<SEC-DOCUMENT>0001178913-21-002133.txt : 20210623
<SEC-HEADER>0001178913-21-002133.hdr.sgml : 20210623
<ACCEPTANCE-DATETIME>20210623083028
ACCESSION NUMBER:		0001178913-21-002133
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210623
FILED AS OF DATE:		20210623
DATE AS OF CHANGE:		20210623

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:		211037241

	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>zk2126216.htm
<DESCRIPTION>6-K
<TEXT>
<html>
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      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">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; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">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; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">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; 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 id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
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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>
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      <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 23, 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: 9%; vertical-align: top;">
              <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Exhibit 99.1:</a></div>
            </td>
            <td style="width: 91%; vertical-align: top;">
              <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Press release dated June 23, 2021.</a></div>
            </td>
          </tr>

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      <div><br>
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        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
      </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>
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          <tr>
            <td style="width: 49.99%; vertical-align: top;">&#160;</td>
            <td colspan="2" style="vertical-align: top;">
              <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif; font-weight: bold;">ENTERA BIO LTD.</div>
              <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">(Registrant)</div>
            </td>
            <td style="width: 23%; 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: 24%; vertical-align: top;">&#160;</td>
            <td style="width: 23%; 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; font-family: 'Times New Roman', Times, serif;">By:</div>
            </td>
            <td nowrap="nowrap" style="width: 24%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
              <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">/s/ Spiros Jamas, Sc.D</div>
            </td>
            <td style="width: 23%; 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: 24%; vertical-align: bottom;">
              <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Name: Spiros Jamas, Sc.D</div>
            </td>
            <td style="width: 23%; 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: 24%; vertical-align: top;">
              <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">Title: Chief Executive Officer and Director</div>
            </td>
            <td style="width: 23%; 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: 24%; vertical-align: top;">&#160;</td>
            <td style="width: 23%; vertical-align: top;">&#160;</td>
          </tr>

      </table>
      <div style="line-height: 1.25;">Date: June 23, 2021</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </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;"></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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    <title></title>
    <!-- Licensed to: company
         Document created using EDGARfilings PROfile 7.5.0.0
         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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    <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;">
    <div style="text-align: right;"> <u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div> <br>
    </div>
    <div>
      <div id="DSPFPageHeader">
        <div style="line-height: 1.25;"><img width="101" height="57" src="image0.jpg"></div>
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      <div style="text-align: center; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;"><font style="background-color: rgb(255, 255, 255); font-weight: bold; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-style: normal; font-variant: normal; text-transform: none;">ENTERA BIO ANNOUNCES EXCELLENT TOPLINE PHASE 2 BMD DATA FOR EB613, THE </font></font></div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;"><font style="background-color: rgb(255, 255, 255); font-weight: bold; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-style: normal; font-variant: normal; text-transform: none;">STUDY MET ITS PRIMARY AND KEY SECONDARY ENDPOINTS</font><br>
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            </td>
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            <td style="width: auto; vertical-align: top;">
              <div style="font-weight: bold;">
                <div style="line-height: 1.25; font-weight: bold;">Subjects receiving the 2.5 mg dose of EB613 showed significant dose-related increases in BMD at the lumbar spine, total hip, and femoral neck at 6 months</div>
              </div>
            </td>
          </tr>

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      <div style="line-height: 1.25">&#160;</div>
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            </td>
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            <td style="width: auto; vertical-align: top;">
              <div style="font-style: italic;">
                <div style="line-height: 1.25; font-style: italic;">Subjects receiving the 2.5 mg dose of EB613 for 6 months had a significant placebo adjusted increase of
                  3.78% in lumbar spine BMD (p&lt;0.008)</div>
              </div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25">&#160;</div>
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            </td>
            <td style="width: 18pt; vertical-align: top; align: right;">-</td>
            <td style="width: auto; vertical-align: top;">
              <div style="font-style: italic;">
                <div style="line-height: 1.25; font-style: italic;">The study&#8217;s primary efficacy endpoint, a statistically significant increase in P1NP at 3 months was
                  achieved, as previously reported</div>
              </div>
            </td>
          </tr>

