<SEC-DOCUMENT>0001193125-18-348603.txt : 20190221
<SEC-HEADER>0001193125-18-348603.hdr.sgml : 20190221
<ACCEPTANCE-DATETIME>20181213120757
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-18-348603
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20181213

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DELCATH SYSTEMS, INC.
		CENTRAL INDEX KEY:			0000872912
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				061245881
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		1633 BROADWAY
		STREET 2:		SUITE 22C
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		(212) 489-2100

	MAIL ADDRESS:	
		STREET 1:		1633 BROADWAY
		STREET 2:		SUITE 22C
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	DELCATH SYSTEMS INC
		DATE OF NAME CHANGE:	19990607
</SEC-HEADER>
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<TYPE>CORRESP
<SEQUENCE>1
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<TITLE>Response Letter</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>DELCATH SYSTEMS, INC. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>1633 Broadway, Suite 22C </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>New York, NY 10019 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(212)
<FONT STYLE="white-space:nowrap">489-2100</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>VIA EDGAR </U></B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">December&nbsp;13, 2018 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporate Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mail Stop 3030 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street N.E. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, D.C. 20005 </P>
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<TD WIDTH="6%" VALIGN="top" ALIGN="left">Attn:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Russell Mancuso, Esq. </P></TD></TR></TABLE>
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<TD WIDTH="6%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Caleb French, Esq. </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>

