As filed with the Securities and Exchange Commission on August 10, 2000.
Registration No. 333-40634
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------------
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
----------------
GENTA INCORPORATED
(Exact name of registrant as specified in its charter)
Delaware 33-0326866
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
99 Hayden Avenue
Lexington, Massachusetts 02421
(781) 860-5150
(Address, including zip code, and telephone
number, including area code, of registrant's principal
executive offices)
----------------
Raymond P. Warrell, Jr., M.D.
President and Chief Executive Officer
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
-----------------
Copy to:
Monica C. Lord, Esq.
Kramer Levin Naftalis & Frankel LLP
919 Third Avenue
New York, New York 10022
-----------------
Approximate date of commencement of proposed sale to the public: As soon as
practicable after the effective date of this Registration Statement.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [ ]
If any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [x]
<PAGE>
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
----------------------------
The Registrant hereby amends this Registration Statement on such date or dates
as may be necessary to delay its effective date until the Registrant shall file
a further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the SEC, acting pursuant to said Section 8(a), may
determine.
<PAGE>
SUBJECT TO COMPLETION, DATED AUGUST 10, 2000
PROSPECTUS
382,787 SHARES
GENTA INCORPORATED
COMMON STOCK
------------------
The selling stockholders of Genta Incorporated listed on page 11 of
this prospectus are offering and selling a total of 382,787 shares of Genta
common stock under this prospectus. These shares were originally issued to the
selling stockholders pursuant to a license agreement between Genta and Molecular
Biosystems, Inc. and an asset purchase agreement between Genta and Relgen LLC.
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 12 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 August 9, 2000, the closing sale price for Genta common stock,
as reported on the Nasdaq National Market, was $6.625. We advise you to obtain a
current market quotation for Genta common stock.
-------------------------------
Investing in Genta common stock involves risks. See "Risk Factors"
beginning on page 6 of this prospectus.
-------------------------------
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.
-------------------------------
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.
-------------------------------
The date of this prospectus is August __, 2000.
<PAGE>
TABLE OF CONTENTS
Page
----
About Genta Incorporated.....................................................3
Risk Factors.................................................................6
Legal Proceedings...........................................................10
Forward-Looking Statements..................................................10
Use of Proceeds.............................................................10
Selling Stockholders........................................................11
Plan of Distribution........................................................12
Legal Matters...............................................................13
Experts.....................................................................13
Where You Can Find Additional Information...................................14
2
<PAGE>
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 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
3
<PAGE>
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, or "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., 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.
On March 4, 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
4
<PAGE>
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 active 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 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. 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 April 1999, Genta closed its offices in San Diego, California and
moved to Lexington, Massachusetts. Genta's principal offices are now located at
99 Hayden Avenue, Suite 200, Lexington, Massachusetts 02421, and its telephone
number is (781) 860-5150.
Current Developments
On May 11, 2000, Promega Biosciences, Inc. (f/k/a JBL Acquisition
Corp.) notified Genta by letter of two claims against Genta 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 asset
purchase agreement, dated March 19, 1999, among Promega, Genko and Genta.
Promega's letter stated that it intends to reduce to zero the principal amount
of the $1.2 million note it issued as partial payment for the assets of Genko
(which note provides for a payment of $700,000 on June 30, 2000) and that
therefore Genta owes Promega approximately $1.6 million. Genta believes that
Promega's claims are without merit and intends to vigorously pursue its rights
under the asset purchase agreement.
5
<PAGE>
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 December 31, 2000. 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:
o delay, scale back or eliminate some or all of our research and
product development programs;
o license third parties to commercialize products or
technologies that we would otherwise seek to develop
ourselves;
o sell Genta to a third party;
o to cease operations; or
o 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 United States Food and Drug Administration 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-
6
<PAGE>
consuming procedures. Satisfaction of these 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:
o inability to obtain sufficient quantities of materials used
for clinical trials;
o inability to adequately monitor patient progress after
treatment;
o unforeseen safety issues;
o the failure of the products to perform well during clinical
trials; and
o 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.
