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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON APRIL 5, 1999
REGISTRATION NO. 333-
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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COCENSYS, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 33-0538836
(State or other jurisdiction of (I.R.S. Employer Identification
incorporation or organization) Number)
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201 TECHNOLOGY DRIVE
IRVINE, CA 92618
(949) 753-6100
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
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F. RICHARD NICHOL, PH.D.
PRESIDENT AND CHIEF EXECUTIVE OFFICER
201 TECHNOLOGY DRIVE
IRVINE, CA 92618
(949) 753-6100
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
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COPIES TO:
ANDREA VACHSS, ESQ. ROBERT HOLMEN, ESQ.
COOLEY GODWARD LLP COCENSYS, INC.
FIVE PALO ALTO SQUARE 201 TECHNOLOGY DRIVE
3000 EL CAMINO REAL IRVINE, CA 92618
PALO ALTO, CALIFORNIA 94306-2155 (949) 753-6100
(650) 843-5000
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Approximate date of commencement of proposed sale to the public:
AS SOON AS PRACTICABLE AFTER THIS REGISTRATION STATEMENT BECOMES EFFECTIVE.
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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 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. / /
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. / /
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
PROPOSED MAXIMUM PROPOSED MAXIMUM AMOUNT OF
TITLE OF CLASS OF AMOUNT TO BE OFFERING PRICE PER AGGREGATE OFFERING REGISTRATION
SECURITIES TO BE REGISTERED REGISTERED SHARE (3) PRICE (3) FEE
---------------------------------------- --------------------- ------------------ ------------------ ------------
<S> <C> <C> <C> <C>
Common Stock, $0.001 par value per share 25,000,000 shares (1) $0.23 $5,859,375 $1,629
Common Stock, $0.001 par value per share 100,000 shares (2) $0.63 $62,500 $18
</TABLE>
(1) Includes (i) up to 25,000,000 shares of common stock to be issued upon
conversion of the Company's Series E Convertible Preferred Stock (the
"Preferred Stock") and (ii) an indeterminate number of additional shares of
common stock as may from time to time become issuable upon conversion of
the Preferred Stock by reason of stock splits, stock dividends and similar
transactions, which shares are registered hereunder pursuant to Rule 416
under the Securities Act. The number of shares of common stock included in
the Registration Statement represents the Company's good faith estimate of
the number of shares of common stock issuable upon conversion of the
Preferred Stock calculated on the basis of a conversion price of $0.21 per
share, which is less than the proposed maximum offering price.
(2) Includes (i) up to 100,000 shares of common stock to be issued upon
exercise of warrants to purchase common stock (the "Warrants") and (ii) an
indeterminate number of additional shares of common stock as may from time
to time become issuable upon exercise of the Warrants by reason of stock
splits, stock dividends and antidilution provisions, which shares are
registered hereunder pursuant to Rule 416 under the Securities Act.
(3) Estimated solely for the purpose of calculating the registration fee in
accordance with Rule 457 under the Securities Act. The prices per share
and aggregate offering prices are based on (i) with respect to the common
stock issuable upon the conversion of Preferred Stock, the average of the
high and low prices of the Registrant's common stock on April 1, 1999 as
reported on the Nasdaq National Market and (ii) with respect to 100,000
shares of common stock issuable upon exercise of Warrants, the exercise
price of the Warrants.
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 THAT 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 COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
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SUBJECT TO COMPLETION, DATED APRIL 5, 1999
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN
OFFER TO SELL THESE SECURITIES AND IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
PROSPECTUS
25,100,000 SHARES
COCENSYS, INC.
COMMON STOCK
The selling stockholders listed on page 13 are offering up to 25,100,000
shares of CoCensys, Inc. common stock that they may acquire by converting Series
E Convertible Preferred Stock or by exercising warrants. The selling
stockholders also may offer additional shares of common stock acquired upon
conversion of Series E Convertible Preferred Stock or exercise of warrants as a
result of stock splits or similar events.
We sold 8,000 shares of our Series E Convertible Preferred Stock and
warrants to purchase 350,000 shares of common stock to the selling stockholders
on June 8, 1998 in a private transaction. As a result of the selling
stockholders' satisfying certain conditions in the agreement for their purchase
of the Series E Convertible Preferred Stock, we issued the selling stockholders
warrants to purchase an additional 100,000 shares of common stock on November 8,
1998. We will not receive any proceeds from the sale of common stock by the
selling stockholders. However, we will receive the exercise price of any
warrants exercised for cash.
Our common stock trades on the Nasdaq National Market under the symbol
COCN. On April 1, 1999, the last reported sale price of our common stock was
$0.25 per share.
We will not be paying any underwriting discounts or commissions in this
offering.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" BEGINNING ON PAGE 5.
THE SECURITIES AND EXCHANGE COMMISSION AND STATE SECURITIES REGULATORS HAVE NOT
APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS
TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
APRIL 5, 1999
<PAGE>
ABOUT COCENSYS
CoCensys is developing small molecule drugs to treat neurological and
psychiatric disorders. Our product discovery and development programs are
focused on exploring novel receptors and their ligands and inhibitors through
three technology platforms: specific GABA(A) receptor modulators named
Epalons; glutamate receptor antagonists; and sodium channel blockers.
We are a Delaware corporation. Our executive offices are located at 201
Technology Drive, Irvine, California 92618, and our telephone number is (949)
753-6100. In this prospectus, "CoCensys," "we" and "our" refer to CoCensys,
Inc., unless the context otherwise requires.
You should rely only on the information provided or incorporated by
reference in this prospectus. We have authorized no one to provide you with
different information. We are not making an offer of these securities in any
state where the offer is not permitted. You should not assume that the
information in this prospectus or any prospectus supplement is accurate as of
any date other than the date on the front of the document.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-3 to
register the common stock offered by this prospectus. However, this
prospectus does not contain all of the information contained in the
registration statement and the exhibits and schedules to the registration
statement. We strongly encourage you to carefully read the registration
statement and the exhibits and schedules to the registration statement.
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file
at the SEC's public reference rooms in Washington, DC, New York, New York and
Chicago, Illinois. You can request copies of these documents by contacting
the SEC and paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for further information on the public reference rooms. Our
SEC filings are also available to the public from the SEC's website at
www.sec.gov.
The SEC allows us to "incorporate by reference" the information
contained in documents that 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 considered to be part of this
prospectus. Information in this prospectus supersedes information
incorporated by reference which we filed with the SEC prior to the date of
this prospectus, while 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 we will make with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934:
1. Our Annual Report on Form 10-K for the fiscal year ended December 31,
1998;
2. The description of the common stock contained in our registration
statement on Form 8-A filed on December 10, 1992; and
3. The description of the Preferred Share Purchase Rights contained in
our registration statement on Form 8-A as filed on May 16, 1995.
You may request a copy of these filings, at no cost to you, by writing or
telephoning us at:
CoCensys, Inc.