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      <div style="line-height: 1.25">&#160;</div>
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            <td style="width: 54pt;"><br>
            </td>
            <td style="width: 18pt; vertical-align: top; align: right;">-</td>
            <td style="width: auto; vertical-align: top;">
              <div>
                <div style="line-height: 1.25;"><font style="font-style: italic;">EB613 exhibited an excellent
                    safety profile, with no drug related serious adverse events</font></div>
              </div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25">&#160;</div>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="z2f3202be53ec493bb814a03aa6f809de">

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            <td style="width: 54pt;"><br>
            </td>
            <td style="width: 18pt; vertical-align: top; align: right;">-</td>
            <td style="width: auto; vertical-align: top;">
              <div>
                <div style="line-height: 1.25; font-style: italic;">An End of Phase 2 meeting with FDA to review the EB613 development program is anticipated in the coming
                  months. It is planned to conduct a single pivotal one-year Phase 3
                  study comparing changes in lumbar spine BMD in patients treated with
                  EB613 versus treatment with Forteo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, as per a 505(b)(2) pathway</div>
              </div>
            </td>
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      </table>
      <div style="line-height: 1.25">&#160;</div>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="z202e79175ce94e10af72d450f394bbd3">

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            <td style="width: 54pt;"><br>
            </td>
            <td style="width: 18pt; vertical-align: top; align: right;">-</td>
            <td style="width: auto; vertical-align: top;">
              <div style="font-style: italic;">
                <div style="line-height: 1.25; font-style: italic;">EB613 is positioned to be the first oral bone building agent for the treatment of osteoporosis</div>
              </div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">
        <div style="line-height: 1.25;"><font style="font-weight: bold;">BOSTON, Massachusetts &amp;
            JERUSALEM, Israel (June 23, 2021)</font> &#8211;<font style="font-weight: bold;">&#160;</font>Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule and
          biologic therapeutics, announced the final 6-month bone mineral density (BMD) results from the completed Phase 2 clinical trial of EB613 for the treatment of osteoporosis. EB613 is an oral formulation of human parathyroid hormone (1-34), or PTH,
          positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients.&#160; Currently, fewer than 5% of osteoporosis patients on any form of
          therapy are treated with an injectable anabolic agent, widely accepted as the most effective form of treatment<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>. The Phase 2 clinical trial of EB613 was a 6-month double blind, dose-ranging, placebo-controlled study in 161
          postmenopausal female subjects with osteoporosis, or with low bone mineral density (BMD). This study was conducted at four leading medical centers in Israel to evaluate the safety and efficacy of varying doses of EB613. All lab tests including biomarkers and safety monitoring were performed at a certified central
          laboratory, and BMD data from clinical sites was analyzed at an independent certified global imaging center.</div>
        <br>
      </div>
      <div style="line-height: 1.25;">The most important BMD endpoint &#8212; change in lumbar spine (LS) BMD after 6 months &#8212; was met.&#160; There were statistically significant dose-related trends in the increases in LS BMD as well as femoral neck and total hip
        BMD, with the largest increases observed in subjects treated with EB613 2.5 mg. Dose dependent increases in biochemical markers of bone formation were previously reported. A significant increase in lumbar spine (LS) BMD was observed in the 1.5 mg
        group, the non-titrated 2.5 mg group (those who received 2.5 mg for the full 6 months) and the titrated 2.5 mg group (who received lower doses during titration and 2.5 mg for 4 months). An increase in LS BMD is the primary endpoint for the
        505(b)(2) pathway as was described by the FDA in Entera&#8217;s pre-IND meeting. At present it is believed that the single Phase 3 Pivotal study necessary under the 505b2 pathway would require a 12-month head-to-head study against Forteo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (the
        &#8220;reference drug&#8221;), designed to achieve non inferiority for increase in BMD of the lumbar spine.<br>
        <br>
        <hr noshade="noshade" align="left" style="background-color: #000000; border: 0px; height: 1px; width: 2in; margin-left: 0pt; margin-right: auto; color: #000000;">
        <div style="line-height: 1.25;"><sup style="font-family: 'Times New Roman', serif; vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> (D. D. Cosman F, Anabolic Agents for Postmenopausal Osteoporosis: How Do You Choose? 2021)</div>
