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 August 2019

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 of 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): ____
 
This Form 6-K (including the text under the headings “Financial Results for the Second Quarter Ended June 30, 2019,” “Financial Results for the Six Months Ended June 30, 2019,” the accompanying financial statements, and “Forward Looking Statements”  in Exhibit 99.1 and Exhibit 99.2) are 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 August 7, 2019, Check-Cap Ltd. (the “Company”) issued a press release announcing its financial results for the second quarter of 2019. In addition, the Company released its consolidated financial statements as of June 30, 2019 (Unaudited).

A copy of both the press release and consolidated financial statements as of June 30, 2019 (Unaudited) are attached hereto as Exhibits 99.1 and 99.2 are incorporated herein by reference.

Exhibit
 
 
 
 
 
Exhibit No
 
Description
 
 
 
 
     
 
 

SIGNATURES
 
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/ Alex Ovadia
 
 
Name: Alex Ovadia
 Date: August 7, 2019
 
Title: Chief Executive Officer
 


Exhibit 99.1


Check-Cap Reports Second Quarter 2019 Financial Results and Corporate Highlights
 
Reported positive final results from post-CE approval study of the C-Scan® System
 
ISFIYA, Israel, August 7, 2019 -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only preparation-free ingestible capsule based system for the prevention of colorectal cancer through the detection of precancerous polyps, today announced financial results for the second quarter and six months ended June 30, 2019.
 
Second Quarter and Recent Highlights:
 

Announced positive final results from its post-CE approval study of the C-Scan System. The study met its primary endpoint, achieving sensitivity (ability to correctly identify patients with polyps) of 76% in patients with polyps ≥10 mm and specificity (ability to correctly identify patients with lack of polyps) of 82% in all patients, compared to FIT that achieved 29% sensitivity and 96% specificity. In addition, the C-Scan System detected all 4 patients (100%) with polyps ≥40 mm, while FIT detected only 1 of the 4 patients (25%) with polyps ≥40mm. Overall, the C-Scan System achieved a sensitivity of 66% in all patients, including patients with polyps <10mm, while FIT achieved a sensitivity of 23% for the same population.
 

Progressed the U.S. pilot study of the C-Scan System at NYU School of Medicine and Mayo Clinic which is evaluating the safety, usability and subject compliance in up to 45 subjects. Results from the U.S. pilot study, if positive, would represent another major milestone towards the initiation of the planned U.S. pivotal study in 2020.
 

Appointed Joshua (Shuki) Belkar as Vice President of Operations, bringing more than 20 years of experience managing operations at global medical device companies, including Medtronic and Mazor Robotics.
 

Presented a poster at Digestive Disease Week®, entitled “Swallow and forget" study: Prepless X-Ray imaging capsule with enhanced algorithms shows substantial improvement in polyp detection."
 
“During the first half of 2019, we achieved two very significant milestones,” said Alex Ovadia, Chief Executive Officer of Check-Cap. “First, we initiated our U.S. pilot study, which, if it yields positive results, will set the stage for a planned pivotal study next year. Second, we reported compelling results from our post-CE approval study, which add to the growing body of evidence demonstrating both the C-Scan System’s positive safety profile and its superior clinical performance relative to FIT for pre-cancerous polyp detection. The C-Scan System is highly differentiated as the only preparation-free colon cancer screening alternative, aimed at addressing what is believed to be the primary cause for avoiding standard of care CRC screening, preventing a significant portion of the target population from being screened according to widely accepted clinical guidelines,” Mr. Ovadia concluded.

Financial Results for the Second Quarter Ended June 30, 2019
 
Research and development expenses, net, were $2.6 million for the three months ended June 30, 2019, compared to $1.7 million for the same period in 2018.  The increase is primarily due to an increase of $0.5 million in expenses for the post-CE approval study and ongoing pilot study, as well an increase of $0.3 million in salaries and related expenses as a result of expansion in head count and $0.1 million in share-based compensation.
 
General and administrative expenses remained consistent at $0.9 million for the three months ended June 30, 2019, similar to the amount for the same period in 2018.
 
Operating loss was $3.5 million for the three months ended June 30, 2019, compared to an operating loss of $2.7 million for the same period in 2018.
 
Financial income, net was $139,000 for the three months ended June 30, 2019, compared to $30,000 for the same period in 2018. The increase was due to income from interest on bank deposits.
 
Net loss was $3.4 million for the three months ended June 30, 2019, compared to $2.7 million for the same period in 2018.
 
Cash and cash equivalents, restricted cash and short-term bank deposits totaled $14.7 million as of June 30, 2019, compared with $17.3 million at March 31, 2019 and $14.6 million as of December 31, 2018.
 
Financial Results for the Six Months Ended June 30, 2019
 
Research and development expenses, net were $4.9 million for the six months ended June 30, 2019, compared to $3.4 million for the same period in 2018. The increase is primarily due to an increase of $0.8 million in expenses related to the post-CE approval study and ongoing pilot study, as well as an increase of $0.4 million in salaries and related expenses as a result of expansion in head count and $0.2 million in share-based compensation. This increase was partially offset by a $58,000 grant received from the Israel Innovation Authority.
 
General and administrative expenses were $1.7 million for the six months ended June 30, 2019, compared to $1.4 million for the same period in 2018. The increase was primarily due to an increase of $0.4 million in share-based compensation and $0.1 million in professional services. This increase was partially offset by a $0.2 million decrease in salaries and related expenses.
 
Operating loss was $6.7 million for the six months ended June 30, 2019, compared to $4.8 million in the same period in 2018.
 
Finance income, net was $153,000 for the six months ended June 30, 2019, compared to $9,000 for the same period in 2018. The increase was due to income from interest on bank deposits.
 
Net loss was $6.5 million for the six months ended June 30, 2019, compared to $4.8 million for the same period in 2018.
 
Net cash used in operating activities was $6.3 million for the six months ended June 30, 2019, compared to $4.8 million for the same period in 2018.
 
The number of outstanding ordinary shares as of June 30, 2019 was 8,238,462. This number includes the 2,906,376 ordinary shares that were issued in the February 2019 registered direct offering.
 
[Financial Tables to Follow]

About Check-Cap
 
Check-Cap is advancing the development of C-Scan® 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. C-Scan is non-invasive and requires no preparation or sedation, allowing the patient to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.

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 "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.
 
