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 August 2022

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 in the first bullet under the heading “Second Quarter and Recent Highlights” as well as the text under the heading “Financial Results for the Second Quarter Ended June 30, 2022,” “Financial Results for the Six Months Ended June 30, 2022,” the accompanying financial statements, and “Legal Notice Regarding Forward-Looking Statements” in Exhibit 99.1 and Exhibit 99.2) 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 Nos. 333-226490 and 333-259666, and into the Form F-3 Registration Statements File Nos. 333-211065, 333-225789 and 333-262401.

Other Information

On August 31, 2022, Check-Cap Ltd. (the “Company”) issued a press release announcing its financial results for the second quarter of 2022. In addition, the Company released its consolidated unaudited financial statements as of June 30, 2022.

A copy of both the press release and consolidated unaudited financial statements as of June 30, 2022 are attached hereto as Exhibits 99.1 and 99.2 are incorporated herein by reference.

Exhibit
Exhibit No.	Description
99.1	Press Release, dated August 31, 2022
99.2	Consolidated Unaudited Financial Statements as of June 30, 2022

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 31, 2022		Title: Chief Executive Officer

EX-99.1

Exhibit 99.1

Check-Cap Reports Second Quarter 2022 Financial Results and Provides a Corporate Update

ISFIYA, Israel, August 31, 2022 - Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced financial results and provided a corporate update for the second quarter and six months ended June 30, 2022.

Second Quarter and Recent Highlights:

• Initiated the first part of the U.S. pivotal study of C-Scan, that focuses on device calibration and enhancement of C-Scan algorithms among the average risk U.S. population, at Mayo Clinic in Rochester, Minnesota and New York University (NYU) School of Medicine.   In parallel , Check-Cap is also enrolling average risk patients in Israel, to further optimize C-Scan functionality and patient experience. The required lead time to activate new sites as well as to recruit patients in the U.S. has been longer than expected. The Company is continuing to work on activating new sites while at the same time calibrating the C-Scan device and its algorithms. Assuming sites’ activation and calibration proceeds as planned, the Company expects the second part of the U.S. pivotal study to start in mid-2023.

• Nominated Aasma Shaukat, M.D., MPH, a Robert M. and Mary H. Glickman Professor of Gastroenterology and Professor of Population Health, Director of Gastroenterology Outcomes Research at NYU Grossman School of Medicine, as Coordinating Principal Investigator (CPI) for the pivotal study. Dr. Aasma brings two decades of experience as a practicing gastroenterologist and clinical researcher with expertise in colon cancer screening, long term outcomes and colorectal cancer non-invasive screening. She is a member of the U.S. Multi-society Task Force on Colorectal Cancer (USMSTF) and was first author of the American College of Gastroenterology (ACG) clinical guideline on Colorectal cancer screening in 2021.

• On August 11, 2022, the Company’s shareholders approved a reverse share split of the Company’s ordinary shares within a range of 1 for 10 to 1 for 20, with the exact ratio and effective date to be determined by further action of the Company’s Board of Directors, and to be announced by the company.

“Since initiation of the pivotal trial in May 2022 we have been diligently working  to expand patient enrollment and data collection,” said Alex Ovadia, chief executive officer of Check-Cap." The team is focused on achieving our study objectives and we intend to provide updates in the coming months. We are also pleased to welcome Dr. Shaukat as Coordinating Principal Investigator. Her extensive clinical experience and involvement in the colorectal cancer screening field will be extremely valuable as we continue to advance the study.”

Financial Results for the Second Quarter Ended June 30, 2022

Research and development expenses were $3.5 million for the three months ended June 30, 2022, compared to $2.8 million for the same period in 2021. The increase is primarily due to (i) an increase of approximately $0.4 million in salary and related expenses, mainly as a result of increased employee head count, and (ii) an increase of approximately $0.3 million in other research and development expenses, including clinical related expenses and regulatory consultants.  The Company expects that clinical related expenses will increase in the upcoming quarters as it progresses in its ongoing U.S. pivotal study.

General and administrative expenses were $1.3 million for the three months ended June 30, 2022, compared to $1.1 million for the same period in 2021. The increase is primarily due to a $0.1 million increase in other general expenses, mainly associated with directors’ and officers’ liability insurance, and a $0.1 million increase in share-based compensation.

Operating loss was $4.9 million for the three months ended June 30, 2022, compared to $3.9 million for the same period in 2021.

Net finance income was $81,000 for the three months ended June 30, 2022, compared to $5,000 for the same period in 2021.

Net loss was $4.8 million for the three months ended June 30, 2022, compared to $3.9 million for the same period in 2021.

Cash and cash equivalents, restricted cash and short-term bank deposits as of June 30, 2022 were $50.2 million, compared with $55.7 million as of March 31, 2022 and $51.9 million as of December 31, 2021.  On March 3, 2022, the Company consummated a registered direct offering for the sale of 20,000,000 of the Company's ordinary shares and accompanying warrants to purchase up to an aggregate of 15,000,000 of the Company's ordinary shares. The registered direct offering resulted in gross proceeds to the Company of $10.0 million or approximately $8.9 million net of offering expenses. The Company believes that it has sufficient capital to fund its ongoing operations and plans into the second quarter of 2024.

Financial Results for the Six Months Ended June 30, 2022

Research and development expenses were $7.7 million for the six months ended June 30, 2022, compared to $5.2 million for the same period in 2021. The increase is primarily due to (i) an increase of approximately $1.2 million in salary and related expenses, mainly as a result of increased employee head count, (ii) an increase of approximately $0.8 million in other research and development expenses, including clinical related expenses and regulatory consultants and (iii) an increase of approximately $0.2 million in share-based compensation.  The increase in net research and development expenses between 2022 and 2021 is also due to a $0.3 million grant from the Israel Innovation Authority, which amount was recorded as a deduction from research and development expenses in the six months ended June 30, 2021.

General and administrative expenses were $3.1 million for the six months ended June 30, 2022, compared to $2.3 million for the same period in 2021. The increase is primarily due to a $0.4 million increase in professional services, a $0.2 million increase in other general expenses, mainly associated with directors’ and officers’ liability insurance, and a $0.2 million increase in share-based compensation.

Operating loss was $10.8 million for the six months ended June 30, 2022, compared to $7.5 million for the same period in 2021.

Net finance income was $132,000 for the six months ended June 30, 2022, compared to finance loss of $4,000 for the same period in 2021.

Net loss was $10.6 million for the six months ended June 30, 2022, compared to $7.5 million for the same period in 2021.

Net cash used in operating activities was $10.3 million for the six months ended June 30, 2022, compared to $7.8 million for the same period in 2021.

About Check-Cap

Check-Cap is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. The Company’s disruptive capsule-based screening technology aims to help millions of people to stay healthy through preventive CRC screening. C-Scan uses 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 as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and requires no sedation. It requires no bowel preparation, allowing the patients to continue their daily routine with no interruption. C-Scan is not intended to replace colonoscopy. A positive C-Scan result should be followed by colonoscopy.  C-Scan is an investigational device and is not available for sale in the United States.

