<SEC-DOCUMENT>0001178913-21-001832.txt : 20210524
<SEC-HEADER>0001178913-21-001832.hdr.sgml : 20210524
<ACCEPTANCE-DATETIME>20210524070057
ACCESSION NUMBER:		0001178913-21-001832
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210524
FILED AS OF DATE:		20210524
DATE AS OF CHANGE:		20210524

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:		21951051

	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>zk2126080.htm
<DESCRIPTION>6-K
<TEXT>
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    <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>
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    <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 May 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: justify; text-indent: 28.35pt; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; Form 40-F&#160;<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 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 Biopharma Presents Analyses of Movantik Onset of Action and Symptom Improvement at DDW 2021&#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="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <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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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
          </td>
          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">(the "Registrant")</div>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 16.42%; 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: May 24, 2021</div>
          </td>
          <td style="width: 3.48%; vertical-align: middle;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle; border-bottom: #000000 2px solid;">
            <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 33.91%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 16.42%; 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: 33.91%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
          </td>
          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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    </table>
    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">
      <div style="text-align: center;">&#160;2</div>
      <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>
    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
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    </div>
    <div style="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="line-height: 1.25; text-align: right;"><u><font style="font-weight: bold;">Exhibit 1</font></u><br style="line-height: 1.25;">
    </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>
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      <table cellspacing="0" cellpadding="0" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;" id="z7bd47e2c7c074066a58d17c19fb42a00">

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            <td style="width: 50%; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none; border-color: rgb(0, 0, 0); border-style: solid; border-width: 2px;" rowspan="1">
              <div style="text-align: center;">Press Release</div>
            </td>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; 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 Presents Analyses of Movantik Onset of </u></div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>Action and Symptom Improvement at DDW 2021</u></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="font-family: 'Times New Roman',Times,serif; text-align: center;"><font style="font-style: italic;">Two new analyses of Movantik</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;"> (naloxegol) data,
          from almost 900 patients, were presented </font></div>
      <div style="font-family: 'Times New Roman',Times,serif; text-align: center;"><font style="font-style: italic;">at Digestive Disease Week 2021 evaluating the onset of action and symptom improvement of </font></div>
      <div style="font-family: 'Times New Roman',Times,serif; text-align: center;"><font style="font-style: italic;">
          Movantik for a broad range of challenging opioid-induced constipation (OIC) symptoms</font></div>
    </div>
    <div style="line-height: 1.25; text-align: center;">-- </div>
    <div style="line-height: 1.25;">
      <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">Movantik is an oral peripherally acting mu-opioid receptor antagonist (PAMORA) approved </div>
      <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">in the U.S. to treat OIC in adult patients with chronic non-cancer pain</div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, May 24, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty
      biopharmaceutical company, today announced presentation at Digestive Disease Week (DDW) 2021 of two new analyses of Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms
      associated with opioid-induced constipation (OIC).</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Both analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two
      doses (12.5 mg and 25 mg), compared to a total of 546 patients in the placebo arms.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;These two new analyses demonstrate rapid and sustained efficacy of naloxegol for a broad range of bothersome OIC symptoms, positively impacting patient care. Given the challenge of OIC symptoms,
      early symptom relief is an important therapeutic consideration&#8221; <font style="font-weight: bold;">said Prof. William D. Chey, Director of the GI Physiology Laboratory at the University of Michigan, and former Co-Editor-in-Chief of the American
        Journal of Gastroenterology</font>.</div>
    <div style="line-height: 1.25; font-weight: bold;"><br>
      Poster 1 (Poster Number: Sa059): Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms: A Pooled Analysis of Two Global Randomized Placebo-Controlled Trials<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup></div>
    <div style="text-align: justify; line-height: 1.25;">Given the clinical importance of rapid and sustained OIC symptom response, this analysis aims to evaluate the efficacy of naloxegol (12.5 and 25 mg) on the key symptoms of OIC.<br>
    </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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    <div style="text-align: justify; line-height: 1.25;"> <br style="line-height: 1.25;">
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    <div style="line-height: 1.25; font-weight: bold;">Poster 2 (Poster Number: Sa058): Rapid Onset of Time to First Spontaneous Bowel Movement (SBM) and Predictable Efficacy of Naloxegol: Pooled Analysis of Two Global Randomized Controlled Trials<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup></div>
    <div style="text-align: justify; line-height: 1.25;">Given the clinical importance of rapid and predictable symptom response, this analysis aims to characterize the predictability of the onset of response within 48 hours following the first dose of
      naloxegol (12.5 mg and 25 mg).</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;OIC is the most common and debilitating gastrointestinal adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy
      each year<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>,&#8221; <font style="font-weight: bold;">said</font>&#160;<font style="font-weight: bold;">Dr. June Almenoff, MD, Ph.D., RedHill&#8217;s Chief Scientific Officer</font>. &#8220;Movantik has demonstrated its ability to help overcome one of the main
      challenges of opioid-based chronic pain management by bringing rapid and sustained relief from OIC.&#8221;</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;</div>
    <div style="text-align: justify; line-height: 1.25;">&#160;&#160;&#160;<font style="font-weight: bold;">&#160;&#160;&#160;</font></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 </font><font style="font-weight: bold;">(Yeliva</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">, ABC294640)</font>,
      a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing 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 (upamostat)</font>, a 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>&#160;<font style="font-weight: bold;">(Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">)</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="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About Movantik&#174; (naloxegol)</div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;"> <br>
    </div>
    <div style="text-align: justify; line-height: 1.25;">Movantik&#174; is an opioid antagonist indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior
      cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
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    </div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Important Safety Information About Movantik</div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;"> <br>
    </div>
    <div style="text-align: justify; line-height: 1.25;">Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (naloxegol) is contraindicated in:</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
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        <tr>
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          </td>
          <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div>Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.</div>
          </td>
        </tr>

