As filed with the Securities and Exchange Commission on October 18, 2000
Registration No. 333-27673
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
---------------
POST-EFFECTIVE AMENDMENT NO. 1 TO
FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CYTOGEN CORPORATION
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(Exact Name of Registrant as Specified in Its Charter)
Delaware
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(State or Other Jurisdiction of Incorporation or Organization)
22-2322400
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(I.R.S. Employer Identification No.)
600 College Road East CN 5308, Princeton, NJ 08540
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(Address of Principal Executive Offices) (Zip Code)
Cytogen Corporation 1988 Stock Option Plan for Non-Employee Directors
Cytogen Corporation 1989 Employee Stock Option Plan
Cytogen Corporation 1989 Special Employee Plan
Cytogen Corporation 1989 Stock Option Policy for Outside Consultants
Cytogen Corporation 1992 Employee Stock Option Plan II
Cytogen Corporation 1995 Stock Option Plan
Cytogen Corporation Employee Stock Purchase Plan
----------
Cellcor, Inc.
1988 Stock Option Plan
1992 Stock Option and Restricted Stock Plan
1992 Director Stock Plan
1995 Stock Incentive Plan
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(Full Title of the Plan)
Catherine M. Verna, Esq.
Vice President and General Counsel
Cytogen Corporation
600 College Road East CN 5308, Princeton, NJ 08540
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(Name and Address of Agent for Service)
(609) 750-8200
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(Telephone Number, Including Area Code, of Agent For Service)
Copy to:
Raymond Thek, Esq.
Buchanan Ingersoll Professional Corporation
650 College Road East
Princeton, NJ 08540
(609) 987-6800
<PAGE>
EXPLANATORY NOTE
The Post-Effective Amendment No. 1 to Form S-8 and the Prospectus filed by
Cytogen Corporation (the "Company") relates to the public resale, from time to
time, of an aggregate of 8,488,960 shares of Common Stock, $0.01 par value per
share (the "Common Stock"), by certain stockholders identified in the section
entitled "Selling Stockholders." Such shares have been or may be acquired upon
the exercise of stock options granted or upon stock purchases pursuant to: (i)
300,000 shares of Common Stock issuable pursuant to the Cytogen Corporation 1988
Stock Option Plan for Non-Employee Directors, as amended (the "1988 Cytogen
Director Plan"); (ii) 2,100,000 shares of Common Stock issuable pursuant to
options previously granted or to be granted under the Cytogen Corporation 1989
Employee Stock Option Plan (the "1989 Cytogen Employee Plan"); (iii) 20,500
shares of Common Stock issuable pursuant to options previously granted or to be
granted under the Cytogen Corporation 1989 Special Employee Plan (the "Cytogen
Special Employee Plan"); (iv) 100,000 shares of Common Stock issuable pursuant
to options previously granted or to be granted under the Cytogen Corporation
1989 Stock Option Policy for Outside Consultants (the "Cytogen Outside
Consultant Plan"); (v) 750,000 shares of Common Stock issuable pursuant to
options previously granted or to be granted under the Cytogen Corporation 1992
Employee Stock Option Plan II, as amended (the "Cytogen 1992 Employee Plan II");
(vi) 4,502,635 shares of Common Stock issuable pursuant to options previously
granted or to be granted under the Cytogen Corporation 1995 Stock Option Plan,
as amended (the "1995 Cytogen Stock Option Plan"); (vii) 500,000 shares of
Common Stock issuable pursuant to options previously granted or to be granted
under the Cytogen Corporate Employee Stock Purchase Plan (the "Cytogen Employee
Stock Purchase Plan"); and (viii) 215,825 shares of Common Stock issuable
pursuant to the Cellcor, Inc. 1988 Stock Option Plan (the "1988 Cellcor Option
Plan"), 1992 Stock Option and Restricted Stock Plan (the "1992 Cellcor Stock
Option Plan"), 1992 Director Stock Plan (the "1992 Cellcor Director Plan"), and
1995 Stock Incentive Plan (the "1995 Cellcor Incentive Plan"). The 1988 Cytogen
Director Plan, 1989 Cytogen Employee Plan, Cytogen Special Employee Plan,
Cytogen Outside Consultant Plan, Cytogen 1992 Employee Plan II, 1995 Cytogen
Stock Option Plan, Cytogen Employee Stock Purchase Plan, 1988 Cellcor Option
Plan, 1992 Cellcor Stock Option Plan, 1992 Cellcor Director Plan, and 1995
Cellcor Incentive Plan are collectively referred to hereinafter as the "Plans."
The shares issuable pursuant to the Plans have been registered on the following
Registration Statements:
o Form S-8 filed with the Securities and Exchange Commission
(the "SEC") on December 8, 1986 registering 700,000 shares of
Common Stock of the Company, to be offered pursuant to the 1989
Cytogen Employee Plan;
o Form S-8 filed with the SEC on August 18, 1989 registering
the following Common Stock of the Company: (i) 100,000 shares to
be offered pursuant to the 1988 Cytogen Director Plan; (ii)
1,400,000 shares to be offered pursuant to the 1989 Cytogen
Employee Plan;
(i)
<PAGE>
o and (iii) 20,500 shares to be offered pursuant to the Cytogen
Special Employee Plan;
o Form S-8 filed with the SEC on September 29, 1992 registering
120,000 shares of Common Stock of the Company, to be offered
pursuant to the Cytogen 1992 Employee Plan II;
o Form S-8 filed with the SEC on January 12, 1993 registering
630,000 shares of Common Stock of the Company, to be offered
pursuant to the Cytogen 1992 Employee Plan II, as amended;
o Form S-8 filed with the SEC via EDGAR on October 10, 1995
registering 2,402,635 shares of Common Stock of the Company, to
be offered pursuant to the 1995 Cytogen Stock Option Plan;
o Form S-8 filed with the SEC via EDGAR on January 26, 1996,
registering 606,952 shares of Common Stock of the Company, to be
offered pursuant to the 1988 Cellcor Option Plan, the 1992
Cellcor Stock Option Plan, the 1992 Cellcor Director Plan and the
1995 Cellcor Incentive Plan;
o Form S-8 filed with the SEC via EDGAR on May 29, 1996,
registering 200,000 shares of Common Stock of the Company, to be
offered pursuant to the 1988 Cytogen Director Plan;
o Form S-8 filed with the SEC via EDGAR on May 29, 1996,
registering 2,100,000 shares of Common Stock of the Company, to
be offered pursuant to the 1995 Cytogen Stock Option Plan; and
o Form S-8 filed with the SEC via EDGAR on May 23, 1997,
registering 500,000 shares of Common Stock of the Company, to be
offered pursuant to the Cytogen Employee Stock Purchase Plan.
(ii)
<PAGE>
PROSPECTUS
S-3 Reoffer Prospectus dated October 18, 2000
CYTOGEN CORPORATION
600 College Road East, CN 5308, Princeton, NJ 08540
Three Hundred Thousand (300,000)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1988 Stock Option Plan for Non-Employee Directors, as
amended
Two Million One Hundred Thousand (2,100,000)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1989 Employee Stock Option Plan
Twenty Thousand Five Hundred (20,500)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1989 Special Employee Plan
One Hundred Thousand (100,000)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1989 Stock Option Policy for Outside Consultants
Seven Hundred Fifty Thousand (750,000)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1992 Employee Stock Option Plan II, as amended
Four Million Five Hundred Two Thousand Six Hundred Thirty Five (4,502,635)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation 1995 Stock Option Plan, as amended
Five Hundred Thousand (500,000)
Shares of Common Stock Issued or Issuable under the
Cytogen Corporation Employee Stock Purchase Plan
Two Hundred Fifteen Thousand Eight Hundred Twenty Five (215,825)
Shares of Common Stock Issued or Issuable under the
Cellcor, Inc. 1988 Stock Option Plan
Cellcor, Inc. 1992 Stock Option and Restricted Stock Plan
Cellcor, Inc. 1992 Director Stock Plan
Cellcore, Inc. 1995 Stock Incentive Plan
--------------------------------------------------------------------------------
This Prospectus relates to the public resale, from time to time, of
8,488,960 shares of our Common Stock (the "Shares") by certain stockholders
identified below in the section entitled "Selling Stockholders." The Shares have
been or may be acquired upon the exercise of stock options granted or upon stock
purchases pursuant to the Plans. Options or Shares may be issued
<PAGE>
under the Plans in amounts and to persons not presently known to us. Such
information, when known, may be included in an amendment to this Prospectus.
We will receive no proceeds from the sale by the Selling Stockholders (as
defined below) of the Shares covered by this Prospectus.
We have not entered into any underwriting arrangements in connection with
the sale of the Shares. The Shares may be sold from time to time by the Selling
Stockholders or by permitted pledgees, donees, transferees or other permitted
successors in interest and may be made on the Nasdaq National Market at such
prices and upon such terms as are then prevailing or at prices related to the
then current market price, or in negotiated transactions.
Our Common Stock is traded on the Nasdaq National Market under the symbol
"CYTO". On October 6, 2000, the last reported sale price of our Common Stock on
the Nasdaq National Market was $5.938 per share.
----------------------------------------
SEE "RISK FACTORS" BEGINNING ON PAGE 5 TO READ ABOUT CERTAIN OF THE RISKS
THAT YOU SHOULD CONSIDER BEFORE PURCHASING SHARES OF OUR COMMON STOCK.
----------------------------------------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this Prospectus is October 18, 2000.
<PAGE>
CYTOGEN CORPORATION
TABLE OF CONTENTS
-----------------
Page
----
About Cytogen Corporation............................................... 3
Risk Factors............................................................ 5
Use of Proceeds......................................................... 22
Selling Stockholders.................................................... 22
Plan of Distribution.................................................... 24
Legal Matters........................................................... 25
Experts................................................................. 25
Information Incorporated by Reference................................... 25
Where You Can Find More Information..................................... 27
Indemnification of Directors and Officers............................... 27
Securities and Exchange Commission Position on Indemnification
for Securities Act Liabilities........................................ 29
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<PAGE>
ABOUT CYTOGEN CORPORATION
Cytogen is an established biopharmaceutical company with two principal
lines of business, oncology and proteomics. We are extending our expertise in
antibodies and molecular recognition to the development of new products and a
proteomics-driven drug discovery platform. We have established a pipeline of
product candidates based upon our proprietary antibody and prostate specific
membrane antigen, or PSMA, technologies. We are also developing a proprietary
protein pathway database as a drug discovery and development tool for the
pharmaceutical and biotechnology industries.
