As
filed with the Securities and Exchange Commission on June 11, 2009
Registration
No. 333-_____
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
——————————
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
——————————
DELCATH
SYSTEMS, INC.
(Exact
name of registrant as specified in its charter)
——————————
|
Delaware
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
06-1245881
(I.R.S.
Employer
Identification
No.)
|
——————————
600
Fifth Avenue, 23rd
Floor
New
York, NY 10020
(212)
489-2100
(Address,
including zip code, and telephone number,
including
area code, of Registrant’s principal executive offices)
——————————
Richard
L. Taney
Chief
Executive Officer
Delcath
Systems, Inc.
600
Fifth Avenue, 23rd
Floor
New
York, NY 10020
(212)
489-2100
(Name,
address, including zip code, and telephone number,
including
area code, of agent for service)
——————————
Copies
to:
Gary
J. Simon
Hughes
Hubbard & Reed LLP
One
Battery Park Plaza
New
York, NY 10004
(212)
837-6000
——————————
Approximate
date of commencement of proposed sale to the public:
From
time to time after this registration statement becomes effective.
——————————
If the
only securities being registered on this Form are being offered pursuant to
dividend or interest reinvestment plans, please check the following
box: o
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: ý
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. o.
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. o
If this
Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. o
If this
Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
|
Large
accelerated filer o
|
Accelerated
filer ý
|
|
Non-accelerated
filer o
|
Smaller
reporting company o
|
|
(Do
not check if a smaller reporting company)
|
——————————
CALCULATION
OF REGISTRATION FEE
|
Title
of Each Class of Securities
to
be Registered
|
Amount
to be
Registered
(1) (2)
|
Proposed
Maximum
Offering
Price
Per Share
|
Proposed
Maximum
Aggregate
Offering
Price
|
Amount
of
Registration
Fee
(3)
|
|
Debt
securities
|
||||
|
Common
stock, par value $0.01 per share (4)
|
||||
|
Preferred
stock, par value $0.01 per share
|
||||
|
Warrants
to Purchase Common Stock
|
||||
|
Warrants
to Purchase Preferred Stock
|
||||
|
Stock
Purchase Contracts
|
||||
|
TOTAL
|
$60,000,000
|
$3,348
|
—————
|
(1)
|
This
registration statement covers up to $60,000,000 of an indeterminate amount
of the securities of each identified class of securities. If any debt
securities are issued at an original issue discount, then the offering
price shall be in such greater principal amount as shall result in an
aggregate initial offering price not to exceed
$60,000,000.
|
2
|
(2)
|
Pursuant
to Rule 416 under the Securities Act, the securities being registered
hereunder include such indeterminate (A) number of shares of common stock,
warrants to purchase shares of common stock, warrants to purchase shares
of preferred stock, shares issuable upon exercise of such warrants and
such shares of common stock or preferred stock as may be issuable with
respect to the shares being registered hereunder as a result of stock
splits, stock dividends or similar transactions and (B) amount of debt
securities as may be sold from time to time at indeterminate prices by the
registrant..
|
|
(3)
|
Calculated
pursuant to Rule 457(o).
|
|
(4)
|
Includes
common stock purchase rights which are attached to, and trade and transfer
with, the common stock. Prior to the occurrence of certain events, such
rights will not be exercisable or evidenced separately from the common
stock and will be transferred with and only with such common
stock.
|
3
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.
Subject
to Completion, Dated June __, 2009
PROSPECTUS
$60,000,000
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
Stock
Purchase Contracts
——————————
Delcath
Systems, Inc. (the “Company”) may offer to sell from time to time debt
securities, common stock, preferred stock, stock purchase contracts and
warrants. The preferred stock of the Company may be convertible into common
stock or preferred stock of another series.
The
Company may offer securities at an aggregate offering price of up to
$60,000,000. The debt securities, common stock, preferred stock, stock purchase
contracts and warrants of the Company and the debt securities of the Company may
be offered separately or together, in multiple series, in amounts, at prices and
on terms that will be set forth in one or more prospectus supplements to this
prospectus. Because the maximum aggregate offering price of all securities is
$60,000,000, the Company’s issuance of any securities will reduce the amount of
other securities that it can issue.
This
prospectus describes some of the general terms that may apply to these
securities and the general manner in which they may be offered. Each time the
Company sells securities, a prospectus supplement will be provided that will
contain specific information about the terms of any securities offered and the
specific manner in which the securities will be offered. The prospectus
supplement will also contain information, where appropriate, about material
United States federal income tax consequences relating to, and any listing on a
securities exchange of, the securities covered by the prospectus supplement. The
prospectus supplement may add to, update or change the information in this
prospectus. You should read this prospectus and any prospectus supplement
carefully before you invest in our securities. This prospectus may not be used
to sell securities unless accompanied by a prospectus supplement.
The
Company may offer the securities directly to investors, through agents
designated from time to time by the Company, or to or through underwriters or
dealers. If any agents, underwriters, or dealers
4
are
involved in the sale of any of the securities, their names, and any applicable
purchase price, fee, commission or discount arrangement with, between or among
them will be set forth, or will be calculable from the information set forth, in
an accompanying prospectus supplement. For more detailed information, see “Plan
of Distribution” on page 22.
Our
common stock is traded on the NASDAQ Global Market under the symbol
“DCTH.” On June 10, 2009, the last reported sale price of our common
stock on the NASDAQ Global Market was $3.65.
——————————
Investing
in our common stock involves a high degree of risk. You should review
carefully the risks and uncertainties referenced under the heading “Risk
Factors” beginning on page8 of this prospectus.
——————————
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a
criminal offense.
——————————
The date
of this prospectus is June __, 2009.
5
|
Page
|
|
|
7
|
|
|
8
|
|
|
8
|
|
|
8
|
|
|
10
|
|
|
11
|
|
|
14
|
|
|
18
|
|
|
19
|
|
|
22
|
|
|
25
|
|
|
25
|
——————————
ABOUT
THIS PROSPECTUS
You
should rely only on the information contained in this prospectus and the
accompanying prospectus supplement or incorporated by reference in these
documents. No dealer, salesperson or other person is authorized to give any
information or to represent anything not contained or incorporated by reference
in this prospectus or the accompanying prospectus supplement. If anyone provides
you with different, inconsistent or unauthorized information or representations,
you must not rely on them. This prospectus and the accompanying prospectus
supplement are an offer to sell only the securities offered by these documents,
but only under circumstances and in jurisdictions where it is lawful to do so.
The information contained in this prospectus or any prospectus supplement is
current only as of the date on the front of those documents.
This
summary highlights information contained elsewhere or incorporated by reference
into this prospectus. Because it is a summary, it does not contain all of the
information that you should consider before investing in our securities. You
should read this entire prospectus carefully, including the section entitled
“Risk Factors” and the documents that we incorporate by reference into this
prospectus, before making an investment decision.
DELCATH
SYSTEMS, INC.
We are a
development stage company that has developed an innovative device designed to
administer high dose chemotherapy and other therapeutic agents to diseased
organs or regions of the body. We were incorporated in the State of
Delaware in 1988 and since inception have focused our efforts on the development
of a single product, The Delcath PHP System™, which isolates the circulatory
system of a specific organ or body region in order to deliver high dose
chemotherapy or other therapeutic agents directly to that diseased organ or body
region. The first application being tested with our system is for the treatment
of cancers of the liver. The Delcath PHP System™ isolates the liver
from the patient’s general circulatory system and delivers high doses of the
chemotherapeutic drug, melphalan hydrochloride, directly to tumors in the liver
while avoiding most of the toxicities that normally result from such high doses
of the drug. In 2006, we began a Phase III clinical trial to support
the United States Food and Drug Administration (the “FDA”) approval process for
the Delcath PHP System™. The Delcath PHP System™ is not currently
approved by the FDA, and it cannot be marketed in the United States without FDA
pre-market approval.
