<SEC-DOCUMENT>0001178913-21-003090.txt : 20211004
<SEC-HEADER>0001178913-21-003090.hdr.sgml : 20211004
<ACCEPTANCE-DATETIME>20211004080422
ACCESSION NUMBER:		0001178913-21-003090
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20211004
FILED AS OF DATE:		20211004
DATE AS OF CHANGE:		20211004

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:		211301064

	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>zk2126613.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160;20549</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">FORM 6-K</div>
    <div style="text-align: center; line-height: 1.25;">&#160;&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25;">For the month of October 2021<br>
      Commission File No.:001-35773</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">REDHILL BIOPHARMA LTD.</div>
    <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
    <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form
      40-F.&#160;&#160;</div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">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">&#160;</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 Reports Further Analysis of Phase 2/3 Data Including a 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients&#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>
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    <div style="text-align: justify; line-height: 1.25;"> <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>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">(the "Registrant")</div>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 3.48%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.46%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
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          <td style="width: 16.43%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">Date: October 4, 2021</div>
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          <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>
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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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          <td style="width: 33.94%; vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
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          <td style="width: 16.43%; vertical-align: bottom;">
            <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;" colspan="2">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
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          <td style="width: 16.43%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
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    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;2</div>
    <div style="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>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
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    <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>
    <div style="line-height: 1.25; text-align: right;"><u><font style="font-weight: bold;">Exhibit 1</font></u><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;"><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>
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            <td style="width: 50%; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none; border-color: rgb(0, 0, 0); border-style: solid; border-width: 2px;" rowspan="1">
              <div style="text-align: center;">Press Release</div>
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          </tr>

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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>RedHill Biopharma Reports Further Analysis of Phase 2/3 </u></div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>Data Including a 62% Reduction in Mortality with Oral </u></div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>Opaganib in Moderately Severe COVID-19 Patients</u></div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;"> opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;"> group by Day 42 (nominal p-value=0.0195)</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">The moderately severe group comprised 53% of study participants requiring a Fraction of inspired </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask)</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Data indicates a potential meaningful benefit with opaganib for these hospitalized, moderately </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">the data also supports opaganib&#8217;s potential use in earlier stages of COVID-19 disease, consistent </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">with opaganib&#8217;s U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-style: italic;">RedHill will hold a webcast on Thursday, October 7, 2021, at 08:30 am EDT to further </div>
    </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">discuss these additional analyses</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, October 4, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical
      company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> vs. the placebo-controlled arm resulted in a 62%
      statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of
      the 475 study participants.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
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    <div style="text-align: justify; line-height: 1.25;">These important new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 &#8804; 60% are
      still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.</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 new findings support the potential for opaganib&#8217;s use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and
      mortality, and who may benefit from opaganib&#8217;s combined antiviral and anti-inflammatory activities,&#8221; <font style="font-weight: bold;">said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill</font>. &#8220;The results provide a strong rationale for
      opaganib&#8217;s potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib&#8217;s earlier U.S Phase 2 study
      results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.&#8221;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of
      hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib&#8217;s potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality,&#8221; <font style="font-weight: bold;">said Dror Ben-Asher, RedHill&#8217;s CEO</font>. &#8220;Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and
      these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib.&#8221;</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;">Analyses of the FiO2 up to 60% patient subset from the opaganib Phase 2/3 study (n=251), the approximate median for FiO2 levels in the study, who were treated with
        either opaganib or placebo in addition to standard-of-care (including dexamethasone and/or remdesivir) demonstrate consistent benefit across endpoints, in this subset of hospitalized moderately severe patients</font>. Given the post-hoc
      characteristics of this subset, statistical inferences of significance cannot be formally attributed (nominal values presented). The Company also conducted a Sensitivity Analysis to account for missing data interpretability<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>:</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
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          <td style="width: 33.75pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div><font style="font-weight: bold;">Mortality</font>: Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk
              2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8).</div>
          </td>
        </tr>