Our cancer management franchise is currently comprised of three marketed
FDA-approved products: ProstaScint(R), used to image the extent and spread of
prostate cancer; OncoScint CR/OV(R), marketed as a diagnostic imaging agent for
colorectal and ovarian cancer and Quadramet(R), marketed for the relief of
cancer-related bone pain. We are extending our cancer pipeline by exploiting
PSMA, which we exclusively licensed from Memorial Sloan-Kettering Cancer Center.
PSMA is a unique antigen highly expressed in prostate cancer cells and in the
neovasculature of a variety of other solid tumors, including breast, lung and
colon. We are developing our PSMA technology as part of our approach to offering
a full range of prostate cancer management products and services throughout the
progression of the disease, including gene-based immunotherapy vaccines,
antibody-delivered therapeutic compounds and novel assays for detection of
primary prostate cancer. We also plan to apply our PSMA technology, including
therapeutics and in vitro diagnostics, toward other types of cancer based upon
our experience in prostate cancer. Our in vivo immunotherapeutic development
program is being conducted in collaboration with Progenics Pharmaceuticals.
Proteomics is the study of the expression and interaction of proteins.
Genomics is the study and identification of an organism's genetic makeup. While
genomics provides important information regarding genetic makeup, it does not
directly provide information regarding protein functions or protein
interactions. However, genomics data can prove useful in proteomics research as
a source of obtaining complete protein sequences of ligands we have identified.
Public availability of this genomics information allows for effective
integration in our database of public and proprietary information. We recognized
in our past research that the key to understanding or developing the means to
intervene in diseases was primarily based on understanding protein interactions
rather than only through the use or study of genomics. We undertook this
approach on our own initiative and with our own funds. Our proteomics program,
under development by our subsidiary, AxCell Biosciences Corporation, is focused
on the identification of protein interaction and signaling pathways within cells
as relating to disease processes.
Cytogen markets and sells ProstaScint and OncoScint through its own
twenty-five member sales and marketing organization. Cytogen has developed
expertise in sales and marketing of its products through urologists,
oncologists, radiation oncologists and nuclear medicine. Cytogen has also
developed educational programs that can be accessed through the world wide web.
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<PAGE>
We utilize our proprietary proteomics technology to map selective
protein-protein interactions and to develop a database, called the
Inter-Functional Proteomic Database, or IFP Database, which includes data
relating to protein signaling pathways linked to a variety of other
bioinformatic data. The IFP Database is designed to permit customers to
integrate existing databases, both public and proprietary, with our proprietary
data to create a 'virtual laboratory' on the computer desktop of researchers
involved in drug discovery. We believe this database has significant potential
commercial value to the pharmaceutical and biotechnology industries as a means
of expediting drug target identification, validation, screen development and
lead compound optimization faster and cheaper than with current methodologies.
These proprietary technologies are designed to provide a platform from which we
can quickly and cost-effectively determine protein-protein interactions and
build pathways of intracellular signaling data. Our IFP Database also offers a
consolidated platform to enable statistical and mathematical modeling of complex
protein pathways.
We are a Delaware corporation. Our principal executive offices are located
at 600 College Road East CN 5308, Princeton, NJ 08540 and our telephone number
at that location is (609) 750-8200.
All references to "we," "us," "our," "Company" or Cytogen in this
Prospectus means Cytogen Corporation and its subsidiaries.
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<PAGE>
RISK FACTORS
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
CAREFULLY CONSIDER THE FOLLOWING RISKS TOGETHER WITH THE OTHER INFORMATION
INCLUDED OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS IN YOUR DECISION AS TO
WHETHER TO INVEST IN OUR COMMON STOCK. IF ANY OF THE FOLLOWING RISKS OR
UNCERTAINTIES ACTUALLY OCCUR, OUR BUSINESS, FINANCIAL CONDITION AND OPERATING
RESULTS COULD BE SIGNIFICANTLY AND ADVERSELY AFFECTED. IF THAT HAPPENS, THE
PRICE OF OUR COMMON STOCK COULD DECLINE, AND YOU COULD LOSE ALL OR PART OF YOUR
INVESTMENT.
WE HAVE A HISTORY OF OPERATING LOSSES AND AN ACCUMULATED DEFICIT AND EXPECT TO
INCUR LOSSES IN THE FUTURE.
We have a history of operating losses since our inception. We had a net
loss of $4,548,000 during the six months ended June 30, 2000. We had net income
of $729,000 during the year ended December 31, 1999 which included certain
non-operating gains. We had net losses of $13,152,000 during the year ended
December 31, 1998 and $30,712,000 during the year ended December 31, 1997. We
had an accumulated deficit of $305,831,000 as of June 30, 2000. In order to
develop and commercialize our technologies, particularly our proteomics program
and our prostate specific membrane antigen, or PSMA, technology, and expand our
oncology products, we expect to incur significant increases in our expenses over
the next several years. As a result, we may need to generate significant
additional revenue to become profitable.
Our ability to generate and sustain significant additional revenues or
achieve profitability will depend upon the factors discussed elsewhere in this
"Risk Factors" Section, as well as numerous other factors outside of our
control, including:
o development of competing products that are more effective or less
costly then our own;
o our ability to, develop and commercialize our own products and
technologies; and
o our ability to achieve increased sales for our existing products and
sales for any new products.
As a result, we may never be able to generate or sustain significant
additional revenue or achieve profitability.
WE ARE HEAVILY DEPENDENT ON MARKET ACCEPTANCE OF PROSTASCINT AND QUADRAMET FOR
NEAR-TERM REVENUES.
ProstaScint and Quadramet are expected to account for a significant
percentage of our product-related revenues in the near future. For the six
months ended June 30, 2000, revenues
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<PAGE>
from ProstaScint and Quadramet accounted for approximately 93% of our product
related revenues.
Because these products contribute the majority of our product-related
revenues, our business, financial condition and results of operations depend on
their acceptance as safe, effective and cost-efficient alternatives to other
available treatment and diagnostic protocols by the medical community,
including:
o health care providers, such as hospitals and physicians; and
o third-party payors, including Medicare, Medicaid, private insurance
carriers and health maintenance organizations.
Our customers, including technologists and physicians, must successfully
complete our Partners in Excellence Program, or PIE Program, a proprietary
training program designed to promote the correct acquisition and interpretation
of ProstaScint images. This product is technique dependent and requires a
learning commitment on the part of users. We cannot assure you that additional
physicians will make this commitment or otherwise accept this product as part of
their treatment practices.
Berlex Laboratories, Inc. markets Quadramet in the United States through an
agreement that we entered into in October 1998. We cannot assure you that Berlex
will be able to successfully market Quadramet or that this agreement will result
in significant revenues for us. We recently obtained marketing rights to
Quadramet in Canada, but have not yet implemented a selling program. We cannot
assure you that Quadramet can be marketed effectively in Canada, or that it will
contribute significantly to our revenues.
We cannot assure you that Quadramet will be approved for additional
indications, due to uncertainty as to efficacy or safety for other purposes,
regulatory obstacles and physician preferences for existing or competing
practices.
Accordingly, we cannot assure you that ProstaScint or Quadramet will
achieve market acceptance on a timely basis, or at all. If ProstaScint or
Quadramet do not achieve broader market acceptance, we may not be able to
generate sufficient revenue to become profitable.
WE HAVE EXPERIENCED FLUCTUATING RESULTS OF OPERATIONS.
Our results of operations have fluctuated on an annual and quarterly basis
and may fluctuate significantly from period to period in the future, due to,
among other factors:
o variations in revenue from sales of and royalties from our products;
o timing of regulatory approvals and other regulatory announcements
relating to our products;
o variations in our marketing, manufacturing and distribution channels;
-6-
<PAGE>
o timing of the acquisition and successful integration of complementary
products and technologies;
o timing of new product announcements and introductions by us and our
competitors; and
o product obsolescence resulting from new product introductions by us or
our competitors.
Many of these factors are outside our control. Due to one or more of these
factors, our results of operations may fall below the expectations of securities
analysts and investors in one or more future quarters. If this happens, the
market price of our Common Stock could decline.
WE MAY NEED TO RAISE ADDITIONAL CAPITAL WHICH MAY NOT BE AVAILABLE.
We have incurred negative cash flows from operations since inception. We
have expended, and will need to continue to expend, substantial funds to
complete our planned product development efforts, including our proteomics and
PSMA programs. Our future capital requirements and the adequacy of our available
funds depend on many factors, including:
o successful commercialization of our products;
o acquisition of complementary products and technologies;
o magnitude, scope and results of our product development efforts;
o progress of preclinical studies and clinical trials;
o progress toward regulatory approval for our products;
o costs of filing, prosecuting, defending and enforcing patent claims
and other intellectual property rights;
o competing technological and market developments; and
o expansion of strategic alliances for the sale, marketing and
distribution of our products.
We may raise additional capital through public or private equity offerings,
debt financings or additional collaborations and licensing arrangements.
Additional financing may not be available to us when we need it, or, if
available, we may not be able to obtain financing on terms favorable to us or
our stockholders. If we raise additional capital by issuing equity securities,
the issuance will result in ownership dilution to our stockholders. If we raise
additional funds through collaborations and licensing arrangements, we may be
required to relinquish rights to
-7-
<PAGE>
certain of our technologies or product candidates or to grant licenses on
unfavorable terms. If we relinquish rights or grant licenses on unfavorable
terms, we may not be able to develop or market products in a manner that is
profitable to us. If adequate funds are not available, we may not be able to
conduct research activities, preclinical studies, clinical trials or other
activities relating to the successful commercialization of our products on a
timely basis, if at all, with the result that our business could be
significantly and adversely affected.
OUR PRODUCTS, GENERALLY, ARE IN THE EARLY STAGES OF DEVELOPMENT AND
COMMERCIALIZATION AND WE MAY NEVER ACHIEVE THE GOALS OF OUR BUSINESS PLAN.
We began operations in 1980 and have been engaged primarily in research
directed toward the development, commercialization and marketing of products to
improve diagnosis and treatment of cancer and other disease. In December 1992,
we introduced for commercial use our ONCOSCINT imaging agent. In October 1996,
we introduced for commercial use our ProstaScint imaging agent. In March 1997,
we introduced for commercial use our Quadramet therapeutic product. These
products have not yet achieved significant commercial success. In 1998, we began
a restructuring of our company to focus on the development of our PSMA and
proteomics technologies as well as the marketing of these existing products.