We also
are conducting Phase II clinical trials, testing the Delcath PHP System™ with
the drug melphalan against hepatocellular tumors (primary liver cancer) and
neuroendocrine and adenocarcinoma tumors that have spread to the liver, as well
as melanomas metastatic to the liver that have received certain prior regional
treatment.
Our
principal executive office is located at 600 Fifth Avenue, 23rd Floor,
New York, NY 10020. Our telephone number is (212)
489-2100. Our website address is
www.delcath.com. Information contained in, or accessible through, our
website does not constitute a part of this prospectus.
Unless
the context indicates otherwise, as used in this prospectus, the terms “Delcath
Systems,” “we,” “us” and “our” refer to Delcath Systems, Inc., a Delaware
corporation. We use The Delcath PHP System™ and the Delcath Systems
logo as trademarks in the United States and other countries. All
other trademarks or trade names, if any, referred to in this prospectus are the
property of their respective owners.
Investing
in our securities involves a high degree of risk. You should consider
carefully the risk factors set forth in the documents and reports filed by us
with the Securities and Exchange Commission, which we refer to as the SEC, that
are incorporated by reference into this prospectus, as well as any risks
described in any applicable prospectus supplement, before deciding whether to
buy our securities. Additional risks not known to us or that we
believe are immaterial may also significantly impair our business operations and
could result in a complete loss of your investment.
This
prospectus and the documents incorporated by reference into this prospectus
contain certain “forward-looking statements” within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of 1995 with
respect to our financial condition, results of operations and
business. Words such as “anticipates,” “expects,” “intends,” “plans,”
“predicts,” “believes,” “seeks,” “estimates,” “could,” “would,” “will,” “may,”
“can,” “continue,” “potential,” “should,” and the negative of these terms or
other comparable terminology often identify forward-looking
statements. Statements in this prospectus and the other documents
incorporated by reference that are not historical facts are hereby identified as
“forward-looking statements” for the purpose of the safe harbor provided by
Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A
of the Securities Act. These forward-looking statements are not
guarantees of future performance and are subject to risks and uncertainties that
could cause actual results to differ materially from the results contemplated by
the forward-looking statements, including the risks discussed in this
prospectus, in our Annual Report on Form 10-K for the fiscal year ended December
31, 2008 in Item 1A under “Risk Factors” as well as in Item 7A “Qualitative and
Quantitative Disclosures About Market Risk,” our Quarterly Report on Form 10-Q
for the period ended March 31, 2009 in Part II, Item 1A under “Risk Factors” as
well as in Part I, Item 3 “Qualitative and Quantitative Disclosures About Market
Risk” and the risks detailed from time to time in our future SEC
reports. These forward-looking statements include, but are not
limited to, statements about:
|
|
●
|
the
progress and results of our research and development
programs;
|
|
●
|
our
estimates regarding sufficiency of our cash resources, anticipated capital
requirements and our need for additional
financing;
|
|
●
|
the
results and timing of our clinical trials and the commencement of future
clinical trials; and
|
|
●
|
submission
and timing of applications for regulatory
approval.
|
Many of
the important factors that will determine these results are beyond our ability
to control or predict. You are cautioned not to put undue reliance on
any forward-looking statements, which speak only as of the date of this
prospectus or, in the case of documents incorporated by reference, as of the
date of such documents. Except as otherwise required by law, we do
not assume any obligation to publicly update or release any revisions to these
forward-looking statements to reflect events or circumstances after the date of
this prospectus or to reflect the occurrence of unanticipated
events.
This
prospectus is part of a registration statement we filed with the
SEC. You should rely only on the information contained in this
prospectus or incorporated by reference. We have not authorized
anyone else 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 is accurate as of any date
other than the date on the front page of this prospectus, regardless of the time
of delivery of this prospectus or any sale of securities.
We file
reports, proxy statements and other information with the SEC. You may
read and copy any reports, proxy statements or other information filed by us at
the SEC’s Public Reference Room at 100 F Street NE, Washington, D.C.
20549. You may obtain information on the operation of the Public
Reference Room by calling the SEC at (800) SEC-0330. The SEC
maintains a website that contains reports, proxy statements and other
information regarding issuers that file electronically with the SEC, including
Delcath Systems, Inc. The address of the SEC website is
http://www.sec.gov.
Important
Information Incorporated By Reference
The SEC
allows us to “incorporate by reference” information into this prospectus, which
means that we can disclose important information to you by referring you to
another document filed separately with the SEC. The SEC file number
for the documents incorporated by reference in this prospectus is
001-16133. The documents incorporated by reference into this
prospectus contain important information that you should read about
us.
The
following documents are incorporated by reference into this
document:
|
●
|
Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and
filed with the SEC on March 3,
2009;
|
|
●
|
The
information specifically incorporated by reference into our Annual Report
on Form 10-K for the fiscal year ended December 31, 2008 from our
definitive proxy statement on Schedule 14A filed with the SEC on April 30,
2009;
|
|
●
|
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 and
filed with the SEC on April 24,
2009;
|
|
●
|
Our
Current Report on Form 8-K, filed on April 10, 2009;
and
|
|
●
|
The
description of our common stock, which is registered under Section 12 of
the Exchange Act, in our registration statement on Form 8-A12B, filed
with the SEC on September 22, 2000, including any amendments or
reports filed for the purpose of updating such
description.
|
We also
incorporate by reference into this prospectus all documents (other than current
reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on
such form that are related to such items) that are filed by us with the SEC
pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act (i) after the
date of the initial registration statement and prior to effectiveness of the
registration statement, or (ii) from the date of this prospectus but prior to
the termination of the offering. These documents include periodic
reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K, as well as proxy statements.
Any
documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or
15(d) after the date of this prospectus and on or before the completion of the
resale of the shares by the selling stockholders shall also be deemed
incorporated herein by reference. These documents include our
periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form
10-Q and Current Reports on Form 8-K.
Unless we
provide otherwise in a supplement to this prospectus, we intend to use the net
proceeds from the sale of our securities covered by this prospectus for general
corporate purposes. These purposes may include funding our clinical trials,
capital expenditures, working capital, repayment of debt and
investments.
The
following description, together with the additional information we may include
in any applicable prospectus supplements and in any related free writing
prospectuses, summarizes the material terms and provisions of the debt
securities that we may offer under this prospectus. While the terms summarized
below will apply generally to any debt securities that we may offer, we will
describe the particular terms of any debt securities in more detail in the
applicable prospectus supplement. The terms of any debt securities offered under
a prospectus supplement may differ from the terms described below.
We may
issue debt securities from time to time in one or more distinct series. The debt
securities may be senior debt securities or subordinated debt securities. Senior
debt securities may be issued under a senior indenture and subordinated debt
securities may be issued under a subordinated indenture. If we issue debt
securities pursuant to an indenture, in the applicable prospectus supplement we
will specify the trustee under such indenture. We will include in a supplement
to this prospectus the specific terms of debt securities being offered,
including the terms, if any, on which debt securities may be convertible into or
exchangeable for common stock, preferred stock or other debt securities. The
statements and descriptions in this prospectus or in any prospectus supplement
regarding provisions of debt securities and any indentures are summaries of
these provisions, do not purport to be complete and are subject to, and are
qualified in their entirety by reference to, all of the provisions of the debt
securities and the indentures (including any amendments or supplements we may
enter into from time to time which are permitted under the debt securities or
any indenture).
Unless
otherwise specified in a prospectus supplement, the debt securities will be
direct unsecured obligations of the Company. Any debt securities designated as
senior will rank equally with any of our other senior and unsubordinated debt.
Any debt securities designated as subordinated will be subordinate and junior in
right of payment to any senior indebtedness. There may be subordinated debt
securities that are senior or junior to other series of subordinated debt
securities.