7
<PAGE>
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. Furthermore, we currently rely on
a potential competitor, which is itself a development stage biotechnology
company, to supply us with chemical compounds necessary to the development of
our drugs. 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.
8
<PAGE>
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 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 a $13.4 million liquidation
preference. Furthermore, holders of shares of Genta series A preferred stock are
contractually entitled to receive cumulative dividends before any dividend
payment may be made on the common stock.
9
<PAGE>
LEGAL PROCEEDINGS
In 1995, Genta Pharmaceuticals Europe S.A., or "Genta Europe," our
wholly owned subsidiary, received a 5.4 million French Franc (or, as of June 30,
2000, approximately $783,200) of funding in the form of a loan from the French
government research agency L'Agence Nationale de Valorisation de la Recherche,
or "ANVAR." In October 1996 Genta Europe terminated all scientific personnel.
ANVAR asserted, in a letter dated February 13, 1998, that, as a result of the
termination of Genta Europe's scientific personnel, Genta Europe was not in
compliance with its agreement with ANVAR, and that ANVAR might request that we
immediately repay the loan. On July 1, 1998, ANVAR notified Genta Europe that it
remained liable for FF4,187,423 (as of June 30, 2000, approximately $607,300)
and is required to pay this amount immediately. We do not believe that ANVAR is
entitled to immediate repayment. We are working with ANVAR to resolve this
dispute; however, we can not assure you we will be able to do so.
On June 30, 1998, Marseille Amenagement, a company affiliated with the
city of Marseilles, France, filed suit against Genta Europe in France to evict
Genta Europe from its facilities in Marseilles demanding payment of alleged back
rent due and seeking to enforce a lease guarantee for nine years' rent. This
prompted Genta Europe to declare a "Cessation of Payment." Under this procedure,
Genta Europe ceased its operations and terminated its only employee. A
liquidator was appointed by the Court to take control of the assets of Genta
Europe and to make payment to creditors. In December 1998, the 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 Genta at the Commercial Court in France,
seeking alleged unpaid rent payment in the amount of FF663,413 (as of June 30,
2000, approximately $96,200) and early termination payment of FF1,852,429 (as of
June 30, 2000, approximately $268,700). A court hearing has been scheduled for
September 4, 2000. We are working with our counsel in France to settle this
dispute but may be unsuccessful.
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.
SELLING STOCKHOLDERS
The selling stockholders are offering and selling a total of 382,787
shares of Genta common stock under this prospectus. The shares being offered
under this prospectus were originally issued to the selling
10
<PAGE>
stockholders pursuant to a license agreement between Genta and Molecular
Biosystems, Inc. and an asset purchase agreement between Genta and Relgen LLC.
Under the license agreement, Molecular Biosystems, Inc. is required to return a
portion of the shares registered hereunder to Genta based upon the closing price
of Genta common stock on the business day preceding the effective date of the
Registration Statement of which this prospectus is a part. In connection with
these transactions, we agreed to register these shares under the Securities Act
of 1933.
The following table sets forth, to the best of our knowledge, based on
information provided to us by the selling stockholders:
o the number of shares of Genta common stock owned by each
selling stockholder; and
o 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.
Number of Shares Number of
of Common Stock Shares of
Beneficially Owned Common Stock
Selling Stockholder Before Offering Being Offered
------------------- --------------- -------------
Molecular Biosystems, Inc. 372,787* 372,787
-------------------------------------------------------------------------------
Raymond P. Warrell, Jr. 4,781,262** 10,000
-------------------------------------------------------------------------------
Total 382,787
-------------
* Less than 1% of Genta's outstanding common stock.
