<SEC-DOCUMENT>0001178913-21-002093.txt : 20210617
<SEC-HEADER>0001178913-21-002093.hdr.sgml : 20210617
<ACCEPTANCE-DATETIME>20210617080247
ACCESSION NUMBER:		0001178913-21-002093
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210617
FILED AS OF DATE:		20210617
DATE AS OF CHANGE:		20210617

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:		211023388

	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>zk2126200.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;"> <br>
    </div>
    <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 June 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;">
    </div>
    <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
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        <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: 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 June 17, 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>
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        <tr>
          <td style="width: 13.24%; vertical-align: top;" rowspan="1">
            <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Exhibit
                99.1:</a>&#160;&#160; <a href="exhibit_99-1.htm">Press release dated June 17, 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">
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    </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" border="0" id="zdf73eb8f0cbb46d0b6db910e4f87456b" 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="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: 13%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 3%; vertical-align: top;">&#160;</td>
          <td style="width: 33.8%; vertical-align: top;">&#160;</td>
          <td style="width: 13%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
          <td style="width: 3%; 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: 13%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 3%; 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: 13%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 3%; 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: 13%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.99%; vertical-align: top;">&#160;</td>
          <td style="width: 3%; vertical-align: top;">&#160;</td>
          <td style="width: 33.8%; vertical-align: top;">&#160;</td>
          <td style="width: 13%; vertical-align: top;">&#160;</td>
        </tr>

    </table>
    <div style="line-height: 1.25;">Date: June 17, 2021</div>
    <div><br>
    </div>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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        </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="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">Entera Bio Receives Foundational Patent for its Oral PTH using its Platform </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">Oral Protein Delivery Technology in European Union</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">&#160;</font><font style="font-style: italic;">&#8210; Oral delivery technology has potential to transform $20 billion injectable biologics market&#160; &#8210;</font></div>
    <div style="text-align: center; line-height: 1.25;"><font style="font-style: italic;"> <br>
      </font></div>
    <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">-&#160;&#160; Final BMD results from company&#8217;s Phase 2 Osteoporosis study of EB 613 expected in </div>
    <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">Q2/2021</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 June 17, 2021) </font>&#8211; Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced the
      European Patent Office has granted a patent titled &#8220;Methods and Compositions for Oral Administration of Proteins&#8221; to Entera. The patent addresses Entera&#8217;s oral PTH formulations currently in advanced clinical stages for osteoporosis and
      hypoparathyroidism.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;This is a critical patent that covers lead PTH products utilizing Entera&#8217;s platform technology. This European Union patent, along with
      a variety of other patents covering oral formulations and target indications, granted and pending, provide Entera with robust protection of its intellectual property. This granted patent comes in addition to numerous issued patents in strategic
      countries including the USA, China, Japan, Australia, New Zealand and Israel. We are particularly pleased to have successfully completed the nine-month time window in which the patent could have been opposed. Entera has fortified its leadership
      position in the oral delivery of proteins as we look forward to reporting the full 6 month BMD results from our Phase 2 study, as planned this Q2/2021 and potentially initiating a pivotal Phase 3 study with our oral PTH for the treatment of
      osteoporosis next year,&#8221; stated Entera CEO Spiros Jamas.&#160; &#8220;We continuously strive to strengthen our portfolio with new patents addressing specific applications as well as novel improvements to our platform.&#8221;</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">
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    </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 complete 3-month biomarker data from the ongoing Phase 2 clinical trial of EB613, the timing of data readouts from the ongoing Phase 2 clinical trial of EB613, the full results of the Phase
      2 clinical trial of EB613, which is still ongoing and our analysis of those full results, the FDA&#8217;s interpretation and review of our results from and analysis of our Phase 2 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 those 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 to 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 EB612 and 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 Annual Report on Form 20-F for the year
      ended December 31, 2020, filed with the SEC in the first quarter of 2021. 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;">Spiros Jamas, CEO</div>
    <div style="line-height: 1.25;">Tel: +001 617-362-3579</div>
    <div style="line-height: 1.25;"><u>spiros@enterabio.com</u></div>
    <div style="line-height: 1.25;"><u> <br>
      </u></div>
    <div 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;"><u> </u></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
