As filed with the Securities and Exchange Commission on January 5, 2000.
Registration No. 333-35215
===============================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------------
AMENDMENT NO. 3 TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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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)
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Copy to:
Monica C. Lord, Esq.
Kramer Levin Naftalis & Frankel LLP
919 Third Avenue
New York, New York 10022
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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]
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. [ ]
<PAGE>
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. [ ]
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
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Proposed Proposed
Amount Maximum Maximum Amount of
Title of Shares to be Offering Price Aggregate Registration
to be Registered Registered Per Share(1) Offering Price(1) Fee(2)
- --------------------------------------------------------------------------------------------------------------------------
<S> <C>
Common Stock, par value $.001 per share 5,238,058 $6.282 $32,905,480 $8,688
- --------------------------------------------------------------------------------------------------------------------------
</TABLE>
(1) Estimated solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457(c) of the Securities Act of
1933, based on the average of the high and low prices of the
Registrant's Common Stock as reported on the Nasdaq SmallCap Market on
January 3, 2000, which is within five business days prior to the date
of this Registration Statement.
(2) $32,278 was paid in connection with the filing of the original
Registration Statement on September 9, 1997.
----------------------------
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 JANUARY 5, 2000
PROSPECTUS
5,238,058 SHARES
GENTA INCORPORATED
COMMON STOCK
------------------
The selling stockholders of Genta Incorporated listed on page 15 of
this prospectus are offering and selling a total of 5,283,058 shares of Genta
common stock under this prospectus. These shares were originally issued to the
selling stockholders in connection with Genta's recently completed private
placement. 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 17 for a
description of sales of the shares by the selling stockholders.
Genta common stock is listed on the Nasdaq SmallCap Market under the
symbol "GNTA." On January 4, 2000, the closing sales price for Genta common
stock, as reported on the Nasdaq SmallCap Market, was $5.875. 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 ___________, 2000.
<PAGE>
TABLE OF CONTENTS
Page
----
About Genta Incorporated......................................................3
Risk Factors..................................................................6
Legal Proceedings............................................................14
Forward-Looking Statements...................................................14
Use of Proceeds..............................................................14
Selling Stockholders.........................................................15
Plan of Distribution.........................................................16
Legal Matters................................................................17
Experts......................................................................17
Where You Can Find Additional Information....................................17
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<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 18 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. Genta and its collaborators have invented a
drug, called G3139, that 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.
G3139 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. G3139 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 G3139 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 1997, a second trial using G3139 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 G3139 given in combination with
standard drugs used in the treatment of different cancers such as lymphoma,
prostate, melanoma, and breast.
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 G3139. Under the agreement,
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<PAGE>
Genta will provide the NCI with G3139. In December 1999, the NCI commenced a
study using G3139 for treatment of relapsed acute leukemia and colorectal
cancer.
Based on the available results from the on-going clinical trials, Genta
is now planning to move the development of G3139 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. Genta is now planning to
begin new studies in small cell lung cancer, colorectal cancer, leukemia, and
possibly other diseases. In October 1999, Genta received confirmation from the
FDA granting "Fast Track" designation to G3139 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.
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 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 1999, Genta closed its offices in San Diego, California and
moved to Lexington, Massachusetts. Genta's principal offices are located at 99
Hayden Avenue, Suite 200, Lexington, Massachusetts 02421, and its telephone
number is (781) 860-5150.
Recent Development
On December 23, 1999, we sold to the selling stockholders (other than
Paramount Capital, Inc.) listed in this prospectus 3,809,502 shares of Genta
common stock and warrants to purchase 952,376
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<PAGE>
shares of Genta common stock, at an initial exercise price of $ 4.83. We raised
approximately $ 10.4 million (net of expenses) in the private placement.
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<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.
We have a history of operating losses and anticipate future losses.
We have never earned a profit and have incurred substantial net
operating losses. From our inception to September 30, 1999, we have incurred a
cumulative net loss of approximately $134.9 million. These losses were caused by
lack of revenues from drug sales to offset costs related to research and
development, preclinical testing, administration, clinical trials, and
development activities undertaken by Genta Jago. We expect to incur additional
operating losses for at least the next several years, as we plan to spend
substantial amounts on research and development, including preclinical studies
and clinical trials, and, if we obtain necessary regulatory approvals, on sales
and marketing efforts. We cannot guarantee that we will successfully develop,
receive regulatory approval for, manufacture, market or sell any additional
products, or achieve or sustain future profitability.