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<TD WIDTH="6%">&nbsp;</TD>
<TD WIDTH="7%" VALIGN="top" ALIGN="left"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Delcath Systems, Inc. </B></P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="6%">&nbsp;</TD>
<TD WIDTH="7%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Amendment No.&nbsp;1 to Registration </B></P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="6%">&nbsp;</TD>
<TD WIDTH="7%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Statement on Form <FONT STYLE="white-space:nowrap">S-3</FONT> Filed </B></P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="6%">&nbsp;</TD>
<TD WIDTH="7%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>November&nbsp;29, 2018 </B></P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="6%">&nbsp;</TD>
<TD WIDTH="7%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>File <FONT STYLE="white-space:nowrap">No.&nbsp;333-227970</FONT> </B></P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear Mr.&nbsp;Mancuso and Mr.&nbsp;French: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">We are writing in
connection with the above-captioned matter regarding Delcath Systems, Inc.&#146;s (the &#147;Company&#148;) Registration Statement on Form <FONT STYLE="white-space:nowrap">S-3,</FONT> File <FONT STYLE="white-space:nowrap">No.&nbsp;333-227970,</FONT>
filed with the Commission on October&nbsp;24, 2018, as amended by Amendment No.&nbsp;1 filed on November&nbsp;29, 2018 (the &#147;Registration Statement&#148;). We hereby provide supplementally the following responses in reply to the Staff&#146;s
comment letter dated today (the &#147;Comment Letter&#148;). The numbered responses set forth below correspond to the numbering set forth in the Comment Letter. For your convenience, we have included each of the Staff&#146;s comments (in bold). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Incorporation by Reference, page 2 </U></B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>1.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your response to prior comment 2. Please list all documents that satisfy the criteria mentioned in
the last clause of your fourth bullet point in this section. </B></P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">We filed a Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> on December&nbsp;12, 2018 with a
complete description of the Company&#146;s common stock. </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Risk Factors, page 5 </U></B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>2.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Please expand your response to prior comment 1 to tell us where the offer of the shares underlying the <FONT
STYLE="white-space:nowrap">pre-funded</FONT> warrants was registered at the time of your offering of the <FONT STYLE="white-space:nowrap">pre-</FONT> funded warrants. Also, tell us (1)&nbsp;whether any
<FONT STYLE="white-space:nowrap">leak-out</FONT> agreements entered into in connection with that offering or otherwise present risks that should be disclosed in this registration statement, and (2)&nbsp;whether you plan to withdraw or amend the
post-effective amendment filed April&nbsp;20, 2018. </B></P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">The offer of the shares underlying the <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrants was
registered on Registration Statement <FONT STYLE="white-space:nowrap">No.&nbsp;333-220898,</FONT> declared effective on February&nbsp;7, 2018. These are shares of common stock intended to be covered. </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">In fact the italicized language in the second paragraph of the prospectus cover page clearly states those
shares underlying the <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrants are intended to be registered: </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">&#147;We are also offering for sale to each purchaser whose purchase of units in this offering would otherwise
result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the
purchaser so chooses, Series B units (each Series B unit consisting of one <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrant to purchase one share of our common stock and Series D common warrants to purchase two shares of our common stock)
in lieu of units that would otherwise result in the purchaser&#146;s beneficial ownership exceeding 4.99% of our outstanding common stock (or at the election of the purchaser, 9.99%). The purchase price of each Series B unit will equal the price per
unit being sold to the public in this offering minus $0.01, and the exercise price of each <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrant included in the Series B unit will be $0.01 per share. <I>This offering also relates to the shares
of common stock issuable upon exercise of any <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrants contained in the Series B units sold in this offering</I> but not the shares underlying the Series D common warrants. Each Series D common
warrant contained in a Series B unit has an exercise price of $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; per share. The Series D common warrants contained in the Series B units will be
exercisable one year from the date of issuance and will expire five years from the date of initial exercisability. For each Series B unit we sell, the number of Series A units we are offering will be decreased on a <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">one-for-one</FONT></FONT> basis. The Series A units and the Series B units will not be issued or certificated. The shares of common stock or <FONT STYLE="white-space:nowrap">pre-funded</FONT> warrants, as the case may be,
and the common warrants can only be purchased together in this offering but the securities contained in the Series A units or Series B units will be issued separately.&#148; </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">There were leakout agreements entered into: </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">&#147;Each investor in this offering will enter into separate and substantially
<FONT STYLE="white-space:nowrap">similar&nbsp;leak-out&nbsp;agreement</FONT> with us. During the period commencing on the date of the securities purchase agreement and ending April&nbsp;16, 2018, each investor who is party to <FONT
STYLE="white-space:nowrap">a&nbsp;leak-out&nbsp;agreement</FONT> (together with certain of its affiliates) may not sell, dispose or otherwise transfer, directly or indirectly (including, without limitation, any sales, short sales, swaps or any
derivative transactions that would be equivalent to any sales or short positions), on any trading day, shares purchased in this offering, including the shares of Common Stock issuable upon exercise of the Series D Warrants, in an amount more than a
specified percentage of the trading volume of the Common Stock on the principal trading market, subject to certain exceptions. The aggregate trading volume for all investors who
<FONT STYLE="white-space:nowrap">execute&nbsp;leak-out&nbsp;agreements</FONT> will be 35% of the trading volume of the Common Stock on the principal trading market </P></TD></TR></TABLE>
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during each trading day during the above-referenced&nbsp;leak-outperiod, subject to certain exceptions. This restriction does not apply to any actual &#147;long&#148; (as defined in Regulation
SHO promulgated under the Securities Exchange Act of 1934, as amended) sales by such investor (together with certain of its affiliates) at a price greater than $0.06. In addition, each investor has agreed to not sell shares purchased in this
offering, including the shares of Common Stock issuable upon exercise of the Series D Warrants, on the date of amendment of our articles of incorporation to increase the authorized shares of common stock and for ten trading days thereafter, provided
that the restriction does not apply to any actual &#147;long&#148; sales by such investor (together with certain of its affiliates) at a price greater than $0.06.&#148; </TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">We intend to withdraw the post-effective amendment and will do so no later than the close of business on
Friday, December&nbsp;14, 2018. </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><U>Exhibits</U> </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>3.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Please reconcile your response to prior comment 6 with your reference to subordinated debt securities on
page 8 and your reference to &#147;one or more indentures&#148; on page 10. Also, if you intend to register only senior debt securities for sale as indicated in your response, please revise the title of the offered securities in your fee table, on
your prospectus cover and elsewhere in your prospectus as appropriate; see Instruction 1 to Regulation <FONT STYLE="white-space:nowrap">S-K</FONT> Item 202. </B></P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">We have revised the Form <FONT STYLE="white-space:nowrap">S-3</FONT> to clarify that the issuer intends to
register only senior debt securities for sale and have revised the prospectus accordingly. </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">We hope that the foregoing is responsive to
the Staff&#146;s comments. Please do not hesitate to contact our counsel, Jolie Kahn, Esq., at (516) <FONT STYLE="white-space:nowrap">222-2230</FONT> if you have any questions regarding this matter. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Very truly yours, </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">DELCATH SYSTEMS, INC. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U><I>/s/ </I>Jennifer Simpson </U></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jennifer Simpson </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Chief Executive Officer </P>
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