Early last year, we completed our restructuring. Our PSMA and proteomics
technologies are still in the early stages of development. We have only recently
begun to incorporate our proteomics technology into commercialized products. We
may be unable to continue to successfully develop or commercialize these
products and technologies.
Our business is therefore subject to the risks inherent in the development
of an early stage biopharmaceutical business enterprise, such as the need:
o to obtain sufficient capital to support the expenses of developing our
technology and commercializing our products;
o to ensure that our products are safe and effective;
o to obtain regulatory approval for the use and sale of our products;
o to manufacture our products in sufficient quantities and at a
reasonable cost;
o to develop a sufficient market for our products; and
o to attract and retain qualified management, sales, technical and
scientific staff.
The problems frequently encountered using new technologies and operating in
a competitive environment also may affect our business. If we fail to properly
address these risks and attain our business objectives, our business could be
significantly and adversely affected.
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<PAGE>
OUR PROTEOMICS PROGRAM IS AT AN EARLY STAGE OF DEVELOPMENT.
We have developed and intend to continue to develop our proteomics program.
This technology involves new approaches to drug research and development and
remains commercially unproven. Our technology and development focus is primarily
directed toward offering an infrastructure to companies for the development of
drugs to treat a variety of complex human diseases. There is limited
understanding generally relating to the role of proteins in diseases, and few
products based on protein interaction discoveries have been developed and
commercialized. Even if our proteomics program is successful in identifying and
validating biological targets, there is no certainty that we or our customers
will be able to develop or commercialize products to improve human health.
Our technology program for proteomics is still in the early stages of
development. We may not be able to populate our IFP DATABASE with information
that is useful to potential customers in a timely manner. Even if we complete
and develop successfully our proteomics technology, the technology may not be
accepted by, or be useful to, our potential customers.
In addition, the success of our proteomics technology will depend upon our
ability to use software tools to generate data that relates protein signaling
pathways to a variety of other bioinformatic data. Because of the complexity of
this data, we may not be able to detect and remedy any design defects or
software errors in our existing or future technologies, including databases.
We may not be successful in addressing or mitigating these risks and
uncertainties, and, if we are not, our business could be significantly and
adversely affected.
THERE IS A LIMITED MARKET FOR OUR POTENTIAL PROTEOMICS PRODUCTS.
Due to the specialized nature and anticipated cost of our proteomics
technology and services, there are a limited number of pharmaceutical and
biotechnology companies that are potential customers. In addition, demand for
our proteomics technology and services is limited because:
o our potential customers may decide to conduct in-house research rather
than subscribe to our IFP database;
o our competitors may offer similar services at competitive prices;
o we may not be able to service satisfactorily the needs of our
potential or actual customers;
o others may publicly disclose or patent proprietary information
contained in our IFP Database (including information related to
protein signaling pathways or target candidates) or relating to
prostate antigens or antibodies;
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<PAGE>
o technological innovations may be discovered that are more advanced
than those used by or available to us; and
We may not be successful in addressing or mitigating these risks and
uncertainties, and, if we are not, our business could be significantly and
adversely affected.
OUR PSMA PRODUCT DEVELOPMENT PROGRAM IS NOVEL AND, CONSEQUENTLY, INHERENTLY
RISKY.
We are subject to the risks of failure inherent in the development of
product candidates based on new technologies, including our PSMA technology.
These risks include the possibility that:
o the technologies we use will not be effective;
o our product candidates will be unsafe;
o our product candidates will fail to receive the necessary regulatory
approvals;
o our product candidates will be hard to manufacture on a large scale or
will be uneconomical to market; and
o we will not successfully overcome technological challenges presented
by our potential new products.
Our objectives include developing our PSMA technology into novel cancer
therapeutics, including a cancer vaccine. To our knowledge, no cancer
therapeutic vaccine has been demonstrated effective or approved for marketing.
Our other research and development programs involve similarly novel approaches
to human therapeutics. Consequently, there is no precedent for the successful
commercialization of therapeutic products based on our PSMA technologies. We
cannot assure you that any products will be successfully developed from our PSMA
technology. If we fail to develop such products for the reasons set forth above
or for any other reason, our business could be significantly and adversely
affected.
ALL OF OUR POTENTIAL ONCOLOGY PRODUCTS WILL BE SUBJECT TO THE RISKS OF FAILURE
INHERENT IN THE DEVELOPMENT OF DIAGNOSTIC OR THERAPEUTIC PRODUCTS BASED ON NEW
TECHNOLOGIES.
Product development for cancer treatment involves a high degree of risk. We
cannot assure you that the product candidates we develop, pursue or offer will
prove to be safe and effective, will receive the necessary regulatory approvals,
will not be precluded by proprietary rights of third parties or will ultimately
achieve market acceptance. These product candidates will require substantial
additional investment, laboratory development, clinical testing and regulatory
approvals prior to their commercialization. We cannot assure you that we will
not experience difficulties that could delay or prevent the successful
development, introduction and marketing of new products.
-10-
<PAGE>
Before we obtain regulatory approvals for the commercial sale of any of our
products under development, we must demonstrate through preclinical studies and
clinical trials that the product is safe and efficacious for use in each target
indication. The results from preclinical studies and early clinical trials may
not be predictive of results that will be obtained in large-scale testing. We
cannot assure you that our clinical trials will demonstrate the safety and
efficacy of any products or will result in marketable products. A number of
companies in the biotechnology industry have suffered significant setbacks in
advanced clinical trials, even after promising results in earlier trials.
Clinical trials or marketing of any potential diagnostic or therapeutic products
may expose us to liability claims for the use of these diagnostic or therapeutic
products. We may not be able to obtain product liability insurance or, if
obtained, sufficient coverage may not be available at a reasonable cost. In
addition, as we develop diagnostic or therapeutic products internally, we will
have to make significant investments in diagnostic or therapeutic product
development, marketing, sales and regulatory compliance resources. We will also
have to establish or contract for the manufacture of products, including
supplies of drugs used in clinical trials, under the current Good Manufacturing
Practices of the FDA. We also cannot assure you that product issues will not
arise following successful clinical trials and FDA approval.
The rate of completion of clinical trials also depends on the rate of
patient enrollment. Patient enrollment depends on many factors, including the
size of the patient population, the nature of the protocol, the proximity of
patients to clinical sites and the eligibility criteria for the study. Delays in
planned patient enrollment may result in increased costs and delays, which could
have a harmful effect on our ability to develop the products in our pipeline. If
we are unable to develop and commercialize products on a timely basis or at all,
our business could be significantly and adversely affected.
COMPETITION IN OUR FIELD IS INTENSE AND LIKELY TO INCREASE.
We face, and will continue to face, intense competition from one or more of
the following entities:
o pharmaceutical companies;
o biotechnology companies;
o bioinformatics companies;
o diagnostic companies;
o academic and research institutions; and
o government agencies.
All of our lines of business are subject to significant competition from
organizations that are pursuing technologies and products that are the same as
or similar to our technology and
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<PAGE>
products. Many of the organizations competing with us have greater capital
resources, research and development staffs and facilities and marketing
capabilities.
Before we recover development expenses for our products and technologies,
the products or technologies may become obsolete as a result of technological
developments by us or others. Our products could also be made obsolete by new
technologies which are less expensive or more effective. We may not be able to
make the enhancements to our technology necessary to compete successfully with
newly emerging technologies and failure to do so could significantly and
adversely affect our business.
WE RELY HEAVILY ON OUR COLLABORATIVE PARTNERS.
Our success depends in significant part upon the success of our
collaborative partners. We have entered into the following agreements for the
sale, marketing, distribution and manufacture of our products, product
candidates and technologies:
o license from The Dow Chemical Company relating to the Quadramet
technology;
o sub-license and marketing agreement with Berlex Laboratories, Inc.
relating to the Quadramet technology which we licensed from The Dow
Chemical Company;
o agreement for manufacture of Quadramet by The DuPont Pharmaceuticals
Company (formerly the radiopharmaceuticals division of The DuPont
Merck Company);
o marketing and platform development agreement with Informax, Inc.
related to our proteomics program;
o joint venture with Progenics Pharmaceuticals for the development of
PSMA for in vivo immunotherapy for prostate and other cancers; and
o licensing agreement with Molecular Staging for technology to be used
in developing in vitro diagnostic tests using PSMA and prostate
specific antogen, or PSA.
Because our collaborative partners are responsible for certain of our
sales, marketing, manufacturing and distribution activities, these activities
are outside our direct control. We cannot assure you that our partners will
perform their obligations under these agreements with us. In the event that our
collaborative partners do not successfully market and sell our products or
breach their obligations under our agreements, our products may not be
commercially successful, any success may be delayed and new product development
could be inhibited with the result that our business could be significantly and
adversely affected.
-12-
<PAGE>
OUR BUSINESS COULD BE HARMED IF OUR COLLABORATIVE ARRANGEMENTS EXPIRE OR ARE
TERMINATED EARLY.
We cannot assure you that we will be able to maintain our existing
collaborative arrangements. If they expire or are terminated, we cannot assure
you that they will be renewed or that new arrangements will be available on
acceptable terms, if at all. In addition, we cannot assure you that any new
arrangements or renewals of existing arrangements will be successful, that the
parties to any new or renewed agreements will perform adequately or that any
former or potential collaborators will not compete with us.
We cannot assure you that our existing or future collaborations will lead
to the development of product candidates or technologies with commercial
potential, that we will be able to obtain proprietary rights or licenses for
proprietary rights for our product candidates or technologies developed in
connection with these arrangements or that we will be able to ensure the
confidentiality of proprietary rights and information developed in such
arrangements or prevent the public disclosure thereof.
THE TERMINATION OF ONE OR MORE LICENSE AGREEMENTS THAT ARE IMPORTANT IN THE
MANUFACTURE OF OUR CURRENT PRODUCTS AND NEW PRODUCT RESEARCH AND DEVELOPMENT
ACTIVITIES WOULD HARM OUR BUSINESS.
We are a party to license agreements under which we have rights to use
technologies owned by other companies in the manufacture of our products and in
our proprietary research, development and testing processes. We are the
exclusive licensee of certain patents and patent applications held by the
University of North Carolina at Chapel Hill covering part of the technology used
in the proteomics program and of certain patents and patent applications held by
the Memorial Sloan-Kettering Institute covering PSMA. We depend upon the
enforceability of our license with The Dow Chemical Company with respect to
Quadramet. If the licenses were terminated, we may not be able to find suitable
alternatives to this technology on a timely basis or on reasonable terms, if at
all. The loss of the right to use these technologies that we have licensed would
significantly and adversely affect our business.
