------- ------------
Human Immunodeficiency Treatment of HIV National Cancer Institute
Virus (HIV) University(1)(2)
Vanderbilt University(1)
University of Mainz,
Germany(1)
Hepatitis B Virus (HBV) Treatment of HBV National Institute
of Allergy and
Infectious Diseases,
Georgetown University
Mouse Hepatitis Virus Treatment of Hepatitis C University of Toronto(1)
Herpes Simplex Virus Treatment of Herpes Medical College of
Type 1 and 2 (HSV-1, Infections Pennsylvania(1)
HSV-2) Juntendo University
Tokyo, Japan
Poliovirus/Respiratory Childhood Viral Diseases Howard University
Syncytial virus
Solid tumors Treatment of various Temple University(1)(2)
types of cancer Hahnemann University
- -------------
(1) Funding provided by the Company. In all other cases, funding provided by
the institution.
(2) The Company was notified in July 1994 that Temple believed the Company was
in breach of its licensing agreement and therefore that the agreement was
being terminated. The Company has filed a lawsuit seeking a declaratory
judgment that the agreement remains in full force and effect and seeking
monetary damages and Temple has filed a lawsuit against the Company. See
"Business--Legal Proceedings" and "Business-- Research and Development,
Licensing and Collaboration Agreements."
Diagnostic Products
The Company is also developing a set of clinical laboratory diagnostic
products, trademarked Diagen products, that are designed to assist physicians in
identifying patients for the Company's RNA drug therapies and to assist in their
clinical management thereafter. The Company believes that the availability of
such tests may lead to improved patient care and increased market penetration by
the Company's products, if and when such products are available for commercial
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<PAGE>
sale. While these tests are at an early stage of commercial development, the
Company believes that they may ultimately provide an opportunity for
diversification of the Company's products and revenues and may help to identify
patients who could benefit from the Company's drug treatment. The Diagen
products would have to go through a regulatory diagnostic product clearance
process prior to commercial sale. See "Business -- Government Regulation" below.
Subsidiary Companies
In September 1994, the Company incorporated three wholly-owned subsidiaries
- -- BioPro Corp. ("BioPro"), Core BioTech Corp. ("Core BioTech"), and BioAegean
Corp. ("BioAegean") -- in the State of Delaware.
The purpose of BioPro is to commercialize tobacco-related products. BioPro
intends to develop methods to utilize RNA technology in conjunction with certain
tobacco and cigarette filter products to provide cleaner tobacco products. The
technology is based in part on recent unpublished experiments in laboratory
animals conducted at the University of California, Davis, which suggest that the
Company's RNA drugs may prevent certain aspects of lung fibrosis under certain
experimental conditions. In September 1994, the Company granted an exclusive
worldwide license and/or sub-license to certain of its patents and assigned
certain other patents to BioPro (the "BioPro License") for a term of three
years, which term will automatically be extended for a term of 15 years in the
event that BioPro provides evidence that it has commercialized one or more of
the patents. BioPro has agreed that it will not develop any product or
technology which may be deemed therapeutic and has granted a right of first
refusal to the Company with respect to any technology which it may develop or
acquire. BioPro has the right to grant sublicenses subject to the requirement
that its sublicensees agree to non-competition arrangements with the Company.
The Company has agreed that it will not develop any technology related to the
business of BioPro and has granted BioPro a right of first refusal with respect
to any technology it may develop with respect to the business of BioPro.
In July 1995, the Company entered into an agreement with Vernacular
Communications, Inc. and certain other individuals (collectively, "Vernacular")
pursuant to which Vernacular will provide various services to and for the
Company and BioPro, including introduction to the Company and BioPro of entities
interested in potential corporate alliances. If, as a result of such
introductions, the Company and BioPro enter into a transaction with such an
entity, the Company shall (i) pay to Vernacular 8%, 6% and 3% of the first,
second and third million dollars, respectively, paid to the Company for the
licensing of its products through BioPro and 2% of each subsequent million
dollars, (ii) pay to Vernacular 10% of all licensing fees/ royalties received in
connection with the transaction and (iii) grant to Vernacular 4% stock interests
in BioPro and/or any other business entity created as a result of the
transaction. In addition, the Company agreed to pay one of the individuals a
one-time consulting fee of $25,000.
The purpose of Core BioTech is to commercialize the Company's diagnostic
oriented patents which provide RNA technology to detect certain difficult to
diagnose viral diseases such as ME/CFS and other immuno-dysfunctional conditions
through strategically located central reference laboratories. In September,
1994, the Company granted an exclusive worldwide license and/or sub-license to
certain of its patents and assigned certain other patents to Core BioTech (the
"Core BioTech License") for a term of three years, which term will automatically
be extended for a term of 15 years in the event that Core BioTech provides
evidence that it has commercialized one or more of the patents. Core BioTech has
agreed that it will not develop any product or technology which may be deemed
therapeutic and has granted a right of first refusal to the Company with respect
to any technology which it may develop or acquire. Core BioTech has the right to
grant sublicenses subject to the requirement that its sublicensees agree to
non-competition arrangements with the Company. The Company has agreed that it
will not develop any technology related to the business of Core BioTech and has
granted Core BioTech a right of first refusal with respect to any technology it
may develop with respect to the business of Core BioTech.
The purpose of BioAegean is to commercialize the Company's consumer
oriented patents, especially in the skin care area including the development of
sunscreens to prevent malignant melanoma and maintain vitality of cutaneous
tissues normally lost with aging or increased sun exposure. In September, 1994,
the Company granted an exclusive worldwide license and/or sub-license to certain
of its patents and assigned certain other patents to BioAegean (the "BioAegean
License") for a term of three years, which term will automatically be extended
for a term of 15 years in the event that BioAegean provides evidence that it has
commercialized one or more of the patents. BioAegean has agreed that it will not
develop any product or technology which may be deemed therapeutic and has
granted a right of first refusal to the Company with respect to any technology
which it may develop or acquire. BioAegean has the right to grant sublicenses
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<PAGE>
subject to the requirement that its sublicensees agree to non-competition
arrangements with the Company. The Company has agreed that it will not develop
any technology related to the business of BioAegean and has granted BioAegean a
right of first refusal with respect to any technology it may develop with
respect to the business of BioAegean.
In exchange for the grant of the BioAegean License, BioAegean has agreed to
issue the following securities to the Company: (i) 1,000,000 shares of common
stock of BioAegean, (ii) an option to purchase 1,000,000 shares of common stock
of BioAegean at an exercise price of the lesser of the initial public offering
price of BioAegean or $5.00 per share, provided the initial public offering of
BioAegean occurs before May 4, 1997 and (iii) 10,000 shares of Preferred Stock
having a liquidation preference and a right to 1,000 votes for each share on all
matters that may come before the shareholders.
In June 1995, the directors of BioAegean approved the private placement of
1,000,000 shares of common stock at $1.00 per share which is expected in 1996 or
1997. In addition, the directors of BioAegean issued 10-year options to purchase
an aggregate of 1,200,000 shares of common stock of BioAegean at an exercise
price of $1.00 per share (the "BioAegean Options") to its officers and
directors. The BioAegean Options are conditional upon the recipient's agreement
to serve BioAegean as needed for at least 24 months unless fully incapacitated.
William A. Carter, M.D., Chairman, President and Chief Executive Officer of the
Company, serves as Chairman, Chief Executive Officer and a Director of BioAegean
and received 300,000 BioAegean Options. Peter Rodino, III, a director and
Secretary of the Company, serves as Vice-Chairman, Secretary, Corporate Counsel
and a director of BioAegean and received 150,000 BioAegean Options. R. Douglas
Hulse serves as Chief Operating Officer of both the Company and BioAegean and
received 50,000 BioAegean Options. Robert Peterson serves as Chief Financial
Officer of both the Company and BioAegean and received 50,000 BioAegean Options.
Sharon Will, Vice President of Investor Relations and Corporate Communications
for the Company, serves as Vice President of Marketing for BioAegean and
received 150,000 BioAegean Options. Harris Freedman serves as Vice President for
Strategic Alliances for both the Company and BioAegean and received 150,000
BioAegean Options. Richard Piani, a director of the Company, serves as a
director and the Advisor for European Affairs of BioAegean and received 50,000
BioAegean Options. Gerald Kay serves as a director for both the Company and
BioAegean and received 50,000 BioAegean Options. BioAegean's remaining director,
Jerome Belson, a principal shareholder of the Company, received 50,000 BioAegean
Options.
While the Company believes it has developed an international patent
position to cover these possible applications of its technology, no assurance
can be given that any of the goals of the three subsidiaries described above
will be achieved, that significant clinical testing will occur, that any
products will ultimately be developed, commercially or otherwise or that the
Company's patent position will be adequate to protect any products which may
result.
Patent Rights
The Company has sought patent protection in four major geographic markets:
the United States, Canada, Europe, and Japan. The Company has filed patent
applications involving chemistry and processes with the U.S. Patent and
Trademark Office and foreign patent applications in other countries, such as
members of the European Patent Convention, Canada, Japan, South Korea,
Australia. The Company's patents and patent applications are principally "field
of therapeutic use" patents and cover various potential uses of the Company's
RNA technology in the health care field, including ethical drugs for anti-viral
and cancer indications, as well as non-prescription consumer health care
products. "Field of therapeutic use" patents restrict the use of the compounds
to specific disease categories or medical conditions but do not restrict
potential competitors from manufacturing the same product for other potential
uses which are not covered by the Company's patents. Of the patent applications
filed worldwide, as of June 30, 1996 approximately 230 had been issued,
including 13 U.S. patents and 13 Canadian patents. None of such issued U.S.
patents will expire prior to the year 2006. No assurances can be given that the
Company's pending applications will mature into patents. The Company believes
that all of these 200 patents are pertinent to the Company's present and future
operations as the Company expects to market its product in Europe, Asia and
certain Third World countries, although the Company has not entered into any
additional agreements with respect to these areas and no assurance can be given
that any business relationship will result.
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<PAGE>
The Company's ability to receive patent protection for the commercial sale
of Ampligen is subject to the Company's obtaining enforceable patents covering
the use of the drug for a particular indication. The Company has been issued
certain patents on the use of Ampligen alone and Ampligen in combination with
certain other drugs for the treatment of HIV. The Company has also been issued a
patent on the use of Ampligen in combination with certain other drugs for the
treatment of HBV and HCV and a patent which affords protection on the use of
Ampligen in patients with ME/CFS. To date, the Company has not been issued any
patents in the U.S. regarding the use of Ampligen for treatment of the cancers
which the Company has sought to target. The Company's applications for such
patents are currently pending; no assurances can be given that such applications
will be allowed. No assurances can be given that competitors will not seek and
obtain patents regarding the use of Ampligen for a particular target indication
before the Company.
The Company's licensor, Temple University, has filed patent applications
regarding the composition of matter, methods of preparation and use of novel
double-stranded RNAs, oligonucleotides, and 2-5A analogues trademarked Oragen.
Composition of matter patent applications have been filed which define
nucleotide sequences and RNA structures that correct certain biochemical
reactions which may be associated with immunological disorders.
In July 1994, Temple University advised the Company that it was in breach
of a certain licensing agreement for Oragen compounds at the preclinical stage
of product development. In November 1994, in an action captioned HEM
Pharmaceuticals Corp. v. Temple University of the Commonwealth System of Higher
Education, the Company filed suit against Temple. In January 1995, Temple filed
a separate litigation against the Company. If the Company were to lose its
claim, the Company would lose its investment to date in certain Oragen compounds
acquired pursuant to the Temple Agreement. While not yet tested on humans these
Oragen compounds have the potential and theoretical advantage of having an
Ampligen-like effect upon oral administration. No assurance can be given that as
a result of such loss, Temple or its new licensee, if any, would not become
competitors of the Company or that the termination of the licensing agreement
will not have a materially adverse effect on the Company's long range business
or financial condition. See "Risk Factors--Disputes and Legal Proceedings
Related to Patent Rights" and "Business--Legal Proceedings" and "--Research and
Development, Licensing and Collaboration Agreements."
The patent positions of pharmaceutical and biotechnology firms, including
the Company, are generally uncertain and involve complex legal and factual
questions. Consequently, even though the Company is currently prosecuting many
patent applications with the U.S. and foreign patent offices, the Company does
not know how many of its applications will result in the issuance of any patents
or, of patents which are issued, whether they will provide significant
proprietary protection or will be circumvented or invalidated. Since patent
applications in the United States are maintained in secrecy until patents issue,
and since publication of discoveries in the scientific or patent literature tend
to lag behind actual discoveries by at least several months, the Company cannot
be certain that it was the first creator of the inventions covered by pending
patent applications or that it was the first to file patent applications for
such inventions. Competitors or potential competitors may have filed (or may
subsequently file) applications for, and may obtain, additional patents and
proprietary rights relating to, compounds or processes competitive with those of
the Company. Accordingly, there can be no assurance that the Company's patent
applications will result in patents being issued or, if issued, that the patents
will afford protection against competitors with similar technology; nor can
there be any assurance that others will not obtain patents that the Company
would need to license or circumvent.
There can be no assurance that any patents issued or which may in the
future be issued to the Company would be upheld by a court of competent
jurisdiction. The Company also relies upon unpatented trade secrets, and no
assurance can be given that others will not independently develop substantially
equivalent proprietary information and techniques or otherwise gain access to
the Company's trade secrets or disclose such technology, or that the Company can
meaningfully protect its right to unpatented trade secrets. See "Risk Factors
- --Uncertainty Regarding Patents and Proprietary Rights."
The Company currently requires its employees, consultants, outside
scientific collaborators and sponsored researchers and other advisors to execute
confidentiality agreements upon the commencement of employment or consulting
relationships with the Company. The Company also has required members of its
Scientific Advisory Board to sign a confidentiality agreement prior to each of
the last two annual meetings, at which confidential information was provided.
The Company will continue this practice in the future. These agreements require
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that all confidential information made known to the individual during the course
of the individual's relationship with the Company be kept confidential and not
disclosed to third parties except in specific circumstances. In the case of
employees, the agreements provide that all inventions conceived by the
individual shall be the exclusive property of the Company. There can be no
assurance, however, that these agreements will provide meaningful protection or
adequate remedies for the Company's trade secrets in the event of unauthorized
use or disclosure of such information.
In connection with the 1994 Common Stock Financing, the Company agreed with
Bridge Ventures to collateralize its patents until the earlier of the effective
date of the IPO or a licensing relationship or corporate partnership agreement
with a third party which provides significant operating capital and clinical
development resources for the Company. Pursuant to this arrangement, the SAB
Agreement has resulted in the release of liens on the Company's patents in the
licensed territories. Bridge Ventures has also released the patents assigned or
licensed to the Company's subsidiaries. Upon consummation of the IPO, the
collateralization of patents in connection with the 1994 Common Stock Financing
were terminated.
In addition, in May 1994, a former officer and director of the Company,
guaranteed payment of two promissory notes in the aggregate amount of $76,000
payable by the Company representing payments due in connection with the Temple
licensing agreement. In return for the guarantee, the Company assigned its
rights, patents and related technology in certain RNA compounds to such officer,
which rights will revert to the Company upon repayment of the principal on the
notes, 12% interest, and certain fees and expenses which were paid out of the
proceeds of the IPO.
In addition, in 1991, Vanderbilt University advised the Company of its
position that employees of the University were the inventors of an issued U.S.
patent regarding the use of Ampligen in combination with various other agents
(including AZT) for the treatment of HIV infection, a position which the Company
believes has no merit. See "Risk Factors--Disputes and Legal Proceedings Related
to Patent Rights" and "Business--Legal Proceedings."
Competition
The development of therapeutic drugs for human disease is intensely
competitive. Many different approaches are being developed for the management of
diseases targeted by the Company. Certain viral diseases and cancers are the
targets for therapeutic product development at numerous entities, many of which
have greater human and financial resources dedicated to product development and
human clinical testing than the Company. In addition, Ampligen will compete with
conventional drug therapy, as well as other modalities of treatment such as
biological and hormonal therapies, prophylactic and therapeutic vaccines and
surgery. Competing products include interferon-alpha and thymosin for treatment
of HBV, interferon-alpha and ribavirin for treatment of HCV and interleukin 2
for treatment of kidney cancer. Interferon, a drug that has been approved by the
FDA for the treatment of chronic HBV, acts by an immune mechanism and is
beneficial in the treatment of HBV, where it will be competitive with the
Company's product. However, its efficacy has thus far not been demonstrated in
HIV, ME/CFS and the primary tumors and indications which the Company has
targeted. The Company is also aware of a European firm which is conducting
clinical trials of an RNA drug for at least one indication (HBV) for which the
Company is testing Ampligen. This firm has also conducted pre-clinical research
of the drug as a possible treatment for HIV infection. The Company is not privy
to further information regarding other competing drug development activities, if
any, of this potential competitor. Competing products for the treatment of HIV
disease include AZT, DDI, DDC, D4T, 3TC and three approved protease inhibitors.
There are a number of other companies engaged in developing nucleic acid
pharmeuticals. The approach used by certain of such companies seeks to identify
specific proteins and /or nucleotide sequences associated with viral replication
or cell dysfunction and to design molecules that will selectively bind to these
"target sites" in order to interfere with the production or activity of the
specific disease-causing protein involved. This is the method currently being
employed by some researchers through the use of so-called "antisense" and
"triple-strand" nucleic acid technologies which are the pre-clinical or early
clinical testing phase. Such an approach requires the design, synthesis and
testing of numerous compounds for each disease or indication being treated.
Although no assurances can be given, the Company believes its RNA drug
development technology has certain advantages over these other technologies
because the Company believes its drugs may activate cell defenses which may
convey broad-spectrum activity against various diseases.
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The pharmaceutical and biotechnology industries are subject to rapid and
substantial technological change. Technological competition from pharmaceutical
and biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase. Most of
these entities have significantly greater research and development capabilities
than the Company, as well as substantial marketing, financial and managerial
resources, and represent significant competition for the Company. Acquisitions
of, or investments in, competing pharmaceutical and biotechnology companies by
large pharmaceutical companies as well as collaborative efforts among such
companies could increase such competitors' financial, marketing and other
resources. There can be no assurance that developments by others will not render
the Company's products or technologies obsolete or noncompetitive, or that the
Company will be able to keep pace with technological developments. Competitors
have developed or are in the process of developing technologies that are, or in
the future may be, the basis for competitive products. Some of these products
may have an entirely different approach or means of accomplishing the
therapeutic effect than products being developed by the Company. These competing
products may be more effective and less costly than the Company's products.
Furthermore, many of the Company's competitors have significantly greater
experience than the Company in pre-clinical testing and human clinical trials of
pharmaceutical products and in obtaining regulatory approvals of products.
Accordingly, the Company's competitors may succeed in obtaining product
approvals more rapidly than the Company. If any of the Company's products
receive regulatory approvals and the Company commences commercial sales of its
products, it will also be competing with respect to manufacturing efficiency and
marketing capabilities, areas in which it has limited or no experience. The
Company's competitors may possess or obtain patent protection or other
intellectual property rights that prevent, limit or otherwise adversely affect
the Company's ability to develop or exploit its products. See "Risk Factors
- --Uncertainty Regarding Patents and Proprietary Rights" and "Risk Factors --
Rapid Technological Change and Substantial Competition."
Research and Development, Licensing and Collaboration Agreements
In fiscal years 1992, 1993, 1994, 1995 and for the six months ended June
30, 1996, the Company expended $4,734,000, $2,119,000, $1,638,000, $258,000 and
$694,505 respectively, on research and development, consisting primarily of
amounts spent on the clinical testing and development of Ampligen. As part of
its research and development activities, the Company has entered into various
collaborative and sponsored research agreements with researchers, universities
and government agencies. The Company believes that these agreements provide the
Company with access to physicians and scientists with expertise in the fields of
clinical medicine, virology, molecular biology, biochemistry, immunology and
cellular biology.
The Company has a clinical pharmacology unit at Hahnemann University
Hospital in Philadelphia. This clinical pharmacology unit performs studies on
Ampligen metabolism in the body, and initiates clinical trials at the Phase I/II
level. The Company also plans to use this unit for its initial clinical studies
of Oragen drugs, subject to receipt of necessary clinical approvals.
The Company does not own its own research and development or drug discovery
laboratories. Instead, employees of the Company's collaborators conduct those
functions at the laboratories of their employers. The Company has a
long-standing relationship with Hahnemann University, which currently provides
laboratory support in conjunction with licensing arrangements and financial
support from the Company. No assurances can be given that such relationship will
continue on terms advantageous to the Company, or at all.
In June 1989, the Company entered into an assignment and research support
agreement (the "Hahnemann Agreement") with Hahnemann University and Dr. David
Strayer, Dr. Isadore Brodsky and Dr. David Gillespie who is now deceased (the
"Scientist Group"). Dr. Strayer is the Company's Medical Director. Prior to the
execution of the Hahnemann Agreement, Hahnemann and the Scientist Group had
participated in the clinical testing of Ampligen. In an effort to obtain the
benefits of the Scientist Group's future contributions to the development of
Ampligen and obtain exclusive rights to certain proprietary and regulatory
rights relating to Ampligen, the Company, Hahnemann and the Scientist Group
entered into the Hahnemann Agreement, which provides (i) for the assignment by
Hahnemann and the Scientist Group to the Company of all of their respective
rights in certain proprietary information which was then owned or subsequently
developed and the exclusive and perpetual right to apply for any patents,
trademarks or copyrights relating to the proprietary information; (ii) for the
payment by the Company to Hahnemann (and the sharing by Hahnemann and the
Scientist Group on such terms as they determine) of a royalty of 2% of net sales
proceeds (up to a maximum royalty of $6 million per year) on all Ampligen sold
by the Company or any entity licensed by the Company after the date of the grant
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by the FDA of the first NDA for Ampligen through January 1, 2005; (iii) for the
payment by the Company to Hahnemann of $162,000 for certain scientific
consultative support services to be performed by the Scientist Group during the
first year of the Hahnemann Agreement; (iv) for the payment by the Company to
Hahnemann of certain incremental amounts for scientific consultative support
services to be rendered by the Scientist Group subsequent to the first year of
the Hahnemann Agreement; (v) that either party may terminate the scientific
consultative support services of the Scientist Group (and the Company's
obligations to pay for those services) on 90 days' notice; and (vi) that all
rights to discovery and inventions resulting from the Hahnemann Agreement are to
be the exclusive property of the Company. The Company satisfied all amounts due
together with 8% annual interest calculable from the due date of each payment
upon the Closing of the IPO.
The Company has entered into an at-will arrangement with Hahnemann
University, and Dr. Strayer, among others, pursuant to which the services of Dr.
Strayer, among others, are made available to the Company in return for monthly
salary subsidization payments made by the Company to the University. The
aggregate amount of these monthly payments is presently $14,896.
In August 1988, the Company entered into a pharmaceutical use license
agreement with Temple University (the "Temple Agreement"). Under the terms of
the Temple Agreement, Temple granted the Company an exclusive world-wide license
for the term of the agreement for the commercial sale of Oragen products using
patents and related technology held by Temple, which license is exclusive except
to the extent Temple is required to grant a license to any governmental agency
or non-profit organization as a condition of funding for research and
development of the patents and technology licensed to the Company. The rights to
such patents and related technology had previously been assigned to Temple by
various parties, including Dr. Robert J. Suhadolnik, an employee of Temple. The
Temple Agreement provides (i) for the payment by the Company to Temple of 4% of
net sales of Oragen products the active ingredients of which consist entirely of
products, processes or uses claimed by Temple's patents and 2% of net sales of
Oragen products some, but not all, of the active ingredients of which consist of
products, processes or uses claimed by Temple's patents, with minimum royalties
of $30,000 per year commencing in 1995; (ii) that the Company must seek all
necessary approvals for the commercial sale of Oragen products; (iii) that the
Company must file an application for marketing approval for at least one
licensed product with the FDA or a foreign counterpart on or before August 3,
1996; (iv) for the funding of specified research payments by the Company; and
(v) that the Company shall have an exclusive option to negotiate for a period of
six months the terms of an exclusive license for the commercial sale of any
future related technology with respect to which Temple shall hold a patent. The
Temple Agreement expires upon the expiration of the last licensed patent, unless
sooner terminated by mutual consent, upon the failure by the Company to pay any
required royalties or upon any material breach of the agreement. Dr. Suhadolnik,
as well as his laboratory, will derive income and financial support from any
royalties paid by the Company. The Company was notified by Temple in July 1994
that it believed the Company was in breach of the Temple Agreement and that
Temple believed that the Temple Agreement was terminated. The Company has filed
a lawsuit seeking a declaratory judgement that the Temple Agreement remains in
full force and effect and seeking monetary damages. Temple has filed a motion to
dismiss this lawsuit and in January 1995, Temple has filed a separate litigation
against the Company seeking declaratory judgment that the Temple Agreement has
been lawfully terminated, together with an award of costs, including attorney
fees. See "Business--Legal Proceedings" and "Risk Factors--Disputes and Legal
Proceedings Related to Patent Rights."
In May 1992, the Company entered into a letter agreement to provide
research payments to Dr. Werner E. Muller at the University of Mainz for various
exclusive 20-year licensing arrangements including certain technologies for
genetic manipulation of the 2-5A pathway. The Company believes that the research
being conducted by Dr. Muller will provide general knowledge with respect to the
manipulation of the cellular mechanism by which Ampligen works. The Company
agreed to make quarterly research payments of $5,000 during the course of the
consultative agreement, which has no explicit duration, which payments are
presently accruing.