Attention: Investor Relations
201 Technology Drive
Irvine, California 92618
Telephone: (949) 753-6100
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements in this prospectus and the documents incorporated
by reference are forward-looking statements. These statements involve known
and unknown risks, uncertainties, and other factors that may cause our or our
industry's results, levels of activity, performance, or achievements to be
materially different from any future results, levels of activity,
performance, or achievements expressed or implied by such forward-looking
statements. These factors include, among others, those listed under "Risk
Factors" and in the documents incorporated by reference.
In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "expects," "plans,"
"anticipates," "believes," "estimates," "predicts," "potential," or
"continue" or the negative of such terms or other comparable terminology.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee future
results, events, levels of activity, performance, or achievements. We do not
assume responsibility for the accuracy and completeness of the
forward-looking statements. We do not intend to update any of the
forward-looking statements after the date of this prospectus to conform them
to actual results.
4.
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RISK FACTORS
BUYING SHARES OF OUR COMMON STOCK IS RISKY. YOU SHOULD CAREFULLY READ AND
CONSIDER THE FOLLOWING RISK FACTORS BEFORE YOU DECIDE WHETHER TO PURCHASE SHARES
OF COCENSYS COMMON STOCK. ANY OF THESE RISK FACTORS COULD MATERIALLY ADVERSELY
AFFECT OUR BUSINESS, OPERATING RESULTS AND FINANCIAL CONDITION AND COULD RESULT
IN A COMPLETE LOSS OF YOUR INVESTMENT.
OUR PRODUCTS ARE IN AN EARLY STAGE OF DEVELOPMENT AND THERE IS A HIGH RISK
OF FAILURE.
We have no products that have received regulatory approval for
commercial sale. All of our drug candidates are in the early stages of
development, and our technology is unproven. The physiology of brain
disorders is highly complex, and the causes of these disorders are not fully
known. We will have to conduct significant research and pre-clinical
(animal) and clinical (human) tests that demonstrate that our products are
safe and effective before we can file applications for approval with the
United States Food and Drug Administration and foreign regulatory
authorities. Any of our products may fail in the testing phase or may fail to
attain market acceptance. Competitors may develop superior products. Third
parties may have proprietary rights that preclude us from marketing our
products. If research and testing is not successful, our products are not
commercially viable or we cannot compete effectively, our business, financial
condition and results of operations will be materially adversely affected.
THE OUTCOME OF CLINICAL DEVELOPMENT IS HIGHLY UNCERTAIN.
Clinical trials, including pre-clinical testing, are lengthy, expensive
and uncertain. Failure can occur at any stage. We have no products that have
successfully completed all necessary clinical testing. Three of our drug
candidates have undergone some clinical testing, and three currently are in
pre-clinical testing. We do not know whether the FDA will allow us to begin
human testing of our drug candidates that have not been tested in humans or
to continue human testing of those candidates that have undergone some human
testing. We cannot rely on interim results of trials to predict their final
results, nor can we count on acceptable results at early stages of testing to
be repeated at later stages. Any of our drug candidates could have
undesirable or unintended side effects or other problems that may prevent or
limit future testing, approval or use of the product.
We have experienced safety and efficacy problems with drug candidates.
In a clinical trial of licostinel, our drug candidate to treat stroke,
crystals of licostinel occurred in the urine of some subjects, a potential
dose-limiting side effect. Although the crystal formation occurred only in
subjects with at least four times the blood plasma level of licostinel that
was necessary for the drug to be effective in animals, our development
partner, Novartis Pharma A.G., ceased its participation in the development of
licostinel. In addition, in October 1998 we announced that ganaxolone, our
drug candidate to treat migraine and epilepsy, was not effective in providing
relief to patients suffering migraine headaches. The results of a clinical
trial in which 325 migraine patients received either ganaxolone or a placebo
drug did not show a statistically significant difference in migraine headache
relief between those patients receiving ganaxolone and those patients
receiving the placebo.
We cannot assure you that any of our clinical trials will be completed
successfully or at all, or that they will result in marketable products. Any
significant delay or failure in the clinical development of our products will
materially adversely affect our business, financial condition and results of
operations.
WE HAVE NEVER BEEN PROFITABLE, AND WE EXPECT TO CONTINUE TO GENERATE
SIGNIFICANT LOSSES.
Since we started business in 1989, we have spent over $174 million
researching and developing our drug candidates. We have raised this money by
selling stock in CoCensys to private investors and the public, licensing
drugs and technologies to other companies and selling assets that we have
developed at CoCensys. We have never been profitable and, through December
31, 1998, we have incurred a cumulative deficit of approximately $116 million.
5.
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We expect to continue to incur substantial and increasing losses over
the next several years as we continue our research and development programs.
To achieve and sustain profitable operations in the long term, we must
successfully develop, obtain regulatory approval for, manufacture, introduce,
market and sell drugs from our technologies. Failure to do so will
materially adversely affect our business, financial conditions and results of
operations.
WE WILL NEED SIGNIFICANT ADDITIONAL FUNDS.
Drug development is capital intensive and requires significant funding
commitments. We will need a substantial amount of funds to continue our
operations both in the near term and over the next several years. If we do
not raise additional funds by the end of 1999, we will be forced to curtail
our operations. Our cash needs beyond 1999 will vary depending on a number of
factors, including the following:
- the size and progress of our research and development programs;
- the results of our animal and human testing of our drugs;
- the time and costs of obtaining regulatory approvals for our drugs (if
approvals can be achieved);
- how good our drugs are compared to other drugs on the market that
treat the same disorders;
- the time, costs and success of establishing sales and marketing
capabilities; and
- the time, costs and success of establishing manufacturing
capabilities.
We do not know if we will be able to raise funds on terms that are
acceptable to us. If we sell additional stock, you may experience
substantial dilution. If we raise cash through licensing additional drugs
and technologies to collaboration partners, we will be required to relinquish
rights to some of our drugs and technologies.
If we cannot raise enough cash to fund our operations, we may be forced
to delay, reduce the scope of or eliminate one or more of our research or
development programs. We may have to cease all operations if we are not
successful in obtaining funds.
WE DEPEND ON THIRD PARTIES TO FUND OUR DRUG DEVELOPMENT.
In order to fund the development, clinical testing, manufacturing and
commercialization of our products, we have entered into various
collaborations with corporate partners, licensors, licensees and others.
Currently, we are a party to a collaboration agreement with Warner-Lambert
Company for research and development of subtype-selective NMDA receptor
antagonists and with Wyeth-Ayerst Laboratories, a division of American Home
Products Corporation, for the development of epalons to treat anxiety. Under
each agreement, we depend on the collaboration partner to provide the funding
to develop drug candidates for potential approval and commercialization.
