<SEC-DOCUMENT>0001178913-19-002214.txt : 20190819
<SEC-HEADER>0001178913-19-002214.hdr.sgml : 20190819
<ACCEPTANCE-DATETIME>20190819064544
ACCESSION NUMBER:		0001178913-19-002214
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20190819
FILED AS OF DATE:		20190819
DATE AS OF CHANGE:		20190819

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Check-Cap Ltd
		CENTRAL INDEX KEY:			0001610590
		STANDARD INDUSTRIAL CLASSIFICATION:	X-RAY APPARATUS & TUBES & RELATED IRRADIATION APPARATUS [3844]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36848
		FILM NUMBER:		191034871

	BUSINESS ADDRESS:	
		STREET 1:		ABBA HUSHI AVENUE
		STREET 2:		P.O. BOX 1271
		CITY:			ISFIYA
		STATE:			L3
		ZIP:			3009000
		BUSINESS PHONE:		972-4-8303400

	MAIL ADDRESS:	
		STREET 1:		ABBA HUSHI AVENUE
		STREET 2:		P.O. BOX 1271
		CITY:			ISFIYA
		STATE:			L3
		ZIP:			3009000
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
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<FILENAME>zk1923421.htm
<DESCRIPTION>6-K
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      <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, DC 20549 <br>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160; <br>
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      <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&#160;13a-16 OR 15d-16 UNDER</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">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 August 2019</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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      <div style="text-align: center; line-height: 1.25;">Commission File No.&#160;001-36848</div>
      <div style="text-align: center; line-height: 1.25;">&#160; <br>
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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;">Check-Cap Ltd.</div>
      <div style="text-align: center; line-height: 1.25;">_____________________________________________________________________________________________</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman', serif; font-size: 1pt;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">&#160; <br>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Check-Cap Building</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Abba Hushi Avenue</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">P.O. Box 1271</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Isfiya, 30090</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Mount Carmel, 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; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;">Form 20-F &#9746; Form 40-F &#9744;</div>
      <div style="text-align: justify; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____</div>
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      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">The first, second and fifth paragraphs and the &#8220;Forward Looking Statements&#8221; of the press release attached to this Form 6-K are hereby incorporated by reference into the
        Post-Effective Amendment No. 1 to the Form S-8 Registration Statement File No. 333-203384, Form S-8 Registration Statement File No. 333-226490, and into the Form F-3 Registration Statements File Nos. 333-211065 and 333-225789.</div>
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      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Other Information</div>
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      <div style="background-color: #FFFFFF; line-height: 1.25;">
        <div style="text-align: justify; text-indent: 36pt; line-height: 1.25;">On August 19, 2019, Check-Cap Ltd. issued a press release announcing the completion of manufacturing line transfer implementation and qualification for the C-Scan System. A
          copy of the press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference.</div>
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              <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Exhibit</div>
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              <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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              <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">Exhibit No</font>.&#160;</div>
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              <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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              <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Description</div>
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              <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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              <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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              <div style="text-align: justify; line-height: 1.25;">&#160;</div>
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              <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">99.1</a></div>
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            <td style="width: 86.87%; vertical-align: top; background-color: #FFFFFF;">
              <div style="text-align: justify; line-height: 1.25;"><a href="exhibit_99-1.htm">Press Release, dated August 19, 2019</a></div>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;"><u>SIGNATURES</u></div>
      <div style="text-align: center; text-indent: 27.5pt; line-height: 1.25;">&#160;</div>
      <div style="text-align: justify; text-indent: 29.7pt; line-height: 1.25;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
        authorized.</div>
      <div style="text-align: justify; text-indent: 29.7pt; line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">Check-Cap Ltd.</div>
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            <td colspan="1" style="width: 23%; vertical-align: top;">&#160;</td>
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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;">&#160;</div>
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              <div style="line-height: 1.25;">By:</div>
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            <td style="width: 24%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
              <div style="line-height: 1.25;">/s/ Alex Ovadia</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;">Name: Alex Ovadia</div>
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              <div style="line-height: 1.25;">&#160;Date: August 19, 2019</div>
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              <div style="line-height: 1.25;">&#160;</div>
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              <div style="line-height: 1.25;">Title: Chief Executive Officer</div>