In addition to the arrangements with Temple University and Hahnemann
University described above, the Company has two types of collaborative research
arrangements. First, the Company has entered into "sponsored research
arrangements" with various institutions which provide for the payment by the
Company of specified financial support to the institutions which conduct the
research. Second, the Company has entered into "collaborative arrangements"
pursuant to which the institution conducts studies of the Company's products at
the institution's expense and gives the Company exclusive commercial rights to
research results. The Company provides its drugs to these institutions free of
charge. Collaborative research arrangements provide that the proprietary
knowledge is the sole property of the Company but permit the collaborator, after
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a specified time period, to publish the results of its research in scientific
medical journals. The Company has research agreements with the National
Institute for Allergy and Infectious Diseases on the use of Ampligen and Oragen
products in the treatment of HBV infection and various herpes and respiratory
viruses and Hahnemann University on the biochemical and molecular activities of
RNA. Other collaborators include the following entities or scientists therefrom:
the National Cancer Institute, Harvard University Medical School, Yale
University Medical School, Vanderbilt University, University of Pittsburgh,
Howard University, Cornell University, Georgetown University, Stanford
University, University of Pennsylvania, Medical College of Pennsylvania,
University of California at Davis and the Uniformed Services University for the
Health Sciences. International collaborations include scientists from Konstanz
University (Germany), University of Mainz (Germany), University of Toronto
(Canada) and Juntendo University (Japan).
The Company intends to continue to engage in such collaborative and
sponsored research with selected institutions. There can be no assurance,
however, that the Company will be able to maintain its existing collaborative
arrangements or enter into new collaborative arrangements.
Marketing
The Company intends to design its marketing strategy to reflect the
differing health care systems around the world, and the different marketing and
distribution systems that are used to supply pharmaceutical products to those
systems. In the United States, the Company expects that, subject to receipt of
regulatory approval, Ampligen will be used in three medical arenas: physicians'
offices or clinics, the hospital and the home setting. The Company currently
plans to use a service provider in the home infusion (non-hospital) segment of
the U.S. market to execute direct marketing activities, conduct physical
distribution of product and handle billings and collections. Accordingly, the
Company is developing marketing plans to facilitate the product distribution and
medical support for indications, if and when they are approved . The Company
believes that this approach will facilitate the generation of revenues without
incurring the substantial costs associated with a sales force. Furthermore, this
approach will enable the Company to retain many options for future marketing
strategies.
In September 1995, the Company entered into an agreement with Rivex Pharma
Inc., a Canadian-based pharmaceutical company ("Rivex"), pursuant to which Rivex
will provide various services in connection with the exclusive distribution of
Ampligen in Canada on an emergency drug release basis. Under the terms of this
agreement, the Company will supply and Rivex will purchase as much Ampligen as
necessary to satisfy Rivex's customers at a mutually agreed upon cost. In
return, Rivex will retain the exclusive right to distribute Ampligen in Canada.
In Europe, the Company plans to adopt a country-by-country and, in certain
cases, an indication-by-indication, marketing strategy due to the heterogeneity
of governmental regulations and alternative distribution systems in these areas.
The Company also plans to adopt an indication-by-indication strategy in Japan.
Subject to receipt of regulatory approval, the Company plans to seek strategic
partnering arrangements with pharmaceutical companies to facilitate product
introductions in these areas. No assurances can be given that any such
arrangement will be entered into on terms acceptable to the Company. The
relative prevalence of people suffering from target indications for Ampligen
varies significantly by geographic region, and the Company intends to adjust its
clinical and marketing planning to reflect the special needs of each area. The
Company does not currently anticipate devoting significant resources to the
establishment of an in-house sales force in the near term.
In countries in South America, the United Kingdom, Ireland, Africa,
Australia, Tasmania, New Zealand, and certain other countries and territories,
the Company contemplates marketing its products through its relationship with
SAB/Bioclones pursuant to the SAB Agreement. See "Business--General."
The Company is also developing a set of clinical laboratory diagnostic
products, trademarked Diagen products, that are designed to assist physicians in
identifying patients for the Company's RNA drug therapies and to assist in their
clinical management thereafter. The Company believes that the availability of
such tests may lead to improved patient care and increased market penetration by
the Company's therapeutic products, if and when such products are available for
commercial sale, although the Company does not anticipate deriving significant
revenues directly from the commercial sale of Diagen products. These tests are
at an early stage of development and the Company has received limited royalties
in 1994 from its licensed reference laboratory in Texas. The Diagen products
would have to go through a regulatory diagnostic product clearance process
applicable to medical devices prior to commercial sale. In some cases, use in
clinical trials may require FDA clearances. See "Business--Government
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Regulation" below. The Company's objective is to license these potential
products to a diagnostic company. The Company has granted rights to certain of
the patents related to the Diagen products to one of its subsidiaries. See
"Business--Subsidiary Companies."
Manufacturing
Drug intermediates used in the production of Ampligen are manufactured to
order by Pharmacia Biotech, Inc. ("Pharmacia"), a division of Pharmacia Upjohn,
Inc., a major multinational pharmaceutical company. In 1987, the Company entered
into an agreement (the "Supply Agreement") with Pharmacia pursuant to which
Pharmacia agreed to supply and the Company agreed to purchase a specified amount
of drug intermediates and pay certain royalties to Pharmacia. The provisions of
the Supply Agreement requiring the sup- ply/purchase of compounds used in the
manufacture of Ampligen expired in December 1992, although the provisions
dealing with the payment of royalties survived. Although the Company does not
currently have a written agreement with Pharmacia for the supply of drug
intermediates, the Company believes that acceptable alternative sources exist
for the Company's present quantity requirements should the Company's arrangement
with Pharmacia terminate. The Company believes that it is not dependent on a
single source for any raw materials used in the manufacture of Ampligen. The
intermediates are analyzed by the Company for compliance with specifications and
then transferred to a contractor which formulates the Ampligen drug
intermediates under controlled conditions to manufacture a freeze-dried dosage
form of Ampligen. The Company does not have a written agreement with such
contractor. The freeze-dried product is tested by the Company to determine
compliance with a set of technical specifications. Upon meeting these
specifications, the product is transferred to the Company and dosage units are
then prepared at the Company's Rockville, Maryland facility or at an appropriate
hospital or other pharmacy facility. Pharmacia owns 9,216 shares of Common
Stock. In addition, pursuant to the terms of the Supply Agreement, the Company
agreed to pay the following royalties to Pharmacia: (a) for each substance based
on Ampligen or related RNA compounds, 0.5% of net sales for 5 years from the
date of the first commercial sale (subject to a cap of $5 million per year and a
minimum of $60,000 per year for each substance) and (b) for each family of RNA
substances, other than substances based on Ampligen or related RNA compounds,
0.5% of net sales for 5 years from the date of the first commercial sale
(subject to a cap of $5 million per year and a minimum of $60,000 per year for
each family of RNA substances). The obligation to pay royalties expires 12 years
from the date of the first royalty payment under the Supply Agreement.
If necessary regulatory approvals for commercial sale of a product are
obtained, the Company's products must be manufactured in commercial quantities
in compliance with all applicable regulatory requirements and at acceptable
costs. The Company's current facilities and personnel are not adequate for the
production of its proposed products for large-scale commercialization. Moreover,
it is not likely that the same processes can be used successfully for
commercial, large scale production. Small changes in methods of manufacture may
affect the chemical identity, as well as the safety and efficacy of drug
products such as Ampligen and other RNA drugs. The Company intends to utilize
third-party facilities or if it is unable to do so, build or acquire
commercial-scale manufacturing facilities and to add appropriate personnel as
the need arises.
Pursuant to the SAB Agreement, the Company owns 24.9% of the capital stock
of a company which is developing and operating a new manufacturing facility
South Africa built to FDA standards to produce the Company's RNA drugs. A pilot
facility is currently being expanded. The Company expects that construction of a
commercial facility will commence in 1997 although the construction is dependent
upon the regulatory status of Ampligen in various global markets, and no
assurance can be given with respect to when, and if, construction will occur.
Government Regulation
Overview. Regulation by governmental authorities in the U.S. and foreign
countries is and will be a significant factor in the manufacture and marketing
of the Company's proposed products and in its ongoing research and product
development activities. All of the Company's proposed products and products of
its ongoing research and product development activities will require regulatory
clearances prior to commercialization. In particular, human new drug products
are subject to rigorous preclinical and clinical testing as a condition of
clearances by the FDA and by similar authorities in foreign countries. The
lengthy process of seeking these approvals, and the ongoing process of
compliance with applicable statutes and regulations, has required and will
continue to require the expenditure of substantial resources. Any failure by the
Company or its collaborators or licensees to obtain, or any delay in obtaining,
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regulatory approvals could materially adversely affect the marketing of any
products developed by the Company and its ability to receive product or royalty
revenue.
The Company is also subject to various federal, state and local laws,
regulations and recommendations relating to such matters as safe working
conditions, laboratory and manufacturing practices, the experimental use of
animals and the use of and disposal of hazardous or potentially hazardous
substances, including radioactive compounds and infectious disease agents, used
in connection with the Company's research work. The Company believes that its
Rockville, Maryland manufacturing and quality assurance/control facility is in
substantial compliance with all material regulations applicable to these
activities.
U.S. Regulatory Process. Before a new drug product may be sold commercially
in the U.S. and other countries, clinical trials of the product must be
conducted and results submitted to the appropriate regulatory agencies as part
of the approval process. The Company's therapeutic and diagnostic products are
subject to regulation in the U.S. under the Food, Drug and Cosmetic Act (the
"FDC Act"). Ampligen and other RNA drugs will be reviewed as new drugs by the
FDA's Center for Drug Evaluation and Research ("CDER"), instead of as biological
products which are regulated by FDA's Center for Biologics Evaluation and
Research ("CBER"). Originally, the Company's RNA drugs were considered
biological products subject to CBER jurisdiction. As part of various memoranda
of understanding executed recently among different FDA divisions, however,
responsibility for regulation of synthetic nucleic acids, such as the Company's
RNA drug products, including Ampligen, was transferred in 1992 to the CDER.
Although important differences exist between the regulation of biological
therapeutics and other drugs, the Company is unable to predict the impact of the
transfer of regulatory responsibility from CBER to CDER.
(a) Drug Products. The steps required before a non-biological drug
product may be marketed in the U.S. include (a) conducting appropriate
pre-clinical laboratory and animal tests, (b) submitting to the FDA an
application for an Investigational New Drug ("IND"), which must become
effective before human clinical trials may commence, (c) conducting
well-controlled human clinical trials which establish the safety and
efficacy of the drug product, (d) filing a New Drug Application ("NDA")
with the FDA, and (e) obtaining FDA approval of the NDA prior to any
commercial sale or shipment of the drug. In addition to obtaining FDA
approval for each indication to be treated with each product, each domestic
drug manufacturing establishment must register with the FDA, list its drug
products with the FDA, comply with current Good Manufacturing Practices
("GMP") requirements and be subject to inspections by the FDA. Foreign
manufacturing establishments also must comply with GMP requirements, and
are subject to periodic inspection by the FDA or by local authorities under
agreement with the FDA.
Pre-clinical tests include formulation development, laboratory evaluation
of product chemistry and animal studies to assess the potential safety and
efficacy of the product formulation. Drug products must be manufactured in
accordance with GMP requirements and pre-clinical tests must be conducted in
accordance with the FDA regulations regarding Good Laboratory Practices. The
results of the pre-clinical tests are submitted to the FDA as part of the IND
and are reviewed by the FDA prior to authorizing the sponsor to conduct clinical
trials in human subjects. Unless the FDA objects to an IND, the IND will become
effective 30 days following its receipt by the FDA. There is no certainty that
submission of an IND will result in FDA authorization to commence clinical
trials or that authorization of one phase of a clinical trial will result in
authorization of other phases or that clinical trials will result in FDA
approval. Clinical trials may be placed on hold by the FDA at any time for a
variety of reasons, particularly if safety or design concerns exist.
(b) Clinical Testing Requirements. Clinical trials involve the
administration of the investigational drug product to human subjects.
Clinical trials typically are conducted in three phases and are subject to
detailed protocols. Each protocol indicating how the clinical trial will be
conducted must usually be submitted for review to the FDA as part of the
IND. The FDA's review of a study protocol does not necessarily mean that,
if the study is successful, it will constitute proof of efficacy or safety.
Further, each clinical study must usually be conducted under the auspices
of an independent Institutional Review Board ("IRB") established pursuant
to FDA regulations. The IRB considers, among other factors, ethical
concerns, informed consent requirements, and the possible liability of the
hospital conducting the trials. The FDA or IRB may require changes in a
protocol both prior to and after the commencement of a trial. There is no
assurance that the IRB or FDA will permit a study to go forward or, once
started, to be completed.
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The three phases of clinical trials are generally conducted sequentially,
but they may overlap. In Phase I, the initial introduction of the drug into
humans, the drug is tested for safety, side effects, dosage tolerance,
metabolism and clinical pharmacology. Phase I testing for an indication
typically takes at least one year to complete. Phase II involves controlled
tests in a larger but still limited patient population to determine the efficacy
of the drug for specific indications, to determine optimal dosage and to
identify possible side effects and safety risks. Phase II testing for an
indication typically takes at least from one and one-half to two and one-half
years to complete. If preliminary evidence suggesting effectiveness has been
obtained during Phase II evaluations, expanded Phase III trials are undertaken
to gather the additional information about effectiveness and safety that is
needed to evaluate the overall benefit-risk relationship of the drug and to
provide an adequate basis for physician labeling. Phase III studies for an
indication generally take at least from two and one-half to five years to
complete. There can be no assurance that Phase I, Phase II or Phase III testing
will be completed successfully within any specified time period, if at all, with
respect to any of the Company's products that have not yet completed any
suchtesting. Nor can there be any assurance that completion of clinical testing
will result in FDA approval. Furthermore, the FDA may suspend clinical trials at
any time if the patients are believed to be exposed to a significant health
risk. Phase III or other clinical studies may be conducted after rather than
before approval under certain circumstances. For example, the FDA may determine
under its accelerated approval regulations that earlier studies, involving the
use of surrogate markers rather than clinical outcomes, may establish an
adequate basis for drug product approval, providing that the sponsor agrees to
conduct an additional study after approval to verify and describe the clinical
benefit of the drug. These and other similar regulations, however, are often
limited to drug products that are intended to treat serious or life-threatening
diseases, especially those diseases for which there are no alternative
therapies, or that provide meaningful therapeutic benefit to patients over
existing treatments. The Company believes that Ampligen may be eligible for
review under the FDA's "accelerated approval" or other similar regulations for
certain indications; however, the Company has not decided whether to seek such
accelerated or other similar approval and no assurances can be given that such
accelerated or other similar approval, if sought, will be granted for any
indication pursuant to such regulations.
In the case of drugs for life-threatening diseases, the initial human
testing is generally done on patients rather than on healthy volunteers. Because
these patients are already afflicted with the target disease, it is possible
that such studies may provide results traditionally obtained in Phase II trials.
These trials are referred to as Phase I/II trials.
Reports of results of the pre-clinical studies and clinical trials for
non-biological drugs are submitted to the FDA in the form of an NDA for approval
of the marketing and commercial shipment. The NDA also includes information
pertaining to the preparation of drug substances, analytical methods, drug
product formulation, details on the manufacture of finished product as well as
proposed product packaging and labeling. Submission of an NDA does not assure
FDA approval for marketing. The application review process generally takes two
to three years to complete, although reviews of treatments for cancer and other
life-threatening diseases may be accelerated or expedited. However, the process
may take substantially longer if, among other things, the FDA has questions or
concerns about the safety and/or efficacy of a product. In general, the FDA
requires at least two properly conducted, adequate and well-controlled clinical
studies demonstrating efficacy with sufficient levels of statistical assurance.
However, additional information may be required. For example, the FDA also may
request long-term toxicity studies or other studies relating to product safety
or efficacy. Notwithstanding the submission of such data, the FDA ultimately may
decide that the application does not satisfy its regulatory criteria for
approval. Finally, the FDA may require additional clinical tests following NDA
approval to confirm product safety and efficacy (Phase IV clinical tests).
Among the requirements for product approval is the requirement that
prospective manufacturers conform to the FDA's GMP standards. In complying with
GMP standards, manufacturers must continue to expend time, money and effort in
production, recordkeeping and quality control to ensure that the product meets
applicable specifications and other requirements. The FDA periodically inspects
drug manufacturing facilities in order to ensure compliance with applicable GMP
requirements. Failure to so comply subjects the manufacturer to possible FDA
action, such as the suspension of manufacturing, seizure of the product, or
voluntary recall of a product.
The product testing and approval process is likely to take a substantial
number of years and involves the expenditure of substantial resources. There can
be no assurance that any approval will be granted on a timely basis, or at all.
The FDA also may require post-marketing testing and surveillance to monitor the
record of the product and continued compliance with regulatory requirements.
Upon approval, a drug may only be marketed for the approved indications in the
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approved dosage forms and at the approved dosages. Adverse experiences with the
product must be reported to the FDA. The FDA also may require the submission of
any lot of the product for inspection and may restrict the release of any lot
that does not comply with FDA standards, or may otherwise order the suspension
of manufacture, recall or seizure. Product approvals may be withdrawn if
compliance with regulatory standards is not maintained or if problems concerning
safety or efficacy of the product occur following approval.
In addition to applicable FDA requirements, the Company is subject to
foreign regulatory authorities governing clinical trials and drug sales. Whether
or not FDA approval has been obtained, approval of a product by the comparable
regulatory authorities of foreign countries must be obtained prior to the
commencement of marketing of the product in those countries. The approval
process varies from country to country and the time required may be longer or
shorter than that required for FDA approval.
(c) Orphan Drug Status. Under the Orphan Drug Act, the FDA may
designate drug products as orphan drugs if they are intended to treat a
rare disease or condition, which is defined as a disease or condition that
affects less than 200,000 persons in the U.S., or if there is no reasonable
expectation of recovery of the costs of research and development from sales
in the U.S. Provided certain conditions are met, orphan drug status confers
upon the sponsor certain tax credits for amounts expended on clinical
trials prior to 1995, as well as marketing exclusivity for seven years
following FDA approval of the product. Marketing exclusivity means that the
FDA cannot approve another version of the same product for the same use for
seven years after approval of the first product. However, the FDA can still
approve a different drug for the same use or the same drug for a different
use. The FDA regulations implementing the Orphan Drug Act define what drugs
are the "same" for purposes of the seven year market exclusivity
provisions. The Company has been advised that nucleic acids and other
complex drugs may present potentially difficult orphan drug issues under
these regulations. The Company cannot predict how these provisions will be
implemented with respect to its RNA products and competitive drugs. Certain
benefits of orphan drug status are only available upon obtaining FDA
approval for marketing. For example, orphan drug exclusivity only vests in
the same designated product that is first to receive FDA marketing
approval. In 1993, Ampligen was designated as an orphan drug by the FDA for
the clinical indications of AIDS and renal cell carcinoma. The Company does
not believe that the former designation extends to HIV disease which has
not progressed to AIDS. In December 1993, the FDA designated Ampligen as an
orphan drug for the clinical indications of invasive malignant melanoma and
chronic fatigue syndrome. The FDA has recently denied a request by the
Company to designate Ampligen as an orphan drug for chronic active HBV
infection. There is no assurance that any future products will receive
orphan drug designation, or that the benefits currently available from such
designations for Ampligen will not hereafter be amended or eliminated.
Various legislative proposals have from time to time been introduced in
Congress to modify various provisions of the Orphan Drug Act. Currently,
Congress is considering legislation that would amend the Orphan Drug Act
and may limit the scope of marketing exclusivity. The tax credit provisions
expired on December 31, 1994. No prediction can be made as to the effect of
any such proposed legislation, or any other legislation which may be
introduced in the future, on the Company's operations.
(d) Diagnostic Products. The Company's potential Diagen diagnostic
products also must receive FDA clearance prior to any commercial marketing.
The FDC Act regulates most in vitro diagnostic products as medical devices,
and provides for two clearance mechanisms. Certain products may qualify for
a Section 510(k) procedure, under which the manufacturer gives the FDA a
premarket notification ("510(k) Notice") of the manufacturer's intent to
commence marketing the product. The manufacturer must establish that the
product to be marketed is "substantially equivalent" to another legally
marketed product which is subject to a 510(k) Notice or was commercially
marketed prior to May 28, 1976 and is not subject to premarket application
("PMA") requirements. In some cases, a 510(k) Notice must include data from
human clinical studies. Normally, marketing may commence when the FDA
issues an order to the manufacturer finding the product to be
"substantially equivalent." If the product does not qualify for the 510(k)
procedure, the manufacturer must file a PMA which includes results of
extensive clinical and nonclinical tests demonstrating that the product is
both safe and effective. The PMA process requires more intensive testing
than the 510(k) procedure, involves a significantly longer FDA review
process, and usually requires review by an FDA scientific advisory
committee. Approval of a PMA allowing commercial sale of a product requires
that its safety and effectiveness be demonstrated through human clinical
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studies, usually conducted under an Investigational Device Exemption
("IDE"). Some diagnostic products may be clinically tested without an FDA
approved IDE. It is unknown at this time whether an IDE will be required in
order to clinically test Diagen products. In responding to a PMA, the FDA
may grant marketing approval, request additional information or deny the
application if it determines that the application does not satisfy its
regulatory approval criteria. There can be no assurance that
investigational or marketing approvals or clearances for Diagen products
will be granted to the Company.
Canadian Regulatory Process. The regulatory approval process in Canada of
pre-clinical and clinical trials, manufacturing and sales of drugs, registration
of establishments which manufacture biologics, compliance with GMP requirements
and periodic inspection by the HPB is, in general, similar to that in the United
States.
(a) Investigational New Drug Application. Before conducting clinical
trials of a new drug in Canada, a company must submit an IND application to
the HPB containing various information about the drug. In November 1992,
the HPB approved the Company's INDs to conduct open-label and controlled
clinical trials of Ampligen for ME/CFS. There is no assurance that the HPB
will accept data obtained from those clinical trials in any submission of
the Company to the HPB to market Ampligen in Canada or that such data, if
accepted, will result in the approval of Ampligen for sale in Canada. The
HPB may place clinical trials on hold at any time if safety concerns exist.
(b) New Drug Submission. Before marketing or selling a new drug in
Canada, the Company must submit a New Drug Submission ("NDS") to the HPB
and receive a notice of compliance from the HPB to sell the drug. The NDS
includes information describing the new drug, including its proper name,
the proposed name under which the new drug will be sold, the specifications
of the new drug, the methods of manufacturing, processing and packaging the
new drug, the controls applicable to these operations, the tests conducted
to establish the safety of the new drug, the tests to be applied to control
the potency, purity, stability and safety of the new drug, the results of
clinical trials and the effectiveness of the new drug when used as
intended. Submission of an NDS does not assure HPB approval of a new drug
for sale. If it determines the NDS meets the requirements of Canada's Food
and Drugs Act and Regulations, the HPB will issue a notice of compliance
for the new drug.
The HPB may deny approval of an NDS if applicable regulatory criteria are
not satisfied or may require additional testing. Product approvals may be
withdrawn if compliance with regulatory standards is not maintained or if
problems occur after the drug reaches the market. The HPB may require testing
and surveillance programs to monitor the new drug once commercialized.
Non-compliance with applicable requirements can result in fines and other
penalties, including product seizures and criminal prosecutions.
Among the requirements for product approval in Canada is the requirement
that a prospective manufacturer conform to the HPB's GMP and good laboratory
practices ("GLP") standards. Before manufacturing a biologic, a manufacturer
must have a license from the HPB that is specific to the site of manufacture.
The HPB periodically inspects the drug manufacturing site in order to ensure
compliance with Canada's Food and Drugs Act and Regulations and GMP and GLP
requirements. If there is a safety concern, the HPB, apart from other sanctions,
can suspend the manufacture of the product.
Certain provinces in Canada have the ability to determine whether the costs
of a drug sold within such province will be reimbursed by a provincial
government health plan by listing drugs on formularies. These provincial
formularies may affect the prices of drugs and the volume of drugs sold within
provinces. The Patented Medicines Prices Review Board has the ability to assess
whether the price of a patented medicine is excessive and, if determined to do
so, the Board has the ability to require the patent owner to reduce the price of
the patented medicine, to reduce the price of another patented medicine or to
remit money to the government.
Proposals have recently been made that, if implemented, would significantly
change Canada's drug approval system. Proposals include establishing a separate
agency for drug regulation and modeled on European Community agencies. It is
uncertain whether drugs such as the Company's would be evaluated by this
separate agency, and the Company is unable to predict the impact, if any, on the
transfer of regulatory responsibility from the HPB to the separate agency. The
Company is unable to predict whether these proposals will be implemented or, if
implemented, the effect thereof on the Company.
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Properties
The Company leases and occupies a total of approximately 18,850 square feet
of laboratory and office space in two states. The corporate headquarters in
Philadelphia, Pennsylvania are located in a suite of offices of approximately
15,000 square feet. The pharmacy, packaging, quality assurance and quality
control laboratories, as well as additional office space, are located in
Rockville, Maryland. These facilities occupy approximately 3,850 square feet,
approximately 2,000 of which are dedicated to the packaging and quality control
product release functions. The Company believes that its Rockville facilities
will meet its production requirements, including sufficient quantities of
Ampligen for planned clinical trials, through 1996, at which time it may need to
increase its manufacturing capacity either through third parties or by building
or acquiring commercial-scale facilities.
In addition, the Company has entered into the SAB Agreement, which provides
the Company with 24.9% of the capital stock of a company which is developing and
operating a new manufacturing facility financed by SAB/Bioclones. The Company
expects that manufacturing at this new facility will commence in 1996, although
no assurance can be given that this will occur. A commercial facility is
expected to be built in 1997.
