<SEC-DOCUMENT>0001178913-21-003750.txt : 20211202
<SEC-HEADER>0001178913-21-003750.hdr.sgml : 20211202
<ACCEPTANCE-DATETIME>20211202070155
ACCESSION NUMBER:		0001178913-21-003750
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20211202
FILED AS OF DATE:		20211202
DATE AS OF CHANGE:		20211202

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:		211464931

	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>zk2126911.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#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;">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;">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 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;">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; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Form 20-F <font style="font-family: 'Segoe UI Symbol',sans-serif;">&#9746; &#160; &#160; &#160;</font> 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="line-height: 1.25;">Attached hereto as <a href="exhibit_99-1.htm">Exhibit 99.1</a> and incorporated by reference herein is a press release issued by the Registrant on December 2, 2021 entitled: &#8220;<font style="font-style: italic;">RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI</font>&#8221;.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">This Report on Form 6-K is 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>
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    <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;">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>
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    </div>
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            <div style="line-height: 1.25;">&#160;</div>
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          <td style="width: 33.94%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
          </td>
          <td style="width: 16.43%; 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: 33.94%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">(the "Registrant")</div>
          </td>
          <td style="width: 16.43%; 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: 3.48%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.46%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 16.43%; 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: December 2, 2021</div>
          </td>
          <td style="width: 3.48%; vertical-align: middle;" rowspan="1" colspan="2">
            <div style="line-height: 1.25;">By: <u>/s/ Dror Ben-Asher&#160;</u></div>
          </td>
          <td style="width: 16.43%; 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 style="width: 33.94%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 16.43%; 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 style="width: 33.94%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
          </td>
          <td style="width: 16.43%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    </div>
    <div style="line-height: 1.25; text-align: right;"><u><font style="font-weight: bold;"> <br>
        </font></u></div>
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                <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Press Release</div>
              </div>
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    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;"><u>RedHill Biopharma Data Published in GastroHep Shows </u></div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;"><u>Consistent Efficacy of Talicia Irrespective of Patient BMI</u></div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">High Body Mass Index and obesity are known risk factors for H. Pylori eradication treatment </div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">failure; Newly published data in GastroHep shows high eradication rates for Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>
      across </div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">BMI groups</div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">Data from a post-hoc analysis showed H. pylori eradication rates with Talicia of 88.1% and </div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">90.9% in patients with BMI&gt; 30/&lt;40kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> and in patients with BMI&gt;40 kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>,
      respectively, </div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">versus active comparator rates of 62.9% and 31.8% respectively &#8211; an almost 50% difference in </div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">efficacy from the active comparator in the severely obese group</div>
    <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 36pt; line-height: 1.25; font-style: italic;">Talicia, an FDA approved therapy, may be used as first-line H. pylori eradication therapy</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, N.C.,
        December 2, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>)
      (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical company, announces the publication<font style="font-style: italic;">&#160;</font>of a new study entitled &#8220;<font style="font-style: italic;">Helicobacter pylori</font> Eradication by Low-Dose Rifabutin Triple Therapy (Talicia&#174;) is
      Unaffected by High Body Mass Index&#8221; in the journal <font style="font-style: italic;">GastroHep</font>, showing the high efficacy of Talicia in eradicating<font style="font-style: italic;"> H. pylori</font> irrespective of patient BMI and level of obesity in clinical trials.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">This new publication, describing a <font style="font-style: italic;">post-hoc</font>
      analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials who had BMI <u>&gt;</u>30 kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>, showed that Talicia
      maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P&lt;0.0001). Patients with a BMI between 30-40 kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> and those with BMI <u>&gt;</u>40kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#160;</sup>treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively &#8211;
      the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.</div>
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    <div style="text-align: justify; line-height: 1.25;">&#8220;High BMI and obesity are known risk factors for <font style="font-style: italic;">H. Pylori</font> eradication treatment failure<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>. Data from previous studies<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> have shown that the failure rate of clarithromycin triple therapy can increase by nearly 300% in patients with high BMI, from
      nearly 15% in patients with BMIs&lt;25 kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> to 45% in subjects with BMIs&#8805;25 kg/m<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>,&#8221; <font style="font-weight: bold;">said Prof. John Yung-Chong Kao, MD, Professor
        of Internal Medicine, Division of Gastroenterology, University of Michigan, and lead author of the paper</font>. &#8220;With more than 70% of American adults being overweight or obese, it is important to understand the influence of patient BMI on <font style="font-style: italic;">H. pylori</font> eradication treatment success. These data support that low-dose rifabutin-containing therapy such as Talicia can be considered as a first
      line therapy to treat <font style="font-style: italic;">H. pylori</font> infection particularly in patients with high BMI.&#8221;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">No cases of rifabutin resistance were identified in this study, compared to a pooled clarithromycin resistance rate of more than 17%
      seen across all BMI groups, which highlights the potential risk of empirically prescribing clarithromycin-containing regimens for the treatment of <font style="font-style: italic;">H.
