<SEC-DOCUMENT>0001171843-20-007627.txt : 20201105
<SEC-HEADER>0001171843-20-007627.hdr.sgml : 20201105
<ACCEPTANCE-DATETIME>20201105070026
ACCESSION NUMBER:		0001171843-20-007627
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20201105
FILED AS OF DATE:		20201105
DATE AS OF CHANGE:		20201105

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:		201288593

	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>f6k_110520.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" /><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" /></head><body style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><div align="center"><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;">&#160;</div></div><p style="font-size: 14pt;" align="center"><strong>UNITED STATES</strong><br /><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br /><strong>Washington, D.C. 20549</strong></p><p style="font-size: 14pt; text-transform: uppercase;" align="center"><strong>Form 6-K</strong></p><p><strong></strong></p><p><strong>Report of Foreign Private Issuer<br />Pursuant to Rule 13a-16 or 15d-16<br />of the Securities Exchange Act of 1934</strong></p><p>For the month of November 2020<br />Commission File No.:&#160;001-35773&#160;</p><p><strong>REDHILL BIOPHARMA LTD.</strong><br />(Translation of registrant's name into English)</p><p><strong>21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</strong><br />(Address of principal executive offices)</p></div><p>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.<br />Form 20-F [&#160;X ] &#160;&#160;&#160;&#160;&#160;Form 40-F [&#160;&#160; ]</p><p>Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):<u>&#160;&#160;&#160;&#160;&#160;</u></p><p>Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):<u>&#160;&#160;&#160;&#160;&#160;</u></p><p>
 <p>Attached hereto and incorporated by reference herein is the following:&#160;</p>   <p><font><a href="exh_1.htm" rel="nofollow">Exhibit 1</a></font>: Registrant's press release entitled: &#8220;RedHill Biopharma to Host Third Quarter Financial Results and Business Highlights Webcast on November 12, 2020&#8221;&#160;</p>   <p align="justify">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).</p> </p><hr style="page-break-after: always;" noshade="noshade" /><p style="text-align: center;"><strong>SIGNATURES</strong></p><p>Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</p><table style="font-family: Times New Roman; font-size: 10pt;" border="0" width="100%" cellspacing="0" cellpadding="0"><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%">REDHILL BIOPHARMA LTD.</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%">(the "Registrant")</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">&#160;</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%"></td></tr><tr valign="top"><td width="47%">Date:&#160;November 5, 2020</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%">By: <u>/s/ Dror Ben-Asher</u></td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%">Dror Ben-Asher</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%">Chief Executive Officer</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-align: left;" align="center" width="47%"></td></tr></table></body></html>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-1
<SEQUENCE>2
<FILENAME>exh_1.htm
<DESCRIPTION>EXHIBIT 1
<TEXT>
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" ><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" ></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 1</strong></p><p style="text-align: center;"><font style="font-size: 14pt;"><strong>RedHill Biopharma to Host Third Quarter Financial Results and Business Highlights Webcast on November 12, 2020</strong></font></p><p style="text-align: center;"><strong></strong></p><p>
       <p align="justify">TEL AVIV, Israel and RALEIGH, N.C., Nov.  05, 2020  (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty biopharmaceutical company, today announced that it will report its third-quarter 2020 financial results and business highlights on Thursday, November 12, 2020.<br ></p>        <p align="justify">The Company will host a conference call and webcast on <strong>Thursday</strong><strong>, </strong><strong>November </strong><strong>12</strong><strong>, 2020</strong><strong>,</strong><strong> at 8:30 a.m. </strong><strong>E</strong><strong>S</strong><strong>T</strong>, during which it will present key highlights for the third quarter of 2020, including:</p>        <ul type="disc"><li style="margin-top:6pt; margin-bottom:6pt; text-align:justify;">Financial performance for the quarter ended September 30, 2020;</li><li style="margin-top:6pt; margin-bottom:6pt; text-align:justify;">Commercial activities status;</li><li style="margin-top:6pt; margin-bottom:6pt; text-align:justify;">The progress of the late-stage development program with opaganib for COVID-19 and preparation for potential emergency use applications;</li><li style="margin-top:6pt; margin-bottom:6pt; text-align:justify;">Pipeline progress, including the granting of Orphan Drug Designation and the Phase 3 study with RHB-204 for first-line pulmonary nontuberculous mycobacteria (NTM) infections.</li></ul>        <p align="justify">The webcast and slides will be broadcasted live on the Company's website: <strong>http://ir.redhillbio.com/events</strong> and available for replay for 30 days.