Legal Proceedings
The Company was a defendant in a lawsuit instituted in 1991 by participants
in a double-blind placebo-controlled clinical trial of Ampligen therapy for
ME/CFS. The plaintiffs alleged that the Company or its alleged agents promised
them that they would receive Ampligen after the placebo-controlled study at no
cost for periods ranging from "until marketable" to "for life". Plaintiffs
sought compensatory and punitive damages. The court granted the Company's
motions for summary judgment upon all claims alleged by the plaintiffs in this
case. The plaintiffs have appealed from these orders before the United States
Court of Appeals for the Ninth Circuit. In January 1996, the Court of Appeals
denied their appeal and sustained the Company's position. On the basis of the
Court of Appeals favorable decision, the Company believes the lawsuit is over
with no material effect on the Company.
In February 1991, Vanderbilt Universit advised the Company of its position
that employees of the university were the inventors of an issued U.S. patent
regarding the use of Ampligen in combination with various other agents
(including AZT) for the treatment of HIV infections. As issued, this patent
names the Company's Chief Executive Officer as sole inventor and the Company as
sole assignee. The university has demanded that the patent be reissued naming
the university's employees as inventors and the university as assignee. The
Company refused to take such action. No formal claim has been filed by the
university. If such claim were field and if such claim were found to have merit,
the loss of the patent at issue would not have a materially adverse effect on
the Company's long-range business since the university would only be able to
limit and/or prevent the Company's use of Ampligen in combinations with AZT in
the treatment of HIV.
In November 1994, the Company filed suit against Temple University
("Temple") in the Superior Court of the State of Delaware ("Superior Court")
seeking a declaratory judgment that the Temple Agreement remains in full force
and effect and seeking monetary damages in excess of $10 million for Temple's
alleged breach of its obligations of good faith and fair dealing and certain
terms of the Temple Agreement. Temple has filed a motion to dismiss this lawsuit
upon the grounds of lack of personal jurisdiction. In January 1995, Temple filed
separate litigation against the Company in the Court of Common Pleas of
Philadelphia County seeking declaratory judgment that the Temple Agreement has
been lawfully terminated as of July 1, 1994, together with an award of costs
including attorney fees, in bringing the action. The court of Common Please has
stayed further proceedings in the litigation pending the outcome of the
Company's Superior Court case. If the Company were to lose its claim, the loss
of the licensing agreement could have a material adverse effect on the Company's
future business as Temple or its new licensees, if any, could become competitors
of the Company.
In March 1995, the Company instituted a declaratory judgment action against
the February 1992 noteholder of a $5 million convertible note and a second
defendant in the United States District Court for the Eastern District of
Pennsylvania (the "Pennsylvania action") to declare as void, set aside and
cancel the February 1992 convertible note between the Company and the noteholder
(the"Note"). In addition, the noteholder instituted suit against the Company on
the Note in the Circuit Court of the 15th Judicial District in and for Palm
Beach County, Florida, seeking judgment on the note, plus attorneys fees, costs
and expenses; in August 1995, this action was stayed by the Florida Court
pending the outcome of the Pennsylvania action. The noteholder also filed a
motion for a preliminary injunction in the Pennsylvania court to enjoin the
Company from disbursing the proceeds of the IPO in the amount of $5.8 million,
47
<PAGE>
which motion was granted in November, 1995. On February 15, 1996, the Company
reached an agreement to settle this matter. Terms and conditions of the
settlement include payment of $6,450,000 to the noteholder to cover the note
balance and legal expenses. The noteholder and related parties are to maintain
certain Warrants that were granted prior to the lawsuit. Other Warrants granted
to the noteholder in the note restructuring in 1994 were relinquished. The funds
under this settlement were paid on March 21, 1996. Mutual releases were executed
which completed the settlement of the litigation.
The Company is subject to claims and legal actions that arise in the
ordinary course of their business. Management believes that the ultimate
liability, if any, with respect to these claims and legal actions will not have
a material effect on the financial position or results of operations of the
Company.
The Company is not currently a party to any other material litigation.
Employees and Consultants
As of July 10, 1996, the Company had 15 full-time employees. Of these
employees, 10 either conduct or support the Company's research, development,
manufacturing, regulatory affairs or preclinical testing. The remaining five
employees perform general administrative functions including financial matters
and investor relations. In addition, as of July 10, 1996, eight individuals
employed at academic institutions served as consultants or independent
contractors to the Company. Such persons are paid pursuant to licensing
agreements with two universities. As of July 10, 1996, there were approximately
29 additional individuals who served as part-time consultants or independent
contractors to the Company. In addition, other individuals throughout the United
States from time to time are retained by the Company as independent contractors,
either on a per diem or monthly basis. The Company believes that it has been
successful in attracting skilled and experienced scientific personnel; however,
competition for such personnel is intense and there can be no assurance that the
Company will be able to attract and retain necessary qualified employees and/or
consultants in the future. None of the Company's employees is covered by
collective bargaining agreements.
Scientific Advisory Board
The Company established its Scientific Advisory Board in March 1991. The
Scientific Advisory Board consists of individuals who the Company believes have
particular expertise in immunology, virology, pharmacology, cancer therapeutics,
biochemistry and related fields. These individuals advise the Company about
present and long-term scientific planning, research and development. The
Scientific Advisory Board holds annual meetings as required by the clinical
studies in progress by the Company. In addition, individual Scientific Advisory
Board members sometimes consult with, and meet informally with, employees of the
Company on a more frequent basis. All members of the Scientific Advisory Board
are employed by employers other than the Company and may have commitments to, or
consulting and/or advisory agreements with, other entities, including potential
competitors of the Company, that may limit their availability to the Company.
The time spent by Scientific Advisory Board members on the Company's affairs
varies. Although individual members of the Scientific Advisory Board may devote
significant time and energy to the affairs of the Company, no member is expected
to devote more than a small portion of his time to the Company. Members of the
Scientific Advisory Board are compensated at a rate of $1,500 per meeting
attended or day devoted to Company affairs. In addition, Doctors Cheng and
Brodsky have been granted options to acquire 4,608 and 5,253 shares of Common
Stock, respectively, at exercise prices of $4.34 and $1.06 per share,
respectively. As described elsewhere herein, Dr. Brodsky is a party to the
Hahnemann Agreement, pursuant to which he is entitled to receive certain
royalties from the Company with respect to sales of Ampligen. See "Research and
Development, Licensing and Collaboration Agreements."
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<PAGE>
The following information is furnished with respect to members of the
Scientific Advisory Board:
<TABLE>
<CAPTION>
NAME POSITIONS INSTITUTION
- ------ ----------- --------------
<S> <C> <C>
Isadore Brodsky, M.D. Professor of Medicine and Head, Medical College of Pennsylvania and
Division of Hematology/Oncology Hahnemann University School of
Medicine, Philadelphia, Pennsylvania
Yung-Chi Cheng, Ph.D. Director, Developmental Therapeutics/ Yale University School of Medicine,
Chemotherapy Program New Haven, Connecticut
Professor of Pharmacology and Yale University Center, New Haven,
Comprehensive Internal Medicine Connecticut
Clyde Crumpacker, M.D. Professor of Medicine Harvard Medical School,
Boston, Massachusetts
Physician Harvard Medical School,
Brigham & Women's Hospital,
Beth Israel Hospital,
Boston, Massachusetts
Robert A. Good, Ph.D. Distinguished Professor Departments of Pediatrics
and M.D., D.Sc. Microbiology, University
of South Florida, Tampa, Florida
Physician-in-Chief All Children's Hospital,
St. Petersburg, Florida
James Greene, Ph.D. Associate Professor of Biology Catholic University, Washington, D.C.
Anthony L. Komaroff, M.D. Professor of Medicine, Harvard Medical School,
Chief, Division of General Medicine Brigham & Women's Hospital,
Boston, Massachusetts
William Mitchell, M.D., Ph.D Professor of Pathology Vanderbilt School of Medicine,
Nashville, Tennessee
Phillip Roane, P h.D. Associate Professor of Howard University, Washington, D.C.
Microbiology
Kenny DeMeirleir, M.D., Ph.D. Professor of Medicine Vrije Universiteit, Brussels, Belgium
</TABLE>
Data Safety Monitoring Board
Because the Company periodically conducts placebo-controlled clinical
studies in chronic incurable diseases, it has designated a Data Safety
Monitoring Board comprised of independent physicians, scientists and patient
advocates. During the conduct of a placebo-controlled clinical trial (i.e.
involving the use of placebo for certain patients involved in the trial), the
Data Safety Monitoring Board meets at pre-determined intervals to evaluate the
safety, efficacy and/or ethical implications of a placebo-controlled trial.
Members of the Data Safety Monitoring Board are compensated at a rate of $1,500
per meeting attended. Members are not allowed to hold stock in the Company.
The following are members of the Data Safety Monitoring Board:
<TABLE>
<CAPTION>
NAME POSITIONS INSTITUTION
- ------ ----------- --------------
<S> <C> <C>
Robert A. Good, M.D., Distinguished Professor Departments of Pediatrics and
Ph.D., D.Sc. Microbiology, University of South Florida,
Tampa, Florida
Physician-in-Chief All Children's Hospital,
St. Petersburg, Florida
Lewis Marshall, M.D. Associate Professor of Medicine Howard University College of
Medicine, Washington, D.C.
Chief, Infectious Diseases Providence Hospital, Washington, D.C.
Chief, Infectious Diseases Columbia Hospital for Women,
Washington, D.C.
The Rev. Daniel Paul Rector Parish of Trinity Church,
Matthews D.D. Wall Street, New York
Kenny DeMeirleir, M.D., Ph.D. Professor of Medicine Vrije Universiteit, Brussels, Belgium
</TABLE>
49
<PAGE>
MANAGEMENT
Directors, Executive Officers and Key Employees
The Directors, executive officers, key employees and advisors of the
Company are as follows:
Name Age Position
----- ---- -------
William A. Carter, M.D. 59 Chairman, Chief Executive Officer,
President
R. Douglas Hulse 52 Chief Operating Officer
Robert E. Peterson 59 Chief Financial Officer
David R. Strayer, M.D. 50 Medical Director, Director of Regulatory
Affairs
Carol A. Smith, Ph.D. 45 Director of Manufacturing and Process
Development
Josephine M. Dolhancryk 33 Treasurer, Assistant Secretary
Cedric C. Philipp 74 Director, Associate Secretary, Special
Advisor to the Board/International
Richard C. Piani 69 Director
Peter W. Rodino III 43 Director, Secretary
Harris Freedman 61 Vice President, Corporate Communications
Sharon D. Will 36 Vice President, Investor Relations
E. Gerald Kay 58 Director
William A. Carter, M.D., the co-inventor of Ampligen, joined the Company in
1978, and has served as (a) the Company's Chief Scientific Officer since May
1989, (b) the Chairman of the Company's Board of Directors since January 1992
(c) the Company's Chief Executive Officer since July 1993, (d) the Company's
President since April, 1995, and (e) a director since 1987. From 1987 to 1988,
Dr. Carter served as the Company's Chairman. Dr. Carter was a leading innovator
in the development of human interferon for a variety of treatment indications
including various viral diseases and cancer. In this context, he received the
first FDA approval to initiate clinical trials on a beta interferon product
manufactured in the U.S. under his supervision. From 1985 to October 1988, Dr.
Carter served as the Company's Chief Executive Officer and Chief Scientist. He
received his M.D. degree from Duke University and underwent his post-doctoral
training at the National Institutes of Health and Johns Hopkins University. Dr.
Carter also serves as Professor of Neoplastic Diseases at Hahnemann University,
a position he has held since 1980. He is also Director of Clinical Research for
Hahnemann University's Institute for Cancer and Blood Diseases. Dr. Carter has
served as a professor at Johns Hopkins School of Medicine, Hahnemann University
and the State University of New York at Buffalo.
R. Douglas Hulse was named Chief Operating Officer on June 1, 1996. Since July
1995, he had been Special Advisor for Licensing and New Product Development to
the Company's Board of Directors. Since 1995 he has served as Executive Director
of The Sage Group, a health care consulting firm specializing in pharmaceutical
and biotechnology business development and strategic planning. Between 1991 and
1994, Mr. Hulse was Vice President of Business Development for Enzon, Inc., a
biopharmaceutical company with proprietary drug delivery technologies, and from
1986 to 1991, Mr. Hulse served as an independent financial and business
development consultant to various biotechnology companies. He was President and
CEO of i-STAT Corporation, a manufacturer of medical biosensors, from 1984 to
1986 and Vice President of Strategic Planning for Engelhard Corporation from
1982 to 1984. Mr. Hulse held several executive positions with Halcon
International, Inc., a leading chemical company, from 1968 to 1982. Mr. Hulse
received Masters degrees in Industrial Management and Chemical Engineering
Practice from M.I.T. and a Bachelors degree in Chemistry from Princeton
University.
50
<PAGE>
Robert E. Peterson has served as Chief Financial Officer of the Company since
April 1993 and served as an independent financial advisor to the Company from
1989 to April 1993. Mr. Peterson has also served since 1990 as Vice President of
the Omni Group, Inc., a business consulting group based in Tulsa, Oklahoma.
During the period 1983 through 1992, Mr. Peterson was self-employed as a
financial consultant to businesses in various industries. Mr. Peterson was Vice
President and Chief Financial Officer of Pepsico Foods International from 1979
to 1983 and responsible for financial management of this multinational operating
unit with approximately $500 million in annual revenues. Mr. Peterson is a
graduate of Eastern New Mexico University.
David R. Strayer, M.D., who serves as Professor of Medicine at Medical College
of Pennsylvania and Hahnemann University, has acted as the Medical Director of
the Company since 1986. He is Board Certified in Medical Oncology and Internal
Medicine with research interests in the fields of cancer and immune system
disorders. Dr. Strayer has served as principal investigator in studies funded by
the Leukemia Society of America, the American Cancer Society, and the National
Institutes of Health. Dr. Strayer attended the School of Medicine at the
University of California at Los Angeles where he received his M.D. in 1972.
Carol A. Smith, Ph.D. has served as the Company's Director of Manufacturing and
Process Development since April 1995, as Director of Operations since 1993 and
as the Manager of Quality Control from 1991 to 1993, with responsibility for the
manufacture, control and chemistry of Ampligen. Dr. Smith has also been
Scientist/Quality Assurance Officer for Virotech International, Inc. from 1989
to 1991 and Director of the Reverse Transcriptase and Interferon Laboratories
and a Clinical Monitor for Life Sciences, Inc. from 1983 to 1989. She received
her Ph.D. from the University of South Florida College of Medicine in 1980 and
was an NIH post-doctoral fellow at the Pennsylvania State University College of
Medicine.
Josephine M. Dolhancryk joined the Company in 1990 as Office Manager, was
promoted to Executive Assistant to the Chairman of the Board and Chief Executive
Officer in 1991 and Assistant Secretary, Treasurer and Executive Administrator
in 1995. From 1989 to 1990 Ms. Dolhancryk was President of Medical/Business
Enterprises. Ms. Dolhancryk was employed by Children's Hospital of Philadelphia
from 1984 to 1989, where she also served as research coordinator on a drug study
from 1986 to 1988. Ms. Dolhancryk attended Saint Joseph's University and
Delaware County College.
E. Gerald Kay has served as a director of the Company since July 1994. From 1980
through the present, he has served as Chairman of the Board and Chief Executive
Officer of Manhattan Drug Co., Inc. a provider of manufacturing services to the
nutritional supplement industry, Chem International, Inc., the parent company of
Manhattan Drug Co., Inc., The Vitamin Factory, Inc. a retailer and direct mail
of nutritional products, and Connaught Press, a publisher. From 1993 to date, he
has served as a Director of Carte Medical Corp. From 1986 to 1988, Mr. Kay was
President and a director of the Rexall Group, Inc. and from 1993 to 1994 served
as a consultant to Rexall Sundown in the establishment of a pharmaceutical
manufacturing facility. Mr. Kay attended the University of Vermont and New York
University from 1961 to 1963.
Cedric C. Philipp has served as a director of the Company since July 1994 and as
Special Advisor for International Marketing since 1993. He is President of
Philipp Pharmaceutical Marketing, a consulting firm which he founded in 1987.
From 1957 to 1987, he was with Wyeth International, a division of American Home
Products, during which time he served in various capacities in international
marketing and sales, most recently as Executive Assistant to the President. Mr.
Philipp received his A.B. degree from Columbia College and later attended
Columbia Law School and the Graduate School of Princeton University.
Richard C. Piani has served as a director of the Company since May 1995. Mr.
Piani has been employed as a principal delegate for Industry to the City of
Science and Industry, Paris, France, a billion dollar scientific and educational
complex since 1995. Mr. Piani provided consulting to the Company in 1993, with
respect to general business strategies for the Company's European operations and
markets. He served as Chairman of Industrielle du Batiment-Morin, a building
materials corporation, from 1986 to 1993. Previously he was Professor of
International Strategy at Paris Dauphine University from 1984 to 1993. From 1979
to 1985 Mr. Piani served as Group Director in Charge of International and
Commercial Affairs for Rhone-Poulenc and from 1973 to 1979 was Chairman and
Chief Executive Officer of Societe "La Cellophane", the French company which
invented cellophane and several other worldwide products. Mr. Piani has a Law
degree from Faculte de Droit, Paris Sorbonne and a Business Administration
degree from Ecole des Hautes Etudes Commerciales, Paris.
51
<PAGE>
Peter W. Rodino III has served as a director of the Company since July 1994 and
Secretary of the Company since November 1994. He had previously served on the
Company's Board of Directors from 1987 to 1989. From 1988 through the present he
has served as Managing Partner of the law firm Rodino and Rodino, which
primarily deals in corporate, commercial, insurance, real estate, environmental,
bankruptcy and immigration law. He was a partner in the law firm of Rodino and
Scalera, Inc. from 1988 to 1991. He has served as Chairman of the Board of
Directors of the Foundation Health Plan of New Jersey, an IPA/HMO providing
health care services, from 1983 to 1988 and as a Director of Columbus Hospital
from 1986 to 1990. Mr. Rodino earned a B.S. in Business Administration from
Georgetown University in 1973 and a J.D. from Seton Hall University School of
Law in 1976.
Harris Freedman has served as Vice President for Strategic Alliances since
August 1994 and has been a private venture capitalist and business consultant
for more than the past five years. He is the Secretary of Bridge Ventures, Inc.
( Bridge Ventures ) and SMACS Holding Corp., both of which are private venture
capital companies, positions he has held for more than five years. His business
experience has encompassed developing significant business contacts and acting
as an officer or director of several companies in the pharmaceutical, health
care and entertainment fields. Mr. Freedman was Vice President of U.S. Alcohol
Testing of America, Inc., from August 1990 to February 1991. Additionally, he
was Vice President East Coast Marketing for MusicSource U.S.A., Inc. from
October 1992 to January 1994. Mr. Freedman attended New York University from
1951 to 1954.
Sharon D. Will has been Vice President for Corporate Communications and Investor
Relations since November 1994. Prior to that time, she was a registered sales
representative and Senior Vice President for Institutional Sales at Westfield
Financial Corporation from September 1994 to October 1994. She was a registered
sales representative with Marsh Block Corporation from July 1994 to September
1994. From October 1993 to July 1994 she served as a registered sales
representative at Seaboard Securities Corp. From October 1991 to present, Ms.
Will has been President of Worldwide Marketing Inc. a manufacturers'
representative of various companies selling to the retail trade markets. Ms.
Will was the National Sales Manager of Innovo, Inc., a domestic manufacturer of
textiles, from October 1989 to November 1991. She attended Baylor College as an
undergraduate for two years with a primary focus on chemistry.
Board Committees
The Board of Directors maintains an Executive Committee consisting of
William A. Carter and Peter W. Rodino III, which makes recommendations to
management regarding general business matters of the Company; a Compensation
Committee consisting of Peter W. Rodino III, Richard C. Piani and E. Gerald Kay,
which makes recommendations concerning salaries and compensation for employees
of and consultants to the Company; an Audit Committee consisting of Cedric C.
Philipp and E. Gerald Kay, which reviews the results and scope of the audit and
other services provided by independent auditors; and a Strategic Planning
Committee consisting of William A. Carter, Peter W. Rodino III and Cedric C.
Philipp, which makes recommendations to the Board of priorities in the
application of the Company's financial assets and human resources in the fields
of research, marketing and manufacturing.
Compensation of Directors
During the fourth quarter of fiscal 1995, each non-employee directors
received $3,750 as compensation for serving on the Board of Directors or any
committee thereof. Certain non-employee directors receive compensation as
consultants to the Company and have been granted options to purchase Common
Stock under the Company's 1990 Stock Option Plan and Rule 701 Warrants to
purchase Common Stock of the Company. All of the directors are reimbursed for
their expenses incurred in attending meetings of the Board of Directors and its
committees. Currently, non-management directors receive an annual retainer of
$15,000 and receive $600 for each Board or committee meeting they attend and
will be reimbursed for out of pocket expenses incurred in attending meetings.
The Company believes such payments are necessary in order for the Company to
attract and retain qualified outside directors.
In addition, in October 1994, the Board of Directors granted to Cedric C.
Philipp, a director of the Company and Special Advisor to the Board for
International Marketing, the right to receive 3% of the gross proceeds of any
licensing fees and prepaid royalties received by the Company pursuant to the SAB
Agreement and a fee of .75% of gross proceeds in the event that SAB/Bioclones
52
<PAGE>
makes a tender offer for all or substantially all of the Company's assets,
including a merger, acquisition or related transaction, and 1% of all products
manufactured by SAB/Bioclones. The Company may prepay in full the obligation to
provide commissions up to $1,050,000 within a ten year period. These rights were
granted to Mr. Philipp in exchange for his services in the negotiation of the
SAB Agreement and his services in connection with various marketing and
licensing opportunities for the Company. In addition, the Company further agreed
to provide a monthly retainer of $2,000 to Mr. Philipp in exchange for
consulting services related to general pharmaceutical and international
marketing services and remuneration for corporate alliances which are
principally introduced by Mr. Philipp. Mr. Philipp has been paid $110,000
pursuant to these arrangements through December 31, 1995.
In June 1995, the Board of Directors of BioAegean, a subsidiary of the
Company, issued an aggregate of 550,000 BioAegean Options at an exercise price
of $1.00 per share to Dr. William A. Carter, E. Gerald Kay, Cedric C. Philipp
and Peter Rodino, III, directors of the Company.
In October and November 1994, the Company granted an aggregate of 1,480,000
Rule 701 Warrants to purchase shares of Common Stock at $3.50 per share to Dr.
Carter, Mr. Kay, Mr. Philipp and Mr. Rodino, directors of the Company, and
Maryann Charlap Azzato a former director of the Company. See "Certain
Transactions."
In 1994 and 1993 the Company issued shares of Series C Preferred Stock at $5.00
per share to certain directors in various transactions including certain sales
of Series C Preferred Stock and conversion of certain debt. See "Certain
Transactions."
Executive Compensation
Summary Compensation Table. The following table sets forth certain
information with respect to the compensation of the Company's Chief Executive
Officer and the other most highly compensated executive officers of the Company
for the fiscal year ended December 31, 1995.
EXECUTIVE COMPENSATION
SUMMARY COMPENSATION TABLE
<TABLE>
<CAPTION>
Name and Other Annual Restricted Stock Option All other
Principal Position Year Salary Compensation($)(1) Awards($)(13) Awards Compensation($)(2)
- ------------------ ---- ------ ------------------ ---------------- ------- ------------------
<S> <C> <C> <C> <C> <C> <C>
William A. Carter 1995 $363,420(3)(4) -- -- 300,000(8) 7,778
Chairman of the Board 1994 363,420(3)(5) -- -- 1,400,000(9) 7,778
Chief Executive Officer 1993 363,420(3) -- -- -- 7,778
Robert E. Peterson 1995 120,000(6) -- -- 50,000(10) --
Chief Financial Officer 1994 110,000(7) -- -- --
1993 86,300 -- -- -- --
Sharon Will 1995 125,000 -- -- 50,000(10) --
Vice President 1994 -- -- -- 200,000(11) --
1993 -- -- -- -- --
David R. Strayer, M.D. 1995 115,083 -- -- -- --
Medical Director 1994 -- -- -- -- --
1993 -- -- -- --
Harris Freedman 1995 112,500 -- -- 150,000(10) --
Vice President 1994 -- -- -- 400,000(12) --
1993 -- -- -- -- --
</TABLE>
- -------------
(1) The Company makes available certain non-monetary benefits to its officers
with a view to attracting and retaining qualified personnel and
facilitating job performance. The Company considers such benefits to be
ordinary and incidental business costs and expenses. The aggregate value of
such benefits, which cannot be precisely ascertained but which is less than
10% of the cash compensation of each of the above-named executive officers,
is not included in the table.
(2) Consists of insurance premiums paid by the Company with respect to term
life insurance for the benefit of the named executive officer.
(3) Includes $63,000 paid to Dr. Carter by Hahnemann University where he serves
as a professor.
53
<PAGE>
(4) Does not include $224,015 paid in 1995 for salary deferred from 1993 and
1994.
(5) Includes $137,692 in deferred salary for 1994.
(6) Mr. Peterson joined the Company in April 1993 and is paid on a fee basis.
Compensation includes $25,625 in deferred salary for 1995.
(7) Includes $33,500 in deferred salary for 1994.
(8) BioAegean Options to purchase 300,000 shares of common stock of BioAegean
Corp., a subsidiary of the Company, at $1.00 per share, which were granted
in May 1995 (the "BioAegean Options").
