<SEC-DOCUMENT>0001193125-18-283992.txt : 20180926
<SEC-HEADER>0001193125-18-283992.hdr.sgml : 20180926
<ACCEPTANCE-DATETIME>20180926163059
ACCESSION NUMBER:		0001193125-18-283992
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20180926
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180926
DATE AS OF CHANGE:		20180926

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			HISTOGENICS CORP
		CENTRAL INDEX KEY:			0001372299
		STANDARD INDUSTRIAL CLASSIFICATION:	ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36751
		FILM NUMBER:		181088252

	BUSINESS ADDRESS:	
		STREET 1:		830 WINTER STREET
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02451
		BUSINESS PHONE:		781-457-7900

	MAIL ADDRESS:	
		STREET 1:		830 WINTER STREET
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02451
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d596747d8k.htm
<DESCRIPTION>8-K
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<HTML><HEAD>
<TITLE>8-K</TITLE>
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, DC 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Current
Report </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event Reported): September&nbsp;26, 2018 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>HISTOGENICS CORPORATION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact Name of Registrant as Specified in its Charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-36751</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">04-3522315</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or Other Jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of Incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(I.R.S. Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification Number)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>830 Winter Street, 3rd Floor </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Waltham, Massachusetts 02451 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(781) <FONT STYLE="white-space:nowrap">547-7900</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2. below): </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule&nbsp;405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or <FONT STYLE="white-space:nowrap">Rule&nbsp;12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9746; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section&nbsp;13(a)&nbsp;of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;8.01. Other Events. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On September&nbsp;26, 2018, Histogenics Corporation (&#147;Histogenics&#148;) issued a press release announcing that the U.S. Food and Drug Administration (the
&#147;FDA&#148;) has granted a Type C meeting on October&nbsp;30, 2018 to discuss the <FONT STYLE="white-space:nowrap">top-line</FONT> results from the NeoCart Phase&nbsp;3 clinical trial and Histogenics&#146; planned Biologics License Application
submission. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Additionally, Histogenics announced that during the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common
stock in <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">at-the-market</FONT></FONT> offerings pursuant to Histogenics&#146; equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72&nbsp;million
after deducting sales agent fees and expenses. Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A copy of Histogenics&#146; press release is attached hereto as Exhibit&nbsp;99.1 and is hereby incorporated by reference herein. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Various statements in this
Current Report on Form 8-K are &#147;forward-looking statements&#148; under the securities laws. Words such as, but not limited to, &#147;anticipate,&#148; &#147;believe,&#148; &#147;can,&#148; &#147;could,&#148; &#147;expect,&#148;
&#147;estimate,&#148; &#147;design,&#148; &#147;goal,&#148; &#147;intend,&#148; &#147;may,&#148; &#147;might,&#148; &#147;objective,&#148; &#147;plan,&#148; &#147;predict,&#148; &#147;project,&#148; &#147;target,&#148; &#147;likely,&#148;
&#147;should,&#148; &#147;will,&#148; and &#147;would,&#148; or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks,
changes in circumstances, assumptions and uncertainties. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Important factors that could cause actual results to differ materially from those reflected in
Histogenics&#146; forward-looking statements include, among others: expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; NeoCart&#146;s potential as a
treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient
population in markets where Histogenics&#146; and its partners expect to compete; updated or refined data based on Histogenics&#146; continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs
of developing and commercializing Histogenics&#146; product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location
transition; Histogenics&#146; expectations regarding its expenses and revenue; Histogenics&#146; ability to obtain additional debt or equity capital and other factors that are described in the &#147;Risk Factors&#148; and &#147;Management&#146;s
Discussion and Analysis of Financial Condition and Results of Operations&#148; sections of Histogenics&#146; Annual Report on Form&nbsp;10-K for the year ended December&nbsp;31, 2017 and Quarterly Report on Form&nbsp;10-Q for the quarter ended June
30, 2018, which are on file with the SEC and available on the SEC&#146;s website at www.sec.gov. In addition to the risks described above and in Histogenics&#146; Annual Report on Form&nbsp;10-K and Quarterly Reports on Form&nbsp;10-Q, Current
Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics&#146; results. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">There can be no
assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that
the outcomes stated in such forward-looking statements and estimates will be achieved. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">All written and verbal forward-looking statements attributable to
Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements
Histogenics makes or that are made on its behalf. The information in this Current Report on Form&nbsp;8-K is provided only as of the date of this Current Report on Form 8-K, and Histogenics undertakes no obligation, and specifically declines any
obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;9.01. Financial Statements and Exhibits. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d)&nbsp;Exhibits </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="92%"></TD></TR>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center"><B>Exhibit<BR>No.</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Description</B></P></TD></TR>