** Represents approximately 9.9% of Genta's outstanding common stock.
Includes 4,763,262 shares of Genta common stock issuable upon exercise of
immediately exercisable options, of which 3,373,981 shares are subject to
transfer restrictions. Raymond P. Warrell, Jr., M.D., Chairman and a
member of of Relgen LLC, has been President, Chief Executive Officer and a
director of Genta since December 1, 1999.
11
<PAGE>
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 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 supplement to this
prospectus, if required, pursuant to Rule 424(b) under the Securities Act of
1933, disclosing:
12
<PAGE>
o the name of the selling stockholder and the participating
broker-dealers;
o the number of shares involved;
o the price at which the shares were sold;
o the commissions paid or discounts or concessions allowed to
these broker-dealers, where applicable;
o that the broker-dealers did not conduct any investigation to
verify the information set out or incorporated by reference in
this prospectus; and
o 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 Kramer Levin Naftalis & Frankel LLP, New York, New
York.
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.
13
<PAGE>
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:
o Annual Report on Form 10-K for the fiscal year ended December
31, 1999 (File No. 0-19635);
o Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2000 (File No. 0-19635); and
o 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
99 Hayden Avenue
Lexington, Massachusetts 02421
Attention: Chief Financial Officer
Telephone number: (781) 860-5150
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.
14
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses, previously paid
or payable by the Registrant in connection with the sale of common stock being
registered under this registration statement. All amounts are estimates except
the SEC registration fee.
AMOUNT TO BE
PAID
----
SEC registration fee................................................ $746
Printing expenses .................................................. 500
Legal fees and expenses............................................. 5,000
Accounting fees and expenses........................................ 5,000
Miscellaneous expenses.............................................. 500
-------
Total.............................................................. $11,746
=======
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Reference is made to Section 102(b)(7) of the Delaware General
Corporation Law (the "DGCL"), which permits a corporation in its certificate of
incorporation or an amendment thereto to eliminate or limit the personal
liability of a director for violations of the director's fiduciary duty, except
(i) for any breach of the director's fiduciary duty of loyalty to the
corporation or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law, (iii)
pursuant to Section 174 of the DGCL (providing for liability of directors for
unlawful payment of dividends or unlawful stock purchases or redemptions), or
(iv) for any transaction from which the director derived an improper personal
benefit. Genta's Restated Certificate of Incorporation, as amended, contains
provisions permitted by Section 102(b)(7) of the DGCL.
Reference is made to Section 145 of the DGCL which provides that a
corporation may indemnify any persons, including directors and officers, who
are, or are threatened to be made, parties to any threatened, pending or
completed legal action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of such
corporation), by reason of the fact that such person is or was a director,
officer, employee or agent of such corporation, or is or was serving at the
request of such corporation as a director, officer, employee or agent of another
corporation or enterprise. The indemnity may include expenses (including
attorney's fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred by such person in connection with such action, suit or
proceeding, provided such director, officer, employee or agent acted in good
faith and in a manner he reasonably believed to be in or not opposed to the
corporation's best interests and, with respect to any criminal actions or
proceedings, had no reasonable cause to believe that his conduct was unlawful. A
Delaware corporation may indemnify directors and/or officers in an action or
suit by or in the right of the corporation under the same conditions, except
that no indemnification is permitted without judicial approval if the director
or officer is adjudged to be liable to the corporation. Where a director or
officer is successful on the merits or otherwise in the defense of any action
referred to above, the corporation must indemnify him or her against the
expenses which such director or officer actually and reasonably incurred.
The Registrant's Restated Certificate of Incorporation, as amended,
provides indemnification of directors and officers of the Registrant to the
fullest extent permitted by the DGCL. Pursuant to the
II-1
<PAGE>
registration rights agreement entered into with the Registrant, the selling
stockholders have agreed to indemnify directors and officers of the Registrant
against certain liabilities, including liabilities under the Securities Act.
The Registrant maintains liability insurance for each director and
officer for certain losses arising from claims or charges made against them
while acting in their capacities as directors or officers of the Registrant.