        <br>
      </div>
      <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
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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>
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      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">Increases in LS BMD versus placebo observed at 6 months in
          previous Forteo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> studies conducted with similar patient populations, were in the 3.9% range<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>. In the current study LS BMD increased 3.78% (p&lt;0.008) in the group treated with 2.5 mg for the full 6 months. When this group was combined with the titrated 2.5 mg group (who received lower doses during titration and 2.5 mg for just 4 months) LS spine BMD increased, 2.73% (p&lt;0.002).</div>
        <br>
      </div>
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">Furthermore, EB613 had a significant impact on both femoral neck and total hip BMD at 6 months.<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#160;</sup>The 2.5 mg EB613 treatment group had a 2.76% (p&lt;0.002) increase in femoral neck, and a 1.84% (p&lt;0.02) increase in total hip at 6 months, as compared to placebo. In contrast,
          significant increases in BMD of the femoral neck and total hip are usually not observed with Forteo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> treatment at 6 months. Increases in hip BMD have been shown to correlate with decreases in non-vertebral fracture risk<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>.</div>
        <br>
      </div>
      <div style="line-height: 1.25;">In this dose-ranging study, various doses of EB613 were tested for their effect on markers of bone metabolism after 3 months and BMD of the lumbar spine, femoral neck, and total hip after 6 months. Subjects were
        initially randomized to receive oral EB613 0.5 mg, 1.0 mg, 1.5 mg, or matching placebo once daily. The study utilized an adaptive design with a limited interim analysis of 3-month biomarker changes in the first 80 subjects treated that demonstrated
        significant, dose-related increases in P1NP (a bone formation marker) after 1 month of treatment. Based on the analysis of the interim data the 2.5 mg dose was introduced.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">As previously reported, the trial&#8217;s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P
        &lt;0.04) as compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Secondary endpoints in the trial included the effect of treatment on several additional serum bone biomarkers at 3 months including, Osteocalcin and CTX. Similar to P1NP, Osteocalcin is a biomarker for bone formation
        by osteoblasts, the cells that build new bone. CTX is a biomarker that indicates the rate of bone resorption by osteoclasts, the cells that remove old bone. An osteoanabolic, or bone building effect, is based on the difference in bone formation and
        bone resorption. An increase in P1NP or Osteocalcin, for example, associated with a smaller increase (or decrease) in CTX, usually results in an increase in bone mass.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMD and a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment,
        as reflected in the 6-month BMD results.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">The study medication, EB613, was generally well tolerated throughout the 6 months of treatment.&#160; There were no adverse events that were
          severe in intensity in any treatment group and no serious drug-related adverse events. However, subjects randomized to the 2.5 mg dose of EB613 presented a higher rate of adverse events (AEs), which are in line with AEs known to be associated
          with daily injections of PTH, such as nausea, headaches, and dizziness (or presyncope). In the clinical study setting, with subjects who are not severely osteoporotic and the COVID pandemic resulting in greater hesitation to remain in a clinical
          study, some of these expected AEs were resulting in subjects withdrawing their consent. Exploiting one of the advantages of an oral treatment, a novel titration
          regimen was introduced through a protocol amendment. Subjects randomized to the 2.5 mg dose (or matched placebo) initiated their treatment with a 1.5 mg dose followed by a 2.0 mg dose at their month 1 clinic visit and ultimately starting the 2.5
          mg dose at the Month 3 clinic visit. This titration regimen minimized adverse events resulting in subjects&#8217; drop-outs, which were within the projected rate of 20% overall, despite the COVID-19 Pandemic.</div>
      </div>
      <div style="line-height: 1.25;"><br>
        <hr noshade="noshade" align="left" style="background-color: #000000; border: 0px; height: 1px; width: 2in; margin-left: 0pt; margin-right: auto; color: #000000;">
        <div style="line-height: 1.25;"><sup style="font-family: 'Times New Roman', serif; vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> (L. N. Cosman F 2010) (Leder BZ 2015)</div>
