<SEC-DOCUMENT>0001193125-21-098947.txt : 20210330
<SEC-HEADER>0001193125-21-098947.hdr.sgml : 20210330
<ACCEPTANCE-DATETIME>20210330060758
ACCESSION NUMBER:		0001193125-21-098947
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210326
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20210330
DATE AS OF CHANGE:		20210330

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Vir Biotechnology, Inc.
		CENTRAL INDEX KEY:			0001706431
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				812730369
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39083
		FILM NUMBER:		21783526

	BUSINESS ADDRESS:	
		STREET 1:		499 ILLINOIS STREET
		STREET 2:		SUITE 500
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158
		BUSINESS PHONE:		415-906-4324

	MAIL ADDRESS:	
		STREET 1:		499 ILLINOIS STREET
		STREET 2:		SUITE 500
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d118531d8k.htm
<DESCRIPTION>8-K
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<TITLE>8-K</TITLE>
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 <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">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) of </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>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): March&nbsp;26, 2021 </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>Vir Biotechnology, Inc. </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">001-39083</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">81-2730369</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>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>499 Illinois Street, Suite 500 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>San Francisco, California 94158 </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, including zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(415) <FONT STYLE="white-space:nowrap">906-4324</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:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report) </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>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">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>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><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>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><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">Securities registered pursuant to Section&nbsp;12(b) of the Act: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Title of each class</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Trading Symbol(s)</B></P></TD>
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<TD VALIGN="bottom" ALIGN="center" STYLE="border-bottom:1.00pt solid #000000"> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Name of each exchange on which registered</B></P></TD></TR>