The
applicable prospectus supplement will set forth the terms of the debt securities
or any series thereof, including, if applicable:
|
●
|
the
title of the debt securities and whether the debt securities will be
senior debt securities or subordinated debt
securities;
|
|
●
|
any
limit upon the aggregate principal amount of the debt
securities;
|
|
●
|
whether
the debt securities will be issued as registered securities, bearer
securities or both, and any restrictions on the exchange of one form of
debt securities for another and on the offer, sale and delivery of the
debt securities in either form;
|
|
●
|
the
date or dates on which the principal amount of the debt securities will
mature;
|
|
●
|
if
the debt securities bear interest, the rate or rates at which the debt
securities bear interest and the date or dates from which interest will
accrue;
|
|
●
|
if
the debt securities bear interest, the dates on which interest will be
payable and the regular record dates for interest
payments;
|
|
●
|
the
place or places where the payment of principal, any premium and interest
will be made, if other than or in addition to the Borough of Manhattan,
The City of New York, where the
debt
|
securities
may be surrendered for transfer or exchange and where notices or demands to or
upon us may be served;
|
●
|
any
optional redemption provisions, which would allow us to redeem the debt
securities in whole or in part;
|
|
●
|
any
sinking fund or other provisions that would obligate us to redeem, repay
or purchase the debt securities;
|
|
●
|
if
the currency in which the debt securities will be issuable is United
States dollars, the denominations in which any registered securities will
be issuable, if other than denominations of $1,000 and any integral
multiple thereof, and the denominations in which any bearer securities
will be issuable, if other than the denomination of
$5,000;
|
|
●
|
if
other than the entire principal amount, the portion of the principal
amount of debt securities which will be payable upon a declaration of
acceleration of the maturity of the debt
securities;
|
|
●
|
the
events of default and covenants relevant to the debt securities,
including, the inapplicability of any event of default or covenant set
forth in the indenture relating to the debt securities, or the
applicability of any other events of defaults or covenants in addition to
the events of default or covenants set forth in the indenture relating to
the debt securities;
|
|
●
|
the
name and location of the corporate trust office of the applicable trustee
under the indenture for such series of
notes;
|
|
●
|
if
other than United States dollars, the currency in which the debt
securities will be paid or
denominated;
|
|
●
|
if
the debt securities are to be payable, at our election or the election of
a holder of the debt securities, in a currency other than that in which
the debt securities are denominated or stated to be payable, the terms and
conditions upon which that election may be made, and the time and manner
of determining the exchange rate between the currency in which the debt
securities are denominated or stated to be payable and the currency in
which the debt securities are to be so
payable;
|
|
●
|
the
designation of the original currency determination agent, if
any;
|
|
●
|
if
the debt securities are issuable as indexed securities, the manner in
which the amount of payments of principal, any premium and interest will
be determined;
|
|
●
|
if
the debt securities do not bear interest, the dates on which we will
furnish to the applicable trustee the names and addresses of the holders
of the debt securities;
|
|
●
|
if
other than as set forth in an indenture, provisions for the satisfaction
and discharge or defeasance or covenant defeasance of that indenture with
respect to the debt securities issued under that
indenture;
|
|
●
|
the
date as of which any bearer securities and any global security will be
dated if other than the date of original issuance of the first debt
security of a particular series to be
issued;
|
|
●
|
whether
and under what circumstances we will pay additional amounts to non-United
States holders in respect of any tax assessment or government
charge;
|
|
●
|
whether
the debt securities will be issued in whole or in part in the form of a
global security or securities and, in that case, any depositary and global
exchange agent for the global security or securities, whether the global
form shall be permanent or temporary and, if applicable, the exchange
date;
|
|
●
|
if
debt securities are to be issuable initially in the form of a temporary
global security, the circumstances under which the temporary global
security can be exchanged for definitive debt securities and whether the
definitive debt securities will be registered securities, bearer
securities or will be in global form and provisions relating to the
payment of interest in respect of any portion of a global security payable
in respect of an interest payment date prior to the exchange
date;
|
|
●
|
the
extent and manner to which payment on or in respect of debt securities
will be subordinated to the prior payment of our other liabilities and
obligations;
|
|
●
|
whether
payment of any amount due under the debt securities will be guaranteed by
one or more guarantors, including one or more of our
subsidiaries;
|
|
●
|
whether
the debt securities will be convertible and the terms of any conversion
provisions;
|
|
●
|
the
forms of the debt securities; and
|
|
●
|
any
other terms of the debt securities, which terms shall not be inconsistent
with the requirements of the Trust Indenture Act of 1939, as
amended.
|
This
prospectus is part of a registration statement that does not limit the aggregate
principal amount of debt securities that we may issue and provides that we may
issue debt securities from time to time in one or more series under one or more
indentures, in each case with the same or various maturities, at par or at a
discount. Unless indicated in a prospectus supplement, we may issue additional
debt securities of a particular series without the consent of the holders of the
debt securities of such series outstanding at the time of the issuance. Any such
additional debt securities, together with all other outstanding debt securities
of that series, will constitute a single series of debt securities under the
applicable indenture.
We intend
to disclose any restrictive covenants for any issuance or series of debt
securities in the applicable prospectus supplement.
The
following description of our common stock and preferred stock, together with the
additional information we include in any applicable prospectus supplements and
in any related free writing prospectuses, summarizes the material terms and
provisions of the common stock and preferred stock that we may offer under this
prospectus. The following description of our capital stock does not purport to
be complete and is subject to, and qualified in its entirety by, our Amended and
Restated Certificate of Incorporation and our Amended and Restated By-Laws,
which are exhibits to the registration statement of which this prospectus forms
a part, and by applicable law. We refer in this section to our Amended and
Restated Certificate of Incorporation as our certificate of incorporation, and
we refer to our Amended and Restated By-Laws as our by-laws. The terms of our
common stock and preferred stock may also be affected by Delaware
law.
Authorized
Capital Stock
Our
authorized capital stock consists of 70,000,000 shares of our common stock,
$0.01 par value per share, and 10,000,000 shares of undesignated
preferred stock, $0.01 par value per share. As of June 10, 2009, we had
25,355,254 shares of common stock outstanding and no shares of preferred
stock outstanding.
Common
Stock
Voting
Holders
of our common stock are entitled to one vote per share on matters to be voted on
by stockholders and also are entitled to receive such dividends, if any, as may
be declared from time to time by our board of directors in its discretion out of
funds legally available therefor. Holders of our common stock have exclusive
voting rights for the election of our directors and all other matters requiring
stockholder action, except with respect to amendments to our certificate of
incorporation that alter or change the powers, preferences, rights or other
terms of any outstanding preferred stock if the holders of such affected series
of preferred stock are entitled to vote on such an amendment or filling
vacancies on the board of directors.
Dividends
Holders
of common stock are entitled to share ratably in any dividends declared by our
board of directors, subject to any preferential dividend rights of any
outstanding preferred stock. Dividends consisting of shares of common stock may
be paid to holders of shares of common stock. We do not intend to pay cash
dividends in the foreseeable future.
Liquidation
and Dissolution
Upon our
liquidation or dissolution, the holders of our common stock will be entitled to
receive pro rata all assets remaining available for distribution to stockholders
after payment of all liabilities and provision for the liquidation of any shares
of preferred stock at the time outstanding.
Other
Rights and Restrictions
Our
common stock has no preemptive or other subscription rights, and there are no
conversion rights or redemption or sinking fund provisions with respect to such
stock. Our common stock is not
subject
to redemption by us. Our certificate of incorporation and bylaws do not restrict
the ability of a holder of common stock to transfer the stockholder’s shares of
common stock. When we issue shares of common stock under this prospectus, the
shares will be fully paid and non-assessable and will not have, or be subject
to, any preemptive or similar rights.
Listing
Our
common stock is listed on The NASDAQ Global Market under the symbol “DCTH.” On
June 10, 2009, the last reported sale price for our common stock on The NASDAQ
Global Market was $3.65 per share.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is American Stock Transfer
& Trust Company.
Preferred
Stock
Our board
of directors has the authority to issue up to 10,000,000 shares of preferred
stock in one or more series and to determine the rights and preferences of the
shares of any such series without stockholder approval, none of which are
outstanding. Our board of directors may issue preferred stock in one or more
series and has the authority to fix the rights, preferences, privileges and
restrictions of this preferred stock, including dividend rights, conversion
rights, voting rights, terms of redemption, liquidation preferences, sinking
fund terms and the number of shares constituting any series or the designation
of a series, without further vote or action by the stockholders. 1 The ability of our board
of directors to issue preferred stock without stockholder approval could have
the effect of delaying, deferring or preventing a change of control of us or the
removal of existing management.