(9) Rule 701 Warrants to purchase Common Stock at $3.50 per share granted in
October 1994. These Rule 701 Warrants vest in 1/3 increments over a 36
month period. Rule 701 Warrants are warrants which were issued to officers,
directors and consultants of the Company in reliance upon Rule 701 of the
Securities Act.
(10) BioAegean Options.
(11) Rule 701 Warrants to purchase common stock at $3.50 per share granted in
November 1994.
(12) Rule 701 Warrants to purchase common stock at $3.50 per share granted in
August 1994.
(13) As of December 31, 1995, Sharon Will had 100,000 shares of 144 restricted
stock valued at $228,125 using the average closing bid and asked price on
December 31, 1995 of $2.28. As of December 31, 1995, Harris Freedman had
150,000 shares of Rule 144 restricted stock valued at $342,000 using the
average closing bid and asked price on December 31, 1995 of $2.28.
Year End Option Table. The following table sets forth certain information
regarding the stock options held as of December 31, 1995 by the individuals
named in the above Summary Compensation Table. David Strayer, M.D. did not
exercise any stock options in the last fiscal year.
AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR
AND FISCAL YEAR-END OPTION
<TABLE>
<CAPTION>
Securities Underlying Value of Unexercised
Unexercised Options at In-the-Money-Options
Fiscal Year End(#) at Fiscal Year End ($)
Shares Acquired Value --------------------------- -------------------------
Name on Exercise (#) Realized ($) Exercisable Unexercisable Exercisable Unexercisable
----- -------------- ------------ ----------- ------------- ---------- ------------
<S> <C> <C> <C> <C> <C> <C>
William A. Carter -- -- 1,091,355(1) 1,233,333(2) 292,188 --
Robert E. Peterson -- -- 6,912(3) 56,912(4) -- --
Sharon Will -- -- 341,667(5) 283,333(6) 146,094 --
Harris Freedman 975,494(7) 416,667(8) 292,188 --
</TABLE>
- ----------
(1) Includes (i) 466,667 currently exercisable Rule 701 Warrants to purchase
Common Stock at $3.50 per share; (ii) 73,728 stock options to purchase
Common Stock at $3.50 per share; (iii) 960 warrants to purchase Common
Stock at $3.50 per share; and (iv) warrants to purchase 550,000 shares of
Common Stock at $1.75 per share.
(2) Includes 933,333 Rule 701 Warrants and 300,000 BioAegean Options.
(3) Stock options to purchase Common Stock at $4.34 per share.
(4) Includes 50,000 BioAegean Options and 6,912 stock options.
(5) Includes 66,667 currently exercisable Rule 701 Warrants and 275,000
warrants to purchase Common Stock at $1.75 per share.
(6) Includes 150,000 BioAegean Options and 133,333 Rule 701 Warrants.
(7) Includes (i) 133,333 Rule 701 Warrants currently exercisable; (ii) 292,161
warrants to purchase common stock at $3.50 per share; and (iii) 550,000
warrants to purchase Common Stock at $1.75 per share.
(8) Includes 266,667 Rule 701 Warrants and 150,000 BioAegean Options.
54
<PAGE>
Option Grant Table. The following table sets forth certain information
regarding options granted during the fiscal year ended December 31, 1995 by the
Company to the individuals named in the above Summary Compensation Table:
OPTION GRANTS IN LAST FISCAL YEAR
% of Total
Options
Options Granted to
Granted Employees in Exercise Price Expiration
Name (#) Fiscal Year $/Share Date
- ----- --------- ----------- ------------ ----------
William A. Carter 300,000(2) 46% $1.00 5/4/05
Robert E. Peterson 50,000(2) 8% $1.00 5/4/05
Sharon Will 150,000(2) 23% $1.00 5/4/05
Harris Freedman 150,000(2) 23% $1.00 5/4/05
- ------------
(1) Amounts represent hypothetical gains that could be achieved for the
respective options if not exercised until the end of the option term. These
gains are based on assumed rates of stock price appreciation of 5% and 10%
(as required under the rules and regulations of the Commission) compounded
annually from the dates the respective options were granted to their
respective expiration dates. This table does not take into account any
appreciation in the price of the Common Stock to date.
(2) In June 1995, the Board of Directors of BioAegean Corp. ("BioAegean"), a
subsidiary of the Company, issued options to purchase the common stock of
BioAegean at an exercise price of $1.00 per share. In consideration of
these options, the recipients agreed to serve BioAegean's needs for at
least 24 months unless fully incapacitated. There is no public market for
BioAegean shares.
LONG-TERM INCENTIVE PLANS - AWARDS IN LAST FISCAL YEAR
Performance or
Number of Other Period
Shares, Units Until Maturation
Name or Other Rights(#)(1) or Payout
- ----- ----------------- ---------------
William A. Carter 300,000 5/4/05
Chairman of the Board
Chief Executive Officer
Robert E. Peterson 50,000 5/4/05
Chief Financial Officer
Sharon Will 150,000 5/4/05
Vice President
Harris Freedman 150,000 5/4/05
- -----------
(1) BioAegean Options to purchase common stock of BioAegean Corp., a subsidiary
of the Company at $1.00 per share which were granted in May 1995.
Employment Agreements
The Company entered into an employment agreement with Sharon Will providing
for her employment as Vice President for Corporate Communications and Investor
Relations on November 1, 1994. The agreement provides for Ms. Will to be
employed for a one-year term for a base salary of $120,000 and provides for
termination of the agreement upon certain circumstances including termination by
the Company or Ms. Will on 14 days written notice or the sale of Ms. Will's
stock in the Company. Pursuant to the agreement, Ms. Will was granted Rule 701
Warrants to purchase 200,000 shares of Common Stock of the Company at $3.50 per
share. Ms. Will's agreement provides that she shall devote 60% of her business
time, attention and energies to the Company during regular business hours. In
the event that Ms. Will's employment is terminated for any reason other than
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breach of contract, she shall be entitled to receive accrued and unpaid
compensation plus an additional three months' compensation. In July 1995, the
term of Ms. Will's employment agreement was extended from one year to three
years.
The Company entered into an employment agreement with Harris Freedman
providing for Mr. Freedman's employment as Vice President for Strategic
Alliances on August 1, 1994. The agreement provides for Mr. Freedman to be
employed for a one year term for a base salary of $120,000 and provides for
termination of the agreement upon certain circumstances including termina-tion
by the Company or Mr. Freedman on 14 days written notice or the sale of Mr.
Freedman's stock in the Company. Pursuant to the agreement, Mr. Freedman was
granted Rule 701 Warrants to purchase 400,000 shares of Common Stock of the
Company at $3.50 per share. Mr. Freedman's agreement provides that he shall
devote 30% of his business time, attention and energies to the Company during
regular business hours. In the event that Mr. Freedman's employment is
terminated for any reason other than breach of contract, he shall be entitled to
receive accrued and unpaid compensation plus an additional three months'
compensation. In July 1995, the term of Mr. Freedman's employ-ment agreement was
extended from one year to three years.
The Company entered into an amended and restated employment agreement with
Dr. William A. Carter, dated as of July 1, 1993 and as amended in July 1995,
which provides for his employment until May 8, 2001 at an initial base annual
salary of $295,832, subject to annual cost of living increases. In addition, Dr.
Carter may receive an annual performance bonus of up to 25% of his base salary,
in the sole discretion of the Board of Directors. Dr. Carter will not
participate in any discussions concerning the determination of his annual bonus.
Dr. Carter is also entitled to an incentive bonus of 0.5% of the gross proceeds
received by the Company from any joint venture or corporate partnering
arrangement, up to an aggregate maximum incentive bonus of $250,000 for all such
transactions. It is contemplated that Dr. Carter will be entitled to this
incentive bonus upon receipt of the gross proceeds from the SAB Agreement (as
defined in "Certain Transactions"). Dr. Carter's agreement also provides that he
shall be paid his base salary and benefits through May 8, 1996 if he is
terminated without "cause," as that term is defined in the agreement. Pursuant
to his original agreement, as amended on August 8, 1991, Dr. Carter was granted
options to purchase 73,728 shares of the Company's Common Stock at an exercise
price of $2.71 per share.
1992 Stock Option Plan
The Company's 1992 Stock Option Plan (the "1992 Plan"), provides for the
grant of options for the purchase of up to an aggregate of 92,160 shares of
Common Stock to the Company's employees, directors, consultants and others whose
efforts are important to the success of the Company. The 1992 Plan is
administered by the Compensation Committee of the Board of Directors, which has
complete discretion to select the eligible individuals to receive and to
establish the terms of option grants. The 1992 Plan provides for the issuance of
either non-qualified options or incentive stock options, provided that incentive
stock options must be granted with an exercise price of not less than fair
market value at the time of grant and that non-qualified stock options may not
be granted with an exercise price of less than 50% of the fair market value at
the time of grant. The number of shares of Common Stock available for grant
under the 1992 Plan is subject to adjustment for changes in capitalization. To
date, no options have been granted under the 1992 Plan.
1990 Stock Option Plan
The Company's 1990 Stock Option Plan, as amended (the "1990 Plan"),
provides for the grant of options to employees, directors, officers, consultants
and advisors of the Company for the purchase of up to an aggregate of 460,798
shares of Common Stock. The plan is administered by the Compensation Committee
of the Board of Directors, which has complete discretion to select eligible
individuals to receive and to establish the terms of option grants. The number
of shares of Common Stock available for grant under the 1990 Plan is subject to
adjustment for changes in capital-ization. As of December 31, 1995, options to
acquire an aggregate of 228,502 shares of the Common Stock were outstanding
under the 1990 Plan.
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401(K) Plan
In December 1995, the Company established a defined contribution plan,
effective January 1, 1995, the HemispherX Biopharma employees 401(K) Plan and
Trust Agreement (the "401(K) Plan"). All full time employees of the company are
eligible to participate in the 401(K) Plan following one year of employment.
Subject to certain limitations imposed by federal tax laws, participants are
eligible to contribute up to 15% of their salary (including bonuses and/or
commissions per annum. Participants' contributions to the 401(K) Plan may be
matched by the Company at a rate determined annually by the Board of Directors.
Each participant immediately vests in his or her deferred salary contributions,
while Company contributions will vest over one year. In 1995 the Company
provided matching contributions to each employee for up to 6% of annual pay or
$25,500. The Company also absorbed the cost of employee contributions of
$25,000.
Compensation Committee Interlocks and Insider Participation
During the fiscal year ended December 31, 1995, the members of the
Company's Compensation Committee were William A. Carter, Peter W. Rodino III,
and E. Gerald Kay. Dr. Carter is an officer of the Company. The Company's
Compen-sation Committee currently consists of Peter W. Rodino III, Richard C.
Piani and E. Gerald Kay. The following transactions describe certain
relationships between the Company and present and former members of the
Compensation Committee:
In May 1995, Dr. Carter, E. Gerald Kay and certain other individuals and
entities entered into a 1995 Standby Financing Agreement with the Company
pursuant to which they were collectively obligated to invest during 1995 an
aggregate of $5,500,000 in the Company in the event the Company was unable to
secure alternative financing and the Board of Directors determined that the sale
of securities to such persons was advisable (the "1995 Standby Financing
Agreement"). In exchange for entering into the 1995 Standby Financing Agreement,
the Company issued to each of the parties ten-year warrants to purchase 50,000
shares of the Company's Common Stock at an exercise price of $1.75 per share for
each $100,000 of standby financing obligation assumed by the party, resulting in
warrants to purchase an aggregate of 2,750,000 shares of Common Stock. In
September 1995, the parties to the 1995 Standby Financing Agreement, including
Dr. Carter and Mr. Kay, agreed to extend their obligations through December 31,
1996.
In June 1995, the directors of BioAegean Corp., a subsidiary of the
Company, issued 10-year options to purchase an aggregate of 1,200,000 shares of
common stock of BioAegean at an exer-cise price of $1.00 per share (the
"BioAegean Options") to its officers and directors. The BioAegean Options are
conditional upon the recipient's agreement to serve BioAegean as needed for at
least 24 months unless fully incapacitated. William A. Carter, M.D., serves as
Chairman, Chief Executive Officer and a Director of BioAegean and received
300,000 BioAegean Options. Peter W. Rodino III serves as Vice-Chairman,
Secretary, Corporate Counsel and a director of BioAegean and received 150,000
BioAegean Options. R. Douglas Hulse serves as Chief Operating Officer of
BioAegean and received 50,000 BioAegean Options. Richard C. Piani serves as a
director and the Advisor for European Affairs of BioAegean and received 50,000
BioAegean Options. E. Gerald Kay serves as a director for BioAegean and received
50,000 BioAegean Options.
In March 1995, the Company received an interest-free loan from William A.
Carter in the amount of $35,000. In March 1995, the Company repaid the loan from
Dr. Carter.
In February 1995, the Company issued notes in the aggregate principal
amount of $600,000 in connection with the Tisch/Tsai Restructuring (as defined
below). The notes were secured by a pledge by Dr. Carter of 112,925 shares of
Series C Preferred Stock and 240,756 shares of Common Stock. The notes have been
paid off and the shares are being returned.
Limitation of Liability and Indemnification Matters
As permitted by the Delaware General Corporation Law ("DGCL"), the Company
has adopted provisions in its Amended and Restated Certificate of Incorporation
which eliminate the personal liability of its directors to the Company and its
stockholders for monetary damages for breach of the directors' fiduciary duties
in certain circumstances and which require the Company to indemnify its
directors, officers and other agents, by Bylaw, agreement, vote of directors or
stockholders or otherwise, to the fullest extent permitted by law.
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<PAGE>
The Company has entered into separate indemnification agreements with its
directors and its officers. These agreements require, among other things, the
Company to indemnify directors and officers against certain liabilities that may
arise by reason of their status or service as directors and officers and to
advance their expenses incurred as a result of any proceed-ing against them as
to which they could be indemnified. The Company believes that these provisions
in its Amended and Restated Certificate of Incorporation and the indemnification
agreements are necessary to attract and retain qualified persons as directors
and officers. See "Business Legal Proceedings".
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL
OWNERS AND MANAGEMENT
The following table sets forth, as of May 15, 1996, the record and
beneficial ownership of Common Stock of the Company by each officer and
director, all officers and directors as a group, and each person known to the
Company to own beneficially or of record five percent or more of the outstanding
shares of the Company:
Shares
Officers, Directors and Beneficially Percent of Shares
Principal Stockholders Owned Beneficially Owned (1)
- -------------------- ----------- -------------------
William A. Carter 4,156,671(2) 21.1%
Harris Freedman 1,025,494(3) 6.2%
E. Gerald Kay 656,667(4) 4.0%
Sharon D. Will 556,667(5) 3.4%
Cedric C. Philipp 27,667(6) *
Peter W. Rodino III 25,099(7) *
Robert E. Peterson 10,368(8) *
Jerome Belson 945,000(9) 5.7%
Belson Enterprises, Inc.
495 Broadway
New York, NY 10012
Josephine Dolhancryk 820(10) *
Richard C. Piani 18,023(11) *
David R Strayer 14,745 *
R. Douglas Hulse 60,000(12) *
All directors, 6,552,221 29.6%
executive officers
as a group (11 persons)
*Less than 1%
- -----------
(1) For purposes of this table, a person or group of persons is deemed to have
"beneficial ownership" of any shares of Common Stock which such person has
the right to acquire such shares within 60 days of May 15, 1996. For
purposes of computing the percentage of outstanding shares of Common Stock
held by each person or group of persons named above, any security which
such person or persons has or have the right to acquire within such date is
deemed to be outstanding but is not deemed to be outstanding for the
purpose of computing the percentage ownership of any other person. Except
as indicated in the footnotes to this table and pursuant to applicable
community property laws, the Company believes based on information supplied
by such persons, that the persons named in this table have sole voting and
investment power with respect to all shares of Common Stock which they
beneficially own.
(2) Includes irrevocable proxies to vote 2,050,000 shares of Common Stock on
all matters that come before the stockholders of the Company until such
time as (i) the Company shall have achieved a market capitalization of
$300,000,000 or greater for at least 20 consecutive days of trading in the
public markets or (ii) the Company shall have received a bona fide offer
for acquisition or merger, the net effect of which, if consummat-ed, would
be to establish a market capitalization of the Company of not less than
$300,000,000. This proxy shall be terminated upon the sale of such shares
in an arm's length public sale. Also includes (i) an option to purchase
73,728 shares of Common Stock from the Company at an exercise price of
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$2.71 per, (ii) warrants to purchase 960 shares of Common Stock at an
exercise price of $3.50 per share, (iii) Rule 701 Warrants to purchase
466,667 shares of Common Stock at a price of $3.50 per share (does not
include 933,333 which are non-exercisable); and (iv) warrants to purchase
500,000 shares of Common Stock at $1.75 per share issued in connection with
the 1995 Standby Financing Agreement. Dr. Carter has pledged 112,925 shares
of Series C Preferred and 240,756 shares of Common Stock to the Tisch/Tsai
Entities as security for the repayment of the $660,000 note executed in
March 1995. The note has been paid off and the shares are being returned.
(3) Includes (i) 50,000 shares of Common Stock held by Bridge Ventures, Inc. of
which Mr. Freedman is an officer; (ii) 50,000 shares of Common Stock held
by SMACS Holding Corp. of which Mr. Freedman is an officer, (iii) warrants
to purchase 292,161 shares of Common Stock at an exercise price of $3.50
per share owned of record by Bridge Ventures, Inc.; (iv) warrants to
purchase 390,000 shares of Common Stock which are exercisable at $1.75 per
share issued in connection with the 1995 Standby Financing Agreement owned
of record by Bridge Ventures, Inc.; and (v) 133,333 Rule 701 Warrants to
purchase Common Stock of the Company at an exercise price of $3.50 (does
not include 266,667 which are non-exercisable); and (iv) 60,000 Units each
consisting of one Common Stock and one warrant to purchase Common Stock at
$3.50. Bridge Ventures, Inc. has given an irrevocable proxy to vote its
150,000 shares to William A. Carter on the same terms as the proxy
described in Note 2.
(4) Includes Rule 701 Warrants to purchase 6,667 shares of Common Stock at an
exercise price of $3.50 per share (does not include 13,333 which are
non-exercisable) and 550,000 warrants to purchase Common Stock of the
Company at an exercises price of $1.75 per share issued in connection with
the 1995 Standby Financing Agreement. Mr. Kay has given an irrevocable
proxy to vote 100,000 shares of Common Stock to William A. Carter on the
same terms as the proxy described in Note 2.
(5) Includes Rule 701 Warrants to purchase 66,667 shares of Common Stock at an
exercise price of $3.50 per share (does not include 133,333 which are
non-exercisable). Also includes 100,000 shares of Common Stock owned of
record by Worldwide Marketing, a company for which Ms. Will serves as
President. Worldwide Marketing has given an irrevoca-ble proxy to vote
these shares to William A. Carter on the same terms as the proxy described
in Note 2. Also includes 390,000 warrants to pur-chase Common Stock of the
Company at an exercise price of $1.75.
(6) Includes Rule 701 Warrants to purchase 6,667 shares of Common Stock at
$3.50 per share (does not include 13,333 which are non-exercisable),
options to purchase 20,000 shares of Common Stock at $3.50 per share and
1,000 Units owned by the Cedric C. Philipp and Sue Jones Philipp Trust of
which Mr. Philipp and his wife are Trustees.
(7) Includes Rule 701 Warrants to purchase 6,667 shares of Common Stock at
$3.50 per share (does not include 13,333 which are non-exercisable).
(8) Consists of options to purchase Common Stock at an exercise price of $4.34
per share. Does not include 50,000 Warrants to purchase Common Stock at an
exercise price of $3.50 per share effective March 1, 1997.
(9) Includes 100,000 Bridgeholder Options to purchase 100,000 Bridge Units at
$.50 per unit consisting of 100,000 shares of Common Stock and 100,000
Class A Warrants exercisable at $4.00 per share. Also includes warrants to
purchase 550,000 shares of Common Stock at $1.75 per share owned of record
by Belson Enterprises, Inc., a company for which Mr. Belson serves as
President, issued in connection with the 1995 Standby Financing Agreement
and 47,500 Units, each consisting of one share of Common Stock and one
warrant.
(10) Consists of options to purchase 820 shares of Common Stock at an exercise
price of $3.80. Does not include 50,000 Warrants to purchase Common Stock
at an exercise price of $3.50 per share effective March 1, 1997.
(11) Includes options to purchase 4,608 shares of Common Stock at an exer-cise
price of $4.34 and 4,608 shares of Common Stock owned of record by Mr.
Piani's wife.
(12) Includes 60,000 options to purchase Common Stock at $3.50 per share held by
The Sage Group, of which Mr. Hulse is an Executive Director. Does not
include 100,000 options to purchase Common Stock at $1.75 per share and
330,000 options to purchase Common Stock at $3.50 per share.
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RESALES BY SELLING SECURITYHOLDERS
This Prospectus relates to the proposed resale by the Selling
Securityholders of up to 2,770 shares of outstanding Common Stock, 2,427,275
shares of Common Stock issuable upon conversion of the Preferred Stock and
890,543 issuable upon exercise of the Warrants. The following table sets forth
as of September 9, 1996 certain information with respect to the persons for whom
the Company is registering the Shares for sale to the public except as footnoted
below. None of such persons has had a material relationship with or has held any
position or office with the Company or any of its affiliates within three years,
other than as footnoted below (see "Certain Transactions"). The Company will not
receive any of the proceeds from the sale of the Common Stock. If the Warrants
are exercised, the Company would receive $4,064,900.
Names of Selling Common Stock Beneficially Common Stock Offered
Security Holders Owned Prior to September, 1996 By Beneficial Owner
--------------- ---------------------------- --------------------
Seymour Cohn(1) 119,807 119,807
Myron Cherry(2) 12,770 12,770
Charles Moore(3) 43,304 43,304
Maurice Schlang(4) 138,432 138,432
The Olmstead Group, LLC(5) 240,000 240,000
Fred Craves(5) 120,000 120,000
Francis F. Bodkin, Jr.(5) 120,000 120,000
GFL Advantage Fund Ltd.(6) 2,527,275 2,527,275
- -----------
(1) Represents shares of Common Stock underlying a Warrant exercisable during
the four year period commencing November 2, 1995, at an exercise price of
$10.85 per share.
(2) Represents (i) 10,000 shares of Common Stock underlying two Warrants of
which 5,000 shares are exercisable at any time commencing November 1, 1994
and expiring December 31, 1998, at an exercise price of $3.50 per share and
5,000 shares exercisable at any time commencing March 20, 1995 and expiring
March 31, 1999, at an exercise price of $3.50 per share; and (ii) 2,770
share of Common Stock.
(3) Represents (i) 40,000 shares of Common Stock underlying two Warrants
exercisable during the five year period commencing November 2, 1995, at an
exercise price of $2.00 per share; and (ii) 2,304 shares of Common Stock
underlying a stock option exercisable during the ten year period commencing
April 16, 1996, at an exercise price of $4.34 per share.
(4) Represents (i) 120,000 shares of Common Stock underlying a Warrant
exercisable during the five year period commencing November 2, 1995, at an
exercise price of $2.00 per share; and (ii) 18,432 shares of Common Stock
underlying a stock option exercisable during the ten year period commencing
January 25, 1995, at an exercise price of $4.34 per share.
(5) Represents Common Stock underlying Warrants exercisable during the five
year period commencing July 3, 1996 at an exercise price of $4.00 per
share.
(6) Represents (i) 2,427,275 shares of Common Stock underlying the Preferred
Stock; and (ii) 100,000 shares of Common Stock underlying a Warrant
exercisable during the period commencing July 3, 1996 and expiring November
2, 2000 at an exercise price of $4.00 per share. The Preferred Stock
Certificate of Designations and the Warrant provides that GFL Advantage
Fund Limited may not convert its Preferred Stock or exercise its Warrant at
any time to acquire a number of shares of Common Stock in excess of 4.9% of
the Company's outstanding Common Stock.
The Selling Securityholders may effect the sale of their shares from time
to time in transactions (which may include block transactions) in the
over-the-counter market, in negotiated transactions, through the writing of
options on the Common Stock, or a combination of such methods of sale, at fixed
prices which may be changed, at market prices prevailing at the time of sale, or
at negotiated prices.
The Company is not aware of any agreements, undertakings or arrangements
with any Underwriters or broker-dealers regarding the sale of their securities
in the United States, nor to the Company's knowledge is the sale of shares on
behalf of the Selling Securityholders in the United States. The Selling
Securityholders may effect such transactions by selling the shares, as
applicable, directly to purchasers or to or through broker-dealers which may act
as agents or principals. Such broker-dealers may receive compensation in the
form of discounts, concessions or commissions from the Selling Securityholders,
and/or the purchasers of their shares, as applicable, for which such
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<PAGE>
broker-dealers may act as agents or to whom they sell as principal, or both
(which compensation as to a particular broker-dealer might be in excess of
customary commissions). The Selling Securityholders and any broker-dealers that
act in connection with the sale of their shares might be deemed to be
"underwriters" within the meaning of Section 2(11) of the Securities Act.
The Company has notified the Selling Securityholders of the prospectus
delivery requirements for sales made pursuant to this Prospectus and that, if
there are material changes to the stated plan of distribution, a post-effective
amendment with current information would need to be filed before offers are made
and no sales could occur until such amendment is declared effective. The Company
has agreed with one Selling Securityholder to promptly prepare, file with the
Commission and obtain effectiveness of any such post-effective amendment.
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
In August 1996, the Company entered into an agreement with Shamrock
Partners, Ltd. ("Shamrock"), an investment banking firm. Shamrock will provide
financial consulting services and advice for a term of one year. In exchange,
the Company will grant Shamrock an option to purchase 600,000 share of Common
Stock during the five year period beginning August 15, 1996 at an exercise price
of $2.50 per share.
