<SEC-DOCUMENT>0000950103-17-010811.txt : 20180731
<SEC-HEADER>0000950103-17-010811.hdr.sgml : 20180731
<ACCEPTANCE-DATETIME>20171103150853
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000950103-17-010811
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20171103

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Entera Bio Ltd.
		CENTRAL INDEX KEY:			0001638097
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		KIRYAT HADASSAH, MINRAV BUILDING
		STREET 2:		FIFTH FLOOR
		CITY:			JERUSALEM
		STATE:			L3
		ZIP:			9112002
		BUSINESS PHONE:		972-2-532-7151

	MAIL ADDRESS:	
		STREET 1:		KIRYAT HADASSAH, MINRAV BUILDING
		STREET 2:		FIFTH FLOOR
		CITY:			JERUSALEM
		STATE:			L3
		ZIP:			9112002
</SEC-HEADER>
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    <TD STYLE="width: 17%; font-size: 8pt; font-weight: bold">New York<BR>
Northern California<BR>
Washington DC<BR>
S&atilde;o Paulo<BR>
London</TD>
    <TD STYLE="width: 17%; font-size: 8pt; font-weight: bold">Paris<BR>
Madrid<BR>
Tokyo<BR>
Beijing<BR>
Hong Kong</TD></TR>
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        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><IMG SRC="image_003.jpg" ALT="DavisPolk" STYLE="height: 30px; width: 155px"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P></TD></TR>
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    <TD COLSPAN="2">
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><B>Michael Kaplan</B></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD NOWRAP STYLE="width: 20%; font-size: 10pt"><FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt">Davis Polk &amp; Wardwell LLP</FONT><BR>
<FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt">450 Lexington Avenue</FONT><BR>
<FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt">New York, NY 10017</FONT></TD>
    <TD STYLE="width: 80%; padding-left: 4pt">
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">212 450 4111 tel</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">212 701 5111 fax&nbsp;</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">michael.kaplan@davispolk.com</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P></TD></TR>
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    <TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
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    <TD COLSPAN="2" STYLE="font-size: 10pt">&nbsp;</TD></TR>
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    <TD COLSPAN="2" STYLE="font-size: 10pt"><P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt">November 3, 2017</FONT></P>
                                            <P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font: 10pt Arial, Helvetica, Sans-Serif">&nbsp;</FONT></P></TD></TR>
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    <TD STYLE="width: 8%; font-size: 10pt"><B>Re:</B></TD>
    <TD STYLE="width: 92%">
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><B>Entera Bio Ltd.</B></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><B>Draft Registration Statement on Form F-1</B>&nbsp;</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><B>Submitted September 20, 2017</B></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0.7in 0pt 0"><B>CIK No. 0001638097</B>&nbsp;</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0; text-align: right">CONFIDENTIAL</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0; text-align: right"></P></TD></TR>
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<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Ms. Ada D. Sarmento and Ms. Mary B. Breslin</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Division of Corporation Finance<BR>
U.S. Securities and Exchange Commission<BR>
100 F Street, N.E.<BR>
Washington, DC 20549-3628</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Dear Ms. Sarmento and Ms. Breslin,</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">On behalf of our client, Entera Bio Ltd., a company incorporated
in Israel with limited liability (the &ldquo;<B>Company</B>&rdquo;), we are responding to the comments from the Staff (the &ldquo;<B>Staff</B>&rdquo;)
of the Securities and Exchange Commission (the &ldquo;<B>Commission</B>&rdquo;) relating to the Company&rsquo;s confidential draft
Registration Statement on Form F-1 (the &ldquo;<B>Registration Statement</B>&rdquo;) contained in the Staff&rsquo;s letter dated
October 4, 2017 (the &ldquo;<B>Comment Letter</B>&rdquo;). In response to the comments set forth in the Comment Letter, the Company
has revised the Registration Statement and is confidentially submitting a revised draft of the Registration Statement together
with this response letter. The revised draft of the Registration Statement also contains certain additional updates and revisions.
We are also sending, under separate cover, a copy of the revised draft of the Registration Statement and three marked copies of
the Registration Statement showing the changes to the Registration Statement confidentially submitted on September 20, 2017.</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Set forth below are the Company&rsquo;s responses to the Staff&rsquo;s
comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For
convenience, the Staff&rsquo;s comments are repeated below, followed by the Company&rsquo;s response to the comments as well as
a summary of the responsive actions taken. We have included page numbers to refer to the location in the revised draft of the Registration
Statement submitted herewith where the revised language addressing a particular comment appears.</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

