<HTML><HEAD>
<TITLE>8-K</TITLE>
</HEAD>
 <BODY BGCOLOR="WHITE">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES
AND EXCHANGE COMMISSION </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P>
<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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Current Report Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; 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:10pt; font-family:Times New Roman" ALIGN="center">Date of Report (Date of earliest event reported):<B> January</B><B></B><B>&nbsp;30, 2019</B> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:22pt; font-family:Times New Roman" ALIGN="center"><B>MeiraGTx Holdings plc </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; 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>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


<TR>
<TD WIDTH="34%"></TD>
<TD VALIGN="bottom"></TD>
<TD WIDTH="32%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="32%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" ALIGN="center"><B>Cayman Islands</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-38520</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>Not applicable</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"><B>(State or other jurisdiction of incorporation or organization)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(Commission File Number)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(I.R.S. Employer Identification No.)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>430 East 29th Street, 10<SUP STYLE="font-size:85%; vertical-align:top">th</SUP> Floor </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>New York, NY 10016 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices) (Zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(646) <FONT STYLE="white-space:nowrap">490-2965</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Not applicable </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former
name or former address, if changed since last report) </B></P> <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: </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&nbsp;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 <FONT STYLE="white-space:nowrap">Rule&nbsp;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 <FONT
STYLE="white-space:nowrap">Rule&nbsp;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 <FONT
STYLE="white-space:nowrap">Rule&nbsp;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 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or Rule <FONT STYLE="white-space:nowrap">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; text-indent:4%; font-size:10pt; font-family:Times New Roman">Emerging growth company&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) of the Exchange
Act.&nbsp;&#9744; </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000">&nbsp;</P>
<P STYLE="font-size:6pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
</DIV></Center>


<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


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

<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="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;1.01.</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>Entry Into a Material Definitive Agreement. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Collaboration Agreement </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On
January&nbsp;30, 2019, (the &#147;Agreement Date&#148;), MeiraGTx Holdings plc (the &#147;Company&#148;) and its wholly owned subsidiary, MeiraGTx UK II Limited, entered into a Collaboration, Option and License Agreement (the &#147;Collaboration
Agreement&#148;) with Janssen Pharmaceuticals, Inc. (&#147;Janssen&#148;) for the research, development and commercialization of gene therapies for the treatment of inherited retinal diseases (&#147;IRDs&#148;). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Collaboration and Licenses </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals
or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the &#147;Effective Date&#148; and such clearance, &#147;Antitrust Clearance&#148;), the Company and Janssen have agreed to collaborate on the
conduct of 3 collaboration programs from the Company&#146;s leading IRD pipeline (the &#147;Clinical Programs&#148;) for the following: (i)&nbsp;a product candidate for achromatopsia (&#147;ACHM&#148;) caused by mutations in CNGB3; (ii) a product
candidate for ACHM caused by mutations in CNGA3; and (iii)&nbsp;a product candidate for <FONT STYLE="white-space:nowrap">X-linked</FONT> retinitis pigmentosa (&#147;XLRP&#148;). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company and Janssen have agreed on a research collaboration to develop a pipeline of IRD gene therapy candidates. The parties will select
and prioritize IRD targets for research. Janssen has the right to <FONT STYLE="white-space:nowrap">opt-in</FONT> to each program coming out of the research collaboration (&#147;Research Program&#148;) at or before the time of clearance of an
Investigational New Drug (&#147;IND&#148;) application by the United States Food and Drug Administration (&#147;FDA&#148;). The Company and Janssen have also agreed on a separate research collaboration to further develop manufacturing technology for
adeno-associated virus (&#147;AAV&#148;)-based gene therapy products (&#147;CMC Development Collaboration&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under the terms of the
Collaboration Agreement, subject to the licenses granted by Janssen back to the Company, the Company has agreed to grant to Janssen, as of the Effective Date, exclusive, worldwide, royalty-bearing, transferable, sublicensable licenses to certain of
the Company&#146;s intellectual property rights, for the research, development, manufacturing and commercialization of gene therapy products (the &#147;Products&#148;) from: (i)&nbsp;the Clinical Programs; and (ii)&nbsp;the Research Programs for
which Janssen <FONT STYLE="white-space:nowrap">opts-in.</FONT> The Company retains all rights to a Product from the Research Program if Janssen does not <FONT STYLE="white-space:nowrap">opt-in</FONT> to the Research Program. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Financial Terms </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under
the terms of the Collaboration Agreement, Janssen has agreed to pay the Company an upfront payment of $100&nbsp;million (the &#147;Upfront Payment&#148;) within 30 days after the Effective Date. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Janssen will fund all clinical development and commercialization costs for the Clinical Programs. Janssen will pay an <FONT
STYLE="white-space:nowrap">opt-in</FONT> fee for each Research Program that Janssen selects for further development and commercialization. Prior to <FONT STYLE="white-space:nowrap">opt-in</FONT> to a Research Program, the parties will share the
research costs for each Research Program, and a significant portion of the costs of the research collaboration will be paid by Janssen. Following <FONT STYLE="white-space:nowrap">opt-in</FONT> to a Research Program, Janssen will fund all clinical
development and commercialization costs for the Research Program. The parties will share the costs associated with the manufacturing collaboration. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Collaboration Agreement provides for: (i)&nbsp;aggregate development and commercial milestone payments from Janssen to the Company of up
to $340&nbsp;million for the Company&#146;s CNGB3, CNGA3 and XLRP programs and (ii)&nbsp;an <FONT STYLE="white-space:nowrap">opt-in</FONT> payment plus development milestones from Janssen to the Company for each Research Program <FONT
STYLE="white-space:nowrap">opted-in</FONT> by Janssen. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Janssen has also agreed to pay the Company royalties, based on future net sales of
the Products. Such royalty percentages, for net sales globally are: (i)&nbsp;an untiered rate of 20&nbsp;percent of annual net sales for the Clinical Programs; and (ii)&nbsp;an untiered high teens percentage of annual net sales for the Research
Programs <FONT STYLE="white-space:nowrap">opted-in</FONT> by Janssen. On a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">country-by-country</FONT></FONT> and
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Product-by-Product</FONT></FONT> basis, royalty payments would commence on the first commercial sale of a Product and terminate on the later of: (a)&nbsp;the expiration of the last
valid claim covering certain aspects of the Product or its approved of use in such country; (b) 10 years from the first commercial sale of </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>