In July 1996, the Company consummated a private offering of its Preferred
Stock pursuant to Rule 506 of Regulation as promulgated by the Commission under
the Securities Act. The Company issued 6,000 shares of Preferred Stock, $.01 par
value at a purchase price of $1,000 per share. In connection therewith, the
Company granted 480,000 Warrants to purchase Common Stock at an exercise price
$4.00 per share to The Olmstead Group, Fred Craves and Francis F. Bodkin, Jr.
for their efforts in placing the Preferred Stock.
In May 1996, the Company entered into two additional agreements with The
Sage Group. Under the first agreement, R. Douglas Hulse will serve as Chief
Operating Officer of the Company. In exchange, The Sage Group will receive from
the Company; (i) a monthly retainer of $10,000 starting June 1, 1996, replacing
the $5,000 monthly retainer provided in the June 1995 agreement; and (ii)
options to purchase 250,000 shares of the Company's Common Stock at an exercise
price of $3.50 per share. Under the second agreement, The Sage Group agreed to
introduce the Company to and assist the Company in negotiations with certain
foreign distribution partners. In exchange, The Sage Group will receive from the
Company; (i) a bonus payment of $500,000 if total sales of Ampligen in Canada
and Europe exceed $10 million for 1996 and 1997 combined; and (ii) options to
purchase 140,000 shares of the Company's Common Stock at an exercise price $3.50
per share. R. Douglas Hulse, Chief Operating Officer of the Company, is an
Executive Director of the Sage Group.
In March 1996, William A. Carter assigned and transferred 50,000 warrants
to purchase Common Stock, at $1.75 per share, to three outside parties that had
loaned the Company money in 1995. These loans were repaid in 1995. The assigned
warrants are subject to a lockup agreement.
In March 1996, Harris Freedman assigned and transferred 160,000 warrants to
purchase Common Stock at $1.75 per share to Sharon Will, an officer of the
Company and two other shareholders. The assigned warrants are subject to a
lockup agreement.
In March 1996, the Compensation Committee of the Board of Directors
approved a grant of 250,000 warrants to purchase common stock at an exercise
price of $3.50 per share to Michael C. Burrows. This grant was made in
accordance with a Letter Agreement dated January 15, 1996, in which Mr. Burrows
agreed to provide consulting services to the Company for twenty four months. Mr.
Burrows served as Director of the Company in past years.
In March 1996 the Compensation Committee of the Board of Directors approved
grants of 50,000 warrants to purchase common stock at an exercise price of $3.50
per share to each of Robert E. Peterson, CFO and Josephine Dolhancryk, Assistant
Secretary of the Company. Such warrants are not exercisable for a period of one
year from issuance.
In March 1995, the Company instituted a declaratory judgment action against
a February noteholder, Seymour Cohn, of a $5,000,000 convertible note and a
secured defendant in United States District Court for the Eastern District of
Pennsylvania to declare as void, set aside, and cancel the February 1992
convertible note between the Company and Mr. Cohn (the "Note"). In addition, Mr.
Cohn instituted suit against the Company on the Note in the Circuit Court of the
15th Judicial District in and for Palm Beach County, Florida, seeking judgment
on the Note, plus attorney fees, costs and expenses; in August 1995, this action
was stayed by the Florida Court pending the outcome of the Pennsylvania action.
Mr. Cohn also filed a motion for a preliminary injunction in the Pennsylvania
court to enjoin the Company from disbursing the proceeds of a public offering in
the amount of $5.8 million, which motion was granted November, 1995. On February
15, 1996, the Company reached an agreement to settle this matter. Terms and
conditions of the settlement include payment of $6,450,000 to Mr. Cohn to cover
the unpaid balance Note balance, legal expenses and the retention of certain
warrants granted prior to the lawsuit. The funds under this settlement were paid
on March 21, 1996. Mutual releases were executed which completed the settlement
of the litigation.
In January 1996, the Company engaged the Research Works, Inc. to produce
four research reports with respect to the securities of the Company over a 13
month period. In exchange for this service, the Company granted 60,000 warrants
to the Research Works, Inc. exercisable at $4.00 per share.
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In January 1996, the Company entered into a one year consulting agreement
with Millenium International Communications, Ltd. ("Millenium"). The
consideration for such services is $120,000, to be paid by the Company in either
monthly payments or balloon payments, in the Company's discretion. Millenium
shall consult with and render advice to the Company specifically concerning
strategic planning, public relations and other related matters. The President of
Millenium, David C. Drescher is related to Steve Drescher, a former director of
the Company.
In December 1995, the Company retained the law firm of Akin, Gump,,
Strauss, Hauer & Feld, LLP (the "Akin Group") to provide general legal counsel,
advice and representation. Initially, the Akin Group will represent the Company
in matters pertaining to the Food and Drug Administration ("FDA"). The agreement
includes incentive payments for obtaining FDA approval of Ampligen for HIV
Disease treatment.
In November 1995, the Company sold 5,313,000 Units of securities through an
initial public offering. Each Unit consists of one share of Common Stock and one
Class A Warrant.
In August 1995, in connection with the settlement of a lawsuit brought by a
former employee of the Company against the Company and David Fries, a former
director of the Company, the Company, Dr. Fries, the Canaan Entities and Dr.
William A. Carter, President, Chairman and CEO of the Company, entered into an
agreement pursuant to which the Company has agreed to reimburse Dr. Fries for
expenses in the amount of $50,000 incurred in connection with such litigation.
As part of such agreement, the parties agreed to mutual releases of certain
claims for expenses and damages arising out of the litigation or arising in
connection with Dr. Fries' service as a director of the Company. The payment of
$50,000 to Dr. Fries is evidenced by an interest-free promissory note pursuant
to which the final payment is due on or before November 15, 1995. The note was
assigned to the Canaan Entities.
In June 1995, the Company entered into an agreement with The Sage Group
pursuant to which The Sage Group has agreed to introduce the Company to and
assist the Company in negotiations with certain prospective distribution
partners listed in the agreement. In exchange, The Sage Group will receive from
the Company: (i) a monthly retainer of $5,000 which began accruing July 1, 1995
and (ii) at The Sage Group's option, a percentage of the proceeds, up to an
aggregate of $150,000, from the Company's first distribution agreement with a
partner listed in the agreement or the sum of $125,000 from such agreement. In
connection with this agreement, the Company will also issue to The Sage Group
options to purchase 100,000 shares of the Company's Common Stock at an exercise
price of $1.75 per share. R. Douglas Hulse, Chief Operating Officer of the
Company, is an Executive Director of The Sage Group.
In May 1995, William A. Carter, M.D., President, Chairman and CEO of the
Company, Bridge Ventures, Sharon Will, a Vice President of the Company,
Associated Funding Services, Inc., Jerome Belson, a director of one of the
Company's subsidiaries and a principal shareholder and E. Gerald Kay, a director
of the Company, entered into a 1995 Standby Financing Agreement with the Company
pursuant to which they are collectively obligated to invest during 1995 an
aggregate of $5,500,000 in the Company in the event the Company is unable to
secure alternative financing and the Board of Directors determines that the sale
of securities to such persons is advisable. In exchange for entering into the
1995 Standby Financing Agreement, the Company issued to each of the parties
ten-year warrants to purchase 50,000 shares of the Company's Common Stock at an
exercise price of $1.75 per share for each $100,000 of standby financing
obligation assumed by the party, resulting in warrants to purchase an aggregate
of 2,750,000 shares of Common Stock. In September 1995, the parties agreed to
extend their obligations under the 1995 Standby Financing Agreement through
December 31, 1996. Harris Freedman, a Vice President of the Company, and his
wife are officers of Bridge Ventures. Gerald Brauser is President of Associated
Funding Services, Inc.
In June 1995, the Board of Directors of BioAegean Corp, a subsidiary of the
Company, issued an aggregate of 1,200,000 BioAegean Options at an exercise price
of $1.00 per share to its officers and directors, including certain officers and
directors of the Company. In consideration for the BioAegean Options, the
recipients agreed to serve BioAegean's needs for at least 24 months unless fully
incapacitated. William A. Carter, M.D., Chairman, President and Chief Executive
Officer of the Company, serves as Chairman, Chief Executive Officer and a
Director of BioAegean and received 300,000 BioAegean Options. Peter W. Rodino
III, a director and Secretary of the Company, serves as Vice-Chairman,
Secretary, Corporate Counsel and a director of BioAegean and received 150,000
BioAegean Options. R. Douglas Hulse serves as Chief Operating Officer of the
Company and BioAegean and received 50,000 BioAegean Options. Robert Peterson
serves as Chief Financial Officer of both the Company and BioAegean and received
50,000 BioAegean Options. Sharon Will, Vice President of Investor Relations and
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Corporate Communications for the Company, serves as Vice President of Marketing
for BioAegean and received 150,000 BioAegean Options. Harris Freedman serves as
Vice President for Strategic Alliances for both the Company and BioAegean and
received 150,000 BioAegean Options. Richard C. Piani, a director of the Company,
serves as a director and the Advisor for European Affairs of BioAegean and
received 50,000 BioAegean Options. E. Gerald Kay serves as a director for both
the Company and BioAegean and received 50,000 BioAegean Options. BioAegean's
remaining director, Jerome Belson, a principal stockholder of the Company,
received 50,000 BioAegean Options.
In March 1995, the Company issued the Original Brauser Note, to Gerald A.
Brauser in the principal amount of $200,000. The Original Brauser Note also
provided for the issuance of warrants to purchase 50,000 shares of the Company's
Common Stock at $1.75 per share. In May 1995, the Company restructured the
Original Brauser Note and issued the New Brauser Note to Mr. Brauser in the
amount of $100,000 along with warrants to purchase 25,000 shares of the
Company's Common Stock at $1.75 per share. As part of the restructuring, Mr.
Brauser agreed to (i) purchase 100,000 shares of Common Stock with $50,000 of
the Original Brauser Note and (ii) apply $50,000 of the Original Brauser Note
towards a Bridge Loan in connection with the Bridge Financing. The New Brauser
Note of $100,000 and the $50,000 Bridge Loan have been paid off. In connection
with both the Original Brauser Note and the New Brauser Note, Bridge Ventures
agreed to permit the Company to collateralize these notes with the Company's
patent estate, which collateral had previously been granted to Bridge Ventures.
Bridge Ventures further guaranteed the Original Brauser Note with certain
publicly traded common stock, which guarantee was released by Mr. Brauser in
connection with the restructuring. Harris Freedman, a Vice President of the
Company, and his wife are both officers of Bridge Ventures.
In March and April 1995, in connection with the Bridge Financing, the
Company issued Bridge Notes to certain lenders in the aggregate principal amount
of $1,500,000, including a Bridge Note in the amount of $250,000 to Stephen
Drescher and a Bridge Note in the amount of $150,000 to Jerome Belson.
Additionally, in connection with the Bridge Loans, the Company has issued
options to purchase 166,665 Bridge Units at $.50 per Bridge Unit to Mr. Drescher
and options to purchase 100,000 Bridge Units at $.50 per Bridge Unit to Jerome
Belson. In July 1995, Mr. Drescher assigned the $250,000 Bridge Note and his
options to purchase 166,665 Bridge Units to certain other investors. Mr.
Drescher is a former director of the Company and presently serves as the
Director of Corporate Finance at Monroe Parker, one of the Underwriters. Jerome
Belson is a principal shareholder and director of BioAegean, a subsidiary of the
Company.
In March 1995, the Company received interest-free loans from William A.
Carter and Harris Freedman in the amounts of $35,000 and $12,000, respectively.
In March 1995, the Company repaid the loan from Dr. Carter. In April 1995, the
Company repaid the loan from Mr. Freedman.
In December 1992 and February 1993, the Company issued to the Tisch/Tsai
Entities, in a private placement, promissory notes in the aggregate principal
amount of $2,400,000 due on April 30, 1994, and warrants to purchase an
aggregate of 36,864 shares of the Company's Common Stock or 40,000 shares of
Series C Preferred Stock at an exercise price of the (i) $13.02 or $12.00 per
share, respectively or (ii) the per share price of Common Stock in the initial
public offering. The warrants expire on December 31, 1997. One-half of the
principal amount of the notes and one-half of the warrants were purchased by FLF
Associates. James S. Tisch, a former director of the Company, is a principal of
FLF Associates. The remaining half of the principal amount of the note and
one-half of the warrants were purchased by Gerald Tsai, Jr. and Lincoln Trust
Company, Custodian FBO Gerald Tsai, Jr. Mr. Tsai is a former director of the
Company. Interest on the notes is payable quarterly at an annual rate of 12% (6%
prior to May 1, 1993).
In February 1995, the Company entered into a settlement agreement with the
Tisch/Tsai Entities to restructure the December 1992 and February 1993
promissory notes in the aggregate principal amount of $2,400,000 and settle
certain threatened claims made by the Tisch/Tsai Entities against the Company
(the "Tisch/Tsai Restructuring"). This debt restructuring consisted of (i) the
repayment by the Company of $1,200,000 in principal, (ii) the issuance of
replacement notes in the aggregate principal amount of $600,000 to the
Tisch/Tsai Entities which notes are due on the earlier of the closing of a
public offering or May 28, 1996 and bear interest at the rate of 8% per annum,
which interest is payable in quarterly installments from an interest reserve
established by the Company, (iii) the conversion of $600,000 of principal into
172,414 shares of Series C Preferred Stock at the rate of $3.48 per share, (iv)
the amendment and restatement of certain warrants issued in connection with the
original notes in order to increase the number of shares of stock issuable
thereunder by 64,000 shares to provide for warrants to purchase a total of
144,000 shares of Common Stock at an exercise price of $2.00 per share, which
warrants are exercisable until December 31, 1997, and (v) the release by all
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parties of any claims. The replacement notes were secured by a pledge by Dr.
William A. Carter, President, Chief Executive Officer and Chairman of the
Company, of 112,925 shares of Series C Preferred Stock and 240,756 shares of
Common Stock. In March, 1996 the notes were repaid and the shares of stock are
being returned.
In November 1994, the Company restructured a $100,000 note issued in June
1993 to Myron Cherry (the "Cherry Note"), a stockholder, pursuant to which the
repayment date of the principal amount of the Cherry Note was extended to the
closing date of the Company's initial public offering and the accrued but unpaid
interest subsequent to September 30, 1993 was converted into Common Stock of the
Company at a price of $5.43 per share. Pursuant to the restructuring, in the
event that the Company's initial public offering was not completed by February
28, 1995, the principal amount would be repaid by the Company or Bridge Ventures
Inc. by March 6, 1995. In addition, the Company issued to Mr. Cherry 5,000
immediately exercisable warrants with an exercise price of $3.50 per share and
Bridge Ventures agreed that the unpaid principal on the Cherry Note would be
collateralized by the Company's patents on the same terms as the Bridge
Financing arranged by Bridge Ventures. In March 1995, the Company and Mr. Cherry
agreed to extend the maturity of the promissory note from March 1, 1995 to March
31, 1995. During this extended period, the Company agreed to pay 8% interest and
grant Mr. Cherry a warrant to purchase 5,000 shares of Common Stock exercisable
at $3.50. The Company further agreed to either register all of Mr. Cherry's
2,770 shares of Common Stock and 10,000 warrants to purchase Common Stock in
connection with this Public Offering or reduce the exercise price of Mr.
Cherry's warrants to $1.75 per share. Because Mr. Cherry has not advised the
Company of his election, the Company has reduced the exercise price of his
warrants to $1.75 per share. As of July, 1995, the Company has repaid the entire
principal amount of the Note, including accrued interest. Harris Freedman, a
Vice President of the Company, and his wife are officers of Bridge Ventures.
In October and November 1994, the Company granted Rule 701 Warrants to
purchase 20,000 shares of Common Stock at $3.50 per share to E. Gerald Kay,
Cedric C. Philipp and Peter Rodino III, directors of the Company and Maryann
Charlap Azzato, a former director of the Company. In addition, the Company
granted the following Rule 701 Warrants to purchase shares of Common Stock at
$3.50 per share: 1,400,000 warrants to William A. Carter; 200,000 warrants to
Sharon Will, Vice President of Investor Relations and Corporate Communications;
and 400,000 warrants to Harris Freedman, Vice President for Strategic Alliances.
From July 1994 to November 1994, the Company completed a private placement
in which it sold 2,050,000 shares of Common Stock to certain accredited
investors for an aggregate consideration of $1,025,000 (the "1994 Common Stock
Financing"). In connection with the private placement, Bridge Ventures
introduced a number of investors and lenders to the Company. Harris Freedman,
Vice President of the Company, and his wife are officers of Bridge Ventures. In
conjunction with the 1994 Common Stock Financing, the Company agreed to
collateralize certain of its patents until the earlier of the effectiveness of
the initial public offering or the consummation of corporate alliances or
licensing arrangement which provide sufficient operating capital and clinical
development support to the Company. Pursuant to the agreement with Bridge
Ventures in connection with the 1994 Common Stock Financing, Messrs. Philipp,
Rodino and Kay were elected to the Board of Directors. Purchasers of 1,950,000
of the shares of Common Stock issued pursuant to the 1994 Common Stock Financing
executed irrevocable proxies naming William A. Carter, the Company's President,
Chief Executive Officer and Chairman, as proxy, with full power to vote their
shares on all matters to be voted on by the stockholders of the Company until
the achievement by the Company of a market capitalization of $300,000,000 or
greater under certain circumstances or the receipt by the Company of a bona fide
offer for acquisition or merger, the net effect of which, if consummated, would
be to establish a market capitalization of at least $300,000,000.
In October 1994, in connection with the 1994 Common Stock Financing, the
Company sold 50,000 shares of Common Stock at a price of $.50 per share to
Stephen J. Drescher, a former director of the Company, 80,000 shares of Common
Stock to the Belfort Family Trust, of which Mr. Drescher serves as Trustee, at a
price of $.50 per share and 50,000 shares of Common Stock at a price of $.50 per
share to Jerome Belson, a director of BioAegean. Mr. Drescher also received
300,000 warrants in connection with general consulting services. In addition, in
October 1994, the Company received a certain loan in the aggregate principal
amount of $150,000 from the Belfort Family Trust. In March 1995, the loan was
repaid without interest from the proceeds from the Bridge Loans. In October
1995, the Belfort Family Trust sold 80,000 shares of Common Stock to Carol
Schiller at a price of $2.00 per share.
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In October 1994, the Company entered into an agreement with Bioclones
Proprietary Limited ("Bioclones"), a biopharmaceutical company which is
associated with The South African Breweries Limited ("SAB"). In connection with
the execution of SAB Agreement, the Company granted Cedric C. Philipp, a
Director of the Company, an option to purchase 20,000 shares of Common Stock at
$3.50 per share. In addition, in October 1994, the Board of Directors granted to
Mr. Philipp, a director of the Company and Special Advisor to the Board for
International Marketing, the right to receive 3% of the gross proceeds of any
licensing fees and prepaid royalties received by the Company pursuant to the SAB
Agreement and a fee of .75% of gross proceeds in the event that SAB/Bioclones
makes a tender offer for all or substantially all of the Company's assets,
including a merger, acquisition or related transaction. In addition, the Company
further agreed to provide a monthly retainer of $2,000 to Mr. Philip in exchange
for consulting services and remuneration for corporate alliances which are
principally introduced by Mr. Philipp. Mr. Philipp has been paid $90,000 to date
in connection with these arrangements.
In September 1994, Maryann Charlap Azzato, formerly Vice President of
Investor Relations and Corporate Communications and the former Vice Chairman and
director of the Company, entered into an agreement with Lloyd DeVos, a
stockholder, former director and holder of a note in the principal amount of
$100,000 (the "DeVos Note") in order to settle a lawsuit filed against the
Company and William A. Carter by Mr. DeVos in the United States District Court
for the Southern District of New York alleging breach of contract, conversion
and certain violations of the federal securities laws in connection with the
issuance of the DeVos Note. Pursuant to the settlement agreement, principal and
interest on the DeVos Note were repaid by Ms. Azzato as well as certain expenses
incurred by Mr. DeVos in the approximate amount of $2,600 and 1,536 shares of
Common Stock of the Company were transferred to Mr. DeVos by Ms. Azzato in
exchange for the assignment to Ms. Azzato by Mr. DeVos of the right to repayment
by the Company of the DeVos Note and warrants to purchase 1,667 share of Series
C Preferred Stock. In addition, certain options to purchase 6,912 shares of
Common Stock of the Company previously issued to Mr. DeVos were delivered to Mr.
DeVos. In exchange for the above agreement, Mr. DeVos, the Company and William
A. Carter executed mutual releases of all claims and Mr. DeVos dismissed the
suit.
In September 1994, the Company incorporated three wholly-owned subsidiaries
BioPro Corp. ("BioPro"), Core BioTech, Corp. ("Core BioTech") and BioAegean
Corp. in Delaware. In September 1994, the Company granted exclusive worldwide
licenses and/or sublicenses to certain of its patents and assigned certain other
patents to BioPro (the "BioPro License"), Core BioTech (the "CoreBiotech
License") and BioAegean (the "BioAegean License"). Bridge Ventures, which has
rights in the Company's patents pursuant to the collateralization of such
patents in connection with the 1994 Common Stock Financing, agreed to release
its rights in the licensed or assigned patents. Harris Freedman, the Vice
President for Strategic Alliances for the Company and BioAegean, and his wife
are officers of Bridge Ventures.
In May 1994, the Company entered into an agreement to borrow $100,000 from
Bridge Ventures for 60 days in exchange for warrants to purchase 92,160 shares
of Common Stock at $3.50 per share. In August 1994, the $100,000 loan was
converted to 200,000 shares of Common Stock and warrants to purchase 200,000
shares of Common Stock at an exercise price of $3.50 per share. Bridge Ventures
transferred 150,000 of its shares of Common Stock to Gerald Kay, a director of
the Company. In addition, Bridge Ventures received a $50,000 consulting fee for
general business and financial consulting services rendered from January 1994 to
July 1994, which it converted into 100,000 shares of Common Stock as part of the
1994 Common Stock Financing. Harris Freedman, the Company's Vice President, and
his wife are officers of Bridge Ventures. Pursuant to the agreement with Bridge
Ventures, Messrs. Kay, Philipp and Rodino were elected to the Board of
Directors. In November 1994, each of Bridge Ventures and Gerald Kay sold 50,000
shares of Common Stock at a price of $.50 per share to Worldwide Marketing.
Sharon Will, an officer of the Company, is President of Worldwide Marketing.
In April 1994, William A. Carter, the Company's Chairman and Chief
Executive Officer, purchased 20,000 shares of Series C Preferred Stock at $5.00
per share. Also Maryann Charlap Azzato purchased 30,000 shares of Series C
Preferred Stock at $5.00 per share and agreed to purchase an additional 10,000
shares at $5.00 per share.
In May 1994, Maryann Charlap Azzato guaranteed payment of two promissory
notes in the aggregate amount of $76,000 payable by the Company representing
payments due in connection with the Temple Agreement (the "Temple Notes"). In
return for the guarantee, the Company assigned all rights, patents and related
technology in the Company's Oragen and Diagen products to Ms. Azzato, which
rights will revert to the Company upon repayment of the principal on the Temple
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Notes, 12% interest, and Ms. Azzato's fees and expenses which are expected to be
paid from the proceeds of this Public Offering. The Company also received a
right of first refusal with respect to the sale or assignment by Ms. Azzato of
this technology.
In January 1994, William A. Carter, the Company's Chairman and Chief
Executive Officer, sold an aggregate of 122,880 shares of Common Stock at $3.26
per share for an aggregate price of $400,000 to Michael Dubilier, Keys
Foundation, Canaan Venture Limited Partnership ("Canaan Venture"), Canaan
Venture Offshore Limited Partnership, C.V. ("Canaan Offshore"), James Tisch and
an unaffiliated individual. Using the proceeds of this sale, Dr. Carter
purchased 80,000 shares of Series C Preferred Stock at $5.00 per share from the
Company. In addition, Maryann Charlap Azzato purchased 3,600 shares of Series C
Preferred Stock at $5.00 for an aggregate price of $18,000, representing her
remaining commitment under the 1993 Standby Financing Agreement.
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DESCRIPTION OF SECURITIES
The Company is authorized to issue up to 50,000,000 shares of Common Stock,
$.001 par value per share, and 5,000,000 shares of Preferred Stock, $.01 par
value per share.
Common Stock
As of July 10, 1996, there were 9,470,675 shares of Common Stock
outstanding and subscribed held of record by 331 stockholders. In addition,
there were 6,110,917 Units outstanding, each Unit consisting of one share of
Common Stock and one Class A Redeemable Warrant. The holders of Common Stock are
entitled to one vote per share on all matters to be voted on by stockholders,
and stockholders have no rights to cumulative votes in the election of
directors. Subject to prior dividend rights and preferences of holders of shares
of Preferred Stock, if any, holders of Common Stock are entitled to receive such
dividends as may be declared by the Board of Directors from funds legally
available therefor. Upon liquidation or dissolution of the Company, subject to
prior liquidation rights of holders of Preferred Stock, if any, the assets of
the Company available for distribution to stockholders will be distributed
ratably among the holders of Common Stock. The holders of Common Stock have no
preemptive or other subscription rights and there are no conversion or
redemption or sinking fund provisions with respect to such shares. All of the
outstanding shares of Common Stock are fully paid and nonassessable and the
shares of Common Stock sold by the Company in this offering will be fully paid
and nonassessable.
Preferred Stock
As of July 10, 1996, there were 6,000 shares of Series D Preferred Stock
which were issued and subscribed. These Preferred shares are convertible into
Common Stock.
