<SEC-DOCUMENT>0001178913-20-003222.txt : 20201120
<SEC-HEADER>0001178913-20-003222.hdr.sgml : 20201120
<ACCEPTANCE-DATETIME>20201120080017
ACCESSION NUMBER:		0001178913-20-003222
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20201120
FILED AS OF DATE:		20201120
DATE AS OF CHANGE:		20201120

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:		201330490

	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>zk2025187.htm
<DESCRIPTION>6-K
<TEXT>
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      <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; margin-left: auto; margin-right: auto;"><font style="font-weight: bold;"><br>
        <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;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>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160;20549</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">FORM 6-K</div>
    <div style="text-align: center; line-height: 1.25;">&#160;&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25;">For the month of November 2020<br>
      Commission File No.:001-35773</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">REDHILL BIOPHARMA LTD.</div>
    <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
    <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form
      40-F.&#160;&#160;</div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; 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>
    <div style="line-height: 1.25;">&#160;</div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="line-height: 1.25;"><a href="exhibit_1.htm">Exhibit 1<font style="font-family: Symbol, serif;">:</font>&#160;Registrant's press release entitled: &#8220;RedHill Biopharma Initiates Phase 3 Study of RHB-204 for First-Line Treatment of NTM Disease&#8221;</a></div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">This Form 6-K is 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) and on July 24, 2019 (File No. 333-232776) 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) and on July 24, 2019 (File No. 333-232777).</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="line-height: 1.25; text-align: center;">2<br>
    </div>
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    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
      behalf by the undersigned, thereunto duly authorized.&#160;</div>
    <div style="text-align: justify; margin-left: 220.65pt; line-height: 1.25;">&#160;</div>
    <table cellspacing="0" cellpadding="0" border="0" id="z571c3307fefb4caaaeac2fb63add5813" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="width: 49.66%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.66%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">(the "Registrant")</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.66%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 3%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.66%; vertical-align: middle;">
            <div style="line-height: 1.25;">Date: November 20, 2020</div>
          </td>
          <td style="width: 3%; vertical-align: middle;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle; border-bottom: #000000 2px solid;">
            <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.66%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.66%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
          </td>
          <td style="width: 15%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>

    </table>
    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">
      <div style="text-align: center;">&#160;3</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>
    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="line-height: 1.25;">&#160;</div>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>exhibit_1.htm
<DESCRIPTION>EXHIBIT 1
<TEXT>
<html>
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    <div style="line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
    <div style="line-height: 1.25;">
      <div style="text-align: right;"><u><font style="font-weight: bold;">Exhibit 1</font></u><br>
      </div>
      <div><br>
      </div>
      <img width="150" height="89" src="image0.jpg">
      <div><br>
      </div>
      <div>
        <table align="center" cellspacing="0" cellpadding="0" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 70%;" id="z3644cfa669144e61a16dcb54d957cdd1">

            <tr>
              <td style="width: 70%; border-color: rgb(0, 0, 0); border-style: solid; border-width: 2px;">
                <div style="text-align: center;">&#160;Press Release</div>
              </td>
            </tr>