Legal Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" about the Company’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. 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, 2021 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

Irina Koffler 
LifeSci Advisors, LLC 
646.970.4681
ikoffler@lifesciadvisors.com

Meirav Gomeh-Bauer
LifeSci Advisors, LLC 
+972(0)-54-476-4979
Meirav@lifesciadvisors.com

Media Contact

Mónica Rouco Molina, Ph.D.
Account Supervisor - Europe
LifeSci Communications
mroucomolina@lifescicomms.com

CHECK CAP LTD

CONSOLIDATED UNAUDITED BALANCE SHEETS

(U.S. dollars in thousands, except share and per share data)

	June 30,			December 31,
	2022			2021
	Unaudited			Audited
Assets
Current assets
Cash and cash equivalents	$	11,637		$	26,457
Restricted cash		351			350
Short-term bank deposit		38,206			25,104
Prepaid expenses and other current assets		996			839
Total current assets		51,190			52,750
Non-current assets
Property and equipment, net		1,836			1,793
Operating leases		1,100			1,116
Total non-current assets		2,936			2,909
Total assets	$	54,126		$	55,659
Liabilities and shareholders' equity
Current liabilities
Accounts payable and accruals
Trade	$	946		$	1,050
Other		701			680
Employees and payroll accruals		1,668			1,961
Other current liabilities		279			-
Operating lease liabilities		332			350
Total current liabilities		3,926			4,041
Non-current liabilities
Royalties provision		107			132
Operating lease liabilities		669			795
Total non-current liabilities		776			927
Shareholders' equity
Share capital, Ordinary shares, 2.4 NIS par value (360,000,000 authorized shares as of June 30, 2022 and December
31, 2021, respectively; 116,411,949 and 96,411,949 shares issued and outstanding as of June 30, 2022 and December
31, 2021, respectively)		83,602			68,787
Additional paid-in capital		84,648			90,089
Accumulated deficit		(118,826	)		(108,185	)
Total shareholders' equity		49,424			50,691
Total liabilities and shareholders' equity	$	54,126		$	55,659

CHECK CAP LTD 

CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS

(U.S. dollars in thousands, except share and per share data)

	Six months ended June 30,					Three months ended June 30,
	2022		2021			2022		2021
Research and development expenses, net	$	7,673	$	5,187		$	3,545	$	2,781
General and administrative expenses		3,100		2,293			1,343		1,142
Operating loss		10,773		7,480			4,888		3,923
Finance Income (loss), net		132		(4	)		81		5
Loss before income tax		10,641		7,484			4,807		3,918
Net loss for the period	$	10,641	$	7,484		$	4,807	$	3,918
Loss per share:
Net loss per ordinary share basic and diluted	$	0.10	$	0.11		$	0.04	$	0.06
Weighted average number of ordinary shares outstanding - basic and diluted		109,561,120		69,284,917			116,411,949		70,485,435

CHECK CAP LTD.

CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

(U.S. dollars in thousands, except share and per share data)

	Number of				Additional						Total
	Ordinary				paid-in			Accumulated			shareholders'
	Shares		Amount		capital			deficit			equity
Balance as of January 1, 2022		96,411,949	$	68,787	$	90,089		$	(108,185(		$	50,691
Issuance of ordinary shares in registered direct offerings, net of
issuance expenses in an amount of $1,150		20,000,000		14,815		(5,965	)		-			8,850
Share-based compensation		-		-		250			-			250
Net loss		-		-		-			(5,834	)		(5,834	)
Balance as of March 31, 2022		116,411,949	$	83,602	$	84,374		$	(114,019	)	$	53,957
Share-based compensation		-		-		274			-			274
Net loss		-		-		-			(4,807	)		(4,807	)
Balance as of June 30, 2022		116,411,949	$	83,602	$	84,648		$	(118,826	)	$	49,424

Balance as of January 1, 2021	46,239,183	$	31,646	$	75,715		$	(90,983	)	$	16,378
Exercise of warrants, net of issuance expenses in
an amount of $22	24,204,682		18,099		1,120			-			19,219
RSUs vesting	24,395		18		(18	)		-			-
Share-based compensation	-		-		73			-			73
Net loss	-		-		-			(3,566	)		(3,566	)
Balance as of March 31, 2021	70,468,260	$	49,763	$	76,890		$	(94,549	)	$	32,104
RSUs vesting	5,381		4		(4	)		-			-
Share-based compensation	-		-		65			-			65
Net loss	-		-		-			(3,918	)		(3,918	)
Balance as of June 30, 2021	70,473,641	$	49,767	$	76,951		$	(98,467	)	$	28,251

CHECK-CAP LTD.

CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands, except share and per share data)

	Six months ended
	June 30,
	2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(10,641	)	$	(7,484	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		159			89
Share-based compensation		525			138
Financial income, net		(239	)		(36	)
Changes in assets and liabilities items:
Increase in prepaid and other current assets and non-current assets		(152	)		(508	)
Increase in trade accounts payable, accruals and other current liabilities		320			27
Decrease in employees and payroll accruals		(293	)		(62	)
(Decrease) increase in royalties provision		(25	)		35
Net cash used in operating activities	$	(10,346	)	$	(7,801	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment		(323	)		(218	)
Investment in short-term bank and other deposits		(13,000	)		(8,814	)
Net cash used in investing activities	$	(13,323	)	$	(9,032	)
CASH FLOWS FROM FINANCING ACTIVITIES
Exercise of warrants into ordinary shares, net of issuance expenses		—			19,219
Issuance of ordinary shares in the registered direct offerings, net of issuance expenses		8,850			—
Net cash provided by financing activities	$	8,850		$	19,219
Net increase in cash, cash equivalents and restricted cash		(14,819	)		2,386
Cash, cash equivalents and restricted cash at the beginning of the period		26,807			8,053
Cash, cash equivalents and restricted cash at the end of the period	$	11,988		$	10,439

	Six months ended June 30,
	2022		2021
Supplemental disclosure of non-cash flow information
Purchase of property and equipment included in accounts payable and accrued expenses		38		59
Financing fees included in other account payable and accruals		—		291
Assets acquired under operating lease		167		916

Supplemental disclosure of cash flow information:
Cash paid for taxes	3	7
Interest received	138	24

EX-99.2

Exhibit 99.2

CHECK CAP LTD.

CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

AS OF JUNE 30, 2022

CHECK CAP LTD.

CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS AS OF JUNE 30, 2022

Table of Contents

	Page
Financial Statements:
Consolidated Unaudited Balance Sheets	3
Consolidated Unaudited Statements of Comprehensive Loss	4
Consolidated Unaudited Statements of Changes in Shareholders Equity	5
Consolidated Unaudited Statements of Cash Flows	6-7
Notes to Consolidated Unaudited Financial Statements	8-13

CHECK CAP LTD

CONSOLIDATED UNAUDITED BALANCE SHEETS

(U.S. dollars in thousands, except share and per share data)

	June 30,			December 31,
	2022			2021
	Unaudited			Audited
Assets
Current assets
Cash and cash equivalents	$	11,637		$	26,457
Restricted cash		351			350
Short-term bank deposit		38,206			25,104
Prepaid expenses and other current assets		996			839
Total current assets		51,190			52,750
Non-current assets
Property and equipment, net		1,836			1,793
Operating leases		1,100			1,116
Total non-current assets		2,936			2,909
Total assets	$	54,126		$	55,659
Liabilities and shareholders' equity
Current liabilities
Accounts payable and accruals
Trade	$	946		$	1,050
Other		701			680
Employees and payroll accruals		1,668			1,961
Other current liabilities		279			-
Operating lease liabilities		332			350
Total current liabilities		3,926			4,041
Non-current liabilities
Royalties provision		107			132
Operating lease liabilities		669			795
Total non-current liabilities		776			927
Shareholders' equity
Share capital, Ordinary shares, 2.4 NIS par value (360,000,000 authorized shares as of June 30, 2022 and December
31, 2021, respectively; 116,411,949 and 96,411,949 shares issued and outstanding as of June 30, 2022 and December
31, 2021, respectively)		83,602			68,787
Additional paid-in capital		84,648			90,089
Accumulated deficit		(118,826	)		(108,185	)
Total shareholders' equity		49,424			50,691
Total liabilities and shareholders' equity	$	54,126		$	55,659

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

3

CHECK CAP LTD

CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS

(U.S. dollars in thousands, except share and per share data)

	Six months ended June 30,					Three months ended June 30,
	2022		2021			2022		2021
Research and development expenses, net	$	7,673	$	5,187		$	3,545	$	2,781
General and administrative expenses		3,100		2,293			1,343		1,142
Operating loss		10,773		7,480			4,888		3,923
Finance Income (loss), net		132		(4	)		81		5
Loss before income tax		10,641		7,484			4,807		3,918
Net loss for the period	$	10,641	$	7,484		$	4,807	$	3,918
Loss per share:
Net loss per ordinary share basic and diluted	$	0.10	$	0.11		$	0.04	$	0.06
Weighted average number of ordinary shares outstanding - basic and diluted		109,561,120		69,284,917			116,411,949		70,485,435

The accompanying notes to the consolidated unaudited 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 and per share data)

	Number of				Additional						Total
	Ordinary				paid-in			Accumulated			shareholders'
	Shares		Amount		capital			deficit			equity
Balance as of January 1, 2022		96,411,949	$	68,787	$	90,089		$	(108,185	)	$	50,691
Issuance of ordinary shares in registered direct offerings, net of issuance
expenses in an amount of $1,150		20,000,000		14,815		(5,965	)		-			8,850
Share-based compensation		-		-		250			-			250
Net loss		-		-		-			(5,834	)		(5,834	)
Balance as of March 31, 2022		116,411,949	$	83,602	$	84,374		$	(114,019	)	$	53,957
Share-based compensation		-		-		274			-			274
Net loss		-		-		-			(4,807	)		(4,807	)
Balance as of June 30, 2022		116,411,949	$	83,602	$	84,648		$	(118,826	)	$	49,424
Balance as of January 1, 2021		46,239,183	$	31,646	$	75,715		$	(90,983	)	$	16,378
Exercise of warrants, net of issuance expenses in
an amount of $22		24,204,682		18,099		1,120			-			19,219
RSUs vesting		24,395		18		(18	)		-			-
Share-based compensation		-		-		73			-			73
Net loss		-		-		-			(3,566	)		(3,566	)
Balance as of March 31, 2021		70,468,260	$	49,763	$	76,890		$	(94,549	)	$	32,104
RSUs vesting		5,381		4		(4	)		-			-
Share-based compensation		-		-		65			-			65
Net loss		-		-		-			(3,918	)		(3,918	)
Balance as of June 30, 2021		70,473,641	$	49,767	$	76,951		$	(98,467	)	$	28,251

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

5

CHECK-CAP LTD.

  CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands, except share and per share data)

	Six months ended
	June 30,
	2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(10,641	)	$	(7,484	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		159			89
Share-based compensation		525			138
Financial income, net		(239	)		(36	)
Changes in assets and liabilities items:
Increase in prepaid and other current assets and non-current assets		(152	)		(508	)
Increase in trade accounts payable, accruals and other current liabilities		320			27
Decrease in employees and payroll accruals		(293	)		(62	)
(Decrease) increase in royalties provision		(25	)		35
Net cash used in operating activities	$	(10,346	)	$	(7,801	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment		(323	)		(218	)
Investment in short-term bank and other deposits		(13,000	)		(8,814	)
Net cash used in investing activities	$	(13,323	)	$	(9,032	)
CASH FLOWS FROM FINANCING ACTIVITIES
Exercise of warrants into ordinary shares, net of issuance expenses		-			19,219
Issuance of ordinary shares in the registered direct offerings, net of issuance expenses		8,850			-
Net cash provided by financing activities	$	8,850		$	19,219
Net increase in cash, cash equivalents and restricted cash		(14,819	)		2,386
Cash, cash equivalents and restricted cash at the beginning of the period		26,807			8,053
Cash, cash equivalents and restricted cash at the end of the period	$	11,988		$	10,439

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

6

CHECK-CAP LTD.

CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share and per share data)

Supplemental information for Cash Flow:

	Six months ended June 30,
	2022		2021
Supplemental disclosure of non-cash flow information
Purchase of property and equipment included in accounts payable and accrued expenses		38		59
Financing fees included in other account payable and accruals		-		291
Assets acquired under operating lease		167		916
Supplemental disclosure of cash flow information:
Cash paid for taxes		3		7
Interest received		138		24

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

7

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

(U.S. dollars in thousands, except share and per share data)

NOTE 1 - GENERAL INFORMATION

A.	General
	(1)	Check-Cap Ltd. (the “Company") was incorporated under the laws of the State of Israel. The registered address of its offices is 29 Abba Hushi Avenue, Isfiya 3009000, Israel.
	(2)	The Company has a wholly-owned subsidiary, Check-Cap US, Inc., that was incorporated under the laws of the State of Delaware on May 15, 2015.
	(3)	The Company is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. The Company’s disruptive capsule-based screening technology aims to help millions of people to stay healthy through preventive CRC screening. C-Scan uses 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 as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and requires no sedation. It requires no bowel preparation, allowing the patients to continue their daily routine with no interruption.
	(4)	On February 24, 2015, the Company consummated an Initial Public Offering in the United States (U.S.) (the "IPO") concurrently with a private placement. On August 11, 2016, the Company consummated a registered direct offering of ordinary shares and pre-funded warrants. On June 2, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants. On November 22, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants. On May 8, 2018, the Company consummated an underwritten public offering of ordinary shares, pre-funded warrants and Series C warrants. On February 6, 2019, the Company consummated a registered direct offering of ordinary shares and warrants. In February 2020, the Company consummated a private placement of ordinary shares. During April and May 2020, the Company consummated three registered direct offerings of ordinary shares and simultaneous private placements of warrants. On July 27, 2020, the Company consummated a warrant exercise transaction to purchase ordinary shares and a simultaneous private placement of warrants. During the first quarter of 2021, certain investors exercised their warrants previously issued by the Company. In July 2021, the Company consummated a registered direct offering of ordinary shares and warrants. On March 3, 2022, the Company consummated a registered direct offering of ordinary shares and warrants. See Note 5(1). The Company's ordinary shares and Series C Warrants are listed on the NASDAQ Capital Market under the symbols "CHEK" and CHEKZ,” respectively. The consolidated financial statements of the Company as of and for the six months ended June 30, 2022 include the financial statements of the Company and its wholly-owned U.S. subsidiary.

