Capstone Dental Pubco (KSD) S-4/ARegistration of securities issued in business combination transactions (amended)

As filed with the Securities and Exchange Commission on October 5, 2023.

No. 333-274297

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 1 TO

FORM S-4

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

CAPSTONE DENTAL PUBCO, INC.

(Exact name of registrant as specified in its charter)

154 Middlesex Turnpike

Burlington, MA 01803

(781) 328-3300

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Amnon Tamir

Chief Financial Officer

154 Middlesex Turnpike

Burlington, MA 01803

(781) 328-3300

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies of all communications, including communications sent to agent for service, should be sent to:

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after this Registration Statement is declared effective and upon completion of the business combination described in the prospectus contained herein.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer) ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer) ☐

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. Capstone Dental Pubco, Inc. may not sell the securities offered by this prospectus until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and Capstone Dental Pubco, Inc. is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS — SUBJECT TO COMPLETION, DATED OCTOBER 5, 2023

Capstone Dental Pubco, Inc.

SHARES OF COMMON STOCK,

PAR VALUE $0.01 PER SHARE

TO BE ISSUED TO HOLDERS OF COMMON STOCK, PAR VALUE $0.01 PER SHARE, OF KEYSTONE DENTAL HOLDINGS, INC. AND TO HOLDERS OF ORDINARY SHARES, PAR VALUE NIS 48.00 PER SHARE, OF CHECK-CAP LTD. IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED UNDER THE BUSINESS COMBINATION AGREEMENT DESCRIBED BELOW.

THIS IS NOT A PROXY STATEMENT OR NOTICE OF MEETING.

WE ARE NOT ASKING YOU FOR A PROXY AND YOU ARE REQUESTED NOT TO SEND US A PROXY.

This prospectus of Capstone Dental Pubco, Inc., a Delaware corporation (“New Parent”, “us” or “we”), relates to shares of New Parent common stock, par value $0.01 per share (“New Parent common stock”), to be issued to holders of shares of common stock, par value $0.01 per share, of Keystone Dental Holdings, Inc., a Delaware corporation (“Keystone”, and such common stock the “Keystone common stock”) and holders of ordinary shares, par value NIS 48.00 per share, of Check-Cap Ltd., an Israeli company (“Check-Cap”, and such ordinary shares the “Check-Cap ordinary shares”) in connection with the transactions contemplated under the Business Combination Agreement, dated as of August 16, 2023 entered into among New Parent, Keystone, Check-Cap, U.S. Merger Sub (as defined below) and Israel Merger Sub (as defined below) (the “Business Combination Agreement”). A copy of the Business Combination Agreement is attached as Annex A to this prospectus.

Pursuant to the Business Combination Agreement, Capstone Merger Sub Corp., a Delaware corporation (“U.S. Merger Sub”) and wholly-owned subsidiary of New Parent, will merge (the “U.S. Merger”) with and into Keystone, with Keystone surviving as a wholly-owned subsidiary of New Parent, and Capstone Merger Ltd., an Israeli company and wholly-owned subsidiary of New Parent (“Israel Merger Sub”), will merge (the “Israeli Merger,” and collectively with the U.S. Merger and the other transactions described in the Business Combination Agreement, the “Business Combination”) with and into Check-Cap, with Check-Cap surviving as a wholly-owned subsidiary of New Parent (such surviving entity sometimes referred to herein for the periods at and after the effective time of the Israeli Merger as the “Israeli Surviving Company”), and each of U.S. Merger Sub and Israel Merger Sub will cease to exist. Check-Cap, as a wholly owned subsidiary of New Parent, will maintain a registered office in the State of Israel. The U.S. Merger will become effective upon the filing of a certificate of merger with the Secretary of State of the State of Delaware executed in accordance with, and in such form as is required by, the relevant provisions of the Delaware General Corporation Law (the “DGCL”), and the Israeli Merger will become effective upon the issuance by the Israeli Companies Registrar of the Certificate of Merger for the Israeli Merger in accordance with Section 323(5) of the Israel Companies Law, 5759-1999 (the “Companies Law”).

Upon consummation of the U.S. Merger, each holder of shares of Keystone common stock will automatically receive that number of shares of New Parent common stock calculated pursuant to an exchange ratio (the “Exchange Ratio”) based on the respective per share valuations of Keystone and Check-Cap, subject to adjustment based on the amount of net cash (as determined pursuant to the Business Combination Agreement) that Check-Cap has as of the date of the closing of the Business Combination (the “Closing Date” and the “Closing”, respectively). The Exchange Ratio is equal to (i) the Keystone implied per share value (equal to the quotient of (x) $225,000,000 divided by (y) the number of shares of Keystone common stock outstanding as of the Closing Date on a fully-diluted basis), divided by (ii) the Check-Cap implied per share value (equal to the quotient of (x) $39,700,000 (subject to adjustment based on Check-Cap’s net cash as of the Closing Date) divided by (y) the number of Check-Cap ordinary shares outstanding as of the Closing Date on a fully-diluted basis). The

number of outstanding shares of each company will be calculated based on the treasury stock method. In addition, each option to purchase shares of Keystone common stock and each warrant to purchase shares of Keystone common stock issued by Keystone will be converted into an option to purchase that number of shares of New Parent common stock or a warrant to purchase that number of shares of New Parent common stock, respectively, calculated pursuant to the Exchange Ratio, on substantially similar terms. For more information, see “The Business Combination—Consideration.”

Upon consummation of the Israeli Merger, each holder of Check-Cap ordinary shares will receive one share of New Parent common stock in exchange for each Check-Cap ordinary share that is issued and outstanding immediately prior to the effective time of the Israeli Merger. Each option to purchase Check-Cap ordinary shares (whether vested or unvested) that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each restricted stock unit award representing the right to receive a Check-Cap ordinary share under the Check-Cap stock plans (a “Check-Cap RSU”) that is outstanding and fully vested immediately prior to the effective time of the Israeli Merger but has not been settled in Check-Cap ordinary shares (“Check-Cap Vested RSU”) will be canceled and automatically convert into and represent the right to receive from New Parent one share of New Parent common stock in exchange for each Check-Cap ordinary share underlying such Check-Cap Vested RSU. Each Check-Cap RSU that is outstanding and unvested immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each of the certain warrants issued pursuant to the certain Check-Cap Credit Line Agreement dated as of August 20, 2014 (“Check-Cap CLA Warrant”) that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire with no consideration delivered in respect thereof. Finally, certain warrants to purchase Check-Cap ordinary shares may be exercised by the holders thereof following the effective time of the Israeli Merger or, for a period of thirty days following the effective time of the Israeli Merger, redeemed at the election of the holders thereof for cash in an amount determined based on the Black-Scholes valuation model pursuant to the terms of such warrants (the warrants containing such redemption feature, the “Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants”). As the Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants are “out of the money” relative to the per share valuation of Check-Cap, it is expected that they will be redeemed in full and the calculation of net cash (as determined in accordance with the Business Combination Agreement) includes a reduction for the aggregate cost of the expected redemptions of such Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants. If any Check-Cap Registered Direct Warrant or Check-Cap Placement Agent Warrant is not redeemed by the end of such thirty-day period, the warrantholder will have the right to receive, upon exercise of such warrant, that number of shares of New Parent common stock that could have been acquired if such warrant had been exercised for ordinary shares of Check-Cap prior to the effective time of the Israeli Merger, and an allocable portion of any distributions with respect to the sale of Check-Cap’s legacy assets, as further described herein. There can be no assurance that any such sale or distributions will occur. For more information, see “The Business Combination—Consideration.”

Following the Closing, current Check-Cap equityholders will own approximately 15% of the issued and outstanding shares of New Parent common stock on a fully diluted basis and current Keystone equityholders will own approximately 85% of the issued and outstanding shares of New Parent common stock on a fully diluted basis. Entities affiliated with Accelmed Partners, L.P. (“Accelmed”), currently the principal shareholder of Keystone, will own approximately 60% of the issued and outstanding shares of New Parent common stock. These percentage are subject to a net cash adjustment, such that if Check-Cap’s net cash (as determined in accordance with the Business Combination Agreement) as of the close of business on the last business day prior to the anticipated closing date is $1.0 million lower or higher than the net cash target of $22.3 million, there will be a linear adjustment to Check-Cap’s equityholders’ ownership in New Parent.

Following the Closing, the sole business and operations of New Parent will be the business and operations of Keystone Dental, Inc. (“Keystone Dental”), a wholly-owned subsidiary of Keystone, and its subsidiaries, and New Parent will continue to run and operate such business and operations. Accordingly, this prospectus includes

a discussion of Keystone Dental’s business prior to the Closing. For more information, see “Keystone Business.” Any business of Check-Cap remaining prior to the Closing will be discontinued following the Closing. Management of Check-Cap is exploring transferring (including by way of sale, license or other disposition) Check-Cap’s remaining assets (including intellectual property). In the event that Check-Cap shall enter into an agreement for any such sale or other disposition of its legacy assets at or prior to the Closing, the net proceeds received at or prior to the Closing, or to which Check-Cap is contractually entitled to receive within ninety (90) days following the date of the Closing (the “Closing Date”) (subject to no conditions other than the passage of time), will be included in the calculation of the net cash of Check-Cap as of the Closing and will increase the number of shares of New Parent common stock that the holders of Check-Cap ordinary shares will receive at the Closing. In the event that Check-Cap enters into an agreement prior to or on the Closing to sell or otherwise dispose of its legacy assets but the proceeds therefor will be received more than 90 days after the Closing, New Parent will procure that the net proceeds of such transactions not otherwise distributed before the Closing are (i) distributed as promptly as possible, or (ii) set aside and reserved for future distribution, as applicable, to the relevant Check-Cap Legacy Holders. For more information, see “The Business Combination Agreement—Check-Cap Legacy Transaction.”