WE MAY BE UNABLE TO FULFILL OUR OBLIGATIONS UNDER THE COLLABORATION
AGREEMENTS. We do not know if we will have the substantial resources needed
to fulfill our research and development obligations under each collaboration
agreement. If we cannot fulfill our obligations, we may be required to
terminate early one or both of the agreements and forfeit many of our rights
under the agreements. In particular, our collaboration agreement with
Wyeth-Ayerst provides that if the lead compound under development to treat
anxiety fails to meet certain criteria, and if at that time we have not yet
produced a back-up compound that meets another set of criteria, Wyeth-Ayerst
can demand repayment of a portion of the funds paid to us under our
collaboration agreement. Currently, the amount that we may be required to
pay back could be as much as $3 million, in cash or common stock. Although
we hope to fulfill our obligations under the collaboration agreement so that
Wyeth-Ayerst will not be able to demand repayment, we cannot assure we will
be able to do so.
6.
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EITHER OF OUR COLLABORATION PARTNERS MAY CANCEL ITS COLLABORATION
AGREEMENT WITH US AT ANY TIME. Each of our collaboration agreements allows
either CoCensys or our collaboration partner to voluntarily terminate its
participation in the collaboration at any time. If either of our current
collaboration partners terminates its agreement with us, that partner would
lose its right to further develop or sell drugs under that collaboration;
however, that partner also no longer would be required to fund development of
those drugs. If either Warner-Lambert or Wyeth-Ayerst cancels its agreement
with us, we would have to find a new collaboration partner to pay for further
development of our drug candidates. We cannot assure you that we would be
able to do so. Collaboration partners have, in the past, terminated their
agreements with us. In 1994, we entered into a development agreement with
Novartis Pharma A.G. to develop licostinel to treat stroke patients. In
1997, Novartis terminated its participation in the development agreement
based on side effects seen in human trials of licostinel. Also, in 1996, we
entered into an agreement with G.D. Searle & Co. to develop epalons to treat
insomnia. In July 1998, Searle terminated its participation in that
agreement, stating that the program no longer met its needs in light of its
entire product pipeline. Since termination of those two agreements, we have
not yet found new collaboration partners to develop those drugs, and we do
not have the money to complete development of those drugs. We do not know if
we will be able to find new collaboration partners for those drugs.
WE MAY BE UNABLE TO ENTER INTO COLLABORATION AGREEMENTS IN THE FUTURE.
We plan to continue to enter into collaboration agreements with
pharmaceutical companies to develop, market and sell our drug candidates. We
do not know if we will be able to find additional potential partners
interested in developing our drugs. Also, even if we find potential partners
interested in our drugs, we do not know if we will be able to enter into
collaboration agreements with these partners on terms and conditions that we
find acceptable. Even if we do enter into additional collaboration
agreements, we do not know if the collaborations will successfully develop
drugs for marketing and sale. If we are unable to secure collaboration
partners, we will not be able to develop our drug candidates.
WE MUST COMPLY WITH EXTENSIVE GOVERNMENTAL REGULATIONS.
Our drug candidates are subject to extensive and rigorous regulation by
the FDA and state and local bodies in the United States and by foreign
regulatory authorities. These regulations cover, among other things, product
development, testing, manufacturing, labeling, sales, advertising and
promotion. The process of obtaining FDA and other required regulatory
approvals is long, expensive and uncertain. In order to market and sell our
drugs in the United States and other countries, we must successfully complete
rigorous testing in animals and humans to prove that the drugs are safe for
human use and are effective in treating one or more specific brain disorders.
We must conduct these tests in a large number of people, including both
healthy volunteers and people who suffer from the disorder for which the drug
is intended. All of our testing must be conducted strictly in accordance
with standards set up by the FDA and foreign regulators. If we successfully
complete those tests for one of our drugs, we then must go through an
extensive regulatory approval process with the FDA, and with foreign
regulators, before we can begin marketing and selling the drug.
Even if our drugs are approved for marketing and sale, the FDA and
foreign regulators may place limitations on the marketing and sale of our
drugs or require that we conduct additional testing on any or all of our
drugs after the drugs are approved for marketing and sale. In addition, each
drug, the manufacturer of that drug and the manufacturing facilities in which
the drug is made are subject to continual review and periodic inspections.
The FDA and regulatory agencies in other countries have the right to withdraw
approval for a drug later if, for example, patients taking our drug
experience serious side effects or we have problems in manufacturing the drug.
We do not know if we will successfully complete the required testing
with any of our drug candidates. Any of our drugs may have unacceptable side
effects or may not be effective in treating the targeted brain disorder. We
may have difficulty recruiting healthy or sick volunteers for our trials.
Either CoCensys or the FDA can halt a trial at any time if either of us
believes that the participants in the trial are being exposed to unacceptable
health risks. Even if we do successfully complete the testing for one or more
of our drugs and prove that our drug is safe for human use and is effective
in treating one or more specific brain disorders, we do not know if the FDA
or any other country's regulatory agency will approve the drug for marketing
and sale in that country. We cannot be sure that our drug candidates will
receive FDA approval in a timely manner, if at all. Regulatory agencies may
limit the uses, or indications, for which any of our products is approved.
Even if approvals are obtained, the marketing and manufacturing of drug
products are subject to continuing FDA and other regulatory requirements,
such as requirements to comply with good manufacturing practices. The
failure to comply with such requirements could
7.
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result in enforcement action, which could adversely affect us and our
business. Later discovery of problems with a product, manufacturer or
facility may result in additional restrictions on the product or
manufacturer, including withdrawal of the product from the market. The
government may impose new regulations which could further delay or preclude
regulatory approval of our drug candidates. We cannot predict the impact of
adverse governmental regulation which might arise from future legislative or
administrative action. Also, we conduct testing on our drugs both in the
United States and in other countries (principally European countries). The
FDA in the United States and regulatory agencies in other countries may be
unwilling to accept the results from trials not conducted in that agency's
"home" country.
OUR PATENTS AND OTHER INTELLECTUAL PROPERTY MAY NOT PROVIDE SUFFICIENT
PROTECTION.
Our success depends in part on our ability to protect our technology
from unauthorized use by obtaining patents in the United States and other
countries and maintaining our trade secrets. Also, our drug candidates must
not infringe on the patent and other proprietary rights of others in the
United States and other countries where we may market and sell them. We work
hard to obtain appropriate patents and to maintain our trade secrets;
however, patents can be highly uncertain and involve complex legal and
factual questions. We do not know if our patent protection and trade secret
protection will be sufficient to allow CoCensys and our development partners
to develop, market and sell our drug candidates.
We file and prosecute patent applications on our own behalf and in
connection with technology that we have licensed from third parties. We have
been issued 23 patents in the United States for our technologies, with
expiration dates ranging from June 9, 2009 to February 11, 2017, and another
21 filed patents are pending. We have also filed for patent protection in
selected foreign countries. We will continue to file and prosecute patent
applications in the United States and in other countries to protect our drug
candidates, but we do not know if we will be issued additional patents for
our technologies, either in the United States or in other countries. We also
do not know if we will invent any new products or processes for which we can
receive patent protection in the future.