        pylori</font>. Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;The obese population experiences more infections and thus has more antibiotic exposure than the general population, potentially leading
      to higher rates of antibiotic-resistant organisms,&#8221; <font style="font-weight: bold;">said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer.</font>&#8221; Given the medical risks
      associated with obesity, it is especially important to use highly effective treatments such as Talicia, to provide patients with a high probability of cure with first-line treatment.&#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 Talicia</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><br>
      Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> is the only rifabutin-based therapy approved for the treatment of <font style="font-style: italic;">H. pylori</font> infection and is designed to address the
      high resistance of <font style="font-style: italic;">H. pylori</font> bacteria to clarithromycin-based therapies. The high rates of <font style="font-style: italic;">H. pylori </font>resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA
      and the World Health Organization (WHO) in recent years.</div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a
        proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> was approved by the U.S. FDA for the treatment of <font style="font-style: italic;">H. pylori</font>
        infection in adults. In the pivotal Phase 3 study, Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174; </sup>demonstrated 84% eradication of <font style="font-style: italic;">H. pylori</font> infection in the
        intent-to-treat (ITT) group vs. 58% in the active comparator arm (p&lt;0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia&#174;, was detected
        in RedHill&#8217;s pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> to their therapy had response rates of 90.3% in the Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> arm vs. 64.7% in the
        active comparator arm<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>.<br>
        <br>
        Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with
        additional patents and applications pending and granted in various territories worldwide.</div>
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        <div style="text-align: center;" id="DSPFPageNumberArea"><font style="color: #000000; font-weight: normal; font-style: normal;" id="DSPFPageNumber">2</font></div>
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      <div style="line-height: 1.25">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">About&#160;</font><font style="font-weight: bold; font-style: italic;">H. pylori</font><br>
        <font style="font-style: italic;">H. pylori</font> is a bacterial infection that affects
          approximately 35%<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> of the U.S. population, with an estimated two million patients treated annually<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>. Worldwide, more than 50% of the population has <font style="font-style: italic;">H. pylori </font>infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#160;</sup>and a major risk factor for peptic ulcer disease<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup>&#160;and gastric
          mucosa-associated lymphoid tissue (MALT) lymphoma<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</sup>. More than 27,000 Americans are diagnosed with gastric cancer annually<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10</sup>. Eradication of&#160;<font style="font-style: italic;">H. pylori</font>&#160;is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain&#160;<font style="font-style: italic;">H. pylori</font>-positive due to high resistance of&#160;<font style="font-style: italic;">H. pylori</font>&#160;to antibiotics &#8211; especially clarithromycin &#8211; which is still commonly used in standard combination therapies<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">11</sup>.</div>
    </div>
    <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; line-height: 1.25; font-weight: bold;"><br>
      <font style="font-weight: bold;">About RedHill Biopharma</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</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;">12</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;">13</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;">14</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 ( 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="line-height: 1.25;">
      <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 Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>&#160;(omeprazole magnesium, amoxicillin and rifabutin)</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;">INDICATION AND USAGE</font><br>
        Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial--, indicated for the treatment of&#160;<font style="font-style: italic;">Helicobacter pylori&#160;</font>infection in adults.<br>
        <br>
        To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by
        bacteria.&#160;</div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
        <div style="text-align: center;" id="DSPFPageNumberArea"><font style="color: #000000; font-weight: normal; font-style: normal;" id="DSPFPageNumber">3</font></div>
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      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">IMPORTANT SAFETY INFORMATION</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;">Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin
        antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Talicia is contraindicated in patients receiving rilpivirine-containing products.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Talicia is contraindicated in patients receiving delavirdine or voriconazole.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Severe cutaneous adverse reactions (SCAR) (e.g. Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported
        with rifabutin, amoxicillin, and omeprazole.&#160; Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-style: italic;">Clostridioides difficile</font>-associated
        diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when
        taking Talicia.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Talicia should not be used in patients with hepatic impairment or severe renal impairment.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events
        have occurred as both new onset and exacerbation of existing autoimmune disease.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">The most common adverse reactions (&#8805;1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal
        pain, vomiting, and vulvovaginal candidiasis.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at<br>
        1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or <u>www.fda.gov/medwatch</u>. &#160;</div>
      <div style="line-height: 1.25">&#160;</div>
    </div>
    <div style="text-align: justify; line-height: 1.25;">Full prescribing information for Talicia&#160;is available at&#160;<u>www.Talicia.com</u></div>
    <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
      <div style="text-align: center;" id="DSPFPageNumberArea"><font style="color: #000000; font-weight: normal; font-style: normal;" id="DSPFPageNumber">4</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. 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, including, without limitation, the risk that Talicia may not be a successful first-line H. pylori eradication therapy, as well as other 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="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" id="z8dec893cda6d435dba7ead8856e97f64" 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 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;">Category: Commercial</div>
    <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> Longo C, Bartlett G, Macgibbon B, et al. The effect of obesity on antibiotic treatment failure: a historical</div>
    <div style="line-height: 1.25;">cohort study. Pharmacoepidemiol Drug Saf. Sep 2013;22(9):970-6. doi:10.1002/pds.3461</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Abdullahi M, Annibale B, Capoccia D, et al. The eradication of Helicobacter pylori is affected by body mass index (BMI). Obes
      Surg. 2008;18(11):1450-1454. doi:10.1007/s11695-008-9477-z</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any
      component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn &gt;250 hours after the last dose.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> The pivotal Phase 3 study with Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> demonstrated 84% eradication of <font style="font-style: italic;">H. pylori</font> infection with Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> vs. 58% in the active comparator arm (ITT analysis, p&lt;0.0001).</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> Hooi JKY et al. Global Prevalence of <font style="font-style: italic;">Helicobacter pylori</font> Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup> IQVIA Custom Study for RedHill Biopharma, 2019</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup> Lamb A et al. Role of the <font style="font-style: italic;">Helicobacter
        pylori</font>&#8208;Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup> NIH &#8211; <font style="font-style: italic;">Helicobacter pylori</font>
      and Cancer, September 2013.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</sup> Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and <font style="font-style: italic;">Helicobacter pylori</font> infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10</sup> National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">11</sup> Malfertheiner P. et al. Management of&#160;<font style="font-style: italic;">Helicobacter pylori</font>&#160;infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O&#8217;Connor A. et al. Treatment of&#160;<font style="font-style: italic;">Helicobacter pylori&#160;</font>Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of&#160;<font style="font-style: italic;">Helicobacter pylori</font>&#160;infection. Digestion 2013;88(1):33-45.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">12</sup> Full prescribing information for Movantik&#174; (naloxegol) is available at: www.Movantik.com.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">13</sup> Full prescribing information for Talicia&#174; (omeprazole magnesium, amoxicillin and rifabutin) is available at:
      www.Talicia.com.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">14</sup> Full prescribing information for Aemcolo&#174; (rifamycin) is available at: www.Aemcolo.com.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"> <br>
    </div>
  </div>
  <div style="text-align: center;" id="DSPFPageNumberArea"><font style="color: #000000; font-weight: normal; font-style: normal;" id="DSPFPageNumber">5</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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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
