<SEC-DOCUMENT>0001178913-23-003058.txt : 20230905
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<ACCEPTANCE-DATETIME>20230905070338
ACCESSION NUMBER:		0001178913-23-003058
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230905
FILED AS OF DATE:		20230905
DATE AS OF CHANGE:		20230905

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:		231234110

	BUSINESS ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
		BUSINESS PHONE:		972-3-541-3131

	MAIL ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
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        <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">&#160;<font style="background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none;">UNITED STATES&#160;</font></font><font style="background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none;">&#160;&#160;</font></div>
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        <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160;20549</div>
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        <div style="text-align: center; line-height: 1.25;">&#160;&#160;</div>
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
        <div style="text-align: center; line-height: 1.25;">For the month of September 2023<br>
          Commission File No.:001-35773</div>
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        <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>
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        <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>
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        <div style="text-align: center; line-height: 1.25;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;&#160; &#160;&#160; &#160; Form 40-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
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      <div style="line-height: 1.25;">
        <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>
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        <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
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      <div style="line-height: 1.25;">
        <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>
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        <div style="line-height: 1.25;">&#160;</div>
        <div style="line-height: 1.25;">Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: &#8220;RedHill Announces New USPTO Notice of Patent Allowance for Opaganib and EU Patent Grant for RHB-102
          (BEKINDA&#174;)&#8221;.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
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      <div style="line-height: 1.25;">
        <div style="text-align: justify; line-height: 1.25;">This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No.
          333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No. 333-232776), on March 25, 2021 (File No. 333-254692), on May
          3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845) and on June 29, 2023 (File No. 333-273001) and its Registration Statements on Form F-3 filed with the Securities and Exchange
          Commission on March 30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).</div>
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        <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
        <div style="line-height: 1.25">&#160;</div>
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      <div style="line-height: 1.25;">
        <div style="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>
            </td>
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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;">Date: September 5, 2023</div>
            </td>
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              <div style="line-height: 1.25;">By:</div>
            </td>
            <td nowrap="nowrap" style="width: 26%; vertical-align: top; border-bottom: 2px solid black;">
              <div style="line-height: 1.25;">/s/ Dror Ben-Asher</div>
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              <div style="line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">Name:</div>
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              <div style="line-height: 1.25;">&#160;Dror Ben-Asher</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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              <div style="line-height: 1.25;">Title:</div>
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              <div style="line-height: 1.25;">Chief Executive Officer</div>
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                  <div style="line-height: 1.25;">
                    <div style="text-align: center; line-height: 1.25;">Press Release</div>
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        <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-weight: bold;"><u><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;">RedHill Announces New USPTO Notice of Patent Allowance </font></u></div>
        <div style="text-align: center; text-indent: 2.25pt; line-height: 1.25; font-weight: bold;"><u><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;">for Opaganib and EU Patent Grant for RHB-102 (BEKINDA<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>)</font></u></div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">USPTO issues Notice of Allowance for a new opaganib patent covering sphingosine kinase 2 </div>
        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">inhibition treatment for Ebola virus disease, supporting opaganib protection until October 2035</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;">Additionally, European Patent Office grants new RHB-102 patent covering ondansetron extended-</div>
        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms, providing </div>
        <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">protection of RHB-102 across multiple indications until March 2035</div>
        <div style="text-align: center; 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 / RALEIGH, NC, September 5, 2023,</font> RedHill Biopharma Ltd. (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical
          company, today announced that the U.S. Patent and Trademark Office (USPTO) had issued a Notice of Allowance for a new opaganib<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> patent covering sphingosine kinase 2 inhibition treatment for Ebola virus disease, supporting opaganib
          protection until October 2035. The Company also announced that the European Patent Office has granted RHB-102 (BEKINDA)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> a new patent, covering ondansetron extended-release solid dosage forms for treating either nausea, vomiting or
          diarrhea symptoms. This new patent is expected to provide protection of RHB-102 across multiple indications until March 2035.</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 RHB-102 (BEKINDA):</div>
        <div style="text-align: justify; line-height: 1.25;">RHB-102&#160;is a proprietary, bimodal release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. RHB-102 24 mg is intended to
          provide patients with relief from nausea, vomiting and diarrhea symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the MHRA, RHB-102 24 mg could become the first oral 24hr extended-release 5-HT3 antiemetic
          drug in the UK indicated for the treatment of CINV/RINV.</div>
        <div style="text-align: justify; line-height: 1.25;"><br>
          Positive results from two successful late-stage RHB-102 studies at different doses, the U.S. Phase III GUARD gastroenteritis study (RHB-102 24 mg) and the U.S. Phase II IBS-D study (RHB-102 12 mg) were published in <u>JAMA Network Open</u><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3