<TR STYLE="font-size:1pt">
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d596747dex991.htm">Press Release of Histogenics Corporation dated September&nbsp;26, 2018. </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Date: September&nbsp;26, 2018</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3"><B>HISTOGENICS CORPORATION</B></TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Adam Gridley</TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Adam Gridley</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">President and Chief Executive Officer</TD></TR>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d596747dex991.htm
<DESCRIPTION>EX-99.1
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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="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g596747histogenics.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>HISTOGENICS TO MEET WITH FDA TO DISCUSS NEOCART PHASE 3 CLINICAL TRIAL DATA AND POTENTIAL REGULATORY
PATHWAY </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>WALTHAM, Mass., September</B><B></B><B>&nbsp;26, 2018 /GLOBE NEWSWIRE/</B> &#150; Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a
leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October&nbsp;30, 2018 to
discuss the <FONT STYLE="white-space:nowrap">top-line</FONT> results from the NeoCart Phase 3 clinical trial and Histogenics&#146; planned Biologics License Application submission. Histogenics submitted its briefing materials regarding the <FONT
STYLE="white-space:nowrap">top-line</FONT> data of the NeoCart Phase 3 clinical trial to the FDA in <FONT STYLE="white-space:nowrap">mid-September</FONT> 2018, and has been working closely with the FDA to schedule the meeting. Histogenics expects to
provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018. During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">at-the-market</FONT></FONT> offerings pursuant to Histogenics&#146; equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72&nbsp;million after
deducting sales agent fees and expenses. Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Histogenics Corporation </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Histogenics (Nasdaq: HSGX)
is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics&#146; lead investigational product, NeoCart, is designed to rebuild a patient&#146;s own knee cartilage to treat
pain at the source and potentially prevent a patient&#146;s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. NeoCart is designed to perform like articular hyaline cartilage
at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics&#146; technology platform has the potential to be used for a broad range of
additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit <U>www.histogenics.com</U>. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Various statements in this
release are &#147;forward-looking statements&#148; under the securities laws. Words such as, but not limited to, &#147;anticipate,&#148; &#147;believe,&#148; &#147;can,&#148; &#147;could,&#148; &#147;expect,&#148; &#147;estimate,&#148;
&#147;design,&#148; &#147;goal,&#148; &#147;intend,&#148; &#147;may,&#148; &#147;might,&#148; &#147;objective,&#148; &#147;plan,&#148; &#147;predict,&#148; &#147;project,&#148; &#147;target,&#148; &#147;likely,&#148; &#147;should,&#148;
&#147;will,&#148; and &#147;would,&#148; or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Important factors that could cause actual results to differ materially from those reflected in
Histogenics&#146; forward-looking statements include, among others: expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; NeoCart&#146;s potential as a
treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient
population in markets where Histogenics&#146; and its </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">1 </P>

</DIV></Center>


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<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">

 <P STYLE="margin-top:0pt;margin-bottom:0pt">


<IMG SRC="g596747histogenics.jpg" ALT="LOGO">
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">
partners expect to compete; updated or refined data based on Histogenics&#146; continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs
of developing and commercializing Histogenics&#146; product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location
transition; Histogenics&#146; expectations regarding its expenses and revenue; Histogenics&#146; ability to obtain additional debt or equity capital and other factors that are described in the &#147;Risk Factors&#148; and &#147;Management&#146;s
Discussion and Analysis of Financial Condition and Results of Operations&#148; sections of Histogenics&#146; Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2017 and Quarterly Report on Form <FONT
STYLE="white-space:nowrap">10-Q</FONT> for the quarter ended June&nbsp;30, 2018, which are on file with the SEC and available on the SEC&#146;s website at www.sec.gov. In addition to the risks described above and in Histogenics&#146; Annual Report
on <FONT STYLE="white-space:nowrap">Form&nbsp;10-K</FONT> and Quarterly Reports on Form <FONT STYLE="white-space:nowrap">10-Q,</FONT> Current Reports on Form <FONT STYLE="white-space:nowrap">8-K</FONT> and other filings with the SEC, other unknown
or unpredictable factors also could affect Histogenics&#146; results. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">There can be no assurance that the actual results or developments anticipated by
Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and
estimates will be achieved. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are
expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The
information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">* * * * </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Contacts: </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Investor Relations: </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Tel: +1 (781) <FONT STYLE="white-space:nowrap">547-7909</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>InvestorRelations@histogenics.com </U></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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