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 cash, together with
the proceeds from our recent private offering, will be adequate to satisfy our
capital needs through the end of 2000. We will need to raise substantial
additional funds to continue our operations and conduct the costly and
time-consuming research, preclinical development and clinical trials necessary
to bring our products to market and to establish production and marketing
capabilities. Our future capital requirements will depend on results of research
and development, results of preclinical studies and bioequivalence and clinical
trials, changes in the focus and direction of our research and development
programs, competitive and technological advances, the FDA and foreign regulatory
processes, and other factors.
If we are unable to raise additional funds, 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.
We intend to seek additional funding through public and private
financings, including equity financings, and through collaborative research and
development or other arrangements. If additional funds are raised by issuing
equity securities, the ownership interest of existing Genta stockholders will be
subject to further dilution and share prices may decline. We cannot guarantee
that additional financing will be available or, if available, will be on
acceptable terms.
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.
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<PAGE>
Holders of common stock will not receive any proceeds until holders of
the 278,300 outstanding shares of Genta's series A preferred stock are paid a
$13.9 million dollar liquidation preference and holders of the 121,717
outstanding of Genta's series D preferred stock are paid a $17.0 million dollar
liquidation preference. We are also obligated to issue an additional 38,104
shares of series D preferred stock, with a liquidation preference of $5,334,560,
upon the exercise of certain warrants. Furthermore, we have never paid cash
dividends on our common stock and do not anticipate paying any dividends in the
foreseeable future. We currently intend to retain any earnings that would
otherwise be available to pay common stock dividends and use those earnings for
the development of our business. Even if we declare a dividend, we are
contractually obligated to pay cumulative dividends on the series A and D
preferred stock before we may make a dividend payment on the common stock.
We are at an early state of development, and we may not achieve profitability in
the near future.
All of our potential therapeutic products are in research and
development, and we have not generated any revenues from the commercial sale of
our drugs. To date, 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, G3139, has begun to be
tested in humans. We cannot guarantee that the novel approach of oligonucleotide
technology will result in products that will receive necessary regulatory
approvals or that will be successful commercially. Further, 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 in research or development may prove to have undesirable and
unintended side effects or other characteristics that may prevent or limit their
commercial use. There can be no assurance that any of our products will obtain
FDA or foreign regulatory approval for any indication or that an approved
compound would be capable of being produced in commercial quantities at
reasonable costs and successfully marketed. If we determine that a drug cannot
be successfully developed, we would not be able to generate revenues from the
sale of that drug.
The success of our business will depend on our obtaining regulatory approval for
our products.
The U.S. 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-consuming procedures.
Satisfaction of these requirements, which includes demonstrating to the
satisfaction of the FDA and foreign regulatory agencies that the product is both
safe and effective, typically takes several years or more depending upon the
type, complexity and novelty of the product. While limited trials of our
products have to date produced favorable results, significant additional trials
will be required, and we may not be able to demonstrate that our drug candidates
are safe or effective. We cannot guarantee that we will be able to obtain
necessary regulatory approvals on a timely basis, if at all, for any of our
products under development.
Clinical trials are costly, time consuming, subject to delays in patient
enrollment and yield uncertain results.
Clinical trials are very costly and time-consuming. 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.
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<PAGE>
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.
We may be unable 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 protection for drug candidates and processes, (2)
preserve trade secrets and (3) operate without infringing the patents 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. As a result, our ability to
obtain and enforce patents that protect our drugs is uncertain and involves
complex legal and factual questions.
The fact that we own or license pending or future patent applications
does not mean that patents based on those applications will ultimately be
issued. To obtain a patent on an invention, one must be the first to invent it
or the first to file a patent application for it. We cannot be completely sure
that the inventors of subject matter covered by patents and patent applications
that we own or license were the first to invent, or the first to file patent
applications for, those inventions. Furthermore existing or future patents may
be challenged, infringed upon, invalidated, found to be unenforceable, or
circumvented by others. Our rights under any issued patents may not provide
sufficient protection against competing drugs or otherwise cover commercially
valuable drugs or processes.
