<SEC-DOCUMENT>0001144204-19-045554.txt : 20190923
<SEC-HEADER>0001144204-19-045554.hdr.sgml : 20190923
<ACCEPTANCE-DATETIME>20190923085024
ACCESSION NUMBER:		0001144204-19-045554
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20190923
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20190923
DATE AS OF CHANGE:		20190923

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ABEONA THERAPEUTICS INC.
		CENTRAL INDEX KEY:			0000318306
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				830221517
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15771
		FILM NUMBER:		191106315

	BUSINESS ADDRESS:	
		STREET 1:		1330 AVENUE OF THE AMERICAS, 33RD FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		646-813-4701

	MAIL ADDRESS:	
		STREET 1:		1330 AVENUE OF THE AMERICAS, 33RD FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PLASMATECH BIOPHARMACEUTICALS INC
		DATE OF NAME CHANGE:	20140922

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ACCESS PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19960209

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CHEMEX PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tv529874_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, DC 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PURSUANT TO SECTION 13 OR 15(d) OF THE</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of report (Date of earliest event reported):
<B>September 23, 2019</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 14pt"><B><U>ABEONA
THERAPEUTICS INC.</U></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified in
its charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="width: 33%; text-align: center"><FONT STYLE="font-size: 10pt"><B><U>Delaware</U></B></FONT></TD>
    <TD STYLE="width: 34%; text-align: center"><FONT STYLE="font-size: 10pt"><B><U>001-15771</U></B></FONT></TD>
    <TD STYLE="width: 33%; text-align: center"><FONT STYLE="font-size: 10pt"><B><U>83-0221517</U></B></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">(State or other jurisdiction of<BR>
incorporation)</FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">(Commission File Number)</FONT></TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">(I.R.S. Employer Identification No.)</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>1330 Avenue of the Americas, 33rd Floor,
</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>New York, NY 10019 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)
(Zip Code)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>(646) 813-4712</U></B><BR>
(Registrant&rsquo;s telephone number, including area code)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>N/A</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Former name or former address, if changed
since last report)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see<I>&nbsp;</I>General
Instruction A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings; font-size: 10pt">&uml;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Securities registered pursuant to Section 12(b) of the Act:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 33%; border: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt">Title of Each Class</FONT></TD>
    <TD STYLE="width: 25%; border-top: black 1pt solid; border-right: black 1pt solid; border-bottom: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt">Trading Symbol</FONT></TD>
    <TD STYLE="width: 42%; border-top: black 1pt solid; border-right: black 1pt solid; border-bottom: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt">Name of each exchange on which registered</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt"><B>Common Stock, $0.01 par value</B></FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt"><B>ABEO</B></FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; padding: 2pt"><FONT STYLE="font-size: 10pt"><B>Nasdaq Capital Markets</B></FONT></TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (&sect;230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (&sect;240.12b-2 of this chapter).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Emerging growth company <FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 13(a) of the Exchange Act. <FONT STYLE="font-family: Wingdings">&uml;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 96px"><FONT STYLE="font-size: 10pt"><B>Item 8.01.</B></FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B>Other Events.</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On September 23, 2019,
Abeona Therapeutics Inc. (the &ldquo;Company&rdquo;) issued a press release entitled &ldquo;Abeona Therapeutics Provides Regulatory
Update Ahead of Pivotal Phase 3 Clinical Trial for EB-101 in Recessive Dystrophic Epidermolysis Bullosa.&rdquo; The full text of
the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 96px"><FONT STYLE="font-size: 10pt"><B>Item 9.01</B></FONT></TD>
    <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B>Financial Statements and Exhibits.</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>(d) Exhibits.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 86px; padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt"><FONT STYLE="font-size: 10pt"><B><U>Exhibit No.</U></B></FONT></TD>
    <TD STYLE="width: 18px; padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt">&nbsp;</TD>
    <TD STYLE="padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt"><FONT STYLE="font-size: 10pt"><B><U>Description</U></B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt"><A HREF="tv529874_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="vertical-align: bottom; padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-top: 1.5pt; padding-right: 1.5pt; padding-left: 1.5pt"><A HREF="tv529874_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-size: 10pt">Press release dated September 23, 2019, entitled &ldquo;Abeona Therapeutics Provides Regulatory Update Ahead of Pivotal Phase 3 Clinical Trial for EB-101 in Recessive Dystrophic Epidermolysis Bullosa.&rdquo;</FONT></A></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURE</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="3"><FONT STYLE="font-size: 10pt">Abeona Therapeutics Inc.</FONT></TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="3"><FONT STYLE="font-size: 10pt">(Registrant)</FONT></TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 28%">&nbsp;</TD>
    <TD STYLE="width: 14%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1pt solid"><FONT STYLE="font-size: 10pt">/s/ Edward A. Sturchio</FONT></TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Name:</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Edward A. Sturchio</FONT></TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Title:&nbsp;&nbsp;&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Senior Vice President and General Counsel </FONT></TD>
    <TD>&nbsp;</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Date: September 23, 2019</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>



