0001178913-17-003311.txt : 20171205 0001178913-17-003311.hdr.sgml : 20171205 20171205112653 ACCESSION NUMBER: 0001178913-17-003311 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20171205 FILED AS OF DATE: 20171205 DATE AS OF CHANGE: 20171205 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: 171238962 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 6-K 1 zk1720873.htm 6-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934

For December 2017

Commission File No. 001-36848
 
Check-Cap Ltd.
Check-Cap Building
Abba Hushi Avenue
P.O. Box 1271
Isfiya, 30090
Mount Carmel, Israel
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES.)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F ☒          Form 40-F ☐

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): ____

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): ____

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes ☐          No ☒
 
If “Yes” marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-___

This Form 6-K is being incorporated by reference into the Post-Effective Amendment No. 1 to the Form S-8 Registration Statement File No. 333-203384, into the Form F-3 Registration Statement File No. 333-211065 and into the Form F-1 Registration Statement File No. 333-219047.


Other Information
 
On December 5, 2017, Check-Cap Ltd. (the “Company”) issued a press release announcing that it has entered the next phase of its manufacturing collaboration with GE Healthcare (“GE”).  The new phase involves GE final assembly, packaging and shipping of C-Scan capsules initially to support the Company’s US pilot trial expected in 1H2018. The Company will supply GE with supporting calibration and final assembly methodology and equipment.

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.


 
SIGNATURE

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.

 
Check-Cap Ltd. 
 
       
 
By:
/s/ Lior Torem
 
 
Name:
Lior Torem
 
 
Title:
Chief Financial Officer         
 
 
Dated: December 5, 2017


EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1
 

Check-Cap Announces Advancement in GE Healthcare Manufacturing Collaboration

New Phase Supports C-Scan® Assembly, Testing & Distribution Initially for US Pilot Trial

ISFIYA, Israel and BOSTON, MA, December 5, 2017 - Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK, CHEKW), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, today announced it has entered the next phase of its manufacturing collaboration with GE Healthcare (“GE”).  The new phase involves GE final assembly, packaging and shipping of C-Scan capsules initially to support the Company’s US pilot trial expected in 1H2018. Check-Cap will supply GE with supporting calibration and final assembly methodology and equipment.

Bill Densel, CEO of Check-cap commented, “We are very pleased to advance our collaboration with GE, moving forward with the initiation of this next phase that prepares us for our C-Scan capsule needs, beginning with our planned US pilot trial in 1H2018. Planning and other activities are also underway for our European post approval study, which is also expected in 1H2018.”
 
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, the first capsule-based system for preparation-free colorectal cancer screening.

Utilizing innovative ultra-low dose X-ray and wireless communication technologies, the capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities. Designed to improve the patient experience and increase the willingness of individuals to participate in recommended colorectal cancer screening, C-Scan removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation. The C-Scan system is currently not cleared for marketing in any jurisdiction.
 
Legal Notice Regarding Forward-Looking Statements
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 "Special Note On Forward-looking Statements" and "Risk Factors" in the Company's Annual Report on Form 20-F 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.
 
Investor Contacts
Vivian Cervantes
PCG Advisory
646-863-6274
vivian@pcgadvisory.com

Meirav Gomeh-Bauer
+972-54-4764979
Meirav@bauerg.com





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