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. It may be that entry into a licensing arrangement would allow us to
avoid any such proceedings. There can be no assurance, however, that we would be
able to enter into any such licensing arrangement on terms acceptable to us, or
at all.
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.
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<PAGE>
We rely on our relationships with research institutions and corporate partners.
Our success will depend in part on our continued ability to develop and
maintain relationships with independent researchers and leading academic and
research institutions. The competition for such relationships is intense, and we
can give no assurances that we will be able to develop and maintain such
relationships on acceptable terms. 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 or expertise. The loss of any of these
collaborative relationships could have a material adverse effect on our research
and development program.
Similarly, strategic alliances with corporate partners, primarily
pharmaceutical and biotechnology companies, may help us develop and
commercialize drugs. Various problems can arise in strategic alliances. A
partner responsible for conducting clinical trials and obtaining regulatory
approval may fail to develop a marketable drug. A partner may decide to pursue
an alternative strategy or alternative partners. A partner that has been granted
marketing rights for a certain drug within a geographic area may fail to market
the drug successfully. Consequently, strategic alliances that we may enter into
in the future may not be scientifically or commercially successful. We may be
unable to negotiate advantageous strategic alliances in the future. The absence
of, or failure of, strategic alliances could harm our efforts to develop and
commercialize our drugs.
Our business will suffer if we fail to compete effectively with our competitors
and to keep up with new technologies.
Our competitors are engaged in all areas of drug discovery in the
United States and other countries, are numerous, and include major
pharmaceutical and chemical companies, specialized biopharmaceutical firms,
universities and other research institutions. Our competitors may succeed in
developing other new therapeutic drug candidates that are more effective and
less costly than those that we propose to develop. These competitive
developments could make our products obsolete or non-competitive. Many of our
competitors have substantially greater financial, technical and human resources
than we do. In addition, many of these competitors have greater experience than
we do in preclinical studies, clinical trials, seeking regulatory approval of
new drugs, and manufacturing and marketing new drugs.
Furthermore, biotechnology and related pharmaceutical technologies have
undergone and continue to be subject to rapid and significant change. We expect
that the technologies associated with biotechnology research and development
will continue to develop rapidly. Our future will depend in large part on our
ability to compete with these technologies. Any compounds, drugs or processes
that we develop may become obsolete before we recover the expenses incurred in
developing them.
Our development capability may be adversely affected by problems with suppliers.
Certain of the raw materials that we require to manufacture our drugs
are available from only a few suppliers, namely those with access to the
necessary patented technology. The number of suppliers is unlikely to increase
in the near future. 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. We can give no assurance as to the
continuing business viability of this potential competitor. We may not be able
to secure an adequate supply of these materials at an acceptable price. Also,
due to regulatory restrictions or other problems, our suppliers may fail to
provide us with drugs of acceptable quality. Such supplier problems would have
an adverse effect on our ability to develop our drugs cost-effectively.
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<PAGE>
We could be subject to product liability claims for which we are not fully
insured.
We risk being the target of product liability claims alleging that our
drugs harm subjects or patients. Such claims could be asserted in connection
with any of our drugs used in clinical trials as well as those to be sold
commercially. We are covered against such claims by a product liability
insurance policy (subject to various deductibles), but such policies are
becoming increasingly expensive, and we may not be able to maintain sufficient
coverage to protect us from incurring significant losses due to product
liability claims.
We have used hazardous material and could be held liable for damages for past or
accidental contamination or injury.
In October of 1996, JBL hired a chemical consulting firm to investigate
an incident of soil and groundwater contamination at JBL's facility. Sampling of
soil and groundwater revealed the presence of contaminants. The California
Regional Water Quality Control Board is monitoring the situation. Results of
recent testing have indicated a reduction in contaminant levels. We recorded a
reserve of $65,000 in 1999 to pay for any potential liability. We have agreed to
indemnify Promega Corporation, the purchaser of JBL's assets, for any liability
that may result from this alleged contamination. We believe that any costs that
result from further investigation or remediation will not have a material
adverse affect on our operation, but we can give no assurance to that end.
