<SEC-DOCUMENT>0001178913-20-003412.txt : 20201222
<SEC-HEADER>0001178913-20-003412.hdr.sgml : 20201222
<ACCEPTANCE-DATETIME>20201222070015
ACCESSION NUMBER:		0001178913-20-003412
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20201222
FILED AS OF DATE:		20201222
DATE AS OF CHANGE:		20201222

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			RedHill Biopharma Ltd.
		CENTRAL INDEX KEY:			0001553846
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35773
		FILM NUMBER:		201406001

	BUSINESS ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
		BUSINESS PHONE:		972-3-541-3131

	MAIL ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2025278.htm
<DESCRIPTION>6-K
<TEXT>
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    <div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-size: 14pt; font-family: 'Times New Roman',Times,serif; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">&#160;UNITED STATES&#160;</font><font style="background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none;">&#160;&#160;</font></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;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160;20549</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</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="text-align: center; line-height: 1.25;">&#160;&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">For the month of December 2020<br>
        Commission File No.:001-35773</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</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;">REDHILL BIOPHARMA LTD.</div>
      <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
      <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
      <div style="line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.&#160;&#160;</div>
      <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;"> <br>
      </div>
      <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F &#9746; Form 40-F &#9744;</div>
      <div style="text-indent: 14.2pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____&#160;</div>
      <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____</div>
      <div style="line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;"><a href="exhibit_1.htm">Exhibit 1<font style="font-family: Symbol, serif;">:</font>&#160;Registrant's press release entitled:
          &#8220;RedHill&#8217;s Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue&#8221;</a></div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">This Form 6-K is incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on
        October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122) and on July 24, 2019 (File No. 333-232776) and its Registration Statements on Form F-3 filed with the
        Securities and Exchange Commission on February 25, 2016 (Registration No. 333-209702), on July 23, 2018 (File No. 333-226278) and on July 24, 2019 (File No. 333-232777).</div>
      <div style="line-height: 1.25">&#160;</div>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
      <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.&#160;</div>
      <div style="text-align: justify; margin-left: 220.65pt; line-height: 1.25;">&#160;</div>
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          <tr>
            <td style="width: 49.66%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td colspan="2" style="vertical-align: middle;">
              <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
            <td style="width: 49.66%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
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              <div style="line-height: 1.25;">(the "Registrant")</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 3%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 27%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
            <td style="width: 49.66%; vertical-align: middle;">
              <div style="line-height: 1.25;">Date: December 22, 2020</div>
            </td>
            <td style="width: 3%; vertical-align: middle;">
              <div style="line-height: 1.25;">By:</div>
            </td>
            <td style="width: 27%; vertical-align: middle; border-bottom: 2px solid rgb(0, 0, 0);">
              <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
            <td style="width: 49.66%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td colspan="2" style="vertical-align: middle;">
              <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
            <td style="width: 49.66%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td colspan="2" style="vertical-align: middle;">
              <div style="line-height: 1.25;">Chief Executive Officer</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>

      </table>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;2</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"> </div>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>exhibit_1.htm
<DESCRIPTION>EXHIBIT 1
<TEXT>
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    <div style="text-align: right;"> <u><font style="font-weight: bold;">Exhibit 1</font></u><br>
    </div>
    <div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg"></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <table cellspacing="0" cellpadding="5" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;" id="z50b968726b844d608ae76678946246e3">

            <tr>
              <td style="width: 100%; border-width: 2px 1px 1px; border-style: solid; border-color: rgb(0, 0, 0) rgb(0, 0, 0) rgb(0, 0, 0); background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 24pt; font-style: normal; font-variant: normal; text-transform: none;">
                <div style="line-height: 1.25;">
                  <div style="text-align: center; line-height: 1.25;">Press Release</div>
                </div>
              </td>
            </tr>

