<SEC-DOCUMENT>0001178913-21-003112.txt : 20211006
<SEC-HEADER>0001178913-21-003112.hdr.sgml : 20211006
<ACCEPTANCE-DATETIME>20211006070253
ACCESSION NUMBER:		0001178913-21-003112
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20211006
FILED AS OF DATE:		20211006
DATE AS OF CHANGE:		20211006

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:		211308809

	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>zk2126624.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 October 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&#8217;s Talicia&#174;
          added to Medi-Cal Contract Drug List with No Prior Authorization Requirements&#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>
      </div>
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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>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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          <tr>
            <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>
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              <div style="line-height: 1.25;">&#160;</div>
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            <td colspan="2" style="vertical-align: middle;">
              <div style="line-height: 1.25;">(the "Registrant")</div>
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            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 3%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 27%; vertical-align: middle;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 20%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
            <td style="width: 49.63%; vertical-align: middle;">
              <div style="line-height: 1.25;">Date: October 6, 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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              <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;">2<br>
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"></div>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <br>
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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 style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg">
        <div><br>
        </div>
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      <div style="line-height: 1.25;">
        <table cellspacing="0" cellpadding="5" border="0" id="z2493164c42cb44648d391bf2ca69abb1" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;">

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                <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-weight: bold;"><font style="font-size: 14pt; font-family: 'Times New Roman',Times,serif;"><u>RedHill Biopharma&#8217;s Talicia</u></font><font style="font-size: 14pt;"><font style="font-size: 12pt;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;"><u>&#174;</u></sup></font><font style="font-family: 'Times New Roman',Times,serif;"><u> added to Medi-Cal Contract </u></font></font></div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;"><u>Drug List with No Prior Authorization Requirements</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;">Addition of Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> by Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no </div>
      <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">prior authorization is an important expansion of coverage for California patients and continues </div>
      <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">to increase Talicia&#8217;s overall unrestricted coverage</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">Coverage commenced for two million patients in Medi-Cal&#8217;s FFS plan on October 1<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">st</sup>, 2021</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, </div>
      <div style="text-align: center; margin-left: 18pt; line-height: 1.25; font-style: italic;">designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric </div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">cancer; H. pylori affects approximately 35% of the U.S. population</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL-AVIV, Israel and RALEIGH, N.C., October 6, 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 that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> to its Contract Drug
        List (CDL) for <font style="font-style: italic;">H. pylori</font> treatment, with no prior authorization required, effective October 1, 2021.</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;">Coverage for Talicia commenced for two million patients in Medi-Cal&#8217;s California FFS plan on October 1, 2021.</div>
        <div style="line-height: 1.25">&#160;</div>
        <div style="text-align: justify; line-height: 1.25;">&#8220;Medi-Cal&#8217;s addition of Talicia with no prior authorization required is an important step in Talicia&#8217;s continuing growth and we are pleased that it will be made available to Medi-Cal&#8217;s 2 million
          FFS lives,&#8221; <font style="font-weight: bold;">said Rick Scruggs, RedHill&#8217;s Chief Commercial Officer</font>. &#8220;There is growing recognition of the need to employ effective, first-line therapy against <font style="font-style: italic;">H. pylori</font>
          infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria.&#8221;<br>
        </div>
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        <div style="text-align: justify; line-height: 1.25;"><br>
          <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 FDA and the World Health Organization (WHO) in recent years.</div>
        <div style="line-height: 1.25">&#160;</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;">2</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;">3</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>
        <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;">4</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;">5</sup>. Worldwide, more than 50% of the
          population has<br>
          <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;">6</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;">7</sup>&#160;and gastric mucosa-associated lymphoid tissue (MALT) lymphoma<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup>. More than 27,000 Americans are diagnosed with gastric cancer annually<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</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 commonly used in standard combination therapies<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10</sup>.</div>
      </div>
      <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; line-height: 1.25;"><font style="font-weight: bold;"><br>
          About RedHill Biopharma<br>
        </font><br style="line-height: 1.25;">
      </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;">11</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;">12</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;">13</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>.<br>
        <br style="line-height: 1.25;">
      </div>
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      </div>
      <div style="line-height: 1.25;">
        <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="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;"><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. 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;">Acute Interstitial 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;">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&#160; 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="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
        <div id="DSPFPageNumberArea" style="text-align: center;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal;">3</font></div>
        <div id="DSPFPageBreak" style="page-break-after: always;">
          <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
      </div>
      <div style="text-align: justify; line-height: 1.25; 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 Company will be unable to secure additional Pharmacy Benefit Management formulary coverage for Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, 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="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <table cellspacing="0" cellpadding="0" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z05819c3093504adeb151dcd51ac7253c">

          <tr>
            <td style="width: 50%; 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: 50%; 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>
      <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> Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is indicated for the treatment of <font style="font-style: italic;">Helicobacter pylori</font>
        (<font style="font-style: italic;">H. pylori</font>) infection in adults. For full prescribing information see: <u>www.Talicia.com</u>.</div>
      <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</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;">3</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;">4</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;">5</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;">6</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;">7</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;">8</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;">9</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;">10</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="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">11</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;">12</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;">13</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>
    <div> <br>
    </div>
    <div>
      <div id="DSPFPageNumberArea" style="text-align: center;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal;">4</font></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