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<TD VALIGN="top" ALIGN="center"><B>Common Stock, $0.0001 par value</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>VIR</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>Nasdaq Global Select Market</B></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 (&#167; <FONT STYLE="white-space:nowrap">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 &#9744; </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;&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>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</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>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On March&nbsp;26, 2021 Vir Biotechnology, Inc. (the &#147;Company&#148;) and GlaxoSmithKline plc (&#147;GSK&#148;) announced the submission of an application
to the U.S. Food and Drug Administration (&#147;FDA&#148;) requesting Emergency Use Authorization (&#147;EUA&#148;) for <FONT STYLE="white-space:nowrap">VIR-7831,</FONT> an investigational dual-action <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT> monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">mild-to-moderate</FONT></FONT> <FONT STYLE="white-space:nowrap">COVID-19</FONT> who are at risk for progression to hospitalization or death. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The FDA EUA submission was based on an interim analysis of efficacy and safety data from the Phase 3 <FONT STYLE="white-space:nowrap">COMET-ICE</FONT> <FONT
STYLE="white-space:nowrap">(COVID-19</FONT> Monoclonal antibody Efficacy Trial&#151;Intent to Care Early) trial, which evaluated <FONT STYLE="white-space:nowrap">VIR-7831</FONT> as monotherapy for the early treatment of <FONT
STYLE="white-space:nowrap">COVID-19</FONT> in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in
those receiving <FONT STYLE="white-space:nowrap">VIR-7831</FONT> compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of
profound efficacy. Data from the registrational <FONT STYLE="white-space:nowrap">COMET-ICE</FONT> trial also will form the basis for a Biologics License Application (&#147;BLA&#148;) submission to the FDA. As the trial remains ongoing and blinded
with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Preclinical data suggest <FONT STYLE="white-space:nowrap">VIR-7831</FONT> targets a highly conserved epitope of the spike protein, which may make it more
difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that <FONT STYLE="white-space:nowrap">VIR-7831</FONT> maintains activity
against current circulating variants of concern including the UK, South African and Brazilian variants. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company and GSK will continue discussions
with the European Medicines Agency (&#147;EMA&#148;) and other global regulators to make <FONT STYLE="white-space:nowrap">VIR-7831</FONT> available to patients with <FONT STYLE="white-space:nowrap">COVID-19</FONT> as soon as possible. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On March&nbsp;29, 2021, the Company, Eli Lilly and Company (&#147;Lilly&#148;) and GSK announced topline data from Lilly&#146;s expanded Phase 2 <FONT
STYLE="white-space:nowrap">BLAZE-4</FONT> trial, studying <FONT STYLE="white-space:nowrap">low-risk</FONT> adult patients with mild to moderate <FONT STYLE="white-space:nowrap">COVID-19.</FONT> Results showed that investigational bamlanivimab <FONT
STYLE="white-space:nowrap">(LY-CoV555)</FONT> 700 mg <FONT STYLE="white-space:nowrap">co-administered</FONT> with <FONT STYLE="white-space:nowrap">VIR-7831</FONT> 500 mg, demonstrated a 70% (p&lt;0.001) relative reduction in persistently high viral
load (&gt; 5.27; cycle threshold value &lt; 27.5) at day 7 compared to placebo, meeting the primary endpoint. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, bamlanivimab administered with
<FONT STYLE="white-space:nowrap">VIR-7831</FONT> demonstrated a statistically significant reduction compared to placebo in the key virological secondary endpoints of mean change from baseline to days 3, 5 and 7 in <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT> viral load. There were no events for the secondary endpoint of <FONT STYLE="white-space:nowrap">COVID-19</FONT> related hospitalization or death by day 29 in either study arm. One patient (in the
treatment arm) visited the emergency room for <FONT STYLE="white-space:nowrap">COVID-19</FONT> related symptoms. No serious adverse events were seen with <FONT STYLE="white-space:nowrap">co-administration</FONT> of bamlanivimab and <FONT
STYLE="white-space:nowrap">VIR-7831.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Bamlanivimab and <FONT STYLE="white-space:nowrap">VIR-7831</FONT> bind to different regions of the spike
protein of <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2.</FONT></FONT> Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT> that are resistant to bamlanivimab. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company, Lilly and GSK
anticipate engaging with global regulators, including the FDA, regarding the possible <FONT STYLE="white-space:nowrap">co-administration</FONT> of bamlanivimab and <FONT STYLE="white-space:nowrap">VIR-7831</FONT> for the treatment of <FONT
STYLE="white-space:nowrap">COVID-19.</FONT> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Forward-Looking Statements </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Words such as &#147;may,&#148; &#147;will,&#148; &#147;plan,&#148; &#147;potential,&#148; &#147;aim,&#148; &#147;promising&#148; and similar expressions (as well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company&#146;s expectations and assumptions as of the date of this Current Report. Forward-looking statements
contained in this Current Report include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to
<FONT STYLE="white-space:nowrap">VIR-7831,</FONT> the ability of <FONT STYLE="white-space:nowrap">VIR-7831</FONT> to treat and/or prevent <FONT STYLE="white-space:nowrap">COVID-19</FONT> (as monotherapy and in combination with bamlanivimab), the
potential of <FONT STYLE="white-space:nowrap">VIR-7831</FONT> in the </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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hospitalized population, the ability of <FONT STYLE="white-space:nowrap">VIR-7831</FONT> to neutralize the
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT> live virus, the ability of <FONT STYLE="white-space:nowrap">VIR-7831</FONT> to maintain full activity against variant strains of the virus, the Company&#146;s
collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA, the EMA and other global regulators. Many factors may cause differences between current expectations and
actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other
companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or
disruptions to our business or clinical trials due to the <FONT STYLE="white-space:nowrap">COVID-19</FONT> pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. </P>
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<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 hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3"><B>VIR BIOTECHNOLOGY, INC.</B></TD></TR>
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<TD VALIGN="top">Date: March&nbsp;30, 2021</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; font-size:10pt; font-family:Times New Roman" ALIGN="center">/s/ Howard Horn</P></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>Howard Horn</B></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>Chief Financial Officer</B></TD></TR>
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