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Filed Pursuant to form 424(B)(3)
to File Number 333-50330
PROSPECTUS
6,723,193 SHARES
GENTA INCORPORATED
COMMON STOCK
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The selling stockholders of Genta Incorporated listed on pages 12 through
15 of this prospectus are offering and selling a total of 6,723,193 shares of
Genta common stock that each own and, in the case of certain selling
stockholders, can acquire by exercising warrants that they own. These shares
were originally issued to the selling stockholders in connection with Genta's
recently completed private placements and pursuant to a license agreement
between Genta and Molecular Biosystems, Inc. Genta will not receive any of the
proceeds from the sale of the shares sold by these selling stockholders and is
not offering any shares for sale under this prospectus. See "Plan of
Distribution" on page 16 for a description of sales of the shares by the selling
stockholders.
Genta common stock is listed on the Nasdaq National Market under the symbol
"GNTA." On November 16, 2000, the closing sale price for Genta common stock, as
reported on the Nasdaq National Market, was $8.25. We advise you to obtain a
current market quotation for Genta common stock.
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INVESTING IN GENTA COMMON STOCK INVOLVES RISKS. SEE "RISK FACTORS"
BEGINNING ON PAGE 6 OF THIS PROSPECTUS.
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NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR
DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
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THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING STOCKHOLDERS MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION
STATEMENT FILED WITH THE SEC IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO
SELL THESE SECURITIES, AND IT IS NOT SOLICITING AN OFFER TO BUY THESE SECURITIES
IN ANY JURISDICTION WHERE THE OFFER OR SALE IS NOT PERMITTED.
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The date of this prospectus is December 4, 2000.
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TABLE OF CONTENTS
PAGE
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About Genta Incorporated...............................................3
Risk Factors...........................................................6
Legal Proceedings.....................................................10
Forward-Looking Statements............................................11
Use of Proceeds.......................................................11
Selling Stockholders..................................................12
Plan of Distribution..................................................16
Legal Matters.........................................................17
Experts...............................................................17
Where You Can Find Additional Information.............................18
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SUMMARY
THIS SUMMARY HIGHLIGHTS SELECTED INFORMATION FROM THIS PROSPECTUS AND MAY
NOT CONTAIN ALL OF THE INFORMATION THAT IS IMPORTANT TO YOU. TO UNDERSTAND THIS
OFFERING FULLY, YOU SHOULD READ THE ENTIRE PROSPECTUS CAREFULLY, INCLUDING "RISK
FACTORS" BEGINNING ON PAGE 6. IN ADDITION, YOU SHOULD ALSO READ THE DOCUMENTS WE
HAVE REFERRED YOU TO IN "WHERE YOU CAN FIND ADDITIONAL INFORMATION" ON PAGE 14
FOR INFORMATION ON OUR COMPANY AND OUR FINANCIAL STATEMENTS.
ABOUT GENTA INCORPORATED
Genta Incorporated is a biopharmaceutical company dedicated to developing
drugs to treat cancer. Genta's primary research efforts have been focused on the
development of a class of drugs designed to target specific genes, namely those
that produce proteins that help cancer cells survive and resist the effects of
treatment. All of our potential therapeutic products are in various stages of
research and development. In late 1996, Genta filed an Investigational New Drug
Application for our leading drug, called Genasense(TM), and in October 1999, we
received confirmation from the United States Food and Drug Administration
("FDA") that Genasense(TM) has been granted "fast track" designation for use in
combination with dacarbazine (a commonly-used anti-cancer drug) to treat
malignant melanoma. "Fast track" designation allows us to submit an application
for regulatory approval to the FDA prior to completion of our clinical trials
and requires the FDA to respond to our application on an expedited basis.
The development of Genasense(TM) has been and will continue to be the
single most important project within the company. Genasense(TM) targets the
"Bcl-2" protein. This protein is one of a family of proteins that controls a
cell's normal process of maintaining its genetic or DNA integrity. When a cell
determines that its genetic sequence or other vital cell structures are
seriously damaged, it commits suicide rather than dividing to produce two new
cells. This process is called "apoptosis," or programmed cell death. Bcl-2
protein inhibits programmed cell death and allows damaged cells to survive. Many
cancer cells have an excess of this protein, making them resistant to many of
the drugs and other treatments such as radiation that are commonly used to treat
cancer.
Genasense(TM) is designed to reduce the level of Bcl-2 protein in cells.
This drug is based on a specific sequence of the gene that is responsible for
producing Bcl-2 protein. Genes, or DNA, are made of four different building
blocks, or nucleotides, arranged in specific sequences that provide the code for
the production of proteins. Genasense(TM) acts by binding to the gene's
messenger, called messenger-RNA, and the combination results in the destruction
of that messenger by an enzyme normally present in cells. Since the
messenger-RNA that enables the cell to make a protein has been called "sense,"
the drugs used to interrupt this process are often called "antisense."
Genta believes that antisense compounds can be designed in such a way so as
to provide a cancer therapy that reduces the risk of side effects of traditional
cancer treatments. Antisense drugs are specific sequences of nucleotides, the
building blocks of genes or DNA, but antisense drugs contain far fewer
nucleotides than the whole gene. As a result of that specific sequence, they
should bind only to the matching sequence of nucleotides in the messenger-RNA.
Because antisense drugs are made up of a series of nucleotides, they are also
called "antisense oligonucleotides."