The Board of Directors are authorized, without further action or vote of
the stockholders, to issue up to 4,400,000 shares of Preferred Stock in one or
more series and to fix the rights, preferences, privileges and restrictions,
including the dividend rights, conversion rights, voting rights, rights and
terms of redemption, redemption price or prices, liquidation preferences and the
number of shares constituting any series or the designations of such series. The
Company has no present plans to issue any shares of Preferred Stock. Issuance of
Preferred Stock, which may be accomplished through a public offering, a private
placement or otherwise may dilute the voting power of holders of Common Stock,
may render more difficult the removal of current management, even if such
removal may be in the stockholders' best interest, and may have the effect of
delaying, deferring or preventing a change in control of the Company.
Warrants
In connection with various debt financings and other agreements, the
Company has issued warrants to acquire an aggregate of up to 6,013,630 shares of
the Company's Common Stock at a weighted average exercise price of $3.15 per
share. In addition, the Company issued Rule 701 Warrants to the Company's
directors and certain officers in October and November 1994, to purchase an
aggregate of 2,080,000 shares of Common Stock at $3.50 per share. See
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" and "Certain Transactions." All of these warrants, except for (i)
the Rule 701 Warrants which vest in 1/3 increments over 36 months and (ii) the
100,000 warrants which may be issued to The Sage Group which vest upon the
occurrence of certain conditions, are currently exercisable by the holders.
Class A Redeemable Warrants
The Class A Redeemable Warrants ("Class A Warrants"), totaling 6,313,000,
(including the Class A Warrants included in the Bridge Units which are issuable
upon exercise of the Bridgeholder Options), are issued pursuant to an agreement,
dated November 2, 1995 (the "Warrant Agreement"), between the Company and
Continental Stock Transfer and Trust Company (the "Warrant Agent"). The
following discussion of certain terms and provisions of the Class A Warrants is
qualified in its entirety by reference to the detailed provisions of the Warrant
Agreement.
Each Class A Warrant represents the right of the registered holder to
purchase one share of Common Stock at an exercise price equal to $4.00, subject
to adjustment (the "Purchase Price"). The Class A Warrants will be entitled to
the benefit of adjustments in the Purchase Price and in the number of shares of
Common Stock and/or other securities deliverable upon the exercise thereof in
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the event of a stock dividend, stock split, reclassification, reorganization,
consolidation, merger or the issuance of Common Stock or options to purchase
Common Stock at a price below the Purchase Price then in effect. The Company has
the right to reduce the Purchase Price or increase the number of shares of
Common Stock issuable upon the exercise of the Class A Warrants.
Unless previously redeemed, the Class A Warrants may be exercised at any
time commencing November 2, 1996 and prior to the close of business on November
2, 2000 (the "Expiration Date"). On and after the Expiration Date, the Class A
Warrants become wholly void and of no value. The Company may, upon 30 days
written notice to all holders of the Class A Warrants, reduce the exercise price
or extend the Expiration Date of all outstanding Warrants for such increased
period of time as it may determine. The Class A Warrants may be exercised at the
office of the Warrant Agent.
The Company has the right at any time after November 2, 1997 to redeem the
Class A Warrants at a price of $.05 each, by written notice mailed 30 days prior
to the redemption date to each Class A Warrant holder at his address as it
appears on the books of the Warrant Agent. Such notice shall only be given
within 10 days following any period of 20 consecutive trading days during which
the high closing bid price of the shares of Common Stock (if then traded on the
Nasdaq or on a national securities exchange) exceeds $9.00, subject to
adjustments for stock dividends, stock splits and the like. If the Class A
Warrants are called for redemption, they must be exercised prior to the close of
business on the date prior to the date of any such redemption or the right to
purchase the applicable shares of Common Stock will lapse.
No holder, as such, of Class A Warrants shall be entitled to vote or
receive dividends or be deemed the holder of shares of Common Stock for any
purpose whatsoever until such Class A Warrants have been duly exercised and the
Purchase Price has been paid in full.
If required, the Company will file a new registration statement with the
Commission with respect to the securities underlying the Class A Warrants prior
to the exercise of the Class A Warrants and deliver a prospectus with respect to
such securities to all Class A Warrant holders as required by Section 10(a)(3)
of the Securities Act. See "Risk Factors--Current Prospectus and State `Blue
Sky' Registration Required to Exercise the Redeemable Warrants."
Units
Pursuant to the IPO in November 1995, the Company registered and issued
5,313,000 Units. Each Unit consists of one share of Common Stock and one Class A
Warrant. As of July 10, 1996 there were 6,110,917 Units outstanding. On July 12,
1996, the Units were de-coupled into their component parts. On August 19, 1996,
the Company voluntarily delisted the Units. The Company's Common Stock and Class
A Warrants are traded publicly.
Bridge Units
In connection with the Bridge Loans, the Company issued to the holders of
the Bridge Loans Bridgeholders Options to purchase 1,000,000 Bridge Units at an
exercise price of $.50 per Bridge Unit. Each Bridge Unit originally contained
one share of Common Stock, one Class A Warrant and one Class B Redeemable
Purchase Warrant (collectively, the "Class B Warrants"). The Company and the
purchasers have amended the Bridge Units to eliminate the Class B Warrants such
that each Bridge Unit contains one share of Common Stock and one Class A
Warrant. The Company has registered the Bridgeholder Options, 900,000 of the
Bridge Units and the 900,000 shares of Common Stock and 900,000 Class A Warrants
contained in the Bridge Units for resale in the Concurrent Offering, although
the Company will not receive any of the proceeds from the sale of such
securities. The Class A Warrants included in the Bridge Units are identical to
the Class A Warrants offered by the Company in the IPO. The holders of the
Bridgeholder Options may exercise such options at an exercise price of $.50 per
Bridge Unit to obtain such Bridge Units at any time. The Bridge Units and the
securities contained therein are not transferable until the earlier of 13 months
from November 2, 1995 or at such earlier date as may be permitted by the
Company. The securities underlying the Bridge Units shall not be traded
separately for a period of 12 months from November 2, 1995 without prior written
consent of the Company.
In November 1995, Bridge Unit holders exercised 797,917 Units at $.50 per
Unit. In May 1996, one Bridge Unit holder exercised 6,250 Units.
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Rule 701 Warrants
In October 1994, the Company issued 2,080,000 warrants to purchase Common
Stock at $3.50 per share pursuant to Rule 701 under the Secutities Act ("Rule
701 Warrants") to certain officers and employees of the Company. These Rule 701
Warrants vest in 1/3 increments over a thirty six month period and are
exercisable until September 30, 1999. In the event that the number of Rule 701
Warrants issued by the Company exceeds the aggregate monetary limits set forth
under Rule 701, the number of Rule 701 Warrants issued to the holders will be
reduced pro rata and the remaining warrants will not be subject to the
provisions of Rule 701. See "Shares Eligible for Future Sales and Registration
Rights."
Delaware Law and Certain Charter and By-Law Provisions
The Company will be subject to the provisions of Section 203 of the General
Corporation Law of Delaware. Section 203 prohibits a publicly-held Delaware
corporation from engaging in a "business combination" with an "interested
stockholder" for a period of three years after the date of the transaction in
which the person became an interested stockholder, unless, among other
exceptions, the business combination is approved by (i) the Board of Directors
prior to the date the interested stockholder obtained such status or (ii) the
holders of two-thirds of the outstanding shares of each class or series of stock
entitled to vote generally in the election of directors, not including those
shares owned by the interested stockholder. A "business combination" includes
mergers, asset sales and other transactions resulting in a financial benefit to
the interested stockholder. Subject to certain exceptions, an "interested
stockholder" is a person who, together with affiliates and associates, owns, or
within three years did own, 15% or more of the corporation's voting stock.
The Company's By-Laws contain a provision whereby a stockholder of the
Company may nominate an individual or individuals for election to the Board of
Directors only if such nomination is made in writing (i) at least ninety days in
advance of the Company's annual meeting of stockholders or (ii) within seven
days following notice of a special meeting of stockholders for the election of
directors. Accordingly, it will be more difficult for stockholders, including
those holding a majority of the outstanding shares, to force an immediate change
in the composition of the Board of Directors.
The Company's Certificate of Incorporation contains certain provisions
permitted under the General Corporation Law of Delaware relating to the
liability of directors. The provisions eliminate a director's liability for
monetary damages for a breach of fiduciary duty, except in certain circumstances
involving wrongful acts, such as the breach of a director's duty of loyalty or
acts or omissions which involve intentional misconduct or a knowing violation of
law. The Company's Certificate of Incorporation also contains provisions to
indemnify its directors and officers to the fullest extent permitted by the
General Corporation Law of Delaware. The Company has entered into
indemnification agreements with its current directors and certain of its
executive officers. These agreements have the practical effect in certain cases
of eliminating the ability of stockholders to collect monetary damages from such
individuals. The Company believes that these provisions and agreements have
assisted the Company in attracting and retaining qualified individuals to serve
as directors and officers.
Transfer Agent and Registrar
The transfer agent and registrar for the Company's Units, Common Stock and
Class A Redeemable Warrants is Continental Stock Transfer and Trust Company, 2
Broadway, New York, New York 10004.
Nasdaq Quotation
The Company's Common Stock and Warrants trade on Nasdaq under the trading
symbols HEMX and HEMXW, respectively.
Shares Eligible for Future Sale and Registration Rights
The Company has 15,587,842 shares of Common Stock outstanding as of July
10, 1996 including the Common Stock included in the 6,110,917 Units outstanding
(each Unit consists of one share of Common Stock and one Class A Warrant). There
are 195,833 unexercised Bridgeholder Options (consisting of one share of Common
Stock and one Class A Warrant) outstanding. In addition, the Company has
9,470,675 shares of Common Stock, 228,502 stock options and 7,997,797 warrants
outstanding. All of these shares, options and warrants other than the 6,110,917
70
<PAGE>
outstanding Units and the 195,833 Bridgeholder Options were issued in private
transactions not involving a public offering and, therefore, are treated as
"restricted securities" subject to the restrictions of Rule 144 under the
Securities Act. Restricted securities may not be resold except in compliance
with the registration requirements of the Securities Act or pursuant to an
exemption therefrom, such as the exemptions provided by Rule 144 and Rule 144A.
In general, under Rule 144 as currently in effect, a person (or persons
whose shares are aggregated), including an affiliate (as that term is defined
under the rules and regulations of the Securities Act), who has beneficially
owned "restricted securities" for at least two years will be entitled to sell
within any three month period a number of shares that does not exceed the
greater of (i) 1% of the then outstanding shares of Common Stock (approximately
15,587,842 shares) or (ii) the average weekly trading volume in the Common Stock
on all national securities exchanges and/or reported through the automated
quotation system of registered securities associations during the four calendar
weeks immediately preceding the date on which notice of the sale is filed with
the Commission. Sales pursuant to Rule 144 are also subject to certain other
requirements regarding the manner of sale, notice and availability of current
public information about the Company. A person (or persons whose shares are
aggregated) who is not deemed to have been an affiliate of the Company at any
time during the three months immediately preceding the sale is entitled to sell
restricted securities pursuant to Rule 144(k) without regard to the limitations
described above, provided that three years have expired since the later of the
date on which such restricted securities were acquired from the Company or the
date they were acquired from an affiliate of the Company. Affiliates, including
members of the Board of Directors and certain of the officers of the Company
continue to be subject to such limitations. As defined in Rule 144, an
"affiliate" of an issuer is a person that directly, or indirectly through one or
more intermediaries, controls or is controlled by, or is under common control
with, such issuer.
Subject to certain limitations on the aggregate offering price of a
transaction and other conditions, Rule 701 under the Securities Act may be
relied upon with respect to the resale of securities originally purchased from
the Company by its employees, directors, officers, consultants or advisers
between May 20, 1988, the effective date of Rule 701, and November 2, 1995 (the
date the Company became subject to the reporting requirements of the Securities
Act), pursuant to written compensatory benefit plans or written contracts
relating to the compensation of such persons. Shares of Common Stock of the
Company issued in reliance on Rule 701 are deemed to be restricted stock and may
be sold by persons other than affiliates subject only to the manner of sale
provisions of Rule 144 and by affiliates under Rule 144 without compliance with
its two year minimum holding period requirements. The Company has issued Rule
701 Warrants to purchase 2,080,000 shares of Common Stock at an exercise price
of $3.50 per share in reliance upon Rule 701. All shares which may qualify for
sale under Rule 701, however, are subject to a two year lockup.
The Company has secured written agreements from all of the current
shareholders, except as described below, not to sell, assign, pledge,
hypothecate or otherwise dispose of (collectively, "Transfer"), directly or
indirectly, any shares of Common Stock and to waive all registration rights for
a period of 24 months from November 2, 1995, subject to certain exceptions,
without the prior written consent of the Company. The Company has agreed to
certain exceptions to its request as follows. William A. Carter, the Company's
President, Chief Executive Officer and Chairman who holds 1,065,235 shares of
Common Stock, has agreed not to sell or transfer his securities for a period of
36 months from November 2, 1995. Holders of the Bridge Notes who own
Bridgeholder Options to purchase up to 1,000,000 Bridge Units in the aggregate
and the holder of 5,898 shares of Common Stock have agreed not to sell or
transfer their securities for a period of 13 months without the Company's
consent. In addition, pursuant to the Tisch/Tsai Restructuring, the Tisch/Tsai
Entities, which hold an aggregate of 485,832 shares of Common Stock, have agreed
with the Company not to exercise their registration rights or otherwise transfer
any securities held by them except to certain permitted transferees for a period
of 18 months commencing November 2, 1995 in the event that the affiliates of the
Company agree to terms no more advantageous that those of the Tisch/Tsai
Entities for a period of 24 months commencing November 2, 1995. The lock-up
period for the Tisch/Tsai Entities shall terminate in the event that any other
securityholders of the Company other than the holders of the Bridge Loans shall
be released from their lock-up periods. In addition, the Canaan Entities, which
hold an aggregate of 511,220 shares of Common Stock, Michael Dubilier, a
principal stockholder of the Company who beneficially owns 689,780 shares of
Common Stock, and three holders of an aggregate of 1,253,227 shares of Common
Stock have agreed not to exercise their registration rights or otherwise
transfer any securities held by them for a period of 18 months commencing
November 2, 1995. The lock-up period for the Canaan Entities, Michael Dubilier
and the holder of 18,432 shares of Common Stock shall terminate in the event
71
<PAGE>
that any other securityholders of the Company shall be released from their
lock-up periods. In addition, the Company has decided not to seek an additional
restriction on the sale of the shares owned by Mr. Cohn and certain related
parties, all of whom hold warrants to purchase 156,672 shares of Common Stock.
See "Business--Legal Proceedings." The Company believes, however, that pursuant
to the terms of the Series A Purchase Agreement, as amended, Mr. Cohn and
related parties are subject to a 180-day restriction of the Transfer of their
securities. In addition, as of October 25, 1995, the holders of approximately
10% of the Company's securities had not executed lock-up agreements.
Under the terms of a Registration Rights Agreement, dated May 9, 1989, as
amended, by and among the Company and E. Paul Charlap, Michael C. Burrows,
Martin H. Dubilier, Keys Foundation and James S. Tisch, if the Company proposes
to register any of its securities under the Securities Act, other than pursuant
to an initial public offering or a registration statement on Forms S-8 or S-4,
such holders, or their successors, are entitled to notice of such registration
and to include their shares of Common Stock in such registration. These rights
are subject to certain conditions and limitations, including the right of the
underwriter to limit the number of shares included in such registration. Certain
of such holders may require the Company to file a Registration Statement under
the Securities Act at the Company's expense with respect to their shares of
Common Stock, and the Company is required to use its best efforts to effect such
registration, subject to certain conditions and limitations. Further, such
holders may require the Company to file additional registration statements on
Form S-3, subject to certain conditions and limitations. The parties to this
Registration Rights Agreement have subordinated their rights therein to the
registration rights granted under the Series A Purchase Agreement (as described
below), to the extent of any conflict between the registration rights granted by
the two agreements. These registration rights have been waived by the holders
for a period of two years commencing November 2, 1995.
Under the terms of the Series A Purchase Agreement, as amended, if the
Company proposes to register any of its securities under the Securities Act,
either for its own account or for the account of any other security holders,
other than pursuant to an initial public offering, such persons are entitled to
notice of such registration to include their shares of Common Stock in such
registration. These rights are subject to certain conditions and limitations
including the right of the underwriters to limit the number of shares included
in such registration. Certain of such holders may require the Company on not
more than two occasions, to file a Registration Statement under the Securities
Act at the Company's expense with respect to their shares of Common Stock, and
the Company is required to use its best efforts with respect to such
registration, subject to certain conditions and limitations. Further, certain of
such holders may require the Company to file additional Registration Statements
on Form S-3, subject to certain conditions and limitations. In addition,
notwithstanding the foregoing, the Agreement provides that immediately prior to
the IPO, as well as subsequent to the IPO, the Company was obligated to file a
"shelf" registration statement pursuant to Rule 415 of the Securities Act with
respect to shares of Common Stock issuable pursuant to the exercise of the
outstanding warrants and/or pursuant to the conversion of any notes then
outstanding, which were issued pursuant to the February 1992 Investor Loan, as
amended by the Cohn Amendment, and June 1993 Investor Loan. Such "shelf"
registration statements must be kept current and effective by the Company for a
maximum of four years. As a condition of the IPO, registration rights, with the
exception of two holders have been waived by the holders.
The Tisch/Tsai Entities have an additional piggyback registration right of
20% of their shares of Common Stock in the event that the Company shall register
securities in a secondary offering expected to result in gross proceeds in
excess of $10 million. In addition, the Company, at its sole expense, has agreed
to take all necessary actions to register all securities held by the Tisch/Tsai
Entities after the expiration of the 18 month lock-up period. For six months
following the expiration of the lock-up period, the Tisch/Tsai Entities may sell
no more than 25,000 shares pursuant to such registration per quarter.
All sales of securities pursuant to Rule 144 by the Tisch/Tsai Entities
during the 24-month affiliate lock-up period, if any, will be made through the
Representative, as broker, provided that all other Rule 144 sales by affiliates
during the affiliate lock-up period shall be conducted through the
Representative.
Pursuant to the 1994 Common Stock Financing, the Company has granted
certain demand registration rights to the holders of 2,050,000 shares of Common
Stock. If holders of 50% or more of these shares give the appropriate notice to
the Company, the Company will file a new registration statement under the
Securities Act with respect to these shares. These holders are subject to a 24
month Lock Up Agreement as described above. Jerome Belson has agreed to waive
his registration rights granted in connection with the 1994 Common Stock
Financing.
72
<PAGE>
The holders of the Bridge Units have agreed not to sell the Bridge Units
for a period of 13 months from November 2, 1995, subject to earlier release at
the Company's discretion. Jerome Belson, owner of 100,000 Bridge Units, has
agreed to waive his registration rights in connection with the Bridge Financing.
In connection with the restructuring of the Original Brauser Note, the
Company has granted to Gerald Brauser a one-time, piggyback registration right
to register 75,000 shares of Common Stock underlying the warrants issued to Mr.
Brauser, subject to the discretion of the underwriter of such subsequent
offering. In addition, the Company has granted Mr. Brauser registration rights
for 100,000 shares of Common Stock issued pursuant to this restructuring, which
rights are identical to those granted to the holders of the shares of Common
Stock issued in connection with the 1994 Common Stock Financing (as described
above); these rights of Mr. Brauser, however, are exercisable only if holders of
50% or more of the shares of Common Stock issued in connection with the 1994
Common Stock Financing give notice and elect to exercise their rights. Mr.
Brauser has entered into a 24-month Lock Up Agreement as described above.
In connection with the extension of a note, the Company granted to Myron
Cherry either registration rights for certain securities owned by him or a
reduction in the exercise price of his options to $1.75 per share. Because Mr.
Cherry has not advised the Company of his election, the Company has reduced the
exercise price of his warrants to $1.75 per share.
LEGAL MATTERS
The validity of the securities offered hereby will be passed upon for the
Company by Silverman, Collura & Chernis, P.C., New York, New York.
EXPERTS
The consolidated financial statements of Hemispherx BioPharma, Inc. and
subsidiaries as of December 31, 1994 and 1995, and for each of the years in the
three year period ended December 31, 1995, have been included herein and in the
registration statement in reliance upon the report of KPMG Peat Marwick LLP,
independent certified public accountants, appearing elsewhere herein, and upon
the authority of said firm as experts in accounting and auditing.
ADDITIONAL INFORMATION
The Company is subject to the reporting requirements of the Securities
Exchange Act. The Company has filed with the Commission, a Registration
Statement on Form S-1 (including any amendments thereto, the "Registration
Statement") under the Securities Act. This Prospectus does not contain all of
the information set forth in the Registration Statement and the exhibits and
schedules thereto. For further information with respect to the Company and the
Common Stock, reference is made to the Registration Statement, and the exhibits
and schedules thereto. Statements contained in this Prospectus as to the
contents of any contract or any other document are not necessarily complete and,
in each instance, reference is made to the copy of such contract or document
filed as an exhibit to the Registration Statement. The Registration Statement
and the exhibits and the schedules thereto filed with the Commission may be
inspected, without charge, at the public reference facilities maintained by the
Commission at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W. Washington,
D.C. 20549, and at the Commission's Regional Offices at 7 World Trade Center,
13th Floor, New York, New York 10048 and Northwestern Atrium Center, 500 West
Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such material may
also be obtained upon written request from the Public Reference Section of the
Commission at 450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed
rates.
73
<PAGE>
GLOSSARY OF TERMS
25A: 2", 5" oligoadenylate; a short polymer of ribonucleic
acid containing the base adenine.
25A Synthetase: A set of specific enzymes that join together certain
building blocks, termed nucleotides, to form 2-5A; 2-5A
synthetase must be activated by a double-stranded RNA
molecule.
AIDS: Acquired Immunodeficiency Syndrome; a disease caused by
HIV infection due to the progressive decline in the
body's immune system leading to fatal infections or
malignancies.
Analogue: A chemical compound with a structure similar to that of
another compound, but differing from it in respect to a
certain component.
Antiviral: Destroying viruses or suppressing their replication.
CD4: A certain type of immune cell which protects the body
against foreign organisms such as bacteria and viruses.
Controlled Study: A clinical trial in which patients are divided into two
groups, one of which receives the drug being tested, and
the second of which receives either a saline solution
(see definition of "Placebo") or another drug purported
to be clinically beneficial in the treatment of the
indication in question. In trials where the second group
receives saline solution, the study is referred to as
"placebo-controlled". In trials where the second group
receives a drug purported to be beneficial, the study is
referred to as "active-controlled".
Cytokine: Proteins released by a cell population on contact with a
stimulus, which act as intracellular mediators.
Double-Blind: Refers to a study where neither the patient nor the
treating physician knows whether the patient is being
administered with drug or placebo.
Enzyme: A protein that accelerates a chemical reaction of other
substances in the body.
FDA: Food and Drug Administration; the United States
governmental agency with authority for drug approval.
Good Laboratory
Practice (GLP): Federal regulations which govern the generation of
laboratory data in a manner that is acceptable to the FDA
in its review of ongoing studies and New Drug
Applications (NDA) for marketing approval.
HIV: Human-immunodeficiency virus; the virus which causes
AIDS.
Interferon: IFN; A family of proteins that exert anti-viral activity;
interferons also have immune regulatory and anti-tumor
activities. IFN can be classified into three distinct
classes termed alpha, beta or gamma.
Interleukin: A group of protein factors, produced by immune cells.
In vitro: Refers to studies taking place within an artificial
environment such as a test tube.
74
<PAGE>
In vivo: Refers to studies taking place within a living body.
Lymphokine: Antiviral and anticancer products, such as interferon,
produced by certain types of blood cells.
Macrophage: A blood cell which ingests foreign substances.
Multicenter: Refers to a trial conducted at more than one clinical
site.
Oncogene: Refers to genes with the capacity to cause production or
growth of a tumor.
Open-Label: Refers to a study where both the patient and the treating
physician know the identity of the drug which is being
administered.
Placebo: A dummy treatment administered to the control group in a
controlled clinical trial in order to distinguish the
specific and nonspecific effects of the experimental
treatments.
Placebo-Controlled: Refers to a trial in which a portion of the patients
receive a drug and a portion of the patients receive a
placebo, and the activity of the drug is compared to the
activity of the placebo.
Protein Kinase: Refers to an enzyme which can modify other protein
factors leading to inhibition of viral replication or
tumor cell growth.
Randomized: Refers to a procedure where the treatment that a patient
will receive (i.e. the active drug or a placebo) is
determined by chance.
Ribonuclease: Any enzyme that decomposes ribonucleic acids, such as
viral RNA.
Ribonuclease L: A specific ribonuclease that is present in human cells,
but dormant (inactive) until activated by 2-5A or Oragen
drugs.
Transitory Response: A tumor response which is characterized by the subsequent
recurrence of disease (notwithstanding the continuation
of treatment) after a limited period of time.
