<SEC-DOCUMENT>0001178913-22-000875.txt : 20220301
<SEC-HEADER>0001178913-22-000875.hdr.sgml : 20220301
<ACCEPTANCE-DATETIME>20220301090304
ACCESSION NUMBER:		0001178913-22-000875
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20220301
FILED AS OF DATE:		20220301
DATE AS OF CHANGE:		20220301

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:		22694309

	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>zk2227389.htm
<DESCRIPTION>6-K
<TEXT>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;"> <font style="font-family: 'Times New Roman',Times,serif;"><br>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">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 March 2022<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: center; text-indent: 14.2pt; line-height: 1.25;"> <br>
      </div>
      <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F &#9746; &#160; &#160;&#160; Form 40-F &#9744;</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; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Attached hereto as <a href="exhibit_99-1.htm">Exhibit 99.1</a>
        and incorporated by reference herein is a press release issued by the Registrant on March 1, 2022, entitled: &#8220;<font style="font-style: italic;">RedHill Announces Positive Phase 2 Study Results with Oral RHB-107 in Non-Hospitalized
          COVID-19</font>&#8221;.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">This Report on Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the
        Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019
        (File No. 333-232776) on March 25, 2021 (File No. 333-254692) and on May 3, 2021 (File No. 333-255710), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 24, 2019 (File No. 333-232777), on March
        30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;"> <br>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Signatures</div>
      <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
        behalf by the undersigned, thereunto duly authorized.&#160;</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <table cellspacing="0" cellpadding="0" id="zcc5ed964deb94a308d61001d2cf37e41" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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              <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">&#160;</div>
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            <td style="width: 33.94%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;" colspan="2">
              <div style="line-height: 1.25;">(the "Registrant")</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">&#160;</div>
            </td>
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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;">&#160;</div>
            </td>
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              <div style="line-height: 1.25;">&#160;</div>
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            <td style="width: 49.63%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">Date: March 1, 2022</div>
            </td>
            <td style="width: 3.48%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">By:</div>
            </td>
            <td style="width: 30.46%; vertical-align: middle; border-bottom: 2px solid rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">&#160;</div>
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            <td style="width: 33.94%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;" colspan="2">
              <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom; font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">&#160;</div>
            </td>
            <td style="width: 33.94%; vertical-align: middle; font-family: 'Times New Roman',Times,serif;" colspan="2">
              <div style="line-height: 1.25;">Chief Executive Officer</div>
            </td>
            <td style="width: 16.43%; vertical-align: bottom; font-family: 'Times New Roman',Times,serif;">
              <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
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u> </div>
    <div> <br>
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      <div style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg"></div>
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                <div>&#160;
                  <div style="line-height: 1.25;">
                    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">Press Release</div>
                    <div style="text-align: center; text-indent: 42.55pt; line-height: 1.25;"> <br>
                    </div>
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      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;"><font style="font-size: 12pt;"><u>RedHill </u><u>Announces Positive Phase 2 Study Results with Oral </u></font></div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;"><u>RHB-107 in Non-Hospitalized COVID-19</u></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">Phase 2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic COVID-19 successfully </div>
        <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">met the study&#8217;s primary endpoint showing good safety and tolerability and highly promising efficacy results</div>
      </div>
      <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">--</div>
      <div style="line-height: 1.25;">
        <div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">100% reduction in hospitalization due to COVID-19 with zero patients (0/41) on the RHB-107 arms </div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">versus 15% (3/20) hospitalized on the placebo-controlled arm</div>
        </div>
        <div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">--</div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">
            <div style="line-height: 1.25;">
              <div style="font-family: 'Times New Roman', Times, serif; font-style: italic;">87.8% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only </div>
              <div style="font-family: 'Times New Roman', Times, serif; font-style: italic;">one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-</div>
              <div style="font-family: 'Times New Roman', Times, serif; font-style: italic;">controlled arm)</div>
            </div>
          </div>
        </div>
        <div>
          <div style="font-family: 'Times New Roman',Times,serif; font-style: italic; text-align: center;">&#8211;</div>
        </div>
        <div>
          <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">The most common variant among patients in the study was Delta; RHB-107, a novel, investigational </div>
