425

Check-Cap Ltd.

/s/ Alex Ovadia

Alex Ovadia

Date: November 27, 2023

Chief Executive Officer

425 1 d536956d425.htm 425 425

Filed by Capstone Dental Pubco, Inc.

Pursuant to Rule 425 under the Securities Act of 1933

Subject Companies:

Check-Cap Ltd.

(Commission File No.: 001-36848)

Keystone Dental Holdings, Inc.

Date: November 28, 2023

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For November 2023

Commission File No. 001-36848

Check-Cap Ltd.

Check-Cap Building

Abba Hushi Avenue

P.O. Box 1271

Isfiya, 3009000, 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 ☐

This Form 6-K (including the text in the first bullet under the heading “Check Cup Propose Business Combination Agreement” as well as the text under the heading “Financial Results for the Third Quarter Ended September 30, 2023,” “Financial Results for the Nine Months Ended September 30, 2023,” the accompanying financial statements, and “Legal Notice Regarding Forward-Looking Statements” in Exhibit 99.1) is hereby incorporated by reference into the Post-Effective Amendment No. 1 to the Form S-8 Registration Statement File No. 333-203384, Form S-8 Registration Statement File 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 November 27, 2023, Check-Cap Ltd. issued a press release entitled “Check-Cap Reports Third Quarter 2023 Financial Results and Provides a Corporate Update”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.


Exhibit No.		Description

99.1		Press Release, dated November 27, 2023.

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.

Exhibit 99.1

Check-Cap Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

Check-Cap shareholders to vote on proposed Business Combination Agreement with Keystone Dental at Annual General Meeting on Monday, December 18^th

ISFIYA, Israel, Nov. 27, 2023 /PRNewswire/ — Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK), today announced financial results and provided a corporate update for the third quarter and nine months ended September 30, 2023.

LOGO

Check Cup Propose Business Combination Agreement

•

In August 2023, Keystone Dental and Check-Cap announced entering into a definitive Business Combination Agreement (the “Business Combination Agreement”) under which the stockholders of Keystone Dental will become the majority holders of the combined company. If completed, the business combination will create a public company headquartered in Irvine, CA and focused on advancing commercial execution and market development of Keystone Dental’s comprehensive portfolio of implants, full arch restorations, and other tooth replacement solutions, in addition to biomaterial and digital dentistry capabilities. Upon closing of the transaction, the combined company will trade on the NASDAQ under the symbol “KSD.” The executive team of Keystone Dental will serve as the executive team of the combined company, led by Melker Nilsson, Keystone’s Chief Executive Officer.

Check-Cap has scheduled an Annual General Meeting of Shareholders (the “Meeting”) to be held on Monday, December 18, 2023 at 2:00 p.m. (Israel time) at the offices of Check-Cap’s Israeli legal counsel, FISCHER (FBC & Co.), located at 146 Menachem Begin Rd., Tel Aviv 6492103, Israel. At the Meeting, investors will be asked to consider and vote on several proposals, including a proposal to approve the Business Combination Agreement. Only shareholders of record at the close of business on November 10, 2023, are entitled to notice of and to vote at the Meeting or at any adjournment thereof.

Keystone Dental Recent Business Development

•

GENESIS ACTIVE^™ Implant System Commercial Launch – Keystone Dental announced the commercial launch of GENESIS ACTIVE^™ Implant System, a state-of-the-art surgical and prosthetic solution that is expected to transform how dental professionals approach implant placement and restoration. The system contains an innovative restorative portfolio of dental implant technologies in one system that enables dental professionals to deliver implant treatments with greater efficiency.

•

Nexus Connect Market Launch – Keystone Dental announced market launch of Nexus Connect, a unique software solution that utilizes proprietary technology and a machine-learning model to analyze implant scans performed with an intraoral scanner. The Nexus Connect employs proprietary 3D computer vision algorithms and geometric processing to detect Nexus Scan Gauges, segment them from tissue, and calculate their positions to ensure the captured data can proceed to prosthetic design. The analysis mechanism is a mathematical regression model based on thousands of completed real-world cases enabling immediate scan data results at the source of capture.

•

Patent for Nexus IOS Solution – Keystone Dental announced that the United States Patent and Trademark Office (USPTO) has granted Osteon Medical, a subsidiary of Keystone Dental, a patent for the innovative Nexus IOS solution. The Nexus iOS Scan Gauge technology allows implant dentists to perform direct full-arch implant scans using an Intraoral Scanner (IOS) with predictable and passive fitting prosthetic outcomes. This technology replaces the traditionally manual impression-taking process through a faster, cost-effective, and accessible workflow.