75
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Index to Consolidated Financial Statements
Page
----
Independent Auditors' Report............................................... F-2
Consolidated Balance Sheets at December 31, 1994 and 1995,
and the unaudited Consolidated Balance Sheet at
June 30, 1996 ............................................................ F-3
Consolidated Statements of Operations for each of the years in the
three-year period ended December 31, 1995, and the unaudited six month
periods ended June 30, 1995 and 1996..................................... F-4
Consolidated Statements of Stockholders' Equity(Deficit) for each of
the years in the three-year period ended December 31, 1995, and the
unaudited six month period ended June 30, 1996........................... F-5
Consolidated Statements of Cash Flows for each of the years in the
three-year period ended December 31, 1995, and the unaudited six month
periods ended June 30, 1995 and 1996..................................... F-6
Notes to Consolidated Financial Statements................................. F-8
F-1
<PAGE>
INDEPENDENT AUDITORS' REPORT
The Board of Directors and Stockholders
Hemispherx BioPharma, Inc.:
We have audited the accompanying consolidated balance sheets of Hemispherx
BioPharma, Inc. and subsidiaries (the Company) as of December 31, 1994 and 1995,
and the related consolidated statements of operations, stockholders'
equity(deficit), and cash flows for each of the years in the three-year period
ended December 31, 1995. These consolidated financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of Hemispherx
BioPharma, Inc. and subsidiaries as of December 31, 1994 and 1995, and the
results of their operations and their cash flows for each of the years in the
three-year period ended December 31, 1995 in conformity with generally accepted
accounting principles.
KPMG PEAT MARWICK LLP
March 1, 1996, except for paragraph 4
of Note 14, which is as of March 21, 1996.
Miami, Florida
F-2
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 1994 and 1995 and June 30, 1996
<TABLE>
<CAPTION>
December 31, June 30,
------------------------------ ----------
(unaudited
1994 1995 1996
---- ---- ----
ASSETS
<S> <C> <C> <C>
Current assets:
Cash and cash equivalents...................... $ 61,005 $11,291,167 $2,538,880
Prepaid expenses and other current assets...... 2,757 62,742 86,949
---------- ----------- ----------
Total current assets........................ 63,762 11,353,909 2,625,829
Property and equipment, net .................... 104,328 53,953 61,064
Patent and trademarks rights, net............... 1,434,420 1,245,092 1,338,155
Security deposits............................... 48,931 46,564 18,323
---------- ----------- -------------
Total assets................................ $1,651,441 $12,699,518 $ 4,043,370
========== =========== =============
LIABILITIES AND STOCKHOLDERS' EQUITY(DEFICIT)
Current liabilities:
Installments of obligation under
capital leases................................... $ 23,308 $ -- $ --
Accounts payable................................... 2,251,721 1,095,637 791,482
Accrued expenses (note 5).......................... 2,296,855 2,263,096 574,115
Notes payable (note 3)............................. 5,045,000 4,920,000 --
Stockholder notes payable (note 4)................. 3,425,910 -- --
---------- ---------- ------------
Total current liabilities....................... 13,042,794 8,278,733 1,365,597
Commitments and contingencies (notes 3, 4, 6,
8, 9, 10, 11, 12 and 14)
Redeemable preferred stock (note 7)................. 3,238,334 -- --
Stockholders' equity(deficit) (notes 4, 6 and 7):
Preferred stock subscribed........................ 4,772,233 -- --
Common stock subscribed........................... 1,061,331 -- --
Preferred stock................................... 7,200,017 -- --
Common stock...................................... 5,136 15,581 15,587
Additional paid-in capital........................ 14,036,082 47,949,530 47,952,649
Accumulated deficit............................... (41,704,486) (43,544,326) (45,290,643)
---------- ---------- ------------
Total stockholders' equity(deficit)............. (14,629,687) 4,420,785 2,677,773
---------- ---------- ---------
Total liabilities and stockholders' equity...... $1,651,441 $12,699,518 $ 4,043,370
========== =========== ============
</TABLE>
See accompanying notes to consolidated financial statements.
F-3
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
For each of the years in the three-year period ended December 31, 1995
and the unaudited six month periods ended June 30, 1995 and 1996
<TABLE>
<CAPTION>
December 31, Six Months Ended June 30,
---------------------------------------------- ------------------------------
1993 1994 1995 1995 1996
---- ---- ---- ---- ----
(Unaudited)
<S> <C> <C> <C> <C> <C>
Revenues:
Research and development ................. $ 48,000 $ 75,758 $ 65,910 $ 33,260 $ 18,369
License fees ............................. -- 100,000 2,900,000 1,000,000 --
----------- ------------ ------------ ----------- -----------
Total revenues ........................ 48,000 175,758 2,965,910 1,033,260 $ 18,369
----------- ------------ ------------ ----------- -----------
Costs and expenses:
Research and development ................. 2,118,896 1,637,769 1,028,662 533,210 694,505
General and administrative ............... 3,347,476 2,617,762 2,880,443 1,274,403 1,235,566
----------- ------------ ------------ ----------- -----------
Total cost and expenses ............... 5,466,372 4,255,531 3,909,105 1,807,613 1,930,070
Debt conversion expense ................... (1,214,500) (10,500) (149,384) (149,384) --
Interest income ........................... 18,427 25,091 95,887 2,910 165,565
Interest expense .......................... (1,087,605) (1,067,869) (843,148) (451,448) --
----------- ------------ ------------ ----------- -----------
Net loss ............................... $(7,702,050) $ (5,133,051) $ (1,839,840) $ (1,372,275) $(1,746,137)
=========== ============ ============ =========== ===========
Pro forma net loss and net loss per
share (note 2(e)):
Pro forma weighted average shares
outstanding ........................... -- 11,536,276 14,199,701 13,047,506
Pro forma net loss per share ............ -- $ (.44) $ (.13) $ (.11)
============ ============ ============
Weighted average shares outstanding ....... -- -- -- -- 15,581,592
Net loss per share ........................ -- -- -- -- $ (.11)
============
</TABLE>
See accompanying notes to consolidated financial statements.
F-4
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Stockholders' Equity(Deficit)
For each of the years in the three-year period ended December 31, 1995
and the unaudited six month period ended June 30, 1996
<TABLE>
<CAPTION>
Preferred Common
stock stock Preferred Common Preferred Common
subscribed subscribed stock stock stock stock
shares shares shares shares subscribed subscribed
------ ------ ------ ------ ---------- ----------
<S> <C> <C> <C> <C> <C> <C>
Balance at December 31, 1992.......... -- -- 810,029 5,133,986 $ -- $ --
Preferred stock subscribed .......... 41,667 -- -- -- 500,004 --
Issuance of stock purchase
warrants, net ...................... -- -- -- -- -- --
Redeemable preferred stock
dividend............................ -- -- -- -- -- --
Debt to preferred stock
conversion.......................... 433,343 -- -- -- 3,381,219 --
Accounts payable to equity
conversion.......................... 42,502 -- -- -- 212,510 --
Net loss............................. -- -- -- -- -- --
--------- --------- --------- --------- --------- ---------
Balance at December 31, 1993.......... 517,512 28,026 810,029 5,133,986 $4,093,733 $30,227
Preferred stock subscribed .......... 130,000 -- -- -- 650,000 --
Debt to preferred/common
stock conversion.................... 3,600 300,000 -- 2,770 28,500 150,000
Redeemable preferred stock
dividend............................ -- -- -- -- -- --
Warrants issued in connection
with imputed and forgiven
interest charges.................... -- -- -- -- -- --
Issuance of stock purchase
warrants, net....................... -- -- -- -- -- --
Common stock subscribed............... -- 1,750,000 -- -- -- 875,000
Stock options exercised.............. -- 4,926 -- -- -- 6,104
Net loss............................. -- -- -- -- -- --
---------- ---------- ----------- --------- ----------- ----------
Balance at December 31, 1994.......... 651,112 2,082,952 810,029 5,136,756 $ 4,772,233 $1,061,331
Redeemable preferred stock
dividend ........................... -- -- -- -- -- --
Debt to preferred stock
dividend ........................... -- -- 172,414 -- -- --
Warrants issued in connection
with imputed and forgiven
interest charges ................... -- -- -- -- -- --
Preferred stock subscribed............ 10,000 -- -- -- 50,000 --
Debt to common stock
conversion ......................... -- 100,000 -- -- -- 50,000
Issuance of common stock
certificates ....................... -- (2,182,952) -- 2,182,952 -- (1,111,331)
Issuance of Preferred Stock
certificates ....................... (626,112) -- 626,112 -- (4,472,233) --
Convert Redeemable to Common.......... -- -- -- 343,879 -- --
Convert Preferred to Common........... (35,000) -- (1,608,555) 1,807,088 (350,000) --
Issuance of Common Stock,
net of issuance cost................ -- -- -- 5,313,000 -- --
Warrants Exercised.................... -- -- -- 797,917 -- --
Net Loss.............................. -- -- -- -- -- --
-------- --------- --------- ---------- ---------- ---------
Balance at December 31, 1995.......... -- -- -- 15,581,592 $ -- $ --
Warrants exercised ................... -- 6,250 -- -- -- 3,125
Net Loss (unaudited).................. -- -- -- -- -- --
--------- --------- --------- ---------- ---------- ---------
Balance at June 30, 1996 (unaudited) -- 6,250 -- 15,581,592 $ -- $ 3,125
========= ========= ========= ========== ========== =========
<CAPTION>
"C" Common stock
--------------------- Common
.001 Additional stock Total
Preferred Par paid-in Accumulated subscriptions stockholders'
stock value capital deficit receivable equity(deficit)
----- ----- ------- ------- ---------- ---------------
<S> <C> <C> <C> <C> <C> <C>
Balance at December 31, 1992.......... $7,200,017 $5,133 $13,842,861 $(28,869,385) $ -- $ (7,821,374)
Preferred stock subscribed .......... -- -- -- -- -- 500,004
Issuance of stock purchase
warrants, net ...................... -- -- 150,000 -- -- 150,000
Redeemable preferred stock
dividend............................ -- -- (329,692) -- -- (329,692)
Debt to preferred stock
conversion.......................... -- -- -- -- -- 3,381,219
Accounts payable to equity
conversion.......................... -- -- -- -- -- 212,510
Net loss............................. -- -- -- (7,702,050) -- (7,702,050)
--------- --------- --------- ----------- --------- -----------
Balance at December 31, 1993.......... $7,200,017 $5,133 $13,663,169 $(36,571,435) $ -- $(11,579,156)
Preferred stock subscribed .......... -- -- -- -- -- 650,000
Debt to preferred/common
stock conversion.................... -- 3 1,382 -- -- 179,885
Redeemable preferred stock
dividend............................ -- -- (372,552) -- -- (372,552)
Warrants issued in connection
with imputed and forgiven
interest charges.................... -- -- 631,583 -- -- 631,583
Issuance of stock purchase
warrants, net....................... -- -- 112,500 -- -- 112,500
Common stock subscribed............... -- -- -- -- -- 875,000
Stock options exercised.............. -- -- -- -- -- 6,104
Net loss............................. -- -- -- (5,133,051) -- (5,133,051)
---------- -------- ----------- ------------- --------- -------------
Balance at December 31, 1994.......... $7,200,017 $ 5,136 $14,036,082 $(41,704,486) $ -- $(14,629,687)
Redeemable preferred stock
dividend ........................... -- -- (314,873) -- -- (314,873)
Debt to preferred stock
dividend ........................... 749,383 -- -- -- -- 749,383
Warrants issued in connection
with imputed and forgiven
interest charges ................... -- -- 572,681 -- -- 572,681
Preferred stock subscribed............ -- -- -- -- -- 50,000
Debt to common stock
conversion ......................... -- -- -- -- -- 50,000
Issuance of common stock
certificates ....................... -- 2,183 1,109,148 -- -- --
Issuance of Preferred Stock
certificates ....................... 4,472,233 -- -- -- -- --
Convert Redeemable to Common.......... -- 344 3,552,863 -- -- 3,553,207
Convert Preferred to Common........... (12,421,633) 1,807 12,769,826 -- -- --
Issuance of Common Stock,
net of issuance cost................ -- 5,313 15,825,644 -- -- 15,830,957
Warrants Exercised.................... -- 798 398,159 -- -- 398,957
Net Loss.............................. -- -- -- (1,839,840) -- (1,839,840)
-------- ------- ----------- ------------ -------- ----------
Balance at December 31, 1995.......... $ -- $15,581 $47,949,530 $(43,544,326) $ -- $4,420,785
Warrants exercised ................... -- 6 3,119 -- -- 3,119
Net Loss (unaudited).................. -- -- -- (1,074,378) -- (1,074,378)
-------- ------- ----------- ------------ -------- ----------
Balance at June 30, 1996 (unaudited) $ -- $15,587 $47,952,649 $(45,290,463) $ -- $2,677,773
========= ======= =========== ============= ========= ==========
</TABLE>
See accompanying notes to consolidated financial statements.
F-5
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
for each of the years in the three-year period ended December 31, 1995
and the unaudited six month periods ended June 30, 1995 and 1996
Increase (Decrease) in Cash and Cash Equivalents
<TABLE>
<CAPTION>
December 31, Six Months Ended June 30
------------------------------------- --------------------------
1993 1994 1995 1995 1996
---- ---- ---- ---- ----
(unaudited)
<S> <C> <C> <C> <C> <C>
Cash flows from operating activities:
Net loss ................................................. $(7,702,050) $(5,133,051) $(1,839,840) $(1,372,275) $(1,746,137)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization of property
and equipment .......................................... 256,190 115,061 54,000 27,000 24,636
Amortization of patent rights ........................... 265,571 256,341 222,000 111,000 43,238
Issuance of stock purchase warrants ..................... 150,000 112,500 -- -- --
Imputed interest charges ................................ -- 150,000 41,360 41,360 --
Debt conversion expense ................................. 1,214,500 10,500 149,384 149,383 --
Write-off of patent rights .............................. -- 285,190 100,017 81,838 --
Gain on disposal of property and equipment .............. -- 17,197 -- -- --
Changes in assets and liabilities:
Prepaid expenses and other current assets .............. 109,069 (1,506) (59,985) (19,749) (24,208)
Accounts payable ....................................... 261,402 661,732 (1,156,084) 73,033 (304,156)
Accrued expenses ....................................... 252,117 1,565,450 547,561 601,987 (1,688,981)
Deferred revenue ....................................... -- -- -- 1,000,000 --
Security deposits ...................................... 22,563 8,441 2,368 1,459 28,241
----------- ----------- ----------- --------- ----------
Net cash (used in)
operating activities ................................ (5,170,638) (1,952,145) (1,939,219) 695,036 (3,667,367)
----------- ----------- ----------- --------- -----------
Cash flows from investing activities:
Purchase of property and equipment ....................... -- (40,000) (3,625) (3,624) (31,745)
Proceeds from disposal of property and equipment ......... -- 11,000 -- -- --
Additions to patent rights ............................... (403,584) (351,470) (132,689) (130,674) (136,300)
Net cash used in investing activities ................ $ (403,584) $ (380,470) $ (136,314) $ (134,289) $ (168,045)
=========== =========== =========== =========== ===========
</TABLE>
(CONTINUED)
See accompanying notes to consolidated financial statements.
F-6
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows (Continued)
<TABLE>
<CAPTION>
December 31, Six Months Ended June 30,
------------------------------------------ ----------------------------
1993 1994 1995 1995 1996
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Cash flows from financing activities:
Proceeds from shareholder loans ....................... $ 2,540,000 $ 925,910 $ 35,000 $ 35,000 $ --
Proceeds from notes payable ........................... 400,000 35,000 1,762,000 1,662,000 --
Payments on notes payable ............................. -- (80,000) (1,837,000) (112,000) (4,920,000)
Payments on stockholder notes ......................... (97,566) (10,000) (2,860,911) (1,985,000) --
Principal payments under capital lease obligation ..... (95,501) (6,923) (23,308) -- --
Deferred offering costs ............................... 130,000 -- -- (187,737) --
Proceeds from exercise of stock options ............... 30,227 -- -- -- --
Common stock subscription proceeds .................... -- 875,000 -- -- --
Preferred stock subscription proceeds ................. 500,004 650,000 -- -- --
Proceeds from issuance of common stock ................ -- -- 18,595,000 -- 3,125
Stock issuance costs .................................. -- -- (2,764,043) -- --
Proceeds from exercise of stock warrants .............. -- -- 398,957 -- --
----------- ----------- ------------ ---------- ----------
Net cash provided (used) in
financing activities ............................. 3,407,164 2,388,987 13,305,695 (587,737) (4,916,875)
----------- ----------- ------------ ---------- ----------
Net increase (decrease) in cash and
cash equivalents ................................. (2,167,058) 56,372 11,230,162 (26,999) (8,752,287)
Cash and cash equivalents at beginning of period ....... 2,171,691 4,633 61,005 61,005 11,291,167
----------- ----------- ------------ ---------- ----------
Cash and cash equivalents at end of period ............. $ 4,633 $ 61,005 $ 11,291,167 $ 34,006 $ 2,538,880
=========== =========== ============ ========== ==========
Supplemental disclosures of cash flow information:
Cash paid during the year for interest ................ $ 459,955 $ -- $ 186,503 $ -- $ --
=========== =========== ============ ========== ==========
Supplemental disclosure of noncash investing activities:
Debt to equity conversion ............................. $ 2,062,434 $ 100,000 $ 799,383 -- --
Accounts payable and accrued expenses to
equity conversion .................................... 264,510 74,104 50,000 -- --
Forgiveness of interest ............................... 52,285 458,333 572,681 -- --
Redeemable preferred stock to equity conversion ....... $ -- $ -- $ 3,238,334 -- --
</TABLE>
See accompanying notes to consolidated financial statements.
F-7
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 1994 and 1995
(1) Business
Hemispherx BioPharma, Inc. and subsidiaries (the Company), formerly known
as HEM Pharmaceuticals Corp., is a pharmaceutical company using nucleic acid
technologies to develop therapeutic products for the treatment of viral diseases
and certain cancers. The Company's drug technology uses specially-configured
ribonucleic acid (RNA). The Company's double-stranded RNA drug product,
trademarked Ampligen, is in human clinical development for various therapeutic
indications. The efficacy and safety of Ampligen is being developed clinically
for three anti-viral indications: myalgic encephalomyelitis, also known as
chronic fatigue syndrome (ME/CFS) (Phase II clinical trial completed and Phase
II/III clinical trial authorized); human immunodeficiency virus associated
disorders (Phase II clinical trial); and chronic hepatitis B virus infection
(Phase I/II clinical trial in process). The Company also has clinical experience
with Ampligen in patients with certain cancers including renal cell carcinoma
(kidney cancer) and metastatic malignant melanoma.
The consolidated financial statements include the financial statements of
Hemispherx BioPharma, Inc. and its three wholly-owned subsidiaries BioPro Corp.,
BioAegean Corp. and Core BioTech Corp. which were incorporated in September 1994
for the purpose of developing technology for ultimate sale into certain
non-pharmaceutical specialty consumer markets. All significant intercompany
balances and transactions have been eliminated in consolidation.
The company plans to continue to finance its operations with a combination
of product sales, stock issuances and strategic alliances. The Company may need
to obtain further financing for the long-term development and commercialization
of its planned products in order to realize the commercial value of its patent
portfolios.
In November, 1995, the Company completed an initial public offering (IPO)
of 5,313,000 units of Hemispherx BioPharma, Inc. resulting in net proceeds of
approximately $15.8 million. Each unit consists of one share of the Company's
Common Stock and one Class A Redeemable Warrant, exercisable for one share of
Common Stock at $4.00 per share. These Class A Redeemable Warrants are subject
to redemption two years from November 2, 1995 at $.05 per warrant in the event
that the closing bid price of the Company's Common Stock exceeds $9.00 for a
specified time period. In connection with the IPO, the underwriter was granted
an option to purchase 462,000 units at $5.775 per unit.
(2) Summary of Significant Accounting Policies
(a) Cash and Cash Equivalents
Cash equivalents consist of money market, bank certificates of deposit, and
overnight repurchase agreements collateralized by money market securities with
original maturities of less than three months.
(b) Property and Equipment
Property and equipment consist of furniture, fixtures, office equipment,
leasehold improvements and vehicles recorded at cost. Depreciation and
amortization is computed using the straight-line method over the estimated
useful lives of the respective assets, ranging from five to seven years.
Property and equipment held under capital leases are amortized on the
straight-line method over the shorter of the lease term or the estimated useful
life of the asset.
Accumulated depreciation and amortization as of December 31, 1994 and 1995
is $587,688 and $545,956, respectively. Accumulated depreciation and
amortization as of June 30, 1996 is $570,592.
(c) Patent and Trademark Rights
Patents and trademarks are stated at cost (primarily legal fees) and are
amortized using the straight-line method over ten years. The Company reviews its
patents and trademarks periodically to determine whether they have continuing
value. Such review includes an analysis of the patent and trademark's ultimate
revenue and profitability potential on an undiscounted cash flow basis to
support the realizability of its respective capitalized cost. In addition,
management's review addresses whether the patent and trademark continues to fit
into the Company's strategic business plans. During the years ended December 31,
1994 and 1995, the Company decided not to renew patents in certain countries and
has recorded $285,190 and $100,017 respectively, relating to the expense of
writing off these patents as a charge to research and development. Accumulated
amortization as of December 31, 1994 and 1995 is $877,990 and $936,407,
respectively. Accumulated amortization as of June 30, 1996 is $792,640.
F-8
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
(d) License Fee Revenue
Revenue is recognized immediately for nonrefundable license fees when
agreement terms require no additional performance on the part of the Company.
(e) Proforma and Supplemental Proforma Net Loss Per Share
Upon the closing of the IPO of common stock, all shares of Series A, B and
C Preferred Stock (Preferred Stock) converted into Common Stock. Proforma net
loss per share for the years end December 31, 1994 and 1995 are calculated by
dividing net loss by the weighted average number of common shares outstanding
during the period after giving effect for Common Stock equivalents arising from
stock options and warrants and Preferred Stock assumed converted to Common
Stock. Pursuant to the requirements of the Securities and Exchange Commission,
Common Stock and Common Stock equivalents issued by the Company during the
twelve months immediately preceding the IPO have been included in the
calculation of the shares used in the calculation of pro forma net loss per
share (using the treasury stock method and the public offering price).
(f) Sales of Subsidiary Stock
The Company intends to account for any sales of its subsidiaries' stock as
capital transactions.
(g) New Accounting Pronouncements
In March, 1995, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 121 "Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of"
(Statement 121). Statement 121 provides guidance for recognition and measurement
of impairment of long-lived assets, certain identifiable intangibles and
goodwill related both to assets to be held and used and assets to be disposed
of. The Company is required to adopt Statement 121 for the year ended December
31, 1996. The Company has not yet quantified the impact, if any, of the adoption
of Statement 121 may have on its consolidated financial statements.
In October 1995, the FASB issued Statement 123, "Accounting for Stock-Based
Compensation" (Statement 123). Statement 123 allows companies the option to
retain the current accounting method for recognizing stock-based expense in the
financial statements or to adopt a new accounting method based on the estimated
fair value of employee stock options. Companies that do not adopt the new fair
value based method will be required to provide expanded disclosures in the
footnotes. The Company is required to adopt Statement 123 for the year ended
December 31, 1996. The Company expects to continue applying its current
accounting method and upon adoption will present the required footnote
disclosures.
(h) Use of estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
(i) Interim Financial Information (Unaudited)
The unaudited interim condensed consolidated financial statements for the
six month periods ended June 30, 1995 and 1996 have been prepared on the same
basis as the Company's audited consolidated financial statements as of and for
the year ended December 31, 1995. In the opinion of the management, all
adjustments, consisting of normal recurring accruals, necessary to present
fairly the financial position of the Company at June 30, 1995 and the results of
operations and cash flows for the six month periods ended June 30, 1995 and
1996. The results of operations for the three month period ended June 30, 1996
are not necessarily indicative of the results expected for the year ending
December 31, 1996.
F-9
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
(3) Notes Payable
Notes payable at December 31, 1994 and 1995 and unaudited June 30, 1996
consisted of the following:
<TABLE>
<CAPTION>
December 31, June 30,
----------------------- -----------
1994 1995 1996
---- ---- ----
(unaudited)
<S> <C> <C> <C>
February 1992 convertible note with detachable
warrants due February 26, 1995, interest payable
quarterly at 12% per annum, as amended (Note 14) $4,920,000 $4,920,000 --
June 1993 convertible note with detachable warrants
due February 28, 1995, interest after September 30,
1993 payable in Common Stock at $10.85 per share,
as amended
100,000 -- --
June 1994 note, payable with 12% interest per
annum upon completion of financing in excess
of $3 million 25,000 -- --
---------- ---------- ------------
$5,045,000 $4,920,000 $ 0
========== ========== ============
</TABLE>
(4) Stockholder Notes
Stockholder notes at December 31, 1994 consisted of the following:
December 31,
1994
------------
December 1992 and February 1993 convertible notes
issued with detachable warrants due April 1994, with
interest at 12% per annum, as amended in 1995................... $2,400,000
March 1993 note due upon demand, interest payable
quarterly at 12% per annum...................................... 100,000
July 1993 note issued with detachable warrants due at
option of holder upon completion of future financings,
with interest at 12% annum, as amended......................... 100,000
December 1994 notes............................................... 750,000
May 1994 note due on demand with interest at 12%
per annum collateralized by certain patents..................... 75,910
----------
$3,425,910
==========
The Company had been in default and amended the terms of the stockholder
notes prior to the completion of its IPO. Upon completion of the IPO, all
stockholders notes and accrued interest were paid in full from the
proceeds.