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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tv529874_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; color: Black"><IMG SRC="image_001.jpg" ALT="" STYLE="height: 61px; width: 204px"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="color: Black">&nbsp;</FONT>&nbsp;</P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black"><B>Abeona Therapeutics
Provides Regulatory Update Ahead of Pivotal Phase 3 Clinical Trial for EB-101 in Recessive Dystrophic Epidermolysis Bullosa</B></FONT></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black"></FONT>&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; color: Black">&middot;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="color: Black">Company
                                         to provide additional transport stability data points in response to FDA Clinical Hold
                                         Letter</FONT></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="color: Black"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; color: Black">&middot;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="color: Black">CMC
                                         clearance for VIITAL&trade; trial anticipated in Q4 2019</FONT></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="color: Black"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; color: Black">&middot;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="color: Black">Investor
                                         conference call today, Monday, September 23 at 09:30 a.m. ET</FONT></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="color: Black">&nbsp;&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black">NEW YORK and
CLEVELAND, September 23, 2019 &ndash; Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy,
today announced that it has recently received a clinical hold letter from the U.S. Food and Drug Administration (FDA) clarifying
that the FDA will not provide approval for the Company to begin its planned Phase 3 clinical trial for EB-101 until it submits
to the FDA additional data points on transport stability of EB-101 to clinical sites. Over the last 12 months, the Company has
worked closely with the FDA to address and narrow open Chemical, Manufacturing and Controls (CMC) items and has been working to
resolve this one item identified in the FDA Clinical Hold Letter. The Company continues to anticipate receiving CMC clearance
for VIITAL&trade; trial in Q4 2019.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black">&nbsp;</FONT>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black">&ldquo;Initiating
the VIITAL&trade; pivotal Phase 3 trial for EB-101 is the Company&rsquo;s top priority,&rdquo; said Jo&atilde;o Siffert, M.D.,
Chief Executive Officer of Abeona. &ldquo;Efforts to gather supplemental data points on transport stability of EB-101 are ongoing
and we are confident that the requested additional data will be submitted to the FDA promptly. Looking ahead, we believe that
completion of our CMC work coupled with the durable safety and efficacy data, now out to five years in some patients, will ultimately
be critical to support a future Biologics License Application. We remain deeply committed to advancing EB-101 to provide a desperately
needed treatment for RDEB patients.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: Black">The Company
will hold a conference call scheduled for Monday, September 23 at 09:30 a.m. ET. Interested parties are invited to participate
in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (international) or via webcast at <U>https://www.investornetwork.com/event/presentation/53728</U>.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black"><B>&nbsp;</B></FONT>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black"><B>About
EB-101</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black">EB-101
is an investigational, autologous, gene-corrected cell therapy poised to enter late-stage development for the treatment of recessive
dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101
involves using gene transfer to deliver COL7A1 genes into a patient&rsquo;s own skin cells (keratinocytes) and transplanting them
back to the patient to enable normal Type VII collagen expression and facilitate wound healing. In the U.S., Abeona holds Regenerative
Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both
the U.S. and EU.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black">&nbsp;&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black"><B>About
Recessive Dystrophic Epidermolysis Bullosa</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black">Recessive
dystrophic epidermolysis bullosa, or RDEB, is a rare connective tissue disorder characterized by severe skin wounds that cause
pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1
gene, leaving them unable to produce functioning Type VII collagen which is necessary to anchor the dermal and epidermal layers
of the skin. There is currently no approved treatment for RDEB.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: right"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black"><B>About
Abeona Therapeutics </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify">Abeona Therapeutics Inc. is a
clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Company&rsquo;s clinical
programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as
ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively.
The Company&rsquo;s portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease,
respectively. Its preclinical assets include ABO-401, which uses the novel AIM&trade; AAV vector platform to address all mutations
of cystic fibrosis. Abeona has received numerous regulatory designations from the FDA and EMA for its pipeline candidates and
is the only company with Regenerative Medicine Advanced Therapy designation for two candidates (EB-101 and ABO-102). For more
information, visit <U>www.abeonatherapeutics.com</U>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 6pt 0pt 0; text-align: justify"><FONT STYLE="color: Black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black"><B>Forward
Looking Statement</B><BR>
<I>This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties.
These statements include statements about the timing for CMC clearance for the VIITAL&trade; trial and the Company&rsquo;s beliefs
relating thereto, the Company&rsquo;s ability to provide additional transport stability data points in response to the FDA clinical
hold letter and the timing thereof, the Company&rsquo;s belief that completion of its CMC work and the durable safety and efficacy
data will ultimately be critical to support a future Biologics License Application, the ability of its management team to lead
the Company and deliver on key strategies, the market opportunities for the Company&rsquo;s products and product candidates, and
the Company&rsquo;s goals and objectives. We have attempted to identify forward looking statements by such terminology as &ldquo;may,&rdquo;
&ldquo;will,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;expect,&rdquo; &ldquo;intend,&rdquo;
and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which
constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated
by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not
limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of
competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability
to achieve or obtain necessary regulatory approvals, the risk of whether or when the FDA will lift the clinical hold respecting
the Company&rsquo;s planned Phase 3 clinical trial for EB-101, the impact of changes in the financial markets and global economic
conditions, risks associated with data analysis and reporting, and other risks as may be detailed from time to time in the Company&rsquo;s
Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other reports filed by the Company with the Securities and
Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect
events or circumstances occurring after the date of this presentation, whether as a result of new information, future developments
or otherwise, except as required by the federal securities laws.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black"><B>Investor
Contact:</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black">Sofia
Warner<BR>
Senior Director, Investor Relations<BR>
Abeona Therapeutics<BR>
+1 (646) 813-4710<BR>
<U>swarner@abeonatherapeutics.com</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black"><B>Media
Contact:</B>&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black">Scott
Santiamo<BR>
Director, Corporate Communications<BR>
Abeona Therapeutics<BR>
+1 (718) 344-5843<BR>
<U>ssantiamo@abeonatherapeutics.com</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="color: Black"></FONT></P>

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