</p>        <p align="justify">To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: <strong>United States: +1-8</strong><strong>77</strong><strong>-</strong><strong>870</strong><strong>-</strong><strong>9135</strong><strong>; International: +1-6</strong><strong>46</strong><strong>-</strong><strong>741</strong><strong>-</strong><strong>3167</strong><strong> and Israel: </strong><strong>+972-3-</strong><strong>530</strong><strong>-</strong><strong>8845</strong><strong>; </strong><strong>t</strong><strong>he access code for the call is:</strong><strong> 4549918.</strong></p>        <p align="justify"><strong>About RedHill Biopharma</strong><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, <strong>Movantik<sup>&#174;</sup></strong><strong>&#160;</strong>for opioid-induced constipation in adults<sup>1</sup>, <strong>Talicia<sup>&#174;</sup></strong>&#160;for the treatment of <em>Helicobacter pylori (H. pylori)</em> infection in adults<sup>2</sup>, and <strong>Aemcolo<sup>&#174;</sup></strong>&#160;for the treatment of travelers&#8217; diarrhea in adults<sup>3</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <strong>RHB-204</strong>, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) <strong>opaganib</strong><strong> (</strong><strong>Yeliva<sup>&#174;</sup></strong><strong>)</strong>, a first<strong>-</strong>in<strong>-</strong>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) <strong>RHB-104</strong>, with positive results from a first Phase 3 study for Crohn's disease; (iv) <strong>RHB-102</strong> (<strong>Bekinda<sup>&#174;</sup></strong>), 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) <strong>RHB-107</strong>, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) <strong>RHB</strong>-<strong>106</strong>, an encapsulated bowel preparation. More information about the Company is available at <u>www.redhillbio.com</u><u>.</u></p>        <p align="justify"><em>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</em><em>,</em><em> and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation,</em> <em>risks and uncertainties associated with (</em><em>i</em><em>) the initiation, timing, progress and results of the Company&#8217;s research, manufacturing, pre</em><em>-</em><em>clinical studies, clinical trials, and other therapeutic candidate development efforts</em><em>, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future</em><em>; (ii) the Company&#8217;s ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre</em><em>-</em><em>clinical studies or clinical trials</em><em> or the development of a commercial companion diagnostic for the detection of MAP</em><em>; (iii) the extent and number</em><em> and type </em><em>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</em><em> and </em><em>Talicia<sup>&#174;</sup></em><em>; (v) the Company&#8217;s ability to successfully </em><em>commercialize and promote </em><em>Talicia<sup>&#174;</sup></em><em>, </em><em>and Aemcolo<sup>&#174;</sup></em>&#160;and Movantik<sup>&#174;</sup><em>; (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 </em><em>and the results obtained with its therapeutic candidates in research, pre</em><em>-</em><em>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)</em> <em>the </em><em>effect of patients suffering adverse experiences using investigative drugs under the </em><em>Company's Expanded Access </em><em>Program; (xiv) competition from other</em><em> companies and technologies within the Company&#8217;s industry</em><em>; and (xv) the hiring and employment commencement date of executive managers</em><em>. 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 </em><em>on </em><em>M</em><em>arch</em> <em>4</em><em>, </em><em>2020</em><em>. All forward-looking statements included in this </em><em>p</em><em>ress </em><em>r</em><em>elease are made only as of the date of this press release. </em><em>The Company</em><em> assume</em><em>s</em><em> no obligation to update any written or oral forward-looking statement</em><em>, whether as a result of new information, future events or </em><em>otherwise</em><em> unless required by law.</em></p>    <table style="width:100%; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="max-width:50%; width:50%; min-width:50%;;vertical-align: top ; "><strong>Company contact:</strong><br >Adi Frish<br >Chief Corporate &amp; Business Development Officer<br >RedHill Biopharma<br >+972-54-6543-112<br >adi@redhillbio.com</td><td style="max-width:50%; width:50%; min-width:50%;;vertical-align: top ; "><strong>Media contact (U.S.):</strong><br >Bryan Gibbs<br >Vice President<br >Finn Partners<br >+1 212 529 2236<br >bryan.gibbs@finnpartners.com</td></tr></table>    <p><sup>_________________________________________________</sup></p>        <p><sup>1</sup> Full prescribing information for Movantik<sup>&#174;</sup> (naloxegol) is available at:&#160;www.Movantik.com.<br ><sup>2</sup> Full prescribing information for Talicia<sup>&#174;</sup> (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.<br ><sup>3</sup> Full prescribing information for Aemcolo<sup>&#174;</sup> (rifamycin) is available at: www.Aemcolo.com.</p> </p><p ></p></body></html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