In late 1995, the first clinical trial of Genasense(TM) was started in the
United Kingdom in non-Hodgkin's lymphoma patients for whom prior therapies had
failed. This clinical trial, which was conducted at the Royal Marsden Hospital,
established a safe dose range in these lymphoma patients. Although the study was
not designed to evaluate drug efficacy, the study showed promising single agent
activity to reduce the lymphoma and the cancer-related symptoms in some
patients. The study also showed frequent reduction of the Bcl-2 protein in the
lymphoma cells of some treated patients. In late
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1996, an Investigational New Drug Application for the Genasense(TM) clinical
program was filed with and allowed to proceed by the FDA.
In late 1997, a second trial using Genasense(TM) was initiated in the
United States at the Memorial Sloan-Kettering Cancer Center in New York City for
patients diagnosed with solid tumors. In 1998, several additional trials were
initiated in North America and Europe. In each of these trials, Genta is
investigating the safety and activity of Genasense(TM) given in combination with
standard drugs used in the treatment of different cancers, such as lymphoma,
prostate, melanoma and breast cancer.
In May 1999 Genta and the National Cancer Institute ("NCI"), one of the U.
S. National Institutes of Health, agreed to collaborate on a development program
for Genasense(TM). Under the agreement, Genta will provide the NCI with
Genasense(TM) Recently, the NCI commenced studies using Genasense(TM) for
treatment of relapsed acute leukemia, colorectal and small cell lung cancer.
Based on the available results from the on-going clinical trials, Genta has
moved the development of Genasense(TM) into Phase 3 studies that will determine
its overall effectiveness and safety in patients with specific types of cancer.
Genta has elected to focus development on cancers that cannot be treated
effectively by the available anti-cancer drugs. In that way, Genta believes that
its development programs will have a higher likelihood of qualifying for "fast
track" designation by the FDA and then for accelerated development and approval
for marketing by the FDA. In October 1999, Genta received confirmation from the
FDA granting "fast track" designation to Genasense(TM) for use in combination
with dacarbazine (a commonly-used anti-cancer drug) to treat malignant melanoma.
Genta also owns 50% of Genta Jago Technologies B.V. ("Genta Jago"), a drug
delivery system joint venture which was established to develop oral
controlled-release drugs. To date, no products from this joint venture have been
commercialized, although an abbreviated new drug application was submitted in
1998 by Genta Jago's marketing partner for one product. Genta Jago's original
plan was to use a patented drug delivery technology (called "GEOMATRIX") in a
two-pronged commercialization strategy: first, the development of generic
versions of successful brand-name controlled-release drugs; and second, the
development of controlled-release formulations of drugs currently marketed in
only immediate-release form. The only products in development to date are those
in the first category.
In March 1999, Genta entered into an interim agreement pursuant to which
Genta was released from all liability relating to unpaid development costs and
funding obligations of Genta Jago. SkyePharma (on behalf of itself and its
affiliates) agreed to be responsible for substantially all the obligations of
the joint venture to third parties and for the further development of the joint
venture's products, with any net income resulting from certain products of the
joint venture to be allocated in agreed-upon percentages between Genta and
SkyePharma.
In May 1999, Genta sold the assets of its subsidiary, JBL Scientific, Inc.,
to raise additional funds for its continuing drug development work.
In August 1999, Genta acquired Androgenics Technologies, Inc., a company
with license rights to a series of compounds invented at the University of
Maryland, Baltimore to treat prostate cancer. These compounds have the potential
to broaden Genta's product portfolio of drugs. These compounds are currently
being evaluated by the inventors. Genta expects to advance a lead compound into
expanded animal safety and pharmacology studies sometime in the year 2000. These
compounds block the production of testosterone which stimulates the growth of
prostate cancer, at both major sources of testosterone in the body, the testes
and the adrenal glands. In addition to reducing the amount of testosterone
available to the tumor, these compounds also block the prostate cancer cell's
receptors for testosterone and a potent biological conversion product or
metabolite, dihydrotestosterone. Animal
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studies suggest that these receptors can change or mutate over time and such
changes could be a cause of resistance to standard hormone receptor blocking
drugs now used to treat prostate cancer. In contrast, the Androgenics compounds
appear to block both the normal receptors and the mutant receptors, which may
make treatment with these new drugs more effective over a longer period of time
than currently available treatments. This research is still early in its
development and the safety and potential benefits will have to be studied and
confirmed in animal and human trials.
In April 2000, we entered into an asset purchase agreement with Relgen LLC,
a privately held corporation and an affiliate of Genta, in which we acquired all
the assets, rights and technology to a portfolio of gallium containing
compounds, known as Ganite(TM), in exchange for 10,000 shares of common stock.
These compounds are used to treat cancer-related hypercalcemia.
In May 2000, we entered into a licensing arrangement with Molecular
Biosystems, Inc. ("MBI") for a broad portfolio of patents and technology that
relate to antisense for therapeutic and diagnostic applications. The arrangement
includes grants of both exclusive and non-exclusive rights from MBI to Genta on
a royalty-free basis in return for cash and shares of Genta common stock.
In October 2000, Genta moved its offices to New Jersey. Genta's principal
offices are now located at Two Oak Way, Berkeley Heights, New Jersey 07922, and
its telephone number is (908) 286-9800.
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RISK FACTORS
INVESTING IN THESE SECURITIES INVOLVES SUBSTANTIAL RISKS. YOU SHOULD CONSIDER
CAREFULLY THE FOLLOWING RISK FACTORS, TOGETHER WITH ALL OF THE OTHER INFORMATION
INCLUDED IN THIS PROSPECTUS AND INCORPORATED BY REFERENCE INTO THIS PROSPECTUS,
IN DECIDING WHETHER TO INVEST IN THE SECURITIES.