WE HAVE LIMITED SALES, MARKETING AND DISTRIBUTION CAPABILITIES FOR OUR PRODUCTS.
We have only recently established a sales force and have limited internal
sales, marketing and distribution capabilities for our products. We depend on
Berlex Laboratories, Inc. for the sale, marketing and distribution of Quadramet
in the United States. In locations outside the United States, we have not
established a selling presence. If we are unable to establish and maintain
significant sales, marketing and distribution efforts, either internally or
through arrangements with third parties, our business may be significantly and
adversely affected.
THERE ARE RISKS ASSOCIATED WITH THE MANUFACTURE OF OUR PRODUCTS.
If we are to be successful, our products will have to be manufactured
either internally or through third-party manufacturers in compliance with
regulatory requirements and at costs acceptable to us. We cannot assure you that
we will be able to continue to manufacture, arrange
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<PAGE>
for manufacture on reasonable terms or successfully outsource the manufacturing
of our products. If we are unable to successfully manufacture or arrange for the
manufacture of our products and product candidates, we will not be able to
successfully commercialize our products and our business may be significantly
and adversely affected.
Quadramet is manufactured by DuPont pursuant to an agreement with both
Berlex and Cytogen. Some components of Quadramet, particularly Samarium153 and
EDTMP, are provided to DuPont by outside suppliers. Due to radioactive decay,
Samarium153 must be produced on a weekly basis. DuPont obtains its requirements
for Samarium153 from one supplier. Alternative sources for these components may
not be readily available. On one occasion, DuPont was unable to manufacture
Quadramet on a timely basis due to the failure of its supplier to provide
Samarium153. If DuPont cannot obtain sufficient quantities of the components on
commercially reasonable terms, or in a timely manner, it would be unable to
manufacture Quadramet on a timely and cost-effective basis and our business
could be significantly and adversely affected.
We and our third-party manufacturers are required to adhere to US Food &
Drug Administration regulations setting forth requirements for current Good
Manufacturing Practices, or cGMP, and similar regulations in other countries,
which include extensive testing, control and documentation requirements. Ongoing
compliance with cGMP, labeling and other applicable regulatory requirements are
monitored through periodic inspections and market surveillance by state and
federal agencies, including the FDA, and by comparable agencies in other
countries. Failure of our third-party manufacturers or us to comply with
applicable regulations could result in sanctions being imposed on us, including
fines, injunctions, civil penalties, failure of the government to grant
premarket clearance or premarket approval of drugs, delays, suspension or
withdrawal of approvals, seizures or recalls of products, operating restrictions
and criminal prosecutions any of which could significantly and adversely affect
our business.
FAILURE OF CONSUMERS TO OBTAIN ADEQUATE REIMBURSEMENT FROM THIRD-PARTY PAYORS
COULD LIMIT MARKET ACCEPTANCE AND AFFECT PRICING OF OUR PRODUCTS.
Our business, financial condition and results of operations will continue
to be affected by the efforts of governments and other third-party payors to
contain or reduce the costs of healthcare. There have been, and we expect that
there will continue to be, a number of federal and state proposals to implement
government control of pricing and profitability of therapeutic and diagnostic
imaging agents such as our products. In addition, an emphasis on managed care
increases possible pressure on pricing of these products. While we cannot
predict whether these legislative or regulatory proposals will be adopted, or
the effects these proposals or managed care efforts may have on our business,
the announcement of these proposals and the adoption of these proposals or
efforts could affect our stock price or our business. Further, to the extent
these proposals or efforts have an adverse effect on other companies that are
our prospective corporate partners, our ability to establish necessary strategic
alliances may be harmed.
Sales of our products depend in part on reimbursement to the consumer from
third-party payors, including Medicare, Medicaid and private health insurance
plans. Third-party payors are increasingly challenging the prices charged for
medical products and services. We cannot assure you that our products will be
considered cost-effective and that reimbursement to consumers will
-14-
<PAGE>
continue to be available, or will be sufficient to allow us to sell our products
on a competitive basis. Approval of our products for reimbursement by a
third-party payor may depend on a number of factors, including the payor's
determination that our products are clinically useful and cost-effective,
medically necessary and not experimental or investigational. Reimbursement is
determined by each payor individually and in specific cases. The reimbursement
process can be time consuming. If we cannot secure adequate third-party
reimbursement for our products, our business could be significantly and
adversely affected.
IF WE ARE UNABLE TO COMPLY WITH APPLICABLE GOVERNMENTAL REGULATIONS, WE MAY NOT
BE ABLE TO CONTINUE OUR OPERATIONS.
Any products tested, manufactured or distributed by us or on our behalf
pursuant to FDA clearances or approvals are subject to pervasive and continuing
regulation by numerous regulatory authorities, including primarily the FDA. We
may be slow to adapt, or we may never adapt to changes in existing requirements
or adoption of new requirements or policies. Our failure to comply with
regulatory requirements could subject us to enforcement action, including
product seizures, recalls, withdrawal of clearances or approvals, restrictions
on or injunctions against marketing our products based on our technology, and
civil and criminal penalties. We cannot assure you that we will not be required
to incur significant costs to comply with laws and regulations in the future or
that laws or regulations will not create an unsustainable burden on our
business.
Numerous federal, state and local governmental authorities, principally the
FDA, and similar regulatory agencies in other countries, regulate the
preclinical testing, clinical trials, manufacture and promotion of any compounds
or agents we or our collaborative partners develop, and the manufacturing and
marketing of any resulting drugs. The drug development and regulatory approval
process is lengthy, expensive, uncertain and subject to delays.
The regulatory risks we face also include the following:
o any compound or agent we or our collaborative partners develop must
receive regulatory agency approval before it may be marketed as a drug
in a particular country;
o the regulatory process, which includes preclinical testing and
clinical trials of each compound or agent in order to establish its
safety and efficacy, varies from country to country, can take many
years and requires the expenditure of substantial resources;
o in all circumstances, approval of the use of previously unapproved
radioisotopes in certain of our products requires approval of either
the Nuclear Regulatory Commission or equivalent state regulatory
agencies. A radioisotope is an unstable form of an element which
undergoes radioactive decay, thereby emitting radiation which may be
used, for example, to image or destroy harmful growths or tissue.
-15-
<PAGE>
We cannot assure you that such approvals will be obtained on a timely
basis, or at all;
o data obtained from preclinical and clinical activities are susceptible
to varying interpretations which could delay, limit or prevent
regulatory agency approval; and
o delays or rejections may be encountered based upon changes in
regulatory agency policy during the period of drug development and/or
the period of review of any application for regulatory agency
approval. These delays could adversely affect the marketing of any
products we or our collaborative partners develop, impose costly
procedures upon our activities, diminish any competitive advantages we
or collaborative partners may attain and adversely affect our ability
to receive royalties.
We cannot assure you that, even after this time and expenditure, regulatory
agency approvals will be obtained for any compound or agent developed by or in
collaboration with us. Moreover, regulatory agency approval for a drug or agent
may entail limitations on the indicated uses that could limit the potential
market for any such drug. Furthermore, if and when such approval is obtained,
the marketing, manufacture, labeling, storage and record keeping related to our
products would remain subject to extensive regulatory requirements. Discovery of
previously unknown problems with a drug, its manufacture or its manufacturer may
result in restrictions on such drug, manufacture or manufacturer, including
withdrawal of the drug from the market. Failure to comply with regulatory
requirements could result in fines, suspension of regulatory approvals,
operating restrictions and criminal prosecution.
The US Food, Drug and Cosmetics Act requires (i) that our products be
manufactured in FDA registered facilities subject to inspection, and (ii) that
we comply with cGMP, which imposes certain procedural and documentation
requirements upon us and our manufacturing partners with respect to
manufacturing and quality assurance activities. If we or our manufacturing
partners do not comply with cGMP we may be subject to sanctions, including
fines, injunctions, civil penalties, recalls or seizures of products, total or
partial suspension of production, failure of the government to grant premarket
clearance or premarket approval for drugs, withdrawal of marketing approvals and
criminal prosecution.
WE DEPEND ON ATTRACTING AND RETAINING KEY PERSONNEL.
We are highly dependent on the principal members of our management and
scientific staff. The loss of their services might significantly delay or
prevent the achievement of development or strategic objectives. Our success
depends on our ability to retain key employees and to attract additional
qualified employees. Competition for personnel is intense, and we cannot assure
you that we will be able to retain existing personnel or attract and retain
additional highly qualified employees in the future.
-16-
<PAGE>
We have an employee retention agreement with our President and Chief
Executive Officer, H. Joseph Reiser, Ph.D., which provides for vesting of stock
options for the purchase of shares of our Common Stock based on continued
employment and on the achievement of performance objectives defined by the board
of directors. We do not have similar retention agreements with our other key
personnel. If we are unable to hire and retain personnel in key positions, our
business could be significantly and adversely affected unless qualified
replacements can be found.
OUR BUSINESS EXPOSES US TO POTENTIAL LIABILITY CLAIMS THAT MAY EXCEED OUR
FINANCIAL RESOURCES, INCLUDING OUR INSURANCE COVERAGE, AND MAY LEAD TO THE
CURTAILMENT OR TERMINATION OF OUR OPERATIONS.
Our business is subject to product liability risks inherent in the testing,
manufacturing and marketing of our products. We cannot assure you that product
liability claims will not be asserted against us, our collaborators or our
licensees. While we currently maintain product liability insurance in amounts we
believe are adequate, we cannot assure you that such coverage will be adequate
to protect us against future product liability claims or that product liability
insurance will be available to us in the future on commercially reasonable
terms, if at all. Furthermore, we cannot assure you that we will be able to
avoid significant product liability claims and adverse publicity. If liability
claims against us exceed our financial resources we may have to curtail or
terminate our operations.
OUR BUSINESS INVOLVES ENVIRONMENTAL RISKS THAT MAY RESULT IN LIABILITY FOR US.
We are subject to a variety of local, state and federal government
regulations relating to storage, discharge, handling, emission, generation,
manufacture and disposal of toxic, infectious or other hazardous substances used
to manufacture our products. If we fail to comply with these regulations, we
could be liable for damages, penalties or other forms of censure and our
business could be significantly and adversely affected.