          </sup>and <u>The American Journal of Gastroenterology</u><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;"><u>4</u></sup>, respectively.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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        <div class="BRPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
          <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="font-weight: normal; font-style: normal;">3</font></div>
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        <div style="line-height: 1.25; font-weight: bold;">About Opaganib (ABC294640)</div>
        <div style="line-height: 1.25; text-align: justify;">Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer,
          anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).</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 (SPHK2, 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;">Opaganib was recently selected by the U.S. Government&#8217;s Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the
          National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will
          undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. 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 has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer.
          Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-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 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>
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          <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="font-weight: normal; font-style: normal;">4</font></div>
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        <div style="text-align: justify; margin-right: 0.1pt; margin-left: 0.1pt; 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; 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>, 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;">5</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;">6</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i)&#160;<font style="font-weight: bold;">opaganib
            (ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple
          indications with a U.S. Government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii)&#160;<font style="font-weight: bold;">RHB-107&#160;</font>(<font style="font-weight: bold;">upamostat</font>), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, and is
          also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii)&#160;<font style="font-weight: bold;">RHB-102</font>, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results
          from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv)&#160;<font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease; and (v)&#160;<font style="font-weight: bold;">RHB-204</font>,&#160;a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="text-align: justify; line-height: 1.25;">More information about the Company is available at: <u>www.redhillbio.com</u> / <u>twitter.com/RedHillBio</u>.<br>
          <br style="line-height: 1.25;">
        </div>
        <div style="line-height: 1.25; font-weight: bold;">Forward Looking Statements</div>
        <div style="line-height: 1.25">&#160;</div>
        <div style="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including, but not
          limited to, statements regarding the intended use of net proceeds therefrom, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential"
          or similar words and include statements regarding anticipated the addition of new revenue generating products, out-licensing of the Company&#8217;s development pipeline assets, timing of opaganib&#8217;s development for Acute Radiation Syndrome, non-dilutive
          development funding from RHB-107 and its inclusion in a key platform study. 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, market and other
          conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such
          development will not be completed or successful; 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 the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or,
          should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107&#8217;s late-stage development for non-hospitalized COVID-19 will not benefit from the resources
          redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use
          or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as
          well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing
          of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or
          clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory
          approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and
          Talicia&#174;; (v) the Company's ability to successfully commercialize and promote Talicia&#174; and Aemcolo&#174;; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for
          marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained
          with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is
          able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses
          its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse
          experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers.
          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 April 28, 2023. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral
          forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.</div>
        <div style="line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div class="BRPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
          <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="font-weight: normal; font-style: normal;">5</font></div>
          <div class="BRPFPageBreak" style="page-break-after: always;">
            <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
        </div>
        <div style="line-height: 1.25">&#160;</div>
        <div style="line-height: 1.25; font-weight: bold;">Company contact:</div>
        <div style="line-height: 1.25">&#160;</div>
        <div style="line-height: 1.25;">Adi Frish<br>
          Chief Corporate &amp; Business Development Officer<br>
          RedHill Biopharma<br>
          +972-54-6543-112<br>
          adi@redhillbio.com</div>
        <div style="line-height: 1.25">&#160;</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> RHB-102 (BEKINDA) 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;">3</sup> Silverman RA,&#160;House SL,&#160;Meltzer AC, et al. Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults:&#160;A Randomized Clinical Trial.&#160;<font style="font-style: italic;">JAMA Netw
            Open.</font>&#160;2019;2(11):e1914988. doi:10.1001/jamanetworkopen.2019.14988</div>
        <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> Plasse, Terry F. MD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>; Barton, Gary MD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>; Davidson, Evelyne MD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>; Abramson, Danielle PhD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>; Kalfus, Ira MD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>; Fathi, Reza PhD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>; Raday, Gilead
          MS<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>; Harris, M. Scott MD<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>.&#160;Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Trial. The American Journal of
          Gastroenterology 115(9):p 1466-1473, September 2020. | DOI: 10.14309/ajg.0000000000000727</div>
        <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</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;">6</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>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
  </div>
  <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="font-weight: normal; font-style: normal;">6</font>
    <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