Financial Results for the Third Quarter Ended September 30, 2023

In anticipation of the initiation of the strategic development plan, management terminated the majority of the Company’s research and development activities. As a result, investment in research and development activities and in clinical trials was reduced to $30,000 for the three months ended September 30, 2023, compared to $3.6 million for the same period in 2022. The decrease is primarily comprised of (i) a decrease of approximately $1.8 million in salary and related expenses and a decrease of $0.4 million in share-based compensation resulting from termination of employees (ii) a decrease of $0.8 million in materials and subcontractors and , (iii) a decrease of approximately $0.5 million in other research and development expenses, including clinical related expenses and regulatory consultants.

General and administrative expenses were $2.8 million for the three months ended September 30, 2023, compared to $1.4 million for the same period in 2022. The increase is primarily due to a $1.8 million increase in professional services mainly related to legal and advisors’ expenses related to the pending transaction with Keystone Dental and strategic activities, offset in part by a $0.1 million reduction in share-based compensation and a $0.3 million decrease in other general expenses.

Impairment of fixed assets was $60,000 for the three months ended September 30, 2023, compared to none for the same period in 2022. The impairment is associated with the reduction in the Company’s operating activities.

Operating loss was $2.9 million for the three months ended September 30, 2023, compared to $5.0 million for the same period in 2022.

Net finance income was $0.3 million for the three months ended September 30, 2023, same as in the comparable period in 2022.

Net loss was $2.6 million for the three months ended September 30, 2023, compared to $4.7 million for the same period in 2022.

Cash and cash equivalents, restricted cash and short-term bank deposits as of September 30, 2023 were $28.2 million, compared with $32.4 million as of June 30, 2023 and $42.1 million as of December 31, 2022.

Financial Results for the Nine Months Ended September 30, 2023

In anticipation of the initiation of the strategic development plan, management terminated the majority of the Company’s research and development activities. As a result, investment in research and development activities and in clinical trials was reduced to $8.2 million for the nine months ended September 30, 2023, compared to $11.3 million for the same period in 2022. The decrease is primarily comprised of (i) a decrease of approximately $1.9 million in salary and related expenses and $0.5 million decrease in share-based compensation as a result of termination of employees (iii) a decrease of approximately $0.7 million in materials and subcontractors and other research and development expenses, including clinical related expenses and regulatory consultants, mainly associated with the termination of clinical studies and operations.

General and administrative expenses were $5.6 million for the nine months ended September 30, 2023, compared to $4.5 million for the same period in 2022. The increase is primarily due to a $1.9 million increase in professional services mainly related to legal and advisors’ expenses relating to the pending transaction with Keystone Dental and strategic activities, and $0.1 million in salary and related expenses including directors’ fees, offset in part by a $0.3 million reduction in share-based compensation and a $0.6 million decrease in other general expenses, mainly associated with directors’ and officers’ liability insurance costs.

Impairment of fixed assets was $1.4 million for the nine months ended September 30, 2023. Due to the changes in circumstances that indicate that the carrying amount of an asset may not be recoverable, the Company reviewed its long-lived assets for impairment in accordance with ASC 360-10 “Accounting for the Impairment or Disposal of Long-Lived Assets”. Therefore, the Company recorded an impairment loss of $1.4 million.

Operating loss was $15.2 million for the nine months ended September 30, 2023, compared to $15.8 million for the same period in 2022.

Net finance income was $1.3 million for the nine months ended September 30, 2023, compared to $0.4 million for the same period in 2022. The increase in finance income, net is primarily due to an increase in interest income on short-term deposits of $0.8 million.

Net loss was $13.9 million for the nine months ended September 30, 2023, compared to $15.4 million for the same period in 2022.

Net cash used in operating activities was $13.4 million for the nine months ended September 30, 2023, compared to $14.6 million for the same period in 2022.

About Keystone Dental Group:

Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners. Headquartered in Irvine, California, and with research and development and manufacturing sites in Caesarea, Israel and Melbourne, Australia, Keystone Dental markets its products worldwide. The Company’s product portfolio includes proprietary offerings such as its innovative implant systems Genesis Active, Molaris^™ and Prima Plus^™ that offer unique solutions to dental practitioners. In addition, the Company also offers an attractive dental implant value brand in Paltop, and a well-regarded portfolio of biomaterials mainly sold under the DYNA brand. Keystone Dental acquired Implant Solutions Pty Ltd (“Osteon”) in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities, not least of which is the groundbreaking Nexus iOS digital workflow solution for restoring the fully edentulous patient. For more information, refer to www.keystonedental.com.