On October 16, 1998, the Environmental Protection Agency identified JBL
as a de minimis potentially responsible party at a California waste disposal
facility showing evidence of environmental contamination. The EPA currently
estimates that Genta will be required to pay approximately $63,200 to settle its
potential liability. We have agreed to indemnify Promega Corporation for any
costs resulting from this contamination, and have reserved $75,000 to pay for
any potential liability arising from this incident. We are expecting to finalize
the terms of settlement by early next year. We believe that any costs that
result from further investigation or remediation will not have a material
adverse affect on our operation, but we can give no assurance to that end.
Restrictions on third-party reimbursement could adversely affect our ability to
commercialize our products.
Our ability to commercialize 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 trend toward managed health-care and government
insurance programs could result in lower prices and reduced demand for our
drugs. Cost containment measures instituted by health-care providers and any
general health-care reform could affect our ability to sell drugs and may have a
material adverse effect on our operations. In addition, we cannot predict what
additional legislation or regulation relating to the health care industry or
third-party coverage and reimbursement may be enacted in the future, or what
effect such legislation or regulation might have on our business. In particular,
we may be forced to reduce our prices; this would in turn adversely affect
profitability.
The "Penny Stock" rules could have an adverse effect on the liquidity of our
securities and our ability to raise additional capital.
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The "penny stock" provisions of the SEC rules impose restrictive sales
practice requirements on broker-dealers that sell penny stock. Prior to any
transaction covered by this rule, the broker-dealer must receive from the
purchaser a written consent to the transaction, and must reasonably determine
that transactions in penny stocks are suitable for the purchaser, and that the
purchaser is capable of evaluating the risks of transactions in penny stocks.
The broker dealer must also give to purchasers, orally or in writing, bid and
offer quotations and information regarding brokers and salesperson compensation.
The SEC defines penny stock as any stock that has a market price of
less than $5.00 per share. However, while the penny stock rules apply to our
securities we are not subject to the penny stock restrictions because we satisfy
the following two conditions: (1) we are listed on the Nasdaq SmallCap Market;
and (2) we have net tangible assets in excess of $2,000,000 and have been in
continuous operation for more than two years.
There can be no assurances that our securities will continue to qualify
under these exemptions for the penny stock restrictions. If our securities were
subjected to the penny stock rules, it would be more difficult for you and
others to sell our securities. A lack of liquidity could reduce the value of our
securities.
Our stock price may continue to be highly volatile.
The market price of our securities is likely to be influenced by the
results of preclinical studies and clinical trials by Genta or our competitors,
fluctuations in our operating results, announcements by Genta or its competitors
of technological innovations or new commercial therapeutic products, changes in
governmental regulation, developments in patent or other proprietary rights of
Genta or our competitors, public concern as to the safety of drugs we develop,
and general market conditions. Furthermore, the market price of the securities
of biotechnology companies in general is highly volatile. The market price of
our common stock could be driven down by general market conditions unrelated to
the results of our operations.
In the past, we have issued securities that are convertible into common
stock. The majority of these convertible securities are held by some of our
affiliates. If the market perceives the likelihood of a pending conversion of
these securities, our stock price could be driven down. In addition, sales of
our common stock under this offering in the public market could lower the market
price of our common stock.
Our ability to utilize net operating losses and tax credits is likely to be
severely restricted.
At December 31, 1998, we had federal net operating loss carryforwards
of approximately $82.0 million and California net operating loss carryforwards
of approximately $14.7 million. The federal tax loss carryforwards will begin
expiring in 2003, unless we can use them. Approximately $2.8 million of the
California tax loss carryforward expired during 1997 and approximately $0.5
million expired during 1998, and the related deferred tax asset and tax loss
carryforward amounts have been reduced accordingly. The remaining California tax
loss will continue to expire in 1999, unless we can use them. The Company also
has federal research and development tax credit carryforwards of $3.2 million
and California research and development tax credit carryforwards of $1.3
million, which will begin expiring in 2003, unless we can use them.