If we
decide to issue any preferred stock pursuant to this prospectus, we will
describe in a prospectus supplement the terms of the preferred stock, including,
if applicable, the following:
|
●
|
the
title of the series and stated
value;
|
|
●
|
the
number of shares of the series of preferred stock offered, the liquidation
preference per share, if applicable, and the offering
price;
|
|
●
|
the
applicable dividend rate(s) or amount(s), period(s) and payment date(s) or
method(s) of calculation thereof;
|
|
●
|
the
date from which dividends on the preferred stock will accumulate, if
applicable;
|
|
●
|
any
procedures for auction and
remarketing;
|
|
●
|
any
provisions for a sinking fund;
|
____________________
1. To
consider conforming to charter.
|
●
|
any
applicable provision for redemption and the price or prices, terms and
conditions on which preferred stock may be
redeemed;
|
|
●
|
any
securities exchange listing;
|
|
●
|
any
voting rights and powers;
|
|
●
|
whether
interests in the preferred stock will be represented by depository
shares;
|
|
●
|
the
terms and conditions, if applicable, of conversion into shares of our
common stock, including the conversion price or rate or manner of
calculation thereof;
|
|
●
|
a
discussion of any material U.S. federal income tax
considerations;
|
|
●
|
the
relative ranking and preference as to dividend rights and rights upon our
liquidation, dissolution or the winding up of our
affairs;
|
|
●
|
any
limitations on issuance of any series of preferred stock ranking senior to
or on a parity with such series of preferred stock as to dividend rights
and rights upon our liquidation, dissolution or the winding up of our
affairs; and
|
|
●
|
any
other specific terms, preferences, rights, limitations or restrictions of
such series of preferred stock.
|
Certain
Anti-Takeover Provisions of Delaware Law and our Certificate of Incorporation
and Bylaws
We are
not subject to Section 203 of the Delaware General Corporation Law, which
prohibits Delaware corporations from engaging in a wide range of specified
transactions with any interested stockholder, defined to include, among others,
any person other than such corporation and any of its majority owned
subsidiaries who own 15% or more of any class or series of stock entitled to
vote generally in the election of directors, unless, among other exceptions, the
transaction is approved by (i) our board of directors prior to the date the
interested stockholder obtained such status or (ii) the holders of two
thirds of the outstanding shares of each class or series of stock entitled to
vote generally in the election of directors, not including those shares owned by
the interested stockholder.
Staggered
Board of Directors
Our
certificate of incorporation and by-laws provide that our board of directors be
classified into three classes of directors of approximately equal size. As a
result, in most circumstances, a person can gain control of our board only by
successfully engaging in a proxy contest at two or more annual
meetings.
Stockholder
Rights Plan;
On
October 30, 2001, the Company entered into a Rights Agreement with American
Stock Transfer & Trust Company (the “Rights Agreement”) in connection with
the implementation of the Company’s stockholder rights plan (the “Rights Plan”).
The purposes of the Rights Plan are to deter, and protect the Company’s
shareholders from, certain coercive and otherwise unfair takeover tactics and to
enable the board of directors to represent effectively the interests of
shareholders in the event of a takeover attempt. The Rights Plan does not deter
negotiated mergers or business combinations that the
board of
directors determines to be in the best interests of the Company and its
shareholders. To implement the Rights Plan, the board of directors declared a
dividend of one Common Stock purchase right (a “Right”) for each share of Common
Stock of the Company, par value $0.01 per share (the “Common Stock”) outstanding
at the close of business on November 14, 2001 (the “Record Date”) or issued by
the Company on or after such date and prior to the earlier of the Distribution
Date, the Redemption Date or the Final Expiration Date (as such terms are
defined in the Rights Agreement). The rights expire October 30, 2011. Each Right
entitles the registered holder, under specified circumstances, to purchase from
the Company for $5.00, subject to adjustment (the “Purchase Price”), a number of
shares determined by dividing the then applicable Purchase Price by 50% of the
then current market price per share in the event that a person or group
announces that it has acquired, or intends to acquire, 15% or more of the
Company’s outstanding Common Stock. On April 9, 2007 the Board of Directors
voted to increase the threshold level to 20%.
Authorized
But Unissued Shares
Our
authorized but unissued shares of common stock and preferred stock are available
for future issuances without stockholder approval and could be utilized for a
variety of corporate purposes, including future offerings to raise additional
capital, corporate acquisitions, employee benefit plans and stockholder rights
plans. The existence of authorized but unissued and unreserved common stock and
preferred stock could render more difficult or discourage an attempt to obtain
control of us by means of a proxy contest, tender offer, merger or
otherwise.
The
following description, together with the additional information that we include
in any applicable prospectus supplements and in any related free writing
prospectuses, summarizes the material terms and provisions of the stock purchase
contracts that we may offer under this prospectus. While the terms we have
summarized below will apply generally to any stock purchase contracts that we
may offer under this prospectus, we will describe the particular terms of any
series of stock purchase contracts in more detail in the applicable prospectus
supplement. The terms of any stock purchase contracts offered under a prospectus
supplement may differ from the terms described below.
We may
issue stock purchase contracts, including contracts obligating holders to
purchase from us and us to sell to the holders, a specified number of shares of
common stock or preferred stock at a future date or dates. Alternatively, the
stock purchase contracts may obligate us to purchase from holders, and obligate
holders to sell to us, a specified or varying number of shares of common stock
or preferred stock. The consideration per share of common stock or preferred
stock may be fixed at the time the stock purchase contracts are issued or may be
determined by a specific reference to a formula set forth in the stock purchase
contracts. The stock purchase contracts may provide for settlement by delivery
by us or on our behalf of shares of the underlying security, or they may provide
for settlement by reference or linkage to the value, performance or trading
price of the underlying security. The stock purchase contracts may require us to
make periodic payments to the holders of the certain of our securities or vice
versa, and such payments may be unsecured or prefunded on some basis and may be
paid on a current or on a deferred basis. The stock purchase contracts may
require holders to secure their obligations thereunder in a specified manner and
may provide for the prepayment of all or part of the consideration payable by
holders in connection with the purchase of the underlying security or other
property pursuant to the stock purchase contracts.
The
securities related to the stock purchase contracts may be pledged to a
collateral agent for our benefit pursuant to a pledge agreement to secure the
obligations of holders of stock purchase contracts to purchase the underlying
security or property under the related stock purchase contracts. The rights of
holders of stock purchase contracts to the related pledged securities will be
subject to our security interest therein created by the pledge agreement. No
holder of stock purchase contracts will be permitted to withdraw the pledged
securities related to such stock purchase contracts from the pledge
arrangement.
The
following description, together with the additional information we may include
in any applicable prospectus supplements, summarizes the material terms and
provisions of the warrants that we may offer under this prospectus and the
related warrant agreements and warrant certificates. While the terms summarized
below will apply generally to any warrants that we may offer, we will describe
the particular terms of any series of warrants in more detail in the applicable
prospectus supplement. The terms of any warrants offered under a prospectus
supplement may differ from the terms described below.
We will
file as exhibits to the registration statement of which this prospectus is a
part, or will incorporate by reference from reports that we file with the SEC,
the form of warrant agreement, including a form of warrant certificate, that
describes the terms of the particular warrants we are offering before the
issuance of the related warrants. The following summaries of material provisions
of the warrants and the warrant agreements are subject to, and qualified in
their entirety by reference to, all the provisions of the warrant agreement and
warrant certificate applicable to the warrants that we may offer under this
prospectus. We urge you to read the applicable prospectus supplements related to
the warrants that we may offer under this prospectus, as well as any related
free writing prospectuses, and the complete warrant agreements and warrant
certificates that contain the terms of the warrants.