PROTECTION OF OUR INTELLECTUAL PROPERTY IS DIFFICULT TO OBTAIN.
Our business and competitive positions are dependent upon our ability to
protect our proprietary technology. Because of the substantial length of time
and expense associated with development of new products, we, like the rest of
the biopharmaceutical industry, place considerable importance on obtaining and
maintaining patent and trade secret protection for new technologies, products
and processes. We have filed patent applications for our technology for
diagnostic and therapeutic products and the methods for their production and
use.
The patent positions of pharmaceutical, biopharmaceutical and biotechnology
companies, including us, are generally uncertain and involve complex legal and
factual questions. Our patent applications may not protect our technologies and
products because, among other things:
o there is no guarantee that any of our pending patent applications
will result in issued patents;
-17-
<PAGE>
o we may develop additional proprietary technologies that are not
patentable;
o there is no guarantee that any patents issued to us, our
collaborators or our licensors will provide a basis for a commercially
viable product;
o there is no guarantee that any patents issued to us or our
collaborators will provide us with any competitive advantage;
o there is no guarantee that any patents issued to us or our
collaborators will not be challenged, circumvented or invalidated by
third parties; and
o there is no guarantee that any patents previously issued to others or
issued in the future will not have an adverse effect on our ability to
do business.
In addition, patent law in the technology fields in which we operate is
uncertain and still evolving, and we cannot assure you as to the degree of
protection that will be afforded any patents we are issued or license from
others. Furthermore, we cannot assure you that others will not independently
develop similar or alternative technologies, duplicate any of our technologies,
or, if patents are issued to us, design around the patented technologies
developed by us. In addition, we could incur substantial costs in litigation if
we are required to defend ourselves in patent suits by third parties or if we
initiate such suits. We cannot assure you that, if challenged by others in
litigation, the patents we have been issued, or which we have been assigned or
have licensed from others will not be found invalid. We cannot assure you that
our activities would not infringe patents owned by others. Defense and
prosecution of patent matters can be expensive and time-consuming and,
regardless of whether the outcome is favorable to us, can result in the
diversion of substantial financial, managerial and other resources. An adverse
outcome could:
o subject us to significant liability to third parties;
o require us to cease any related research and development activities
and product sales; or
o require us to obtain licenses from third parties.
We cannot assure you that any licenses required under any such third-party
patents or proprietary rights would be made available on commercially reasonable
terms, if at all. Moreover, the laws of certain countries may not protect our
proprietary rights to the same extent as the laws of the United States. We
cannot predict whether our or our competitors' pending patent applications will
result in the issuance of valid patents which may significantly and adversely
affect our business.
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WE CANNOT BE CERTAIN THAT OUR SECURITY MEASURES PROTECT OUR UNPATENTED
PROPRIETARY TECHNOLOGY.
We also rely upon trade secret protection for some of our confidential and
proprietary information that is not subject matter for which patent protection
is available. To help protect our rights, we require all employees, consultants,
advisors and collaborators to enter into confidentiality agreements that require
disclosure, and in most cases, assignment to us, of their ideas, developments,
discoveries and inventions, and that prohibit the disclosure of confidential
information to anyone outside Cytogen. We cannot assure you, however, that these
agreements will provide adequate protection for our trade secrets, know-how or
other proprietary information or prevent any unauthorized use or disclosure.
WE ARE CURRENTLY SUBJECT TO PATENT LITIGATION.
We are a defendant in litigation filed against us in the United States
Federal Court for the District of New Jersey by M. David Goldenberg and
Immunomedics, Inc. This lawsuit was filed on March 16, 2000. The litigation
claims that our ProstaScint product infringes a patent purportedly owned by Dr.
Goldenburg and licensed to Immunomedics. We believe that the purported patent
sought to be enforced in the litigation has now expired. As a result, the claim,
even if successful, would not result in a bar of the continued sale of
ProstaScint or affect any other of our products or technology. However, given
the uncertainty associated with litigation, we cannot give any assurance that
the litigation will not result in a material expenditure to us or in a loss of
important rights by us.
IF WE MAKE ANY ACQUISITIONS, WE WILL INCUR A VARIETY OF COSTS AND MAY NEVER
REALIZE THE ANTICIPATED BENEFITS.
If appropriate opportunities become available, we may attempt to acquire
businesses, technologies, services or products that we believe are a strategic
fit with our business. We currently have no commitments or agreements with
respect to any acquisitions, however, if we do undertake any transaction of this
sort, the process of integrating an acquired business, technology, service or
product may result in operating difficulties and expenditures and may absorb
significant management attention that would otherwise be available for ongoing
development of our business. Moreover, we may never realize the anticipated
benefits of any acquisition. Future acquisitions could result in potentially
dilutive issuances of equity securities, the incurrence of debt, contingent
liabilities and amortization expenses related to goodwill and other intangible
assets. These factors could adversely affect our results of operations and
financial condition, which could cause a decline in the market price of our
Common Stock.
OUR STOCK PRICE HAS BEEN AND MAY CONTINUE TO BE VOLATILE, AND YOUR INVESTMENT IN
OUR STOCK COULD DECLINE IN VALUE.
The market prices for securities of biotechnology and pharmaceutical
companies have historically been highly volatile, and the market has from time
to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. The market price of our
Common Stock has fluctuated over a wide range and may
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<PAGE>
continue to fluctuate for various reasons, including, but not limited to,
announcements concerning our competitors or us regarding:
o results of clinical trials;
o technological innovations or new commercial products;
o changes in governmental regulation or the status of our regulatory
approvals or applications;
o changes in earnings;
o changes in health care policies and practices;
o developments or disputes concerning proprietary rights;
o litigation or public concern as to safety of the our potential
products; and
o changes in general market conditions.
WE HAVE ADOPTED VARIOUS ANTI-TAKEOVER PROVISIONS WHICH MAY AFFECT THE MARKET
PRICE OF OUR COMMON STOCK.
Our Board of Directors has the authority, without further action by the
holders of Common Stock, to issue from time to time, up to 5,400,000 shares of
preferred stock in one or more classes or series, and to fix the rights and
preferences of the preferred stock. Pursuant to these provisions, we have
implemented a stockholder rights plan by which one preferred stock purchase
right is attached to each share of Common Stock, as a means to deter coercive
takeover tactics and to prevent an acquirer from gaining control of us without
some mechanism to secure a fair price for all of our stockholders if an
acquisition was completed. These rights will be exercisable if a person or group
acquires beneficial ownership of 20% or more of our Common Stock and can be made
exercisable by action of our board of directors if a person or group commences a
tender offer which would result in such person or group beneficially owning 20%
or more of our Common Stock. Each right will entitle the holder to buy one
one-thousandth of a share of a new series of our junior participating preferred
stock for $20. If any person or group becomes the beneficial owner of 20% or
more of our Common Stock (with certain limited exceptions), then each right not
owned by the 20% stockholder will entitle its holder to purchase, at the right's
then current exercise price, common shares having a market value of twice the
exercise price. In addition, if after any person has become a 20% stockholder,
we are involved in a merger or other business combination transaction with
another person, each right will entitle its holder (other than the 20%
stockholder) to purchase, at the right's then current exercise price, common
shares of the acquiring company having a value of twice the right's then current
exercise price.
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<PAGE>
We are subject to provisions of Delaware corporate law which, subject to
certain exceptions, will prohibit us from engaging in any "business combination"
with a person who, together with affiliates and associates, owns 15% or more of
our Common Stock for a period of three years following the date that the person
came to own 15% or more of our Common Stock unless the business combination is
approved in a prescribed manner.
These provisions of the stockholder rights plan, our certificate of
incorporation, and of Delaware law may have the effect of delaying, deterring or
preventing a change in control of us, may discourage bids for our Common Stock
at a premium over market price and may adversely affect the market price, and
the voting and other rights of the holders, of our Common Stock.
A LARGE NUMBER OF OUR SHARES ARE ELIGIBLE FOR FUTURE SALE WHICH MAY ADVERSELY
IMPACT THE MARKET PRICE OF OUR COMMON STOCK.
A large number of shares of Common Stock already outstanding, or issuable
upon exercise of options and warrants, are eligible for resale, which may
adversely affect the market price of the Common Stock. As of October 6, 2000, we
had 76,452,600 shares of Common Stock outstanding. An additional 4,567,566
shares of Common Stock are issuable upon the exercise of outstanding stock
options and warrants. Substantially all of such shares subject to outstanding
options will, when issued upon exercise thereof, be available for immediate
resale in the public market pursuant to currently effective registration
statements under the Securities Act of 1933 (the "Securities Act"), as amended,
or pursuant to Rule 701 promulgated thereunder.
Berlex Laboratories, Inc. exercised its registration rights with respect to
1,000,000 shares of Common Stock and we are contractually obligated to register
these shares. A registration statement with respect to these shares was filed on
April 11, 2000 and declared effective April 27, 2000. Such registration
statement also covered 86,394 shares of Common Stock issuable to consultants
upon exercise of warrants.
In addition, on March 28, 2000, we filed with the Securities and Exchange
Commission a shelf registration statement on Form S-3 covering six million nine
hundred thousand (6,900,000) shares of our Common Stock.
Availability of a significant number of additional shares could depress the
price of our Common Stock.
BECAUSE WE DO NOT INTEND TO PAY ANY CASH DIVIDENDS ON OUR SHARES OF COMMON
STOCK, OUR STOCKHOLDERS WILL NOT BE ABLE TO RECEIVE A RETURN ON THEIR SHARES
UNLESS THEY SELL THEM.
