<SEC-DOCUMENT>0001178913-21-000644.txt : 20210217
<SEC-HEADER>0001178913-21-000644.hdr.sgml : 20210217
<ACCEPTANCE-DATETIME>20210217070901
ACCESSION NUMBER:		0001178913-21-000644
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210217
FILED AS OF DATE:		20210217
DATE AS OF CHANGE:		20210217

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:		21642624

	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>zk2125611.htm
<DESCRIPTION>6-K
<TEXT>
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      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">&#160;UNITED STATES&#160;</font>&#160;&#160;</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 February 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; text-indent: 14.2pt; line-height: 1.25;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#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;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;"><a href="exhibit_1.htm">Exhibit 1<font style="font-family: Symbol, serif;">:</font>&#160;Registrant's press release entitled:
          &#8220;RedHill Biopharma Announces First Patient Dosed in U.S. Phase 2/3 COVID-19 Outpatient Study with RHB-107&#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>
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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>
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              <div style="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;">(the "Registrant")</div>
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              <div style="line-height: 1.25;">&#160;</div>
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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: 30.44%; 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>
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            <td style="width: 49.66%; vertical-align: middle;">
              <div style="line-height: 1.25;">Date: February 17, 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>
          </tr>
          <tr>
            <td style="width: 49.66%; vertical-align: top;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td colspan="2" style="width: 33.91%; vertical-align: middle;">
              <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
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            <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 colspan="2" style="width: 33.91%; vertical-align: middle;">
              <div style="line-height: 1.25;">Chief Executive Officer</div>
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            <td style="width: 16.42%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
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      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;2</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"> </div>
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      </div>
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      </div>
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      </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;">
        <div><br>
        </div>
        <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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                  <div style="line-height: 1.25;">
                    <div style="text-align: center; text-indent: 42.55pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Press Release</div>
                  </div>
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              </td>
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      </div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-weight: bold;"><u>RedHill Biopharma Announces First Patient Dosed in U.S. Phase 2/3 COVID-19 Outpatient Study </u><u>with RHB-107</u></div>
      <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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              <div style="font-style: italic;">The U.S. Phase 2/3 study with once-daily, orally-administered RHB-107 (upamostat) evaluates </div>
              <div style="font-style: italic;">treatment of patients with symptomatic COVID-19 who do not require hospitalization - the vast majority of patients</div>
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            </td>
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              <div style="font-style: italic;">--</div>
            </td>
          </tr>

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              <div style="font-style: italic;">RHB-107 is a novel serine protease inhibitor targeting human cell factors involved in viral entry, </div>
              <div style="font-style: italic;">and is therefore expected to be effective against emerging viral variants with mutations in the spike protein</div>
            </td>
          </tr>

      </table>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="ze36d0ba71c274e61935448f21af0d8bc">

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            </td>
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            </td>
            <td style="width: auto; vertical-align: top; text-align: center;">
              <div style="font-style: italic;">--</div>
            </td>
          </tr>

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      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="zf17ec5a08df14f67b8c53453c70d3440">

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            <td style="width: auto; vertical-align: top; text-align: center;">
              <div style="font-style: italic;">The RHB-107 Phase 2/3 study allows patients to remain in the comfort of their home while being </div>
              <div style="font-style: italic;">monitored at a level previously possible only in a hospital setting</div>
            </td>
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      </table>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="z3caab8baf0d94cb3a9588954fdad60bf">

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            </td>
            <td style="width: auto; vertical-align: top; text-align: center;">
              <div style="font-style: italic;">--</div>
            </td>
          </tr>

      </table>
      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" class="DSPFListTable" id="z2df3271212c043619e7be484be1623b6">