The United States Patent and Trademark Office and similar agencies in
other countries have substantial backlogs of patent applications waiting for
consideration. In the United States, patent applications remain secret until
the patent is issued; in other countries, patent applications remain secret
for at least six months after filing. Therefore, we do not know whether any
of our competitors has filed patents that may interfere with our ability to
gain patent protection for our discoveries. We do not know whether our
competitors may have invented some of our technology prior to the time that
we invented the technology. Generally, only the person who first invents
technology is entitled to a patent for that technology. Even if we are the
first to invent certain technology and we have filed a patent application, we
do not know when that application will be considered by the United States
Patent and Trademark Office or any agency in other countries where we may
have filed a patent application for the technology.
Patents that have been issued to us are always subject to being
challenged, invalidated or circumvented; we do not know if any of our patents
or patents in which we have rights will provide adequate protection for
CoCensys. Also, we may have to participate in litigation or interference
proceedings to determine whether one or more of our patents is valid. Even
if we win the litigation or interference proceeding, we may be required to
spend substantial amounts of money defending the validity of our patents. We
do not know if we will have sufficient money to defend all of our patents if
they are challenged.
Our success will also depend, in part, on our not infringing patents
issued to others. We do not know if any patents held or patent applications
filed by other people or companies will force us to alter our drug candidates
or processes, stop development of one or more of our drug candidates or
obtain licenses, if possible, from those other people or companies.
A number of pharmaceutical companies, biotechnology companies,
universities and research institutions have filed patent applications or
received patents that may be competitive with the our patents and patent
applications. We do not know the effect that those patents and patent
applications may have on our ability to continue to develop and, eventually,
market and sell our drug products. If we attempt to obtain licenses to use
patents held by other people, we do not know if we will be granted licenses
or whether the terms of those licenses, if granted, will be fair and
acceptable to CoCensys.
8.
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If we infringe another person's patent, or we fail to obtain an
appropriate license to use any other person's technology that is required to
develop, market and sell our drug products, we may have to participate in
interference proceedings or litigation, which could result in substantial
costs, fines and penalties assessed against CoCensys and we may be forced to
cease all use of the other person's technology. In fact, we are aware of a
patent that has issued that contains claims that may, if valid, block us from
selling certain compounds for one particular indication. Although we are not
currently pursing that indication for those compounds, if we do decide to
pursue that indication, we will have to either institute an interference
proceeding to determine the validity of the other patent or attempt to
license rights to the patent from the holder. We do not know if we will be
successful if we decide to institute an interference proceeding. Also, we do
not know if the patent holder would be willing to license us rights to the
patent, whether or not on terms acceptable to CoCensys.
We have developed a substantial amount of information constituting our
trade secrets. We rely on confidentiality agreements with our employees,
consultants and certain contractors to protect these trade secrets. We do
not know if the other parties to these agreements will abide by the
agreements or breach them. If any agreement is breached, we do not know
whether we will be able to adequately protect CoCensys from damage caused by
our trade secrets being disclosed to the public or to a competitor.
WE FACE SIGNIFICANT COMPETITION.
We are engaged in a highly competitive, rapidly changing field.
Existing products and therapies, as well as those under development by other
companies, will compete directly with products that we are seeking to develop
and market. Competition from fully integrated pharmaceutical companies,
including larger biotechnology companies and our collaboration partners, is
intense and is expected to increase. Most of these companies have
significantly greater financial resources and expertise than we do in
research and development, manufacturing, pre-clinical and clinical testing,
obtaining regulatory approvals, marketing and distribution. Many of our
competitors also have significant products to treat neurological and/or
psychiatric disorders approved or in development and operate large,
well-funded research and development programs. Academic institutions,
governmental agencies and other public and private research organizations
also conduct research, seek patent protection and establish collaborative
arrangements for product and clinical development and marketing. Further, we
face competition based on product efficacy, safety, the timing and scope of
regulatory approvals, availability of supply, marketing and sales capability,
reimbursement coverage, price and patent position. We do not know whether
our competitors will be able to develop more effective or more affordable
products, or achieve earlier patent protection or product commercialization
than us. If we are unable to compete successfully, our business, financial
condition and results of operations will be materially adversely affected.
WE MAY NOT BE ABLE TO ATTRACT AND RETAIN KEY EMPLOYEES.
We are highly dependent on the key members of our scientific and
management staff. If we lost the services of one or more key people, we may
experience significant delays in our development programs. In addition, we
rely on consultants and advisors to assist us in conducting our operations
and formulating our research and development strategy. Attracting and
retaining qualified personnel, consultants and advisors is critical to our
success. We compete with pharmaceutical companies, biotechnology companies,
universities and other entities and institutions in recruiting and retaining
highly qualified scientific and management personnel. We do not know if we
will be able to attract and retain qualified personnel on acceptable terms or
at all.
WE DO NOT HAVE MANUFACTURING EXPERIENCE.
We do not have any manufacturing facilities. We rely solely on contract
manufactures to produce supplies of our compounds and, at this time, we
likely will be forced to rely on contract manufactures to produce commercial
supplies of any of our drug candidates that are approved for marketing and
sale. We do not know whether our drugs can be manufactured in commercial
quantities at an acceptable cost.
In addition, we must rely on contractors for packaging, labeling and
distribution of our drug products. We do not know if we will be able to
enter into agreements for these services on terms acceptable and fair to us.
We do not know if our contractors will perform all of their obligations on
time and in an acceptable manner. Delays or defaults by our contractors
could delay or jeopardize our efforts to develop, market and sell our drug
products.
9.
<PAGE>
Moreover, our contract manufacturers must adhere to current good
manufacturing practice regulations enforced by the FDA through its facilities
inspection program. We do not know if the facilities that we use will pass
FDA inspections. Failure to pass inspections could delay or jeopardize our
ability to market and sell any future products and materially adversely
affect our business, financial condition and results of operations.
WE DO NOT HAVE A SALES FORCE TO SELL FUTURE PRODUCTS.
We sold our Pharmaceutical Sales and Marketing Division to Watson
Pharmaceuticals in 1997. To market products in the future, we must develop
or acquire, and thereafter maintain and expand, a new sales and marketing
organization with technical expertise and supporting distribution capability.
We do not know if we will be successful developing or acquiring and,
thereafter, maintaining and expanding an appropriate sales and marketing
organization. Any failure on our part may have a material adverse effect on
our business, financial conditions and results of operations.
WE DO NOT KNOW IF OUR PRODUCTS WILL BE COMMERCIALLY SUCCESSFUL OR REIMBURSED
BY THIRD-PARTY PAYORS.