We have never paid or declared any cash dividends on our Common Stock or
other securities and intend to retain any future earnings to finance the
development and expansion of our business. We do not anticipate paying any cash
dividends on our Common Stock in the foreseeable future. Unless we pay
dividends, our stockholders will not be able to receive a return on their shares
unless they sell them.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
THIS PROSPECTUS CONTAINS FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF
SECTION 27A OF THE SECURITIES ACT OF 1933 AND SECTION 21E OF THE SECURITIES
EXCHANGE ACT OF 1934. SUCH STATEMENTS CAN BE IDENTIFIED BY THE USE OF WORDS SUCH
AS "MAY," "WOULD," "COULD," "INTEND," "PLAN," "ESTIMATE," "BELIEVE,"
"ANTICIPATE" AND "EXPECT." THESE STATEMENTS DISCUSS FUTURE EXPECTATIONS, CONTAIN
PROJECTIONS OR STATE OTHER "FORWARD-LOOKING" INFORMATION. ACTUAL RESULTS COULD
DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED IN THE FORWARD-LOOKING
STATEMENTS AS A RESULT OF THE RISK FACTORS SET FORTH ABOVE AND ELSEWHERE IN THIS
PROSPECTUS OR FOR OTHER REASONS. READERS ARE CAUTIONED NOT TO PLACE UNDUE
RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH REFLECT MANAGEMENT'S VIEWS
ONLY AS OF THE DATE OF THIS PROSPECTUS.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the Shares covered
by this Prospectus. While we will receive sums upon any exercise of options by
the Selling Stockholders, we currently have no plans for their application,
other than for general corporate purposes. We cannot assure you that any of such
options will be exercised.
SELLING STOCKHOLDERS
The individuals listed below (the "Selling Stockholders") have or will
acquire the Shares being registered hereunder pursuant to the exercise of
options we previously granted to them or the purchase of Shares pursuant to the
Plans. The Shares may not be sold or otherwise transferred by the Selling
Stockholders unless and until the applicable options are exercised in accordance
with their terms.
The following table sets forth: (i) the name and position of each Selling
Stockholder, whose name is known as of the date of the filing of the
registration statement of which this prospectus forms a part, under the Plan who
may sell Common Stock pursuant to this prospectus; (ii) the number of shares of
Common Stock owned (or subject to option) by each Selling Stockholder as of the
date of this prospectus; (iii) the number of shares of Common Stock which may be
offered and are being registered for the account of each Selling Stockholder by
this prospectus (all of which may be acquired by the Selling Stockholders
pursuant to the exercise of options); and (iv) the amount and percentage of
Common Stock to be owned by each such Selling Stockholder if such Selling
Stockholder were to sell all of the shares of Common Stock covered by this
prospectus. There can be no assurance that any of the Selling Stockholders will
offer for sale or sell any or all of the Shares offered by them pursuant to this
prospectus. Options or shares of Common Stock may be issued under the Plans in
amounts and to persons not presently known by us; when known, such persons,
their holdings of Common Stock and certain other information may be included in
a subsequent version of this prospectus.
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<TABLE>
<CAPTION>
---------------------------------------------------------------------------------------------------------------------------
Number of Shares of Number of
Common Stock both Shares of Number of Shares of
directly held or subject Common Common Stock
to options prior to Stock to be Owned After
Name Position with Cytogen Offering/Percentage(1) Offered Offering/Percentage(2)
---------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
H. Joseph Reiser Chief Executive Officer, 2,505,000/3.3% 150,000 2,355,000/3.1%(3)
President and Director
---------------------------------------------------------------------------------------------------------------------------
Lawrence Hoffman Vice President and Chief 500,000/* 200,000 300,000/*(4)
Financial Officer
---------------------------------------------------------------------------------------------------------------------------
Richard Krawiec Vice President, Investor 50,000/* 50,000 0/*
Relations and Corporate
Communications
---------------------------------------------------------------------------------------------------------------------------
Nicholas Borys Vice President, Medical 50,000/* 50,000 0/*
Affairs
---------------------------------------------------------------------------------------------------------------------------
Terence Novak Vice President, Sales and 95,000/* 95,000 0/*
Marketing
---------------------------------------------------------------------------------------------------------------------------
John D. Rodwell Acting President and Chief 798,200/1.0% 419,500 378,700/*(5)
Technical Officer, AxCell
BioSciences, a subsidiary
---------------------------------------------------------------------------------------------------------------------------
Catherine M. Verna Vice President and General 50,000/* 50,000 0/*
Counsel
---------------------------------------------------------------------------------------------------------------------------
John E. Bagalay, Jr. Director 253,467/* 125,000 128,467/*(6)
---------------------------------------------------------------------------------------------------------------------------
Stephen K. Carter Director 43,600/* 8,000 35,600/*(7)
---------------------------------------------------------------------------------------------------------------------------
James A. Grigsby Director 233,867/* 70,000 163,867/*(8)
---------------------------------------------------------------------------------------------------------------------------
Robert F. Hendrickson Director 90,600/* 29,000 61,600/*(9)
---------------------------------------------------------------------------------------------------------------------------
S. Leslie Misrock Director 755,833/* 10,000 745,833/*(10)
---------------------------------------------------------------------------------------------------------------------------
</TABLE>
-----------------
* Less than one percent.
(1) Applicable percentage of ownership is based on 76,452,600 shares of Common
Stock outstanding on October 6, 2000.
(2) Assumes that all Shares are sold pursuant to this offering and that no
other shares of Common Stock are acquired or disposed of by the Selling
Stockholders prior to the termination of this offering. Because the Selling
Stockholders may sell all, some or none of their Shares or may acquire or
dispose of other shares of Common Stock, no reliable estimate can be made
of the aggregate number of Shares that will be sold pursuant to this
offering or the number or percentage of shares of Common Stock that each
Selling Stockholder will own upon completion of this offering.
(3) Includes 2,050,000 shares of Common Stock issuable pursuant to options held
as of the date hereof and not registered or sold hereunder.
(4) Includes 300,000 shares of Common Stock issuable pursuant to options held
as of the date hereof and not registered or sold hereunder.
(5) Does not include 100,000 shares of AxCell Biosciences Corporation Common
Stock, $0.01 par value per share, issuable pursuant to options held as of
the date hereof and not registered or sold hereunder.
(6) Includes 31,000 shares of Common Stock issuable pursuant to options held as
of the date hereof and not registered or sold hereunder.
(7) Includes 31,000 shares of Common Stock issuable pursuant to options held as
of the date hereof and not registered or sold hereunder.
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(8) Includes 61,000 shares of Common Stock issuable pursuant to options held as
of the date hereof and not registered or sold hereunder.
(9) Includes 31,000 shares of Common Stock issuable pursuant to options held as
of the date hereof and not registered or sold hereunder.
(10) Includes 18,333 shares of Common Stock issuable pursuant to options held as
of the date hereof and not registered or sold hereunder.
PLAN OF DISTRIBUTION
The Selling Stockholders have not advised us of any specific plan for
distribution of the Shares offered hereby, but it is anticipated that the Shares
will be sold from time to time by the Selling Stockholders or by permitted
pledgees, donees, transferees or other permitted successors in interest. Such
sales may be made in any of the following manners:
o On the Nasdaq National Market (or through the facilities of any
national securities exchange or U.S. inter-dealer quotation system of
a registered national securities association, on which the Shares are
then listed, admitted to unlisted trading privileges or included for
quotation);
o In public or privately negotiated transactions;
o In transactions involving principals or brokers;
o In a combination of such methods of sale; or
o Any other lawful methods.
Although sales of the Shares are, in general, expected to be made at market
prices prevailing at the time of sale, the Shares may also be sold at prices
related to such prevailing market prices or at negotiated prices, which may
differ considerably.
When offering the Shares covered by this Prospectus, each of the Selling
Stockholders and any broker-dealers who sell the Shares for the Selling
Stockholders may be "underwriters" within the meaning of the Securities Act, and
any profits realized by such Selling Stockholders and the compensation of such
broker-dealers may be underwriting discounts and commissions.
Sales through brokers may be made by any method of trading authorized by
any stock exchange or market on which the Shares may be listed, including block
trading in negotiated transactions. Without limiting the foregoing, such brokers
may act as dealers by purchasing any or all of the Shares covered by this
Prospectus, either as agents for others or as principals for their own accounts,
and reselling such Shares pursuant to this Prospectus. The Selling Stockholders
may effect such transactions directly, or indirectly through underwriters,
broker-dealers or agents acting on their behalf. In connection with such sales,
such broker-dealers or agents may receive compensation in the form of
commissions, concessions, allowances or discounts, any or all of which might be
in excess of customary amounts.
Each of the Selling Stockholders is acting independently of us in making
decisions with respect to the timing, manner and size of each sale of Shares. We
have not been advised of any definitive selling arrangement at the date of this
Prospectus between any Selling Stockholder and any broker-dealer or agent.
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To the extent required, the names of any agents, broker-dealers or
underwriters and applicable commissions, concessions, allowances or discounts,
and any other required information with respect to any particular offer of the
Shares by any of the Selling Stockholders, will be set forth in a supplement to
this Prospectus.
The expenses of preparing and filing this Prospectus and the related
Registration Statement with the SEC will be paid entirely by the Company. The
Shares covered by this Prospectus also may qualify to be sold pursuant to Rule
144 under the Securities Act, rather than pursuant to this Prospectus. The
Selling Stockholders have been advised that they are subject to the applicable
provisions of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), including without limitation, Rule 10b-5 thereunder.
Neither the Company nor the Selling Stockholders can estimate at the
present time the amount of commissions or discounts, if any, that will be paid
by the Selling Stockholders on account of their sales of the Shares from time to
time.
LEGAL MATTERS
The validity of the shares of Common Stock offered hereby will be passed
upon for the Company by Buchanan Ingersoll Professional Corporation, 650 College
Road East, Princeton, New Jersey.
EXPERTS
The consolidated financial statements incorporated by reference in this
Prospectus and elsewhere in this Registration Statement have been audited by
Arthur Andersen LLP, independent public accountants, as indicated in their
report with respect thereto, and are included herein in reliance upon the
authority of said firm as experts in giving said reports.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to "incorporate by reference" the information we file
with the SEC, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
an important part of this prospectus. All documents subsequently filed by the
Company pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act,
prior to the filing of a post-effective amendment which indicates that all
securities offered have been sold or which deregisters all securities then
remaining unsold, shall be deemed to be incorporated by reference into this
Prospectus and to be a part hereof from the date of filing of such documents.
We incorporate by reference the documents listed below and any future
filings we make with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the
Securities Exchange Act of 1934 until the filing of a post-effective amendment
to this Prospectus which indicates that all securities registered have been sold
or which deregisters all securities then remaining unsold:
o Our Annual Report on Form 10-K for the year ended December 31, 1999
(File No. 000-14879), filed with the SEC on March 28, 2000;
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<PAGE>
o All other reports filed by Cytogen pursuant to Section 13(a) or 15(d)
of the Exchange Act since December 31, 1999; and
o The description of our Common Stock, $0.01 par value, contained in our
Registration Statement on Form 8-A (File No. 000-14879) filed pursuant
to Section 12(g) of the Securities Exchange Act of 1934, as amended,
including any subsequent amendments or reports filed for the purpose
of updating such description.