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<TR>
    <TD STYLE="vertical-align: top; width: 34%; font-size: 10pt">Ms. Ada D. Sarmento,<BR>
Ms. Mary B. Breslin<BR>
Division of Corporation Finance<BR>
U.S. Securities and Exchange Commission</TD>
    <TD STYLE="vertical-align: bottom; width: 33%; text-align: center; font-size: 10pt">2</TD>
    <TD STYLE="vertical-align: bottom; width: 33%; text-align: right; font-size: 10pt">November 3, 2017</TD></TR>
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<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><U>Draft Registration Statement on Form F-1</U></P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><U>Risk Factors</U><BR>
<U>We may not be successful in our efforts to use and expand our drug delivery technology to other product candidates, page 22</U></P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top">
<TD STYLE="width: 18pt"></TD><TD STYLE="width: 18pt; text-align: left">1.</TD><TD>We note your response to our prior comment 6 and reissue
in part. We note your statement in this risk factor that your synthesized PTH molecule has an established safety profile. Please
remove statements suggesting that your product candidates are safe and effective as approval by the FDA and other regulatory agencies
is dependent on such agencies making this determination.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 1in"><B>Response:</B></TD><TD>&nbsp;&nbsp;In response to the Staff&rsquo;s comment, we have revised the disclosure on page 26 of the Registration
                                                                              Statement. </TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Arial, Helvetica, Sans-Serif">&nbsp;</P>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Arial, Helvetica, Sans-Serif"></P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Preclinical and Clinical Development of EB612, page 85</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top">
<TD STYLE="width: 18pt"></TD><TD STYLE="width: 18pt; text-align: left">2.</TD><TD>Please disclose how many possibly-related mild adverse
events of anemia and nausea were reported and why you were not able to determine whether such events were drug-related.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 1in"><B>Response:</B></TD><TD>In response to the Staff&rsquo;s comment, we have revised the disclosure on page 94 of the Registration Statement.</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Arial, Helvetica, Sans-Serif">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Preclinical and Clinical Development of EB613, page 89</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top">
<TD STYLE="width: 18pt"></TD><TD STYLE="width: 18pt; text-align: left">3.</TD><TD>Please disclose the number of participants that experienced
the drug-related adverse events discussed in this section.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 1in"><B>Response:</B></TD><TD>In response to the Staff&rsquo;s comment, we have revised the disclosure on page 97 of the Registration Statement.</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Arial, Helvetica, Sans-Serif">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">The Israeli Innovation Authority Grant, page 92</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top">
<TD STYLE="width: 18pt"></TD><TD STYLE="width: 18pt; text-align: left">4.</TD><TD>We note your revised disclosure in response to prior comment
11 that you believe the UK agreement will not affect the royalty rates to be paid to the IIA. Please expand your disclosure to
quantify the amount of the grants that you have received that could be payable to the IIA.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 12pt Arial, Helvetica, Sans-Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 1in"><FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt"><B>Response:</B></FONT></TD><TD><FONT STYLE="font-family: Arial, Helvetica, Sans-Serif; font-size: 10pt">In response to the Staff&rsquo;s comment, we have
revised the disclosure on page 101 of the
Registration Statement.&#9;</FONT></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 12pt Arial, Helvetica, Sans-Serif">&nbsp;</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Please do not hesitate to contact me at (212) 450-4111, (212)
701-5111 (fax) or michael.kaplan@davispolk.com or Sophia Hudson at (212) 450-4762, (212) 701-5762 (fax) or sophia.hudson@davispolk.com
if you have any questions regarding the foregoing or if I can provide any additional information.</P>

<P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Arial, Helvetica, Sans-Serif; width: 100%; border-collapse: collapse">
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top; font-size: 10pt">Very truly yours,<BR>
<BR>
<BR>
/s/ Michael Kaplan<BR>
Michael Kaplan</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="font-size: 10pt">cc:</TD>
    <TD COLSPAN="2">
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><U>Via E-mail</U></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Dr. Phillip Schwartz, Chief Executive Officer</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Mira Rosenzweig, Chief Financial Officer</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Entera Bio Ltd.</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Sophia Hudson, Davis Polk</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">Ivan Blumenthal, Mintz Levin</P>
        <P STYLE="font: 10pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"></P></TD></TR>
<TR>
    <TD STYLE="width: 5%">&nbsp;</TD>
    <TD STYLE="width: 56%">&nbsp;</TD>
    <TD STYLE="width: 39%">&nbsp;</TD></TR>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
