<SEC-DOCUMENT>0001178913-21-000372.txt : 20210208
<SEC-HEADER>0001178913-21-000372.hdr.sgml : 20210208
<ACCEPTANCE-DATETIME>20210208083015
ACCESSION NUMBER:		0001178913-21-000372
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210208
FILED AS OF DATE:		20210208
DATE AS OF CHANGE:		20210208

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:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38556
		FILM NUMBER:		21598661

	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>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2125471.htm
<DESCRIPTION>6-K
<TEXT>
<html>
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    <title></title>
    <!-- Licensed to: Z-K GLOBAL
         Document created using EDGARfilings PROfile 7.3.2.0
         Copyright 1995 - 2021 Broadridge -->
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<body bgcolor="#ffffff" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; text-align: left; color: #000000;">
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  <br>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">UNITED STATES</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C. 20549</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">FORM 6-K</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">For the month of February 2021</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25;">Commission file number: 001-38556</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">ENTERA BIO LTD.</div>
    <div style="text-align: center; line-height: 1.25;">(Exact Name of Registrant as Specified in Its Charter)</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Kiryat Hadassah<br>
      Minrav Building &#8211; Fifth Floor</div>
    <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">Jerusalem, Israel</font><br>
      (Address of principal executive office)</div>
    <div style="text-align: center; line-height: 1.25;">_____________________</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25;">Form 20-F &#9746;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; Form 40-F &#9744;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): &#9744;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): &#9744;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25;"><u>CONTENTS</u></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;">This report on Form 6-K of the registrant consists of a press release issued by the registrant on February 08, 2021, attached hereto
        as an exhibit and incorporated by reference herein.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">This report on Form 6-K and Exhibit 99.1 hereto shall be deemed to be incorporated by reference into the registration statements on
        Form F-3 (Registration Number: 333-238988) and Form F-3 (Registration Number: 333-239843) of Entera Bio Ltd. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently
        filed or furnished.</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;"><u>Exhibit</u></div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <table cellspacing="0" cellpadding="0" border="0" id="zff3e5f2e16484ebb8253e6ec9be14e0c" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="vertical-align: top;" colspan="2">
            <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Exhibit
                99.1:</a></div>
          </td>
          <td style="width: 93%; vertical-align: top;">
            <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Press
                release dated February 08, 2021.</a></div>
          </td>
        </tr>

    </table>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
        <div style="page-break-after: always;" id="DSPFPageBreak">
          <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;"><u>SIGNATURES</u></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">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.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" id="zd1081b8541c2477e8c830123ae22fd75" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 39.68%; vertical-align: top;" colspan="2">
            <div style="line-height: 1.25; font-weight: bold;">ENTERA BIO LTD.</div>
            <div style="line-height: 1.25;">(Registrant)</div>
          </td>
          <td style="width: 10.32%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 5.88%; vertical-align: top;">&#160;</td>
          <td style="width: 33.8%; vertical-align: top;">&#160;</td>
          <td style="width: 10.32%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
          <td style="width: 5.88%; vertical-align: top; padding-bottom: 2px;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td nowrap="nowrap" style="width: 33.8%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
            <div style="line-height: 1.25;">/s/ Spiros Jamas, Sc.D</div>
          </td>
          <td style="width: 10.32%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 5.88%; vertical-align: top;">&#160;</td>
          <td nowrap="nowrap" style="width: 33.8%; vertical-align: bottom;">
            <div style="line-height: 1.25;">Name: Spiros Jamas, Sc.D</div>
          </td>
          <td style="width: 10.32%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 5.88%; vertical-align: top;">&#160;</td>
          <td style="width: 33.8%; vertical-align: top;">
            <div style="line-height: 1.25;">Title: Chief Executive Officer and Director</div>
          </td>
          <td style="width: 10.32%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 5.88%; vertical-align: top;">&#160;</td>
          <td style="width: 33.8%; vertical-align: top;">&#160;</td>
          <td style="width: 10.32%; vertical-align: top;">&#160;</td>
        </tr>