General
We may
issue warrants for the purchase of common stock or preferred stock in one or
more series. We may issue warrants independently or together with common stock
and preferred stock, and the warrants may be attached to or separate from these
securities.
We may
evidence each series of warrants by warrant certificates that we will issue
under a separate agreement. We may enter into a warrant agreement with a warrant
agent. We will indicate the name and address and other information regarding the
warrant agent in the applicable prospectus supplement relating to a particular
warrants.
If we
decide to issue warrants pursuant to this prospectus, we will specify in a
prospectus supplement the terms of the warrants, including, if applicable, the
following:
|
●
|
the
offering price and aggregate number of warrants
offered;
|
|
●
|
the
designation and terms of the securities with which the warrants are issued
and the number of warrants issued with each such security or each
principal amount of such security;
|
|
●
|
the
date on and after which the warrants and the related securities will be
separately transferable;
|
|
●
|
in
the case of warrants to purchase stock, the number of shares of stock
purchasable upon the exercise of one warrant and the price at which these
shares may be purchased upon such
exercise;
|
|
●
|
the
effect of any merger, consolidation, sale or other disposition of our
business on the warrant agreement and the
warrants;
|
|
●
|
the
terms of any rights to redeem or call the
warrants;
|
|
●
|
any
provisions for changes to or adjustments in the exercise price or number
of securities issuable upon exercise of the
warrants;
|
|
●
|
the
dates on which the right to exercise the warrants will commence and
expire;
|
|
●
|
the
manner in which the warrant agreement and warrants may be
modified;
|
|
●
|
a
discussion of any material U.S. federal income tax considerations of
holding or exercising the warrants;
|
|
●
|
the
terms of the securities issuable upon exercise of the warrants;
and
|
|
●
|
any
other specific terms, preferences, rights or limitations of or
restrictions on the warrants.
|
Before
exercising their warrants, holders of warrants may have no rights of holders of
the securities purchasable upon such exercise, including, in the case of
warrants to purchase common stock or preferred stock, the right to receive
dividends, if any, or payments upon our liquidation, dissolution or winding up
or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase shares of our stock at the exercise
price that we describe in the applicable prospectus supplement. Holders of the
warrants may exercise the warrants at any time up to the specified time on the
expiration date that we set forth in the applicable prospectus supplement. After
the close of business on the expiration date, unexercised warrants will become
void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information,
and paying the required amount to the warrant agent in immediately available
funds, as provided in the applicable prospectus supplement. If we so indicate in
the applicable prospectus supplement, the warrants may also provide that they
may be exercised on a “cashless” or net basis. We will set forth on the reverse
side of the warrant certificate, if applicable, and in the applicable prospectus
supplement the information that the holder of the warrant will be required to
deliver to us or a warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed
and duly executed at our offices, the corporate trust office of a warrant agent
or any other office indicated in the applicable prospectus supplement, we will
issue and deliver the common stock or preferred stock purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant
certificate are exercised, then we will issue a new warrant certificate for the
remaining amount of warrants. If we so indicate in the applicable prospectus
supplement, holders of the warrants may surrender shares of common stock or
preferred stock as all or part of the exercise price for warrants.
Enforceability
of Rights by Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant
agreement and will not assume any obligation or relationship of agency or trust
with any holder of any warrant. A single bank or trust company may act as
warrant agent for more than one issue of warrants. A warrant agent will have no
duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a
warrant may, without the consent of the related warrant agent or
the
holder of
any other warrant, enforce by appropriate legal action its right to exercise,
and receive the securities purchasable upon exercise of, its
warrants.
We may
sell the securities in any one or more of the following ways:
|
●
|
directly
to investors, including through a specific bidding, auction or other
process;
|
|
●
|
to
investors through agents;
|
|
●
|
directly
to agents;
|
|
●
|
to
or through brokers or dealers;
|
|
●
|
to
the public through underwriting syndicates led by one or more managing
underwriters;
|
|
●
|
to
one or more underwriters acting alone for resale to investors or to the
public; and
|
|
●
|
through
a combination of any such methods of
sale.
|
The
Company’s common stock or preferred stock may be issued upon conversion of debt
securities or preferred stock of the Company. Securities may also be issued upon
exercise of warrants of the Company. The Company reserves the right to sell
securities directly to investors on its own behalf in those jurisdictions where
it is authorized to do so.
If we
sell securities to a dealer acting as principal, the dealer may resell such
securities at varying prices to be determined by such dealer in its discretion
at the time of resale without consulting with us and such resale prices may not
be disclosed in the applicable prospectus supplement.
Any
underwritten offering may be on a best efforts or a firm commitment basis. We
may also offer securities through subscription rights distributed to our
stockholders on a pro rata basis, which may or may not be transferable. In any
distribution of subscription rights to stockholders, if all of the underlying
securities are not subscribed for, we may then sell the unsubscribed securities
directly to third parties or may engage the services of one or more
underwriters, dealers or agents, including standby underwriters, to sell the
unsubscribed securities to third parties.
Sales of
the securities may be effected from time to time in one or more transactions,
including negotiated transactions:
|
●
|
at
a fixed price or 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.
|
Any of
the prices may represent a discount from the then prevailing market
prices.
In the
sale of the securities, underwriters or agents may receive compensation from us
in the form of underwriting discounts or commissions and may also receive
compensation from purchasers of the securities, for whom they may act as agents,
in the form of discounts, concessions or commissions.
Underwriters
may sell the securities to or through dealers, and such dealers may receive
compensation in the form of discounts, concessions or commissions from the
underwriters and/or commissions from the purchasers for whom they may act as
agents. Discounts, concessions and commissions may be changed from time to time.
Dealers and agents that participate in the distribution of the securities may be
deemed to be underwriters under the Securities Act, and any discounts,
concessions or commissions they receive from us and any profit on the resale of
securities they realize may be deemed to be underwriting compensation under
applicable federal and state securities laws.
The
applicable prospectus supplement will, where applicable:
|
●
|
identify
any such underwriter, dealer or
agent;
|
|
●
|
describe
any compensation in the form of discounts, concessions, commissions or
otherwise received from us by each such underwriter or agent and in the
aggregate by all underwriters and
agents;
|
|
●
|
describe
any discounts, concessions or commissions allowed by underwriters to
participating dealers;
|
|
●
|
identify
the amounts underwritten; and
|
|
●
|
identify
the nature of the underwriter’s or underwriters’ obligation to take the
securities.
|
Unless
otherwise specified in the related prospectus supplement, each series of
securities will be a new issue with no established trading market, other than
shares of common stock of the Company, which are listed on the NASDAQ Global
Market. Any common stock sold pursuant to a prospectus supplement will be listed
on the NASDAQ Global Market, subject to official notice of issuance. We may
elect to list any warrants or series of debt securities or preferred stock on an
exchange, but we are not obligated to do so. It is possible that one or more
underwriters may make a market in the securities, but such underwriters will not
be obligated to do so and may discontinue any market making at any time without
notice. No assurance can be given as to the liquidity of, or the trading market
for, any offered securities.
We may
enter into derivative transactions with third parties, or sell securities not
covered by this prospectus to third parties in privately negotiated
transactions. If disclosed in the applicable prospectus supplement, in
connection with those derivative transactions third parties may sell securities
covered by this prospectus and such prospectus supplement, including in short
sale transactions. If so, the third party may use securities pledged by us or
borrowed from us or from others to settle those short sales or to close out any
related open borrowings of securities, and may use securities received from us
in settlement of those derivative transactions to close out any related open
borrowings of securities. If the third party is or may be deemed to be an
underwriter under the Securities Act, it will be identified in the applicable
prospectus supplements.
Until the
distribution of the securities is completed, rules of the SEC may limit the
ability of any underwriters and selling group members to bid for and purchase
the securities. As an exception to these rules, underwriters are permitted to
engage in some transactions that stabilize the price of the securities. Such
transactions consist of bids or purchases for the purpose of pegging, fixing or
maintaining the price of the securities.