Even if one or more of our products prove safe and effective, we do not
know if the products will be successful commercially. For example, our
products may be too difficult or expensive to make, or our products may not
be acceptable to patients, health care providers and third-party payors. In
both the United States any many foreign countries, sales of our products, if
any, will depend in part on the availability of reimbursement from
third-party payors, such as government health administration authorities,
private health insurers and other organizations. Third-party payors are
increasingly challenging the price and cost-effectiveness of medical products
and services. We do not know whether our drug products will be considered
cost effective or that adequate third-party reimbursement will be available
to enable us to maintain price levels sufficient to realize an appropriate
return on our investment in product development. In certain foreign
countries, our products may be subject to governmentally mandated prices. If
governments and third-party payors do not provide adequate reimbursement for
our potential drug products or if foreign governments force unreasonably low
pricing for our drugs, our business, financial condition and results of
operations may be materially adversely affected.
WE ARE SUBJECT TO SUBSTANTIAL PRODUCT LIABILITY RISKS.
Our business exposes us to potential product liability risks if any of
our compounds or future products cause illness, injury or death. Although we
currently have liability insurance covering our clinical trials, our coverage
may not be sufficient to cover all potential claims. We do not know if we
will be able to obtain and maintain such insurance for all of our clinical
trials and future products. We will need to increase our insurance coverage
in the future if we begin to market and sell any of our drug products under
development. However, we do not know if we will be able to obtain or maintain
product liability insurance in the future on acceptable terms or with
adequate coverage against potential liabilities. A liability claim,
regardless of merit or eventual outcome, could materially adversely affect
our business, financial condition and results of operations.
OUR STOCK PRICE IS VERY VOLATILE.
The securities markets have from time to time experienced significant
price and volume fluctuations that may be unrelated to the operating
performance of particular companies. In addition, the market prices of the
10.
<PAGE>
common stock of many publicly traded biopharmaceutical companies, including
ours, have in the past been, and can in the future be expected to be,
especially volatile. Our stock price may fluctuate greatly as a result of a
number of factors, including:
- announcements of technological innovations or new products by us or by
our competitors;
- developments or disputes concerning patents or proprietary rights;
- publicity regarding actual or potential medical results relating to
drug products that we or our competitors are developing;
- regulatory developments in both the United States and foreign
countries;
- public concern as to the safety of biotechnology products; and
- economic and other external factors, as well as period-to-period
fluctuations in our financial results.
THE SALE OF A LARGE NUMBER OF SHARES OF OUR COMMON STOCK MAY FURTHER DEPRESS OUR
STOCK PRICE.
The sale of a large number of shares of our common stock in the public
market, including the shares offered by this prospectus, could depress the
market price of our common stock. Substantially all of the outstanding
shares of our common stock may be sold at any time in the public markets.
Approximately 5.2 million freely tradable additional shares may be issued on
exercise of vested options to purchase CoCensys stock. Current and former
employees, consultants, officers and directors of CoCensys hold these
options.
We may be required to issue millions of additional shares of CoCensys
common stock upon conversion of Series E Convertible Preferred Stock. As of
March 1, 1999, 5,135 shares of our Series E Convertible Preferred Stock
remained issued and outstanding. Each share of the Series E Convertible
Preferred Stock is convertible into shares of CoCensys common stock at
discount to the current market price of our common stock. If converted on
March 1, 1999, based on the then-applicable conversion price of $0.197 per
share, the remaining Series E Convertible Preferred Stock would have been
convertible into approximately 27.5 million additional shares of CoCensys
common stock. The number of shares of common stock that may be issued could
prove to be significantly greater if the market price of our common stock
declines. You may experience substantial dilution in your investment from
issuance of additional common stock on conversion of the Series E Convertible
Preferred Stock.
We also may be required to issue several million additional shares of
CoCensys common stock in fulfillment of our obligations to Warner-Lambert
Company. Under our collaboration agreement with Warner-Lambert, we will owe
Warner-Lambert $1 million on December 31, 1999. The $1 million is payable in
common stock or cash, at the election of Warner-Lambert. If the amount had
been paid on March 1, 1999, and Warner-Lambert elected to receive the payment
in stock, we would have had to issue to Warner-Lambert approximately 3.2
million shares of common stock. The number of shares of common stock that
may be issued could prove to be significantly greater if the market price of
our common stock declines. CoCensys stockholders could experience
substantial dilution from issuance of additional common stock in satisfaction
of our obligation to Warner-Lambert.
FAILURE TO MAINTAIN OUR LISTING ON THE NASDAQ NATIONAL MARKET MAY ADVERSELY
AFFECT THE LIQUIDITY OF OUR COMMON STOCK AND OUR FINANCIAL CONDITION.
Our common stock is traded on the Nasdaq National Market under the symbol
"COCN." In order to maintain our listing on the Nasdaq National Market, we
must meet a number of listing requirements established by Nasdaq. Currently,
we meet all Nasdaq National Market requirements other than the minimum bid
price. Generally, we must maintain a minimum bid price of $1.00 per share;
however, our bid price is significantly below $1.00 per share and has been
below $1.00 per share since October 1998.
11.
<PAGE>
On December 1, 1998, Nasdaq informed us that our common stock would be
delisted on March 1, 1999 if we failed to have a closing bid price of at
least $1.00 per share for ten consecutive days on or before February 28,
1999. We have been unable to achieve that closing bid price; however, we
have applied for a hearing before Nasdaq to discuss our delisting. That
hearing is scheduled for April 29, 1999. While the hearing is pending,
Nasdaq has said that it will not take further action to delist our common
stock from the Nasdaq National Market as a result of our stock price.
On January 27, 1999, CoCensys stockholders approved a reverse split of
our common stock, subject to the Board of Director's right not to implement
the reverse split, in the alternative ratios of one share for six shares, one
for seven and one for eight. CoCensys will consider implementing the reverse
stock split as necessary to increase the per share price of CoCensys common
stock in an effort to avoid delisting.
If we cannot maintain continued listing of our common stock on the
Nasdaq National Market or the Nasdaq SmallCap Market, our common stock could
trade on the OTC Bulletin Board or in the over-the-counter market in what is
commonly referred to as the "pink sheets." If this occurs, a stockholder
will find it more difficult to dispose of the securities or to obtain
accurate quotations as to the price of the securities. In addition, our
common stock could become subject to the "penny stock" regulations of the
SEC, which impose additional restrictions on broker-dealers who trade in such
stock and could severely limit the liquidity of our common stock. If we do
not maintain our listing on the Nasdaq National Market or Nasdaq SmallCap, we
may be required to redeem the Series E Preferred Stock. Redemption of the
Series E Preferred Stock would significantly deplete our cash reserves and
materially adversely affect our operations and financial condition.
WE GENERATE HAZARDOUS MATERIALS IN OUR BUSINESS AND OPERATIONS.
Our research and development involves the controlled use of hazardous
materials, chemicals and various radioactive compounds. Although we believe
that our safety procedures for handling and disposing of such materials
comply with the standards prescribed by state and federal regulations, the
risk of accidental contamination or injury from these materials cannot be
completely eliminated. If an accident occurs, we could be held liable for
any damages that result and any such liability could exceed our resources.
