<SEC-DOCUMENT>0001193125-21-307471.txt : 20211026
<SEC-HEADER>0001193125-21-307471.hdr.sgml : 20211026
<ACCEPTANCE-DATETIME>20211026100701
ACCESSION NUMBER:		0001193125-21-307471
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20211026
FILED AS OF DATE:		20211026
DATE AS OF CHANGE:		20211026

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Mereo Biopharma Group plc
		CENTRAL INDEX KEY:			0001719714
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38452
		FILM NUMBER:		211346693

	BUSINESS ADDRESS:	
		STREET 1:		ONE CAVENDISH PLACE
		STREET 2:		FOURTH FLOOR
		CITY:			LONDON
		STATE:			X0
		ZIP:			W1G0QF
		BUSINESS PHONE:		4403330237300

	MAIL ADDRESS:	
		STREET 1:		ONE CAVENDISH PLACE
		STREET 2:		FOURTH FLOOR
		CITY:			LONDON
		STATE:			X0
		ZIP:			W1G0QF
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>d227135d6k.htm
<DESCRIPTION>6-K
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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, D.C. 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">6-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>REPORT OF
FOREIGN PRIVATE ISSUER PURSUANT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> or
<FONT STYLE="white-space:nowrap">15d-16</FONT> UNDER THE</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>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"><B>For the month of October, 2021 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission File Number: <FONT STYLE="white-space:nowrap">001-38452</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:24pt; font-family:Times New Roman" ALIGN="center"><B>MEREO BIOPHARMA GROUP PLC </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Translation of registrant&#146;s name into English) </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" ALIGN="center"><B>4<SUP
STYLE="font-size:85%; vertical-align:top">th</SUP> Floor, One Cavendish Place,</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>London, W1G 0QF, United Kingdom</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 office) </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">Indicate by check mark whether
the registrant files or will file annual reports under cover of Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT>
&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form <FONT STYLE="white-space:nowrap">40-F&nbsp;&nbsp;&#9744;</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT
STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(1):&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark if the registrant is submitting the Form <FONT
STYLE="white-space:nowrap">6-K</FONT> in paper as permitted by Regulation <FONT STYLE="white-space:nowrap">S-T</FONT> Rule 101(b)(7):&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><U>Exhibit Index </U></B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d227135dex991.htm">Press release dated October 26, 2021 titled &#147;Mereo BioPharma Receives U.S. Orphan Drug Designation for alvelestat in the Treatment of <FONT STYLE="white-space:nowrap">alpha-1</FONT> antitrypsin deficiency.&#148;
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </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, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date: October&nbsp;26, 2021 </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="bottom" COLSPAN="3"><B>MEREO BIOPHARMA GROUP PLC</B></TD></TR>
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<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="bottom">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Charles Sermon</TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name:&nbsp;Charles Sermon</TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title:&nbsp;General Counsel</TD></TR>
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<TYPE>EX-99.1
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<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="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Mereo BioPharma Receives U.S. Orphan Drug Designation for alvelestat in </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>the Treatment of <FONT STYLE="white-space:nowrap">alpha-1</FONT> antitrypsin deficiency </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>London</B> <B>and Redwood City, Calif., October</B><B></B><B>&nbsp;26, 2021</B>&nbsp;- Mereo BioPharma Group plc (NASDAQ: MREO), &#147;Mereo&#148; or the
&#147;Company&#148;, a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to alvelestat for the treatment of <FONT
STYLE="white-space:nowrap">alpha-1</FONT> antitrypsin deficiency (AATD). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mereo is currently developing alvelestat for the treatment of AATD-Lung Disease <FONT
STYLE="white-space:nowrap">(AATD-LD).</FONT> AATD is a rare and life-threatening disease. &#147;We believe that the orphan drug designation represents an important regulatory milestone, recognizing the significant and urgent unmet need for new
therapies to address AATD and specifically <FONT STYLE="white-space:nowrap">AATD-LD,&#148;</FONT> said Dr.&nbsp;Denise Scots-Knight, Chief Executive Officer of Mereo. &#147;We look forward to providing an update on our program before the end of the
year.&#148; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">AATD is a rare, genetic disease that results in a deficiency of <FONT STYLE="white-space:nowrap">alpha-1</FONT> antitrypsin (AAT), a protein
that is produced in the liver and normally protects the lungs against damaging enzymes that the body releases during inflammation. These damaging enzymes, specifically neutrophil elastase, lead to lung damage because of the irreversible destruction
of elastin, which is critical to the structure and function of the lung. AATD can cause pulmonary emphysema, a progressive, life-threatening lung disease, which results in severe shortness of breath, wheezing, chronic cough and sputum production, as
well as asthma, recurring chest infections and bronchiectasis. Lung symptoms start in early adult life and, over time, individuals with <FONT STYLE="white-space:nowrap">Alpha-1</FONT> lung disease may progress to needing oxygen to perform even
normal daily tasks and some eventually require a lung transplant. The production of abnormal AAT in the liver can also lead to liver disease in children and adults. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Orphan Drug Designation by the US FDA originates from the Orphan Drug Act, which was enacted in 1983 to encourage the development of innovative drugs to