Underwriters
may engage in overallotment. If any underwriters create a short position in the
securities in an offering in which they sell more securities than are set forth
on the cover page of the
applicable
prospectus supplement, the underwriters may reduce that short position by
purchasing the securities in the open market.
The lead
underwriters may also impose a penalty bid on other underwriters and selling
group members participating in an offering. This means that if the lead
underwriters purchase securities in the open market to reduce the underwriters’
short position or to stabilize the price of the securities, they may reclaim the
amount of any selling concession from the underwriters and selling group members
who sold those securities as part of the offering.
In
general, purchases of a security for the purpose of stabilization or to reduce a
short position could cause the price of the security to be higher than it might
be in the absence of such purchases. The imposition of a penalty bid might also
have an effect on the price of a security to the extent that it were to
discourage resales of the security before the distribution is
completed.
We do not
make any representation or prediction as to the direction or magnitude of any
effect that the transactions described above might have on the price of the
securities. In addition, we do not make any representation that underwriters
will engage in such transactions or that such transactions, once commenced, will
not be discontinued without notice.
Under
agreements into which we may enter, underwriters, dealers and agents who
participate in the distribution of the securities may be entitled to
indemnification by us against or contribution towards certain civil liabilities,
including liabilities under the applicable securities laws.
Underwriters,
dealers and agents may engage in transactions with us, perform services for us
or be our tenants in the ordinary course of business.
If
indicated in the applicable prospectus supplement, we will authorize
underwriters or other persons acting as our agents to solicit offers by
particular institutions to purchase securities from us at the public offering
price set forth in such prospectus supplement pursuant to delayed delivery
contracts providing for payment and delivery on the date or dates stated in such
prospectus supplement. Each delayed delivery contract will be for an amount no
less than, and the aggregate amounts of securities sold under delayed delivery
contracts shall be not less nor more than, the respective amounts stated in the
applicable prospectus supplement. Institutions with which such contracts, when
authorized, may be made include commercial and savings banks, insurance
companies, pension funds, investment companies, educational and charitable
institutions and others, but will in all cases be subject to our approval. The
obligations of any purchaser under any such contract will be subject to the
conditions that (a) the purchase of the securities shall not at the time of
delivery be prohibited under the laws of any jurisdiction in the United States
to which the purchaser is subject, and (b) if the securities are being sold to
underwriters, we shall have sold to the underwriters the total amount of the
securities less the amount thereof covered by the contracts. The underwriters
and such other agents will not have any responsibility in respect of the
validity or performance of such contracts.
To comply
with applicable state securities laws, the securities offered by this prospectus
will be sold, if necessary, in such jurisdictions only through registered or
licensed brokers or dealers. In addition, securities may not be sold in some
states 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.
Underwriters,
dealers or agents that participate in the offer of securities, or their
affiliates or associates, may have engaged or engage in transactions with and
perform services for, the Company in
the
ordinary course of business for which they may have received or receive
customary fees and reimbursement of expenses.
The
validity of the securities being offered hereby will be passed upon for us by
Hughes Hubbard & Reed LLP, New York, New York.
CCR LLP,
independent registered public accounting firm, has audited our financial
statements and schedule included in our Annual Report on Form 10-K for the year
ended December 31, 2008, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration
statement. Our financial statements and schedule are incorporated by
reference in reliance on CCR LLP’s report, given on their authority as experts
in accounting and auditing.
PART
II
INFORMATION
NOT REQUIRED IN THE PROSPECTUS
Item
14. Other Expenses of
Issuance and Distribution.
The
following table sets forth the estimated costs and expenses payable by the
registrant in connection with the common stock being registered. The
warrant holders will not bear any portion of such expenses. All the
amounts shown are estimates, except for the SEC registration fee.
|
SEC
registration
fee
|
$ |
3,348
|
||
|
Accounting
fees and
expenses
|
5,000
|
|||
|
Legal
fees and
expenses
|
20,000
|
|||
|
Printing
and miscellaneous
expenses
|
1,652
|
|||
|
Total
|
$ |
30,000
|
Item
15. Indemnification of
Directors and Officers.
The
registrant’s amended and restated certificate of incorporation contains
provisions permitted under Delaware law relating to the liability of
directors. These provisions eliminate a director’s personal liability
for monetary damages resulting from a breach of fiduciary duty, except in
circumstances involving wrongful acts, such as:
|
●
|
any
breach of the director’s duty of loyalty to the registrant or its
stockholders;
|
|
●
|
any
act or omission not in good faith or that involves intentional misconduct
or a knowing violation of the law;
|
|
●
|
any
act related to unlawful stock repurchases, redemptions or other
distribution or payments of dividends;
or
|
|
●
|
any
transaction from which the director derived an improper personal
benefit.
|
These
provisions do not limit or eliminate the registrant’s rights or any
stockholder’s rights to seek non-monetary relief, such as an injunction or
rescission, in the event of a breach of a director’s fiduciary
duty. These provisions will not alter a director’s liability under
federal securities laws.
The
registrant has entered into indemnification agreements with each of its
directors and executive officers that require it to indemnify such persons
against any and all expenses (including attorneys’ fees), witness fees,
judgments, fines, settlements and other amounts incurred (including expenses of
a derivative action) in connection with any action, suit or proceeding or
alternative dispute resolution mechanism, inquiry hearing or investigation,
whether threatened, pending or completed, to which any such person may be made a
party by reason of the fact that such person is or was a director, an officer or
an employee of the registrant or is or was serving at the request of the Company
as a director, officer or employee of another corporation, limited liability
company, partnership or other enterprise, provided that such person’s conduct
did not constitute a breach of his or her duty of loyalty to the registrant or
its stockholders, and was not an act or omission not in good faith or which
involved intentional misconduct or a knowing violation of laws. The
indemnification agreements also set forth certain procedures that will apply in
the event of a claim for indemnification thereunder. At present,
there
is no
pending litigation or proceeding involving any of the registrant’s directors,
officers or employees for which indemnification is sought, nor is the registrant
aware of any threatened litigation that may result in claims for indemnification
by the registrant.
The
registrant is required to indemnify its other employees and other agents, as
permitted by the DGCL or any other applicable law.
The
registrant maintains directors’ and officers’ liability insurance. The policy
insures the registrant’s directors and officers against unindemnified losses
arising from certain wrongful acts in their capacities as directors and officers
and reimburses the registrant for those losses for which the registrant has
lawfully indemnified the directors and officers.
Item
16. Exhibits.
See the
Exhibit Index which is incorporated herein by reference.
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
of 1933;
|
|
|
(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. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in
the effective 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
paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information
required to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the Commission by the registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference in the registration statement, or is
contained in a form of prospectus filed pursuant to Rule 424(b) that is part of
the registration statement.
|
|
(2)
|
That,
for the purpose of determining any liability under the Securities Act of
1933, 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.
|
|
|
(4)
|
That,
for the purpose of determining liability under the Securities Act of 1933
to any purchaser:
|
|
|
(i)
|
If
the registrant is relying on Rule
430B:
|
|
|
(A)
|
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed
prospectus was deemed part of and included in the registration statement;
and
|
|
|
(B)
|
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or
(b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x)
for the purpose of providing the information required by Section 10(a) of
the Securities Act of 1933 shall be deemed to be part of and included in
the registration statement as of the earlier of the date such form of
prospectus is first used after effectiveness or the date of the first
contract of sale of securities in the offering described in the
prospectus. As provided in Rule 430B, for liability purposes of
the issuer and any person that is at that date an underwriter, such date
shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering
thereof. Provided, however, that
no statement made in a registration statement or prospectus that is part
of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a
time of contract of sale prior to such effective date, supersede or modify
any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document
immediately prior to such effective date;
or
|
|
|
(ii)
|
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to
Rule 424(b) as part of a registration statement relating to an offering,
other than registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be deemed to be part of
and included in the registration statement as of the date it is first used
after effectiveness. Provided, however, that
no statement made in a registration statement or prospectus that is part
of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a
time of contract of sale
|
prior to
such first use, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of first
use.