Federal and California tax laws limit the utilization of income tax net
operating loss and credit carryforwards that arise prior to certain cumulative
changes in a corporation's ownership resulting in
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change of control of a corporation. The future annual use of net operating loss
carryforwards and research and development tax credits will be limited due to
the ownership changes that occurred during 1990, 1991, 1993, 1996, 1997 and
1998.
We may be adversely affected by year 2000 compliance related problems.
As has been widely publicized, many computer systems and
microprocessors are not programmed to accommodate dates beyond the year 1999.
Our exposure to this Y2K problem comes not only from our own internal computer
systems and microprocessors, but also from the systems and microprocessors of
its key suppliers, including utility companies and payroll services. While we
currently believe that all of our internal systems are Y2K compliant as of the
end of the third quarter of 1999, and are taking appropriate measures to ensure
that its suppliers are Y2K compliant, it is nevertheless possible that Y2K
problems will have a material effect on our business.
There currently exist certain interlocking relationships and potential conflicts
of interest.
Certain of our affiliates, Aries Domestic Fund, L.P., Aries Domestic
Fund II, L.P., and Aries Trust (together the "Aries Funds") have the contractual
right to appoint a majority of the members of our Board of Directors. Paramount
Capital Asset Management, Inc. is the investment manager of the Aries Funds. The
Aries Funds have the right to convert and exercise their securities into a
significant portion of the outstanding common stock. Dr. Lindsay A. Rosenwald,
the Chairman and sole stockholder of Paramount Capital Asset Management, is also
the Chairman of Paramount Capital, Inc. and of Paramount Capital Investments,
LLC, a New York-based merchant banking and venture capital firm specializing in
biotechnology companies. In the regular course of its business, Paramount
Capital Inc. identifies, evaluates and pursues investment opportunities in
biomedical and pharmaceutical products, technologies and companies. Generally,
the law requires that any transactions between Genta and any of our affiliates
be on terms that, when taken as a whole, are substantially as favorable to us as
those then reasonably obtainable from a person who is not an affiliate in an
arms-length transaction. Nevertheless, our affiliates, including Paramount
Capital Asset Management and Paramount Capital Inc., are not obligated pursuant
to any agreement or understanding with the Company to make any additional
products or technologies available to the Company, nor can there be any
assurance, and we do not expect and you should not expect, that any biomedical
or pharmaceutical product or technology developed by any affiliate in the future
will be made available to us. In addition, some of our officers and directors
may from time to time serve as officers or directors of other biopharmaceutical
or biotechnology companies. We cannot assure you that these other companies will
not have interests in conflict with ours.
Concentration of stock ownership may delay or prevent a change of control.
Our directors, executive officers and principal stockholders and their
affiliates own a significant percentage of our outstanding common stock and
preferred stock. They also own, through the exercise of options and warrants,
the right to acquire even more common stock and preferred stock. As a result,
these stockholders, if acting together, have the ability to influence the
outcome of corporate actions requiring stockholder approval. This concentration
of ownership may have the effect of delaying or preventing a change in control
of Genta.
Provisions in our certificate of incorporation and Delaware law may prevent our
stockholders from receiving a premium for their shares.
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Our certificate of incorporation and by-laws include provisions that
could discourage takeover attempts and impede stockholders ability to change
management. The approval of 66-2/3% of our voting stock is required to approve
certain transactions and to take certain stockholder actions, including the
amendment of the by-laws and the amendment, if any, of the anti-takeover
provisions contained in our certificate of incorporation.
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<PAGE>
LEGAL PROCEEDINGS
In 1995, Genta Pharmaceuticals Europe S.A., or "Genta Europe," our
wholly owned subsidiary, received a 5.4 million French Franc 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 November 22, 1999,
approximately $657,600) 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 the Company at the Commercial Court in
France, seeking alleged unpaid rent payment in the amount of FF663,412.64 (as of
November 22, 1999, approximately $104,200) and early termination payment of
FF1,852,429 (as of November 22, 1999, approximately $290,900). On December 7,
1999, the Commercial Court postponed the proceedings until January 10, 2000,
where a new hearing date is to be set. 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 identity
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. The shares of common stock underlying the warrants
issued in the recently completed private placement are subject to an initial
exercise price of $4.83 per share. Assuming the exercise of all warrants, we
would receive approximately $5.06 million dollars, which would be used to fund
our research and development as well as our general operating expenses.