Also, we may incur substantial costs to comply with environmental regulations
if we ever decide to develop manufacturing capacity.
12.
<PAGE>
USE OF PROCEEDS
CoCensys will not receive any proceeds from the sales of common stock by
the selling stockholders in the offering.
SELLING STOCKHOLDERS
The following table sets forth the names of the selling stockholders,
the number of shares of common stock owned beneficially by each of them as of
March 1, 1999, the number of shares which may be offered pursuant to this
prospectus and the number of shares to be owned by each selling stockholder
after this offering. This information is based upon information provided by
the selling stockholders. Because the selling stockholders may offer all,
some or none of their common stock, no definitive estimate as to the number
of shares thereof that will be held by the selling stockholders after such
offering can be provided.
The number of shares set forth in the table represents an estimate of
the number of shares of common stock to be offered by the selling
stockholders. The selling stockholders will acquire such shares upon
conversion of outstanding shares of Series E Convertible Preferred Stock and
exercise of outstanding warrants. The actual number of shares of common
stock issuable upon conversion of Series E Convertible Preferred Stock and
exercise of warrants is indeterminate, is subject to adjustment and could be
materially less or more than such estimated number depending on factors which
cannot be predicted by the Company at this time, including, among other
factors, the future market price of the common stock. The actual number of
shares of common stock offered hereby, and included in the registration
statement of which this Prospectus is a part, includes such additional number
of shares of common stock as may be issued or issuable upon conversion of the
Series E Convertible Preferred Stock and exercise of the warrants by reason
of any stock split, stock dividend or similar transaction involving the
common stock, in accordance with Rule 416 under the Securities Act.
<TABLE>
<CAPTION>
Beneficial Ownership
After Offering
Maximum ---------------------------
Number of
Shares of Common Shares of Number of
Stock Beneficially Common Shares of
Owned Prior to Stock Being Common
Name of Selling Stockholder Offering (1)(2) Offered (3) Stock(4) Percent(1)(2)
--------------------------- ------------------ ----------- ----------- -------------
<S> <C> <C> <C> <C>
RGC International Investors, LDC(5) . . . . 25,433,628 15,687,500 6,072,517 10.3%
Heracles Fund(6) . . . . . . . . . . . . . . 5,647,500 5,647,500 0 0
Themis Partners L.P.(7) . . . . . . . . . . . 3,765,000 3,765,000 0 0
</TABLE>
- -------------------
(1) Shares of common stock beneficially owned includes common stock issuable on
conversion of Series E Convertible Preferred Stock (including accrued and
capitalized dividends) and exercise of warrants as of March 1, 1999.
Common stock issuable on conversion of Series E Convertible Preferred Stock
is based on a conversion price of $0.158 per share, which is less than the
conversion price applicable at March 1, 1999. If the shares of Series E
Convertible Preferred Stock actually had been converted on March 1, 1999,
the applicable conversion price would have been $0.197 per share. The
actual number of shares issuable on conversion of the Series E Convertible
Preferred Stock will vary based on the conversion price applicable at the
time of the conversion plus such other adjustments to the conversion price
that may be applicable at that time. Percent of beneficial ownership is
calculated assuming 33,508,678 shares of common stock outstanding as of
March 1, 1999.
(2) Pursuant to its terms, the Series E Convertible Preferred Stock is
convertible by any holder only to the extent that the number of shares of
common stock thereby issuable, together with the number of shares of common
stock owned by such holder and its affiliates (but not including shares of
common stock
13.
<PAGE>
underlying unconverted Series E Convertible Preferred Stock) would not
exceed 4.9% of the then outstanding common stock as determined in
accordance with Section 13(d) of the Exchange Act. Accordingly, the
number of shares of common stock set forth in the table as beneficially
owned by the selling stockholders exceeds the number of shares of
common stock that they could own beneficially at any given time as a
result of their ownership of the Series E Convertible Preferred Stock.
In that regard, beneficial ownership of the selling stockholders set
forth in the table is not determined in accordance with Rule 13d-3
under the Exchange Act. This limitation may be waived by the holder
upon 61 days notice to CoCensys. Except as indicated in the footnotes
to this table and pursuant to applicable community property laws, the
persons named in the table have sole voting and investment power with
respect to all shares of common stock beneficially owned.
(3) Represents the maximum number of shares of common stock which will be sold
by each selling stockholder under this prospectus upon conversion of Series
E Convertible Preferred Stock and exercise of warrants.
(4) Assumes the sale of all the common stock offered hereby. RGC International
Investors, LDC, has the right to sell an additional 3,673,611 shares of
CoCensys common stock issuable upon conversion of Series E Convertible
Preferred Stock and exercise of warrants pursuant to a prospectus dated
September 4, 1998; shares of common stock held after the offering assumes
that RGC International Investors, LDC also sold all shares available under
such prospectus.
(5) Includes up to 25,152,377 shares of common stock issuable upon the
conversion of Series E Convertible Preferred Stock and up to 281,250 shares
of common stock issuable upon the exercise of warrants held of record by
RGC International Investors, LDC.
(6) Includes up to 5,546,250 shares of common stock issuable upon the
conversion of Series E Convertible Preferred Stock and up to 101,250 shares
of common stock issuable upon the exercise of warrants held of record by
Heracles Fund.
(7) Includes up to 3,697,500 shares of common stock issuable upon the
conversion of Series E Convertible Preferred Stock and up to 67,500 shares
of common stock issuable upon the exercise of warrants held of record by
Themis Partners L.P.
PLAN OF DISTRIBUTION
The common stock offered hereby may be sold by the selling stockholders or by
pledgees, donees, transferees or other successors in interest that receive
such shares as a gift, partnership distribution or other non-sale related
transfer. The common stock may be sold from time to time in transactions in
the over-the-counter market, in negotiated transactions, or a combination of
such methods of sale, at fixed prices which may be changed, at market prices
prevailing at the time of sale, at prices related to prevailing market prices
or at negotiated prices. The selling stockholders may effect such
transactions by selling the common stock to or through broker-dealers,
including block trades in which brokers or dealers will attempt to sell the
common stock as agent but may position and resell the block as principal to
facilitate the transaction, or in one or more underwritten offerings on a
firm commitment or best effort basis. Sales of selling stockholders' shares
of common stock may also be made pursuant to Rule 144 under the Securities
Act, where applicable.
To the extent required under the Securities Act, the aggregate amount of
selling stockholders' shares of common stock being offered and the terms of
the offering, the names of any such agents, brokers, dealers or underwriters
and any applicable commission with respect to a particular offer will be set
forth in an accompanying Prospectus supplement. Any underwriters, dealers,
brokers or agents participating in the distribution of the common stock may
receive compensation in the form of underwriting discounts, concessions,
commissions or fees from a selling stockholder and/or purchasers of selling
stockholders' shares of common stock, for whom they may act (which
compensation as to a particular broker-dealer might be in excess of customary
commissions).