        </table>
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-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;">RedHill Biopharma Initiates Phase 3 Study of RHB-204 for </div>
    <div style="text-align: center; margin-left: 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;">First-Line Treatment of NTM Disease</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line
      therapy</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">--</div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">The Phase 3 study is expected to recruit up to 125 patients across approximately 40 U.S.
      clinical sites</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;">RHB-204 Orphan Drug designation and QIDP designation extend potential market exclusivity up to </div>
    <div style="text-align: center; margin-left: 2.25pt; line-height: 1.25; font-style: italic;">12 years post-approval and provide eligibility for Fast-Track development and NDA Priority
      Review</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC,
        November 20, 2020, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>)
      (&#8220;RedHill&#8221; or &#8220;the Company&#8221;), a specialty biopharmaceutical company, today announced that it has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary
      nontuberculous mycobacteria (NTM) disease caused by&#160; <font style="font-style: italic;">Mycobacterium avium</font> Complex (MAC) &#8211; a rare disease for which there is no FDA-approved
      first-line therapy.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#8220;NTM is a debilitating disease that can cause scarring, fibrosis and the formation of cavities or pits in the lungs, which can lead to
      potentially fatal respiratory failure. People with existing lung conditions, such as bronchiectasis and those with COPD, are particularly susceptible,&#8221; <font style="font-weight: bold;">said
        Prof. Kevin Winthrop, MD, MPH, Professor of Infectious Diseases, Oregon Health &amp; Science University, and study Principal Investigator</font>. &#8220;NTM is notoriously resistant to most antibiotics and challenging to treat, and there is no
      FDA-approved first-line therapy for the approximately 110,000 cases of NTM infection in the U.S. This study of orally-administered RHB-204, if successful, represents an opportunity to make a breakthrough in managing NTM infections.&#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;Treatment of NTM disease requires multiple antibiotics and an extended treatment course due to the risk of development of resistance<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>,&#8221;
      <font style="font-weight: bold;">said Aida Bibliowicz, RedHill&#8217;s Vice President of Clinical Affairs</font>. &#8220;Many patients fail these types of therapies and more than half will have
      either recurring disease or a new infection after completing treatment<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>, making new treatment options for NTM an urgent need.&#8221;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The multi-center, randomized, double-blind, two-part, placebo-controlled, parallel-group Phase 3 study will be conducted at up to 40
      sites across the U.S. and aims to enroll 125 patients, randomized at a 3:2 ratio to receive either RHB-204 or placebo. The study is designed to evaluate the safety and efficacy of RHB-204 in patients with symptomatic <font style="font-style: italic;">Mycobacterium avium</font> Complex (MAC) lung disease. Study endpoints include sputum culture conversion at month six of treatment with RHB-204, compared to placebo and
      patient-reported outcomes, including improvements in physical functioning, respiratory symptoms and fatigue. Following this assessment (part one of the study), patients may be eligible to continue double-blinded treatment for up to 16 months (part
      two). Sustainability of clinical benefit and durability of microbiological response will be assessed at month 16 and again three months after treatment completion.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">RHB-204 was recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 by an additional seven years, for a
      potential total of 12 years upon FDA approval. RHB-204 had also previously been granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for Fast-Track development, NDA Priority Review and a five-year
      extension of U.S. market exclusivity, if approved.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;">The Phase 3 study of RHB-204&#160;is 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;&#160;</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
      <div style="page-break-after: always;" id="DSPFPageBreak">
        <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;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About Pulmonary Nontuberculous Mycobacteria (NTM) Disease</div>
    <div style="text-align: justify; line-height: 1.25;">Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental
      bacteria found in soil, as well as natural and engineered water systems. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>. Pulmonary NTM disease can lead to recurring cases of bronchitis and
      pneumonia and can, in some cases, lead to respiratory failure<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup>. There were an estimated 110,000 pulmonary NTM
      disease patients in the U.S. in 2017<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>. Pulmonary manifestations account for 80-90% of all NTM-associated diseases<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>, and approximately 80% of pulmonary NTM disease are caused by <font style="font-style: italic;">Mycobacterium avium</font> Complex (MAC)<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup>.</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-204</div>
    <div style="text-align: justify; line-height: 1.25;">RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for
      the treatment of pulmonary NTM disease caused by <font style="font-style: italic;">Mycobacterium avium </font>Complex (MAC). RHB-204 was granted both FDA Orphan Drug designation for the
      treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval. RHB-204 is also
      covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: justify; line-height: 1.25;">&#160;&#160; &#160; &#160; &#160;</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><br>
        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;">9</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;">10</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;">11</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;">)</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) <font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3 study for Crohn's disease; (iv) <font style="font-weight: bold;">RHB-102</font> (<font style="font-weight: bold;">Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>), with positive results from a Phase 3 study
        for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) <font style="font-weight: bold;">RHB-107 </font>(<font style="font-weight: bold;">upamostat</font>), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory
        gastrointestinal diseases;&#160; 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>.</u></div>
    <div style="text-align: justify; line-height: 1.25;"><u> <br>
          </u></div>
    <div style="text-align: center; line-height: 1.25;">2<font style="font-family: 'Times New Roman',Times,serif;"><u><br>
          </u></font></div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation
      Reform Act of 1995. Such statements may be preceded by the words &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words. Forward-looking statements
      are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company&#8217;s control and cannot be predicted or quantified, and consequently, actual results may differ materially from
      those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not succeed to complete the patient recruitment; the risk that the U.S. Phase 3 clinical study
      evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation,
      timing, progress and results of the Company&#8217;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&#8217;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&#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 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>and Movantik<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 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, pre-clinical 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 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 experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition
      from other companies and technologies within the Company&#8217;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 March 4, 2020. 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="z5a9e12350d6e40e28682d039625537a1" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="width: 53.27%; vertical-align: top;">
            <div style="line-height: 1.25; font-weight: bold;">Company contact:</div>
            <div style="line-height: 1.25;">Adi Frish</div>
            <div style="line-height: 1.25;">Chief Corporate &amp; Business Development Officer</div>
            <div style="line-height: 1.25;">RedHill Biopharma</div>
            <div style="line-height: 1.25;">+972-54-6543-112</div>
            <div style="line-height: 1.25;"><u>adi@redhillbio.com</u></div>
          </td>
          <td style="width: 46.73%; vertical-align: top;">
            <div style="line-height: 1.25; font-weight: bold;">Media contact (U.S.):</div>
            <div style="text-align: justify; line-height: 1.25;">Bryan Gibbs</div>
            <div style="text-align: justify; line-height: 1.25;">Vice President</div>
            <div style="text-align: justify; line-height: 1.25;">Finn Partners</div>
            <div style="text-align: justify; line-height: 1.25;">+1 212 529 2236</div>
            <div style="line-height: 1.25;"><u>bryan.gibbs@finnpartners.com</u></div>
          </td>
        </tr>