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<PAGE>
SELLING STOCKHOLDERS
The selling stockholders are offering and selling a total of 5,238,058
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 placement. In connection with
the private placement, we agreed to register these shares under the Securities
Act of 1933. The shares being registered for resale include:
o 3,809,502 shares of common stock;
o 952,376 shares issuable upon exercise of warrants (at an initial
exercise price of $ 4.83 per share of common stock);
o 380,946 shares issuable upon exercise of placement warrants that
were issued to Paramount Capital, as placement agent, in
connection with the private placement;
o 95,234 shares issuable upon exercise of warrants underlying the
placement warrants; and
o an indeterminate number of additional shares as may from time to
time become issuable upon a decrease in the exercise price of the
warrants issued in the private placement which may occur under
certain circumstances and by reason of stock splits, stock
dividends and other similar transactions.
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 as of _________ __, 2000;
o the number of shares being offered by each selling stockholder
under this prospectus; and
o the number of shares of Genta common stock which will be owned by
each selling stockholder after the completion of the offering.
All information with respect to share ownership has been provided by
the selling stockholders. The information regarding percentage of beneficial
ownership is determined in accordance with rules promulgated by the SEC. These
rules require us to include in a selling stockholder's percentage of beneficial
ownership any shares a selling stockholder has a right to acquire, through the
exercise of a derivative security or otherwise, within 60 days of _________ __,
2000. The shares offered under this prospectus may be offered from time to time,
in whole or in part, by the selling stockholders or their transferees. 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.
<TABLE>
<CAPTION>
Number of Shares Number of Common Stock
of Common Stock Shares of Beneficially Owned
Beneficially Owned Common Stock After Offering
Selling Stockholder Before Offering Being Offered Number Percent
------------------- --------------- ------------- ------ -------
<S> <C> <C> <C> <C> <C>
</TABLE>
NOTES:
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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 SmallCap 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:
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<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 of Genta as of and for the year
ended December 31, 1998 incorporated in this prospectus by reference from
Genta's Annual Report on Form 10-K for the year ended December 31, 1998 have
been audited by Deloitte & Touche LLP, 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'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 Jago Technologies B.V.
as of and for the year ended December 31, 1998 incorporated in this prospectus
by reference from Genta's Annual Report on Form 10-K for the year ended December
31, 1998, 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 years ended December 31, 1996 and
December 31, 1997 appearing in Genta's Annual Report on Form 10-K for the year
ended December 31, 1998 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.
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
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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, as amended, for the fiscal year ended
December 31, 1998;
o Quarterly Reports on Form 10-Q, for the quarterly periods ended
March 31, 1999, June 30, 1999 and September 30, 1999;
o Current Reports on Form 8-K and 8-K/A filed on January 6, 1999,
February 12, 1999, April 21, 1999, April 28, 1999, April 29, 1999,
May 3, 1999, May 11, 1999, May 18, 1999, May 21, 1999, July 20,
1999, August 11, 1999 and November 12, 1999; 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.
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<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................................................ $32,278
Printing expenses .................................................. 5,000
Legal fees and expenses............................................. 25,000
Accounting fees and expenses........................................ 15,000
Miscellaneous expenses.............................................. 5,000
--------
Total .................................................. $82,278
========
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. The Registrant'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.
II-1
<PAGE>
Pursuant to the 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 (contained on the signature page of this
Registration Statement).
- ------------------
* Filed herewith.
** To be filed by amendment.
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.
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<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 December 29, 1999.
GENTA INCORPORATED
By: /s/ Raymond P. Warrell
------------------------------------
Name: Raymond P. Warrell, Jr., M.D.
Title: President and Chief Executive
Officer
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints each of Mark C. Rogers and Raymond P.