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^®, a screening test designed to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. 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, 2022 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.

Participants in the Solicitation

Check-Cap, Keystone Parent and their respective directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies from the shareholders of Check-Cap in connection with the business combination. Information about Check-Cap’s directors and executive officers is set forth in Check-Cap’s Annual Report on Form 20-F for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023. Information about Keystone Dental’s directors and executive officers will be set forth in the prospectus (when available). Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the business combination, will be set forth in the prospectus, the proxy statement and other relevant materials to be filed or submitted with the SEC when they become available. Investors, Keystone security holders and Check-Cap security holders and other readers should read the prospectus and the proxy statement carefully when they become available before making any voting or investment decisions.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Logo: https://mma.prnewswire.com/media/820848/Check_Cap_Logo.jpg

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)


	September 30,			December 31,
	2023			2022
	Unaudited			Audited
Assets
Current assets
Cash and cash equivalents	$	3,383		$	4,090
Restricted cash		130			352
Short-term bank deposit		24,684			37,609
Prepaid expenses and other current assets		577			579

Total current assets		28,774			42,630

Non-current assets
Property and equipment, net		183			1,751
Operating leases		73			1,060

Total non-current assets		256			2,811

Total assets	$	29,030		$	45,441

Liabilities and shareholders’ equity
Current liabilities
Accounts payable and accruals
Trade	$	108		$	952
Other		717			802
Employees and payroll accruals		757			1,261
Other current liabilities		23			56
Operating lease liabilities		30			337

Total current liabilities		1,635			3,408

Non-current liabilities
Royalties provision		—			94
Operating lease liabilities		—			627

Total non-current liabilities		—			721

Shareholders’ equity
Share capital, Ordinary shares, 48 NIS par value (18,000,000 authorized shares as of September 30, 2023 and December 31, 2022, respectively; 5,850,100 and 5,844,463 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively)		83,740			83,664
Additional paid-in capital		84,858			84,941
Accumulated deficit		(141,203	)		(127,293	)

Total shareholders’ equity		27,395			41,312

Total liabilities and shareholders’ equity	$	29,030		$	45,441

CHECK CAP LTD

CONSOLIDATED UNAUDITED STATEMENTS OF COMPREHENSIVE LOSS

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


	Nine months ended September 30,				Three months ended September 30,
	2023		2022		2023		2022
Research and development expenses, net	$	8,181	$	11,315	$	30	$	3,641
General and administrative expenses		5,595		4,504		2,833		1,404
Impairment of fixed assets		1,426		—		62		—

Operating loss		15,202		15,819		2,925		5,045

Finance Income , net		1,292		424		335		291

Loss before income tax		13,910		15,395		2,590		4,754

Net loss for the period	$	13,910	$	15,395	$	2,590	$	4,754

Loss per share:
Net loss per ordinary share basic and diluted	$	2.38	$	2.74	$	0.44	$	0.81

Weighted average number of ordinary shares outstanding - basic and diluted		5,849,189		5,613,696		5,849,756		5,842,205

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, 2023		5,844,463	$	83,664	$	84,941		$	(127,293	)	$	41,312
RSUs vesting		5,637		76		(76	)		—			—
Share-based compensation		—		—		(7	)		—			(7	)
Net loss		—		—		—			(13,910	)		(13,910	)
Balance as of September 30, 2023		5,850,100	$	83,740	$	84,858		$	(141,203	)	$	27,395

Balance as of January 1, 2022		4,840,089	$	68,787	$	90,089		$	(108,185	)	$	50,691
Issuance of ordinary shares and warrants in March 2022 registered direct offerings, net of issuance expenses in an amount of $1,150		1,000,000		14,815		(5,965	)		—			8,850
RSUs vesting		3,564		51		(51	)		—			—
Share-based compensation		—		—		779			—			779
Net loss		—		—		—			(15,395	)		(15,395	)
Balance as of September 30, 2022		5,843,653	$	83,653	$	84,852		$	(123,580	)	$	44,925

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 June 30, 2023		5,849,216	$	83,728	$	85,075		$	(138,613	)	$	30,190
RSU’s vesting		884	$	12		(12	)					—
Share-based compensation		—		—	$	(205	)				$	(205	)
Net loss		—		—		—		$	(2,590	)	$	(2,590	)
Balance as of September 30, 2023		5,850,100	$	83,740	$	84,858		$	(141,203	)	$	27,395

Balance as of June 30, 2022		5,840,089	$	83,602	$	84,648		$	(118,826	)	$	49,424
RSU’s vesting		3,564	$	51	$	(51	)		—			—
Share-based compensation		—		—	$	255			—		$	255
Net loss		—		—		—		$	(4,754	)		(4,754	)
Balance as of September 30, 2022		5,843,653	$	83,653	$	84,852		$	(123,580	)	$	44,925

CHECK-CAP LTD.