treat rare diseases with a target patient population of less than 200,000 in the US. Upon marketing approval, drugs with ODD qualify for seven-year market exclusivity. In addition, US FDA also rewards ODD drugs with comprehensive incentives
including tax credit for clinical trial cost, waiver of marketing registration application fee, waiver or reduced annual product fee, and other benefits, such as clinical protocol assistance and qualification for expedited development programs. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Alvelestat </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Alvelestat <FONT
STYLE="white-space:nowrap">(MPH-966)</FONT> is a novel, oral small molecule designed to inhibit neutrophil elastase (NE), a neutrophil protease, a key enzyme involved in the destruction of lung tissue. Mereo is conducting a Phase 2 <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">proof-of-concept</FONT></FONT> clinical trial with alvelestat for the treatment of severe <FONT STYLE="white-space:nowrap">alpha-1</FONT> antitrypsin deficiency (&#147;AATD&#148;). By
inhibiting NE, Mereo believes alvelestat has the potential to protect AATD patients from further lung damage. An investigator-initiated study with alvelestat is also underway in <FONT STYLE="white-space:nowrap">AATD-LD</FONT> funded through an NIH
National Center for Advancing Translational Sciences (NCATS) program and led by Professor Mark Dransfield (University of Alabama at Birmingham). Alvelestat is also under clinical investigation in ongoing Phase 1b/2 studies in <FONT
STYLE="white-space:nowrap">COVID-19</FONT> and Bronchiolitis Obliterans Syndrome (BOS) following allogeneic hematopoietic stem cell transplant. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About
Mereo BioPharma </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mereo BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to
improve outcomes for oncology and rare diseases. The Company has developed a portfolio of six clinical stage product candidates. Mereo&#146;s lead oncology product candidate, etigilimab (anti-TIGIT), has recently advanced into an open label Phase
1b/2 basket study evaluating anti-TIGIT in combination with an <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">anti-PD-1</FONT></FONT> in a range of tumor types including three rare tumors and three gynecological carcinomas,
cervical, ovarian and endometrial </P>
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carcinomas. The Company&#146;s second oncology product, navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has been partnered with OncXerna
Therapeutics, Inc., formerly Oncologie, Inc. The Company has two rare disease product candidates: alvelestat for the treatment of severe <FONT STYLE="white-space:nowrap">Alpha-1</FONT> antitrypsin deficiency (AATD), which is being investigated in an
ongoing Phase 2 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">proof-of-concept</FONT></FONT> study in the U.S. and Europe, for which the Company expects to provide an update in the fourth quarter of 2021, and setrusumab for the
treatment of osteogenesis imperfecta (OI). In September 2020, the FDA granted Rare Pediatric Disease designation to setrusumab for the treatment of OI. In December 2020, the Company signed a license and collaboration agreement for setrusumab in OI
with Ultragenyx Pharmaceutical Inc. </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">This press release contains &#147;forward-looking statements.&#148; All statements other than statements of historical fact contained in this press release are
forward-looking statements within the meaning of Section&nbsp;27A of the United States Securities Act of 1933, as amended (the &#147;Securities Act&#148;), and Section&nbsp;21E of the United States Securities Exchange Act of 1934, as amended (the
&#147;Exchange Act&#148;). Forward-looking statements usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the
words &#147;believe,&#148; &#147;expect,&#148; &#147;anticipate,&#148; &#147;plan,&#148; &#147;intend,&#148; &#147;foresee,&#148; &#147;should,&#148; &#147;would,&#148; &#147;could,&#148; &#147;may,&#148; &#147;estimate,&#148; &#147;outlook&#148;
and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company&#146;s current expectations, beliefs
and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future
developments affecting the Company will be those that it anticipates. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">All of the Company&#146;s forward-looking statements involve known and unknown
risks and uncertainties some of which are significant or beyond its control and assumptions that could cause actual results to differ materially from the Company&#146;s historical experience and its present expectations or projections. You should
carefully consider the foregoing factors and the other risks and uncertainties that affect the Company&#146;s business, including those described in the &#147;Risk Factors&#148; section of its latest Annual Report on Form <FONT
STYLE="white-space:nowrap">20-F,</FONT> reports on Form <FONT STYLE="white-space:nowrap">6-K</FONT> and other documents furnished or filed from time to time by the Company with the Securities and Exchange Commission. The Company wishes to caution
you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of our forward-looking statements after the date they are made, whether
as a result of new information, future events or otherwise, except to the extent required by law. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Mereo BioPharma Contacts: </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><B>Mereo</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"><B>+44 (0)333 023 7300</B></TD></TR>
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<TD VALIGN="bottom">Denise Scots-Knight, Chief Executive Officer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
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<TD VALIGN="bottom">Christine Fox, Chief Financial Officer</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
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<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="bottom"><B>Burns McClellan (US Investor Relations Adviser to&nbsp;Mereo)</B></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"><B>+01 212 213 0006</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Lee Roth</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"></TD></TR>
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<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="bottom">Investors</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom"><U>investors@mereobiopharma.com</U></TD></TR>
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