(5) Accrued Expenses
Accrued expenses at December 31, 1994 and 1995 and unaudited June 30, 1996
consists of the following:
<TABLE>
<CAPTION>
December 31, June 30,
------------------------------- -----------
1994 1995 1996
---- ---- ----
(Unaudited)
<S> <C> <C> <C>
Accrued research and development fees........ $ 413,940 $ -- $ --
Deferred rent................................ 285,309 228,189 --
Deferred and Accrued payroll and benefits.... 470,951 144,047 190,952
Accrued interest............................. 831,995 898,733 --
Accrued professional fees.................... 186,950 727,996 227,279
Accrued taxes and other...................... 107,710 264,131 155,884
---------- ---------- -------
$2,296,855 $2,263,096 $574,110
========== ========== ========
</TABLE>
(6) Stockholders' Equity(Deficit)
(a) Common Stock
The Company is authorized to issue 50,000,000 shares of $.001 par value
Common Stock. On May 9, 1994, the Company declared a 1:2.17015 reverse stock
split and change in par value to $.001 on shares of the Company's Common Stock
effective June 29, 1994. Effective November 30, 1994 and June 5, 1995, the
Company effected a 2:1 forward stock split and changed its name to Hemispherx
F-10
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
BioPharma, Inc., respectively. The accompanying consolidated financial
statements reflect for all periods presented the effect of the 1:2.17015 reverse
stock split, 2:1 forward stock split, and a change in par value to $.001 per
common share.
(b) Common Stock Options and Warrants
(i) Stock Options
(A) At December 31, 1994 and 1995, the Company had outstanding options
to purchase 556 shares of Common Stock exercisable at any time in the
future at $1.07 to $2.17 per share, for options granted prior to 1990. The
option price represents the fair market value of each underlying share of
Common Stock at the date of grant, as determined by the Company's board of
directors.
(B) The 1990 Stock Option Plan provides for the grant of options to
purchase up to 460,798 shares of the Company's Common Stock to employees,
directors, and officers of the Company and to consultants, advisers, and
other persons whose contributions are important to the success of the
Company. The recipients of options granted under the 1990 Stock Option
Plan, the number of shares to be covered by each option, and the exercise
price, vesting terms, if any, duration and other terms of each option shall
be determined by the Company's board of directors or, if delegated by the
board, its Compensation Committee. No option is exercisable more than 10
years and one month from the date as of which an option agreement is
executed. These shares become vested through various periods not to exceed
four years from the date of grant. Certain shares became vested upon the
underwritten public offering concluded by the Company in November 1995. The
option price represents the fair market value of each underlying share of
Common Stock at the date of grant, as determined by the Company's board of
directors.
Information regarding the options approved by the Board of Directors under
the 1990 Stock Option Plan is summarized below:
December 31 June 30,
------------------ -----------
(Unaudited)
Option
Price 1994 1995 1996
--------- ---- ---- ----
Outstanding, beginning of year $ .11-4.34 331,486 285,620 232,830
Granted ...................... 3.50-4.34 49,952 0 0
Exercised .................... 1.07-3.80 (4,926) 0 0
Canceled ..................... .11-4.34 (90,892) (52,790) (4,328)
----------- -------- -------- --------
Outstanding, end of year ..... $1.07-4.34 285,620 232,830 228,502
=========== ======== ======== ========
Exercisable .................. 107,000 165,244 174,489
======== ======== ========
Available for future grants .. 175,178 227,968 232,296
======== ======== ========
The outstanding options include the right to purchase 45,344 shares of the
Company's Common Stock at $3.50 per share.
In December 1992, the Board of Directors approved the 1992 Stock Option
Plan (the 1992 Stock Option Plan) which provides for the grant of options to
purchase up to 92,160 shares of the Company's Common Stock to employees,
directors, and officers of the Company and to consultants, advisers, and other
persons whose contribution are important to the success of the Company. The
recipients of the options granted under the 1992 Stock Option Plan, the number
of shares to be covered by each option, and the exercise price, vesting terms,
if any, duration and other terms of each option shall be determined by the
Company's board of directors. No option is exercisable more than 10 years and
one month from the date as of which an option agreement is executed. To date, no
options have been granted under the 1992 Stock Option Plan.
A general outline of the Company's 1993 Employee Stock Purchase Plan (the
1993 Purchase Plan) was approved by the board of directors in July 1993. The
outline of the 1993 Purchase Plan provides for the issuance, subject to
adjustment for capital changes, of an aggregate of 138,240 shares of Common
Stock to employees. The 1993 Purchase Plan will be administered by the
F-11
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
Compensation Committee of the board of directors. Under the 1993 Purchase Plan,
Company employees will be eligible to participate in semi-annual plan offerings
in which payroll deductions may be used to purchase shares of Common Stock. The
purchase price for such shares will be equal to the lower of 85% of the fair
market value of such shares on the date of grant or 85% of its fair market value
of such shares on the date such right is exercised. There have been no offerings
under the 1993 Purchase Plan to date and no shares of Common Stock have been
issued thereunder.
(ii) Warrants
The warrants outstanding at December 31, 1995, related to the issuance of
notes payable and shareholder notes payable (notes 3 and 4) which were
exercisable in either Common Stock, Series B or Series C Preferred Stock and
subject to certain antidilution adjustments. Upon completion of the IPO, these
warrants became exercisable only in Common Stock.
Common Stock
-----------------------
Exercise Number of
Price Shares Expiration
----- ------ ----------
Notes payable:
5 years
February 1992 from
convertible note (see Note 14).... $2.00 420,000 IPO date
Stockholders:
Stockholders....................... $3.50 292,160 Sept. 1997
Stockholder........................ $3.50 300,000 Oct. 1999
Stockholders....................... $3.50 72,697 Dec. 1997
Stockholder........................ 2.72 4,608 May 1996
Stockholders....................... 2.00 144,000 Dec. 1997
Stockholder........................ 1.75 75,000 Mar. 2000
Stockholders....................... 1.75 2,750,000 June 2005
Stockholders....................... 3.50 2,080,000 Sept. 1999
---------
Subtotal: 6,138,465
=========
(iii) Other Warrants
In addition, the Company has issued other warrants outstanding totalling
7,535,847 which consists of the following:
From February through April 1995, the Company executed Bridge Loan
Agreements and promissory notes with 17 accredited lenders totaling $1,500,000.
These notes required interest at 8% per annum and were paid on the closing date
of the IPO. Interest has been imputed at 12% and is recognized as interest
expense and additional paid in capital in 1995 to reflect the issuance of
additional warrants to reflect the reduction in interest. Such agreements also
included various affirmative and negative covenants. As additional
consideration, the lenders have options to purchase 1,000,000 bridge units
issuable upon the effective date of the IPO at an exercise price of $.50 for a
period of five years. Management believes these sales are a good measure of fair
value because they represent the only notable third-party sales of Common Stock
in 1994 and 1995, prior to the IPO. Such exercise price is estimated to be at
fair market value at the date of issuance based on recent sales of securities to
third-parties. Each bridge unit consists of one share of Common Stock and one
Class A Redeemable Common Stock Purchase Warrant exercisable at $4.00 per share.
797,917 units were exercised in 1995 at $.50 per Warrant.
In June 1995, the Company entered into an agreement with The Sage Group
whereby, in return for identifying certain distribution partners, The Sage Group
will receive certain percentages of the proceeds from the first distribution
agreement arising from such identification. In addition, the Company will pay to
The Sage Group a monthly retainer and warrants to purchase 100,000 shares of
Common Stock at an exercise price of $1.75 share.
In connection with the IPO completed on November 7, 1995, the Company sold
5,313,000 units. Each unit consisted of one share of common stock and one Class
A Redeemable Warrant exercisable at $4.00 per share.
Also, as part of the underwriting agreement, the underwriter received
warrants to purchase 462,000 shares of common stock at $5.775 per share as well
as 462,000 Class A Redeemable Warrants to purchase common stock at $6.60 per
share. These warrants expire five years from the date of the IPO.
F-12
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
(iv) Subsidiary Warrants
In May 1995, the officers and directors of BioAegean Corp. were elected and
approved. The board of directors approved the issuance of 6,000,000 shares of
Common Stock, of which 1,000,000 shares are to be offered for sale to certain
investors at $1.00 per share. In addition, the directors approved options for
directors and officers totaling 1,200,000 shares at an exercise price of $1.00.
In consideration for licensing certain patents, the board authorized 1,000,000
shares of common stock to be issued to Hemispherx BioPharma, Inc., options for
an additional 1,000,000 shares of common stock at the lesser of the initial
public offering price of BioAgean Corp. or $5.00 per share and 10,000 shares of
Preferred stock to Hemispherx BioPharma, Inc.
The Company has granted certain rights to the debtholders to have their
securities registered under the Act. The Company believes the warrants have a
value which is not material for purposes of the financial statements and
accordingly, no value has been attributed to these warrants in the accompanying
consolidated financial statements.
(7) Preferred Stock
The Company is authorized to issue 5,000,000 shares of $.01 par value
Preferred Stock.
The Company had the following Preferred Stock shares issued, outstanding
and subscribed at December 31, 1994. All preferred stock was converted to Common
Stock in 1995 in connection with the IPO.
<TABLE>
<CAPTION>
December 31, 1994
---------------------------------------------------------------
Number of Number Stated
shares of shares Stated par value
subscribed issued par value subscribed
---------- ------ --------- ----------
<S> <C> <C> <C> <C>
Series A1 Redeemable Preferred Stock..... -- 370,370 $1,999,998
Series A2 Preferred Stock................ -- 487,805 4,000,001
Series B Preferred Stock................. -- 222,224 2,000,016
Series C Preferred Stock................. 651,112 100,000 1,200,000 4,772,233
</TABLE>
The preferred shares accrued a compounded annual cumulative dividend of
$.702 per share on Series A 1, $1.23 per share on Series A 2, $1.35 per share on
Series B and $1.80 per share on Series C. As of December 31, 1994, preferred
dividends in arrears amounted to approximately $2,941,000, $1,100,000, and
$1,004,000 on outstanding shares of the Series A 2, Series B and Series C
Preferred Stock, respectively. Cumulative dividends on Series A1 Redeemable
Preferred Stock have been reflected as an addition to Redeemable Preferred Stock
and as a charge to additional paid-in capital.
(8) Research, Consulting and Supply Agreements
The Company has entered into various clinical research agreements for the
purpose of undertaking clinical evaluations of the safety and efficacy of
Ampligen. The Company's obligation under these agreements is primarily dependent
on the number of actual patients enrolled in the study. During 1993, 1994 and
1995, the Company incurred approximately $325,000, $247,000 and $179,000
respectively, of research fees under these agreements.
The Company has entered into a pharmaceutical use license agreement with
Temple University (the Temple Agreement) pursuant to which Temple granted the
Company a world-wide license for the term of the agreement for the commercial
sale of Oragen products using patents and related technology held by Temple.
Under the agreement the Company agreed, among other things, to pay royalties
between 2% and 4% of net sales, with a minimum of $30,000 per year commencing in
1995. In May and June 1994, Temple University gave notice of certain purported
violations of certain reporting requirements contained in its Temple Agreement
with the Company and nonpayment of certain invoices in the approximate amount of
$1,500. In July 1994, Temple notified the Company that it considered the Temple
Agreement terminated (note 14).
The Company has entered into agreements for consulting services which are
performed at certain institutions and by certain individuals. The Company's
obligation to fund these agreements can generally be terminated after the
initial funding period, which generally ranges from one to three years or on an
as-needed monthly basis. During 1993, 1994 and 1995, the Company incurred
approximately $243,000, $130,000 and $87,000, respectively, of consulting fees
under these agreements.
F-13
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
In 1987, the Company entered into an agreement (the "Supply Agreement") to
purchase $2.7 million of compounds used in the manufacture of Ampligen which
expired in December 1992. Pursuant to the terms of the Supply Agreement, the
Company agreed to pay royalties of .5% of net sales, subject to certain minimum
and maximum requirements, for 5 years to the supplier of raw materials for the
manufacture of Ampligen.
In September 1995, the Company entered into an agreement with Rivex Pharma
Inc., ("Rivex"), pursuant to which Rivex will provide various services in
connection with the marketing and exclusive distribution of Ampligen in Canada
on an emergency drug release basis. Under the terms of this agreement, the
Company will supply and Rivex will purchase as much Ampligen as necessary to
satisfy Rivex's customers at a mutually agreed upon cost. In return, Rivex will
retain the exclusive right to market and distribute Ampligen in Canada.
(9) 401(K) Plan
In December 1995, the Company established a defined contribution plan,
effective January 1, 1995, the Hemispherx BioPharma Employees 401(K) Plan and
Trust Agreement (the 401(K) Plan). All full time employees of the Company are
eligible to participate in the 401(K) Plan following one year of employment.
Subject to certain limitations imposed by federal tax laws, participants are
eligible to contribute up to 15% of their salary (including bonuses and/or
commissions) per annum. Participants' contributions to the 401(K) Plan may be
matched by the Company at a rate determined annually by the Board of Directors.
Each participant immediately vests in his or her deferred salary contributions,
while Company contributions will vest over one year. In 1995 the Company
provided matching contributions to each employee for up to 6% of annual pay or
$25,500. The Company also absorbed the cost of employee contributions of
$25,500.
(10) Vendor Agreements
The Company and a law firm entered into a stand-still agreement. The
Company provided for an aggregate payment of $85,000 before November 18, 1994
and monthly payments beginning February 1, 1995 in the amount of $15,000,
subject to escalation, until all obligations are paid in full. In addition, the
stand-still agreement provides for additional payments upon any financings and
repayment in full from the proceeds of an IPO. The outstanding balance at
December 31, 1994 of approximately $484,000 was paid in 1995.
On February 20, 1996 the Company entered into an agreement to amend the
lease for its principal office. For a payment of $85,000 all outstanding rent
and charges accrued through December 31, 1995 were forgiven by the landlord. The
term of the lease was extended through April 30, 2000 with an average rent of
$14,507 per month, plus applicable taxes and charges. Note 12, leases, reflects
these new terms.
(11) Royalties, License, and Employment Agreements
The Company also has entered into a licensing agreement with a group of
individuals and Hahnemann University relating to their contributions to the
development of certain compounds, including Ampligen, and to obtain exclusive
information and regulatory rights relating to these compounds. Under this
agreement, the Company will pay 2% of net sales proceeds of Ampligen not to
exceed an aggregate amount of $6 million per year through 2005.
As described in note 8, the Company has agreed to pay royalties under the
Temple Agreement and to its supplier of raw materials.
The Company has employment agreements with four of its officers. The
aggregate annual base compensation under the employment agreements is $576,000
and $540,000 respectively. In addition, certain of these officers are entitled
to receive performance bonuses of up to 25% of the annual base salary (in
addition to the bonuses described below). Pursuant to the employment agreements,
certain officers were granted options under the 1990 Stock Option Plan to
purchase an aggregate of 82,942 shares of the Company's Common Stock at exercise
prices ranging from $2.72-$4.34 and Rule 701 Warrants to purchase 2,000,000
shares of Common Stock at $3.50 per share. One of the employment agreements
provides for bonuses based on gross proceeds received by the Company from any
joint venture or corporate partnering agreement.
The Company has a non-exclusive license (the "Hopkins License") with Johns
Hopkins University ("Hopkins") in the U.S., Canada and France related to nucleic
acid complexes. Pursuant to the Hopkins Agreement, the Company is obligated to
pay a royalty ranging from 3% to 6% of net commercial sales for products sold by
the Company with certain minimum annual royalties.
F-14
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
In October 1994, the Company entered into a licensing agreement with
Bioclones (Propriety) Limited (SAB/Bioclones) with respect to codevelopment of
various RNA drugs, including Ampligen, for a period ending three years from the
expiration of the last licensed patents. The licensing agreement provides
SAB/Bioclones with an exclusive manufacturing and marketing license for certain
southern hemisphere countries (including certain countries in South America,
Africa and Australia) as well as the United Kingdom and Ireland (the licensed
territory). In exchange for these marketing and manufacturing rights, the
licensing agreement provides for: (a) a $3 million cash payment to the Company,
all of which has been received as of December 31, 1995; (b) the formation and
issuance to the Company of 24.9% of the capital stock of a company which shall
develop and operate a new manufacturing facility by SAB/Bioclones, and (c)
royalties of 6% to 8% of net sales of the licensed products in the licensed
territories as defined, after the first $50 million of sales. SAB/Bioclones will
be granted a right of first refusal to manufacture and supply to the Company
licensed products for not less than one-third of its world-wide sales of
Ampligen, excluding SAB/Bioclones-related sales. In addition, SAB/Bioclones will
have the right of first refusal for oral vaccines in the licensed territory.
In October 1994, the Board of Directors granted a director of the Company
the right to receive 3% of gross proceeds of any licensing fees received by the
Company pursuant to the SAB licensing agreement, a fee of .75% of gross proceeds
in the event that SAB makes a tender offer for all or substantially all of the
Company's assets, including a merger, acquisition or related transaction, and a
fee of 1% on all products manufactured by SAB. The Company may prepay in full
its obligation to provide commissions up to $1,050,000 within a ten year period.
In July 1995, the Company entered into an agreement with the Vernacular
Group whereby, in return for identifying certain corporate partners for the
BioPro subsidiary, the Vernacular Group would receive from the Company a
minority stock position in the subsidiary and a percentage of all licensing fees
and royalties received in connection therewith.
On December 5, 1995, the Company retained the law firm of Akin, Gump,
Strauss, Hauer & Feld, L.L.P. (Akin, Gump) to provide general legal counsel,
advise and representation with respect to various United States regulatory
agencies. Initially, Akin, Gump will provide representation before the Food and
Drug Administration (FDA). In addition, the agreement allows for incentive
payments for obtaining a letter from the FDA evidencing Ampligen's approvability
for HIV disease treatment. If such approval is obtained by March 15, 1996 the
incentive payment is $1,000,000. If obtained by June 15, 1996 the incentive
payment is $750,000.
(12) Leases
The Company has several noncancelable operating leases for the space in
which its principal offices are located and certain office equipment. See note
10 above.
Future minimum lease payments under noncancelable operating leases are as
follows:
Year ending Operating
December 31, leases
- ------------ ----------
1996................................................... $ 263,246
1997................................................... 271,791
1998................................................... 280,411
1999................................................... 292,144
2000................................................... 91,516
----------
Total minimum lease payments........................ $1,199,108
==========
Rent expense charged to operations for the years ended December 31, 1993,
1994 and 1995 amounted to approximately $223,000, $173,000 and $289,000
respectively. The Company recognizes rent expense on a straight-line basis over
the lease term, and the difference between rent expense on a straight-line basis
and the base rental is deferred and included in accrued expenses at December 31,
1994 and 1995 (note 5).
F-15
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
(13) Income Taxes
At December 31, 1995, the Company had available net operating loss
carryforwards of approximately $39,300,000 million for Federal and state income
tax which expire over various years through 2010. The difference between the net
operating losses for tax and financial statement purposes relates principally to
amortization of patents and related costs, inventory usage, and leases
capitalized for financial statements purposes, which are operating leases for
tax purposes. In addition, for Federal income tax purposes, the Company has
approximately $9,000 of unused investment and job tax credits available to
offset future taxes, if any, expiring 1996 through 1999.
The expiration dates of the net operating loss carryforwards are as
follows:
Expiration Tax loss
date carryforwards
---- -------------
1999.............................................. $ 130,974
2003............................................... 1,773,967
2004............................................... 5,402,521
2005............................................... 3,534,484
2006............................................... 8,654,551
Thereafter......................................... 19,821,428
-----------
$39,317,925
===========
If certain substantial changes in ownership should occur there would be an
annual limitation on the amount of tax attribute carryforwards which can be
utilized in the future.
The Company has provided a valuation allowance for it's deferred tax assets
in an amount equal to it's net operating loss carry-forwards.
(14) Contingencies
The Company was a defendant in a lawsuit instituted in 1991 by participants
in a double-blind placebo-controlled clinical trial of Ampligen therapy for
ME/CFS. The plaintiffs alleged that the Company or its alleged agents promised
them that they would receive Ampligen after the placebo-controlled study at no
cost for periods ranging from "until marketable" to "for life." Plaintiffs
sought compensatory and punitive damages. The court granted the Company's
motions for summary judgment upon all claims alleged by the plaintiffs in this
case. The plaintiffs have appealed from these orders before the United States
Court of Appeals for the Ninth Circuit. In January 1996, the Court of Appeals
denied their appeal and sustained the Company's position. On the basis of the
Court of Appeals favorable decision, the Company believes the lawsuit is over
with no material effect on the Company.
In February 1991, a university advised the Company of its position that
employees of the university were the inventors of an issued U.S. patent
regarding the use of Ampligen in combination with various other agents
(including AZT) for the treatment of HIV infection. As issued, this patent names
the Company's Chief Executive Officer as sole inventor and the Company as sole
assignee. The university has demanded that the patent be reissued naming the
university's employees as inventors and the university as assignee. The Company
has refused to take such action. No formal claim has been filed by the
university. If such claim were filed and if such claim were found to have merit,
the loss of the patent at issue would not have a materially adverse effect on
the Company's long-range business since the university would only be able to
limit and/or prevent the Company's use of Ampligen in combinations with AZT in
the treatment of HIV.
In November 1994, the Company filed suit against Temple University
("Temple") in the Superior Court of the State of Delaware ("Superior Court")
seeking a declaratory judgment that the Temple Agreement (note 8) remains in
full force and effect and seeking monetary damages in excess of $10 million for
Temple's alleged breach of its obligations of good faith and fair dealing and
certain terms of the Temple Agreement. Temple has filed a motion to dismiss this
lawsuit upon the grounds of lack of personal jurisdiction. In January 1995,
Temple filed separate litigation against the Company in the Court of Common
Pleas of Philadelphia County seeking declaratory judgment that the Temple
Agreement has been lawfully terminated as of July 1, 1994, together with an
award of costs including attorney fees, in bringing the action. The Court of
Common Pleas has stayed further proceedings in that litigation pending the
outcome of the Company's Superior Court case. If the Company were to lose its
claim, the loss of the licensing agreement could have a material adverse effect
on the Company's future business as Temple or its new licensees, if any, could
become competitors of the Company.
F-16
<PAGE>
HEMISPHERx BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued)
December 31, 1994 and 1995
In March 1995, the Company instituted a declaratory judgment action against
the February 1992 noteholder of a $5 million convertible note and a second
defendant in the United State District Court for the Eastern District of
Pennsylvania ("the Pennsylvania action") to declare as void, set aside, and
cancel the February 1992 convertible note between the Company and the noteholder
("the Note"). In addition, the noteholder instituted suit against the Company on
the Note in the Circuit Court of the 15th Judicial District in and for Palm
Beach County, Florida, seeking judgment on the note, plus attorneys fees, costs
and expenses; in August 1995, this action was stayed by the Florida Court
pending the outcome of the Pennsylvania action. The noteholder also filed a
motion for a preliminary injunction in the Pennsylvania court to enjoin the
Company from disbursing the proceeds of a public offering in the amount of $5.8
million, which motion was granted in November, 1995. On February 15, 1996, the
Company reached an agreement to settle this matter. Terms and conditions of the
settlement include payment of $6,450,000 to the noteholder to cover the note
balance and legal expenses. The noteholder and related parties are to maintain
certain Warrants that were granted prior to the lawsuit. Other Warrants granted
to the noteholder in the note restructuring in 1994 were relinquished. The funds
under this settlement were paid on March 21, 1996. Mutual releases were executed
which completed the settlement of the litigation.
The Company is subject to claims and legal actions that arise in the
ordinary course of their business. Management believes that the ultimate
liability, if any, with respect to these claims and legal actions will not have
a material effect on the financial position or results of operations of the
Company.
(15) Subsequent Events (Unaudited)
In July 1996, the Company consummated a private offering of its preferred
stock pursuant to Rule 506 of regulation as promulgated by the SEC under the
Securities Act of 1933 as amended. The Company issued 6,000 shares of Series D
Preferred Stock, $.01 par value at a purchase price of $1,000 per share.
The Company entered into several consulting arrangements whereby the
Company issued warrants to purchase the Company's Common Stock as compensation
for services to be performed. The Company will record a non-cash expense of
approximately $670,000 in 1996 and $30,000 in 1997 (over the period in which the
warrants vest) with corresponding credits to additional paid in capital for the
same amounts.
F-17
<PAGE>
================================================================================
No dealer, salesman or any other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus in connection with the offer made by this Prospectus and, if given or
made, such information or representations must not be relied upon as having been
authorized by the Company or the Representative. Neither the delivery of this
Prospectus nor any sale made hereunder shall under any circumstances create any
implication that there has been no change in the affairs of the Company since
the date hereof. This Prospectus does not constitute an offer or solicitation by
anyone in any jurisdiction in which such offer or solicitation is not authorized
or in which the person making such offer or solicitation is not qualified to do
so or to anyone to whom it is unlawful to make such offer or solicitation.
--------------
TABLE OF CONTENTS
Page
----
Additional Information ................................................ 2, 73
Prospectus Summary .................................................... 3
Risk Factors .......................................................... 7
Capitalization ........................................................ 16
Selected Financial Data ............................................... 17
Price Range of Common Stock ........................................... 18
Dividends ............................................................. 18
Use of Proceeds ....................................................... 18
Management's Discussion and Analysis of
Financial Condition and Results
of Operations ...................................................... 19
Business .............................................................. 23
Management ............................................................ 50
Resales by Selling Securityholders .................................... 60
Certain Transactions .................................................. 62
Description of Securities ............................................. 68
Shares Eligible for Future Sale ....................................... 73
Legal Matters ......................................................... 73
Experts ............................................................... 73
Financial Statements .................................................. F-1
================================================================================
================================================================================
HEMISPHERx BIOPHARMA, INC.
2,770 SHARES OF COMMON STOCK
2,427,275 SHARES OF COMMON STOCK
UNDERLYING SERIES D PREFERRED STOCK
890,543 SHARES OF COMMON STOCK
UNDERLYING COMMON STOCK
PURCHASE WARRANTS
----------
PROSPECTUS
----------
September 16, 1996
================================================================================