          <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">oral antiviral serine protease inhibitor, targeting host rather than viral factors, is expected to </div>
          <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">maintain effect against emerging viral variants</div>
        </div>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, March 1, 2022, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty
        biopharmaceutical company, today announced positive top-line results from the Phase 2 part of the Phase 2/3 study of once-daily oral RHB-107 (upamostat)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> in non-hospitalized symptomatic COVID-19 patients, predominantly conducted in the
        U.S. (60/61 patients) as well as South Africa.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Although not powered for efficacy assessment, the study showed highly promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107
        hospitalized with COVID-19 (0/41) compared to 15% on the placebo-controlled arm requiring hospitalization (3/20) (nominal p-value=0.0317). Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one
        patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms (nominal p-value=0.036).</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;">The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107. Study arms were well balanced with respect to baseline disease severity, risk
        factors and vaccination status. Patients were also tested for the specific viral strain (last patient randomized November 12, 2021), with the most common variant being <font style="font-style: italic;">Delta</font>, found in 62.5% of the patients
        that had next generation sequencing (NGS).</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">&#8220;These very promising efficacy results, achieved despite a small overall sample size, are impressive. Coupling the efficacy results with successfully meeting the primary endpoint of good safety and
        tolerability and convenient once-daily dosing, positions oral RHB-107 as a potential highly beneficial treatment for COVID-19 outpatients early in the course of disease in order to reduce symptom severity and prevent disease progression and
        hospitalization. Given the limitations of current options for early treatment of COVID-19, we are excited to progress the development of RHB-107, subject to additional discussions with regulatory authorities,&#8221; <font style="font-weight: bold;">said
          Terry F. Plasse MD, Medical Director at RedHill</font>. &#8220;Equally important is our expectation that RHB-107, with its human cell factor targeting, would maintain its action irrespective of spike protein mutations, thus likely making it a highly
        desirable variant-agnostic potential treatment option.&#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 multicenter, randomized, double-blind, placebo-controlled, parallel-group 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 once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The Phase 2 part of the study was designed to evaluate safety for dose selection and to
        provide preliminary assessment of parameters to be used for efficacy evaluation in Part B. A total of 61 patients were enrolled in Part A and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Next steps for the study will follow data submission and discussion with regulators.</div>
      <div style="text-align: justify; 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 host 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. 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 studies and two Phase 2 studies, demonstrating its clinical safety profile in
        approximately 200 patients. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from
        Germany&#8217;s Heidelberg Pharma (FSE: HPHA) (formerly WILEX AG) for all indications.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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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<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</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;">3</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;">4</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib ( ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class, oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) <font style="font-weight: bold;">RHB-107 </font>(<font style="font-weight: bold;">upamostat</font>), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) <font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease; (v) <font style="font-weight: bold;">RHB-102</font>, with positive results from a Phase 3 study for acute gastroenteritis and
        gastritis and positive results from a Phase 2 study for IBS-D; and (vi) <font style="font-weight: bold;">RHB</font>-<font style="font-weight: bold;">106</font>, an encapsulated bowel preparation. More information about the Company is available at
        <u>www.redhillbio.com</u> / <u>https://twitter.com/RedHillBio</u>.</div>
      <div style="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 &#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 the follow up for Part A and the commencement of Part B of the 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" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z5c860da7dc9b4352958daebb20f08b34">

          <tr>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25; font-weight: bold;">Company contact:</div>
              <div style="line-height: 1.25;">Adi Frish</div>
              <div style="line-height: 1.25;">Chief Corporate &amp; Business Development Officer</div>
              <div style="line-height: 1.25;">RedHill Biopharma</div>
              <div style="line-height: 1.25;">+972-54-6543-112</div>
              <div style="line-height: 1.25;"><u>adi@redhillbio.com</u></div>
            </td>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25; font-weight: bold;">Media contacts:</div>
              <div style="line-height: 1.25;"><font style="font-weight: bold;">U.S. / 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>
      <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> 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> Full prescribing information for Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (naloxegol) is available at: www.Movantik.com.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Full prescribing information for Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> Full prescribing information for Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (rifamycin) is available at: www.Aemcolo.com.</div>
      <div 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>
