0001178913-18-002813.txt : 20181105 0001178913-18-002813.hdr.sgml : 20181105 20181105083413 ACCESSION NUMBER: 0001178913-18-002813 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20181105 FILED AS OF DATE: 20181105 DATE AS OF CHANGE: 20181105 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: 181158832 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 zk1822231.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 November 2018
 
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, Form S-8 Registration Statement File No. 333-226490, and into the Form F-3 Registration Statements File Nos. 333-211065 and 333-225789.

 
Other Information
 
On November 5, 2018, Check-Cap Ltd. (the “Company”) issued a press release announcing its financial results for the Third Quarter of 2017.

A copy of the press release is attached hereto as Exhibits 99.1 and is incorporated herein by reference.
 
Exhibits
 
Exhibit No.
  
 
Description
     
99.1    

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: November 5, 2018


 EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1
 

Check-Cap Reports Third Quarter 2018 Financial Results
 
Announced Interim Results from Post-CE Approval Study of C-Scan®
 
Announces Update on Scheduled Initiation of U.S. Pilot Study  
 
ISFIYA, Israel, Nov. 5, 2018 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, a preparation free capsule-based screening method for the prevention of colorectal cancer through the detection of precancerous polyps, announced today financial results for the third quarter and nine months ended September 30, 2018.
 
Recent Highlights
 
·
Submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) that, if approved, would allow the Company to initiate a U.S. pilot study of the C-Scan system by the end of 2018, in collaboration with GE Healthcare as manufacturing partner.
 
·
Received approval from the Israeli Ministry of Health, the Medical Device Division (AMAR) to initiate commercial sales in Israel of the C-Scan system that received CE Mark approval in January 2018.
 
·
Announced on September 04, 2018, encouraging interim results from its ongoing post-CE approval study of its C-Scan® System Version 3, demonstrating 76% sensitivity (P=0.0038) and 80% specificity. Final results from the study are expected in 2Q 2019.
 
Alex Ovadia, Chief Executive Officer of Check-Cap, stated: "Despite strong evidence that screening can decrease the incidence of colorectal cancer, the lack of patient-friendly screening options continues to present an obstacle to adherence. We believe that the C-Scan system addresses all major barriers to standard screening methods, offering a screening option for those unable or unwilling to undergo colonoscopy. During the third quarter, we made significant progress toward our goal of commercializing the C-Scan system Version 3 in Israel, the EU and major markets worldwide. Most notably, we submitted an IDE to the FDA and are preparing to initiate a U.S. pilot study in collaboration with our manufacturing partner, GE Healthcare. We believe that the C-Scan system has the potential to make a meaningful impact on the rates of colorectal cancer screening and precancerous polyp detection, and we look forward to making this novel technology available to patients worldwide."
 
 
Financial Results for the Third Quarter Ended Sept. 30, 2018
 
Net research and development expenses were $1.9 million in the three months ended September 30, 2018, compared to $1.6 million in the same period in 2017. The increase is primarily attributable to a $232,000 increase in other R&D expenses primarily associated with the Company's post CE approval study of the C-Scan system and the IDE submission to the FDA, as well as a $52,000 decrease in grants received from the Israel Innovation Authority (IIA), which was reflected as a credit to research and development expenses.
 
General and administrative expenses were $937,000 in the three months ended September 30, 2018, compared to $810,000 in the same period in 2017. The increase was primarily due to a $62,000 increase in professional fees and $35,000 of expenses related our annual general meeting of shareholders which was held in September 2018.
 
Operating loss was $2.8 million for the three months ended September 30, 2018, compared to $2.4 million in the same period in 2017.
 
Net finance income was $99,000 in the three months ended September 30, 2018, compared to $10,000 in the same period in 2017.
 
Net loss was $2.7 million in the three months ended September 30, 2018, compared to $2.4 million in the same period in 2017.
 
Non-GAAP net loss was $2.6 million in the three months ended September 30, 2018, compared to $2.0 million in the same period in 2017.
 
Cash, cash equivalents and short-term bank deposit totaled $17.6 million at September 30, 2018, compared to $20 million at June 30, 2018. 
 