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


CHECK CAP LTD
CONSOLIDATED BALANCE SHEETS
 (U.S. dollars in thousands)
 
   
June 30,
   
December 31,
 
 
 
2019
   
2018
 
 
 
(unaudited)
   
(audited)
 
Assets
           
Current assets
           
Cash and cash equivalents
   
8,315
     
8,572
 
Restricted cash
   
350
     
350
 
Short-term bank deposit
   
6,044
     
5,643
 
Prepaid expenses and other current assets
   
370
     
419
 
Total current assets
   
15,079
     
14,984
 
 
               
Non-current assets
               
Property and equipment, net
   
446
     
452
 
Operating leases
   
423
     
-
 
Total non-current assets
   
869
     
452
 
Total assets
   
15,948
     
15,436
 
 
               
Liabilities and shareholders' equity
               
Current liabilities
               
Accounts payable and accruals
               
  Trade
   
855
     
1,113
 
  Other
   
290
     
249
 
Employees and payroll accruals
   
874
     
859
 
Operating lease liabilities
   
187
     
-
 
Total current liabilities
   
2,206
     
2,221
 
 
               
Non-current liabilities
               
Royalties provision
   
188
     
185
 
Operating lease liabilities
   
236
     
-
 
Total non-current liabilities
   
424
     
185
 
 
               
Shareholders' equity
               
Share capital
   
5,384
     
3,456
 
Additional paid-in capital
   
77,740
     
72,888
 
Accumulated other comprehensive loss
   
-
     
(13
)
Accumulated deficit
   
(69,806
)
   
(63,301
)
Total shareholders' equity
   
13,318
     
13,030
 
 
               
Total liabilities and shareholders' equity
   
15,948
     
15,436
 


CHECK CAP LTD
CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. dollars in thousands, except per share data)

 
 
Six months ended June 30,
   
Three months ended June 30,
 
 
 
2019
   
2018
   
2019
   
2018
 
 
                       
Research and development expenses, net
   
4,909
     
3,357
     
2,570
     
1,737
 
General and administrative expenses
   
1,749
     
1,435
     
924
     
950
 
Operating loss
   
6,658
     
4,792
     
3,494
     
2,687
 
 
                               
Finance income, net
   
153
     
9
     
139
     
30
 
Loss before income tax
   
6,505
     
4,783
     
3,355
     
2,657
 
Taxes on income
   
-
     
(1
)
   
-
     
(2
)
Net loss
   
6,505
     
4,782
     
3,355
     
2,655
 
                                 
Other comprehensive loss:
                               
                                 
Change in fair value of cash flow hedge
   
13
     
-
     
(4
)
   
-
 
Comprehensive loss
   
6,518
     
4,782
     
3,351
     
2,655
 
                                 
Net loss per ordinary share - basic and diluted
   
0.85
     
1.74
     
0.41
     
0.7
 
                                 
Weighted average number of ordinary shares outstanding - basic and diluted
   
7,663
     
2,741
     
8,238
     
3,796
 


CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
  (U.S. dollars in thousands, except per share data)
 
 
 
Six months ended
June 30,
 
 
 
2019
   
2018
 
CASH FLOWS FROM OPERATING ACTIVITIES
     
Net loss for the period
   
(6,505
)
   
(4,782
)
Adjustments required to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
   
55
     
82
 
Share-based compensation
   
269
     
(393
)
Financial (income) expenses, net
   
(32
)
   
(18
)
Increase in royalties provision
   
3
     
25
 
Changes in assets and liabilities items:
               
Decrease in prepaid and other current assets and non-current assets
   
50
     
35
 
Decrease in trade accounts payable, accruals and other current liabilities
   
(204
)
   
(131
)
Increase (decrease) in employees and payroll accruals
   
15
     
288
 
Net cash used in operating activities
   
(6,349
)
   
(4,894
)
 
               
CASH FLOWS FROM INVESTING ACTIVITIES
               
Purchase of property and equipment
   
(49
)
   
(8
)
Investments in short-term bank deposits, net
   
(370
)
   
(10,000
)
Net cash used in investing activities
   
(419
)
   
(10,008
)
 
               
CASH FLOWS FROM FINANCING ACTIVITIES
               
Issuance of ordinary shares in the 2018 public offering, net of issuance expenses
   
-
     
17,862
 
Issuance of ordinary shares in the 2019 registered direct offering, net of issuance expenses
   
6,511
     
-
 
Net cash provided by financing activities
   
6,511
     
17,862
 
 
               
Net increase (decrease) in cash and cash equivalents and restricted cash
   
(257
)
   
2,960
 
Cash and cash equivalents and restricted cash at the beginning of the period
   
8,922
     
6,997
 
Cash and cash equivalents and restricted cash at the end of the period
   
8,665
     
9,957
 


CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
 (U.S. dollars in thousands, except per share data)
 
Supplemental information for Cash Flow:
 
 
 
Six months ended
June 30,
 
 
 
2019
   
2018
 
Supplemental disclosure of non-cash flow information
           
Cashless exercise of warrants to purchase ordinary shares into ordinary shares
   
-
     
9
 
Purchase of property and equipment
   
-
     
7
 
 Recognition of operating leases and operating lease liabilities from adoption of ASU 2016-02
   
490
     
-
 


 

Exhibit 99.2

CHECK CAP LTD.

CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2019
 

 
CHECK CAP LTD.

CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2019
 
Table of Contents
 
 
Page
 
 
Financial Statements:
 
 
 
3
 
 
4
 
 
5-6
 
 
7-8
 
 
9-13
 

2

 
CHECK CAP LTD
CONSOLIDATED BALANCE SHEETS
 (U.S. dollars in thousands)
 
   
June 30,
   
December 31,
 
 
 
2019
   
2018
 
 
 
(unaudited)
   
(audited)
 
Assets
           
Current assets
           
Cash and cash equivalents
   
8,315
     
8,572
 
Restricted cash
   
350
     
350
 
Short-term bank deposit
   
6,044
     
5,643
 
Prepaid expenses and other current assets
   
370
     
419
 
Total current assets
   
15,079
     
14,984
 
 
               
Non-current assets
               
Property and equipment, net
   
446
     
452
 
Operating leases
   
423
     
-
 
Total non-current assets
   
869
     
452
 
Total assets
   
15,948
     
15,436
 
 
               
 
               
Liabilities and shareholders' equity
               
Current liabilities
               
Accounts payable and accruals
               
  Trade
   
855
     
1,113
 
  Other
   
290
     
249
 
Employees and payroll accruals
   
874
     
859
 
Operating lease liabilities
   
187
     
-
 
Total current liabilities
   
2,206
     
2,221
 
 
               
                 
Non-current liabilities
               
Royalties provision
   
188
     
185
 
Operating lease liabilities
   
236
     
-
 
Total non-current liabilities
   
424
     
185
 
 
               
Shareholders' equity
               
Share capital
   
5,384
     
3,456
 
Additional paid-in capital
   
77,740
     
72,888
 
Accumulated other comprehensive loss
   
-
     
(13
)
Accumulated deficit
   
(69,806
)
   
(63,301
)
Total shareholders' equity
   
13,318
     
13,030
 
 
               
Total liabilities and shareholders' equity
   
15,948
     
15,436
 

The accompanying notes to the consolidated financial statements are an integral part of them.