</DIV></Center>


<p Style='page-break-before:always'>
<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; font-size:10pt; font-family:Times New Roman">
the Product in such country; and (c)&nbsp;the expiration of data exclusivity in such country (the &#147;Royalty Term&#148;). Royalty payments may be reduced by up to 50% in specified
circumstances. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Manufacturing </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company will initially be responsible for the manufacture of Products for research and development activities in accordance with applicable
research plans and development plans. Further clinical and commercial supply of Products will occur under a separate clinical supply agreement and commercial supply agreement negotiated between the Company and Janssen. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Intellectual Property </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under the terms of the Collaboration Agreement and subject to specified exceptions therein, each party owns the entire right, title and
interest in and to all intellectual property rights made solely by its employees or agents in the course of the collaboration. The parties jointly own all rights, title and interest in and to all intellectual property rights: (i)&nbsp;made or
invented jointly by employees or agents of both parties; and (ii)&nbsp;made or invented under the CMC Development Collaboration. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Termination </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Unless
earlier terminated, the Collaboration Agreement expires on the expiration of the last to expire Royalty Term with respect to a Product in all countries. Either party may terminate the Collaboration Agreement: if specified regulatory agencies seek to
enjoin the transaction, if the parties are unable to obtain Antitrust Clearance within 180 days of the applicable antitrust filings, or for the other party&#146;s uncured material breach, insolvency or bankruptcy. Beginning on the first anniversary
of the Effective Date, Janssen may terminate the Collaboration Agreement in its entirety or on a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Product-by-Product</FONT></FONT> basis by providing prior written notice to the
Company: (i)&nbsp;ninety (90) days if before the first commercial sale of such Product; and (ii)&nbsp;six (6) months following the first commercial sale of such Product. The Company may terminate the Collaboration Agreement, subject to specified
conditions, if Janssen challenges the validity or enforceability of certain of the Company intellectual property rights. </P> <P STYLE="font-size:18pt;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="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;7.01.</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>Regulation FD Disclosure. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;31, 2019, the Company issued a press release announcing the Collaboration Agreement, a copy of which is filed as Exhibit 99.1
hereto and incorporated herein by reference. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The information in this Item 7.01 of this Current Report on Form <FONT
STYLE="white-space:nowrap">8-K</FONT> (including Exhibit 99.1) shall not be deemed &#147;filed&#148; for purposes of Section&nbsp;18 of the Securities Exchange Act of 1934, as amended (the &#147;Exchange Act&#148;), or otherwise subject to the
liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing. </P>
<P STYLE="font-size:18pt;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="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01.</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>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d)&nbsp;&nbsp;&nbsp;&nbsp;<I>Exhibits</I>. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" ALIGN="center">