The Business Combination Agreement requires that the various transactions contemplated by the Business Combination be approved by the shareholders of Keystone, Check-Cap, U.S. Merger Sub and Israel Merger Sub. The special meeting of the holders of Check-Cap ordinary shares is scheduled to be held on [●], 2023, at [●] p.m., Israel Time, at the offices of [●], which meeting and any adjournments or postponements thereof is referred to as the “Check-Cap Shareholder Meeting”. The Check-Cap board of directors has fixed the close of business on [●], [●] [●], 2023, as the Check-Cap record date for determination of Check-Cap shareholders entitled to vote at the Check-Cap Shareholder Meeting. At the Check-Cap Shareholder Meeting, holders of Check-Cap ordinary shares of record as of the record date will be asked to consider and approve the Israeli Merger, the Business Combination and the other transactions to which Check-Cap is a party. In light of the above, at the time of the Check-Cap Shareholder Meeting, holders of Check-Cap ordinary shares will not know the exact number of shares of New Parent common stock they will be entitled to receive following the Closing.

There is currently no established public trading market for New Parent’s securities. New Parent has applied to list the New Parent common stock to be issued in the Business Combination on the Nasdaq Capital Market under the symbol “KSD”. The authorization for the listing on the Nasdaq Capital Market of the shares of New Parent common stock to be issued to Check-Cap shareholders in the Business Combination, subject to official notice of issuance, is a condition to the consummation of the Business Combination.

New Parent is an “emerging growth company” and a “smaller reporting company” and, since Accelmed will own a majority of New Parent’s outstanding common stock following the Closing, New Parent expects to qualify as a “controlled company” under the Nasdaq listing rules and is subject to reduced public company disclosure and corporate governance standards. See “Implications of Being an Emerging Growth Company, Smaller Reporting Company and Controlled Company.”

We urge you to read this prospectus, including each Annex, carefully and in its entirety. In particular, we urge you to read carefully the section entitled “Risk Factors” beginning on page 24. Neither the Securities and Exchange Commission (the “Commission”) nor any state securities commission has approved or disapproved of the Business Combination or the other transactions described in this prospectus or the securities to be issued in connection with the Business Combination or determined if this prospectus is accurate or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is [●], 2023.

ABOUT THIS PROSPECTUS

This document, which forms part of a Registration Statement on Form S-4 filed with the Commission by New Parent (File No. 333-274297), constitutes a prospectus of New Parent under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”) with respect to the shares of New Parent common stock to be issued pursuant to the Business Combination Agreement.

All information concerning New Parent contained in this prospectus has been furnished by New Parent, all information concerning Keystone contained in this prospectus has been furnished by Keystone, and all information concerning Check-Cap contained in this prospectus has been furnished by Check-Cap.

You should rely only on the information contained in this prospectus. New Parent, Keystone, and Check-Cap have not authorized anyone to provide you with information or to make any representation with respect to the matters described in this prospectus other than those contained herein and, if given or made, such information or presentation must not be relied upon as having been authorized by New Parent, Keystone, Check-Cap or any other person. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities in any jurisdiction in which, or to any person to whom, it is not lawful to make any such offer or solicitation.

This prospectus is dated [●], 2023, and you should not assume that the information contained in this prospectus is accurate as of any date other than such date. Neither the delivery of this prospectus nor the issuance by New Parent of shares of New Parent common stock registered hereunder shall, under any circumstances, create any implication that there has been no change in the assets, properties or affairs of New Parent, Keystone or Check-Cap since such date or that the information contained herein is correct as of any time subsequent to such date.

MARKET AND INDUSTRY DATA

This prospectus includes estimates regarding market and industry data that we prepared based on our management’s knowledge and experience in the markets in which we operate, together with information obtained from various sources, including publicly available information, industry reports and publications, surveys, our dental customers, distributors, suppliers, trade and business organizations and other contacts in the markets in which we operate. Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data and our knowledge of such industry and markets which we believe to be reasonable.

In presenting this information, we have made certain assumptions that we believe to be reasonable based on such data and other similar sources and on our knowledge of, and our experience to date in, the markets for the products we distribute. Any such market data, information or forecast is subject to change and may prove to be inaccurate because of the method by which we obtain it or because it cannot always be verified with complete certainty given the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations inherent in any statistical survey of market shares, including those discussed in the “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” sections. In addition, customer preferences are subject to change.

Our estimates presented elsewhere in this prospectus of our addressable market are based on multiple assumptions and our analysis of multiple sources, including publicly available information, academic articles, data from governmental agencies and reports by industry organization, as well as on our internal estimates.

Certain monetary amounts, percentages, and other figures included elsewhere in this prospectus have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables or charts may not be the

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arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.

CERTAIN TRADEMARKS

This prospectus includes references to trademarks and service marks owned by us, including Keystone Dental, the Keystone Dental logo and Genesis, Prima Plus, PrimaConnex, Molaris, DynaCore, DynaGraft D, Dyna Blast, DynaMatrix, We Follow Science, Smarter Thinking, Simpler Design, K-Lean, Ti-Lobe Tite, Anatite, BioSpark, TiLobeMAXX, I-Hexmrt and Genesis The Biomimetic Implant System. This prospectus also contains references to trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus may appear without the ^®, ^™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

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TABLE OF CONTENTS

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QUESTIONS AND ANSWERS

The following questions and answers are intended to briefly address some commonly asked questions regarding the Business Combination, the Business Combination Agreement, the shares of New Parent common stock to be issued pursuant to the Business Combination and the Check-Cap Shareholder Meeting. These questions and answers may not address all questions that may be important to you as a stockholder of Keystone or a shareholder of Check-Cap. Please refer to the section entitled “Summary” beginning on page 8 of this prospectus and the more detailed information contained elsewhere in this prospectus, the annexes to this prospectus and the documents referred to in this prospectus, which you should read carefully and in their entirety.

Q: Why am I receiving this prospectus?

Upon consummation of the proposed Business Combination, shares of New Parent common stock will be issued to holders of shares of Keystone common stock and holders of Check-Cap ordinary shares. Pursuant to the Business Combination Agreement, subject to approval of the Check-Cap shareholders, U.S. Merger Sub Corp., a Delaware corporation and wholly-owned subsidiary of New Parent, will merge with and into Keystone, with Keystone surviving as a wholly-owned subsidiary of New Parent, and Israel Merger Ltd., a company organized under the laws of the State of Israel and a wholly-owned subsidiary of New Parent, will merge with and into Check-Cap, with Check-Cap surviving as a wholly-owned subsidiary of New Parent, and each of U.S. Merger Sub and Israel Merger Sub will cease to exist. Check-Cap, as a wholly owned subsidiary of New Parent, will maintain a registered office in the State of Israel. The U.S. Merger will become effective upon the filing of a certificate of merger with the Secretary of State of the State of Delaware executed in accordance with, and in such form as is required by, the relevant provisions of the DGCL, and the Israeli Merger will become effective upon the issuance by the Companies Registrar of the Certificate of Merger for the Second Merger in accordance with Section 323(5) of the Israel Companies Law.

Check-Cap is holding a special meeting of its shareholders, which we generally refer to as the “Check-Cap Shareholder Meeting,” to ask its shareholders to consider and vote upon a proposal to approve the Israeli Merger, the Business Combination and the other transactions to which Check-Cap is a party. At the time of the Check-Cap Shareholder Meeting, holders of Check-Cap ordinary shares will not know the exact number of shares of New Parent common stock they will be entitled to receive following the Closing.

New Parent has applied to list the New Parent common stock to be issued in the Business Combination on the Nasdaq Capital Market under the symbol “KSD”.

This prospectus includes important information about the Business Combination, the Business Combination Agreement, a copy of which is attached as Annex A to this prospectus, the shares of New Parent common stock to be issued pursuant to the Business Combination and the Check-Cap Shareholder Meeting. You should read this information carefully and in its entirety.

Q: Who is Keystone?