8

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 1 - GENERAL INFORMATION

A. General (cont.)

(5) 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 Company has incurred losses of $10,641 and $7,484 for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, the Company's accumulated deficit was approximately $118,826. The extent of the Company's future operating losses and the timing of becoming profitable are uncertain.   The Company has funded its operations to date primarily through equity financings, sale of its ordinary shares and warrants, the exercise of warrants and other financing transactions and through grants from the Israel Innovation Authority of the Ministry of Economy and Industry (the "IIA").   Additional funding will be required to complete the Company's research and development and clinical trials, to attain regulatory approvals, to establish manufacturing infrastructure and to begin the commercialization efforts of C-Scan. The Company has not yet commercialized its product. Even if the Company commercializes its product, it may not become profitable in the foreseeable future. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product, successfully complete any post-approval regulatory obligations and successfully commercialize its product alone or in partnership.   To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings and other financing transactions. While the Company has been successful in raising funds 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.   The Company believes that current cash on hand, will be sufficient to fund its ongoing operations and plans into the second quarter of 2024. Management expects that the Company will continue to generate losses from the development, manufacturing and infrastructure costs, clinical development and regulatory activities of C-Scan, which will result in negative cash flow from operating activity. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the initiation, timing, progress and results of clinical trials and other product development efforts regulatory path along with cost to commercialize its product.

(6) On December 23, 2021, the Company received a notification from the Nasdaq Listing Qualifications (the “Staff”) that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share, and that the Company had 180 calendar days from December 23, 2021, or until June 21, 2022, to regain compliance with the minimum bid price requirement. On June 22, 2022, the Company was notified by the Staff that it is eligible for an additional 180 calendar day period, or until December 19, 2022, to regain compliance (the “Extension Period”). The Company can regain compliance, if by the end of the Extension Period, the closing bid price of its ordinary shares is at least $1.00 for a minimum of ten consecutive business days. If the Company cannot demonstrate compliance by the end of the Extension Period, the Staff will notify the Company that its ordinary shares are subject to delisting. On August 11, 2022, our shareholders approved a reverse share split (“Reverse Split”) of the Company’s ordinary shares within a range of 1 for 10 to 1 for 20, the exact ratio to be determined by further action of the Company’s Board of Directors, to be effective on a date to be determined by the Company’s Board of Directors and announced by the Company, and to amend the Company’s Articles of Association accordingly. If the Reverse Split is implemented, the number of authorized shares as well as the issued and outstanding ordinary shares would be reduced in accordance with the Reverse Split ratio and the par value per ordinary share will be increased proportionately. In addition, if the Reverse Split is implemented, the exercise price and the number of ordinary shares issuable pursuant to outstanding warrants will be adjusted pursuant to the terms of the respective warrants in connection with the Reverse Split.   Furthermore, upon completion of the Reverse Split, if implemented, the number of ordinary shares issuable pursuant to the Company’s 2006 Unit Option Plan and 2015 Equity Incentive Plan and 2015 US Sub-Plan to the 2015 Equity Incentive Plan, as well as the number of shares and exercise prices subject to outstanding options under the plans and the number of shares subject to outstanding restricted stock units (“RSUs”) under the plans shall be appropriately adjusted.

(7) In early 2020, the World Health Organization declared the rapidly spreading coronavirus disease (COVID-19) outbreak a pandemic. The Company has in the past experienced temporary disruptions to its operations as a result of the COVID-19 pandemic including disruptions to the Company’s clinical studies and implemented several temporary cost reduction measures. The Company has also implemented several measures according to the Israel Ministry of Health’s guidelines, including remote working whenever possible, physical separation between employees and daily employee health monitoring. The extent to which the COVID-19 pandemic shall impact the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, the impact on the global economy, the impact of any further waves of COVID-19, the efficacy of the vaccines and the other actions that may be required to contain COVID-19 or treat its impact. In particular, the continued spread of COVID-19 globally could materially adversely impact the Company’s operations and workforce, including its research and clinical trials and its ability to continue raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the Company’s development plans, and could result in the inability of the Company’s suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have a material adverse impact on the Company’s business, financial condition and results of operation.

9

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 2 - CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

The accompanying consolidated unaudited financial statements have been prepared in a condensed format and include the consolidated unaudited financial operations of the Company as of June 30, 2022 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, the accompanying consolidated unaudited financial statements do not include all the information and footnotes required by generally accepted accounting principles for complete set of financial statements. These consolidated unaudited 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, 2021 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on April 6, 2022 (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, 2022, are not necessarily indicative of the results that may be expected for the year ended December 31, 2022.

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 the Annual Report.

NOTE 4 - LEASES

The Company leases vehicles and offices under various operating lease agreements.
 
At June 30, 2022, the Company’s operating lease assets and lease liabilities (both the current and non-current portion) for operating leases totaled $1,100 and $1,001, respectively.

10

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 4 - LEASES (Cont.)

Supplemental cash flow information related to operating leases was as follows:

	Six months ended June 30, 2022
Cash payments for operating leases	$	203

The Company uses its incremental borrowing rate as the discount rate for its leases, as the implicit rate in the lease is not readily determinable. As of June 30, 2022, the Company’s operating leases had a weighted average remaining lease term of 3.7 years and a weighted average borrowing rate of 4.1%. Future lease payments under operating leases as of June 30, 2022 were as follows:  

	Operating
	Leases
Second half of 2022	$	175
2023	$	324
2024 and after	$	623
Total future lease payments	$	1,122
Less imputed interest		(121	)
Total lease liability balance	$	1,001

11

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 5 - SHAREHOLDERS' EQUITY

The following change occurred during the six months ended June 30, 2022:

On March 1, 2022, the Company entered into a definitive agreement with several institutional and accredited investors for the purchase and sale of 20,000,000 of the Company's ordinary shares and accompanying warrants to purchase up to an aggregate of 15,000,000 of the Company's ordinary shares in a registered direct offering (the “March 2022 Registered Direct Offering”). The March 2022 Registered Direct Offering was consummated on March 3, 2022. The warrants are immediately exercisable and will expire five years from the issuance date at an exercise price of $0.65 per share, subject to certain adjustments. The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the ordinary shares underlying the warrants. The terms of the warrants did not include features that would preclude equity classification. The Company also issued registered placement agent warrants to purchase up to an aggregate of 1,000,000 ordinary shares, substantially on the same terms as the warrants issued to the investors in the private placement, except they have an exercise price of $0.625 per share and expiration date is March 1, 2027. Upon any exercise of the warrants for cash, the Company agreed to pay the placement agent warrants to purchase up to 5.0% of the number of ordinary shares issued upon the cash exercise of the warrants (up to 750,000 warrants). Simultaneously with this offering, the Company entered into a warrant amendment agreement (the “Warrant Amendment Agreement”), with the investors in the March 2022 Registered Direct Offering. Pursuant to the Warrant Amendment Agreement, certain warrants to purchase up to an aggregate of 18,525,927 ordinary shares of the Company that were issued to the investors in July 2021 were amended to have a reduced exercise price of $0.65 per share and the term of exercise was extended to January 2, 2025. The Company received gross proceeds from the March 2022 Registered Direct Offering of $10,000, or approximately $8,850, net of issuance expenses in the amount of approximately $1,150.