3


CHECK CAP LTD
CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. dollars in thousands, except per share data)

 
 
Six months ended June 30,
   
Three months ended June 30,
 
 
 
2019
   
2018
   
2019
   
2018
 
 
                       
Research and development expenses, net
   
4,909
     
3,357
     
2,570
     
1,737
 
General and administrative expenses
   
1,749
     
1,435
     
924
     
950
 
Operating loss
   
6,658
     
4,792
     
3,494
     
2,687
 
 
                               
Finance income, net
   
153
     
9
     
139
     
30
 
Loss before income tax
   
6,505
     
4,783
     
3,355
     
2,657
 
Taxes on income
   
-
     
(1
)
   
-
     
(2
)
Net loss
   
6,505
     
4,782
     
3,355
     
2,655
 
                                 
Other comprehensive loss:
                               
                                 
Change in fair value of cash flow hedge
   
13
     
-
     
(4
)
   
-
 
Comprehensive loss
   
6,518
     
4,782
     
3,351
     
2,655
 
                                 
Net loss per ordinary share - basic and diluted
   
0.85
     
1.74
     
0.41
     
0.7
 
                                 
Weighted average number of ordinary shares outstanding - basic and diluted
   
7,663
     
2,741
     
8,238
     
3,796
 

The accompanying notes to the consolidated financial statements are an integral part of them.

4



CHECK CAP LTD
CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share data)

 
 
Number of ordinary shares
   
  Amount
   
Additional paid-in capital
   
Other comprehensive loss
   
Accumulated deficit
   
Total shareholders’ equity
 
Balance as of January 1, 2019
   
5,330,684
   
$
3,456
   
$
72,888
   
$
(13
)
 
$
(63,301
)
 
$
13,030
 
Issuance of ordinary shares in the 2019 registered direct Offering, net of issuance expenses in an amount of $987 (1)
   
2,906,376
     
1,928
     
4,583
     
-
     
-
     
6,511
 
RSU’s vesting
   
718
     
(*
)
   
-
                     
(*
)
Share-based compensation
   
-
     
-
     
83
     
-
     
-
     
83
 
Other comprehensive loss
   
-
     
-
     
-
     
17
     
-
     
17
 
Net loss
   
-
     
-
     
-
     
-
     
(3,150
)
   
(3,150
)
Balance as of March 31, 2019
   
8,237,778
   
$
5,384
   
$
77,554
   
$
4
   
$
(66,451
)
   
16,491
 
Share-based compensation
   
-
             
186
                     
186
 
RSU’s vesting
   
684
     
(*
)
   
-
     
-
     
-
     
(*
)
Other comprehensive loss
   
-
     
-
     
-
     
(4
)
   
-
     
(4
)
Net loss
   
-
     
-
     
-
     
-
     
(3,355
)
   
(3,355
)
Balance as of June 30, 2019
   
8,238,462
   
$
5,384
   
$
77,740
   
$
-
   
$
(69,806
)
   
13,318
 


(1)
Includes pre-funded warrants to purchase 1,024,876 ordinary shares at a purchase price of $2.57 per pre-funded warrant, issued in connection with the registered direct offering. See Note 5A.

(*) Represents amount less than 1 thousand.


5


CHECK CAP LTD
CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share data)
      Number of ordinary shares
     
Amount
     
Additional
paid-in capital
     

Other comprehensive loss
     
Accumulated
deficit
     
Total shareholders’ equity
 
Balance as of January 1, 2018
   
1,605,434
   
$
974
   
$
57,643
   
$
-
   
$
(52,712
)
 
$
5,905
 
 RSU’s vesting
   
2,267
     
1
     
(1
)
                       
Share-based compensation
   
-
     
-
     
(436
)
   
-
     
-
     
(436
)
Net loss
   
-
     
-
     
-
     
-
     
(2,127
)
   
(2,127
)
Balance as of March 31, 2018
   
1,607,701
   
$
975
   
$
57,206
   
$
-
   
$
(54,839
)
 
$
3,342
 
Issuance of ordinary shares in May 2018 in the Public Offering, net of issuance expenses in an amount of $2,381 (2)
   
3,669,129
     
2,444
     
15,343
     
-
     
-
     
17,787
 
Exercise of warrants into ordinary shares
   
13,576
     
9
     
(9
)
                   
-
 
RSU’s vesting
   
951
     
1
     
(1
)
   
-
     
-
     
-
 
Share-based compensation
   
-
     
-
     
43
     
-
     
-
     
43
 
Net loss
   
-
     
-
     
-
     
-
     
(2,655
)
   
(2,655
)
Balance as of June 30, 2018
   
5,291,357
   
$
3,429
   
$
72,587
   
$
-
   
$
(57,494
)
 
$
18,522
 


(2)
Includes pre-funded warrants to purchase 450,909 ordinary shares at a purchase price of $5.49 per pre-funded warrant, issued in connection with the registered direct offering.

The accompanying notes to the consolidated financial statements are an integral part of them.

6


CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
  (U.S. dollars in thousands, except per share data)
 
 
 
Six months ended
June 30,
 
 
 
2019
   
2018
 
CASH FLOWS FROM OPERATING ACTIVITIES
     
Net loss for the period
   
(6,505
)
   
(4,782
)
Adjustments required to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
   
55
     
82
 
Share-based compensation
   
269
     
(393
)
Financial (income) expenses, net
   
(32
)
   
(18
)
Increase in royalties provision
   
3
     
25
 
Changes in assets and liabilities items:
               
Decrease in prepaid and other current assets and non-current assets
   
50
     
35
 
Decrease in trade accounts payable, accruals and other current liabilities
   
(204
)
   
(131
)
Increase (decrease) in employees and payroll accruals
   
15
     
288
 
Net cash used in operating activities
   
(6,349
)
   
(4,894
)
 
               
CASH FLOWS FROM INVESTING ACTIVITIES
               
Purchase of property and equipment
   
(49
)
   
(8
)
Investments in short-term bank deposits, net
   
(370
)
   
(10,000
)
Net cash used in investing activities
   
(419
)
   
(10,008
)
 