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<DOCUMENT>
<TYPE>EX-99.1
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<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right;"> <u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div> <br>
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    <div>
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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;">Check-Cap and GE Healthcare Announce Completion of Manufacturing Line Transfer Implementation </div>
      <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;">and Qualification for the C-Scan&#174; System operated by GE Healthcare</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">GE Healthcare facility in Chicago to support clinical investigation needs of the C-Scan&#174; System in the U.S.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">ISFIYA, Israel, August 19, 2019 -- <u>Check-Cap Ltd.</u>
        (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of the C-Scan&#174; System, the first and only preparation-free ingestible scanning capsule based
        system for the prevention of colorectal cancer through the detection of precancerous polyps, and GE Healthcare, today announced the completion of manufacturing line transfer implementation and qualification for the C-Scan System.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">This collaboration between Check-Cap and GE Healthcare was primarily initiated to enable the manufacture of C-Scan Systems for U.S.
        clinical trials. Upon the successful completion of this current clinical trial phase, both companies intend to explore collaboration expansion opportunities.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">&#8220;Our collaboration with GE Healthcare, a global leader in medical technology manufacturing, has established a solid manufacturing
        infrastructure for the C-Scan System,&#8221; said Alex Ovadia, chief executive officer of Check-Cap. &#8220;We are confident in GE&#8217;s ability to scale up production and intend to explore other possible collaboration opportunities, primarily in the U.S., while adhering to regulatory and safety standards in various markets worldwide, as
        we advance our pilot clinical trial in the U.S.&#8221;</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">&#8220;We have worked closely with the experienced Check-Cap team to transfer and qualify the manufacturing process of the C-Scan System to GE
        Healthcare,&#8221; said Marco Campione, General Manager, Americas Pharmaceutical Diagnostics, GE Healthcare. &#8220;This partnership reflects our commitment to helping
        Check-Cap increase capacity, improve productivity and potentially leverage our global infrastructure to improve people&#8217;s lives.&#8221;</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Check-Cap is currently conducting a pilot clinical trial&#160;in the U.S. (NCT03735407) to evaluate the safety, usability and subject
        compliance of the C-Scan&#160;System at the&#160;New York University&#160;School of Medicine and Mayo Clinic. In addition, Check-Cap intends to continue collecting clinical data in additional studies in preparation for its planned pivotal study. Assuming positive
        pilot clinical trial results, the Company plans to file with the U.S. FDA for approval of a pivotal clinical trial, to be initiated in-2020. The C-Scan System has received CE marking for marketing in Europe and approval from the Israeli Ministry of
        Health, the Medical Device Division (AMAR) for marketing in Israel.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25; font-weight: bold;">About Check-Cap</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">Check-Cap is advancing the development of the C-Scan&#174; System, the first and only preparation-free ingestible scanning capsule-based
        system for the prevention of colorectal cancer (CRC) through the detection of precancerous polyps. The patient-friendly test has the potential to increase screening adherence and reduce the overall incidence of CRC. The C-Scan System utilizes an
        ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon.&#160; The C-Scan System is non-invasive and requires no preparation or
        sedation, allowing patients to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.</div>
      <div style="line-height: 1.25">&#160;</div>
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      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25; font-weight: bold;">Legal Notice Regarding Forward-Looking Statements</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">This press release contains "forward-looking statements." Words such as "may," "should," "could," "would," "predicts," "potential,"
        "continue," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as
        a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or
        management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
        statements. For a discussion of these and other risks that could cause such differences and that may affect the realization of forward-looking statements, please refer to the " Forward-looking Statements" and "Risk Factors" in the Company's Annual
        Report on Form 20-F for the year ended December 31, 2018 and other filings with the Securities and Exchange Commission (SEC). Investors and security holders are urged to read these documents free of charge on the SEC's web site at
        http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.</div>
      <div style="line-height: 1.25">&#160; <br>
      </div>
      <div style="line-height: 1.25; font-weight: bold;">Investor Contacts</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">Jeremy Feffer</div>
      <div style="line-height: 1.25;">LifeSci Advisors, LLC</div>
      <div style="line-height: 1.25;">212.915.2568</div>
      <div style="line-height: 1.25;">jeremy@lifesciadvisors.com</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">Meirav Gomeh-Bauer (Israel)</div>
      <div style="line-height: 1.25;">LifeSci Advisors, LLC</div>
      <div style="line-height: 1.25;">+972(0)-54-476-4979</div>
      <div style="line-height: 1.25;">Meirav@lifesciadvisors.com</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25; font-weight: bold;">Media Contacts</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="line-height: 1.25;">Alison Chen<br>
        LifeSci Public Relations<br>
        +1-646-876-4932<br>
        achen@lifescipublicrelations.com</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Meirav Gomeh-Bauer (Israel)<br>
        LifeSci Advisors, LLC<br>
        +972(0)-54-476-4979&#160;<br>
        Meirav@lifesciadvisors.com</div>
      <div style="line-height: 1.25">&#160;
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