    </table>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; margin-left: 36pt; line-height: 1.25;">A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the
      benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib.</div>
    <div style="text-align: justify; margin-left: 36pt; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">2<br>
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          <td style="width: 33.75pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div><font style="font-weight: bold;">Reaching Room Air by Day 14 (primary endpoint of the study): </font>77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo &#8211; an efficacy benefit of 21% with opaganib (nominal
              p-value= 0.033).</div>
          </td>
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    </table>
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          <td style="width: 33.75pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div><font style="font-weight: bold;">Median time to discharge: </font>Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib
              patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195</div>
          </td>
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          <td style="width: 33.75pt; vertical-align: top; align: right;">&#8226;</td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div><font style="font-weight: bold;">Safety</font>: Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient
              population and earlier stage populations. <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup></div>
          </td>
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    </table>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with
      supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The new data of the sub-group analysis follows the Company&#8217;s previously announced top-line results of the Phase 2/3 study. Analysis of the top-line data is still ongoing, including further analysis
      of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the study outcomes with regulators, including U.S. FDA and U.S. government agencies, as well as other regulators
      and governments and international agencies, to help determine next steps.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory
      effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication and is expected to be effective against emerging viral
      variants, having already preclinically demonstrated strong inhibition against variants of concern, including <font style="font-style: italic;">Delta</font>.</div>
    <div style="line-height: 1.25; text-align: center;">
      <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;">
        <div style="line-height: 1.25; font-weight: bold;">Webcast and Conference Call Information:</div>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The Company will host a webcast on Thursday, October 7, 2021, at 8:30 a.m. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; text-align: left;">
        <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">The webcast including slides will be broadcast live on the Company's website, <u>https://www.redhillbio.com/investors/events-and-presentations/default.aspx</u>, and will be available for replay for 30 days.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman', Times, serif;">To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United
          States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.</div>
      </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>
      3<br style="line-height: 1.25;">
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    <br>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About Opaganib (ABC294640)</div>
    <div style="text-align: justify; line-height: 1.25;">Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is
      host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including <font style="font-style: italic;">Delta</font>. Opaganib has also shown anticancer
      activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, submitted for peer review and recently <u>published in medRxiv</u>.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Opaganib&#160;has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2
      study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19,&#160;inhibiting viral replication of all SARS-CoV-2 variants tested to date in an <font style="font-style: italic;">in vitro</font> model of human lung bronchial tissue. Additionally, preclinical <font style="font-style: italic;">in vivo</font> studies have demonstrated opaganib&#8217;s potential to ameliorate inflammatory lung disorders,
      such as pneumonia, have demonstrated opaganib&#8217;s potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of <font style="font-style: italic;">Pseudomonas aeruginosa</font>-induced
      lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The ongoing clinical studies with opaganib&#160;are registered on&#160;<u>www.ClinicalTrials.gov</u>, a web-based service by the U.S. National Institute of Health, which provides public access to information
      on publicly and privately supported clinical studies.&#160; &#160;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature. The Company intends to further examine the data from this study in greater detail, along with all the
      information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings which are new or inconsistent with the top-line data disclosed in this release. As such, investors should not rely on
      the analyses reported in this release as the final definitive results of the study.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="line-height: 1.25;">
      <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;">5</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;">6</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;">7</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib </font><font style="font-weight: bold;">(ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) <font style="font-weight: bold;">RHB-107 </font>(<font style="font-weight: bold;">upamostat</font>), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and
        inflammatory gastrointestinal diseases; (iv) <font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease; (v) <font style="font-weight: bold;">RHB-102</font> , with positive results from a
        Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) <font style="font-weight: bold;">RHB</font>-<font style="font-weight: bold;">106</font>, an encapsulated bowel preparation. More
        information about the Company is available at <u>www.redhillbio.com</u> / <u>https://twitter.com/RedHillBio</u>.</div>
    </div>
    <div style="line-height: 1.25; text-align: center;"> <br>
    </div>
    <div style="line-height: 1.25; text-align: center;"> <br>
    </div>
    <div style="line-height: 1.25; text-align: center;">4<br style="line-height: 1.25;">
    </div>
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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;"><font style="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</font>&#160;<font style="font-style: italic;">the risk that further analysis of the top-line results of the Phase 2/3 COVID-19 study for opaganib results in findings inconsistent with the data disclosed
        in this release; that no further COVID-19 studies for opaganib will be commenced, and if commenced, may not be successful, including with respect to moderately severe COVID-19&#160; and patients in earlier stages of COVID-19 on low flow oxygen support;
        that any additional studies for opaganib in COVID-19 patients, even if successful, will not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107
        will be required by regulatory authorities to support such potential applications and the use or marketing of opaganib or RHB-107 for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, 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</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (v) the
        Company&#8217;s ability to successfully commercialize and promote Movantik</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">, Talicia</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;"> and
        Aemcolo</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (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.</font></div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" id="zd184819262fe47398af0a39b19c14754" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <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>
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    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> Opaganib is an investigational new drug, not available for commercial distribution.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> While the overall risk factors are balanced, we are evaluating each individually for potential effects on endpoints.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> A detailed safety analysis is still ongoing.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas
      aeruginosa&#160;stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> Full prescribing information for Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (naloxegol) is available at: www.Movantik.com.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup> Full prescribing information for Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</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="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">5<br>
    </div>
    <div style="text-align: justify; 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>