12

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 6 - SHARE-BASED COMPENSATION

1.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, 2022
						Weighted
				Weighted		average
				average		remaining
				exercise price		contractual life (in
	Number			(in $)		years)
Options outstanding at beginning of period		2,916,209			2.41		9.13
Options granted		528,398			0.59
Options forfeited and expired		(173,632	)		1.35
Options outstanding at end of period		3,270,975			2.17		8.79
Options exercisable at end of period		618,075			6.83		6.75

2.A summary of the Company’s RSU activity is as follows:

	For the six
	months
	ended June
	30, 2022
Unvested at beginning of period		332,542
Granted		201,000
Vested		-
Forfeited		(40,500	)
Unvested at end of period		493,042

 

On January 27, 2022, the Company's Board of Directors resolved to increase the number of ordinary shares of the Company reserved for issuance under the Check-Cap Ltd. 2015 Equity Incentive Plan by an additional 500,000 shares.

On January 27, 2022, the Company's Board of Directors approved the award of options to purchase 336,000 ordinary shares and 144,000 RSUs to certain employees. The options have an exercise price equal to $0.65.

On March 21, 2022, the Company's Board of Directors approved the award of options to purchase 169,314 ordinary shares and 57,000 RSUs to the Company’s officers (except the CEO) and certain employees. The options have an exercise price equal to $0.51.

On May 31, 2022, the Company's Board of Directors approved the award of options to purchase 23,084 ordinary shares to certain employees. The options have an exercise price equal to $0.36.

The exercise price of the options granted is equal to the higher of the closing price of the Company’s ordinary shares on the Nasdaq Capital Market on the applicable grant date and the average closing price of the Company’s ordinary shares on the Nasdaq Capital Market during the 30 trading days prior to the applicable grant date.

The options and RSUs vest over a period of four years commencing on the date of grant, such that 25% of the options and RSUs vest on the first anniversary of the applicable date of grant and thereafter, vest monthly in equal portions at the end of each month over the subsequent thirty-six (36) months.

13

CHECK CAP LTD

NOTES TO CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

NOTE 7 - SUBSEQUENT EVENTS

On August 29, 2022, the Company's Board of Directors approved the award of options to purchase 33,138 ordinary shares to certain employees. The options have an exercise price equal to the higher of the closing price of the Company’s ordinary shares on the Nasdaq Capital Market on the applicable grant date and the average closing price of the Company’s ordinary shares on the Nasdaq Capital Market during the 30 trading days prior to the applicable grant date.

14

XML

Document and Entity Information	6 Months Ended
	Jun. 30, 2022
Document and Entity Information [Abstract]
Entity Registrant Name	Check-Cap Ltd.
Document Type	6-K
Document Period End Date	Jun. 30, 2022
Amendment Flag	false
Entity Central Index Key	0001610590
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q2
Entity Address, Address Line One	Check-Cap Building
Entity Address, Address Line Two	Abba Hushi Avenue
Entity Address, Address Line Three	P.O. Box 1271
Entity Address, City or Town	Isfiya
Entity Address, Postal Zip Code	30090
Entity Address, Country	IL

XML

CONSOLIDATED UNAUDITED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 11,637	$ 26,457
Restricted cash	351	350
Short-term bank deposit	38,206	25,104
Prepaid expenses and other current assets	996	839
Total current assets	51,190	52,750
Non-current assets
Property and equipment, net	1,836	1,793
Operating leases	1,100	1,116
Total non-current assets	2,936	2,909
Total assets	54,126	55,659
Accounts payable and accruals
Trade	946	1,050
Other	701	680
Employees and payroll accruals	1,668	1,961
Other current liabilities	279	0
Operating lease liabilities	332	350
Total current liabilities	3,926	4,041
Non-current liabilities
Royalties provision	107	132
Operating lease liabilities	669	795
Total non-current liabilities	776	927
Shareholders' equity
Share capital, Ordinary shares, 2.4 NIS par value (360,000,000 authorized shares as of June 30, 2022 and December 31, 2021, respectively; 116,411,949 and 96,411,949 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively)	83,602	68,787
Additional paid-in capital	84,648	90,089
Retained Earnings (Accumulated Deficit)	(118,826)	(108,185)
Total shareholders' equity	49,424	50,691
Total liabilities and shareholders' equity	$ 54,126	$ 55,659

XML

CONSOLIDATED UNAUDITED BALANCE SHEETS (Parenthetical) - ₪ / shares	Jun. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Ordinary shares, par value per share	₪ 2.4	₪ 2.4
Ordinary shares, shares authorized	360,000,000	360,000,000
Ordinary shares, shares issued	116,411,949	96,411,949
Ordinary shares, shares outstanding	116,411,949	96,411,949

XML

CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Income Statement [Abstract]
Research and development expenses, net	$ 3,545	$ 2,781	$ 7,673	$ 5,187
General and administrative expenses	1,343	1,142	3,100	2,293
Operating loss	4,888	3,923	10,773	7,480
Finance Income (loss), net	81	5	132	(4)
Loss before income tax	4,807	3,918	10,641	7,484
Net loss for the period	$ 4,807	$ 3,918	$ 10,641	$ 7,484
Loss per share:
Net loss per ordinary share basic	$ 0.04	$ 0.06	$ 0.1	$ 0.11
Net loss per ordinary share diluted	$ 0.04	$ 0.06	$ 0.1	$ 0.11
Weighted average number of ordinary shares outstanding - basic	116,411,949	70,485,435	109,561,120	69,284,917
Weighted average number of ordinary shares outstanding - diluted	116,411,949	70,485,435	109,561,120	69,284,917

XML

CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands	Ordinary Share	Additional paid-in capital	Accumulated deficit	Total
Beginning balance at Dec. 31, 2020	$ 31,646	$ 75,715	$ (90,983)	$ 16,378
Beginning balance, shares at Dec. 31, 2020	46,239,183
Exercise of warrants, net of issuance expenses in an amount of $22	$ 18,099	1,120	0	19,219
Exercise of warrants, net of issuance expenses in an amount of $22, shares	24,204,682
RSUs vesting	$ 18	(18)	0	0
RSUs vesting, shares	24,395
Share-based compensation	$ 0	73	0	73
Net Income (Loss) Attributable to Parent	0	0	(3,566)	(3,566)
Ending balance at Mar. 31, 2021	$ 49,763	76,890	(94,549)	32,104
Ending balance, shares at Mar. 31, 2021	70,468,260
Beginning balance at Dec. 31, 2020	$ 31,646	75,715	(90,983)	16,378
Beginning balance, shares at Dec. 31, 2020	46,239,183
Net Income (Loss) Attributable to Parent				(7,484)
Ending balance at Jun. 30, 2021	$ 49,767	76,951	(98,467)	28,251
Ending balance, shares at Jun. 30, 2021	70,473,641
Beginning balance at Mar. 31, 2021	$ 49,763	76,890	(94,549)	32,104
Beginning balance, shares at Mar. 31, 2021	70,468,260
RSUs vesting	$ 4	(4)	0	0
RSUs vesting, shares	5,381
Share-based compensation	$ 0	65	0	65
Net Income (Loss) Attributable to Parent	0	0	(3,918)	(3,918)
Ending balance at Jun. 30, 2021	$ 49,767	76,951	(98,467)	28,251
Ending balance, shares at Jun. 30, 2021	70,473,641
Beginning balance at Dec. 31, 2021	$ 68,787	90,089	(108,185)	50,691
Beginning balance, shares at Dec. 31, 2021	96,411,949
Issuance of ordinary shares in registered direct offerings, net of issuance expenses in an amount of $1,150	$ 14,815	(5,965)	0	8,850
Issuance of ordinary shares in registered direct offerings, net of issuance expenses in an amount of $1,150 ( In Shares)	20,000,000
Share-based compensation	$ 0	250	0	250
Net Income (Loss) Attributable to Parent	0	0	(5,834)	(5,834)
Ending balance at Mar. 31, 2022	$ 83,602	84,374	(114,019)	53,957
Ending balance, shares at Mar. 31, 2022	116,411,949
Beginning balance at Dec. 31, 2021	$ 68,787	90,089	(108,185)	50,691
Beginning balance, shares at Dec. 31, 2021	96,411,949
Net Income (Loss) Attributable to Parent				(10,641)
Ending balance at Jun. 30, 2022	$ 83,602	84,648	(118,826)	49,424
Ending balance, shares at Jun. 30, 2022	116,411,949
Beginning balance at Mar. 31, 2022	$ 83,602	84,374	(114,019)	53,957
Beginning balance, shares at Mar. 31, 2022	116,411,949
Share-based compensation	$ 0	274	0	274
Net Income (Loss) Attributable to Parent	0	0	(4,807)	(4,807)
Ending balance at Jun. 30, 2022	$ 83,602	$ 84,648	$ (118,826)	$ 49,424
Ending balance, shares at Jun. 30, 2022	116,411,949