<TR>
<TD></TD>
<TD VALIGN="bottom" WIDTH="9%"></TD>
<TD WIDTH="88%"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:10pt; font-family:Times New Roman; "><B>Exhibit&nbsp;No.</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Description</B></P></TD></TR>


<TR STYLE="font-size:1pt">
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d653029dex991.htm">Press Release of MeiraGTx Holdings plc, dated January&nbsp;31, 2019</A></TD></TR>
</TABLE>
 <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">3 </P>

</DIV></Center>


<p Style='page-break-before:always'>
<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; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURE </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date: February&nbsp;5, 2019 </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt">


<TR>
<TD WIDTH="12%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="87%"></TD></TR>


<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" COLSPAN="3">MEIRAGTX HOLDINGS PLC</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<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/ Richard Giroux</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Name:</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Title:</P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Richard Giroux</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Chief Operating
Officer</P></TD></TR>
</TABLE></DIV>
 <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">4 </P>

</DIV></Center>

</BODY></HTML>
[{"type": "8-K", "sequence": "1", "filename": "d653029d8k.htm", "description": "8-K", "secsgml_size_bytes": 24302}]
{"company-data": {"conformed-name": "MeiraGTx Holdings plc", "cik": "0001735438", "assigned-sic": "2836", "irs-number": "000000000", "state-of-incorporation": "E9", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-38520", "film-number": "19568822"}, "business-address": {"street1": "450 EAST 29TH STREET", "street2": "15TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10016", "phone": "6464902965"}, "mail-address": {"street1": "450 EAST 29TH STREET", "street2": "15TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10016"}}
8-K
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
Current Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
January
30, 2019
MeiraGTx Holdings plc
(Exact name of registrant as specified in its charter)
Cayman Islands
001-38520
Not applicable
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
430 East 29th Street, 10
th
Floor
New York, NY 10016
(Address of principal executive offices) (Zip code)
(646)
490-2965
(Registrant's telephone number, including area code)
Not applicable
(Former
name or former address, if changed since last report)
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:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to
Rule 14a-12
under the Exchange Act
(17 CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to
Rule 14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
☐
Pre-commencement
communications pursuant to
Rule 13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☒
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. ☐
Item 1.01.
Entry Into a Material Definitive Agreement.
Collaboration Agreement
On
January 30, 2019, (the "Agreement Date"), MeiraGTx Holdings plc (the "Company") and its wholly owned subsidiary, MeiraGTx UK II Limited, entered into a Collaboration, Option and License Agreement (the "Collaboration
Agreement") with Janssen Pharmaceuticals, Inc. ("Janssen") for the research, development and commercialization of gene therapies for the treatment of inherited retinal diseases ("IRDs").
Collaboration and Licenses
Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any required approvals
or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the "Effective Date" and such clearance, "Antitrust Clearance"), the Company and Janssen have agreed to collaborate on the
conduct of 3 collaboration programs from the Company's leading IRD pipeline (the "Clinical Programs") for the following: (i) a product candidate for achromatopsia ("ACHM") caused by mutations in CNGB3; (ii) a product
candidate for ACHM caused by mutations in CNGA3; and (iii) a product candidate for
X-linked
retinitis pigmentosa ("XLRP").
The Company and Janssen have agreed on a research collaboration to develop a pipeline of IRD gene therapy candidates. The parties will select
and prioritize IRD targets for research. Janssen has the right to
opt-in
to each program coming out of the research collaboration ("Research Program") at or before the time of clearance of an
Investigational New Drug ("IND") application by the United States Food and Drug Administration ("FDA"). The Company and Janssen have also agreed on a separate research collaboration to further develop manufacturing technology for
adeno-associated virus ("AAV")-based gene therapy products ("CMC Development Collaboration").
Under the terms of the
Collaboration Agreement, subject to the licenses granted by Janssen back to the Company, the Company has agreed to grant to Janssen, as of the Effective Date, exclusive, worldwide, royalty-bearing, transferable, sublicensable licenses to certain of
