<SEC-DOCUMENT>0001178913-23-002630.txt : 20230731
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<ACCEPTANCE-DATETIME>20230731070333
ACCESSION NUMBER:		0001178913-23-002630
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230731
FILED AS OF DATE:		20230731
DATE AS OF CHANGE:		20230731

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:		231125026

	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
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            <font style="font-size: 14pt;">UNITED STATES&#160;</font></font>&#160;&#160;</div>
        <div style="text-align: center; line-height: 1.25; color: rgb(0, 0, 0); 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; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-weight: bold;">Washington, D.C.&#160;20549</div>
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        <div style="text-align: center; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">FORM 6-K</div>
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        <div style="text-align: center; line-height: 1.25; color: #000000; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
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        <div style="text-align: center; line-height: 1.25; color: #000000;">For the month of July 2023<font style="font-family: 'Times New Roman',Times,serif;"><br>
          </font>Commission File No.:001-35773</div>
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        <div style="text-align: center; line-height: 1.25; color: rgb(0, 0, 0); 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; color: #000000;">(Translation of registrant&#8217;s name into English)</div>
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        <div style="text-align: center; line-height: 1.25; color: #000000; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
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        <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or
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        <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T
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        <div style="line-height: 1.25; color: #000000;">Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: &#8220;RedHill&#8217;s RHB-107 Included in U.S. Government-Supported COVID-19 Platform Trial and Cleared
          for Initiation by FDA&#8221;.</div>
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        <div style="text-align: justify; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif;">This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities
          and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No.
          333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845) and on June 29, 2023 (File No. 333-273001) and its Registration
          Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).</div>
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        <div style="text-align: center; line-height: 1.25; color: #000000; font-weight: bold;">SIGNATURES</div>
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        <div style="line-height: 1.25; color: #000000;">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; font-family: 'Times New Roman',Times,serif;">Date: July 31, 2023</div>
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              <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">By:</div>
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              <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">/s/ Dror Ben-Asher</div>
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        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-size: 18pt; font-weight: bold;"><u> <br>
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        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-size: 12pt; font-weight: bold;"><u>RedHill&#8217;s RHB-107 Included in U.S. Government-Supported</u></div>
        <font style="font-size: 12pt;"> </font>
        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-size: 12pt; font-weight: bold;"><u> COVID-19 Platform Trial and Cleared for Initiation by FDA</u></div>
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        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

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                 </td>
              <td style="width: 18pt; vertical-align: top; color: rgb(255, 255, 255);">o</td>
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                <div style="color: rgb(0, 0, 0); font-style: italic;">RHB-107 (upamostat) accepted for inclusion in ACESO&#8217;s PROTECT adaptive platform trial for early COVID-19 outpatient treatment to be conducted in the <br>
                  U.S., Thailand, Ivory Coast and South Africa</div>
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              <td style="width: 18pt; vertical-align: top; color: rgb(255, 255, 255);">o</td>
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                <div style="color: rgb(0, 0, 0); font-style: italic;">--</div>
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                <div><font style="font-style: italic; color: #000000;">The substantial 300-patient Phase 2 study, predominantly funded by the U.S. Government Department of Defense's Joint Program Executive Office for</font></div>
                <div><font style="font-style: italic; color: #000000;"> Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has received FDA clearance to start (expected Q3/23) and is estimated to be</font></div>
                <div><font style="font-style: italic; color: #000000;"> completed by end of 2024</font></div>
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              <td style="width: 18pt; vertical-align: top; color: rgb(255, 255, 255);">o</td>
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                <div style="color: rgb(0, 0, 0); font-style: italic;">&#8211;</div>
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                <div style="font-size: 12pt;"><font style="font-style: italic; color: rgb(0, 0, 0); font-size: 10pt;">If approved, RHB-107, a novel, oral, once-daily, broad-acting, host-directed antiviral is expected to act independently of viral spike
                    protein mutations</font><font style="font-size: 10pt;"><sup style="color: #000000; font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup><font style="font-style: italic; color: #000000;">,</font></font></div>
                <div style="font-size: 12pt;"><font style="font-size: 10pt;"><font style="font-style: italic; color: #000000;"> would potentially target a multi-billion-dollar early COVID-19 treatment market</font></font></div>
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                <div style="color: rgb(0, 0, 0); font-style: italic;">--</div>
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                <div style="font-size: 12pt;"><font style="font-style: italic; color: rgb(0, 0, 0); font-size: 10pt;">RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked
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                <div style="font-size: 12pt;"><font style="font-style: italic; color: rgb(0, 0, 0); font-size: 10pt;"> hospitalization due to COVID-19 in a U.S. Phase 2 study</font><font style="font-size: 10pt;"><sup style="color: #000000; vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup></font></div>
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        <div style="text-align: justify; line-height: 1.25; font-size: 12pt;"><font style="font-weight: bold; font-size: 10pt;">TEL AVIV, Israel and RALEIGH, NC, July 31, 2023, </font><font style="font-size: 10pt;">RedHill Biopharma Ltd. (Nasdaq: RDHL)
            (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical company, today announced that RHB-107 (upamostat)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> has been accepted for inclusion in the Austere environments Consortium for Enhanced Sepsis Outcomes&#8217; (ACESO) U.S.
            Government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. The Company also announced that the Phase 2 study, predominantly funded by
            the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has received FDA clearance to start and is estimated to be completed by end of 2024.</font></div>