Warrell, Jr., and each of them, his true and lawful attorney-in-fact and agent,
with full power of substitution and resubstitution, for him and in his name,
place and stead, in any and all capacities, to sign any or all amendments to
this Registration Statement, and to file the same, with all exhibits thereto,
and other documents in connection therewith, with the SEC, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to do
and perform each and every act and thing requisite and necessary to be done in
and about the premises, as fully for all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or any of them or his substitute or substitutes,
may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
- --------- ----- ----
/s/ Mark C. Rogers
- -------------------- Chairman of the Board December 29, 1999
Mark C. Rogers, M.D. of Directors
/s/ Raymond P. Warrell President and Chief December 29, 1999
- ---------------------- Executive Officer
Raymond P. Warrell, Jr., M.D (Principal Executive
Officer)
/s/ Gerald M. Schimmoeller
- -------------------------- Vice President and Chief December 29, 1999
Gerald M. Schimmoeller Financial Officer
(Principal Financial
and Accounting Officer)
/s/ Glenn L. Cooper
- --------------------- Director December 29, 1999
Glenn L. Cooper, M.D.
/s/ Donald G. Drapkin
- --------------------- Director January 3, 2000
Donald G. Drapkin
<PAGE>
/s/ Kenneth G. Kasses
_________________________ Director December 23, 1999
Kenneth G. Kasses, Ph.D.
_________________________ Director
Robert E. Klem, Ph.D.
/s/ Lawrence J. Kessel
_________________________ Director December 23, 1999
Lawrence J. Kessel, M.D.
/s/ Peter Salomon
_________________________ Director December 22, 1999
Peter Salomon, M.D.
/s/ Bobby W. Sandage
_________________________ Director December 22, 1999
Bobby W. Sandage, Jr., Ph.D.
Harlan J. Wakoff
__________________________ Director January 3, 2000
Harlan J. Wakoff
/s/ Michael S. Weiss
_________________________ Director December 22, 1999
Michael S. Weiss
<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 (contained on the signature page of this
Registration Statement).
* Filed herewith.
** To be filed by amendment.
Exhibit 23.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the incorporation by reference in this Registration
Statement of Genta Incorporated (No. 333-35215) on Amendment No. 3 to Form S-3
of our report dated April 15, 1999 with respect to the consolidated financial
statements of Genta Incorporated appearing in the Annual Report on Form 10-K of
Genta Incorporated and its subsidiaries for the year ended December 31, 1998
(which report expresses an unqualified opinion and includes an explanatory
paragraph which indicates that there are matters that raise substantial doubt
about the Company's ability to continue as a going concern) and to the reference
to us under the heading "Experts" in the prospectus, which is part of this
Registration Statement.
/s/ DELOITTE & TOUCHE LLP
Boston, Massachusetts
January 4, 2000
Exhibit 23.2
CONSENT OF INDEPENDENT AUDITORS
We consent to the incorporation by reference in this Registration
Statement (No. 333-35215) of Genta Incorporated on Form S-3 of our report dated
April 15, 1999, with respect to the financial statements of Genta Jago
Technologies B.V., appearing in the Annual Report on Form 10-K, as amended, of
Genta Incorporated for the year ended December 31, 1998 (which report expresses
an unqualified opinion and includes an explanatory paragraph which indicates
that there are matters that raise substantial doubt about the Company's ability
to continue as a going concern) and to the reference to us under the heading
"Experts" in the Prospectus, which is part of this Resgistration Statement.
/s/ DELOITTE & TOUCHE EXPERTA LTD.
Bernardin Marty Tobias Pfeiffer
Basle, Switzerland
January 4, 2000
Exhibit 23.3
Consent of Ernst & Young LLP, Independent Auditors
We consent to the reference to our firm under the caption "Experts" in
Amendment No. 3 to the Registration Statement (Form S-3 No. 333-35215) and to
the incorporation by reference therein of our reports dated June 18, 1998, with
respect to the consolidated financial statements of Genta Incorporated and the
financial statements of Genta Jago Technologies B.V. included in the Genta
Incorporated Annual Report on Form 10-K for the year ended December 31, 1998,
filed with the Securities and Exchange Commission.
/s/ ERNST & YOUNG LLP
San Diego, California
January 4, 2000