               
CASH FLOWS FROM FINANCING ACTIVITIES
               
Issuance of ordinary shares in the 2018 public offering, net of issuance expenses
   
-
     
17,862
 
Issuance of ordinary shares in the 2019 registered direct offering, net of issuance expenses
   
6,511
     
-
 
Net cash provided by financing activities
   
6,511
     
17,862
 
 
               
Net increase (decrease) in cash and cash equivalents and restricted cash
   
(257
)
   
2,960
 
Cash and cash equivalents and restricted cash at the beginning of the period
   
8,922
     
6,997
 
Cash and cash equivalents and restricted cash at the end of the period
   
8,665
     
9,957
 


7


CHECK-CAP LTD.
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
 (U.S. dollars in thousands, except per share data)
 
Supplemental information for Cash Flow:
 
 
 
Six months ended
June 30,
 
 
 
2019
   
2018
 
Supplemental disclosure of non-cash flow information
           
Cashless exercise of warrants to purchase ordinary shares into ordinary shares
   
-
     
9
 
Purchase of property and equipment
   
-
     
7
 
 Recognition of operating leases and operating lease liabilities from adoption of ASU 2016-02
   
490
     
-
 
 
The accompanying notes to the consolidated financial statements are an integral part of them.


8


CHECK CAP LTD
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
NOTE 1 -       GENERAL INFORMATION
     
 
                        A.         General
 
 
   1)
Check Cap Ltd. (together with its wholly-owned subsidiary, the "Company") was incorporated under the laws of the state of Israel. The registered address of its offices is 29 Abba Hushi Ave, Isfiya 3009000, Israel.

 
   2)
Check-Cap Ltd has a wholly-owned subsidiary, Check-Cap U.S. Inc., incorporated under the laws of the United States (U.S.) on May 15, 2015.

 
   3)
The Company is a clinical-stage medical diagnostics company developing C-Scan®, the first capsule-based system for preparation-free colorectal cancer screening (the "C-Scan system"). 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, the C-Scan system removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation.

 
   4)
On February 24, 2015 the Company consummated an Initial Public Offering in the U.S. (the "IPO") concurrently with a Private Placement (the "Private Placement").

 


On August 11, 2016, the Company consummated a registered direct offering of ordinary shares and pre-funded warrants (the "August 2016 RD Offering").

On June 2, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants (the "June 2017 RD Offering").

On November 22, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants (the "November 2017 RD Offering").

On May 8, 2018, the Company consummated an underwritten public offering of ordinary shares, pre-funded warrants and warrants.

On February 6, 2019, the Company consummated a registered direct offering of ordinary shares, and pre-funded warrants and warrants. See Note 5(A).

The Company's ordinary shares, Series A Warrants and Series C Warrants are listed on the NASDAQ Capital Market under the symbols "CHEK", "CHEKW" and CHEKZ” respectively.

 
   5)
The consolidated financial statements of the Company as of and for the six months ended June 30, 2019 include the financial statements of the Company and its wholly-owned U.S. subsidiary.

B.        Going concern and management plans
 
The accompanying unaudited consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since its inception, the Company has devoted substantially all of its efforts to research and development, clinical trials, recruiting management and technical staff, acquiring assets and raising capital. The Company is still in its development and clinical stage and has not yet generated revenues. The extent of the Company's future operating losses and the timing of becoming profitable are uncertain. The Company has incurred losses net of $6.5 million and $4.8 million for the six months ended June 30, 2019 and 2018, respectively. As of June 30, 2019, the Company's accumulated deficit was $69.8 million. The Company has funded its operations to date primarily through equity financing and through grants from the Israel Innovation Authority of the Ministry of Economy and Industry (the "IIA") (formerly the Office of the Chief Scientist of the Ministry of Economy and Industry (the "OCS)).

9


CHECK CAP LTD
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1 -        GENERAL INFORMATION (Cont.)

B.        Going concern and management plans (Cont.)

Additional funding will be required to complete the Company's research and development and clinical trials, to attain regulatory approvals, to begin the commercialization efforts of the Company's C-Scan system and to achieve a level of sales adequate to support the Company's cost structure.

To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings and other funding transactions. While the Company has been successful in raising financing in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. Uncertain market conditions and approval by regulatory bodies and adverse results from clinical trials may (among other reasons) adversely impact the Company's ability to raise capital in the future.

During the six months ended June 30, 2019, the Company consummated a registered direct offering and received gross proceeds (before deducting issuance expenses) of approximately $7.5 million.  (see Note 3A).
 
The Company believes that current cash on hand will be sufficient to fund operations into February 2020. Management expects that the Company will continue to generate losses from the development, clinical development and regulatory activities of the Company's C-Scan system, which will result in a negative cash flow from operating activity. This has led management to conclude that substantial doubt about the Company's ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the end of 2019, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects and clinical trials, until it is able to obtain sufficient financing. If such sufficient financing is not received timely, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. The Company's unaudited consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty.
 
NOTE 2 -          UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying unaudited consolidated financial statements have been prepared in a condensed format and include the consolidated financial operations of the Company as of June 30, 2019 and for the six and three month periods then ended, in accordance with U.S. GAAP, relating to the preparation of financial statements for interim periods. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete set of financial statements. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2018 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 28, 2019 (the "Annual Report"). In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2019, are not necessarily indicative of the results that may be expected for the year ended December 31, 2019.

NOTE 3 -          SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies that have been applied in the preparation of the unaudited consolidated financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F except for the adoption of the following:

In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842). This ASU requires entities that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. The Company adopted this ASU effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted.

10


CHECK CAP LTD
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 3 -        SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONT.)

In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for nonemployee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. The Company adopted these amendments on January 1, 2019. The adoption of these amendments did not have a material impact on the consolidated financial statements and related disclosures.

Recent Accounting Standards:
In June 2016, the FASB issued ASU 2016-13 “Financial Instruments – Credit Losses” to improve information on credit losses for financial assets and net investment in leases that are not accounted for at fair value through net income. The ASU replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses. This ASU is effective for the Company in the first quarter of 2020, with early adoption permitted. The Company is currently evaluating the effect the adoption of this ASU will have on its consolidated financial statements.
 
In August 2018, the FASB issued ASU 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements”, which will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies, and adds certain disclosure requirements, and is effective for the Company beginning on January 1, 2020. The Company does not expect that this standard will have a material effect on the Company’s consolidated financial statements.

NOTE 4-        LEASES

On January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”) using the modified retrospective approach for all lease arrangements at the beginning period of adoption. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. The Company leases office space and vehicles under operating leases. At June 30, 2019, the Company’s right-of-use assets and lease liabilities for operating leases totaled $423 thousands and $423 thousands, respectively. The impact of adopting the new lease standard was not material to the Company’s condensed consolidated statement of operations for the periods presented.