|
|
(5)
|
That,
for purposes of determining any liability under the Securities Act of
1933, 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.
|
|
|
(6)
|
That,
for the purpose of determining liability of the registrant under the
Securities Act of 1933 to any purchaser in the initial distribution of the
securities: The undersigned registrant undertakes that in a primary
offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell
the securities to the purchaser, if the securities are offered or sold to
such purchaser by means of any of the following communications, the
undersigned registrant will be a seller to the purchaser and will be
considered to offer or sell such securities to such
purchaser:
|
|
|
1.
|
Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424;
|
|
2.
|
Any
free writing prospectus relating to the offering prepared by or on behalf
of the undersigned registrant or used or referred to by the undersigned
registrant;
|
|
3.
|
The
portion of any other free writing prospectus relating to the offering
containing material information about the undersigned registrant or its
securities provided by or on behalf of the undersigned registrant;
and
|
|
4.
|
Any
other communication that is an offer in the offering made by the
undersigned registrant to the
purchaser.
|
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 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 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 Act and will
be governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant 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, in New York, NY, on
June 9, 2009.
| DELCATH SYSTEMS, INC. | |||
|
|
By:
|
/s/ Richard L. Taney | |
| Richard L. Taney | |||
| Chief Executive Officer | |||
POWER
OF ATTORNEY
KNOW ALL
PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Richard L. Taney, and each or any one of them, his or
her true and lawful attorney-in-fact and agent, 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 any and all amendments (including post-effective
amendments) to this Registration Statement and to sign any and all additional
registration statements relating to the Registration Statement and filed
pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and to file
the same, with all exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorney-in-fact and agent or his substitute or substitutes, 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 attorney-in-fact and agent 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 below by the following persons in the capacities and on the
dates indicated.
|
Signature
|
Title
|
Date
|
|
/s/
Richard L. Taney
|
Chief
Executive Officer and Director
|
June
9, 2009
|
|
Richard
L. Taney
|
(principal
executive officer)
|
|
|
/s/
Barbra Keck
|
Controller
|
June
9, 2009
|
|
Barbra
Keck
|
(principal
financial and accounting officer)
|
|
|
/s/
Harold S. Koplewicz
|
Chairman
of the Board
|
June
9, 2009
|
|
Harold
S. Koplewicz, M.D.
|
||
|
/s/
Laura Philips
|
Director
|
June
9, 2009
|
|
Laura
Philips, Ph.D.
|
|
Signature
|
Title
|
Date
|
|
/s/
Eamonn Hobbs
|
Director
|
June
9, 2009
|
|
Eamonn
Hobbs
|
||
|
/s/
Robert Ladd
|
Director
|
June
9, 2009
|
|
Robert
Ladd
|
||
|
/s/
Pamela Contag
|
Director
|
June
9, 2009
|
|
Pamela
Contag
|
||
|
/s/
Roger Stoll
|
Director
|
June
9, 2009
|
|
Roger
Stoll
|
EXHIBIT
INDEX
|
Exhibit
Number
|
Description
of the Document
|
|
|
4.1
|
Amended
and Restated Certificate of Incorporation of Delcath Systems, Inc., as
amended to June 30, 2005 (incorporated by reference to Exhibit 3.1 to
Company’s Current Report on Form 8-K filed June 5, 2006 (Commission File
No. 001-16133).
|
|
|
4.2
|
Amended
and Restated By-Laws of Delcath Systems, Inc. (incorporated by reference
to Exhibit 3.2 to Amendment No. 1 to Company’s Registration Statement on
Form SB-2 (Registration No. 333-39470)).
|
|
|
4.3
|
Rights
Agreement, dated October 30, 2001, by and between Delcath Systems, Inc.
and American Stock Transfer & Trust Company, as Rights Agent
(incorporated by reference to Exhibit 4.7 to the Company’s Form 8-A filed
November 14, 2001 (Commission File No. 001-16133)).
|
|
|
5.1*
|
Opinion
of Hughes Hubbard & Reed LLP as to the legality of the securities
being registered.
|
|
|
23.1*
|
Consent
of CCR LLP
|
|
|
23.2
|
Consent
of Hughes Hubbard & Reed LLP (included in Exhibit
5.1).
|
|
|
24.1*
|
Power
of Attorney (included on the signature page
hereto).
|
—————
* Filed
herewith.
II-7
Exhibit 5.1
 |
Hughes
Hubbard & Reed
LLP
One
Battery Park Plaza
New
York, New York 10004-1482
Telephone:
212-837-6000
Fax:
212-422-4726
hugheshubbard.com
|
June 11,
2009
Delcath
Systems, Inc.
600 Fifth
Avenue, 23rd
Floor
New York,
NY 10020
Re: Securities Being Registered
under Registration Statement on Form S-3
Ladies
and Gentlemen:
We have
acted as counsel to Delcath Systems, Inc., a Delaware corporation (the
“Company”), in connection with the preparation and filing with the
Securities and Exchange Commission (the “Commission”) of a Registration
Statement on Form S-3 (the “Registration Statement”) under the Securities Act of
1933 (the “Securities Act”) relating to the registration under the Securities
Act and the proposed issuance and sale from time to time pursuant to Rule 415
under the Securities Act of common stock, par value $0.01 per share (“Common
Stock”), of the Company, debt securities of the Company (“Debt Securities”),
preferred stock (“Preferred Stock”) of the Company, Common Stock of the Company
as may from time to time be issued, including upon conversion of Debt Securities
or Preferred Stock, warrants to purchase Common Stock or Preferred Stock
(“Warrants”) of the Company and stock purchase contracts to purchase Common
Stock or Preferred Stock (“Stock Purchase Contracts”) of the Company (the Debt
Securities, Preferred Stock, Common Stock, Warrants and Stock Purchase Contracts
are collectively referred to herein as the “Securities”).
In
connection with this opinion, we have examined originals, or copies certified or
otherwise identified to our satisfaction, of such corporate records,
certificates of corporate officers and government officials and such other
documents as we have deemed necessary or appropriate for the purposes of this
opinion, including: (a) the Amended and Restated Certificate of Incorporation of
the Company; (b) the Amended and Restated Bylaws of the Company; (c) resolutions
adopted by the board of directors of the Company on June 9, 2009; and (d) the
Registration Statement. As to various questions of fact material to this
opinion, we have relied upon representations of officers or directors of the
Company and documents furnished to us by the Company, without independent
verification of their accuracy. We have also assumed the genuineness
of all signatures, the authenticity of all documents submitted to us as
originals, and the conformity to authentic original documents of all documents
submitted to us as copies.