OUR BUSINESS WILL SUFFER IF WE FAIL TO OBTAIN TIMELY FUNDING.
Our operations to date have consumed substantial amounts of cash. Based on
our current operating plan, we believe that our available resources, including
the proceeds from our recent private offering, will be adequate to satisfy our
capital needs through September 2002. Our future capital requirements will
depend on the results of our research and development activities, preclinical
studies and bioequivalence and clinical trials, competitive and technological
advances, and regulatory processes of the FDA and other regulatory authority. If
our operations do not become profitable before we exhaust existing resources, we
will need to raise substantial additional financing in order to continue our
operations. We may seek additional financing through public and private
resources, including debt or equity financings, or through collaborative or
other arrangements with research institutions and corporate partners. If we
raise additional capital by issuing equity, or securities convertible into
equity, the ownership interest of existing Genta stockholders will be subject to
further dilution and share prices may decline. If we are unable to raise
additional financing when needed or on acceptable terms, we will need to do the
following:
- delay, scale back or eliminate some or all of our research and product
development programs;
- license third parties to commercialize products or technologies that we
would otherwise seek to develop ourselves;
- sell Genta to a third-party;
- to cease operations; or
- declare bankruptcy.
OUR PRODUCTS ARE IN AN EARLY STAGE OF DEVELOPMENT.
Most of our resources have been dedicated to applying molecular biology and
medicinal chemistry to the research and development of potential Anticode(TM)
pharmaceutical products based upon oligonucleotide technology. While we have
demonstrated the activity of Anticode(TM) oligonucleotide technology in model
systems in vitro in animals, only one of these potential Anticode(TM)
oligonucleotide products, Genasense(TM), has begun to be tested in humans.
Results obtained in preclinical studies or early clinical investigations are not
necessarily indicative of results that will be obtained in extended human
clinical trials. Our products may prove to have undesirable and unintended side
effects or other characteristics that may prevent our obtaining FDA or foreign
regulatory approval for any indication. In addition, it is possible that
research and discoveries by others will render our oligonucleotide technology
obsolete or noncompetitive.
WE CANNOT SELL OUR PRODUCTS IF WE FAIL TO OBTAIN THE NECESSARY REGULATORY
APPROVALS.
The FDA and comparable agencies in foreign countries impose substantial
premarket approval requirements on the introduction of pharmaceutical products
through lengthy and detailed preclinical and clinical testing procedures and
other costly and time-consuming procedures. Satisfaction of these
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requirements typically takes several years or more depending upon the type,
complexity and novelty of the product.
BECAUSE WE RELY ON OTHERS TO CONDUCT OUR CLINICAL TRIALS, WE CANNOT CONTROL
THEIR COMPLETION RATE OR COST, WHICH MAY AFFECT OUR ABILITY TO SUCCESSFULLY
COMMERCIALIZE OUR PRODUCTS.
We rely on others to conduct our clinical trials. How quickly we are able
to complete a clinical study depends upon several factors, including the size of
the patient population, how easily patients can get to the site of the clinical
study, and the criteria for determining which patients are eligible to join the
study. Delays in patient enrollment could delay completion of a clinical study
and increase its costs, and could also delay the commercial sale of the drug
that is the subject of the clinical trial.
Our commencement and rate of completion of clinical trials also may be
delayed by many other factors, including the following:
- inability to obtain sufficient quantities of materials used for clinical
trials;
- inability to adequately monitor patient progress after treatment;
- unforeseen safety issues;
- the failure of the products to perform well during clinical trials; and
- government or regulatory delays.
THE SUCCESS OF OUR BUSINESS DEPENDS ON OUR ABILITY TO OBTAIN OR ENFORCE PATENTS
AND OTHER PROPRIETARY RIGHTS.
Our success will depend to a large extent on our ability to (1) obtain U.S.
and foreign patent or other proprietary protection for our technologies,
products and processes, (2) preserve trade secrets and (3) operate without
infringing the patent and other proprietary rights of third parties. Legal
standards relating to the validity of patents covering pharmaceutical and
biotechnological inventions and the scope of claims made under such patents are
still developing. There is no consistent policy regarding the breadth of claims
allowed in biotechnology patents. As a result, our ability to obtain and enforce
patents that protect our drugs is highly uncertain and involves complex legal
and factual questions.
We have more than 100 U.S. and international patents and applications to
aspects of oligonucleotide technology, which includes novel compositions of
matter, methods of large-scale synthesis and methods of controlling gene
expression. We may not receive any issued patents based on pending or future
applications. Our issued patents may not contain claims sufficiently broad to
protect us against competitors with similar technology. Additionally, our
patents, our partners' patents and patents for which we have license rights may
be challenged, narrowed, invalidated or circumvented. Furthermore, rights
granted under our patents may not cover commercially valuable drugs or processes
and may not provide us with any competitive advantage.
We may have to initiate arbitration or litigation to enforce our patent and
license rights. If our competitors file patent applications that claim
technology also claimed by us, we may have to participate in interference or
opposition proceedings to determine the priority of invention. An adverse
outcome could subject us to significant liabilities to third parties and require
us to cease using the technology or to license the disputed rights from third
parties.