    </table>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <br>
    <hr align="left" noshade="noshade" style="background-color: #000000; border: 0px; height: 1px; width: 2in; margin-left: 0pt; margin-right: auto; color: #000000;">
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> Daley CL, <font style="font-style: italic;">et al.</font> Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official
        ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. <font style="font-style: italic;">Clinical Infectious Diseases. </font>Ciaa241,&#160;https://doi.org/10.1093/cid/ciaa241<font style="font-style: italic;">.</font></div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Henkle E, <font style="font-style: italic;">et al</font>.
      Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report <font style="font-style: italic;">Annals of the
        American Thoracic Society</font> 2016; S379-84.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Kim RD, <font style="font-style: italic;">et al.</font>
      Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome <font style="font-style: italic;">Am J Respir Crit Care Med.</font> 2008;
      178(10):1066&#8211;74.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup> The American Lung Association, 2020.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup> Henkle E, <font style="font-style: italic;">et al.</font>
      Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 <font style="font-style: italic;">Annals of the American Thoracic Society</font>.
      2015; 12(5):642-7.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>&#160;Foster|Rosenblatt, 2017.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup> Griffith DE, <font style="font-style: italic;">et al.</font>
      An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases <font style="font-style: italic;">Am J Respir Crit Care Med</font>.
      2007;175(4):367-416.</div>
    <div style="line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup> Prevots DR <font style="font-style: italic;">et al.</font>
      Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. <font style="font-style: italic;">Am J Respir Crit Care Med</font> 2010; 182:970-76;&#160;Winthrop KL, <font style="font-style: italic;">et al.</font> Pulmonary nontuberculous mycobacterial
      disease prevalence and clinical features: an emerging public health disease. <font style="font-style: italic;">Am J Respir Crit Care Med</font> 2010; 182: 977-82</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</sup> Full prescribing information for Movantik<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (naloxegol) is available at: <u>www.Movantik.com</u>.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10</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: <u>www.Talicia.com</u>.</div>
    <div style="text-align: justify; line-height: 1.25;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">11</sup> Full prescribing information for Aemcolo<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup> (rifamycin) is available at: <u>www.Aemcolo.com</u>.</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;">3<br>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
