<SEC-DOCUMENT>0001178913-21-002975.txt : 20210913
<SEC-HEADER>0001178913-21-002975.hdr.sgml : 20210913
<ACCEPTANCE-DATETIME>20210913070319
ACCESSION NUMBER:		0001178913-21-002975
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210913
FILED AS OF DATE:		20210913
DATE AS OF CHANGE:		20210913

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:		211248594

	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>zk2126575.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 September 2021<br>
        Commission File No.:001-35773</div>
      <div style="text-align: center; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">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; <br>
        <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 Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval&#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;"> <br>
      </div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Signatures</div>
      <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
        behalf by the undersigned, thereunto duly authorized.&#160;</div>
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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;">REDHILL BIOPHARMA LTD.</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
          </tr>
          <tr>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 33.94%; vertical-align: middle;" colspan="2">
              <div style="line-height: 1.25;">(the "Registrant")</div>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <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>
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            <td style="width: 49.63%; vertical-align: middle;">
              <div style="line-height: 1.25;">Date: September 13, 2021</div>
            </td>
            <td style="width: 3.48%; vertical-align: middle;">
              <div style="line-height: 1.25;">By:</div>
            </td>
            <td style="width: 30.46%; 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: 16.43%; 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>
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            <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>
          </tr>

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      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">
        <div style="text-align: center;">&#160;2</div>
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      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="line-height: 1.25;">&#160;</div>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>exhibit_1.htm
<DESCRIPTION>EXHIBIT 1
<TEXT>
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      <div style="line-height: 1.25; text-align: right;"><font style="font-weight: bold;"><u>Exhibit 1</u></font><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg"></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <table cellspacing="0" cellpadding="0" border="0" id="z4b5f8ef5b77a4151b61bbc5023244fec" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;">

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                <div>
                  <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 18pt;">Press Release</div>
                </div>
              </td>
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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; font-size: 18pt;"><br>
        </div>
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;"><font style="font-size: 14pt;"><u>RedHill Biopharma </u></font><font style="font-size: 14pt;"><u>Accelerates Ongoing U.S. Phase 2/3 </u></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>COVID-19 Study of Once-Daily Oral RHB-107 in Non-</u></div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;"><font style="font-size: 14pt;"><u>Hospitalized Patients</u></font><font style="font-size: 14pt;"><u>&#160;</u></font><font style="font-size: 14pt;"><u>with South African Approval</u></font></div>
      <br>
      <div>
        <div style="text-align: center; line-height: 1.25; font-style: italic;">
          <div style="font-style: italic;">
            <div style="font-style: italic;">
              <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 </div>
              <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic </div>
              <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">COVID-19 who do not require hospital care</div>
              <div>&#8211;</div>
            </div>
            <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">Number of U.S. sites for the study has also been expanded</div>
            <div>&#8211;</div>
          </div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be </div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">effective against emerging viral variants</div>
        </div>
        <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">&#8211;</div>
        <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early </div>
        <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">course of COVID-19</div>
        <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;"> &#8211;</div>
        <div style="text-align: center; line-height: 1.25; font-style: italic;">
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;">In parallel RedHill&#8217;s leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global</div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic;"> Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming</div>
          <br>
        </div>
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, September 13, 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 South Africa has joined the U.S. in approving the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> for non-hospitalized patients with symptomatic
        COVID-19. The study is already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107
        is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an <font style="font-style: italic;">in vitro</font> human
        bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, 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;South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the
        world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting,&#8221; <font style="font-weight: bold;">said Terry F. Plasse MD, Medical Director at RedHill.</font> &#8220;As clearly
        highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of
        study sites in the U.S., are aimed at accelerating our efforts to bring RedHill&#8217;s two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world.&#8221;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The Phase 2/3 study (<u>NCT04723527</u>) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral
        treatment that can be prescribed and used in the largest, non-hospitalized, patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107.
        The study is designed for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.</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, top-line results are upcoming from the opaganib<sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill&#8217;s
        other advanced COVID-19 oral drug candidate.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </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 antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. 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
        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 several indications in oncology, inflammatory and gastrointestinal disease. 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="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">About RedHill Biopharma</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<font style="font-weight: bold;">&#160;&#160;&#160;</font></div>
      <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; line-height: 1.25;">RedHill Biopharma Ltd. (Nasdaq: <u>RDHL</u>) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
        RedHill promotes the gastrointestinal drugs, <font style="font-weight: bold;">Movantik</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174; </sup>for opioid-induced constipation in adults, <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, 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. 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="text-align: justify; line-height: 1.25; font-style: italic;"><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 and/or opaganib 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 RHB-107 and/or 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 RHB-107 in certain geographies, including South Africa, will
        not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that 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 relatively new disease, 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 RHB-107, 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 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" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z43a1f477fa434a7ca1ec95f9f717abc3">

          <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>
      <br>
      <hr noshade="noshade" align="left" style="background-color: #000000; border: 0px; height: 1px; width: 2in; margin-left: 0pt; margin-right: auto; color: #000000;">
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> 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 (ABC294640) is an investigational new drug, not available for commercial distribution in the United States.</div>
      <div style="line-height: 1.25;"> <br>
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal;">2</font>
      </div>
      <div style="line-height: 1.25;"> <br>
      </div>
      <div style="line-height: 1.25;">
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"> </div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