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The cost to us of any litigation or proceeding relating to patent rights,
even if resolved in our favor, could be substantial. Some of our competitors may
be able to sustain the costs of complex patent litigation more effectively than
we can because of their substantially greater resources. Uncertainties resulting
from the initiation and continuation of any pending patent or related litigation
could prevent us from marketing our products.
THE DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCTS COULD BE DELAYED IF WE ARE
UNABLE TO MAINTAIN OUR COLLABORATIVE ARRANGEMENTS WITH RESEARCH INSTITUTIONS.
Our business strategy depends in part on our continued ability to develop
and maintain relationships with leading academic and research institutions and
independent researchers. The competition for such relationships is intense. We
have entered into a number of collaborative relationships relating to specific
disease targets and other research activities in order to augment our internal
research capabilities and to obtain access to specialized knowledge and
expertise. The loss of any of these collaborative relationships could prevent
the completion of our clinical trials, which are necessary for regulatory
approval.
BECAUSE THERE ARE FEW SOURCES FOR ESSENTIAL RAW MATERIALS, WE MAY NOT BE ABLE TO
OBTAIN SUFFICIENT QUANTITIES TO MEET MARKET DEMAND.
The raw materials that we require to manufacture our drugs, particularly
oligonucleotides, are available from only a few suppliers, namely those with
access to our patented technology. If these few suppliers cease to provide us
with the necessary raw materials or fail to provide us with adequate supply of
materials at an acceptable price and quality, we would not be able to continue
our clinical trials or to sell our drugs.
UNLESS WE OBTAIN COVERAGE AND REIMBURSEMENT FOR USE OF OUR PRODUCTS FROM
THIRD-PARTY PAYORS, WE MAY NOT BE ABLE TO SUCCESSFULLY MARKET OUR PRODUCT.
Our ability to market drugs successfully will depend in part on the extent
to which various third parties are willing to reimburse patients for the costs
of our drugs and related treatments. These third parties include government
authorities, private health insurers, and other organizations, such as health
maintenance organizations. Third-party payors often challenge the prices charged
for medical products and services. Accordingly, if less costly drugs are
available, third-party payors may not authorize or may limit reimbursement for
our drugs, even if they are safer or more effective than the alternatives. In
addition, the federal government and private insurers have considered ways to
change, and have changed, the manner in which health care services are provided
and paid for in the United States. In particular, these third-party payors are
increasingly attempting to contain health care costs by limiting both coverage
and the level of reimbursement for new therapeutic products. In the future, it
is possible that the government may institute price controls and further limits
on Medicare and Medicaid spending. These controls and limits could affect the
payments we collect from sales of our products. Internationally, medical
reimbursement systems vary significantly, with some medical centers having fixed
budgets, regardless of levels of patient treatment, and other countries
requiring application for, and approval of, government or third-party
reimbursement.
WE COULD BECOME INVOLVED IN TIME-CONSUMING AND EXPENSIVE PATENT LITIGATION AND
ADVERSE DECISIONS IN PATENT LITIGATION COULD CAUSE US TO INCUR ADDITIONAL COSTS
AND EXPERIENCE DELAYS IN BRINGING NEW DRUGS TO MARKET.
The pharmaceutical and biotechnology industries have been characterized by
time-consuming and extremely expensive litigation regarding patents and other
intellectual property rights. We may be
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required to commence, or may be made a party to, litigation relating to the
scope and validity of our intellectual property rights, or the intellectual
property rights of others. Such litigation could result in adverse decisions
regarding the patentability of our inventions and products, or the
enforceability, validity, or scope of protection offered by our patents. Such
decisions could make us liable for substantial money damages, or could bar us
from the manufacture, use, or sale of certain products, resulting in additional
costs and delays in bringing drugs to market. We may not have sufficient
resources to bring any such proceedings to a successful conclusion.
We also may be required to participate in interference proceedings declared
by the U.S. Patent and Trademark Office and in International Trade Commission
proceedings aimed at preventing the importing of drugs that would compete
unfairly with our drugs. Such proceedings could cause us to incur considerable
costs.
OUR INSURANCE MAY NOT BE ADEQUATE TO PROTECT US AGAINST POTENTIAL PRODUCT
LIABILITY.
The nature of our business exposes us to potential product and professional
liability risks which are inherent in the testing, production, marketing and
sale of human therapeutic products. While we are covered against those claims by
a product liability insurance policy (subject to various deductibles), our
insurance coverage may not provide us with adequate protection against potential
liabilities.
IF WE CEASE DOING BUSINESS AND LIQUIDATE OUR ASSETS, WE ARE REQUIRED TO
DISTRIBUTE PROCEEDS TO HOLDERS OF OUR PREFERRED STOCK BEFORE WE DISTRIBUTE
PROCEEDS TO HOLDERS OF OUR COMMON STOCK.
In the event of a dissolution or liquidation of Genta, holders of Genta
common stock will not receive any proceeds until holders of 268,700 outstanding
shares of Genta series A preferred stock are paid an aggregate of $13.4 million
liquidation preference.
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LEGAL PROCEEDINGS
In October 1996, our subsidiary, JBL Scientific, Inc., retained a chemical
consulting firm to advise it with respect to an incident of soil and groundwater
contamination. Sampling conducted at the JBL facility in California revealed the
presence of chloroform and perchloroethylenes ("PCEs") in the soil and
groundwater. A semi-annual groundwater monitoring program is being conducted,
under the supervision of the California Regional Water Quality Control Board,
for the purpose of determining whether the levels of chloroform and PCEs have
decreased over time. The results of the latest sampling conducted show that
chloroform and PCEs have decreased in all but one of the monitoring sites. We
have agreed to indemnify Promega, which purchased the assets of JBL, in respect
of this matter. Based on an estimate provided to us by a consulting firm at
December 31, 1999 and September 30, 2000, we have $39,100 and $49,700,
respectively, accrued to cover remedial costs. Prior to 1999, such costs were
not estimable and, therefore, no loss provision had been recorded. We believe
that any costs stemming from further investigating or remediating this
contamination will not have a material adverse effect on our business, although
there can be no assurance thereof.
