<SEC-DOCUMENT>0001178913-21-002105.txt : 20210621
<SEC-HEADER>0001178913-21-002105.hdr.sgml : 20210621
<ACCEPTANCE-DATETIME>20210621070336
ACCESSION NUMBER:		0001178913-21-002105
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210621
FILED AS OF DATE:		20210621
DATE AS OF CHANGE:		20210621

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:		211027349

	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
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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 June 2021<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>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.&#160;&#160;</div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;"> <br>
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    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F &#9746;&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;"> &#160; &#160; &#160;</font> Form 40-F&#160;<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>
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    <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
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    <div style="line-height: 1.25;"><a href="exhibit_99-1.htm">Exhibit 1<font style="font-family: Symbol, serif;">:</font>&#160;Registrant's press release entitled:
        &#8220;RedHill Biopharma Announces Presentation of Positive Oral Opaganib Phase 2 Data in COVID-19&#8221;</a></div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Exhibit 99.1 (solely with respect to the first two paragraphs) 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 February 25, 2016 (Registration No. 333-209702), on
      July 23, 2018 (File No. 333-226278), on July 24, 2019 (File No. 333-232777) and on March 30, 2021 (File No. 333-254848).</div>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
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    <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;">REDHILL BIOPHARMA LTD.</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: June 21, 2021</div>
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            <div style="line-height: 1.25;">By:</div>
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            <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
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            <div style="line-height: 1.25;">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;">Chief Executive Officer</div>
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            <div style="line-height: 1.25;">&#160;</div>
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      <div style="text-align: center;">&#160;2</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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    <div style="line-height: 1.25; text-align: right;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u><br style="line-height: 1.25;">
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    <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 Phase 2 Data in COVID-19</u></div>
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    </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">Positive U.S. Phase 2 safety and efficacy data for opaganib, a leading novel, oral, dual-mechanism </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">drug candidate for moderate-to-severe COVID-19, presented at the World Microbe Forum</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;">Opaganib was associated with a reduction in the need for supplemental oxygen support, earlier time</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;"> to discharge from hospital and was well tolerated</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;">Opaganib&#8217;s global 475-patient Phase 2/3 study is fully enrolled, with study completion expected in <br>
      the coming weeks</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; line-height: 1.25; font-style: italic;">Opaganib is host-targeted and expected to be effective against emerging viral variants</div>
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    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, June 21, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical
      company, today announced presentation of the positive Phase 2 safety and efficacy data for oral opaganib (Yeliva&#174;, ABC294640)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum (WMF) 2021 (poster #: 5574).</div>
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    </div>
    <div style="text-align: justify; line-height: 1.25;">Results and post hoc analyses of data from the 40-patient U.S. Phase 2 study were presented in a poster entitled, &#8220;<font style="font-style: italic;">Opaganib, an Oral Sphingosine Kinase-2 (SK2)
        Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (</font><font style="font-style: italic;"><u>NCT: 04414618</u></font><font style="font-style: italic;">)</font>&#8221;<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>. Patients in the study were randomized to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir. Findings include:</div>
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            <div>50% of patients treated with opaganib (n=22) reached room air by Day 14 compared to 22% in the placebo group (n=18). The benefit of reaching room air by Day 14 for patients on opaganib was maintained regardless of whether the patients were
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            <div>86.4% of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6% of patients treated with placebo</div>
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            <div>Median time to discharge was 6 days for the opaganib group compared to 7.5 days for the placebo group</div>
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            <div>81.8% of opaganib patients achieved a 2-point improvement in the WHO Ordinal Scale compared to 55.6% of patients in the placebo group &#8211; achieved in a median time of 6 days versus 7.5 days, respectively</div>
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            <div>No significant differences in safety-related measures between the two groups (with diarrhea being the main treatment-emergent difference in tolerability)</div>
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    <div style="text-align: justify; line-height: 1.25;">&#8220;The need for an effective oral therapy to treat COVID-19 is clear. Such a therapy would greatly improve our ability to manage this pandemic,&#8221; <font style="font-weight: bold;">said Kevin Winthrop,