Following the Closing, the sole business and operations of New Parent will be the business and operations of Keystone Dental, a wholly-owned subsidiary of Keystone, and its subsidiaries, and New Parent will continue to run and operate such business and operations. Keystone is a global commercial stage medical technology company focused on providing end-to-end solutions for dental practitioners and tooth replacement procedures. Its comprehensive portfolio of tooth replacement solutions is comprised of implants, prosthetic solutions, biomaterial solutions and digital dentistry capabilities. Keystone develops and offers technologies it believes are effective and advanced technologies for dental practitioners, dental laboratories and patients at an attractive price, driving significant value to both practitioners and patients. Keystone believes its products offer strong value proposition for dental practitioners through its innovative products with high quality manufacturing and design at

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various pricing options. Keystone has premium and high touch customer service with an experienced direct sales force and third-party distributors, simplifying a complex procedure through the digitalization of workflow for multiple clinical indications. Based on Keystone’s estimates, it believes its digital capabilities for dental practices have the potential to reduce the number of office visits and decrease patient chair time per procedure. Keystone’s various brands, including Genesis, Prima, Paltop, Molaris, Dyna, Osteon and Nexus iOS, are widely known amongst dental practitioners. For more information, see the section entitled “Information about Keystone– Keystone Business” beginning on page 196 of this prospectus.

Q: What is the approval requirement at the Check-Cap Shareholder Meeting?

The approval of the Business Combination requires the affirmative vote of the holders of a majority of the Check-Cap ordinary shares present, in person or by proxy, and entitled to vote and voting on the matter at the Check-Cap Shareholder Meeting, excluding abstentions and broker non-votes (and other invalid votes) and excluding any Check-Cap ordinary shares that are held by (a) New Parent, Keystone, Israel Merger Sub or by any person holding directly or indirectly 25% or more of the voting power or the right to appoint 25% or more of the directors of New Parent, Keystone or Israeli Merger Sub, (b) a person or entity acting on behalf of New Parent, Keystone or Israeli Merger Sub or a person or entity described in clause (a) above, or (c) a family member of an individual contemplated by either of clause (a) or (b) above, or an entity controlled by New Parent, Keystone, Israeli Merger Sub or any of the foregoing. All holders of record of Check-Cap ordinary shares as of the close of business on [●], 2023, the record date for the Check-Cap Shareholder Meeting, will be entitled to vote at the Check-Cap Shareholder Meeting. Each holder of Check-Cap ordinary shares will be entitled to cast one vote on each matter properly brought before the Check-Cap Shareholder Meeting for each Check-Cap ordinary share that such holder owned of record as of the record date.

Q: Is consummation of the Business Combination contingent upon any future approval by the holders of New Parent common stock?

Following the execution of the Business Combination Agreement, Keystone obtained all approvals and consents of the holders of its capital stock necessary to effect the U.S. Merger, the Business Combination and the other transactions contemplated by the Business Combination Agreement. No further approvals by the holders of Keystone capital stock are required to consummate the Business Combination or the other transactions contemplated by the Business Combination Agreement other than those already obtained.

Q: Has the board of directors of each of Keystone and Check-Cap approved the Business Combination?

Yes. The board of directors of each Keystone and Check-Cap have approved the Business Combination and recommended that the stockholders of Keystone and the shareholders of Check-Cap, respectively, vote in favor of the Business Combination, vote to adopt the Business Combination Agreement and approve the Business Combination and related transactions. As noted above, Keystone has already obtained all approvals and consents of the holders of its capital stock necessary to effect the Business Combination and the other transactions contemplated by the Business Combination Agreement.

Q: Did Check-Cap’s board of directors obtain a third-party valuation or fairness opinion in determining whether or not to proceed with the Business Combination?

Yes. In considering the Business Combination, Check-Cap’s board of directors engaged Ladenburg Thalmann & Co. Inc. (“Ladenburg”) as its financial advisor. Ladenburg evaluated the fairness of the Business Combination, from a financial point of view, to the holders of Check-Cap ordinary shares, and provided a written opinion to the Check-Cap board of directors. The full text of the written opinion of Ladenburg is attached as Annex B to this prospectus, and a summary of the opinion is set forth in “The Business Combination–Opinion of Check-Cap’s Financial Advisors—Fairness Opinion of Ladenburg” below.

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In addition, Check-Cap’s board of directors engaged Variance Economic Consulting Ltd. (“Variance”) as an additional financial advisor. Variance evaluated the fairness of the Exchange Ratio, from a financial point of view, to the holders of Check-Cap ordinary shares, and provided a written opinion to the Check-Cap board of directors. The full text of the written opinion of Variance is attached as Annex C to this prospectus, and a summary of the opinion is set forth in “The Business Combination—Opinion of Check-Cap’s Financial Advisors—Fairness Opinion of Variance” below.

Q: What are the conditions to the consummation of the Business Combination?

In addition to approval of the Business Combination by Check-Cap shareholders as described above, completion of the Business Combination is subject to the satisfaction of a number of other conditions, including (among others): authorization for listing of New Parent common stock on the Nasdaq Capital Market; the effectiveness of the Registration Statement of which this prospectus forms a part; the accuracy of representations and warranties under the Business Combination Agreement (subject to certain materiality exceptions) the absence of a material adverse effect on Keystone or Check-Cap; Keystone’s and Check-Cap’s performance of their respective obligations under the Business Combination Agreement; the receipt of a “no-action” letter from the Israel Securities Authority (the “ISA”); the receipt of certain tax rulings from the Israel Tax Authority (the “ITA”); the termination of any stockholders agreements, voting agreements, registration rights agreements, co-sale agreements and any other similar contracts between Keystone and any holders of Keystone capital stock; the Registration Rights Agreement pursuant to which New Parent will provide certain Keystone stockholders certain registration rights with respect to the shares of New Parent common stock shall have been executed by the parties; New Parent shall have delivered an undertaking of New Parent, and Check-Cap shall have delivered a notice, in each case to be submitted to the Israel Innovation Authority; Check-Cap taken all actions necessary to terminate the employment of substantially all of the Check-Cap employees and terminate the consulting relationship with substantially all of the independent contractors of Check-Cap; and the Israeli District Court shall have approved a distribution by Check-Cap in the amount of $21.3 million (including an amount for the redemption of all of the redeemable Check-Cap warrants), subject to and following the Closing. In addition, under the Companies Law, a minimum of 50 days must elapse from the date of the filing of the merger proposal by both merging companies with the Israeli Companies Registrar before the Israeli Merger can become effective, and the Israeli Merger may not be effective until the expiration of 30 days from the date of the approval of the Israeli Merger by Check-Cap’s shareholders. The Business Combination Agreement provides that the consummation of the Israel Merger and the consummation of the U.S. Merger will occur on the Closing Date; as such, the two mergers are conditioned upon each other. For more information, see “The Business Combination Agreement–Conditions to Closing” and “—Structure of the Transactions” below.

Q: When is the Business Combination expected to be consummated?

Subject to the satisfaction or waiver of the closing conditions described under the section entitled “The Business Combination Agreement—Conditions to Closing”, including the approval of the Business Combination by Check-Cap shareholders at the Check-Cap Shareholder Meeting, Keystone and Check-Cap expect that the Business Combination will be consummated in January 2024. However, it is possible that factors outside the control of both companies could result in the Business Combination being consummated at a different time or not at all. In addition, under the Companies Law, a minimum of 50 days must elapse from the date of the filing of the merger proposal by both merging companies with the Israeli Companies Registrar before the Israeli Merger can become effective, and the Israeli Merger may not be effective until the expiration of 30 days from the date of the approval of the Israeli Merger by Check-Cap’s shareholders.

Q: What happens if the Business Combination is not consummated?

If the Business Combination is not approved by Check-Cap shareholders, or if the Business Combination is not consummated for any other reason, neither the Keystone equityholders nor the Check-Cap equityholders will receive shares of New Parent common stock in exchange for their Keystone or Check-Cap equity, as applicable.

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In addition, in certain instances of termination by Keystone or Check-Cap of the Business Combination Agreement such terminating party will be required to pay the other party a termination fee, in such amount and in accordance with the Business Combination Agreement. In addition, if the Business Combination is not approved by Check-Cap shareholders, or if the Business Combination is not consummated, Check-Cap will remain a public reporting company and Check-Cap shareholders will continue to hold equity in Check-Cap. For more information, see “The Business Combination Agreement—Termination” below.

Q: What will Keystone stockholders and optionholders receive if the Business Combination is consummated?

Upon consummation of the U.S. Merger, each holder of shares of Keystone common stock will automatically receive that number of shares of New Parent common stock calculated pursuant to the Exchange Ratio. In addition, each option to purchase shares of Keystone common stock and each warrant to purchase shares of Keystone common stock issued by Keystone will be converted into an option to purchase that number of shares of New Parent common stock or a warrant to purchase that number of shares of New Parent common stock, respectively, calculated pursuant to the Exchange Ratio, on substantially similar terms. For more information, see “The Business Combination—Consideration to be Received in the Business Combination.”

Q: What will Check-Cap shareholders, optionholders, holders of RSUs and warrantholders receive in the Business Combination?