        <div style="line-height: 1.25;"><sup style="font-family: 'Times New Roman', serif; vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> (Cosman 2020)</div>
        <br style="line-height: 1.25;">
      </div>
      <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
        <div id="DSPFPageBreak" style="page-break-after: always;">
          <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="text-align: justify; line-height: 1.25;">
        <div style="line-height: 1.25;">&#8220;We are very excited and encouraged by these great results which will support advancing discussions with potential strategic
          partners. These results are in line with our previously reported biomarker results and further validate Entera&#8217;s platform technology and its potential to enable oral formulation of various large molecules for a range of indications that could
          benefit from an oral drug,&#8221; said Spiros Jamas, CEO of Entera Bio. &#8220;We are looking forward to an end of Phase 2 meeting with the FDA. More detailed results will
          also be presented in a future scientific conference and publications. The company will evaluate potential additional osteoporosis market opportunities specifically related to increases in hip BMD.&#8221;</div>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-weight: bold;">About EB613</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <div style="line-height: 1.25;">EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, drug candidate positioned as the first potential once daily,
          oral, bone building (anabolic) treatment for osteoporosis patients. Teriparatide for injection (marketed under the brand name Forteo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>) was approved in the U.S. in 2002 for the treatment of osteoporosis in men and postmenopausal women
          who are at high risk for having a fracture and is taken daily via a subcutaneous injection.</div>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-weight: bold;">About Osteoporosis</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, which leads to greater fragility and an increase in fracture risk. Osteoporosis is also a silent disease, often
        displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. The debilitating effects of osteoporosis have substantial costs and osteoporotic fractures
        create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated
        that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. In US women 55 years of age and older, the hospitalization burden of osteoporotic
        fractures and population facility-related hospital cost is greater than that of myocardial infarction, stroke, or breast cancer.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-weight: bold;">About Entera Bio Ltd.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="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 www.enterabio.com.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
        <div id="DSPFPageBreak" style="page-break-after: always;">
          <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; font-weight: bold;">Forward Looking Statements</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <div style="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>
      <div style="line-height: 1.25;"> <br>
      </div>
      <div style="line-height: 1.25;">
        <div style="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:&#160; changes in our interpretation of the complete 3-month biomarker data and the interim BMD 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 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<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> 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, to be 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>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-indent: -36pt; margin-left: 36pt; line-height: 1.25; font-weight: bold;">References:</div>
      <div style="text-indent: -36pt; margin-left: 36pt; line-height: 1.25;">Cosman F, Dempster DW. 2021. "Anabolic Agents for Postmenopausal Osteoporosis: How Do You Choose?" Curr Osteoporos Rep. 19 (2): 189-205.</div>
      <div style="text-indent: -36pt; margin-left: 36pt; line-height: 1.25;">Cosman F, Lane NE, Bolognese MA, et al. 2010. "Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women." J Clin Endocrinol Metab 95:
        151-158.</div>
      <div style="text-indent: -36pt; margin-left: 36pt; line-height: 1.25;">Cosman, F et. al. 2020. "T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial." J Bone Miner Res. 35 (7): 1333-1342.</div>
      <div style="text-indent: -36pt; margin-left: 36pt; line-height: 1.25;">Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. 2015. "Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone
        mineral density in postmenopausal women with osteoporosis." J Clin Endocrinol Metab. 102 (2): 697-706.</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;">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;"><br style="line-height: 1.25;">
      </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;"></div>
      <br>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