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            </td>
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            </td>
            <td style="width: auto; vertical-align: top; text-align: center;">
              <div style="font-style: italic;">In parallel, top-line data from global Phase 2/3 study in hospitalized patients with opaganib, </div>
              <div style="font-style: italic;">RedHill&#8217;s second COVID-19 candidate, is expected Q2/2021</div>
            </td>
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      </table>
      <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, February 17, 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 the first patient was dosed in its U.S. Phase 2/3 study of orally-administered RHB-107 (upamostat)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>, an investigational new drug for patients with symptomatic COVID-19 who do not require
        hospital care.</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;">Dror Ben-Asher, RedHill&#8217;s CEO said</font>: &#8220;RedHill is rapidly advancing two Phase 3-stage, orally-administered, novel molecules for the treatment of COVID-19:
        RHB-107 for outpatient use and opaganib for hospitalized patients. With these two promising and complementary shots on goal across the disease severity spectrum, RedHill is positioned at the very forefront of COVID-19 therapeutic research, aiming
        to address both existing and emerging mutations.&#8221;</div>
      <div style="text-align: justify; line-height: 1.25;"> <br>
      </div>
      <div style="text-align: justify; line-height: 1.25;">The U.S. Phase 2/3 study (<u>NCT04723527</u>) is aimed at evaluating treatment with RHB-107 in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral
        treatment in an outpatient setting.</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;">
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      <!--PROfilePageNumberReset%Num%2%%%-->
      <div style="text-align: justify; line-height: 1.25;">RHB-107 is a novel, potent inhibitor of serine proteases, that targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be
        effective against emerging viral variants with mutations in the spike protein. RHB-107 demonstrated strong inhibition of SARS-CoV-2 viral replication in an <font style="font-style: italic;">in vitro</font> human bronchial epithelial cell model and
        previous preclinical work demonstrated potential tissue-protective action. Previous clinical studies of RHB-107 included several Phase 1 and Phase 2 studies in different indications, demonstrating its clinical safety profile in approximately 200
        patients.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">&#8220;Dosing of the first patient in the Phase 2/3 study of RHB-107 in patients with symptoms but not needing hospital care, the largest COVID-19 patient group, is a key step forward in RedHill&#8217;s
        efforts to help combat the widespread effects of this pandemic. Together with opaganib, we now have two novel, orally-administered compounds, with unique mechanisms of action, in advanced development for treating patients at different stages of
        COVID-19 disease,&#8221; <font style="font-weight: bold;">said Terry F. Plasse MD, Medical Director at RedHill</font>. &#8220;The ability to treat patients early in the course of COVID-19 disease, with an oral therapy designed to be used outside the hospital,
        and with a compound expected to be effective against emerging viral variants, has the potential to be a game-changer in managing this disease. The ground-breaking design of the study allows us to collect data at a level previously possible only in
        hospital while enabling patients to stay in the comfort of their homes and decreasing exposure risk of this highly contagious disease.&#8221;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; margin-right: 2.9pt; line-height: 1.25;">This study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The first part of the
        study is designed for dose selection and is planned to enroll 60 patients. The second part of the study is planned to enroll 250 patients and will evaluate time to sustained recovery from illness as the primary endpoint. Each patient will be tested
        for specific viral strain.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; margin-right: 2.9pt; line-height: 1.25;">The study is unique in a COVID-19 trial setting in its extensive use of telemetry and electronic patient-reported outcome (ePRO) data collection and is based on the latest FDA
        guidance for symptom monitoring. Following the patients&#8217; initial visit to a medical facility, a research-trained nurse will make periodic home visits to study patients to collect samples for safety and virology monitoring. This innovative use of
        home-based safety and efficacy monitoring technologies, together with home nursing support, enables patients to participate in the study from home with the benefit of hospital-level monitoring, enhancing patient comfort and markedly decreasing the
        risk of SARS-CoV-2 exposure to medical staff and other members of the public.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">In parallel, the late-stage development program for RedHill&#8217;s second COVID-19 drug candidate, opaganib<sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> in patients hospitalized with severe COVID-19, is
        progressing rapidly. Recently announced <u>top-line results</u> from the U.S. Phase 2 study of opaganib demonstrated safety and positive efficacy data across key primary and secondary endpoints. The global Phase 2/3 study continues to enroll,
        having recently received a <u>positive DSMB futility review</u>, with top-line data and potential subsequent global emergency use authorization applications expected in the second quarter of 2021.</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;">2</font></div>
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          <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; font-weight: bold;">About RHB-107 (upamostat)</div>
      <div style="text-align: justify; line-height: 1.25;">RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. RHB-107 targets
        human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a U.S. Phase
        2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases. RHB-107 has undergone several Phase 1
        studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany&#8217;s Heidelberg
        Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">About RedHill Biopharma</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<font style="font-weight: bold;">&#160;&#160;&#160;</font></div>
      <div style="text-align: justify; line-height: 1.25;">RedHill Biopharma Ltd. (Nasdaq: <u>RDHL</u>) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, <font style="font-weight: bold;">Movantik</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174; </sup>for opioid-induced constipation in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>, <font style="font-weight: bold;">Talicia</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">&#160;</font>for the treatment of <font style="font-style: italic;">Helicobacter pylori (H. pylori)</font> infection in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>, and <font style="font-weight: bold;">Aemcolo</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>
        for the treatment of travelers&#8217; diarrhea in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3
        study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib </font><font style="font-weight: bold;">(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 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>), 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>
        (<font style="font-weight: bold;">Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; 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 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;"><br style="line-height: 1.25;">
        <br>
        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 enrollment in the Company&#8217;s Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 will not be effective against emerging viral variants with
        mutations in the spike protein; the risk that the Company&#8217;s Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to
        support emergency use applications or in making such emergency use applications, if at all;; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and
        that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease
        that is still little understood, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19;
        the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company&#8217;s
        research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the
        Company&#8217;s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to
        conduct and the Company&#8217;s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of
        the Company&#8217;s therapeutic candidates and Talicia<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 Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> and Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (vi) the Company&#8217;s ability to establish and
        maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the
        interpretation of the properties and characteristics of the Company&#8217;s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company&#8217;s
        business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and
        its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the
        Company&#8217;s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from
        other companies and technologies within the Company&#8217;s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities
        and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company
        assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
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      <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z82132167eb374d63ab496bf027fd1c65">

          <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;"><br style="line-height: 1.25;">
      </div>
      <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> RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Opaganib (Yeliva&#174;, ABC294640) is an investigational new drug, not available for commercial distribution in the United States.</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;">3</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;">4</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;">5 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 style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"> <br>
      </div>
    </div>
  </div>
  <div id="DSPFPageNumberArea" style="text-align: center;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal;">5</font></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