Supplemental cash flow information related to operating leases was as follows (unaudited in thousands):

   
Six Months Ended June 30, 2019
 
Cash payments for operating leases
 
$
97
 

As of June 30, 2019, our operating leases had a weighted average remaining lease term of 2.6 years and a weighted average borrowing rate of 5%. Future lease payments under operating leases as of June 30, 2019 were as follows (unaudited in thousands):

   
Operating Leases
 
Remainder of 2019
 
$
95
 
2020
 
$
177
 
2021
 
$
135
 
2022
 
$
42
 
Total future lease payments
 
$
449
 
Less imputed interest
   
(26
)
Total lease liability balance
 
$
423
 


11


CHECK CAP LTD
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 5 -        SHAREHOLDERS' EQUITY

The following changes occurred during the six months ended June 30, 2019:

 
A.
On February 6, 2019, the Company issued 1,881,500 units, at a purchase price of $2.58 per unit, and 1,024,876 pre-funded units, at a purchase price of $2.57 per pre-funded unit, in a registered direct offering. Each unit consisted of one ordinary share of the Company and one Series D Warrant to purchase 0.5 ordinary share of the Company. Each pre-funded unit consisted of one pre-funded warrant to purchase one ordinary share and one Series D Warrant to purchase 0.5 ordinary share. The exercise price of each pre-funded warrant included in the pre-funded unit was $0.01 per share. The Series D Warrants have an exercise price of $2.58 per ordinary share and are immediately exercisable and will expire on the fifth anniversary of the original issuance date. The Company received gross proceeds from the registered direct offering of approximately $7.5 million (including proceeds from the exercise of 1,024,876 pre-funded warrants), or $6.5 million, net of issuance expenses in the amount of $987 thousands.

 
B.
Warrants that expired during the six months ended June 30, 2019:

 

On June 1, 2019, certain warrants that were granted in June 1, 2009 to purchase 3,487 and 4,202 ordinary shares at an exercise price of $59.88 and $65.56 per share, respectively, expired.

NOTE 6 -        SHARE-BASED COMPENSATION

A summary of the Company's option activity related to options granted to employees, service providers and directors, and related information is as follows:

 
 
For the six months ended June 30, 2019
 
 
 
Number
   
Weighted
average
exercise price
(in $)
   
Weighted
average
remaining contractual life (in years)
 
 
                 
Options outstanding at beginning of period
   
422,784
     
15.54
     
8.6
 
Options granted
   
20,814
     
2.68
         
Options forfeited
   
(50,492
)
   
12.92
         
 
                       
Options outstanding at end of period
   
393,106
     
14.14
     
7.98
 
 
                       
Options exercisable at end of period
   
95,675
     
44.92
     
4.35
 



12



CHECK CAP LTD
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 6 -       SHARE-BASED COMPENSATION

A summary of the Company’s RSUs activity is as follows:

   
For the six months ended June 30, 2019
 
       
Unvested at beginning of year
   
109,469
 
Granted
   
-
 
Vested
   
(1,402
)
Forfeited
   
(18,228
)
Unvested at end of year
   
89,839
 
 
13

v3.19.2
Document and Entity Information
6 Months Ended
Jun. 30, 2019
Document and Entity Information [Abstract]  
Document Type 6-K
Document Period End Date Jun. 30, 2019
Amendment Flag false
Entity Registrant Name Check-Cap Ltd
Entity Central Index Key 0001610590
Current Fiscal Year End Date --12-31
Document Fiscal Year Focus 2019
Document Fiscal Period Focus Q2
v3.19.2
CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Current assets    
Cash and cash equivalents $ 8,315 $ 8,572
Restricted cash 350 350
Short-term bank deposit 6,044 5,643
Prepaid expenses and other current assets 370 419
Total current assets 15,079 14,984
Non-current assets    
Property and equipment, net 446 452
Operating leases 423
Total non-current assets 869 452
Total assets 15,948 15,436
Accounts payable and accruals    
Trade 855 1,113
Other 290 249
Employees and payroll accruals 874 859
Operating lease liabilities 187
Total current liabilities 2,206 2,221
Non-current liabilities    
Royalties provision 188 185
Operating lease liabilities 236
Total non-current liabilities 424 185
Shareholders' equity    
Share capital 5,384 3,456
Additional paid-in capital 77,740 72,888
Accumulated other comprehensive loss (13)
Accumulated deficit (69,806) (63,301)
Total shareholders' equity 13,318 13,030
Total liabilities and shareholders' equity $ 15,948 $ 15,436
v3.19.2
CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Income Statement [Abstract]        
Research and development expenses, net $ 2,570 $ 1,737 $ 4,909 $ 3,357
General and administrative expenses 924 950 1,749 1,435
Operating loss 3,494 2,687 6,658 4,792
Finance income, net 139 30 153 9
Loss before income tax 3,355 2,657 6,505 4,783
Taxes on income (2) (1)
Net loss 3,355 2,655 6,505 4,782
Other comprehensive loss:        
Change in fair value of cash flow hedge (4) 13
Comprehensive loss $ 3,351 $ 2,655 $ 6,518 $ 4,782
Net loss per ordinary share - basic and diluted $ 0.41 $ 0.7 $ 0.85 $ 1.74
Weighted average number of ordinary shares outstanding - basic and diluted 8,238 3,796 7,663 2,741
v3.19.2
CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($)
$ in Thousands
Ordinary share [Member]
Additional paid-in capital [Member]
Other comprehensive loss [Member]
Accumulated deficit [Member]
Total
Beginning balance at Dec. 31, 2017 $ 974 $ 57,643 $ (52,712) $ 5,905
Beginning balance, shares at Dec. 31, 2017 1,605,434        
Share-based compensation (436) (436)
RSU's vesting $ 1 (1)      
RSU's vesting, shares 2,267        
Net loss (2,127) (2,127)
Ending balance at Mar. 31, 2018 $ 975 57,206 (54,839) 3,342
Ending balance, shares at Mar. 31, 2018 1,607,701        
Beginning balance at Dec. 31, 2017 $ 974 57,643 (52,712) 5,905
Beginning balance, shares at Dec. 31, 2017 1,605,434        
Net loss         (4,782)
Ending balance at Jun. 30, 2018 $ 3,429 72,587 (57,494) 18,522
Ending balance, shares at Jun. 30, 2018 5,291,357        
Beginning balance at Mar. 31, 2018 $ 975 57,206 (54,839) 3,342
Beginning balance, shares at Mar. 31, 2018 1,607,701        
Issuance of ordinary shares in May 2018 in the Public Offering, net of issuance expenses in an amount of $2,381 [1] $ 2,444 15,343 17,787
Issuance of ordinary shares in May 2018 in the Public Offering, net of issuance expenses in an amount of $2,381, shares [1] 3,669,129        
Exercise of warrants into ordinary shares $ 9 (9)    
Exercise of warrants into ordinary shares, shares 13,576        
Share-based compensation 43 43
RSU's vesting $ 1 (1)
RSU's vesting, shares 951        
Net loss (2,655) (2,655)
Ending balance at Jun. 30, 2018 $ 3,429 72,587 (57,494) 18,522
Ending balance, shares at Jun. 30, 2018 5,291,357        
Beginning balance at Dec. 31, 2018 $ 3,456 72,888 (13) (63,301) 13,030
Beginning balance, shares at Dec. 31, 2018 5,330,684        
Issuance of ordinary shares in the 2019 registered direct Offering, net of issuance expenses in an amount of $987 [2] $ 1,928 4,583 6,511
Issuance of ordinary shares in the 2019 registered direct Offering, net of issuance expenses in an amount of $987, shares [2] 2,906,376        
Share-based compensation 83 83
RSU's vesting [3]     [3]
RSU's vesting, shares 718        
Other comprehensive loss 17 17
Net loss (3,150) (3,150)
Ending balance at Mar. 31, 2019 $ 5,384 77,554 4 (66,451) 16,491
Ending balance, shares at Mar. 31, 2019 8,237,778        
Beginning balance at Dec. 31, 2018 $ 3,456 72,888 (13) (63,301) 13,030
Beginning balance, shares at Dec. 31, 2018 5,330,684        
Net loss         (6,505)
Ending balance at Jun. 30, 2019 $ 5,384 77,740 (69,806) 13,318
Ending balance, shares at Jun. 30, 2019 8,238,462        
Beginning balance at Mar. 31, 2019 $ 5,384 77,554 4 (66,451) 16,491
Beginning balance, shares at Mar. 31, 2019 8,237,778        
Share-based compensation 186     186
RSU's vesting [3] [3]
RSU's vesting, shares 684        
Other comprehensive loss (4) (4)
Net loss (3,355) (3,355)
Ending balance at Jun. 30, 2019 $ 5,384 $ 77,740 $ (69,806) $ 13,318
Ending balance, shares at Jun. 30, 2019 8,238,462        
[1] Includes pre-funded warrants to purchase 450,909 ordinary shares at a purchase price of $5.49 per pre-funded warrant, issued in connection with the registered direct offering.
[2] Includes pre-funded warrants to purchase 1,024,876 ordinary shares at a purchase price of $2.57 per pre-funded warrant, issued in connection with the registered direct offering. See Note 5A.
[3] Represents amount less than 1 thousand.
v3.19.2
CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Warrant [Member]    
Pre-funded warrants to purchase ordinary shares 1,024,876 450,909
Pre-funded warrants to purchase price $ 2.57 $ 5.49
Registered Direct Public Offering [Member]    
Issuance expenses $ 987 $ 2,381
v3.19.2
CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
CASH FLOWS FROM OPERATING ACTIVITIES    
Net loss for the period $ (6,505) $ (4,782)
Adjustments required to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 55 82
Share-based compensation 269 (393)
Financial (income) expenses, net (32) (18)
Increase in royalties provision 3 25
Changes in assets and liabilities items:    
Decrease in prepaid and other current assets and non-current assets 50 35
Decrease in trade accounts payable, accruals and other current liabilities (204) (131)
Increase (decrease) in employees and payroll accruals 15 288
Net cash used in operating activities (6,349) (4,894)
CASH FLOWS FROM INVESTING ACTIVITIES    
Purchase of property and equipment (49) (8)
Investments in short-term bank deposits, net (370) (10,000)
Net cash used in investing activities (419) (10,008)
CASH FLOWS FROM FINANCING ACTIVITIES    
Issuance of ordinary shares in the 2018 public offering, net of issuance expenses 17,862
Issuance of ordinary shares in the 2019 registered direct offering, net of issuance expenses 6,511
Net cash provided by financing activities 6,511 17,862
Net increase (decrease) in cash and cash equivalents and restricted cash (257) 2,960
Cash and cash equivalents and restricted cash at the beginning of the period 8,922 6,997
Cash and cash equivalents and restricted cash at the end of the period 8,665 9,957
Supplemental disclosure of non-cash flow information    
Cashless exercise of warrants to purchase ordinary shares into ordinary shares 9
Purchase of property and equipment 7
Recognition of operating leases and operating lease liabilities from adoption of ASU 2016-02 $ 490
v3.19.2
GENERAL INFORMATION
6 Months Ended
Jun. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
GENERAL INFORMATION
NOTE 1 -       GENERAL INFORMATION
     
 
                        A.         General
 
 
   1)
Check Cap Ltd. (together with its wholly-owned subsidiary, the "Company") was incorporated under the laws of the state of Israel. The registered address of its offices is 29 Abba Hushi Ave, Isfiya 3009000, Israel.

 
   2)
Check-Cap Ltd has a wholly-owned subsidiary, Check-Cap U.S. Inc., incorporated under the laws of the United States (U.S.) on May 15, 2015.

 
   3)
The Company is a clinical-stage medical diagnostics company developing C-Scan®, the first capsule-based system for preparation-free colorectal cancer screening (the "C-Scan system"). 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, the C-Scan system removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation.

 
   4)
On February 24, 2015 the Company consummated an Initial Public Offering in the U.S. (the "IPO") concurrently with a Private Placement (the "Private Placement").

 

On August 11, 2016, the Company consummated a registered direct offering of ordinary shares and pre-funded warrants (the "August 2016 RD Offering").

On June 2, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants (the "June 2017 RD Offering").

On November 22, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants (the "November 2017 RD Offering").

On May 8, 2018, the Company consummated an underwritten public offering of ordinary shares, pre-funded warrants and warrants.

On February 6, 2019, the Company consummated a registered direct offering of ordinary shares, and pre-funded warrants and warrants. See Note 5(A).

The Company's ordinary shares, Series A Warrants and Series C Warrants are listed on the NASDAQ Capital Market under the symbols "CHEK", "CHEKW" and CHEKZ” respectively.

 
   5)
The consolidated financial statements of the Company as of and for the six months ended June 30, 2019 include the financial statements of the Company and its wholly-owned U.S. subsidiary.

