<SEC-DOCUMENT>0001178913-23-000646.txt : 20230215
<SEC-HEADER>0001178913-23-000646.hdr.sgml : 20230215
<ACCEPTANCE-DATETIME>20230215070208
ACCESSION NUMBER:		0001178913-23-000646
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20230215
FILED AS OF DATE:		20230215
DATE AS OF CHANGE:		20230215

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:		23633582

	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>zk2329255.htm
<DESCRIPTION>6-K
<TEXT>
<html>
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<body bgcolor="#ffffff" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; text-align: left; color: #000000;">
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      <div style="line-height: 1.25;">
        <div style="text-align: center; line-height: 1.25; font-weight: bold;"><font style="font-size: 14pt; font-family: 'Times New Roman',Times,serif; background-color: rgb(255, 255, 255); font-weight: bold; color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">UNITED STATES<br>
            SECURITIES AND EXCHANGE COMMISSION</font><br>
          Washington, D.C. 20549</div>
        <div style="line-height: 1.25">&#160;</div>
      </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="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer<br>
        Pursuant to Rule 13a-16 or 15d-16<br>
        of the Securities Exchange Act of 1934</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">For the month of February 2023<br>
        Commission File No.:&#160; 001-35773</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-size: 16pt; font-family: 'Times New Roman',Times,serif; 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.</font><br>
        (Translation of registrant&#8217;s name into English)</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">21 Ha&#8217;arba&#8217;a Street, Tel Aviv, 6473921, Israel</font><br>
        (Address of principal executive offices)</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form&#160;40&#8209;F.&#160; </div>
      <div style="line-height: 1.25;"> <br>
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Form&#160;20&#8209;F &#9746; Form 40-F &#9744;</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation&#160;S&#8209;T Rule 101(b)(7): ____</div>
      <div style="line-height: 1.25">&#160;</div>
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      <div style="line-height: 1.25;">
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K</div>
        <div style="line-height: 1.25">&#160;</div>
      </div>
      <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm"><u>Exhibit 99.1</u>:&#160; Registrant&#8217;s press release entitled &#8220;<font style="font-style: italic;">RedHill
            Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome</font>&#8221;.</a></div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">
        <div style="text-align: justify; line-height: 1.25;">This Form 6-K and Exhibit 99.1 are hereby incorporated by reference into the Company&#8217;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) and on June 27, 2022 (File No. 333-265845), 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>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Date: February 15, 2023</div>
      <div style="line-height: 1.25">&#160;</div>
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          <tr>
            <td colspan="1" style="width: 50%; vertical-align: top;">&#160;</td>
            <td style="width: 50%; vertical-align: top;">
              <div style="text-align: justify; line-height: 1.25;">REDHILL BIOPHARMA LTD.<br>
                (the &#8220;Registrant&#8221;),</div>
              <div style="line-height: 1.25;"><font style="line-height: 1.25;">&#160;</font></div>
            </td>
          </tr>
          <tr>
            <td colspan="1" style="width: 50%; vertical-align: top;">&#160;</td>
            <td style="width: 50%; vertical-align: top;">
              <div style="line-height: 1.25;">By: <u>/s/ Dror Ben-Asher</u></div>
              <div style="line-height: 1.25;">Dror Ben-Asher</div>
              <div style="line-height: 1.25;">Chief Executive Officer</div>
            </td>
          </tr>

      </table>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <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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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <title></title>
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    <div style="text-align: right;"> <u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div>
      <div class="BRPFPageHeader">
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
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      <div style="line-height: 1.25;"><img width="149" height="70" src="image0.jpg"></div>
      <div style="line-height: 1.25;">
        <table cellspacing="0" cellpadding="3" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;" id="z13516e0b04a64d148eee1f5826636832">

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              <td style="width: 100%; border-width: 1px; border-style: solid; border-color: rgb(0, 0, 0); background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 24pt; font-style: normal; font-variant: normal; text-transform: none;">
                <div style="line-height: 1.25;">
                  <div style="text-align: center; line-height: 1.25;">Press Release</div>
                </div>
              </td>
            </tr>