        </table>
      </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;"><u>RedHill&#8217;s Phase 2/3 COVID-19 Study of Opaganib Passes </u></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;"><u>Second DSMB with Unanimous Recommendation to Continue</u></div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 </div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">treated patients</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">
        <div style="margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 </div>
        <div style="margin-left: 2.25pt; line-height: 1.25; font-style: italic;">expected in the coming days; this non-powered study was designed to evaluate safety and
          potential</div>
        <div style="margin-left: 2.25pt; line-height: 1.25; font-style: italic;"> identification of preliminary efficacy signals in support of the global Phase 2/3 study of
          opaganib</div>
      </div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human </div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">cell component involved in viral replication</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, December 22, 2020, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty
        biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva&#174;, ABC294640)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to
        continue, following a second independent Data Safety Monitoring Board (DSMB) safety review. The DSMB&#8217;s recommendation is based on an analysis of unblinded safety data from the first 155 patients treated for 14 days.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">&#8220;This second unanimous independent DSMB recommendation to continue the global Phase 2/3 study of opaganib in patients with severe COVID-19 confirms the safety of opaganib and means we can continue
        to focus on completing enrollment for this study as rapidly as possible, with a view to having top-line data in the first quarter of 2021. If successful, we expect to make subsequent global emergency use applications the same quarter,&#8221; <font style="font-weight: bold;">said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill</font>.</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">
        <div style="page-break-after: always;" id="DSPFPageBreak">
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      <!--PROfilePageNumberReset%Num%2%%%-->
      <div style="text-align: justify; line-height: 1.25;">Enrollment in the 270-patient global Phase 2/3 study of orally-administered opaganib in hospitalized patients with severe COVID-19 pneumonia (<u>NCT04467840</u>) is more than 60% complete, and is
        on track to deliver top-line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation. A pre-scheduled, unblinded futility interim analysis will be conducted by the DSMB in the coming weeks, evaluating data
        from the first 135 subjects that have reached the primary endpoint.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The parallel U.S. Phase 2 study with opaganib (<u>NCT04414618</u>) has completed enrollment of all 40 subjects, with top-line data expected by year&#8217;s end. This study is not powered for efficacy and
        is focused on safety evaluation and potential identification of preliminary efficacy signals.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib is a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with a preclinically demonstrated triple-action mechanism that inhibits viral replication, reduces
        hyper-immune inflammatory response and diminishes ARDS-related thrombosis (blood clots) &#8211; a dangerous complication of COVID-19 disease &#8211; in effect acting on the cause and effect of COVID-19 disease. Opaganib&#8217;s target is a human host cell component
        involved in viral replication, potentially minimizing the likelihood of resistance due to viral mutations.</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;">About Opaganib (ABC294640, Yeliva<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>)</div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with a demonstrated unique triple-action effect on the
        pathophysiological processes associated with COVID-19 disease, that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to
        target multiple oncology, viral, inflammatory and gastrointestinal indications.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib is being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19 pneumonia. Opaganib&#160;also received Orphan Drug designation from the U.S. FDA for
        the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary
        fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19,&#160;completely inhibiting viral replication in an <font style="font-style: italic;">in vitro</font> model of human lung bronchial
        tissue. Additionally, preclinical <font style="font-style: italic;">in vivo</font> studies<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated <font style="font-style: italic;">Pseudomonas