XML

CONSOLIDATED UNAUDITED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Issuance expenses	$ 1,150
Issuance expenses warrant exercise transaction		$ 22

XML

CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (10,641)	$ (7,484)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation	159	89
Share-based compensation	525	138
Financial income, net	(239)	(36)
Changes in assets and liabilities items:
Increase in prepaid and other current assets and non-current assets	(152)	(508)
Increase in trade accounts payable, accruals and other current liabilities	320	27
Decrease in employees and payroll accruals	(293)	(62)
(Decrease) increase in royalties provision	(25)	35
Net cash used in operating activities	(10,346)	(7,801)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment	(323)	(218)
Investment in short-term bank and other deposits	(13,000)	(8,814)
Net cash used in investing activities	(13,323)	(9,032)
CASH FLOWS FROM FINANCING ACTIVITIES
Exercise of warrants into ordinary shares, net of issuance expenses	0	19,219
Issuance of ordinary shares in the registered direct offerings, net of issuance expenses	8,850	0
Net cash provided by financing activities	8,850	19,219
Net increase in cash, cash equivalents and restricted cash	(14,819)	2,386
Cash, cash equivalents and restricted cash at the beginning of the period	26,807	8,053
Cash, cash equivalents and restricted cash at the end of the period	11,988	10,439
Supplemental disclosure of non-cash flow information
Purchase of property and equipment included in accounts payable and accrued expenses	38	59
Financing fees included in other account payable and accruals	0	291
Assets acquired under operating lease	167	916
Supplemental disclosure of cash flow information:
Cash paid for taxes	3	7
Interest received	$ 138	$ 24

XML

GENERAL INFORMATION

6 Months Ended

Jun. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

GENERAL INFORMATION

NOTE 1 - GENERAL INFORMATION

A.	General
	(1)	Check-Cap Ltd. (the “Company") was incorporated under the laws of the State of Israel. The registered address of its offices is 29 Abba Hushi Avenue, Isfiya 3009000, Israel.
	(2)	The Company has a wholly-owned subsidiary, Check-Cap US, Inc., that was incorporated under the laws of the State of Delaware on May 15, 2015.
	(3)	The Company is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. The Company’s disruptive capsule-based screening technology aims to help millions of people to stay healthy through preventive CRC screening. C-Scan uses 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 as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and requires no sedation. It requires no bowel preparation, allowing the patients to continue their daily routine with no interruption.
	(4)	On February 24, 2015, the Company consummated an Initial Public Offering in the United States (U.S.) (the "IPO") concurrently with a private placement. On August 11, 2016, the Company consummated a registered direct offering of ordinary shares and pre-funded warrants. On June 2, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants. On November 22, 2017, the Company consummated a registered direct offering of ordinary shares and a simultaneous private placement of warrants. On May 8, 2018, the Company consummated an underwritten public offering of ordinary shares, pre-funded warrants and Series C warrants. On February 6, 2019, the Company consummated a registered direct offering of ordinary shares and warrants. In February 2020, the Company consummated a private placement of ordinary shares. During April and May 2020, the Company consummated three registered direct offerings of ordinary shares and simultaneous private placements of warrants. On July 27, 2020, the Company consummated a warrant exercise transaction to purchase ordinary shares and a simultaneous private placement of warrants. During the first quarter of 2021, certain investors exercised their warrants previously issued by the Company. In July 2021, the Company consummated a registered direct offering of ordinary shares and warrants. On March 3, 2022, the Company consummated a registered direct offering of ordinary shares and warrants. See Note 5(1). The Company's ordinary shares and Series C Warrants are listed on the NASDAQ Capital Market under the symbols "CHEK" and CHEKZ,” respectively. The consolidated financial statements of the Company as of and for the six months ended June 30, 2022 include the financial statements of the Company and its wholly-owned U.S. subsidiary.

(5) 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 Company has incurred losses of $10,641 and $7,484 for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, the Company's accumulated deficit was approximately $118,826. The extent of the Company's future operating losses and the timing of becoming profitable are uncertain.   The Company has funded its operations to date primarily through equity financings, sale of its ordinary shares and warrants, the exercise of warrants and other financing transactions and through grants from the Israel Innovation Authority of the Ministry of Economy and Industry (the "IIA").   Additional funding will be required to complete the Company's research and development and clinical trials, to attain regulatory approvals, to establish manufacturing infrastructure and to begin the commercialization efforts of C-Scan. The Company has not yet commercialized its product. Even if the Company commercializes its product, it may not become profitable in the foreseeable future. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product, successfully complete any post-approval regulatory obligations and successfully commercialize its product alone or in partnership.   To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings and other financing transactions. While the Company has been successful in raising funds 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.   The Company believes that current cash on hand, will be sufficient to fund its ongoing operations and plans into the second quarter of 2024. Management expects that the Company will continue to generate losses from the development, manufacturing and infrastructure costs, clinical development and regulatory activities of C-Scan, which will result in negative cash flow from operating activity. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the initiation, timing, progress and results of clinical trials and other product development efforts regulatory path along with cost to commercialize its product.