Upon consummation of the Israeli Merger, each holder of Check-Cap ordinary shares will receive one share of New Parent common stock in exchange for each Check-Cap ordinary share that is issued and outstanding immediately prior to the effective time of the Israeli Merger. Each option to purchase Check-Cap ordinary shares (whether vested or unvested) that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each Check-Cap Vested RSU that is outstanding immediately prior to the effective time of the Israeli Merger will be canceled and will automatically convert into and represent the right to receive from New Parent one share of New Parent common stock in exchange for each Check-Cap ordinary share underlying such RSU. Each Check-Cap RSU that is outstanding and unvested immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each Check-Cap CLA Warrant that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire with no consideration delivered in respect thereof. Finally, the Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants may be exercised by the holders thereof following the effective time of the Israeli Merger or, for a period of thirty days following the effective time of the Israeli Merger, redeemed at the election of the holders thereof for cash in an amount determined based on the Black-Scholes valuation model pursuant to the terms of such warrants. As the Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants are “out of the money” relative to the per share valuation of Check-Cap, it is expected that they will be redeemed in full and the calculation of net cash (as determined in accordance with the Business Combination Agreement) includes a reduction for the aggregate cost of the expected redemptions of such Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants. If any Check-Cap Registered Direct Warrant or Check-Cap Placement Agent Warrant is not redeemed by the end of such thirty-day period, the warrantholder will have the right to receive, upon exercise of such warrant, that number of shares of New Parent common stock that could have been acquired if such warrant had been exercised for ordinary shares of Check-Cap prior to the effective time of the Israeli Merger, and an allocable portion of any distributions with respect to the sale of Check-Cap’s legacy assets, as further described herein. There can be no assurance that any such sale or distributions will occur. For more information, see “The Business Combination—Consideration to be Received in the Business Combination.”

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Q: Do any of the directors or executive officers of Keystone or Check-Cap have any interests in the Business Combination that may be different from, or in addition to, those of Keystone’s stockholders of Check-Cap’s shareholders?

In considering the Business Combination, you should be aware that the directors and executive officers of Keystone and Check-Cap may have interests in the Business Combination that may be different from, or in addition to, those of Keystone’s stockholders and Check-Cap’s shareholders generally. The board of directors of each of Keystone and Check-Cap were aware of and considered these interests among other matters, in evaluating and approving the Business Combination Agreement and the Business Combination, and in recommending that the Keystone stockholders or Check-Cap shareholders (as applicable) vote to adopt the Business Combination Agreement and approve the Business Combination. These interests include post-Business Combination roles at New Parent, as following the Closing it is expected that Melker Nilsson will serve as Chief Executive Officer of New Parent and Amnon Tamir will serve as Chief Financial Officer of New Parent. It is also expected that Uri Geiger will serve as chairman of the board of directors of New Parent, each of Melker Nilsson, Erin Enright, Howard Zauberman, Shmuel Rubinstein, Stanley Stern and Sheryl Conley will serve as a member of, and Michael Tuckman will serve as an observer on, the board of directors of New Parent, and two of the current members of the Check-Cap board of directors will serve as members of the board of directors of New Parent. Messrs. Nilsson, Tamir and Stern will also each receive a one-time transaction bonus, and Messrs. Nilsson’s and Tamir’s respective annual base salaries and annual bonus targets will be increased. Finally, the Business Combination Agreement requires that the organizational documents of New Parent contain provisions no less favorable with respect to exculpation, indemnification, advancement or expense reimbursement than are set forth in the organizational documents of Keystone and Check-Cap, and the parties will purchase a “tail” directors’ and officers’ liability insurance policy that will provide coverage to Keystone’s and Check-Cap’s executive officers and directors with respect to matters occurring prior to the Closing until the seventh anniversary of the Closing. For more information, see “The Business Combination – Interests of Check-Cap’s Directors and Executive Officers in the Business Combination” and “—Interests of Keystone’s Directors and Executive Officers in the Business Combination” below.

Q: What are the material U.S. federal tax consequences to Keystone securityholders of the Business Combination?

Assuming that the U.S. Merger and the Israeli Merger will be consummated as described in the Business Combination Agreement, (i) the U.S. Merger should qualify as a “reorganization” under Section 368(a)(1) of the Internal Revenue Code of 1986, as amended (the “Code”), and (ii) taken together, the Business Combination should qualify as a transaction described in Section 351 of the Code. Therefore, subject to various conditions and assumptions, a U.S. holder of shares of Keystone common stock receiving shares of New Parent common stock pursuant to the Business Combination should not recognize gain or loss with respect to the receipt of such shares for U.S. federal tax purposes. Likewise, the Keystone warrants and options and the New Parent warrants and options received in exchange therefore should constitute “securities” that can be exchanged tax-free in the reorganization, much like the stock exchanged in the Business Combination. If the Business Combination fails to qualify as a “reorganization under Section 368(a) of the Code and as an “exchange” described in Section 351 of the Code, then a U.S. holder would recognize gain or loss upon the exchange of the holder’s shares of Keystone common stock for shares of New Parent common stock equal to the difference between the fair market value, at the time of the exchange, of the New Parent common stock and such U.S. holder’s tax basis in the shares of Keystone common stock surrendered in the Business Combination. Likewise, if the Business Combination does not qualify as a reorganization under Section 368(a)(1) of the Code, then even if the Business Combination qualifies as an exchange under Section 351 of the Code with respect to the stock, Section 351 of the Code does not permit the receipt of securities or other property that is not stock (such as the New Parent warrants and options to be received in exchange for the Keystone warrants and options) on a tax-free basis and therefore holders of Keystone warrants and options should recognize gain or loss on the exchange equal to the difference between the fair market value of the New Parent warrants and options received and the holder’s tax basis in the Keystone warrants and options surrendered in the exchange. The conclusion that the U.S. Merger should qualify

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as a reorganization under Section 368(a) of the Code depends, in part, on at least 80% of the shares of Keystone common stock being exchanged for New Parent common stock. If dissenters exercise their dissenters’ rights with respect to more than 20% of the shares of Keystone common stock, the U.S. Merger will fail to qualify as a reorganization under Section 368(a) of the Code.

Tax matters are complicated, and the tax consequences of the Business Combination to Keystone securityholders will depend on their particular situation. You are encouraged to consult your tax advisors regarding the specific tax consequences of the Business Combination applicable to you.

For more information, see “The Business Combination – Material U.S. Tax Consequences of the Business Combination for Holders of Keystone Securities” below.

Q: What are the material Israeli tax consequences to Keystone and Check-Cap securityholders of the Business Combination?

Generally, the exchange of Keystone securities and Check-Cap securities for the Business Combination consideration should be treated as a sale and subject to Israeli tax both for Israeli and non-Israeli resident securityholders. However, certain relief and/or exemptions may be available under Israeli law or under applicable tax treaties. In addition, Keystone and Check-Cap have filed applications for various tax rulings with the ITA relating to the consideration to be received in the Business Combination. Obtaining such tax rulings is a condition to the closing of the Business Combination; however, if one or more tax rulings is not received, the parties may determine to waive the condition and proceed to closing. In such an event, the relief sought under such rulings, which include tax exemptions or deferrals to Keystone and Check-Cap securityholders, will not have been obtained, and the Business Combination could be taxable to certain of such securityholders.

Tax matters are complicated, and the tax consequences of the Business Combination to Check-Cap securityholders and Keystone securityholders will depend on their particular situation. You are encouraged to consult your tax advisors regarding the specific tax consequences of the Business Combination applicable to you.

For more information, see “The Business Combination – Material Israeli Tax Consequences of the Business Combination” below.

Q: What are the material U.S. federal income tax consequences of the Israeli Merger to U.S. holders of Check-Cap ordinary shares?

The Business Combination should constitute an integrated transaction that qualifies as a tax-deferred exchange under Section 351(a) of the Code. Assuming such qualification, and subject to the application of the passive foreign investment company (“PFIC”) rules, U.S. holders (as defined under the section entitled “The Business Combination – Material U.S. Tax Consequences of the Business Combination for Holders of Check-Cap”) of Check-Cap ordinary shares should not recognize any gain or loss on such exchange.

For additional discussion of the U.S. federal income tax consequences of the Israeli Merger, including the PFIC rules, see the section entitled “The Business Combination – Material U.S. Tax Consequences of the Business Combination for Holders of Check-Cap Securities” beginning on page 148 of this prospectus.

Q: Do I have appraisal rights if I object to the Business Combination?

Appraisal rights are not available to holders of Check-Cap ordinary shares in connection with the Business Combination and the transactions contemplated thereby. Keystone stockholders are entitled to statutory appraisal rights in connection with the Business Combination under Section 262 of the DGCL. For more information about such rights, please see the provisions of Section 262 of the DGCL and the section entitled “Appraisal Rights” beginning on page 322 of this prospectus.

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Q: What will happen to Check-Cap’s ordinary shares following the Business Combination?

As a result of the Business Combination, Check-Cap will no longer be a publicly held company, and all shares of Check-Cap will be owned by New Parent. Following the consummation of the Business Combination, Check-Cap ordinary shares will be delisted from Nasdaq and deregistered under the Exchange Act, and Check-Cap will no longer be required to file reports with the Commission in respect of Check-Cap ordinary shares.

Q: What equity stake will current Keystone stockholders and Check-Cap shareholders have in New Parent following the Business Combination?

Following the Closing, current Keystone equityholders will own approximately 85% of the issued and outstanding shares of common stock of New Parent on a fully diluted basis and current Check-Cap equityholders will own approximately 15% of the issued and outstanding shares of common stock of New Parent on a fully diluted basis. Entities affiliated with Accelmed, currently the principal stockholder of Keystone, will own approximately 60% of the issued and outstanding shares of New Parent common stock. These percentages are subject to a net cash adjustment, such that if Check-Cap’s net cash (as determined in accordance with the Business Combination Agreement) as of the close of business on the last business day prior to the anticipated closing date is $1.0 million lower or higher than the net cash target of $22.3 million, there will be a linear adjustment to Check-Cap’s equityholders’ ownership in New Parent.