From time to time, one or more of the selling stockholders may pledge,
hypothecate or grant a security interest in some or all of the shares of
common stock owned by them, and the pledgees, secured parties or persons to
whom such securities have been hypothecated shall, upon foreclosure in the
event of default, be deemed to be selling stockholders hereunder. In
addition, a selling stockholder may, from time to time, sell short the
CoCensys
14.
<PAGE>
common stock, and in such instances, this Prospectus may be delivered in
connection with such short sales and the shares of common stock offered
hereby may be used to cover such short sales.
From time to time one or more of the selling stockholders may transfer,
pledge, donate or assign such selling stockholders' shares of common stock to
lenders or others and each of such persons will be deemed to be a "selling
stockholder" for purposes of this Prospectus. The number of selling
stockholders' shares of common stock beneficially owned by those selling
stockholders who so transfer, pledge, donate or assign shares of common stock
will decrease as and when they take such actions. The plan of distribution
for selling stockholders' shares of common stock sold hereunder will
otherwise remain unchanged, except that the transferees, pledgees, donees or
other successors will be selling stockholders hereunder.
A selling stockholder may enter into hedging transactions with
broker-dealers and the broker-dealers may engage in short sales of the common
stock in the course of hedging the positions they assume with such selling
stockholder, including, without limitation, in connection with distributions
of the common stock by such broker-dealers. A selling stockholder may also
enter into option or other transactions with broker-dealers that involve the
delivery of the common stock to the broker-dealers, who may then resell or
otherwise transfer such common stock. A selling stockholder may also loan or
pledge the common stock to a broker-dealer and the broker-dealer may sell the
common stock so loaned or upon a default may sell or otherwise transfer the
pledged common stock.
In order to comply with the securities laws of certain states, if
applicable, the common stock will be sold in such jurisdictions only through
registered or licensed brokers or dealers. In addition, in certain states
the Shares may not be sold unless they have been registered or qualified for
sale in the applicable state or an exemption from the registration or
qualification requirement is available and is complied with.
The selling stockholders and any broker-dealers or agents that
participate with the selling stockholders in the distribution of the common
stock may be deemed to be "underwriters" within the meaning of the Securities
Act, and any commissions received by them and any profit on the resale of
common stock purchased by them may be deemed to be underwriting commissions
or discounts under the Securities Act.
The selling stockholders and any other persons participating in the sale
or distribution of the Shares will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, which provisions may
limit the timing of purchases and sales of any of the common stock by the
selling stockholders or any other such person. The foregoing may affect the
marketability of the common stock.
The shares of common stock were originally issued to the selling
stockholders pursuant to an exemption from the registration requirements of
the Securities Act provided by Section 4(2) thereof. The Company agreed to
register the common stock under the Securities Act and to indemnify and hold
the selling stockholders harmless against certain liabilities under the
Securities Act that could arise in connection with the sale by the selling
stockholders of the common stock. The Company has agreed to pay all
reasonable fees and expenses incident to the filing of this registration
statement, and a related registration statement covering 12,350,000 shares of
CoCensys common stock, estimated in the aggregate to be approximately
$85,000. The Company also agreed to reimburse Rose Glen Capital Management,
L.P., investment manager to RGC International Investors, LDC, for expenses
incurred by the selling stockholders in their purchase of the Series E
Preferred Stock and Warrants up to a maximum of $30,000.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed upon for
the Company by Robert R. Holmen, Esq., Vice President and General Counsel of
CoCensys, Inc.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our financial
statements included in our Annual Report on Form 10-K for the year ended
December 31, 1998, as set forth in their report, which is incorporated in this
Prospectus by reference. Our financial statements are incorporated by
reference in reliance on their report, given on their authority as experts in
accounting and auditing.
15.
<PAGE>
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- -------------------------------------------------------------------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
About CoCensys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Where You Can Find More Information. . . . . . . . . . . . . . . . . . . . 3
Forward Looking Statements . . . . . . . . . . . . . . . . . . . . . . . . 4
Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Use of Proceeds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Selling Stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Plan of Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Legal Matters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Experts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
</TABLE>
25,100,000 SHARES
COCENSYS, INC.
COMMON STOCK
----------
PROSPECTUS
----------
APRIL 5, 1999
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses expected to be incurred
by the Registrant in connection with the sale and distribution of the securities
being registered hereby. All amounts are estimated except the Securities and
Exchange Commission registration fee and the Nasdaq National Market listing fee.
<TABLE>
<S> <C>
SEC Registration Fee . . . . . . . . . . . $ 1,647
Nasdaq National Market Listing Fee . . . . 2,000
Accounting Fees and Expenses . . . . . . . 5,000
Legal Fees and Expenses . . . . . . . . . 15,000
Printing Expenses . . . . . . . . . . . . 1,000
Miscellaneous Fees and Expenses . . . . . . 1,353
Total $ 26,000
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Registrant's Certificate of Incorporation and Bylaws include
provisions to (i) eliminate the personal liability of its directors for
monetary damages resulting from breaches of their fiduciary duty to the
extent permitted by Section 102(b)(7) of the General Corporation Law of
Delaware (the "Delaware Law") and (ii) authorize the Registrant to indemnify
its directors and officers to the fullest extent permitted by Section 145 of
the Delaware Law, including circumstances in which indemnification is
otherwise discretionary. Pursuant to Section 145 of the Delaware Law, a
corporation generally has the power to indemnify its present and former
directors, officers, employees and agents against expenses incurred by them
in connection with any suit to which they are, or are threatened to be made,
a party by reason of their serving in such positions so long as they acted in
good faith and in a manner they reasonably believed to be in, or not opposed
to, the best interests of a corporation, and with respect to any criminal
action, they had no reasonable cause to believe their conduct was unlawful.
The Registrant believes that these provisions are necessary to attract and
retain qualified persons as directors and officers. These provisions do not
eliminate liability for breach of the director's duty of loyalty to the
Registrant or its stockholders, for acts or omissions not in good faith or
involving intentional misconduct or knowing violations of law, for any
transaction from which the director derived an improper personal benefit or
for any willful or negligent payment of any unlawful dividend or any unlawful
stock purchase agreement or redemption.
The Registrant has entered into agreements with its directors and
executive officers that require the Registrant to indemnify such persons
against expenses, judgments, fines, settlements and other amounts actually
and reasonably incurred (including expenses of a derivative action) in
connection with any proceeding, whether actual or threatened, to which any
such person may be made a party by reason of the fact that such person is or
was a director or officer of the Registrant or any of its listed enterprises,
provided such person acted in good faith and in a manner such person
reasonably believed to be in or not opposed to the best interests of the
Registrant and, with respect to any criminal proceeding, had no reasonable
cause to believe his or her conduct was unlawful. The indemnification
agreements also set forth certain procedures that will apply in the event of
a claim for indemnification thereunder.