          aeruginosa</font>-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.</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">
        <div style="text-align: center;" id="DSPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" id="DSPFPageNumber">2</font></div>
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      </div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib&#160;was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well
        as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of
        these first patients with severe COVID-19 with opaganib have been <u>published</u><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>. Analysis of treatment outcomes suggests substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and
        inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation,
        whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched
        case-control group.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The development of opaganib&#160;has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S.
        Department of Defense and the FDA Office of Orphan Products Development.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The ongoing studies with opaganib&#160;are registered on&#160;<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">www.ClinicalTrials.gov</sup>, a web-based service by the U.S. National Institute of Health, which provides public access to information on
        publicly and privately supported clinical studies.&#160;&#160; &#160;</div>
      <div style="text-align: justify; line-height: 1.25;">&#160;&#160; &#160; &#160; &#160;</div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About RedHill Biopharma</div>
      <div style="text-align: justify; line-height: 1.25;">RedHill Biopharma Ltd. (Nasdaq: <u>RDHL</u>) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, <font style="font-weight: bold;">Movantik</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174; </sup>for opioid-induced constipation in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>, <font style="font-weight: bold;">Talicia</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">&#160;</font>for the treatment of <font style="font-style: italic;">Helicobacter pylori (H. pylori)</font> infection in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup>, and <font style="font-weight: bold;">Aemcolo</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>
        for the treatment of travelers&#8217; diarrhea in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3
        study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib (Yeliva</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) <font style="font-weight: bold;">RHB-104</font>,
        with positive results from a first Phase 3 study for Crohn's disease; (iv) <font style="font-weight: bold;">RHB-102</font> (<font style="font-weight: bold;">Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>), with positive results from a Phase
        3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) <font style="font-weight: bold;">RHB-107 </font>(<font style="font-weight: bold;">upamostat</font>), a Phase 2-stage serine protease
        inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases;&#160; and (vi) <font style="font-weight: bold;">RHB</font>-<font style="font-weight: bold;">106</font>, an
        encapsulated bowel preparation. More information about the Company is available at <u>www.redhillbio.com</u> / <u>https://twitter.com/RedHillBio</u>.</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">
        <div style="text-align: center;" id="DSPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" id="DSPFPageNumber">3</font></div>
        <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="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words
        &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2
        trial evaluating opaganib, and the timing, if at all, of potential emergency use applications of opaganib and reporting of data, from the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are
        subject to various known and unknown risks and uncertainties, many of which are beyond the Company&#8217;s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such
        forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company&#8217;s Phase 2/3 study evaluating opaganib will not be completed or successful; the risk of a delay in receiving data from the Phase 2/3
        study with opaganib or delay in making emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed,
        if at all; the risk that other COVID-19 patients treated with opaganib will not show any or insufficient clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including
        difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients
        suffering serious adverse events using opaganib under compassionate use programs; the risk that the ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease will be delayed, not be completed, or will not be successful, as well
        as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company&#8217;s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the
        commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the lack of sufficient financial resources which may result in material adverse impact on the Company&#8217;s research, manufacturing, preclinical
        studies, clinical trials, and other therapeutic candidate development activities including delay or termination of preclinical or clinical activities or of any other such activities (iii) the Company&#8217;s ability to advance its therapeutic candidates
        into clinical trials or to successfully complete its preclinical studies or clinical trials (iv) the extent and number and type of additional studies that the Company may be required to conduct and the Company&#8217;s receipt of regulatory approvals for
        its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company&#8217;s therapeutic candidates and Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>;
        (vi) the Company&#8217;s ability to successfully commercialize and promote Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> and Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (vii) the Company&#8217;s ability to establish and maintain corporate collaborations; (viii) the Company's ability to
        acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company&#8217;s
        therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company&#8217;s business model, strategic plans for its business and therapeutic
        candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the
        intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company&#8217;s expenses, future revenues, capital requirements and
        needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company&#8217;s industry.
        More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual
        Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral
        forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <table cellspacing="0" cellpadding="0" id="z117c215903344101a36e0c30248bccfe" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

          <tr>
            <td style="width: 53.27%; vertical-align: top;">
              <div style="line-height: 1.25; font-weight: bold;">Company contact:</div>
              <div style="line-height: 1.25;">Adi Frish</div>
              <div style="line-height: 1.25;">Chief Corporate &amp; Business Development Officer</div>
              <div style="line-height: 1.25;">RedHill Biopharma</div>
              <div style="line-height: 1.25;">+972-54-6543-112</div>
              <div style="line-height: 1.25;"><u>adi@redhillbio.com</u></div>
            </td>
            <td style="width: 46.73%; vertical-align: top;">
              <div style="line-height: 1.25; font-weight: bold;">Media contact (U.S.):</div>
              <div style="text-align: justify; line-height: 1.25;">Bryan Gibbs</div>
              <div style="text-align: justify; line-height: 1.25;">Vice President</div>
              <div style="text-align: justify; line-height: 1.25;">Finn Partners</div>
              <div style="text-align: justify; line-height: 1.25;">+1 212 529 2236</div>
              <div style="line-height: 1.25;"><u>bryan.gibbs@finnpartners.com</u></div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <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="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> Opaganib is an investigational new drug, not available for commercial distribution.</div>
      <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas
        aeruginosa&#160;stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010</div>
      <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> Full prescribing information for Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (naloxegol) is available at: www.Movantik.com.</div>
      <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> Full prescribing information for Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.</div>
      <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup> Full prescribing information for Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (rifamycin) is available at: www.Aemcolo.com.</div>
    </div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