As set forth above, following the Closing it is expected that Accelmed will own approximately 60% of the issued and outstanding shares of New Parent common stock. Accordingly, it will have substantial influence over the outcome of a corporate action requiring stockholder approval, including the election of directors, any approval of a merger, consolidation or sale of all or substantially all of New Parent’s assets or any other significant corporate transaction, even if the outcome sought by such stockholders is not in the interest of New Parent’s other stockholders. In addition, the significant concentration of stock ownership may adversely affect the value of New Parent common stock due to a resulting lack of liquidity of New Parent common stock or a perception among investors that conflicts of interest may exist or arise. For more information, see “Risk Factors – Risks Related to the Business Combination – Ownership of New Parent’s common stock will be highly concentrated after consummation of the Business Combination” below.

Q: Who will be the officers and directors of New Parent following the Closing?

The Business Combination Agreement provides that, immediately following the Closing, Melker Nilsson will serve as Chief Executive Officer of New Parent and Amnon Tamir will serve as Chief Financial Officer of New Parent. The board of directors of New Parent will be comprised of those individuals designated by Keystone, provided, however, that Check-Cap shall have the right to designate (x) one (1) initial director of New Parent if the New Parent board of directors as of immediately following the effective time of the U.S. Merger will have up to seven (7) members, and (y) two (2) initial directors of New Parent if the New Parent board of directors as of immediately following the effective time of the U.S. Merger will have more than seven (7) members. For more information, see “The Business Combination – Governance of New Parent Following the Business Combination” below.

Q: Who can help answer any other questions I have?

If you have additional questions about the Business Combination or need additional copies of this prospectus, please contact Amnon Tamir, the Chief Financial Officer of Keystone, at atamir@keystonedental.com.

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RISK FACTORS

Investing in New Parent common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with the information included elsewhere in this prospectus. The risks and uncertainties described below are those that we have identified as material, but are not the only risks and uncertainties facing us. Keystone’s business is also subject to general risks and uncertainties that affect many other companies, such as market conditions, economic conditions, geopolitical events, changes in laws, regulations or accounting rules, fluctuations in interest rates, terrorism, wars or conflicts, major health concerns, natural disasters or other disruptions of expected business conditions. Additional risks and uncertainties not currently known to us or that we currently believe are immaterial also may impair our business, including our results of operations, liquidity and financial condition. In such case, the trading price of New Parent common stock could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking statements and estimates that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of specific factors, including the risks and uncertainties described below.

Risks Related to the Business Combination

The number of shares of New Parent common stock that Keystone stockholders and Check-Cap shareholders will receive under the Agreement is based on fixed exchange ratios. The market value of the shares of New Parent common stock to be issued upon completion of the Business Combination is unknown, and therefore, Keystone stockholders and Check-Cap shareholders cannot be certain, at the time they are being asked to vote, of the value of the portion of the Business Combination consideration to be paid in New Parent common stock.

Keystone stockholders and Check-Cap shareholders will receive a fixed number of shares of New Parent common stock in the Business Combination rather than a number of shares with a particular fixed market value. The market value of Check-Cap ordinary shares has fluctuated since the date of the announcement of the Business Combination and will continue to fluctuate from the date of this filing to the date of the Check-Cap Shareholder Meeting and the closing date of the Business Combination, which could occur a considerable amount of time after the date of the Check-Cap Shareholder Meeting. The market value of Check-Cap ordinary shares at the time of the closing of the Business Combination may vary significantly from its price on the date of the Business Combination Agreement, the date of this filing or the date of the Check-Cap Shareholder Meeting. Because the exchange ratio will not be adjusted to reflect any change to the value of Check-Cap ordinary shares, the market value of New Parent common stock issued in the Business Combination and the Check-Cap ordinary shares surrendered in the Business Combination may be higher or lower than the value of such stock on earlier dates. Also, because the market value of the shares of New Parent common stock to be issued upon completion of the Business Combination is unknown, Keystone stockholders and Check-Cap shareholders cannot be certain, at the time they are being asked to vote, of the value of the portion of the Business Combination consideration to be paid in New Parent common stock.

The amount of Business Combination consideration is dependent on the amount of net cash of Check-Cap as of the Closing.

Following the Closing, current Check-Cap equityholders will own approximately 15% of the issued and outstanding shares of common stock of New Parent on a fully diluted basis and current Keystone equityholders will own approximately 85% of the issued and outstanding shares of common stock of New Parent on a fully diluted basis. These percentage are subject to a net cash adjustment, such that if Check-Cap’s net cash (as determined in accordance with the Business Combination Agreement) as of the close of business on the last business day prior to the anticipated closing date is $1.0 million lower or higher than the net cash target of $22.3 million, there will be a linear adjustment to Check-Cap’s equityholders’ ownership in New Parent. We cannot assure you that any actions taken by Check-Cap to attempt to maintain its current level of net cash between now and Closing will be successful.

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Keystone will be subject to business uncertainties and contractual restrictions while the Business Combination are pending.

Uncertainty about the effect of the Business Combination on employees, vendors and customers may have an adverse effect on Keystone after the Closing. These uncertainties may impair Keystone’s ability to retain and motivate key personnel and could cause customers and others that deal with Keystone to defer or decline entering into contracts with Keystone, making other decisions concerning Keystone or seek to change existing business relationships with Keystone. In addition, if key employees depart because of uncertainty about their future roles and the potential complexities of the Business Combination, Keystone’s businesses could be harmed. Furthermore, the Business Combination Agreement places certain restrictions on the operation of each of Keystone and Check-Cap prior to the Closing, which may delay or prevent Keystone and Check-Cap from undertaking certain actions or business opportunities that may arise prior to the consummation of the Business Combination. See “The Business Combination Agreement—Interim Operation Covenants of Check-Cap” beginning on page 165 of this prospectus and “The Business Combination Agreement—Interim Operation Covenants of Keystone” beginning on page 167 of this prospectus for a description of the restrictive covenants applicable to Keystone and Check-Cap.

Third parties may terminate or alter existing contracts or relationships with Keystone.

Keystone has contracts with customers, vendors and other business partners. Counterparties to these contracts and other third parties with which Keystone may reduce the scope of or otherwise materially adversely alter their relationships with Keystone in anticipation of the Business Combination. The pursuit of such rights may result in Keystone suffering a loss of potential future revenue, incurring liabilities in connection with a breach of such agreements or losing rights that are material to its business. Any such disruptions could limit our ability to achieve the anticipated benefits of the Business Combination. The adverse effect of such disruptions could also be exacerbated by a delay in the completion of the Business Combination or the termination of the Business Combination.

Keystone or Check-Cap may waive one or more of the closing conditions to the Business Combination without re-soliciting stockholder approval.

Each of Keystone and Check-Cap has the right to waive certain of the closing conditions to the Business Combination. Any such waiver may not require re-solicitation of shareholders, in which case stockholders of Keystone and shareholders of Check-Cap will not have the chance to change their votes as a result of any such waiver and Keystone and Check-Cap will have the ability to complete the Business Combination without seeking further stockholder approval. Any determination whether to waive any condition to the Business Combination, whether stockholder approval would be re-solicited as a result of any such waiver or whether this prospectus would be amended as a result of any waiver, will be made by Keystone or Check-Cap, as applicable, at the time of such waiver based on the facts and circumstances as they exist at that time, and any such waiver could have an adverse effect on New Parent.

The unaudited pro forma combined financial statements included in this prospectus are preliminary and the actual financial condition and results of our operations after the Business Combination may differ materially.

This prospectus includes unaudited pro forma condensed combined financial statements for New Parent. The unaudited pro forma combined statements of comprehensive loss for the year ended December 31, 2022 and the six months ended June 30, 2023, combine the historical consolidated statements of comprehensive loss of Keystone and Check-Cap, giving effect to the Business Combination as if it had occurred on January 1, 2022, and the unaudited pro forma condensed combined balance sheet as of June 30, 2023 combines the historical consolidated balance sheets of Keystone and Check-Cap, giving effect to the Business Combination as if it had occurred on June 30, 2023. Both the unaudited pro forma combined statements of comprehensive loss and the unaudited pro forma combined balance sheet of New Parent should be read in conjunction with the financial

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statements and accompanying notes of each of Keystone and Check-Cap, which are included in this prospectus. The unaudited pro forma financial statements are presented for illustrative purposes only, are based on certain assumptions, address a hypothetical situation and reflect limited historical financial data. Therefore, the unaudited pro forma financial statements are presented for informational purposes only and are not necessarily indicative of what New Parent’s actual financial condition or results of operations would have been had the Business Combination been completed on the dates indicated. Accordingly, New Parent’s business, assets, results of operations and financial condition may differ significantly from those indicated by the pro forma financial statements included in this prospectus. For more information, see “Unaudited Pro Forma Combined Financial Information” and “Where You Can Find Additional Information” beginning on pages 183 and 323, respectively, of this prospectus.