JBL received notice on October 16, 1998 from Region IX of the Environmental
Protection Agency ("EPA") that it had been identified as a potentially
responsible party at the Casmalia Disposal Site, which is located in Santa
Barbara, California. JBL has been designated as a de minimis potentially
responsible party by the EPA. Based on volume amounts from the EPA, we concluded
that it was probable that a liability had been incurred and accrued $75,000
during 1998. In 1999, the EPA estimated that we will be required to pay
approximately $63,200 to settle the potential liability. We expect to receive a
revised settlement proposal from the EPA by the fourth quarter of 2000. While
the terms of the settlement with the EPA have not been finalized, they should
contain standard contribution protection and release language. We believe that
any costs stemming from further investigating or remediating this contamination
will not have a material adverse effect on our business, although there can be
no assurance thereof. The Company has agreed to indemnify Promega in respect of
this matter.
In 1995, our wholly-owned subsidiary, Genta Pharmaceuticals Europe S.A.
("Genta Europe"), received approximately 5.4 million French Francs (as of
September 30, 2000, approximately $723,600) of funding in the form of a loan
from the French government agency L'Agence Nationale de Valorisation de la
Recherche ("ANVAR") towards research and development activities pursuant to an
agreement between ANVAR, Genta Europe and us. In October 1996, as part of our
restructuring program, Genta Europe terminated all scientific personnel. ANVAR
asserted, in a letter dated February 13, 1998, that Genta Europe was not in
compliance with the agreement, and that ANVAR might request the immediate
repayment of such loan. On July 1, 1998, ANVAR notified Genta Europe by letter
of its claim that we remain liable for FF4,187,423 (as of September 30, 2000,
approximately $561,500) and is required to pay this amount immediately. We do
not believe that under the terms of the agreement ANVAR is entitled to request
early repayment. ANVAR notified us that we were responsible as a guarantor of
the loan for the repayment. Our legal counsel in Europe has again notified ANVAR
that we do not agree that the loan is payable. We are working with ANVAR to
achieve a mutually satisfactory resolution. However, there can be no assurance
that such a resolution will be obtained. There can be no assurance that we will
not incur material costs in relation to these terminations and/or assertions of
default or liability.
On June 30, 1998, Marseille Amenagement, a company affiliated with the city
of Marseilles, France, filed suit in France to evict Genta Europe from its
facilities in Marseilles and to demand payment of alleged back rent due and of a
lease guarantee for nine years' rent. Following the filing of this claim and in
consideration of the request for repayment of the loan from ANVAR, Genta
Europe's Board of Directors directed the management to declare a "Cessation of
Payment." Under this procedure, Genta Europe ceased any operations and
terminated its only employee. A liquidator was appointed by the Court to take
control of any assets of Genta Europe and to make payment to creditors. In
December 1998, the
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Court in Marseilles dismissed the case against Genta Europe and indicated that
it had no jurisdiction against Genta Incorporated. In August 1999, Marseille
Amenagement instituted legal proceedings against us at the Commercial Court in
France, claiming alleged back rent payment of FF663,412.64 (as of September 30,
2000, approximately $89,000) and an early termination payment of FF1,852,429 (as
of September 30, 2000, approximately $248,600). A court hearing has been
scheduled for January 8, 2001. We are working with our counsel in France to
achieve a mutually satisfactory resolution. However, there can be no assurance
that such a resolution will be obtained. On September 30, 2000, we have $574,800
of net liabilities of a liquidated subsidiary recorded, and, therefore,
management believes no additional accrual is necessary. There can be no
assurance that we will not incur material costs in relation to this claim.
In May 2000, Promega notified us by letter of two claims against us and
Genta's subsidiary, Genko Scientific, Inc. (f/k/a JBL Scientific, Inc.), for
indemnifiable damages in the aggregate amount of $2,820,000 under the agreement
pursuant to which we sold to Promega JBL's assets. Promega's letter stated that
it intends to reduce to zero the principal amount of the $1.2 million promissory
note it issued as partial payment for the assets of JBL (which note provided for
a payment of $700,000 on June 30, 2000) and that, as a result, we owe Promega
approximately $1.6 million. We believe that Promega's claims are without merit
and intend to vigorously pursue our rights under the agreement. Accordingly, On
October 16, 2000, we filed suit in the US District Court of California against
Promega for the non-payment of the $1.2 million note plus interest. On November
6, 2000, Promega filed a countersuit against us in the US District Court of
California. There can be no assurance that we will be successful in our lawsuit
or that we will not incur material costs and/or that losses may occur in
relation to this claim.
FORWARD-LOOKING STATEMENTS
When used in this prospectus, the words "believes," "plans," "expects," and
"anticipates," and similar expressions are intended to identify forward-looking
statements. Except for historical information contained in this prospectus, the
matters discussed and the statements made herein or in the information
incorporated by reference herein concerning Genta's future prospects are
"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. Genta
intends that all forward-looking statements be subject to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect Genta's views as of the date they are made
with respect to future events, but are subject to known and unknown risks,
uncertainties and other factors that may cause our actual results, performance
or achievements to be materially different from any future results, performance
or achievements expressed or implied by those forward-looking statements.