        MD, MPH, Professor of Infectious Diseases at Oregon Health &amp; Science University, who presented the findings at WMF.</font> &#8220;These data, from this proof-of-concept clinical study of opaganib in patients with severe COVID-19, suggest a potential
      role of SK2 inhibition in combating the effects of this virus. With much more data on opaganib expected in the coming weeks, we could make some real progress toward having access to a much-needed oral therapy for patients who currently have a paucity
      of options available to them.&#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;Presentation of these positive data from our exploratory Phase 2 study support our growing confidence that opaganib could be the first novel, oral therapy to demonstrate efficacy in the treatment of
      COVID-19 in a large late-stage study. With the recent completion of enrollment of our 475-patient global Phase 2/3 study, we will have a clearer picture of that in the very near future,&#8221; <font style="font-weight: bold;">said Mark L. Levitt, MD,
        Ph.D., Medical Director at RedHill</font>. &#8220;Opaganib acts on both the cause and effect of COVID-19 via a unique dual antiviral and anti-inflammatory mode of action. Being host-targeted, opaganib is also expected to maintain effect against the
      emerging SARS-CoV-2 variants, which continue to threaten the progress being made against the pandemic and underscore the urgent need for effective COVID-19 therapeutics.&#8221;</div>
    <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The global 475-patient Phase 2/3 study of opaganib in severe COVID-19 has been approved in 10 countries and completed enrollment, through 57 participating sites, on June 6<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup>. The primary
      endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14. Additional important outcome measures, such as time to discharge from hospital, improvement according to the World Health Organization Ordinal
      Scale for Clinical Improvement and incidence of intubation and mortality, will also be captured in the follow-up period of up to 6 weeks. The study received four independent DSMB recommendations to continue following unblinded safety reviews and a
      futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient
      populations<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
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    </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 Opaganib (Yeliva<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, 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, that is
      host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and 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 is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in
      preliminary top-line data from the 40-patient U.S. Phase 2 study.</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.</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;completely inhibiting viral replication 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, and has shown decreased
      fatality rates from influenza virus infection and ameliorated <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 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;"><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;">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 (Yeliva</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">, ABC294640)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing 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 (upamostat)</font>, a 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>&#160;<font style="font-weight: bold;">(Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">)</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 id="DSPFPageBreakArea" style="clear: both; margin-top: 10pt; margin-bottom: 10pt;">
      <div id="DSPFPageNumberArea" style="text-align: center;"><font id="DSPFPageNumber" style="font-weight: normal; font-style: normal;">3</font></div>
      <div id="DSPFPageBreak" style="page-break-after: always;">
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    </div>
    <div style="text-align: justify; line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words
      &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words. Forward-looking statements are based on certain assumptions and are subject to various known
      and unknown risks and uncertainties, many of which are beyond the Company&#8217;s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such
      risks and uncertainties include the delay in last patient visit and top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not 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 likely to be 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 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or
      oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <table cellspacing="0" cellpadding="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;" id="z9b6cea8828cf47a4b3dccd8538208249">

        <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;"><u> <br>
              </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>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <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> Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia
      (NCT: 04414618). K. L. Winthrop, A. W. Skolnick, A. M. Rafiq, S. H. Beegle, J. Suszanski, G. Koehne, O.Barnett-Griness, A. Bibliowicz, R. Fathi, P. Anderson, G. Raday, G. Eagle, V. Katz Ben-Yair, H. S. Minkowitz, M. L. Levitt, M. S. Gordon</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase
      2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison
      as if the Company conducted a head-to-head comparison study.</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:<font style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-style: normal; font-variant: normal; text-transform: none;"> www.Movantik.com.</font></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: <font style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-style: normal; font-variant: normal; text-transform: none;">www.Talicia.com.</font></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:<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;"><font style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-style: normal; font-variant: normal; text-transform: none;"> </font></sup><font style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-style: normal; font-variant: normal; text-transform: none;">www.Aemcolo.com.</font></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;">4<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>