B.        Going concern and management plans
 
The accompanying unaudited consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since its inception, the Company has devoted substantially all of its efforts to research and development, clinical trials, recruiting management and technical staff, acquiring assets and raising capital. The Company is still in its development and clinical stage and has not yet generated revenues. The extent of the Company's future operating losses and the timing of becoming profitable are uncertain. The Company has incurred losses net of $6.5 million and $4.8 million for the six months ended June 30, 2019 and 2018, respectively. As of June 30, 2019, the Company's accumulated deficit was $69.8 million. The Company has funded its operations to date primarily through equity financing and through grants from the Israel Innovation Authority of the Ministry of Economy and Industry (the "IIA") (formerly the Office of the Chief Scientist of the Ministry of Economy and Industry (the "OCS)).

Additional funding will be required to complete the Company's research and development and clinical trials, to attain regulatory approvals, to begin the commercialization efforts of the Company's C-Scan system and to achieve a level of sales adequate to support the Company's cost structure.

To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings and other funding transactions. While the Company has been successful in raising financing in the past, there can be no assurance that it will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. Uncertain market conditions and approval by regulatory bodies and adverse results from clinical trials may (among other reasons) adversely impact the Company's ability to raise capital in the future.

During the six months ended June 30, 2019, the Company consummated a registered direct offering and received gross proceeds (before deducting issuance expenses) of approximately $7.5 million.  (see Note 3A).
 
The Company believes that current cash on hand will be sufficient to fund operations into February 2020. Management expects that the Company will continue to generate losses from the development, clinical development and regulatory activities of the Company's C-Scan system, which will result in a negative cash flow from operating activity. This has led management to conclude that substantial doubt about the Company's ability to continue as a going concern exists. In the event the Company is unable to successfully raise additional capital during or before the end of 2019, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects and clinical trials, until it is able to obtain sufficient financing. If such sufficient financing is not received timely, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. The Company's unaudited consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty
v3.19.2
UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
6 Months Ended
Jun. 30, 2019
Unaudited Consolidated Financial Statements  
UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 -          UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying unaudited consolidated financial statements have been prepared in a condensed format and include the consolidated financial operations of the Company as of June 30, 2019 and for the six and three month periods then ended, in accordance with U.S. GAAP, relating to the preparation of financial statements for interim periods. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles for complete set of financial statements. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2018 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 28, 2019 (the "Annual Report"). In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2019, are not necessarily indicative of the results that may be expected for the year ended December 31, 2019.
v3.19.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2019
Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
NOTE 3 -          SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies that have been applied in the preparation of the unaudited consolidated financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F except for the adoption of the following:

In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842). This ASU requires entities that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. The Company adopted this ASU effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted.
In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for nonemployee share-based payment transactions by aligning the measurement and classification guidance, with certain exceptions, to that for share-based payment awards to employees. The amendments expand the scope of the accounting standard for share-based payment awards to include share-based payment awards granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations and supersedes the guidance related to equity-based payments to non-employees. The Company adopted these amendments on January 1, 2019. The adoption of these amendments did not have a material impact on the consolidated financial statements and related disclosures.

Recent Accounting Standards:
In June 2016, the FASB issued ASU 2016-13 “Financial Instruments – Credit Losses” to improve information on credit losses for financial assets and net investment in leases that are not accounted for at fair value through net income. The ASU replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses. This ASU is effective for the Company in the first quarter of 2020, with early adoption permitted. The Company is currently evaluating the effect the adoption of this ASU will have on its consolidated financial statements.
 
In August 2018, the FASB issued ASU 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements”, which will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies, and adds certain disclosure requirements, and is effective for the Company beginning on January 1, 2020. The Company does not expect that this standard will have a material effect on the Company’s consolidated financial statements.
v3.19.2
LEASES
6 Months Ended
Jun. 30, 2019
Leases [Abstract]  
LEASES
NOTE 4-        LEASES

On January 1, 2019, the Company adopted ASU 2016-02, Leases (Topic 842) (“ASU 2016-02”) using the modified retrospective approach for all lease arrangements at the beginning period of adoption. Leases existing for the reporting period beginning January 1, 2019 are presented under ASU 2016-02. The Company leases office space and vehicles under operating leases. At June 30, 2019, the Company’s right-of-use assets and lease liabilities for operating leases totaled $423 thousands and $423 thousands, respectively. The impact of adopting the new lease standard was not material to the Company’s condensed consolidated statement of operations for the periods presented.

Supplemental cash flow information related to operating leases was as follows (unaudited in thousands):

   
Six Months Ended June 30, 2019
 
Cash payments for operating leases
 
$
97
 

As of June 30, 2019, our operating leases had a weighted average remaining lease term of 2.6 years and a weighted average borrowing rate of 5%. Future lease payments under operating leases as of June 30, 2019 were as follows (unaudited in thousands):

   
Operating Leases
 
Remainder of 2019
 
$
95
 
2020
 
$
177
 
2021
 
$
135
 
2022
 
$
42
 
Total future lease payments
 
$
449
 
Less imputed interest
   
(26
)
Total lease liability balance
 
$
423
 
v3.19.2
SHAREHOLDERS' EQUITY
6 Months Ended
Jun. 30, 2019
Stockholders' Equity Note [Abstract]  
SHAREHOLDERS' EQUITY
NOTE 5 -        SHAREHOLDERS' EQUITY

The following changes occurred during the six months ended June 30, 2019:

 
A.
On February 6, 2019, the Company issued 1,881,500 units, at a purchase price of $2.58 per unit, and 1,024,876 pre-funded units, at a purchase price of $2.57 per pre-funded unit, in a registered direct offering. Each unit consisted of one ordinary share of the Company and one Series D Warrant to purchase 0.5 ordinary share of the Company. Each pre-funded unit consisted of one pre-funded warrant to purchase one ordinary share and one Series D Warrant to purchase 0.5 ordinary share. The exercise price of each pre-funded warrant included in the pre-funded unit was $0.01 per share. The Series D Warrants have an exercise price of $2.58 per ordinary share and are immediately exercisable and will expire on the fifth anniversary of the original issuance date. The Company received gross proceeds from the registered direct offering of approximately $7.5 million (including proceeds from the exercise of 1,024,876 pre-funded warrants), or $6.5 million, net of issuance expenses in the amount of $987 thousands.