Forward-looking statements are not guarantees of future performance, and
necessarily involve risks and uncertainties, and Genta's results could differ
materially from those anticipated in the forward-looking statements contained in
this prospectus.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the common stock by the
selling stockholders.
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SELLING STOCKHOLDERS
The selling stockholders are offering and selling a total of [6,723,193]
shares of Genta common stock under this prospectus. The shares being offered
under this prospectus were originally issued to the selling stockholders in
connection with Genta's recently completed private placements and pursuant to a
license agreement between Genta and Molecular Biosystems, Inc. In connection
with these transactions, we agreed to register these shares under the Securities
Act of 1933. The shares being registered for resale include:
- 6,566,913 shares of common stock;
- 20,641 shares of common stock issuable upon exercise of warrants which we
were required to issue to certain selling shareholders depending on the
date this registration statement was filed; and
- 135,639 shares of common stock issuable upon exercise of warrants that were
issued to Gruntal & Co., L.L.C., our advisor in connection with a portion
of the private placement;
The following table sets forth, to the best of our knowledge, based on
information provided to us by the selling stockholders:
- the number of shares of Genta common stock owned by each selling
stockholder; and
- the number of shares being offered by each selling stockholder under this
prospectus.
All information with respect to share ownership has been provided by the
selling stockholders. Except as described below, none of the selling
stockholders holds any position or office with, or has otherwise had a material
relationship with, Genta for the past three years. Because the selling
stockholders identified below may have sold, transferred or otherwise disposed
of all or a portion of the shares of common stock owned by them since the date
of which they provided the information regarding their share ownership in
transactions exempt from the registration requirements of the Securities Act of
1933, no estimate can be given as to the number of shares of common stock that
will be held by the selling stockholders after the offering.
<TABLE>
<CAPTION>
NUMBER OF SHARES NUMBER OF
OF COMMON STOCK SHARES OF
BENEFICIALLY OWNED BEFORE COMMON STOCK
SELLING STOCKHOLDER OFFERING (1) BEING OFFERED
-----------------------------------------------------------------------------------------------
<S> <C> <C>
Edward Apuzzi 7,407 7,407
--------------------------------------------------------------------------------------------
BGS Capital Management, Inc. 30,000 30,000
--------------------------------------------------------------------------------------------
Caduceus Capital II, L.P. (2) 107,720 106,760
--------------------------------------------------------------------------------------------
Castle Creek Healthcare Partners LLC (3) 37,389 37,389
--------------------------------------------------------------------------------------------
CCL Fund LLC (4) 37,389 37,389
--------------------------------------------------------------------------------------------
Crescent International Ltd. (5) 88,142 50,475
--------------------------------------------------------------------------------------------
Joe Edelman (31) 131,625 100,000
--------------------------------------------------------------------------------------------
EndPointe (6) 299,111 299,111
--------------------------------------------------------------------------------------------
Eugenia VI Venture Holdings, Ltd. 740,740 740,740
--------------------------------------------------------------------------------------------
First Investors Holding Co. Inc. (7) 74,778 74,778
--------------------------------------------------------------------------------------------
Albert Fried, Jr. 247,222 222,222
--------------------------------------------------------------------------------------------
Gruntal & Co., L.L.C. (8) 135,639 135,639
--------------------------------------------------------------------------------------------
</TABLE>
-12-
<PAGE> 13
<TABLE>
<CAPTION>
NUMBER OF SHARES NUMBER OF
OF COMMON STOCK SHARES OF
BENEFICIALLY OWNED BEFORE COMMON STOCK
SELLING STOCKHOLDER OFFERING (1) BEING OFFERED
-----------------------------------------------------------------------------------------------
<S> <C> <C>
Halifax Fund, L.P. 300,000 300,000
--------------------------------------------------------------------------------------------
J.F. Shea Co., Inc., as Nominee 1999-101 (9) 200,945 44,445
--------------------------------------------------------------------------------------------
Scott A. Katzmann 56,582 30,000
--------------------------------------------------------------------------------------------
Bonnie B. Kazam 30,000 30,000
--------------------------------------------------------------------------------------------
Keys Foundation (10) 116,023 74,074
--------------------------------------------------------------------------------------------
Lakeshore International, Ltd. (11) 74,778 74,778
--------------------------------------------------------------------------------------------
Timothy McInerney 141,736 30,000
--------------------------------------------------------------------------------------------
Merced Partners Limited Partnership (12) 74,778 74,778
--------------------------------------------------------------------------------------------
Michael C. Miles (32) 35,898 14,815
--------------------------------------------------------------------------------------------
Molecular Biosystems, Inc. 3,684 3,684
--------------------------------------------------------------------------------------------
Montrose Investments Ltd. (13) 149,555 149,555
--------------------------------------------------------------------------------------------
MSB Research (33) 244,255 200,000
--------------------------------------------------------------------------------------------
Narragansett I, LP (14) 141,935 141,935
--------------------------------------------------------------------------------------------
Narragansett Offshore, Ltd. (15) 200,634 200,634
--------------------------------------------------------------------------------------------
Steven Oliveira (34) 58,833 50,000
--------------------------------------------------------------------------------------------
Omicron Partners, L.P. (30) 192,315 148,148
--------------------------------------------------------------------------------------------
Perceptive Life Sciences Fund, L.P. (16) 396,396 258,762
--------------------------------------------------------------------------------------------
Perceptive Life Sciences Offshore Fund, LTD. (17) 28,385 28,385
--------------------------------------------------------------------------------------------
Alexander Pomper 30,000 30,000
--------------------------------------------------------------------------------------------
Tis Prager (18) 19,232 14,815
--------------------------------------------------------------------------------------------
ProQuest Companion Fund, L.P. 4,741 4,741
--------------------------------------------------------------------------------------------