The market price for shares of New Parent common stock may decline as a result of some of New Parent’s stockholders selling their shares of New Parent common stock following the closing of the Business Combination.

Sales of New Parent common stock by our stockholders after the completion of the Business Combination may cause the market price of New Parent common stock to decrease. Many Keystone stockholders and Check-Cap shareholders may decide not to hold the shares of New Parent common stock that they receive in the Business Combination. Other of our stockholders, such as funds with limitations on their permitted holdings of stock in individual issuers, may be required to sell the shares of New Parent common stock that they receive in the Business Combination. Such sales of New Parent common stock could have the effect of depressing the market price for New Parent common stock and may take place promptly following the Business Combination.

Ownership of New Parent’s common stock will be highly concentrated after consummation of the Business Combination.

After consummation of the Business Combination, a limited number of Keystone stockholders will have beneficial ownership of significant blocks of outstanding common stock of New Parent. Accelmed will own or control approximately 60% of the outstanding capital stock of Parent after the Business Combination. Accordingly, it will have the ability to control any corporate action requiring stockholder approval, including the election of directors, any approval of a business combination, consolidation or sale of all or substantially all of our assets or any other significant corporate transaction, even if the outcome sought by such stockholders is not in the interest of our other stockholders. It may also delay or prevent a change in control, even if such change in control would benefit our other stockholders. In addition, the significant concentration of stock ownership may adversely affect the value of New Parent common stock due to a resulting lack of liquidity of New Parent common stock or a perception among investors that conflicts of interest may exist or arise.

The market price of New Parent common stock after the Business Combination may be affected by factors different from those currently affecting the financial condition, results of operations and business of Check-Cap.

The business of Keystone differs from the Check-Cap business and, accordingly, the results of operations and the market price of New Parent common stock following the Business Combination may be significantly different from those currently affecting the independent results of operations of Check-Cap. For a discussion of the business of Keystone and of certain factors to consider in connection with those businesses, see the section entitled “Information about Keystone—Keystone Business” beginning on page 196 of this prospectus as well as the risks described elsewhere in “Risk Factors” and throughout this prospectus.

The termination fee and restrictions on solicitation contained in the Business Combination Agreement may discourage other companies from trying to acquire Keystone or Check-Cap.

Until the effective time of the Business Combination, with certain exceptions, the Business Combination Agreement prohibits both Keystone and Check-Cap from entering into or soliciting any acquisition proposal or

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offer for a Business Combination or other business combination with any other party. The Business Combination Agreement provides each of Keystone and Check-Cap with specified termination rights. If the Business Combination Agreement is terminated by Check-Cap to accept a superior acquisition proposal or under other circumstances specified in the Business Combination agreement, Check-Cap will be required to pay to Keystone a termination fee of $1.5 million, plus, in certain circumstances, up to $1.5 million of Keystone’s expenses associated with the Business Combination. These provisions could discourage other companies from trying to acquire Check-Cap unless those other companies are willing to offer significantly greater value. Likewise, if the Business Combination Agreement is terminated by Keystone to accept a superior acquisition proposal or under other circumstances specified in the Business Combination Agreement, Keystone will be required to pay to Check-Cap a termination fee of $4.0 million, plus, in certain circumstances, up to $1.0 million of Check-Cap’s expenses associated with the Business Combination. These provisions could discourage other companies from trying to acquire Keystone unless those other companies are willing to offer significantly greater value.

Failure to consummate the Business Combination could adversely affect Keystone’s and Check-Cap’s future prospects.

The Business Combination is subject to the satisfaction of various closing conditions, and neither Keystone nor Check-Cap can guarantee that the Business Combination will be successfully consummated. In the event that the Business Combination is not consummated for any reason, Keystone and Check-Cap will be subject to many risks, including the costs related to the Business Combination, such as legal, accounting and advisory fees, which must be paid even if the Business Combination is not consummated, and, potentially, the payment of a termination fee by Check-Cap or Keystone, as applicable under certain circumstances. If the Business Combination is not consummated, the market price of Check-Cap ordinary shares could decline. Keystone and Check-Cap also could be subject to litigation related to any failure to consummate the Business Combination or related to any enforcement proceeding commenced against Keystone or Check-Cap to perform their respective obligations under the Business Combination Agreement. Finally, if the Business Combination Agreement is terminated, Keystone or Check-Cap may be unable to find another party willing to engage in a similar transaction on terms as favorable as those set forth in the Business Combination Agreement, or at all. In particular, the negative publicity that could accompany such a termination could adversely impact Check-Cap’s ability to find an alternate partner for a strategic transaction or to obtain required financing for any such transaction. This could limit each company’s ability to pursue its strategic goals in the event the Business Combination is not consummated.

The rights of holders of Check-Cap ordinary shares will change as a result of the Business Combination.

After the Business Combination, the rights of those shareholders of Check-Cap who will become stockholders of New Parent will be governed by the laws of the State of Delaware, where New Parent is incorporated, which may be different from the laws of the State of Israel, and by New Parent’s Certificate of Incorporation and Bylaws, which may differ from Check-Cap’s organizational documents. For more information, see the section entitled “Comparison of Rights of Holders of New Parent Common Stock and Holders of Check-Cap Ordinary Shares” beginning on page 307 of this prospectus.

Some of Keystone’s and Check-Cap’s directors and officers may have interests that are different from yours, which may influence them to support or approve the Business Combination and the issuance of shares of New Parent common stock.

Certain officers and directors of Keystone and Check-Cap participate in arrangements that provide them with interests in the Business Combination that are different from those of other Check-Cap shareholders, including in some cases, their continued service as a director of New Parent, receipt of transaction bonuses and changes in executive compensation following the Closing and continued indemnification of directors and officers. These interests, among others, may influence the officers and directors of Keystone or Check-Cap to support or approve the Business Combination and the issuance of shares of New Parent common stock in the

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Business Combination. For more information, see the section entitled “Comparison of Rights of Holders of New Parent Common Stock and Holders of Check-Cap Ordinary Shares” beginning on page 307 of this prospectus.

The lack of a public market for New Parent common stock makes it more difficult to evaluate the fairness of the Business Combination.

New Parent common stock is not traded in any public market. Accordingly, this makes it more difficult to determine the fair value of New Parent. Because the percentage of New Parent common stock to be issued to Check-Cap equityholders was determined based on negotiations between the parties to the Business Combination Agreement, it is possible that the value of the shares of New Parent common stock to be issued to Check-Cap shareholders in connection with the Business Combination will be greater than, or less than, the fair value of Check-Cap.

New Parent’s Certificate of Incorporation will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for certain legal actions between New Parent and its stockholders, which could limit our stockholders’ ability to obtain a judicial forum viewed by the stockholders as more favorable for disputes with New Parent or its directors, officers or employees, and the enforceability of the exclusive forum provision may be subject to uncertainty.

New Parent’s Certificate of Incorporation provides that, unless New Parent consents in writing to the selection of an alternative forum, the sole and exclusive forum, to the fullest extent permitted by law, for (1) any derivative action or proceeding brought on New Parent’s behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of New Parent’s current or former directors, officers or other employees or stockholders to us or New Parent’s stockholders, (3) any action asserting a claim against us or any of New Parent’s directors or officers or other employees or stockholders arising pursuant to, any action to interpret, apply, enforce any right, obligation or remedy under, any provision of the DGCL New Parent’s Certificate of Incorporation or Bylaws, or (4) any action asserting a claim that is governed by the internal affairs doctrine, under the DGCL shall be the Court of Chancery of the State of Delaware (or any state or federal court located within the State of Delaware if the Court of Chancery does not have jurisdiction) (the “Delaware Forum Provision”). Notwithstanding the foregoing, New Parent’s Certificate of Incorporation provides that the Delaware Forum Provision will not apply to suits brought to enforce a duty or liability created by the Exchange Act or the rules and regulations thereunder, or any other claim for which the federal courts have exclusive jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in New Parent’s securities shall be deemed to have notice of and consented to this provision. Although New Parent believes these provisions benefit us by providing increased consistency in the application of Delaware law for the specified types of actions and proceedings, the provisions may have the effect of increasing shareholders’ difficulty in bringing claims against us or our directors and officers, increasing the costs associated with bringing such claims and discouraging such claims.

Additionally, New Parent’s Certificate of Incorporation provides that unless it consents in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Any person or entity purchasing or otherwise acquiring any interest in shares of New Parent’s capital stock are deemed to have notice of and consented to this provision. The Supreme Court of Delaware has held that this type of exclusive federal forum provision is enforceable. There may be uncertainty, however, as to whether courts of other jurisdictions would enforce such provision, if applicable.

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If the U.S. Merger does not qualify as a reorganization for federal income tax purposes, holders of Keystone warrants and options will recognize taxable gain as a result of the U.S. Merger to the extent the fair market value of the New Parent warrants and options received exceed the tax basis of the Keystone warrants and options exchanged even if the Business Combination qualifies as an exchange under Section 351 of the Code, and if the U.S. Merger does not qualify as a reorganization for federal income tax purposes and the Business Combination does not qualify as an exchange under Section 351 of the Code, holders of Keystone common stock and holders of Keystone warrants and options will recognize taxable gain to the extent the fair market value of the New Parent commons stock or warrants and options exceed the tax basis of the Keystone common stock or warrants and options exchanged as a result of the U.S. Merger.