Based
upon and subject to the foregoing, and assuming that (i) the Registration
Statement and any supplements and amendments thereto (including post-effective
amendments)
2
will have
become effective and will comply with all applicable laws; (ii) the Registration
Statement will be effective and will comply with all applicable laws at the time
the Securities are offered or issued as contemplated by the Registration
Statement; (iii) a prospectus supplement will have been prepared and filed with
the Commission describing the Securities offered thereby and will comply with
all applicable laws; (iv) all Securities will be issued and sold in compliance
with all applicable federal and state securities laws and in the manner stated
in the Registration Statement and the appropriate prospectus supplement; (v)
none of the terms of any Security to be established subsequent to the date
hereof, nor the issuance and delivery of such Security, nor the compliance by
the Company with the terms of such Security will violate any applicable law or
will result in a violation of any provision of any instrument or agreement then
binding upon the Company or any restriction imposed by any court or governmental
body having jurisdiction over the Company; (vi) a definitive purchase,
underwriting or similar agreement and any other necessary agreement with respect
to any Securities offered or issued will have been duly authorized and validly
executed and delivered by the Company and the other parties thereto; and (vii)
any Securities issuable upon conversion, exchange, or exercise of any Security
being offered or issued will be duly authorized, created, and, if appropriate,
reserved for issuance upon such conversion, exchange, or exercise, we are of
opinion that:
(1) with
respect to Debt Securities, when (A) a trustee is qualified to act as such under
an indenture under which such Debt Securities are to be issued, as applicable,
(B) such trustee has duly executed and delivered such indenture, as applicable,
(C) such indenture, as applicable, has been duly qualified under the Trust
Indenture Act of 1939, as amended, (D) the board of directors of the Company, a
duly constituted and acting committee thereof or any officers of the Company
delegated such authority (such board of directors, committee or officers being
hereinafter referred to as the “Board”) has taken all necessary corporate action
to approve the issuance and terms of the particular Debt Securities, the terms
of the offering thereof, and related matters, and (E) such Debt Securities have
been duly executed, authenticated, issued, and delivered in accordance with the
provisions of such indenture, as applicable, and the applicable definitive
purchase, underwriting, or similar agreement approved by the Board upon payment
of the consideration therefor provided for therein, such Debt Securities will be
validly issued and will constitute valid and binding obligations of the Company,
enforceable against the Company in accordance with their terms (subject to
applicable bankruptcy, insolvency, reorganization, fraudulent conveyance,
moratorium, or other similar laws affecting creditors’ rights generally from
time to time in effect and subject to general principles of equity, including
concepts of materiality, reasonableness, good faith and fair dealing, regardless
of whether such enforceability is considered in a proceeding in equity or at
law);
(2) with
respect to shares of Preferred Stock, when (A) the Board has taken all necessary
corporate action to approve the issuance and terms of a particular series of
Preferred Stock, the terms of the offering thereof, and related matters,
including the adoption of a Certificate of Designation relating to such
Preferred Stock (a “Certificate”) and the filing of such Certificate with the
Secretary of State of the State of Delaware, (B) such Certificate has been
properly filed with the Secretary of State of Delaware and (C) certificates
representing such shares of Preferred Stock have been duly executed,
countersigned, registered and delivered either (i) in accordance with the
applicable
3
definitive
purchase, underwriting, or similar agreement approved by the Board upon payment
of the consideration therefor (which consideration is not less than the par
value of the Preferred Stock) provided for therein or (ii) upon conversion or
exercise of any other Security, in accordance with the terms of such Security or
the instrument governing such Security providing for such conversion or exercise
as approved by the Board, for the consideration approved by the Board (which
consideration is not less than the par value of the Preferred Stock), then such
shares of Preferred Stock will be validly issued, fully paid and
non-assessable;
(3) with
respect to shares of Common Stock, when both (A) the Board has taken all
necessary corporate action to approve the issuance of and the terms of the
offering of (i) the Debt Securities or Preferred Stock, as the case may be,
convertible or exchangeable into Common Stock and (ii) the shares of Common
Stock, and related matters and (B) certificates representing the shares of
Common Stock have been duly executed, countersigned, registered and delivered
either (i) in accordance with the applicable definitive purchase, underwriting,
or similar agreement approved by the Board or such officers upon payment of the
consideration therefor (which consideration is not less than the par value of
the Common Stock) provided for therein or (ii) upon conversion or exercise of
such Debt Security or Preferred Stock, as the case may be, in accordance with
the terms of such Security or the instrument governing such Security providing
for such conversion or exercise as approved by the Board, for the consideration
approved by the Board (which consideration is not less than the par value of the
Common Stock), then the shares of Common Stock will be validly issued, fully
paid and non-assessable;
(4) with
respect to Warrants, when (A) the Board has taken all necessary corporate action
to approve the creation of and the issuance and terms of the Warrants, the terms
of the offering thereof, and related matters, (B) an applicable warrant or
warrant agreement relating to the Warrants has been duly authorized and validly
executed and delivered by the Company, the warrant agent , as applicable,
appointed by the Company and each other party thereto, and (C) the Warrants or
certificates representing the Warrants have been duly executed, countersigned,
registered, and delivered in accordance with the appropriate warrant agreement
or agreements and the applicable definitive purchase, underwriting, or similar
agreement approved by the Board or such officers upon payment of the
consideration therefor provided for therein, the Warrants will be validly issued
and will constitute valid and binding obligations of the Company, enforceable
against the Company in accordance with their terms (subject to applicable
bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium, or
other similar laws affecting creditors’ rights generally from time to time in
effect and subject to general principles of equity, including concepts of
materiality, reasonableness, good faith and fair dealing, regardless of whether
such enforceability is considered in a proceeding in equity or at law);
and
(5) with
respect to Stock Purchase Contracts, when (A) the Board has taken all necessary
corporate action to approve the creation of and the issuance and terms of the
Stock Purchase Contracts, the terms of the offering thereof, and related
matters, (B) an applicable stock purchase agreement relating to the Stock
Purchase Contracts has been duly authorized and validly executed and delivered
by the Company and each other party
4
thereto,
and (C) the Stock Purchase Contracts or certificates representing the Stock
Purchase Contracts have been duly executed, countersigned, registered, and
delivered in accordance with the appropriate warrant agreement or agreements and
the applicable definitive purchase, underwriting, or similar agreement approved
by the Board or such officers upon payment of the consideration therefor
provided for therein, the Stock Purchase Contracts will be validly issued and
will constitute valid and binding obligations of the Company, enforceable
against the Company in accordance with their terms (subject to applicable
bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium, or
other similar laws affecting creditors’ rights generally from time to time in
effect and subject to general principles of equity, including concepts of
materiality, reasonableness, good faith and fair dealing, regardless of whether
such enforceability is considered in a proceeding in equity or at
law).
We
express no opinion herein as to any provision of Debt Securities that (a)
relates to the subject matter jurisdiction of any Federal court of the United
States of America, or any Federal appellate court, to adjudicate any controversy
related thereto, (b) contains a waiver of an inconvenient forum, (c) relates to
the waiver of rights to jury trial or (d) provides for indemnification,
contribution or limitations on liability. We also express no opinion
as to (i) the enforceability of the provisions of Debt Securities to the extent
that such provisions constitute a waiver of illegality as a defense to
performance of contract obligations or any other defense to performance which
cannot, as a matter of law, be effectively waived, (ii) whether a state court
outside the State of New York or a Federal court of the United States would give
effect to the choice of New York law provided for therein or (iii) the effect of
any provision in the amended and restated Certificate of Incorporation of the
Company of the type permitted by Section 102(b)(2) of the General Corporation
Law of the State of Delaware.
We are
admitted to practice only in the State of New York and express no opinion as to
matters governed by any laws other than the laws of the State of New York, the
Delaware General Corporation Law and the Federal laws of the United States of
America.
We
understand that we may be referred to as counsel who has passed upon the
validity of Debt Securities, the issuance of Preferred Stock, Common Stock or
Warrants on behalf of the Company in the prospectus and in a supplement to the
prospectus forming a part of the Registration Statement relating to the
Securities filed with the Commission pursuant to the Securities Act, and we
hereby consent to such use of our name in said Registration Statement and to the
use of this opinion for filing with said Registration Statement as Exhibit 5.1
thereto. In giving this consent, we do not hereby admit that we are
within the category of persons whose consent is required under Section 7 of the
Securities Act or the Rules and Regulations of the Commission promulgated
thereunder.
Very
truly yours,
/s/
HUGHES HUBBARD & REED LLP
HUGHES
HUBBARD & REED LLP
Exhibit
23.1
CONSENT
OF REGISTERED INDEPENDENT PUBLIC ACCOUNTING FIRM
We
consent to the use of our report dated February 27, 2009, relating to the
balance sheets of Delcath Systems, Inc. (the “Company”) as of December 31, 2008
and 2007, and the related statements of operations, other comprehensive loss,
stockholders’ equity, and cash flows for each of the years in the three year
period ended December 31, 2008, and cumulative from inception (August 5, 1988)
to December 31, 2008 (which report expressed an unqualified opinion), relating
to the financial statement schedule and relating to the Company’s internal
control over financial reporting as of December 31, 2008, included in the
Company’s Annual report on Form 10-K for the fiscal year ended December 31, 2008
and incorporated by reference herein and to the reference to our firm under the
heading “Experts” in the prospectus.
/s/ CCR
LLP
Glastonbury,
CT
June 11,
2009