ProQuest Investments, L.P. 365,630 365,630
--------------------------------------------------------------------------------------------
Wayne Rothbaum (19) 206,613 190,713
--------------------------------------------------------------------------------------------
Royal Bank of Canada by Agent RBC
Dominion Securities Corporation (20) 437,167 437,167
--------------------------------------------------------------------------------------------
S.A.C. Capital Associates, LLC 740,741 740,741
--------------------------------------------------------------------------------------------
Sands Point Partners, L.P. 100,000 100,000
--------------------------------------------------------------------------------------------
SDS Merchant Fund, LP (21) 74,703 74,703
--------------------------------------------------------------------------------------------
S.G. Cowen Enterprise Fund L.P. (22) 32,304 32,304
--------------------------------------------------------------------------------------------
S.G. Cowen Enterprise Fund N.V. (23) 124,169 124,169
--------------------------------------------------------------------------------------------
S.G. Cowen Opportunity Fund (24) 83,965 70,665
--------------------------------------------------------------------------------------------
Mitchell D. Silber 100,000 100,000
--------------------------------------------------------------------------------------------
The Kaufman Fund (25) 399,111 299,111
--------------------------------------------------------------------------------------------
Ursus Capital L.P. 100,000 100,000
--------------------------------------------------------------------------------------------
Bruce Widmer (26) 8,291 7,407
--------------------------------------------------------------------------------------------
Winchester Global Trust Limited as
Trustee for Caduceus Capital Trust (27) 229,615 219,615
--------------------------------------------------------------------------------------------
Enivia P.T.E., LTD 31,625 31,625
--------------------------------------------------------------------------------------------
Porlana Capital P.T.E., LTD 31,625 31,625
--------------------------------------------------------------------------------------------
Tokenhouse Trading S.P. 42,166 42,166
--------------------------------------------------------------------------------------------
Brad Miles (28) 5,048 5,048
--------------------------------------------------------------------------------------------
Jonathan Fassberg (29) 5,048 5,048
--------------------------------------------------------------------------------------------
TOTAL 6,723,193
</TABLE>
----------------
(1) The number of shares of common stock held by each selling stockholder named
herein is less than 1% of Genta's outstanding common stock as of November
16, 2000.
-13-
<PAGE> 14
(2) Includes 1,720 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(3) Includes 352 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(4) Includes 352 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(5) Includes 18,142 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(6) Includes 2,815 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(7) Includes 704 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(8) Consists of 135,639 shares of common stock that may be acquired upon
exercise of a warrant that is currently exercisable.
(9) Includes 26,500 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(10) Includes 22,083 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(11) Includes 704 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(12) Includes 704 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(13) Includes 1,407 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(14) Includes 750 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(15) Includes 1,079 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(16) Includes 1,283 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(17) Includes 123 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(18) Includes 4,417 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(19) Includes 16,613 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
-14-
<PAGE> 15
(20) Includes 1,056 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(21) Includes 703 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(22) Includes 304 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(23) Includes 1,169 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(24) Includes 665 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(25) Includes 2,815 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(26) Includes 833 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(27) Includes 1,615 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(28) Includes 48 shares of common stock that may be acquired upon exercise of a
warrant that is currently exerciseable.
(29) Includes 48 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(30) Includes 44,167 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(31) Includes 6,625 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(32) Includes 4,417 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
(33) Includes 44,255 shares of common stock that may be acquired upon exercise
of a warrant that is currently exerciseable.
(34) Includes 8,833 shares of common stock that may be acquired upon exercise of
a warrant that is currently exerciseable.
-15-
<PAGE> 16
PLAN OF DISTRIBUTION
We are registering the shares of Genta common stock offered under this
prospectus on behalf of the selling stockholders. As used herein, "selling
stockholders" includes donees and pledgees selling shares received from the
selling stockholders after the date of this prospectus. We will pay all expenses
of registration of the shares offered hereby, other than commissions, discounts
and concessions of underwriters, dealers or agents. Brokerage commissions and
similar selling expenses, if any, attributable to the sale of the shares will be
borne by the selling stockholders. We will not receive any of the proceeds from
the sale of the shares by the selling stockholders.
The shares may be sold from time to time by the selling stockholders, or by
their pledgees, donees, distributees, transferees or other successors in
interest. Sales of the shares may be made in one or more types of transactions
(which may include block transactions) on one or more exchanges, in the
over-the-counter market, in negotiated transactions, through put or call options
transactions relating to the shares, through short sales of the shares, or a
combination of such methods of sale, at market prices prevailing at the time of
sale, or at negotiated prices. These transactions may or may not involve brokers
or dealers.
The selling stockholders may effect these transactions by selling their
shares directly to purchasers or to or through broker-dealers, which may act as
agents or principals. These broker-dealers may receive compensation in the form
of discounts, concessions or commissions from the selling stockholders and/or
the purchasers of shares for whom these broker-dealers may act as agents or to
whom they sell as principal, or both (which compensation as to a particular
broker-dealer might be in excess of customary commissions).