Although the U.S. Merger should qualify as a reorganization under Section 368(a) of the Code and the Business Combination should qualify as an exchange under Section 351 of the Code, the U.S. income tax rules regarding reorganizations under Section 368(a) of the Code and exchanges under Section 351 of the Code differ. Under Section 368(a) of the Code, securities (such as warrants and options) can be exchanged tax-free, but under Section 351 of the Code warrants and options are not allowed to be exchanged tax-free. Thus, if the U.S. Merger fails to qualify as a reorganization under Section 368(a) of the Code, holders of Keystone warrants and options will recognize taxable gain to the extent the fair market value of the New Parent warrants and options received exceed the tax basis of the Keystone warrants and options surrendered in the exchange even if the Business Combination qualifies as an exchange under Section 351 of the Code. If the U.S. Merger fails to qualify as a reorganization under Section 368(a) of the Code and the Business Combination fails to qualify as an exchange under Section 351 of the Code, then holders of Keystone common stock, warrants and options will all recognize taxable gain on the exchange to the extent the fair market value of New Parent common stock, warrants, or options received exceeds the holder’s tax basis in the Keystone common stock, warrants, or options exchanged. The conclusion that the U.S. Merger should qualify as a reorganization under Section 368(a) of the Code depends, in part, on at least 80% of the shares of Keystone common stock being exchanged for New Parent common stock. If dissenters exercise their dissenters’ rights with respect to more than 20% of the shares of Keystone common stock, the U.S. Merger will fail to qualify as a reorganization under Section 368(a) of the Code. Furthermore, the federal income tax rules regarding reorganizations under Section 368(a) of the Code and exchanges under Section 351 of the Code are complicated, and there is no assurance the Internal Revenue Service would not challenge the treatment of the transaction as tax-free.

If the Business Combination does not qualify as a tax-deferred exchange for U.S. federal income tax purposes, U.S. holders of Check-Cap ordinary shares may recognize taxable gain as a result of the Israeli Merger.

Although the Business Combination should constitute an integrated transaction that qualifies as a tax-deferred exchange under Section 351(a) of the Code, the requirements for tax-deferred treatment are complex and there can be no assurance that the IRS or any court will agree with this position. If the IRS were to successfully challenge the qualification of the Mergers under Section 351(a) of the Code, U.S. holders (as defined under the section entitled “The Business Combination—Material U.S. Federal Income Tax Considerations for Holders of Check-Cap Securities”) of Check-Cap ordinary shares could recognize taxable gain as a result of the Israeli Merger. In addition, even if the Business Combination qualifies for tax-deferred treatment under Section 351(a) of the Code, U.S. holders of Check-Cap ordinary shares may be required to recognize gain as a result of the application of the PFIC rules. Further, the Israeli Merger generally should be a taxable transaction to U.S. holders of Check-Cap warrants regardless of whether it qualifies under Section 351(a) of the Code.

The requirements for tax-deferred treatment, including the PFIC rules, are discussed in more detail under the section entitled “The Business Combination—Material U.S. Federal Income Tax Considerations for Holders of Check-Cap.” If you are a U.S. holder exchanging Check-Cap ordinary shares in the Israeli Merger, you should consult with your tax advisors to determine the tax consequences thereof.

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The U.S. federal income tax treatment of the arrangement relating to the Check-Cap legacy assets is uncertain.

As described under the section entitled “Check-Cap Legacy Assets,” if Check-Cap receives proceeds from the transfer of its legacy assets, holders of Check-Cap ordinary shares may be entitled to receive (i) additional shares of New Parent common stock, if such proceeds are received prior to the Closing or if Check-Cap is contractually entitled to such proceeds within 90 days following the Closing Date, or (ii) a distribution of such proceeds, if such proceeds are received later. As discussed in more detail under the section entitled “Material U.S. Tax Consequences of Holders of Check-Cap Securities—U.S. Holders—The Israeli Mergers—Check-Cap Legacy Assets,” there is no authority directly on point addressing how such an arrangement should be treated for U.S. federal income tax purposes. Accordingly, holders of Check-Cap ordinary shares are urged to consult with their tax advisors regarding this issue.

Risks Related to Keystone and Ownership of New Parent Common Stock Following the Business Combination

Risks Related to Keystone’s Business, Financial Condition and Capital Requirements

Keystone is a company with a history of significant net losses, it expects to continue to incur operating losses for the foreseeable future and it may not be able to achieve or sustain profitability.

Keystone has incurred significant net losses in the substantial majority of its reporting periods since its inception. For the years ended December 31, 2022 and 2021, Keystone had a net loss of $27.8 million and $10.1 million, respectively, and for the six months ended June 30, 2023, it had a net loss of $10.6 million. Keystone expects to continue to incur additional losses in the future. As of December 31, 2022 and 2021, it had an accumulated deficit of $493.6 million and $465.8 million, respectively, and as of June 30, 2023, it had an accumulated deficit of $504.3 million. To date, Keystone has financed its operations primarily through net proceeds from the sale of its stock in private placements, indebtedness, including its credit agreement and, to a lesser extent, product revenues from sales of its implants, prosthetic solutions, biomaterial solutions and digital dentistry technology. The losses and accumulated deficit have primarily been due to the substantial investments Keystone has made to develop its products and software, costs related to its sales and marketing efforts, including costs related to clinical and regulatory initiatives to obtain marketing clearance or approval, and infrastructure improvements.

Keystone may also encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by medical technology companies in rapidly evolving fields. In addition, as a public company, it will incur significant legal, accounting and other expenses that it did not incur as a private company. Accordingly, Keystone expects to continue to incur significant operating losses for the foreseeable future and it cannot assure you that it will achieve profitability in the future or that, if it does become profitable, it will sustain profitability.

Keystone may never be successful in achieving its objectives and, even if it does, may never generate revenue that is significant or large enough to achieve profitability. If it does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis and it will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. Keystone’s failure to achieve and sustain profitability in the future will make it more difficult to finance its capital requirements needed to operate our business and accomplish our strategic objectives, which would have a material adverse effect on its business, financial condition and results of operations and cause the market price of New Parent common stock to decline.

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There is substantial doubt about Keystone’s ability to continue as a going concern and, while this condition is expected to be alleviated by the consummation of the Business Combination, there is no assurance that Keystone will have sufficient resources to fund its operations in the future.

Keystone’s recurring losses from operations, recurring cash used in operating activities, accumulated deficit, expected working capital needs to fund its operations and debt obligations raise substantial doubt about Keystone’s ability to continue as a going concern.

As of June 30, 2023, Keystone’s available liquidity totaled $15.8 million, which was comprised of undrawn amounts on Keystone’s revolving line of credit of $5.0 million and available cash as of June 30, 2023, represented by Keystone’s total cash and cash equivalents of $10.8 million. Keystone’s net cash used in operations for the six months ended June 30, 2023 was $4.7 million. For the years ended December 31, 2022, and 2021, Keystone’s net losses from operations were $27.8 million and $10 million, respectively, and Keystone’s net cash used in operations was $25 million and $5 million, respectively.

As a result of Keystone’s losses, along with Keystone’s current cash and working capital position, Keystone currently does not have sufficient current resources to fund its planned operations for the next twelve months. If the Business Combination is consummated, it is anticipated that the net cash of Check-Cap will be distributable by Check-Cap to New Parent and made available to fund Keystone’s business, thereby alleviating this condition in the short term. Keystone believes that this amount, together with its existing cash and cash equivalents, will be sufficient to meet its capital requirements and fund its operations through at least the next 12 months from the date of this prospectus.

Keystone’s management’s plans include the continued increase in the sale of its products and raising capital through the sale of additional equity securities or debt. There can be no assurance that such plans will be achieved. If, following the consummation of the Business Combination, New Parent cannot successfully operate as a going concern, its stockholders may lose a large proportion of or even their entire investment.

See the risk factor below entitled “Keystone may need additional funding to finance its planned operations, and may not be able to raise capital when needed, which could force it to delay, reduce or eliminate one or more of its product development programs and future commercialization efforts.”

Keystone has grown significantly in a short period of time. If it ever fails to manage its growth effectively, its business could be materially adversely affected.

Keystone has experienced significant growth in a short period of time. For example, its total revenues for the year ended December 31, 2022 was $60.7 million, which represented an increase of $10.4 million, or 20.6%, over the year ended December 31, 2021, and for the six months ended June 30, 2023 was $33.4 million, which represented an increase of $3.0 million, or 9.8%, over the six months ended June 30, 2022. The number of Keystone’s full-time employees increased from 269 at December 31, 2021 to 323 at June 30, 2023. Keystone has also grown by way of acquisition, including the acquisitions of Paltop in 2019 and Osteon Medical in August 2021.