CONSOLIDATED UNAUDITED STATEMENTS OF CASH FLOWS

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


	Nine months ended
	September 30,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(13,910	)	$	(15,395	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		190			254
Impairment of fixed assets		1,426			—
Share-based compensation		(7	)		779
Financial income, net		374			(295	)
Changes in assets and liabilities items:
Decrease in prepaid and other current assets and non-current assets		37			248
(Decrease) Increase in trade accounts payable, accruals and other current liabilities		(926	)		6
Decrease in employees and payroll accruals		(505	)		(127	)
Decrease in royalties provision		(94	)		(30	)
Net cash used in operating activities	$	(13,415	)	$	(14,560	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment		(83	)		(395	)
Investment in short-term bank and other deposits		12,569			(11,000	)
Net cash used in investing activities	$	12,486		$	(11,395	)
CASH FLOWS FROM FINANCING ACTIVITIES
Issuance of ordinary shares in the registered direct offerings, net of issuance expenses		—			8,850
Net cash provided by financing activities	$	—		$	8,850
Net decrease in cash, cash equivalents and restricted cash		(929	)		(17,105	)
Cash, cash equivalents and restricted cash at the beginning of the period		4,442			26,807
Cash, cash equivalents and restricted cash at the end of the period	$	3,513		$	9,702


	Nine months ended September 30,
	2023		2022
Supplemental disclosure of non-cash flow information
Purchase of property and equipment included in accounts payable and accrued expenses		—		89
Assets acquired under operating lease		136		307
Supplemental disclosure of cash flow information:
Cash paid for taxes		2		23
Interest received		1,720		377

* * * * *

Important Additional Information and Where to Find It

In connection with the business combination between Keystone Dental Holdings, Inc. (“Keystone”) with Check-Cap Ltd. (“Check-Cap”), a newly formed wholly owned subsidiary of Keystone (“Keystone Parent”) has filed with the SEC a registration statement on Form S-4 that has been declared effective by the SEC, and constitutes a prospectus with respect to shares of common stock of Keystone Parent to be issued in the business combination, and Check-Cap has delivered a proxy statement to its shareholders in connection with the annual meeting of its shareholders. Check-Cap and Keystone Parent may also file other documents with the SEC regarding the business combination. This filing is not a substitute for the prospectus or any other document which Keystone Parent or Check-Cap may file with the SEC. INVESTORS, KEYSTONE SECURITY HOLDERS AND CHECK-CAP SECURITY HOLDERS ARE URGED TO READ THE PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY KEYSTONE PARENT OR CHECK-CAP WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND RELATED MATTERS. Investors, Keystone security holders and Check-Cap security holders can also obtain free copies of the prospectus and other documents containing important information about Check-Cap, Keystone and the business combination that are or will be filed with the SEC by Check-Cap or Keystone through the website maintained by the SEC at www.sec.gov.

Participants in the Solicitation

No Offer or Solicitation

Legal Notice Regarding Forward-Looking Statements

Certain statements in this document may constitute “forward-looking statements”. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies of Check-Cap and/or Keystone Dental regarding the future including, without limitation, statements regarding Keystone’s prospects, financial results, technology and the benefits of tooth replacement solutions, expectations regarding the ownership structure of the combined company, and the structure, timing and completion of the proposed business combination. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions; the outcome of any legal proceedings that may be instituted against Keystone Dental or Check-Cap following the announcement of the business combination; the inability to complete the business combination, including due to the inability to concurrently close the business combination or due to failure to obtain approval of the shareholders of Check-Cap; delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals, or delays in completing regulatory reviews, required to complete the business combination; the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth, maintain relationships with customers and suppliers and retain key employees; costs related to the business combination; the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors; other risks and uncertainties indicated from time to time in the registration statement on Form S-4, and other risks, uncertainties and factors set forth under “Risk Factors” therein as well as in the section entitled “Risk Factors,” in Check-Cap’s Report on Form 6-K furnished to the SEC on August 4, 2023, and its other filings with the SEC, as well as factors associated with companies, such as Keystone and Check-Cap, that operate in the life science industry. Nothing herein should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Check-Cap nor Keystone undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or in the events, conditions or circumstances on which any such statement is based. This filing does not purport to summarize all of the conditions, risks and other attributes of an investment in Keystone, Check-Cap or the combined company.