ITEM 16. EXHIBITS
Exhibit No. Description
----------- -----------
4.1 Form of specimen stock certificate for the Registrant's common
stock (incorporated herein by reference to Exhibit 1 filed as
part of the Registrant's Registration Statement under the
Securities Exchange Act of 1934 on Form 8-A filed with the SEC
on November 7, 1991).
5.1* Opinion of Kramer Levin Naftalis & Frankel LLP.
23.1** Consent of Deloitte & Touche LLP.
23.2** Consent of Deloitte & Touche Experta Ltd.
23.3** Consent of Ernst & Young LLP.
23.4* Consent of Kramer Levin Naftalis & Frankel LLP (contained in
the opinion filed as Exhibit 5.1 hereto).
24.1** Power of Attorney.
------------------
* Filed herewith.
** Previously filed.
ITEM 17. UNDERTAKINGS
Insofar as indemnification for liabilities arising under the Securities
Act 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 SEC 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.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration
Statement:
II-2
<PAGE>
i. To include any prospectus required by Section
10(a)(3) of the Securities Act;
ii. To reflect in the prospectus any facts or events
arising after the effective date of the Registration
Statement (or the most recent post-effective
amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the
information set forth in the Registration Statement;
iii. To include any material information with respect to
the plan of distribution not previously disclosed in
the Registration Statement or any material change to
such information in the Registration Statement;
provided, however, that clauses (i) and (ii) do not apply if
the Registration Statement is on Form S-3, Form S-8 or Form
F-3, and the information required to be included in a
post-effective amendment by such clauses is contained in
periodic reports filed with or furnished to the Commission by
the Registrant pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 that are incorporated by
reference in the Registration Statement;
(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.
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 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the 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.
II-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, Genta Incorporated certifies that it has reasonable grounds to believe
that it meets all of the requirements for filing on Form S-3 and has duly caused
this Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, on August 10, 2000.
GENTA INCORPORATED
By: /s/ RAYMOND P. WARRELL, JR.
--------------------------------------------
Name: Raymond P. Warrell, Jr., M.D.
Title: President and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
* Chairman of the Board
---------------------------- of Directors
Mark C. Rogers, M.D.
/s/ RAYMOND P. WARRELL, JR. President and Chief August 10, 2000
---------------------------- Executive Officer
Raymond P. Warrell, Jr., M.D. (Principal Executive
Officer)
/s/ GERALD M. SCHIMMOELLER Vice President and August 10, 2000
--------------------------- Chief Financial Officer
Gerald M. Schimmoeller (Principal Financial and
Accounting Officer)
* Director
---------------------------
Donald G. Drapkin
* Director
---------------------------
Kenneth G. Kasses, Ph.D.
* Director
---------------------------
Ralph Snyderman, M.D.
* Director
---------------------------
Daniel D. Von Hoff, M.D.
* Director
---------------------------
Harlan J. Wakoff
<PAGE>
* Director
---------------------------
Michael S. Weiss
*By: /s/ RAYMOND P. WARRELL, JR.
---------------------------
Raymond P. Warrell, Jr., M.D.
Attorney-in-Fact
<PAGE>
EXHIBIT INDEX
Exhibit No. Description
----------- -----------
4.1 Form of specimen stock certificate for the Registrant's common
stock (incorporated herein by reference to Exhibit 1 filed as
part of the Registrant's Registration Statement under the
Securities Exchange Act of 1934 on Form 8-A filed with the SEC
on November 7, 1991).
5.1* Opinion of Kramer Levin Naftalis & Frankel LLP.
23.1** Consent of Deloitte & Touche LLP.
23.2** Consent of Deloitte & Touche Experta Ltd.
23.3** Consent of Ernst & Young LLP.
23.4* Consent of Kramer Levin Naftalis & Frankel LLP (contained in
the opinion filed as Exhibit 5.1 hereto).
24.1** Power of Attorney.
-----------------
* Filed herewith.
** Previously filed.
