<SEC-DOCUMENT>0001178913-21-003002.txt : 20210914
<SEC-HEADER>0001178913-21-003002.hdr.sgml : 20210914
<ACCEPTANCE-DATETIME>20210914081808
ACCESSION NUMBER:		0001178913-21-003002
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210914
FILED AS OF DATE:		20210914
DATE AS OF CHANGE:		20210914

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:		211251270

	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>zk2126579.htm
<DESCRIPTION>6-K
<TEXT>
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    <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;">&#160;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; 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 September 2021<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 <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;Form 40-F <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></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;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein are the following:</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_1.htm">Exhibit 1: Registrant's press release entitled &#8220;RedHill Biopharma Reports
          Top-Line Data from Opaganib Phase 2/3 Study in Severe COVID-19 Patients&#8221;.</a></div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Exhibits 99.1 (solely with respect to the Financial Highlights for the second quarter ended June 30, 2021, Commercial Highlights, R&amp;D Highlights, the Condensed Consolidated Interim Statements
        of Comprehensive Loss, Condensed Consolidated Interim Statements of Financial Position and Condensed Consolidated Interim Statements of Cash Flows) and 99.2 to this Report on Form 6-K are hereby 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), on July 24, 2019 (File No. 333-232776) on March 25, 2021 (File No. 333-254692) and on May 3, 2021 (File No. 333-255710), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on
        July 24, 2019 (File No. 333-232777), on March 30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;"> <br>
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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;">Signatures</div>
      <div style="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="line-height: 1.25;"><br style="line-height: 1.25;">
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            <td style="width: 49.63%; 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>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td colspan="2" style="vertical-align: middle;">
              <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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            <td style="width: 49.63%; vertical-align: middle;">
              <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: 49.63%; vertical-align: middle;">
              <div style="line-height: 1.25;">Date: September 14, 2021</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>
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            <td style="width: 49.63%; 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: 49.63%; 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
        <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>
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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> <br>
    </div>
    <div>
      <div id="DSPFPageHeader">
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
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      </div>
      <div style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg"></div>
      <div style="line-height: 1.25;">
        <table cellspacing="0" cellpadding="5" border="0" id="zb18d888de95e442cac67a29f9490bde6" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;">