    </table>
    <div style="line-height: 1.25;">Date: February 08, 2021</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<html>
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        <div style="text-align: right;">
          <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
        </div>
        <img width="101" height="57" src="image0.jpg"></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">ENTERA BIO INITIATES NEW RESEARCH PROGRAM FOR ORAL GLP-2</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-style: italic;">&#8210; Program Leverages Entera&#8217;s Platform for Potential Development of Oral GLP-2 Analogs for </div>
    <div style="text-align: center; line-height: 1.25; font-style: italic;">Gastrointestinal and Other Indications &#8210;</div>
    <div style="text-align: center; line-height: 1.25; font-style: italic;">&#8210; GLP-2 Analogs Currently Administered Via Daily Injection to Treat Short Bowel Syndrome &#8210;</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">BOSTON, Massachusetts &amp; JERUSALEM,
        Israel (February 8, 2021) </font>&#8211; Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced a
      new research program for an oral glucagon-like peptide-2 (GLP-2) analog based on the Company&#8217;s platform technology. GLP-2, a peptide produced in the intestine and the central nervous system via the&#160;brainstem and hypothalamus, is known to enhance intestinal absorption, specifically the increased absorption of nutrients.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">The only GLP-2 analog currently on the market, teduglutide, was approved in 2012 as a once daily injection for the treatment of short
      bowel syndrome in the U.S. and Europe, registering global sales of $574 million in 2019. In preclinical models, Entera&#8217;s oral formulation of a GLP-2 analog has shown
      a comparable pharmacokinetic profile to a subcutaneous injection. The ability of GLP-2 analogs to improve intestinal function, combined with new findings about the gut-bone and gut-brain connections, indicates these peptides may also have a role in
      the treatment of other diseases.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;We see significant potential for Entera&#8217;s platform technology beyond our lead programs in human parathyroid hormone. GLP-2 is a very good fit with our platform from a technical perspective and also meets our strategic objective of developing patient friendly, orally delivered drugs to
      improve convenience and compliance, while lowering treatment costs,&#8221;&#160;stated Entera CEO Spiros Jamas. &#8220;GLP-2 analogs are an important category of new therapies for
      many metabolic diseases and therefore we believe this product candidate is well positioned for partnering opportunities.&#8221;</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Entera&#8217;s platform technology, which enables the oral delivery of large molecules, has the potential for use in biologics which
      represented approximately 30% of all U.S. FDA drug approvals between 2015 and 2018, and $20 billion in annual sales.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About Entera Bio</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical
      need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company&#8217;s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high
      variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic
      degradation and support delivery to targeted tissues. The Company&#8217;s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in Phase 2 clinical development. Entera also licenses
      its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit <u>www.enterabio.com</u>.</div>
    <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
      <div style="page-break-after: always;" id="DSPFPageBreak">
        <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Forward Looking Statements</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Various statements in this release are &#8220;forward-looking statements&#8221; under the securities laws. Words such as, but not limited to,
      &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;can,&#8221; &#8220;could,&#8221; &#8220;expect,&#8221; &#8220;estimate,&#8221; &#8220;design,&#8221; &#8220;goal,&#8221; &#8220;intend,&#8221; &#8220;may,&#8221; &#8220;might,&#8221; &#8220;objective,&#8221; &#8220;plan,&#8221; &#8220;predict,&#8221; &#8220;project,&#8221; &#8220;target,&#8221; &#8220;likely,&#8221; &#8220;should,&#8221; &#8220;will,&#8221; and &#8220;would,&#8221; or the negative of these terms and similar
      expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a
      guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Important factors that could cause actual results to differ materially from those reflected in Entera&#8217;s forward-looking statements
      include, among others: changes in our interpretation of the interim data from the ongoing Phase 2 clinical trial of EB613, the timing of data readouts from the ongoing Phase 2 clinical trial of EB613, unexpected changes in our ongoing and planned
      preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; a possible suspension of the Phase 2 clinical trial of EB613 for clinical
      or data-related reasons; the impact of COVID-19 on Entera&#8217;s business operations including the ability to collect the necessary data from the Phase 2 trial of EB613; the potential disruption and delay of manufacturing supply chains, loss of available
      workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera
      is contractually obligated to provide, such as pursuant to Entera&#8217;s agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs
      or believe that the amount of Phase 2 clinical data collected are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability,
      quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability find a dose that demonstrates the comparability of EB613 to FORTEO in the ongoing Phase 2 clinical trial of EB613; the size and growth of
      the potential market for EB613 and Entera&#8217;s other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing
      Entera&#8217;s product candidates including GLP-2; Entera&#8217;s reliance on third parties to conduct its clinical trials; Entera&#8217;s expectations regarding licensing, business transactions and strategic collaborations; Entera&#8217;s operation as a development stage
      company with limited operating history; Entera&#8217;s ability to continue as a going concern absent access to sources of liquidity; Entera&#8217;s expectations regarding its expenses, revenue, cash resources, liquidity and financial condition; Entera&#8217;s ability
      to raise additional capital; Entera&#8217;s interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera&#8217;s ability to obtain and maintain regulatory approval for any of its product candidates; Entera&#8217;s
      ability to comply with Nasdaq&#8217;s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera&#8217;s intellectual property position and its ability to protect its
      intellectual property; and other factors that are described in the &#8220;Special Note Regarding Forward-Looking Statements,&#8221; &#8220;Risk Factors&#8221; and &#8220;Management&#8217;s Discussion and Analysis of Financial Condition and Results of Operations&#8221; sections of Entera&#8217;s
      annual and current filings which are on file with the SEC and available free of charge on the SEC&#8217;s website at http://www.sec.gov. Additional factors may be set forth in those sections of Entera&#8217;s Quarterly Report on Form 6-K for the quarter ended
      September 30, 2020, filed with the SEC in the fourth quarter of 2020. In addition to the risks described above and in Entera&#8217;s annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable
      factors also could affect Entera&#8217;s results. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on,
      Entera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in
      their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf. The information in this release is provided
      only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Contact:</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">Jonathan Lieber, CFO</div>
    <div style="line-height: 1.25;">Tel: +001 617-362-3579</div>
    <div style="line-height: 1.25;"><u>jon@enterabio.com</u></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