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        <div style="text-align: justify; line-height: 1.25;">Expected to begin enrolling patients in Q3 2023, the ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by
          researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The study will compare investigational products (IPs) to control, in standard-risk,
          non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the initial drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early
          treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms. Participants will be followed for a period of up to 12 weeks.</div>

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           </div>

        <div style="text-align: justify; line-height: 1.25;">Selection of investigational products for inclusion in the study was based on review of the preclinical and early clinical data, evaluating, safety, tolerability, and efficacy of
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        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25;">&#8220;Having RHB-107 accepted for inclusion in the PROTECT platform study, following an extensive review of the potential value it can bring, by both the scientific and governmental
          bodies involved in the study offers us a chance to further verify the promising efficacy results, including 100% reduction in hospitalization due to COVID-19, that we delivered in our earlier U.S. Phase 2 study,&#8221; said <font style="font-weight: bold;">Gilead Raday, RedHill&#8217;s Chief Operating Officer and Head of R&amp;D</font>. &#8220;RHB-107 is a novel, broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations and, if approved, would add to
          treatment options such as Paxlovid (a multi-billion-dollar product), in the early COVID-19 treatment paradigm. RHB-107&#8217;s development runs alongside RedHill&#8217;s other U.S. Government-funded program with opaganib, a novel oral drug being developed in
          collaboration with the National Institutes of Health Radiation and Nuclear Countermeasures Program for Acute Radiation Syndrome.&#8221;</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25;">Data from RHB-107&#8217;s U.S. Phase 2 study showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized
          for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only 2.4% of the RHB-107 treated group (1/41) versus 20%
          (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further <font style="font-style: italic;">post-hoc</font> analysis showed faster recovery from severe COVID-19 symptoms with a
          median of 3 days to recovery with upamostat compared to 8 days with placebo.</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25;">Discussions for external non-dilutive funding for RHB-107 Phase 3 COVID-19 development, in addition to the platform study, are advancing. Several collaborative projects for
          pandemic preparedness testing RHB-107, with government and non-government bodies, in a range of preclinical studies against other viral targets are ongoing and under discussion with government and non-government bodies.</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div class="BRPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
          <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="color: #000000; font-weight: normal; font-style: normal;">2</font></div>
          <div class="BRPFPageBreak" 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="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, once-daily orally administered investigational antiviral, 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.</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25;">In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies,
          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;">RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany'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-weight: bold;">About HJF</div>

        <div style="text-align: justify; line-height: 1.25;">The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), now celebrating its 40th anniversary, is a global nonprofit organization with the mission to
          advance military medicine. HJF&#8217;s scientific, administrative and program operations services empower investigators, clinicians, and medical researchers around the world to make discoveries in all areas of medicine. HJF serves as a trusted and
          responsive link between the military medical community, federal and private partners, and the millions of warfighters, veterans, and civilians who benefit from military medicine. For more information, visit www.hjf.org.&#160;&#160;</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="line-height: 1.25; font-weight: bold;">About the JPEO-CBRND</div>