Financial Results for the Nine Months Ended September 30, 2018
 
Net research and development expenses were $5.2 million in the nine months ended September 30, 2018, compared to $5.4 million in the same period in 2017. The decrease is primarily attributable to a $511,000 decrease in salaries and related expenses as a result of a reduction in head count in 2018 and a $66,000 decrease in share-based compensation. The decrease was partially offset by a $325,000 increase in other R&D expenses associated with the Company's post CE approval study of the C–Scan system and the IDE submission to the FDA, as well as a $52,000 decrease in grants received from the IAA, which was credited to research and development expenses.
 
General and administrative expenses were $2.4 million in the nine months ended September 30, 2018, compared to $2.5 million in the same period in 2017. The decrease was primarily due to a decrease of $861,000 in share-based compensation, of which $502,000 relates to reversal of expenses associated with an equity award to the Company's former CEO which was forfeited as a result of his separation from employment. The decrease was partially offset by a $376,000 increase in salary and related expenses primarily due to a onetime payment to the Company's former CEO as a result of his separation from employment, a $199,000 increase in professional expenses and a $144,000 increase in other general and administrative expenses.
 
Operating loss was $7.6 million for the nine months ended September 30, 2018, compared to $7.9 million in the same period in 2017.
 
Net finance income was $108,000 in the nine months ended September 30, 2018, compared to $80,000 in the same period in 2017.
 
Net loss was $7.5 million in the nine months ended September 30, 2018, compared to $7.9 million in the same period in 2017.
 
Non-GAAP net loss was $7.7 million in the nine months ended September 30, 2018, compared to $7.1 million in the same period in 2017.
 
A reconciliation of GAAP results to non-GAAP results is provided below.
 
 
Net cash used in operating activities was $7.3 million in the nine months ended September 30, 2018, compared to $7.0 million in the same period in 2017.
 
The number of outstanding ordinary shares as of September 30, 2018, was 5,329,891.
 
[Financial Tables to Follow]
 
About Check-Cap
 
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, an ingestible capsule-based device 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.
 
Use of Non-GAAP Financial Results
 
In addition to disclosing financial results calculated in accordance with U.S. GAAP, the Company's financial results release contains Non-GAAP financial measures of net loss for the period that exclude the effects of share-based compensation and changes in royalties provision. The Company's management believes the Non-GAAP financial information provided in this release is useful to investors' understanding and assessment of the Company's on-going operations.  Management also uses both GAAP and Non-GAAP information in evaluating and operating business internally and as such deemed it important to provide all this information to investors. The Non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations to those financial statements should be carefully evaluated. Reconciliations between GAAP measures and Non-GAAP measures are provided later in this press release.
 
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 for the year ended December 31, 2017 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.
 
 
 
CHECK CAP LTD
CONSOLIDATED UNAUDITED BALANCE SHEETS
 (U.S. dollars in thousands, except share and per share data)
 
   
September 30,
2018
    
December 31,
2017
  
Assets
            
Current assets
            
Cash and cash equivalents
    
8,485
      
6,997
  
Short-term bank deposit
    
9,080
      
-
  
Prepaid expenses and other current assets
    
496
      
406
  
Total current assets
    
18,061
      
7,403
  
                 
Non-current assets
                
Property and equipment, net
    
435
      
503
  
Total non-current assets
    
-
      
503
  
Total assets
    
18,496
      
7,906
  
                 
Liabilities and shareholders' equity
                
Current liabilities
                
Accounts payable and accruals
                
  Trade
    
813
      
608
  
  Other
    
308
      
347
  
Other current liabilities
    
9
      
5
  
Employees and payroll accruals
    
951
      
602
  
Total current liabilities
    
2,081
      
1,562
  
                 
Non-current liabilities
                
Royalties provision
    
479
      
439
  
Total non-current liabilities
    
479
      
439
  
                 
Shareholders' equity
                
Share capital
    
3,455
      
974
  
Additional paid-in capital
    
72,678
      
57,643
  
Accumulated deficit
    
(60,197
)
    
(52,712
)
Total shareholders' equity
    
15,936
      
5,905
  
                 
Total liabilities and shareholders' equity
    
18,496
      
7,906
  
 
 