We will provide, without charge, to each person, including any beneficial
owner, to whom a copy of this prospectus is delivered, upon the written or oral
request of such person, a copy of any or all of the information incorporated in
this prospectus by reference but not delivered with the prospectus. The requests
should be made to:
Catherine M. Verna, Esq.
Cytogen Corporation
600 College Road East CN 5308
Princeton, New Jersey 08540
(609) 750-8200
You should rely only on the information incorporated by reference or
provided in this Prospectus or any supplement hereto. We have not authorized
anyone to provide you with different information. Neither Cytogen nor the
Selling Stockholders are making an offer of these securities in any state where
the offer is not permitted. You should not assume that the information in this
Prospectus is accurate as of any date other than the date on the front of any
such document.
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<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. You may read and copy any document the Company files
at the SEC's public reference room at 450 Fifth Street, N.W., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for further information on the
public reference room. Our SEC filings are also available to the public from the
SEC's website at http://www.sec.gov.
We have filed with the SEC a Registration Statement on Form S-8 under the
Securities Act with respect to the Shares offered hereby. This Prospectus, which
constitutes a part of that registration statement, does not contain all the
information contained in the registration statement and its exhibits. For
further information with respect to the Shares, you should consult the
registration statement and its exhibits. Statements contained in this Prospectus
concerning the provisions of any documents are necessarily summaries of those
documents, and each statement is qualified in its entirety by reference to the
copy of the document filed with the SEC. The registration statement and any of
its amendments, including exhibits filed as part of the registration statement
or an amendment to the registration statement, are available for inspection and
copying as described above.
INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145(a) of the Delaware General Corporation Law (the "DGCL")
provides that a Delaware corporation may indemnify any person who was or is
threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative
(other than an action by or in the right of the corporation) by reason of the
fact that the person is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred by the person in connection with such action, suit or proceeding if the
person acted in good faith and in a manner the person reasonably believed to be
in or not opposed to the best interests of the corporation, and, with respect to
any criminal action or proceeding, had no reasonable cause to believe the
person's conduct was unlawful.
Section 145(b) of the DGCL provides that a Delaware corporation may
indemnify any person who was or is a party or is threatened to be made a party
to any threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor by reason of the fact that the
person is or was a director, officer, employee or agent of the corporation, or
is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or
other enterprise, against expenses (including attorneys' fees) actually and
reasonably incurred by the person in connection with the defense or settlement
of such action or suit if he or she acted in good faith and in a manner the
person reasonably believed to be in or not opposed to the best interests of the
corporation and except that no indemnification shall be made in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to the corporation unless
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<PAGE>
and only to the extent that the Court of Chancery or the court in which such
action or suit was brought shall determine upon application that, despite the
adjudication of liability but in view of all of the circumstances of the case,
such person is fairly and reasonably entitled to indemnity for such expenses
which the Court of Chancery or such other court shall deem proper.
Section 145 further provides that to the extent a present or former
director or officer of a corporation has been successful in the defense of any
action, suit or proceeding referred to in subsections (a) and (b) of Section
145, or in the defense of any claim, issue or matter therein, such person shall
be indemnified against expenses (including attorneys' fees) actually and
reasonably incurred by such person in connection therewith; that the
indemnification provided by Section 145 shall not be deemed exclusive of any
other rights to which the indemnified party may be entitled; and that the scope
of indemnification extends to directors, officers, employees, or agents of a
constituent corporation absorbed in a consolidation or merger and persons
serving in that capacity at the request of the constituent corporation for
another. Section 145 also empowers the corporation to purchase and maintain
insurance on behalf of a director or officer of the corporation against any
liability asserted against him or her or incurred by him or her in any such
capacity or arising out of his or her status as such whether or not the
corporation would have the power to indemnify him or her against such
liabilities under Section 145.
Section 102(b)(7) of the DGCL provides that a corporation in its original
certificate of incorporation or an amendment thereto validly approved by
stockholders may eliminate or limit personal liability of members of its board
of directors or governing body for breach of a director's fiduciary duty.
However, no such provision may eliminate or limit the liability of a director
for breaching his duty of loyalty, failing to act in good faith, engaging in
intentional misconduct or knowingly violating a law, paying a dividend or
approving a stock repurchase which was illegal, or obtaining an improper
personal benefit. A provision of this type has no effect on the availability of
equitable remedies, such as injunction or rescission, for breach of fiduciary
duty. Cytogen's restated certificate of incorporation contains such a provision.
Cytogen's certificate of incorporation and bylaws provide that Cytogen shall
indemnify officers and directors and, to the extent permitted by the board of
directors, employees and agents of Cytogen, to the full extent permitted by and
in the manner permissible under the laws of the State of Delaware. In addition,
the bylaws permit the board of directors to authorize Cytogen to purchase and
maintain insurance against any director, officer, employee or agent of Cytogen
arising out of his capacity as such.
At present, there is no pending litigation or proceeding involving a
director or officer of the Registrant as to which indemnification is being
sought nor is the Registrant aware of any threatened litigation that may result
in claims for indemnification by any director or officer.
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<PAGE>
SECURITIES AND EXCHANGE COMMISSION POSITION
ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the Company
pursuant to the foregoing provisions, or otherwise, the Company has been advised
that in the opinion of the SEC such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable.
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<PAGE>
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF DOCUMENTS BY REFERENCE.
The SEC allows us to "incorporate by reference" the information we file
with the SEC, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
an important part of this Prospectus, and information that we file later with
the SEC will automatically update and supersede this information. We incorporate
by reference the documents listed below and any future filings made by us with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act until the
filing of a post-effective amendment to this Prospectus which indicates that all
securities registered have been sold or which deregisters all securities then
remaining unsold:
o Our Annual Report on Form 10-K for the year ended December 31, 1999
(Commission File No. 000-14879), filed with the SEC on March 28, 2000;
o All other reports filed by Cytogen pursuant to Section 13(a) or 15(d)
of the Exchange Act since December 31, 1999; and
o The description of our Common Stock, $0.01 par value, contained in our
Registration Statement on Form 8-A (Commission File No. 000-14879)
filed pursuant to Section 12(g) of the Securities Exchange Act of
1934, as amended, including any subsequent amendments or reports filed
for the purpose of updating such description.
ITEM 4 DESCRIPTION OF SECURITIES.
Not Applicable.
ITEM 5. INTERESTS OF NAMED EXPERTS AND COUNSEL.
Not Applicable.
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<PAGE>
ITEM 6. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section 145(a) of the DGCL provides that a Delaware corporation may
indemnify any person who was or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the
right of the corporation) by reason of the fact that the person is or was a
director, officer, employee or agent of the corporation, or is or was serving at
the request of the corporation as a director, officer, employee or agent of
another corporation, partnership, joint venture, trust or other enterprise,
against expenses (including attorneys' fees), judgments, fines and amounts paid
in settlement actually and reasonably incurred by the person in connection with
such action, suit or proceeding if the person acted in good faith and in a
manner the person reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe the person's conduct was
unlawful.
Section 145(b) of the DGCL provides that a Delaware corporation may
indemnify any person who was or is a party or is threatened to be made a party
to any threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor by reason of the fact that the
person is or was a director, officer, employee or agent of the corporation, or
is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or
other enterprise, against expenses (including attorneys' fees) actually and
reasonably incurred by the person in connection with the defense or settlement
of such action or suit if he or she acted in good faith and in a manner the
person reasonably believed to be in or not opposed to the best interests of the
corporation and except that no indemnification shall be made in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to the corporation unless and only to the extent that the Court of
Chancery or the court in which such action or suit was brought shall determine
upon application that, despite the adjudication of liability but in view of all
of the circumstances of the case, such person is fairly and reasonably entitled
to indemnity for such expenses which the Court of Chancery or such other court
shall deem proper.
Section 145 further provides that to the extent a present or former
director or officer of a corporation has been successful in the defense of any
action, suit or proceeding referred to in subsections (a) and (b) of Section
145, or in the defense of any claim, issue or matter therein, such person shall
be indemnified against expenses (including attorneys' fees) actually and
reasonably incurred by such person in connection therewith; that the
indemnification provided by Section 145 shall not be deemed exclusive of any
other rights to which the indemnified party may be entitled; and that the scope
of indemnification extends to directors, officers, employees, or agents of a
constituent corporation absorbed in a consolidation or merger and persons
serving in that capacity at the request of the constituent corporation for
another. Section 145 also empowers the corporation to purchase and maintain
insurance on behalf of a director or officer of the corporation against any
liability asserted against him or her or incurred by him or her in any such
capacity or arising out of his or her status as such whether or not the
corporation would have the power to indemnify him or her against such
liabilities under Section 145.
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<PAGE>
Section 102(b)(7) of the DGCL provides that a corporation in its original
certificate of incorporation or an amendment thereto validly approved by
stockholders may eliminate or limit personal liability of members of its board
of directors or governing body for breach of a director's fiduciary duty.
However, no such provision may eliminate or limit the liability of a director
for breaching his duty of loyalty, failing to act in good faith, engaging in
intentional misconduct or knowingly violating a law, paying a dividend or
approving a stock repurchase which was illegal, or obtaining an improper
personal benefit. A provision of this type has no effect on the availability of
equitable remedies, such as injunction or rescission, for breach of fiduciary
duty. Cytogen's restated certificate of incorporation contains such a provision.
Cytogen's certificate of incorporation and bylaws provide that Cytogen shall
indemnify officers and directors and, to the extent permitted by the board of
directors, employees and agents of Cytogen, to the full extent permitted by and
in the manner permissible under the laws of the State of Delaware. In addition,
the bylaws permit the board of directors to authorize Cytogen to purchase and
maintain insurance against any director, officer, employee or agent of Cytogen
arising out of his capacity as such.
At present, there is no pending litigation or proceeding involving a
director or officer of the Registrant as to which indemnification is being
sought nor is the Registrant aware of any threatened litigation that may result
in claims for indemnification by any director or officer.
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED.
The issuance of the Shares being offered by the Form S-3 Reoffer Prospectus
were deemed exempt from registration under the Securities Act in reliance upon
either Section 4(2) of the Securities Act as transactions not involving any
public offering or Rule 701 under the Securities Act as transactions made
pursuant to a written compensatory plan or pursuant to a written contract
relating to compensation.
