<SEC-DOCUMENT>0001104659-21-040030.txt : 20210323
<SEC-HEADER>0001104659-21-040030.hdr.sgml : 20210323
<ACCEPTANCE-DATETIME>20210323081046
ACCESSION NUMBER:		0001104659-21-040030
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210323
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20210323
DATE AS OF CHANGE:		20210323

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Akero Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001744659
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38944
		FILM NUMBER:		21763206

	BUSINESS ADDRESS:	
		STREET 1:		601 GATEWAY BOULEVARD, SUITE 350
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080
		BUSINESS PHONE:		650-487-6488

	MAIL ADDRESS:	
		STREET 1:		601 GATEWAY BOULEVARD, SUITE 350
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tm219778d3_8k.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES </B></P>

<P STYLE="font: 14pt 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, D.C. 20549 </B></P>

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

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 18pt 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">&nbsp;</P>

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<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&nbsp;13 or 15(d)
</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of The 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"><B>Date of Report (Date of earliest event
reported): March 23, 2021</B></P>

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

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<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Akero Therapeutics, Inc. </B></P>

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

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

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    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
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    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="width: 32%">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Delaware</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>001-38944</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>81-5266573</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(State or other jurisdiction</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of incorporation)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Commission</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>File Number)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(I.R.S. Employer</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Identification No.)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR>
    <TD STYLE="vertical-align: top; width: 60%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>601 Gateway Boulevard, Suite&nbsp;350</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>South San Francisco, CA</B></P></TD>
    <TD STYLE="vertical-align: bottom; width: 40%; text-align: center"><FONT STYLE="font-size: 10pt"><B>94080</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Address of principal executive offices)</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Zip Code)</B></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>Registrant&#8217;s telephone number,
including area code (650) 487-6488</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>Not Applicable </B></P>

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

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

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<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:</P>

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

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    <TD STYLE="width: 4%"><FONT STYLE="font-family: Wingdings">&#168;</FONT><FONT STYLE="font-size: 10pt"></FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425) </FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TR STYLE="vertical-align: top">
    <TD STYLE="width: 4%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Soliciting material pursuant to Rule&nbsp;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>

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<TR STYLE="vertical-align: top">
    <TD STYLE="width: 4%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Pre-commencement communications pursuant to Rule&nbsp;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 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: 4%"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Pre-commencement communications pursuant to Rule&nbsp;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; color: #211D1E">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #211D1E">Securities registered pursuant to Section 12(b)
of the Act:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #211D1E">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 40%; border: Black 1pt solid; padding-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><FONT STYLE="font-size: 10pt">Title of each class</FONT></TD>
    <TD STYLE="width: 17%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><FONT STYLE="font-size: 10pt">Trading symbol(s)</FONT></TD>
    <TD STYLE="width: 43%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><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-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><FONT STYLE="font-size: 10pt">Common Stock, par value $0.0001 per share</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">AKRO</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-top: 6pt; padding-right: 5.4pt; padding-left: 5.4pt"><FONT STYLE="font-size: 10pt">The Nasdaq Global Select Market </FONT></TD></TR>
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<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">Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (&sect;&nbsp;230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (&sect;&nbsp;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&nbsp;<FONT STYLE="font-family: Wingdings">&#120;</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&nbsp;13(a) of the Exchange Act.&nbsp;<FONT STYLE="font-family: Wingdings">&#168;</FONT></P>










<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></B></P>

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<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></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01. Other Events.</B></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">Akero Therapeutics, Inc. (the &#8220;Company&#8221;) announced
on March 23, 2021 that the first patient has been randomized for dosing in its Phase 2b clinical study (the &#8220;HARMONY Study&#8221;)
of Efruxifermin (&#8220;EFX&#8221;) in the treatment of patients with F2/F3 non-alcoholic steatohepatitis (&#8220;NASH&#8221;).
The HARMONY Study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients
with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX, or placebo.
The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo after 24
weeks during a long-term follow-up period to provide additional safety data.</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">Statements contained under this Item 8.01 regarding matters
that are not historical facts are &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation
Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such statements include, but are not limited to: the Company&#8217;s guidance
regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well
as the safety and tolerability of EFX; and the Company&#8217;s Phase 2b HARMONY study, including the dosing of its first subject
in and the timing of results.</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">Any forward-looking statements are based on management&#8217;s
current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to
differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to
the uncertain nature of the forward-looking statements include: risks related to the impact of public health epidemics affecting
countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero&#8217;s
employees, manufacturers, supply chain and production as well as on global economies and financial markets; the company&#8217;s
ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of
future or ongoing clinical studies; regulatory developments in the United States; and risks related to the competitive landscape.
For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the Company&#8217;s
actual results to differ from those contained in the forward-looking statements, see the section entitled &#8220;Risk Factors&#8221;
in the Company&#8217;s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly
reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors
in the Company&#8217;s other filings with the SEC. All forward-looking statements contained in this Current Report on Form 8-K
speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they were made.</P>

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

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

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



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES </B></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">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 CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-size: 10pt">Date: March 23, 2021</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-size: 10pt"><B>AKERO THERAPEUTICS, INC.</B></FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 50%"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 4%"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid; width: 46%"><FONT STYLE="font-size: 10pt">/s/ Andrew Cheng</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Andrew Cheng, M.D., Ph.D.</FONT></TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">President and Chief Executive Officer</FONT></TD></TR>
</TABLE>


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