the Company's intellectual property rights, for the research, development, manufacturing and commercialization of gene therapy products (the "Products") from: (i) the Clinical Programs; and (ii) the Research Programs for
which Janssen
opts-in.
The Company retains all rights to a Product from the Research Program if Janssen does not
opt-in
to the Research Program.
Financial Terms
Under
the terms of the Collaboration Agreement, Janssen has agreed to pay the Company an upfront payment of $100 million (the "Upfront Payment") within 30 days after the Effective Date.
Janssen will fund all clinical development and commercialization costs for the Clinical Programs. Janssen will pay an
opt-in
fee for each Research Program that Janssen selects for further development and commercialization. Prior to
opt-in
to a Research Program, the parties will share the
research costs for each Research Program, and a significant portion of the costs of the research collaboration will be paid by Janssen. Following
opt-in
to a Research Program, Janssen will fund all clinical
development and commercialization costs for the Research Program. The parties will share the costs associated with the manufacturing collaboration.
The Collaboration Agreement provides for: (i) aggregate development and commercial milestone payments from Janssen to the Company of up
to $340 million for the Company's CNGB3, CNGA3 and XLRP programs and (ii) an
opt-in
payment plus development milestones from Janssen to the Company for each Research Program
opted-in
by Janssen.
Janssen has also agreed to pay the Company royalties, based on future net sales of
the Products. Such royalty percentages, for net sales globally are: (i) an untiered rate of 20 percent of annual net sales for the Clinical Programs; and (ii) an untiered high teens percentage of annual net sales for the Research
Programs
opted-in
by Janssen. On a
country-by-country
and
Product-by-Product
basis, royalty payments would commence on the first commercial sale of a Product and terminate on the later of: (a) the expiration of the last
valid claim covering certain aspects of the Product or its approved of use in such country; (b) 10 years from the first commercial sale of
2
the Product in such country; and (c) the expiration of data exclusivity in such country (the "Royalty Term"). Royalty payments may be reduced by up to 50% in specified
circumstances.
Manufacturing
The Company will initially be responsible for the manufacture of Products for research and development activities in accordance with applicable
research plans and development plans. Further clinical and commercial supply of Products will occur under a separate clinical supply agreement and commercial supply agreement negotiated between the Company and Janssen.
Intellectual Property
Under the terms of the Collaboration Agreement and subject to specified exceptions therein, each party owns the entire right, title and
interest in and to all intellectual property rights made solely by its employees or agents in the course of the collaboration. The parties jointly own all rights, title and interest in and to all intellectual property rights: (i) made or
invented jointly by employees or agents of both parties; and (ii) made or invented under the CMC Development Collaboration.
Termination
Unless
earlier terminated, the Collaboration Agreement expires on the expiration of the last to expire Royalty Term with respect to a Product in all countries. Either party may terminate the Collaboration Agreement: if specified regulatory agencies seek to
enjoin the transaction, if the parties are unable to obtain Antitrust Clearance within 180 days of the applicable antitrust filings, or for the other party's uncured material breach, insolvency or bankruptcy. Beginning on the first anniversary
of the Effective Date, Janssen may terminate the Collaboration Agreement in its entirety or on a
Product-by-Product
basis by providing prior written notice to the
Company: (i) ninety (90) days if before the first commercial sale of such Product; and (ii) six (6) months following the first commercial sale of such Product. The Company may terminate the Collaboration Agreement, subject to specified
conditions, if Janssen challenges the validity or enforceability of certain of the Company intellectual property rights.
Item 7.01.
Regulation FD Disclosure.
On January 31, 2019, the Company issued a press release announcing the Collaboration Agreement, a copy of which is filed as Exhibit 99.1
hereto and incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form
8-K
(including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the
liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01.
Financial Statements and Exhibits.
(d)
Exhibits
.
Exhibit No.
Description
99.1
Press Release of MeiraGTx Holdings plc, dated January 31, 2019
3
SIGNATURE
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.
Date: February 5, 2019
MEIRAGTX HOLDINGS PLC
By:
/s/ Richard Giroux
Name:
Title:
Richard Giroux
Chief Operating
Officer
4