The Registrant has purchased an insurance policy covering the officers
and directors of the Registrant with respect to certain liabilities arising
under the Securities Act or otherwise.
II-1
<PAGE>
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The following exhibits are filed as part of this Registration Statement.
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- -------- -----------------------
<S> <C>
5.1 Opinion of Robert R. Holmen, Esq.
23.1 Consent of Independent Auditors
23.2 Consent of Robert R. Holmen, Esq. Reference is made to Exhibit 5.1.
24.1 Power of Attorney. Reference is made to pages II-4 and II-5.
</TABLE>
ITEM 17. UNDERTAKINGS
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: (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; and (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 (i) and (ii) do not apply if the Registration
Statement is on Form S-3 or Form S-8, and the information required to be
included in a post-effective amendment by (i) and (ii) is contained in
periodic reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Exchange Act 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.
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 Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that a claim
for indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Exchange Act (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Exchange Act) that is
incorporated by reference in 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-2
<PAGE>
The undersigned Registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act,
the information omitted from the form of prospectus filed as part of this
Registration Statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the Registrant pursuant to Rule 424(b) (1) or (4) or
497(h) under the Securities Act shall be deemed to be part of this
Registration Statement as of the time it was declared effective.
(2) For purposes of determining any liability under the Securities Act,
each post-effective amendment that contains a form of prospectus 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, the Company
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 on Form S-3 to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Irvine, County of Orange, State of
California, on the 1st day of April, 1999.
COCENSYS, INC.
By: /s/ F. Richard Nichol, Ph.D.
--------------------------------------
F. Richard Nichol, Ph.D.
President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below does hereby constitute and appoint jointly and severally, F.
Richard Nichol, Ph.D., and Robert R. Holmen, or either of them, as his or her
true and lawful attorneys-in-fact and agents, with full power of substitution
and resubstitution, for him or her and in his or her name, place and stead,
in any and all capacities, to sign the Registration Statement filed herewith
and any and all amendments to said Registration Statement (including
post-effective amendments and registration statements filed pursuant to Rule
462 and otherwise), and to file the same, with all exhibits thereto, and
other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of
them, full power and authority to do and perform each and every act and thing
requisite and necessary to be done in connection therewith, as fully to all
intents and purposes as he or she might or could do in person, hereby
ratifying and confirming all that said attorneys-in-fact and agents, or any
of them, or their substitute of substitutes, may lawfully do or cause to be
done by virtue hereof.
II-4
<PAGE>
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the persons whose signatures
appear below, which persons have signed such Registration Statement in the
capacities and on the dates indicated:
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<S> <C> <C>
/s/ F. Richard Nichol, Ph.D. President, Chief Executive April 1, 1999
------------------------------- Officer and Chairman
F. Richard Nichol Ph.D. (PRINCIPAL EXECUTIVE OFFICER)
/s/ Robert R. Holmen Vice President and General April 1, 1999
------------------------------- Counsel (PRINCIPAL
Robert R. Holmen FINANCIAL OFFICER)
/s/ Thomas Miller Controller April 1, 1999
------------------------------- (PRINCIPAL ACCOUNTING OFFICER)
Thomas Miller
/s/ Lowell E. Sears Director April 1, 1999
-------------------------------
Lowell E. Sears
/s/ James C. Blair, Ph.D. Director April 1, 1999
-------------------------------
James C. Blair, Ph.D.
/s/ Kelvin W. Gee, Ph.D. Director April 1, 1999
-------------------------------
Kelvin W. Gee, Ph.D.
/s/ Alan C. Mendelson Director April 1, 1999
-------------------------------
Alan C. Mendelson
/s/ Timothy J. Rink, M.D., Sc.D. Director April 1, 1999
-------------------------------
Timothy J. Rink, M.D., Sc.D.
/s/ Robert L. Roe, M.D. Director April 1, 1999
-------------------------------
Robert L. Roe, M.D.
/s/ Eckard Weber, M.D. Director April 1, 1999
-------------------------------
Eckard Weber, M.D.
</TABLE>
II-5
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- --------- -----------------------
<S> <C>
5.1 Opinion of Robert R. Holmen, Esq.
23.1 Consent of Independent Auditors
23.2 Consent of Robert R. Holmen, Esq. Reference is made to Exhibit 5.1.
</TABLE>
<PAGE>
EXHIBIT 5.1
[COCENSYS, INC.]
April 1, 1999
CoCensys, Inc.
201 Technology Drive
Irvine, CA 92618
Ladies and Gentleman:
You have requested my opinion with respect to certain matters in connection
with the filing by CoCensys, Inc., a Delaware corporation (the "Company"), of
a Registration Statement on Form S-3 (the "Registration Statement") with the
Securities and Exchange Commission (the "Commission"), covering the offering
of a total of 25,100,000 shares of the Company's common stock with a par
value of $0.001 (the "Shares") issuable upon conversion of 5,135 shares of
Series E Convertible Preferred Stock (the "Preferred Stock") and the exercise
of warrants to purchase up to 100,000 shares of the Company's common stock
(the "Warrants") issued by the Company in November 1998 pursuant to a private
placement in June 1998 (the "Private Placement"). All of the Shares are to
be sold by certain stockholders as described in the Registration Statement.
In connection with this opinion, I have examined and relied upon the
Registration Statement and related Prospectus included therein, the Company's
Amended and Restated Certificate of Incorporation and Bylaws, and the
originals or copies certified to our satisfaction of such records, documents,
certificates, memoranda and other instruments as in my judgment are necessary
or appropriate to enable me to render the opinion expressed below. I have
assumed the genuineness and authenticity of all documents submitted to me as
originals, and the conformity to originals of all documents where due
execution and delivery are a prerequisite to the effectiveness thereof.
On the basis of the foregoing, and in reliance thereon, I am of the opinion
that the Shares, when issued and delivered upon conversion of the Preferred
Stock in accordance with the terms of the Certificate of Powers, Designation,
Preferences, Rights and Limitations of the Preferred Stock and exercise of
the Warrants in accordance with their terms, will be validly issued, fully
paid and nonassessable.
I consent to the reference to me under the caption "Legal Matters" in the
Prospectus included in the Registration Statement and to the filing of this
opinion as an exhibit to the Registration Statement.
Very truly yours,
By: /s/ Robert R. Holmen
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" in the
Registration Statement (Form S-3) and related Prospectus of CoCensys, Inc.
for the registration of 25,100,000 shares of its common stock and to the
incorporation by reference therein of our report dated January 29, 1999
(except for the second paragraph of Note 2 as to which the date is March 24,
1999), with respect to the financial statements of CoCensys, Inc. included in
its Annual Report (Form 10-K) for the year ended December 31, 1998, filed
with the Securities and Exchange Commission.
/s/Ernst & Young LLP
Orange County, California
March 31, 1999