        </table>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; text-indent: 2.25pt; 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 Announces Positive FDA Meeting </u></div>
      <div style="text-align: center; text-indent: 2.25pt; 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>Regarding Opaganib for Acute Nuclear Radiation Syndrome</u></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">FDA provided guidance on opaganib&#8217;s regulatory pathway under the Animal Rule for Acute </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">Radiation
          Syndrome (ARS)</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">The FDA&#8217;s Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA </div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">approval of new drugs when human clinical trials are not ethical or feasible</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">Opaganib is an oral, novel, highly stable, small molecule pill with a five-year shelf
          life that is </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">potentially suitable, if approved, for central stockpiling by governments against mass
          casualty </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">nuclear radiation incidents</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">RedHill plans to
          work closely with the FDA on development of opaganib as a nuclear medical </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">countermeasure
          and is set to continue to collaborate with a range of U.S. agencies and other </div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">governments on this and other indications</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-style: italic;">Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher</div>
      <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC,
          February 15, 2023, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical company, today announced the
        positive outcome of a scheduled Type B meeting with the U.S. Food and Drug Administration (FDA) for the development of opaganib for Acute Radiation Syndrome (ARS) in which the FDA provided guidance on opaganib&#8217;s developmental pathway to potential
        approval under the Animal Rule.</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 pleased to align with the FDA on the Animal Rule development pathway for opaganib for ARS. The FDA has provided very helpful
        guidance regarding the applicability in the case of opaganib of pivotal animal model efficacy studies in place of human clinical trials, and we plan to work closely with them to advance the development program in support of opaganib as a nuclear
        medical countermeasure,&#8221; <font style="font-weight: bold;">said Dr Mark Levitt, MD, PhD, Chief Scientific Officer at RedHill</font>. &#8220;Given the promising data already generated with
        opaganib for ARS, we are set to continue collaborating with a range of U.S. agencies in addition to discussions with other governments.&#8221;</div>
      <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
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      <!--PROfilePageNumberReset%Num%2%%%-->
      <div style="text-align: justify; line-height: 1.25;">A recent publication in the <u>International Journal of
            Molecular Sciences</u><u>,</u><u> entitled &#8220;Opaganib Protects against
            Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy&#8221;</u><u>, </u>describes the collective results of eight U.S.
        government-funded preclinical <font style="font-style: italic;">in vivo</font> studies by RedHill and Apogee Biotechnology Corporation (&#8220;Apogee&#8221;), as well as additional experiments,
        indicating opaganib&#8217;s<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> potential nuclear radiation protection capabilities<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>. In the relevant study models, opaganib was associated with protection of normal tissue, including gastrointestinal tissue, from radiation damage due
        to ionizing radiation exposure or cancer radiotherapy. Additional independent studies demonstrate the potential role of inhibition of sphingosine kinase-2 in radioprotection in bone marrow, with knockout of sphingosine kinase-2 correlated with
        enhanced survival following both lethal and half-lethal whole-body radiation<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>. Sphingosine kinase-2 is the target of opaganib. Opaganib&#8217;s protection is not expected to be limited to specific radioactive materials or individual parts of
        the body.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib, an oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting, if approved,
        potential central government stockpiling for use in mass casualty nuclear radiation incidents. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher.</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 Acute Radiation Syndrome (ARS)</div>
      <div style="text-align: justify; line-height: 1.25;">ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, one event, such as a nuclear power plant
        disaster, can affect very large numbers of people. ARS is an acute illness caused by irradiation of the body by a high dose of penetrating radiation in a short period of time (usually a matter of minutes). Much of the damage caused by ARS is caused
        by inflammation secondary to the effects of ionizing radiation itself.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">There are four stages of ARS:</div>
      <div>
        <table cellspacing="0" cellpadding="0" id="z2de4f360c7404f66a00e0704bc7fd607" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

            <tr>
              <td style="width: 36pt; vertical-align: top; text-align: right;">
                <div style="text-align: left; margin-left: 18pt; line-height: 1.25;">1.</div>
              </td>
              <td style="width: auto; vertical-align: top;">
                <div style="line-height: 1.25;">Prodromal stage &#8211; characterized by nausea, vomiting, anorexia and diarrhea (depending on dose), occurring within minutes to
                  days post-exposure</div>
              </td>
            </tr>

        </table>
      </div>
      <div>
        <table cellspacing="0" cellpadding="0" id="z0c00910a69494ecbab237a72e912c53b" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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              <td style="width: 36pt; vertical-align: top; text-align: right;">
                <div style="text-align: left; margin-left: 18pt; line-height: 1.25;">2.</div>
              </td>
              <td style="width: auto; vertical-align: top;">
                <div style="line-height: 1.25;">Latent stage &#8211; where the patient may look and feel generally healthy for a period lasting from a few hours up to a few weeks</div>
              </td>
            </tr>

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      </div>
      <div>
        <table cellspacing="0" cellpadding="0" id="zc043abc6aaf444ffbe91993ce40ba7a4" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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              <td style="width: 36pt; vertical-align: top; text-align: right;">
                <div style="text-align: left; margin-left: 18pt; line-height: 1.25;">3.</div>
              </td>
              <td style="width: auto; vertical-align: top;">
                <div style="line-height: 1.25;">Manifest illness stage &#8211; symptoms for which can vary according to the focus of the radiation damage (<font style="font-style: italic;">i.e.</font> bone marrow, gastrointestinal, cardiovascular, <font style="font-style: italic;">etc.</font>)
                  and can last from hours up to several months</div>
              </td>
            </tr>

        </table>
      </div>
      <div>
        <table cellspacing="0" cellpadding="0" id="z8236de3c2d094740a8b3617ea244e05e" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