    </table>
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        <tr>
          <td style="width: 18pt;"><br>
          </td>
          <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div>Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.</div>
          </td>
        </tr>

    </table>
    <table cellspacing="0" cellpadding="0" id="z24b1b1e3c3d9483b8396eff835c57746" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="width: 18pt;"><br>
          </td>
          <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div>Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.</div>
          </td>
        </tr>

    </table>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients
      receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with
      disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer&#8217;s disease, and uncontrolled epilepsy) were not enrolled in the
      clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5
      mg once daily.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when
      Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with
      bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5%
      vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs &lt;1%).</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer
      or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Click here for the&#160;<u>Medication Guide</u>&#160;and full&#160;<u>Prescribing Information</u>&#160;for Movantik.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at&#160;1-833-ADRHILL&#160;(1-833-237-4455)&#160;or FDA at&#160;1-800-FDA-1088&#160;or&#160;<u>www.fda.gov/medwatch</u>.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; margin-right: 0.1pt; line-height: 1.25;">MOVANTIK is a registered trademark of the AstraZeneca group of companies.</div>
    <div style="text-align: justify; margin-right: 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="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; 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. 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 will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation,
      timing, progress and results of the Company&#8217;s research, manufacturing, pre-clinical 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 pre-clinical studies or clinical trials or the development of a commercial companion diagnostic
      for the detection of MAP; (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<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (v) the Company&#8217;s ability to successfully commercialize and
      promote 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>and Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (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 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, pre-clinical 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 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 experiences using investigative drugs
      under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company&#8217;s industry; and (xv) the hiring and employment commencement date of executive managers. 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.</div>
    <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" id="z84f59e0c0586410198ddcb8134bdeebf" 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 and 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 style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <br>
    <hr align="left" noshade="noshade" 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> Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)</div>
    <div style="line-height: 1.25;">Symptoms: A Pooled Analysis of Two Global Randomized Placebo-Controlled Trials. Chey, William D.; Rockett, Carol B.; Bortey, Enoch; Almenoff, June.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Rapid Onset of Time to First Spontaneous Bowel Movement (SBM) and Predictable</div>
    <div style="line-height: 1.25;">Efficacy of Naloxegol: Pooled Analysis of Two Global Randomized Controlled Trials. Chey, William D.; Rockett, Carol B.; Bortey, Enoch; Almenoff, June.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.</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 style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">4<br>
    </div>
    <div style="text-align: justify; line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"> </div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