(6) On December 23, 2021, the Company received a notification from the Nasdaq Listing Qualifications (the “Staff”) that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share, and that the Company had 180 calendar days from December 23, 2021, or until June 21, 2022, to regain compliance with the minimum bid price requirement. On June 22, 2022, the Company was notified by the Staff that it is eligible for an additional 180 calendar day period, or until December 19, 2022, to regain compliance (the “Extension Period”). The Company can regain compliance, if by the end of the Extension Period, the closing bid price of its ordinary shares is at least $1.00 for a minimum of ten consecutive business days. If the Company cannot demonstrate compliance by the end of the Extension Period, the Staff will notify the Company that its ordinary shares are subject to delisting. On August 11, 2022, our shareholders approved a reverse share split (“Reverse Split”) of the Company’s ordinary shares within a range of 1 for 10 to 1 for 20, the exact ratio to be determined by further action of the Company’s Board of Directors, to be effective on a date to be determined by the Company’s Board of Directors and announced by the Company, and to amend the Company’s Articles of Association accordingly. If the Reverse Split is implemented, the number of authorized shares as well as the issued and outstanding ordinary shares would be reduced in accordance with the Reverse Split ratio and the par value per ordinary share will be increased proportionately. In addition, if the Reverse Split is implemented, the exercise price and the number of ordinary shares issuable pursuant to outstanding warrants will be adjusted pursuant to the terms of the respective warrants in connection with the Reverse Split.   Furthermore, upon completion of the Reverse Split, if implemented, the number of ordinary shares issuable pursuant to the Company’s 2006 Unit Option Plan and 2015 Equity Incentive Plan and 2015 US Sub-Plan to the 2015 Equity Incentive Plan, as well as the number of shares and exercise prices subject to outstanding options under the plans and the number of shares subject to outstanding restricted stock units (“RSUs”) under the plans shall be appropriately adjusted.

(7) In early 2020, the World Health Organization declared the rapidly spreading coronavirus disease (COVID-19) outbreak a pandemic. The Company has in the past experienced temporary disruptions to its operations as a result of the COVID-19 pandemic including disruptions to the Company’s clinical studies and implemented several temporary cost reduction measures. The Company has also implemented several measures according to the Israel Ministry of Health’s guidelines, including remote working whenever possible, physical separation between employees and daily employee health monitoring. The extent to which the COVID-19 pandemic shall impact the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, the impact on the global economy, the impact of any further waves of COVID-19, the efficacy of the vaccines and the other actions that may be required to contain COVID-19 or treat its impact. In particular, the continued spread of COVID-19 globally could materially adversely impact the Company’s operations and workforce, including its research and clinical trials and its ability to continue raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the Company’s development plans, and could result in the inability of the Company’s suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have a material adverse impact on the Company’s business, financial condition and results of operation.

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CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

6 Months Ended

Jun. 30, 2022

Unaudited Consolidated Financial Statements [Abstract]

CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

NOTE 2 - CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

The accompanying consolidated unaudited financial statements have been prepared in a condensed format and include the consolidated unaudited financial operations of the Company as of June 30, 2022 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, the accompanying consolidated unaudited financial statements do not include all the information and footnotes required by generally accepted accounting principles for complete set of financial statements. These consolidated unaudited 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, 2021 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on April 6, 2022 (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, 2022, are not necessarily indicative of the results that may be expected for the year ended December 31, 2022.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2022

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 the Annual Report.

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LEASES

6 Months Ended

Jun. 30, 2022

Leases [Abstract]

LEASES

NOTE 4 - LEASES

The Company leases vehicles and offices under various operating lease agreements.
 
At June 30, 2022, the Company’s operating lease assets and lease liabilities (both the current and non-current portion) for operating leases totaled $1,100 and $1,001, respectively.

Supplemental cash flow information related to operating leases was as follows:

	Six months ended June 30, 2022
Cash payments for operating leases	$	203

The Company uses its incremental borrowing rate as the discount rate for its leases, as the implicit rate in the lease is not readily determinable. As of June 30, 2022, the Company’s operating leases had a weighted average remaining lease term of 3.7 years and a weighted average borrowing rate of 4.1%. Future lease payments under operating leases as of June 30, 2022 were as follows:  

	Operating
	Leases
Second half of 2022	$	175
2023	$	324
2024 and after	$	623
Total future lease payments	$	1,122
Less imputed interest		(121	)
Total lease liability balance	$	1,001

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SHAREHOLDERS' EQUITY

6 Months Ended

Jun. 30, 2022

Stockholders' Equity Note [Abstract]

SHAREHOLDERS' EQUITY

NOTE 5 - SHAREHOLDERS' EQUITY

The following change occurred during the six months ended June 30, 2022:

On March 1, 2022, the Company entered into a definitive agreement with several institutional and accredited investors for the purchase and sale of 20,000,000 of the Company's ordinary shares and accompanying warrants to purchase up to an aggregate of 15,000,000 of the Company's ordinary shares in a registered direct offering (the “March 2022 Registered Direct Offering”). The March 2022 Registered Direct Offering was consummated on March 3, 2022. The warrants are immediately exercisable and will expire five years from the issuance date at an exercise price of $0.65 per share, subject to certain adjustments. The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the ordinary shares underlying the warrants. The terms of the warrants did not include features that would preclude equity classification. The Company also issued registered placement agent warrants to purchase up to an aggregate of 1,000,000 ordinary shares, substantially on the same terms as the warrants issued to the investors in the private placement, except they have an exercise price of $0.625 per share and expiration date is March 1, 2027. Upon any exercise of the warrants for cash, the Company agreed to pay the placement agent warrants to purchase up to 5.0% of the number of ordinary shares issued upon the cash exercise of the warrants (up to 750,000 warrants). Simultaneously with this offering, the Company entered into a warrant amendment agreement (the “Warrant Amendment Agreement”), with the investors in the March 2022 Registered Direct Offering. Pursuant to the Warrant Amendment Agreement, certain warrants to purchase up to an aggregate of 18,525,927 ordinary shares of the Company that were issued to the investors in July 2021 were amended to have a reduced exercise price of $0.65 per share and the term of exercise was extended to January 2, 2025. The Company received gross proceeds from the March 2022 Registered Direct Offering of $10,000, or approximately $8,850, net of issuance expenses in the amount of approximately $1,150.

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SHARE-BASED COMPENSATION

6 Months Ended

Jun. 30, 2022

Share-Based Payment Arrangement [Abstract]

SHARE-BASED COMPENSATION

NOTE 6 - SHARE-BASED COMPENSATION

1.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, 2022
						Weighted
				Weighted		average
				average		remaining
				exercise price		contractual life (in
	Number			(in $)		years)
Options outstanding at beginning of period		2,916,209			2.41		9.13
Options granted		528,398			0.59
Options forfeited and expired		(173,632	)		1.35
Options outstanding at end of period		3,270,975			2.17		8.79
Options exercisable at end of period		618,075			6.83		6.75

2.A summary of the Company’s RSU activity is as follows:

	For the six
	months
	ended June
	30, 2022
Unvested at beginning of period		332,542
Granted		201,000
Vested		-
Forfeited		(40,500	)
Unvested at end of period		493,042

 

On January 27, 2022, the Company's Board of Directors resolved to increase the number of ordinary shares of the Company reserved for issuance under the Check-Cap Ltd. 2015 Equity Incentive Plan by an additional 500,000 shares.

On January 27, 2022, the Company's Board of Directors approved the award of options to purchase 336,000 ordinary shares and 144,000 RSUs to certain employees. The options have an exercise price equal to $0.65.

On March 21, 2022, the Company's Board of Directors approved the award of options to purchase 169,314 ordinary shares and 57,000 RSUs to the Company’s officers (except the CEO) and certain employees. The options have an exercise price equal to $0.51.