            <tr>
              <td style="width: 100%; border-width: 1px; border-style: solid; border-color: 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 Biopharma Reports Top-Line Data from Opaganib </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>Phase 2/3 Study in Severe COVID-19 Patients</u></div>
      <div style="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;">While preliminary top-line data of the study efficacy endpoints showed consistent trends in favor of </div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">the opaganib arm, the study endpoints did not achieve statistical significance</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;">Analysis of the top-line data is ongoing, including regarding the potential for increased benefit of</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;"> opaganib in patients at earlier stages of the disease on low flow oxygen support</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 safety data shows good tolerability with balanced adverse events between the study arms</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="font-style: italic;">Additional data will be presented upon further analysis</font>&#160;<font style="font-style: italic;">and will be discussed with U.S. and </font></div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25;"><font style="font-style: italic;">non-U.S. regulators to help determine next steps</font></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;">RedHill plans to hold a conference call to discuss the results in greater detail following further data analysis</div>
      <div><br>
      </div>
      <div>
        <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC,
            September 14, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical company, today announced
          preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> in hospitalized patients with severe COVID-19 pneumonia.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show
          trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings,
          together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced
          results from the U.S. Phase 2 study and the previously observed antiviral activity of opaganib.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
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        <!--PROfilePageNumberReset%Num%2%%%-->
        <div style="text-align: justify; line-height: 1.25;">&#8220;We would like to thank the patients, physicians and supporting medical staff who took part in this important study. While we are
          disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease. This correlates with what we know about
          opaganib&#8217;s strong antiviral mechanism and effect against variants, as well as its mechanism of action and previously announced results from the Phase 2 U.S. study with opaganib,&#8221; <font style="font-weight: bold;">said Dror Ben Asher, RedHill CEO</font>. &#8220;In parallel, we continue to make progress with our Phase 2/3 study with another novel, orally-administered drug candidate, RHB-107 (upamostat) in non-hospitalized
          symptomatic COVID-19 patients, with the recent approval of the study in South Africa and its expansion within the United States. We are determined to continue our efforts to advance potential treatments to address COVID-19 and its overwhelming
          impact worldwide.&#8221;</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study enrolled 475 subjects with severe
          COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. The primary endpoint of the study is the
          proportion of patients breathing room air without oxygen support by Day 14.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">Analysis of the top-line data is ongoing, including an analysis of the potential for increased benefit of treatment with opaganib in
          patients at earlier stages of disease. RedHill intends to discuss the data with regulators, including U.S. FDA and foreign regulators, to help determine next steps.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature, as they are based solely on
          top-line information provided to the Company by an independent third-party contractor. The Company intends to examine the data from this study in greater detail, along with all of the information gathered during this study, including all safety,
          and secondary outcome measures. Such analysis may result in findings inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the top-line results reported in this release as the final definitive
          results of the study.</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 small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and
          anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the
          virus to support its replication.</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; font-weight: bold;">About Opaganib (ABC294640)</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 dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including <font style="font-style: italic;">Delta</font>. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also 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 previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently <u>published in medRxiv</u>.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">Opaganib&#160;has 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. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment
          and analysis in this study are ongoing.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19,&#160;inhibiting viral replication of all SARS-CoV-2 variants tested to date 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 have demonstrated opaganib&#8217;s potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib&#8217;s potential to decrease renal fibrosis and have shown decreased fatality rates from influenza
          virus infection and amelioration of <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<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>.</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 clinical studies with opaganib&#160;are registered on&#160;<u>www.ClinicalTrials.gov</u>, 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;</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;">About RedHill Biopharma</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<font style="font-weight: bold;">&#160;&#160;&#160;</font></div>
        <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; 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;">3</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;">4</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;">5</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 </font><font style="font-weight: bold;">(ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class oral 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-107
          </font>(<font style="font-weight: bold;">upamostat</font>), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple
          other cancer and inflammatory gastrointestinal diseases; (iv) <font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease;
          (v) <font style="font-weight: bold;">RHB-102</font> , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for
          IBS-D; 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="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; line-height: 1.25;"> <br>
        </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; margin-right: 0.1pt; margin-left: 0.1pt; line-height: 1.25;"> <br>
        </div>
        <div style="text-align: justify; line-height: 1.25;"><font style="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. 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</font>&#160;<font style="font-style: italic;">the risk that in the next studies opaganib will not be found effective in decreasing renal fibrosis; that further analysis of the top-line results of the Phase 2/3 COVID-19
            study for opaganib results in findings inconsistent with the top-line data disclosed in this release; that no further COVID-19 studies for opaganib will be commenced, and if commenced, may not be successful, including with respect to patients
            in earlier stages of COVID-19 on low flow oxygen support; that the Phase 2/3 study for RHB-107 in COVID-9 patients may not be successful;&#160; that any additional studies for opaganib and the Phase 2/3 study for RHB-107 in COVID-19 patients, even
            if successful, will not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 will be required by regulatory authorities to support such
            potential applications and the use or marketing of opaganib or RHB-107 for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, 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 Company&#8217;s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) 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; (iv) the manufacturing,
            clinical development, commercialization, and market acceptance of the Company&#8217;s therapeutic candidates and Talicia</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (v) the Company&#8217;s ability to successfully commercialize and promote Movantik</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">,
            Talicia</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;"> and Aemcolo</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (vi) the Company&#8217;s ability to establish and maintain corporate collaborations; (vii) 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; (viii) 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; (ix) the implementation of the Company&#8217;s business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company
            licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company&#8217;s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering
            adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) 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 18, 2021. 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.</font></div>
        <br>
      </div>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z1a9129b5109147cba523b0f782a6ed76">

          <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 contacts:</div>
              <div style="line-height: 1.25;"><font style="font-weight: bold;">U.S.:</font> Bryan Gibbs, Finn Partners</div>
              <div style="line-height: 1.25;">+1 212 529 2236</div>
              <div style="line-height: 1.25;"><u>bryan.gibbs@finnpartners.com</u></div>
              <div style="line-height: 1.25;"><font style="font-weight: bold;">UK:</font> Amber Fennell, Consilium</div>
              <div style="line-height: 1.25;">+44 (0) 7739 658 783</div>
              <div style="line-height: 1.25;"><u>fennell@consilium-comms.com</u></div>
            </td>
          </tr>

      </table>
    </div>
    <div><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="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="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</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;">4</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;">5</sup> Full prescribing information for Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (rifamycin) is available at:<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;"> </sup>www.Aemcolo.com.</div>
    </div>
    <br>
  </div>
  <div style="text-align: center;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal; font-family: 'Times New Roman',Times,serif;">4</font>
    <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>
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M:VJ* "BBB@ HHHH **** "BBB@ HHHH **** "BBB@ HHHH **** "BBB@ H
5HHH **** "BBB@ HHHH **** /_9

end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