            <tr>
              <td style="width: 36pt; vertical-align: top; text-align: right;">
                <div style="text-align: left; margin-left: 18pt; line-height: 1.25;">4.</div>
              </td>
              <td style="width: auto; vertical-align: top;">
                <div style="text-align: justify; line-height: 1.25;">Recovery or death - most patients who do not recover are expected to die within several months, or less, of exposure</div>
              </td>
            </tr>

        </table>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Current treatment of ARS is generally limited to supportive care, including blood transfusions, antibiotics, colony-stimulating
        factors, or stem cell transplantation &#8211; with very few options available to treat or prevent the damage caused by radiation exposure. Opaganib, which may offer a new therapeutic approach, is a sphingosine kinase-2 (SK2) inhibitor thought to exert
        its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from
        unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting the
        possibility of increased survival.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" class="BRPFPageBreakArea">
        <div style="text-align: center;" class="BRPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" class="BRPFPageNumber">2</font></div>
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      </div>
      <div style="line-height: 1.25; font-weight: bold;">About the FDA Animal Rule</div>
      <div style="line-height: 1.25;">The use of the Animal Rule is intended for drugs developed to reduce or prevent serious or life-threatening conditions caused by exposure
        to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">The Animal Rule allows for the use of pivotal animal model efficacy studies when human clinical trials are not ethical or feasible.&#160; In
        such cases efficacy is established using well-controlled studies in animal models of the human disease, with safety being evaluated under the preexisting requirements for drugs.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Products approved under the Animal Rule are critical for the protection of public health and national security, and to date 13 drugs have
        previously been approved under the Animal Rule.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="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 an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2
        (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.</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 thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of
        viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS).</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide
        elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that
        inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.</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;is also being developed as a host-directed antiviral against SARS-CoV-2 and other viruses, has received Orphan Drug
        designation from the U.S. FDA for the treatment of cholangiocarcinoma and has undergone a Phase 2a study in advanced cholangiocarcinoma and a prostate cancer study is ongoing. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for
        IND submission.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other
        viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with
        moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global
        Phase 2/3 study has been submitted for peer review and recently published in&#160;<u>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 has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology,
        radioprotection, 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; font-weight: bold;">About RedHill Biopharma</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;">Talicia</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">&#160;</font>for the treatment of <font style="font-style: italic;">Helicobacter pylori (H. pylori)</font> infection in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>, and <font style="font-weight: bold;">Aemcolo</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> for the treatment of travelers&#8217; diarrhea in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib (ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class oral broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase
        2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; (iii) <font style="font-weight: bold;">RHB-107 </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 for
        treatment of non-hospitalized symptomatic COVID-19, and is 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; and (v) <font style="font-weight: bold;">RHB-102</font>, with expected 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. More information about the Company is available at <u>www.redhillbio.com</u>/ <u>twitter.com/RedHillBio</u>.</div>
      <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" class="BRPFPageBreakArea">
        <div style="text-align: center;" class="BRPFPageNumberArea"><font style="font-weight: normal; font-style: normal;" class="BRPFPageNumber">3</font></div>
        <div style="page-break-after: always;" class="BRPFPageBreak">
          <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
      </div>
      <div style="text-align: justify; line-height: 1.25; font-style: italic;">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 the risk that opaganib will not be shown to elevate ceramide and reduce sphingosine 1-phosphate (S1P) in cells, increasing the antitumor efficacy of
        radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation in an oncology &amp;
        radiological setting, the risk that the FDA does not agree with the Company&#8217;s proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical
        trials, the risk that opaganib will not be shown to be broad acting, host-directed candidate therapies for pandemic preparedness, the risk that the Company will not be successful in collaborating with U.S. agencies and other governments, the risk
        that a pivotal Phase 3 trial for opaganib will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications,
        and that additional COVID-19 studies for opaganib are required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib 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<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 17, 2022, and the
        Company&#8217;s Report on Form 6-K filed with the SEC on November 10, 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>
      <table cellspacing="0" cellpadding="0" id="ze8f6fc4560944aabb25854081c3419b0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

          <tr>
            <td style="width: 53.29%; 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: 46.71%; 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> 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> Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity:
        Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. https://doi.org/10.3390/ijms232113191.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Li C. et al., Loss of Sphingosine Kinase 2 Promotes the Expansion of Hematopoietic Stem Cells by Improving Their Metabolic
        Fitness. Blood. October 2022;140(15):1686-1701.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> Talicia<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of <font style="font-style: italic;">H. pylori </font>infection in adults. For full prescribing information see: <u>www.Talicia.com</u>.</div>
      <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (rifamycin) is indicated for the treatment of travelers&#8217; diarrhea caused by noninvasive strains of <font style="font-style: italic;">Escherichia coli</font> in adults. For full prescribing information see: <u>www.aemcolo.com</u><u>.</u></div>
      <div style="line-height: 1.25;"><u> <br>
          </u></div>
      <div style="text-align: center;"><font style="font-family: 'Times New Roman',Times,serif; font-weight: normal; font-style: normal;" class="BRPFPageNumber">4</font><u> </u></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;"><u> </u></div>
    </div>
    <div> <br>
    </div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