 
B.
Warrants that expired during the six months ended June 30, 2019:

 

On June 1, 2019, certain warrants that were granted in June 1, 2009 to purchase 3,487 and 4,202 ordinary shares at an exercise price of $59.88 and $65.56 per share, respectively, expired.
v3.19.2
SHARE-BASED COMPENSATION
6 Months Ended
Jun. 30, 2019
Share-based Payment Arrangement [Abstract]  
SHARE-BASED COMPENSATION
NOTE 6 -        SHARE-BASED COMPENSATION

A summary of the Company's option activity related to options granted to employees, service providers and directors, and related information is as follows:

 
 
For the six months ended June 30, 2019
 
 
 
Number
   
Weighted
average
exercise price
(in $)
   
Weighted
average
remaining contractual life (in years)
 
 
                 
Options outstanding at beginning of period
   
422,784
     
15.54
     
8.6
 
Options granted
   
20,814
     
2.68
         
Options forfeited
   
(50,492
)
   
12.92
         
 
                       
Options outstanding at end of period
   
393,106
     
14.14
     
7.98
 
 
                       
Options exercisable at end of period
   
95,675
     
44.92
     
4.35
 


A summary of the Company’s RSUs activity is as follows:

   
For the six months ended June 30, 2019
 
       
Unvested at beginning of year
   
109,469
 
Granted
   
-
 
Vested
   
(1,402
)
Forfeited
   
(18,228
)
Unvested at end of year
   
89,839
 
v3.19.2
LEASES (Table)
6 Months Ended
Jun. 30, 2019
Leases [Abstract]  
Schedule of Supplemental Cash Flow Information Related to Operating Leases
Supplemental cash flow information related to operating leases was as follows (unaudited in thousands):

   
Six Months Ended June 30, 2019
 
Cash payments for operating leases
 
$
97
 
Schedule of Future Lease Payments
Future lease payments under operating leases as of June 30, 2019 were as follows (unaudited in thousands):

   
Operating Leases
 
Remainder of 2019
 
$
95
 
2020
 
$
177
 
2021
 
$
135
 
2022
 
$
42
 
Total future lease payments
 
$
449
 
Less imputed interest
   
(26
)
Total lease liability balance
 
$
423
 
v3.19.2
SHARE-BASED COMPENSATION (Tables)
6 Months Ended
Jun. 30, 2019
Schedule of Stock Option Activity
A summary of the Company's option activity related to options granted to employees, service providers and directors, and related information is as follows:

 
 
For the six months ended June 30, 2019
 
 
 
Number
   
Weighted
average
exercise price
(in $)
   
Weighted
average
remaining contractual life (in years)
 
 
                 
Options outstanding at beginning of period
   
422,784
     
15.54
     
8.6
 
Options granted
   
20,814
     
2.68
         
Options forfeited
   
(50,492
)
   
12.92
         
 
                       
Options outstanding at end of period
   
393,106
     
14.14
     
7.98
 
 
                       
Options exercisable at end of period
   
95,675
     
44.92
     
4.35
 
RSU [Member]  
Schedule of Stock Option Activity
A summary of the Company’s RSUs activity is as follows:

   
For the six months ended June 30, 2019
 
       
Unvested at beginning of year
   
109,469
 
Granted
   
-
 
Vested
   
(1,402
)
Forfeited
   
(18,228
)
Unvested at end of year
   
89,839
 
v3.19.2
GENERAL INFORMATION (Financial Position) (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Mar. 31, 2019
Jun. 30, 2018
Mar. 31, 2018
Jun. 30, 2019
Jun. 30, 2018
Dec. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]              
Net loss $ 3,355 $ 3,150 $ 2,655 $ 2,127 $ 6,505 $ 4,782  
Accumulated deficit $ 69,806       69,806   $ 63,301
Gross proceeds from underwritten public offering         $ 7,500    
v3.19.2
LEASES (Details) - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Leases [Abstract]    
Operating leases $ 423
Lease liabilities $ 423  
Weighted average remaining lease term 2 years 7 months 6 days  
Weighted average borrowing rate 5.00%  
v3.19.2
LEASES (Schedule of Supplemental Cash Flow Information Related to Operating Leases) (Details)
$ in Thousands
6 Months Ended
Jun. 30, 2019
USD ($)
Leases [Abstract]  
Cash payments for operating leases $ 97
v3.19.2
LEASES (Schedule of Future Lease Payments) (Details)
$ in Thousands
Jun. 30, 2019
USD ($)
Leases [Abstract]  
Remainder of 2019 $ 95
2020 177
2021 135
2022 42
Total future lease payments 449
Less imputed interest (26)
Total lease liability balance $ 423
v3.19.2
SHAREHOLDERS' EQUITY (Ordinary Shares) (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended
Feb. 06, 2019
Jun. 30, 2019
Jun. 30, 2018
Jun. 02, 2019
Jun. 02, 2009
Class of Stock [Line Items]          
Issuance of ordinary shares in IPO, net of issuance expense   $ 17,862    
Warrant [Member]          
Class of Stock [Line Items]          
Exercise price       $ 59.88 $ 65.56
Shares called by warrants       3,487 4,202
Pre-funded Warrants [Member]          
Class of Stock [Line Items]          
Exercise of warrants 1,024,876        
Issuance of ordinary shares in IPO, net of issuance expense $ 7,500        
Stock issuance costs 987        
Pre-funded Warrants one [Member]          
Class of Stock [Line Items]          
Issuance of ordinary shares in IPO, net of issuance expense $ 6,500        
Series D Warrants [Member]          
Class of Stock [Line Items]          
Exercise price $ 2.58        
IPO [Member]          
Class of Stock [Line Items]          
Shares issued 1,881,500        
Share price $ 2.58        
Pre funded Units [Member]          
Class of Stock [Line Items]          
Shares issued 1,024,876        
Share price $ 2.57        
Exercise price $ 0.01        
v3.19.2
SHARE-BASED COMPENSATION (Option Activity) (Details)
6 Months Ended
Jun. 30, 2019
$ / shares
shares
Number of options  
Outstanding at beginning of period 422,784
Options granted 20,814
Options forfeited (50,492)
Outstanding at end of period 393,106
Exercisable at end of period 95,675
Weighted average of exercise price  
Outstanding at the beginning of the year | $ / shares $ 15.54
Granted | $ / shares 2.68
Forfeited | $ / shares 12.92
Outstanding at end of period | $ / shares 14.14
Exercisable at the end of the year | $ / shares $ 44.92
Average remaining contractual life  
Outstanding at beginning of period 8 years 7 months 6 days
Outstanding at end of period 7 years 11 months 23 days
Exercisable at end of period 4 years 4 months 6 days
RSU [Member]  
Number of options  
Outstanding at beginning of period 109,469
RSUs granted
RSUs vested (1,402)
RSUs forfeited (18,228)
Outstanding at end of period 89,839