 
CHECK CAP LTD
CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
   
Nine months ended
    
Three months ended
  
 
September 30,
    
September 30,
  
   
2018
    
2017
    
2018
    
2017
  
Research and development expenses, net
    
5,222
      
5,437
      
1,865
      
1,564
  
General and administrative expenses
    
2,372
      
2,506
      
937
      
810
  
Operating loss
    
7,594
      
7,943
      
2,802
      
2,374
  
                                 
Finance income (expenses), net
    
108
      
80
      
99
      
(10
)
Loss before tax
    
7,486
      
7,863
      
2,703
      
2,384
  
Tax expenses (gains) on income
    
(1
)
    
6
      
-
      
-
  
Net loss for the period
    
7,485
      
7,869
      
2,703
      
2,384
  
                                 
Net loss per ordinary share basic and diluted
    
2.07
      
5.25
      
0.50
      
1.38
  
                                 
Weighted average number of ordinary shares 
 outstanding - basic and diluted (in thousands)
    
3,622
      
1,500
      
5,356
      
1,723
  
 
 
 
CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except per share data)
 
   
   
Nine months ended
September 30,
  
   
2018
    
2017
  
CASH FLOWS FROM OPERATING ACTIVITIES
            
Net loss for the period
    
(7,485
)
    
(7,869
)
Adjustments required to reconcile net loss to net cash used in operating activities:
                
Depreciation and amortization
    
118
      
115
  
Share-based compensation
    
(271
)
    
657
  
Financial expense, net
    
(43
)
    
(155
)
Changes in assets and liabilities items:
                
Decrease in prepaid and other current assets and non-current assets
    
(90
)
    
(73
)
Increase in trade accounts payable, accruals and other current liabilities
    
60
      
64
  
Increase in employees and payroll accruals
    
349
      
162
  
Increase in royalties provision
    
40
      
78
  
Net cash used in operating activities
    
(7,322
)
    
(7,021
)
                 
CASH FLOWS FROM INVESTING ACTIVITIES
                
Purchase of property and equipment
    
(14
)
    
(221
)
Short-term investments
    
(9,000
)
    
-
  
Net cash used in investing activities
    
(9,014
)
    
(221
)
                 
CASH FLOWS FROM FINANCING ACTIVITIES
                
Exercise of pre-funded warrants into ordinary shares
    
4
      
82
  
Issuance of ordinary shares in the June 2017 RD Offering, net of issuance
expenses in an amount of $349
    
-
      
2,308
  
Issuance of ordinary shares in the 2018 Public Offering, net of issuance expenses in an amount of $2,381
    
17,858
      
-
  
Net cash provided by financing activities
    
17,862
      
2,390
  
                 
Effect of exchange rate changes on cash and cash equivalents
    
(38
)
    
153
  
Net increase (decrease) in cash and cash equivalents
    
1,488
      
(4,699
)
Cash and cash equivalents at the beginning of the period
    
6,997
      
11,639
  
Cash and cash equivalents at the end of the period
    
8,485
      
6,940
  
 
 
 
CHECK-CAP LTD.
  
SUPPLEMENTAL RECONCILIATION OF GAAP TO NON-GAAP RESULTS
  
(U.S. dollars in thousands)
  
   
   
Nine months ended
    
Three months ended
  
   
September 30,
    
September 30,
  
   
2018
    
2017
    
2018
    
2017
  
                         
GAAP net loss for the period
    
(7,485
)
    
(7,869
)
    
(2,703
)
    
(2,384
)
Share-based compensation (1)
    
(271
)
    
657
      
122
      
310
  
Changes in royalties
    
40
      
78
      
15
      
29
  
Non-GAAP net loss for the period
    
(7,716
)
    
(7,134
)
    
(2,566
)
    
(2,045
)
                                 
(1) Share-based compensation:
                                
Research and development expenses, net
    
115
      
182
      
81
      
108
  
General and administrative expenses:
                                
    General and administrative expenses
    
116
      
475
      
41
      
202
  
    One time reversal of equity award to the Company's Former CEO  
    
(502
)
    
-
      
-
      
-
  
     
(271
)
    
657
      
122
      
310
  
 
Investor Contacts          
Jeremy Feffer       
LifeSci Advisors, LLC    
212-915-2568   
jeremy@lifesciadvisors.com 
 
Meirav Gomeh-Bauer  
LifeSci Advisors, LLC   
+972(0)-54-476-4979     
Meirav@lifesciadvisors.com