ITEM 8. EXHIBITS.
4.1 Cytogen Corporation 1988 Stock Option Plan for Non-Employee
Directors, as amended. Filed as exhibits to Form S-8 Registration
Statement (No. 33-30595) and Form 10-Q Quarterly Report for the
quarter ended June 30, 1996 (Commission File No. 000-14879) and
incorporated herein by reference.
4.2 Cytogen Corporation 1989 Employee Stock Option Plan. Filed as
an exhibit to Form S-8 Registration Statement (No. 33-30595) and
incorporated herein by reference.
4.3 Cytogen Corporation 1989 Special Employee Plan. Filed as an exhibit
to Form S-8 Registration Statement (No. 33-30595) and incorporated
herein by reference.
4.4 Cytogen Corporation 1989 Stock Option Policy for Outside
Consultants. Filed as an exhibit to Amendment No. 1 to Form S-1
Registration Statement (No. 33-
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<PAGE>
31280) and incorporated herein by reference.
4.5 Cytogen Corporation 1992 Employee Stock Option Plan II, as amended.
Filed as an exhibit to Form S-4 Registration Statement (No. 33-
88612) and incorporated herein by reference.
4.6 Cytogen Corporation 1995 Stock Option Plan, as amended. Filed as
exhibits to Form 10-K Annual Report for the year ended December 31,
1995 (Commission File No. 000-14879) and Form 10-Q Quarterly Report
for the quarter ended June 30, 1996 (Commission File No. 000-14879)
and incorporated herein by reference.
4.7 Cytogen Corporation Employee Stock Purchase Plan. Filed as an
exhibit to Form S-8 Registration Statement (No. 333-27673) and
incorporated herein by reference.
4.8 Cellcor, Inc. 1988 Stock Option Plan. Filed as an exhibit to Form
S-8 Registration Statement (No. 333-00431) and incorporated herein
by reference.
4.9 Cellcor, Inc. 1992 Stock Option and Restricted Stock Plan. Filed as
an exhibit to Form S-8 Registration Statement (No. 333-00431)
and incorporated herein by reference.
4.10 Cellcor, Inc. 1992 Director Stock Plan. Filed as an exhibit to Form
S-8 Registration Statement (No. 333-00431) and incorporated herein
by reference.
4.11 Cellcor, Inc. 1995 Stock Incentive Plan. Filed as an exhibit to Form
S-8 Registration Statement (No. 333-00431) and incorporated herein
by reference.
5 Opinion of Buchanan Ingersoll Professional Corporation.
23.1 Consent of Arthur Andersen LLP.
23.2 Consent of Buchanan Ingersoll Professional Corporation (contained in
the opinion filed as Exhibit 5).
24 Power of Attorney (contained on the signature page of this
Registration Statement).
ITEM 9. UNDERTAKINGS.
a. Cytogen hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement to include
any material information with respect to the plan of distribution not
previously disclosed in this registration statement or any material change
to such information in this registration statement.
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(2) That, for the purpose of determining any liability under the
Securities Act, each such post-effective amendment shall be deemed to be a
new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at
the termination of the offering.
b. The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Exchange Act (and, where applicable, each filing of an employee benefit plan's
annual report pursuant to Section 15(d) of the Exchange Act) that is
incorporated by reference in this Registration Statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
c. Insofar as indemnification for liabilities arising under the
Securities, may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
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<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-8 and has duly caused this Amendment
No. 1 to the Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Princeton, State of New
Jersey, on this 18th day of October, 2000.
CYTOGEN CORPORATION
By: /s/ H. Joseph Reiser
------------------------------------
President and
Chief Executive Officer
<PAGE>
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each individual whose signature
appears below constitutes and appoints H. Joseph Reiser and, Lawrence Hoffman
and each of them, his true and lawful attorneys-in-fact and agents with full
power of substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign any and all amendments (including
post-effective amendments) to this Registration Statement, and to file the same
with all exhibits thereto, and all documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorneys-in-fact and
agents, and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said attorneys-in-fact and
agents or any of them, or their or his substitute or substitutes, may lawfully
do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in the
capacities and on the date indicated.
Signature Title Date
--------- ----- ----
/s/ H. Joseph Reiser President and Chief Executive Officer October 9, 2000
-------------------- and Director (Principal Executive and
H. Joseph Reiser Financial Officer)
/s/ John E. Bagalay Director October 9, 2000
-------------------
John E. Bagalay
/s/ Stephen K. Carter Director October 9, 2000
---------------------
Stephen K. Carter
/s/ James A. Grigsby Director October 9, 2000
--------------------
James A. Grigsby
/s/ S. Leslie Misrock Director October 9, 2000
---------------------
S. Leslie Misrock
/s/ Robert F. Hendrickson Director October 9, 2000
-------------------------
Robert F. Hendrickson
<PAGE>
EXHIBIT INDEX
Exhibit Description
Number -----------
------
4.1 Cytogen Corporation 1988 Stock Option Plan for Non-Employee
Directors, as amended. Filed as exhibits to Form S-8 Registration
Statement (No. 33-30595) and Form 10-Q Quarterly Report for the
quarter ended June 30, 1996 (Commission File No. 000-14879) and
incorporated herein by reference.
4.2 Cytogen Corporation 1989 Employee Stock Option Plan. Filed as an
exhibit to Form S-8 Registration Statement (No. 33-30595) and
incorporated herein by reference.
4.3 Cytogen Corporation 1989 Special Employee Plan. Filed as an
exhibit to Form S-8 Registration Statement (No. 33-30595) and
incorporated herein by reference.
4.4 Cytogen Corporation 1989 Stock Option Policy for Outside
Consultants. Filed as an exhibit to Amendment No. 1 to Form S-1
Registration Statement (No. 33-31280) and incorporated herein by
reference.
4.5 Cytogen Corporation 1992 Employee Stock Option Plan II, as
amended. Filed as an exhibit to Form S-4 Registration Statement
(No. 33-88612) and incorporated herein by reference.
4.6 Cytogen Corporation 1995 Stock Option Plan, as amended. Filed as
exhibits to Form 10-K Annual Report for the year ended December
31, 1995 (Commission File No. 000-14879) and Form 10-Q Quarterly
Report for the quarter ended June 30, 1996 (Commission File No.
000-14879) and incorporated herein by reference.
4.7 Cytogen Corporation Employee Stock Purchase Plan. Filed as an
exhibit to Form S-8 Registration Statement (No. 333-27673) and
incorporated herein by reference.
4.8 Cellcor, Inc. 1988 Stock Option Plan. Filed as an exhibit to
Form S-8 Registration Statement (No. 333-00431) and incorporated
herein by reference.
4.9 Cellcor, Inc. 1992 Stock Option and Restricted Stock Plan. Filed
as an exhibit to Form S-8 Registration Statement (No. 333-00431)
and incorporated herein by reference.
4.10 Cellcor, Inc. 1992 Director Stock Plan. Filed as an exhibit to
Form S-8 Registration Statement (No. 333-00431) and incorporated
herein by reference.
4.11 Cellcor, Inc. 1995 Stock Incentive Plan. Filed as an exhibit to
Form S-8
<PAGE>
Registration Statement (No. 333-00431) and incorporated herein by
reference.
5 Opinion of Buchanan Ingersoll Professional Corporation.
23.1 Consent of Arthur Andersen LLP.
23.2 Consent of Buchanan Ingersoll Professional Corporation (contained
in the opinion filed as Exhibit 5).
24 Power of Attorney (contained on the signature page of this
Registration Statement).
<PAGE>
EXHIBIT 5
<PAGE>
Buchanan Ingersoll
Professional Corporation
(Incorporated in Pennsylvania)
Attorneys
650 College Road East
Princeton, New Jersey 08540
October 18, 2000
Cytogen Corporation
600 College Road East CN 5308
Princeton, New Jersey 08540
Gentlemen:
We have acted as counsel to Cytogen Corporation, a Delaware corporation
(the "Company"), in connection with the filing by the Company of a
Post-Effective Amendment No. 1 to a Registration Statement on Form S-8 (the
"Amendment") together with a Reoffer Prospectus (the "Prospectus") which relates
to the public resale, from time to time, of an aggregate of 8,488,960 shares of
the Company's Common Stock, $0.01 par value per share, which have been or may be
acquired upon the exercise of stock options granted or upon stock purchases
pursuant to: (i) the Company's 1988 Stock Option Plan for Non-Employee
Directors; (ii) the Company's 1989 Employee Stock Option Plan; (iii) the
Company's 1989 Special Employee Plan; (iv) the Company's 1989 Stock Option
Policy for Outside Consultants; (v) the Company's 1992 Employee Stock Option
Plan II, as amended; (vi) the Company's 1995 Stock Option Plan, as amended;
(vii) the Company's Employee Stock Purchase Plan; (viii) Cellcor, Inc.'s
("Cellcor") 1988 Stock Option Plan; (ix) Cellcor's 1992 Stock Option and
Restricted Stock Plan; (x) Cellcor's 1992 Director Stock Plan; and (xi)
Cellcor's 1995 Stock Incentive Plan, collectively referred to hereinafter as the
"Plans". The shares underlying the Amendment and Prospectus are collectively
referred to hereinafter as the "Shares."
In connection with the Amendment and Prospectus, we have examined such
corporate records and documents, other documents, and such questions of law as
we have deemed necessary or appropriate for purposes of this opinion. On the
basis of such examination, it is our opinion that:
1. The issuance of the Shares has been duly and validly authorized; and
2. The Shares underlying the Plans, when issued, delivered and sold in
accordance with the terms of the Plans and the stock options, or other
instruments authorized by the Plans, granted or to be granted
thereunder, will be legally issued, fully paid and non-assessable.
<PAGE>
We hereby consent to the filing of this opinion as Exhibit 5 to the
Amendment and Prospectus.
Very truly yours,
/s/BUCHANAN INGERSOLL
PROFESSIONAL CORPORATION
/s/ Raymond Thek
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By: Raymond Thek, a member of the firm
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EXHIBIT 23.1
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CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation by
reference in this registration statement of our report dated January 27, 2000,
included in Cytogen Corporation's Form 10-K for the year ended December 31, 1999
and to all references to our Firm included in this registration statement.
Arthur Andersen LLP
Philadelphia, Pennsylvania
October 18, 2000
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EXHIBIT 23.2
(contained in Exhibit 5)
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EXHIBIT 24
(contained on signatures page)