On May 31, 2022, the Company's Board of Directors approved the award of options to purchase 23,084 ordinary shares to certain employees. The options have an exercise price equal to $0.36.

The exercise price of the options granted is equal to the higher of the closing price of the Company’s ordinary shares on the Nasdaq Capital Market on the applicable grant date and the average closing price of the Company’s ordinary shares on the Nasdaq Capital Market during the 30 trading days prior to the applicable grant date.

The options and RSUs vest over a period of four years commencing on the date of grant, such that 25% of the options and RSUs vest on the first anniversary of the applicable date of grant and thereafter, vest monthly in equal portions at the end of each month over the subsequent thirty-six (36) months.

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SUBSEQUENT EVENTS

6 Months Ended

Jun. 30, 2022

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 7 - SUBSEQUENT EVENTS

On August 29, 2022, the Company's Board of Directors approved the award of options to purchase 33,138 ordinary shares to certain employees. The options have an exercise price equal to the higher of the closing price of the Company’s ordinary shares on the Nasdaq Capital Market on the applicable grant date and the average closing price of the Company’s ordinary shares on the Nasdaq Capital Market during the 30 trading days prior to the applicable grant date.

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LEASES (Tables)

6 Months Ended

Jun. 30, 2022

Leases [Abstract]

Schedule of supplemental cash flow information related to operating leases

	Six months ended June 30, 2022
Cash payments for operating leases	$	203

Schedule of future lease payments

	Operating
	Leases
Second half of 2022	$	175
2023	$	324
2024 and after	$	623
Total future lease payments	$	1,122
Less imputed interest		(121	)
Total lease liability balance	$	1,001

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SHARE-BASED COMPENSATION (Tables)

6 Months Ended

Jun. 30, 2022

Share-Based Payment Arrangement [Abstract]

Schedule of stock option activity

	For the six months ended June 30, 2022
						Weighted
				Weighted		average
				average		remaining
				exercise price		contractual life (in
	Number			(in $)		years)
Options outstanding at beginning of period		2,916,209			2.41		9.13
Options granted		528,398			0.59
Options forfeited and expired		(173,632	)		1.35
Options outstanding at end of period		3,270,975			2.17		8.79
Options exercisable at end of period		618,075			6.83		6.75

Schedule of unvested Restricted Stock Units

	For the six
	months
	ended June
	30, 2022
Unvested at beginning of period		332,542
Granted		201,000
Vested		-
Forfeited		(40,500	)
Unvested at end of period		493,042

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GENERAL INFORMATION (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended				6 Months Ended
	Aug. 11, 2022	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2021	Mar. 31, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021	Dec. 23, 2021
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Net loss		$ 4,807	$ 5,834	$ 3,918	$ 3,566	$ 10,641	$ 7,484
Accumulated deficit		$ 118,826				$ 118,826		$ 108,185
Minimum bid price of listed securities									$ 1
Subsequent Event
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Reverse share split ratio	range of 1 for 10 to 1 for 20

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LEASES (Detail Textuals) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Operating lease assets	$ 1,100	$ 1,116
Lease liabilities	$ 1,001
Weighted average remaining lease term	3 years 8 months 12 days
Approximate weighted average borrowing rate	4.10%

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LEASES (Schedule of supplemental cash flow Information related to operating leases) (Details) $ in Thousands	6 Months Ended
	Jun. 30, 2022 USD ($)
Leases [Abstract]
Cash payments for operating leases	$ 203

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LEASES (Schedule of future lease payments) (Details) $ in Thousands	Jun. 30, 2022 USD ($)
Leases [Abstract]
Second half of 2022	$ 175
2023	324
2024 and after	623
Total future lease payments	1,122
Less imputed interest	(121)
Total lease liability balance	$ 1,001

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SHAREHOLDERS' EQUITY (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	6 Months Ended
	Mar. 01, 2022	Mar. 31, 2022	Jun. 30, 2022	Jun. 30, 2021
Class of Stock [Line Items]
Net proceeds warrant from the registered direct offering			$ 8,850	$ 0
Registered Direct Offerings | Placement Agent Warrants
Class of Stock [Line Items]
Warrants to purchase up to aggregate of ordinary shares	1,000,000
Exercise price	$ 0.625
Number of warrants to be granted upon exercise of warrants		750,000
Registered Direct Offerings | Placement Agent Warrants | Ordinary Shares
Class of Stock [Line Items]
Percentage of ordinary shares upon cash exercise of warrants to placement agent		5.00%
Several Institutional And Accredited Investors | Registered Direct Offerings
Class of Stock [Line Items]
Issuance of ordinary shares	20,000,000
Warrants issued	15,000,000
Exercise price	$ 0.65
Term of warrants		5 years
Warrant Amendment Agreement | Registered Direct Offerings
Class of Stock [Line Items]
Warrants to purchase up to aggregate of ordinary shares	18,525,927
Exercise price	$ 0.65
Issuance expenses		$ 1,150
Warrant Amendment Agreement | Minimum | Registered Direct Offerings
Class of Stock [Line Items]
Net proceeds warrant from the registered direct offering		8,850
Warrant Amendment Agreement | Maximum | Registered Direct Offerings
Class of Stock [Line Items]
Proceeds from issuance of registered direct offering		$ 10,000

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SHARE-BASED COMPENSATION (Detail Textuals) - $ / shares	1 Months Ended			6 Months Ended
	May 31, 2022	Mar. 21, 2022	Jan. 27, 2022	Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Options granted				528,398
Vesting period				4 years
Vesting percentage				25.00%
Company’s Officers
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Options granted		169,314
Exercise price of options granted		$ 0.51
Certain Employees
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Options granted	23,084		336,000
Exercise price of options granted	$ 0.36		$ 0.65
2015 Equity Incentive Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Increase in shares available for additional grant			500,000
RSU's
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of RSU's granted				201,000
RSU's | Company’s Officers
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of RSU's granted		57,000
RSU's | Certain Employees
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of RSU's granted			144,000

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SHARE-BASED COMPENSATION (Schedule of option activity related to options granted to employees) (Details) - $ / shares	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Number of options
Options outstanding at beginning of period	2,916,209
Options granted	528,398
Options forfeited and expired	(173,632)
Options outstanding at end of period	3,270,975
Options exercisable at end of period	618,075
Weighted average exercise price
Options outstanding at beginning of period	$ 2.41
Options granted	0.59
Options forfeited and expired	1.35
Options outstanding at end of period	2.17
Options exercisable at end of period	$ 6.83
Weighted average remaining contractual life
Options outstanding	8 years 9 months 14 days	9 years 1 month 17 days
Options exercisable at end of period	6 years 9 months

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SHARE-BASED COMPENSATION (Schedule of RSU activity) (Details) - RSU's	6 Months Ended
	Jun. 30, 2022 shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Unvested at beginning of period	332,542
Granted	201,000
Vested	0
Forfeited	(40,500)
Unvested at end of period	493,042

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SUBSEQUENT EVENTS (Detail Textuals) - shares	1 Months Ended	6 Months Ended
	Aug. 29, 2022	Jun. 30, 2022
Subsequent Event [Line Items]
Number of shares granted during the period		528,398
Subsequent Event
Subsequent Event [Line Items]
Number of shares granted during the period	33,138