The selling stockholders and any broker-dealers that act in connection with
the sale of the shares might be deemed to be "underwriters" within the meaning
of Section 2(11) of the Securities Act of 1933. Consequently, any commissions
received by these broker-dealers and any profit on the resale of the shares sold
by them while acting as principals might be deemed to be underwriting discounts
or commissions under the Securities Act of 1933. We have agreed to indemnify the
selling stockholders against certain liabilities, including liabilities arising
under the Securities Act of 1933, or to contribute to payments which the selling
stockholders may be required to make in respect thereof. The selling
stockholders may agree to indemnify any agent, dealer or broker-dealer that
participates in transactions involving sales of the shares against certain
liabilities, including liabilities arising under the Securities Act of 1933.
Because the selling stockholders may be deemed to be "underwriters" within
the meaning of Section 2(11) of the Securities Act of 1933, the selling
stockholders will be subject to the prospectus delivery requirements of the
Securities Act of 1933, which may include delivery through the facilities of the
Nasdaq National Market pursuant to Rule 153 under the Securities Act of 1933. We
have informed the selling stockholders that the anti-manipulative provisions of
Regulation M under the Securities Exchange Act of 1934 may apply to their sales
in the market.
The selling stockholders also may resell all or a portion of the shares in
open market transactions in reliance upon Rule 144 under the Securities Act of
1933, provided that they meet the criteria and conform to the requirements of
that rule.
Upon being notified by any selling stockholder that he/she has entered into
any material arrangement with a broker-dealer for the sale of the shares through
a block trade, special offering, exchange distribution or secondary distribution
or a purchase by a broker or dealer, we will file a
-16-
<PAGE> 17
supplement to this prospectus, if required, pursuant to Rule 424(b) under the
Securities Act of 1933, disclosing:
- the name of the selling stockholder and the participating broker-dealers;
- the number of shares involved;
- the price at which the shares were sold;
- the commissions paid or discounts or concessions allowed to these
broker-dealers, where applicable;
- that the broker-dealers did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus; and
- other facts material to the transaction.
We have agreed with the selling stockholders to keep the registration
statement, of which this prospectus is a part, effective for a period ending on
the earlier of (i) the date on which the shares offered under this prospectus
can be sold without registration under Rule 144(k) under the Securities Act of
1933 or any applicable state securities laws, or (ii) the date on which all
shares offered hereby have been sold and the distribution contemplated hereby
has been contemplated, subject to certain exceptions and limitations.
LEGAL MATTERS
The validity of the securities being offered under this prospectus has been
passed upon for Genta by Morgan, Lewis & Bockius LLP, Princeton, New Jersey.
EXPERTS
The consolidated financial statements incorporated in this prospectus by
reference, from the Genta Incorporated Annual Report on Form 10-K for the year
ended December 31, 1999, have been audited by Deloitte & Touche LLP, independent
auditors, as stated in their report which is incorporated herein by reference,
and have been so incorporated in reliance upon the report of such firm given
upon their authority as experts in accounting and auditing.
The financial statements of Genta Jago Technologies B.V. as of and for the
year ended December 31, 1998, incorporated in this prospectus by reference from
the Genta Incorporated Annual Report on Form 10-K for the year ended December
31, 1999, have been audited by Deloitte & Touche Experta Ltd., independent
auditors, as stated in their report (which report expresses an unqualified
opinion and includes an explanatory paragraph relating to matters that raise
substantial doubt about Genta Jago's ability to continue as a going concern)
which is incorporated herein by reference, and have been so incorporated in
reliance upon the report of such firm given upon their authority as experts in
accounting and auditing.
The consolidated financial statements of Genta Incorporated and Genta Jago
Technologies B.V. as of and for the year ended December 31, 1997, appearing in
Genta's Annual Report on Form 10-K for the year ended December 31, 1999, have
been audited by Ernst & Young LLP, independent auditors, as set forth in their
reports thereon included therein and incorporated herein by reference. Such
consolidated financial statements are incorporated herein by reference in
reliance upon such reports given on the authority of such firm as experts in
accounting and auditing.
-17-
<PAGE> 18
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and special reports and other information with
the SEC. You may read and copy any document that we file at the SEC's public
reference rooms in Washington, D.C., New York, New York and Chicago, Illinois.
Please call the SEC at 1-800-SEC-0330 for further information on the public
reference rooms. The SEC filings are also available to the public on the SEC's
Internet web site at http://www.sec.gov.
The SEC allows us to "incorporate by reference" the information we file
with them, which means that we can disclose important information to you by
referring you to those documents. 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 Securities Exchange Act
of 1934 until the offering of securities under this prospectus is terminated.
The following documents are incorporated by reference into this prospectus:
- Annual Report on Form 10-K for the fiscal year ended December 31, 1999;
- Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2000;
- Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2000;
- Quarterly Report on Form 10-Q for the fiscal quarter ended September 30,
2000; and
- The description of Genta's capital stock set forth in the Registration
Statement on Form S-1 filed on November 4, 1991, and all amendment thereto
(Registration No. 33-43642).
You may request a copy of these filings, at no cost, by writing or
telephoning us at the following address:
Genta Incorporated
Two Oak Way
Berkeley Heights, NJ 07922
Attention: Chief Financial Officer
Telephone number: (908) 286-9800
You should rely only on the information incorporated by reference or
provided in this prospectus. We have not authorized anyone else to provide you
with different or additional information. You should not assume that the
information in this prospectus is accurate as of any date other than the date on
the front of those documents.
-18-