        <div style="text-align: justify; line-height: 1.25;">The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and
          defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND&#8217;s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced
          development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND&#8217;s COVID-19 response, visit
          https://www.jpeocbrnd.osd.mil/coronavirus exit disclaimer icon or follow JPEO-CBRND on social media at @JPEOCBRND.</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About ACESO</div>

        <div style="text-align: justify; line-height: 1.25;">The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) aims to improve survival for patients with sepsis in resource-limited settings through development of
          host-based technology solutions and evidence-based clinical management strategies. Founded in 2010, ACESO brings together a consortium comprised of academic, non-profit, governmental, and industry partners that is administered by HJF. ACESO has
          established a global clinical research network to develop and deliver cutting-edge tools and strategies to save lives in austere settings.</div>

        <div style="text-align: justify; line-height: 1.25;">For more information, visit www.aceso-sepsis.org.</div>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div class="BRPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
          <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="color: #000000; font-weight: normal; font-style: normal;">3</font></div>
          <div class="BRPFPageBreak" 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="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: <font style="color: #0000FF;"><u>RDHL</u></font>) is a specialty biopharmaceutical company primarily
          focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs <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)&#160;<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 broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. Government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for
          hospitalized COVID-19, and a Phase 2 program in oncology; (ii)&#160;<font style="font-weight: bold;">RHB-107&#160;</font>(<font style="font-weight: bold;">upamostat</font>), an oral broad-acting, host-directed, serine protease inhibitor with potential for
          pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii)&#160;<font style="font-weight: bold;">RHB-102</font>,
          with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv)&#160;<font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease; and (v)&#160;<font style="font-weight: bold;">RHB-204</font>,&#160;a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM)
          disease. More information about the Company is available at <font style="color: #0000FF;"><u>www.redhillbio.com</u></font> / <font style="color: #0000FF;"><u>https://twitter.com/RedHillBio</u></font>.</div>

        <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be
          preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" 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's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such
          forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the growth in prescriptions will not continue and the addition of new generating products will not occur, that we will not be successful in
          obtaining non-dilutive development funding for RHB-107, that we will not be successful in increasing sales of our commercial products, including due to market conditions, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and,
          even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as
          risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company'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's
          ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical 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'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's therapeutic candidates and Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (v) the Company's ability to successfully commercialize and promote Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>&#160;and Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>; (vi) the Company'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'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'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'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; and (xiv) competition from other companies and technologies within the Company's
          industry.&#160;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 17, 2022. 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 style="text-align: justify; line-height: 1.25; font-style: italic;">The views expressed in this press release reflect the results of research conducted by the author and do not necessarily reflect the official policy or
          position of the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., the Department of the Navy, Department of the Army, Department of Defense, nor the United States Government. This project was supported by the Joint
          Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).&#160; The study protocol is in compliance with all applicable federal regulations governing the protection of human subjects.</div>

        <div style="text-align: justify; 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="z77b5160490cc4e91a57cb7c7367b762e">

            <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;">adi@redhillbio.com</div>
              </td>
              <td style="width: 46.73%; vertical-align: top;">&#160;</td>
            </tr>

        </table>

        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
           </div>

        <div style="line-height: 1.25;">Category: R&amp;D</div>
         <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><font style="color: rgb(0, 0, 0);"> Preliminary data from a recent </font><font style="font-style: italic; color: rgb(0, 0, 0);">in vitro</font><font style="color: rgb(0, 0, 0);"> study</font></div>

        <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup><font style="color: rgb(0, 0, 0);">&#160;</font><font style="color: rgb(0, 0, 255);"><u>https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext</u></font></div>

        <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</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;">4</sup><font style="color: rgb(0, 0, 0);"> Full prescribing information for Talicia</font><sup style="color: #000000; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="color: rgb(0, 0, 0);"> (omeprazole magnesium,
            amoxicillin and rifabutin) is available at: www.Talicia.com.</font></div>

        <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup><font style="color: rgb(0, 0, 0);"> Full prescribing information for Aemcolo</font><sup style="color: #000000; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="color: rgb(0, 0, 0);"> (rifamycin) is available at:
            www.Aemcolo.com.</font></div>
         </div>

      <div> <br>

        <div style="text-align: center;"><font style="font-family: 'Times New Roman',Times,serif; color: rgb(0, 0, 0); font-weight: normal; font-style: normal;" class="BRPFPageNumber">4</font></div>
      </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>