This growth has placed significant demands on Keystone’s management, financial, operational, technological, and other resources, and Keystone expects that its growth will continue to place significant demands on its management and other resources and will require it to continue developing and improving our operational, financial, and other internal controls, both in the United States and internationally. In particular, continued growth increases the challenges involved in a number of areas, including: recruiting and retaining sufficient skilled personnel, particularly in the United States where Keystone hopes to increase sales, providing adequate training and supervision to maintain its high quality standards, creating and marketing new and innovative products, keeping up with market trends and demands and preserving its culture and values. Keystone may not be able to address these challenges in a cost-effective manner or at all. If it does not effectively manage its growth, Keystone may not be able to execute on its business plan, respond to competitive pressures, take

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advantage of market opportunities, satisfy member requirements, or maintain high-quality product offerings, and its business, financial condition, and results of operations could be materially harmed.

The terms of Keystone’s credit agreement require Keystone to meet certain operating and financial covenants and place restrictions on its operating and financial flexibility, which, if violated, could result in the acceleration of the amounts due. If Keystone raises additional capital through debt financing, the terms of any new debt could further restrict its ability to operate its business.

Keystone’s outstanding debt instruments contain financial ratios and certain other covenants, which it is required to satisfy. Complying with these restrictions and covenants may make it more difficult for Keystone to successfully execute its business strategy. It may need to reduce the amount of its indebtedness outstanding from time to time in order to comply with such financial ratios, though no assurance can be given that Keystone will be able to do so.

As of June 30, 2023, Keystone had the following amount in debt outstanding: $5 million undrawn revolving credit facility due May 2027, $39.1 million, net of debt discount and issuance costs, under its Midcap Credit Agreement due May 2027 and $0.3 million under its Israel loan due August 2025. All of Keystone’s assets are pledged under its Midcap Credit Agreement, and its financial covenants require that Keystone maintains Minimum Net Revenue and provide Evidence of Compliance. As of June 30, 2023, Keystone was in compliance with the covenants under the Midcap Credit Agreement. Pursuant to the Midcap Credit Agreement, Keystone also issued 95,975 warrants to purchase shares of its common stock to Midcap at a price per share of $20.88.

The Midcap Credit Agreement contains customary representations and warranties, affirmative covenants and certain restrictive covenants related to, among others, limitations on the incurrence of additional debt, liens and other encumbrances on property, fundamental changes and acquisitions, including Business Combinations, consolidations and liquidations, changes to its type of business, use of cash and investment activities, dividends and other payments in respect of Keystone’s capital stock, payments and prepayments of certain debt, changes in Keystone’s fiscal year, sales of assets including Business Combinations with affiliates, licensing arrangements, modifications to material agreements and foundational documents, sale and leaseback arrangements and handling of hazardous materials.

The Midcap Credit Agreement also contains customary events of default. If Keystone fails to comply with its affirmative and restrictive covenants, including the financial covenants, payments or other terms of the agreement, Midcap could declare an event of default, which would give it the right to terminate its commitments and declare all amounts outstanding under the Midcap Credit Agreement immediately due and payable, together with accrued interest and all fees and other obligations. The amount of such repayment will include payment of any prepayment premium applicable due to the time of such payment. In addition, Midcap would have the right to proceed against the assets Keystone provided as collateral. If the debt under the Midcap Credit Agreement were accelerated, Keystone may not have sufficient cash or be able to sell sufficient assets to repay this debt, which would harm its business and financial condition.

If Keystone does not have or is unable to generate sufficient cash to repay its debt obligations when they become due and payable, either upon maturity or in the event of a default, Keystone’s assets could be foreclosed upon and it may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact its ability to operate and continue its business as a going concern. Moreover, regardless of a potential event of default, the debt under the Midcap Credit Agreement requires monthly payments starting June 1, 2025, and matures on May 1, 2027. As a result, Keystone may need to refinance or secure separate financing in order to repay amounts outstanding when due. However, no assurance can be given that an extension will be granted, that Keystone will be able to renegotiate the terms of the agreement with the Midcap or that Keystone will be able to secure separate debt or equity financing on favorable terms, if at all.

For additional information regarding Keystone’s indebtedness, see “Information about Keystone – Keystone’s Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity

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and Capital Resources—Capital Resources” and Note 8 “Debt” to Keystone’s consolidated financial statements included elsewhere in this prospectus.

Keystone’s quarterly and annual operating results may fluctuate significantly and may not fully reflect the underlying performance of Keystone’s business. This makes Keystone’s future operating results difficult to predict and could cause its operating results to fall below expectations or any guidance we may provide.

Keystone’s quarterly and annual results of operations, including its revenues, profitability and cash flow, may vary significantly in the future, and period-to-period comparisons of our operating results may not be meaningful. Accordingly, the results of any one quarter or period should not be relied upon as an indication of future performance. Keystone’s quarterly and annual operating results may fluctuate significantly as a result of a variety of factors, many of which are outside its control and, as a result, may not fully reflect the underlying performance of Keystone’s business. Such fluctuations in quarterly and annual operating results may decrease the value of New Parent common stock. Because Keystone’s quarterly operating results may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of its business and should only be relied upon as one factor in determining how Keystone’s business is performing. These fluctuations may occur due to a variety of factors, many of which are outside of Keystone’s control, including, but not limited to:

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The cumulative effects of these factors could result in large fluctuations and unpredictability in Keystone’s quarterly and annual operating results. If Keystone’s assumptions regarding the risks and uncertainties it faces, which Keystone uses to plan its business, are incorrect or change due to circumstances in our business or our markets, or if it does not address these risks successfully, Keystone’s operating and financial results could deviate materially from its expectations and its business could suffer.

This variability and unpredictability could also result in Keystone’s failure to meet the expectations of industry or financial analysts or investors for any period. If its revenues or operating results fall below the expectations of analysts or investors or below any forecasts it may provide to the market, it will negatively affect Keystone’s business, financial condition and results of operations and cause the market price of our common stock to decline.

Keystone’s revenues also fluctuate on a seasonal basis, which affects the comparability of our results between periods. In particular, Keystone has experienced and expects to continue to experience seasonality in its business, with higher United States sales volumes in the fourth calendar quarter. Keystone’s United States sales volumes in the fourth calendar quarter tend to be higher as many patients elect to have implant treatment to help fully utilize any outstanding balances remaining on their flexible spending accounts and when they have time to recover over the winter holidays.

Keystone faces risks relating to public health conditions such as the COVID-19 pandemic, which could adversely affect its dentist customers, its business and its results of operations

Keystone’s business and prospects were materially adversely affected by the COVID-19 pandemic and could be materially adversely affected by future recurrences of COVID-19 (including COVID-19 variants) or any other similar diseases in the future. Material adverse effects from COVID-19 and similar diseases could result in numerous known and currently unknown ways including from quarantines and lockdowns which impair Keystone’s marketing and sales efforts to dentists or other medical professionals.

Numerous state and local jurisdictions have imposed, and others in the future may impose, “shelter-in-place” orders, quarantines, executive orders, and similar government orders and restrictions for their residents to control the spread of COVID-19. During the COVID-19 pandemic, dental offices throughout the United States shut down for extended periods of time (and may be shut down again due to recurrences of COVID-19 or other pandemics), thus negatively impacting Keystone’s product revenues. In addition, clinicians and dental practitioners have experienced financial hardship and some of them may not fully recover. This could lead to some of these practices temporarily or permanently shutting down, filing for bankruptcy, or being acquired by larger health systems, leading to reduced procedures or additional pricing pressure on Keystone’s products.

The pandemic and reactions to the pandemic or future outbreaks of COVID-19 or other pandemics could also impair the timing of obtaining necessary consents and approvals from the FDA, as its employees could also be under such quarantines and lockdowns and their time could be mandatorily required to be allocated to more immediate global and domestic concerns relating to COVID-19. Under any circumstances, FDA approval of products is not guaranteed and may take longer than expected. In addition, Keystone purchases materials for its products from suppliers located in affected areas, and it may not be able to procure required components or secure manufacturing capability. The effects of the COVID-19 pandemic have also placed travel restrictions on Keystone and its distributors and manufacturers, as well as temporary closures of the facilities of our suppliers as non-essential medical and dental procedures have been limited, which could also adversely impact its business. In addition, a significant outbreak of contagious diseases in the human population could result in a widespread

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health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn that could reduce the demand for Keystone’s products and impair Keystone’s business prospects including as a result of being unable to raise additional capital on acceptable terms to Keystone, if at all.

Keystone may need additional funding to finance its planned operations, and may not be able to raise capital when needed, which could force it to delay, reduce or eliminate one or more of its product development programs and future commercialization efforts.

Keystone has incurred significant net losses and expects to continue to incur net losses for the foreseeable future. Since Keystone’s inception, its operations have been financed primarily by net proceeds from the sale of its stock in private placements, indebtedness and, to a lesser extent, product revenues from sales of its implants, prosthetic solutions, regenerative solutions and digital dentistry technology. As of June 30, 2023, Keystone had $10.8 million in cash and cash equivalents, and an accumulated deficit of $504.3 million. Based on Keystone’s current operating plan, it currently believes that its cash and cash equivalents, anticipated revenues and available debt financing arrangements will not be sufficient to meet its capital requirements and fund its operations through at least the next 12 months from the date of this prospectus. If the Business Combination is consummated, it is anticipated that the net cash of Check-Cap will be distributable by Check-Cap to New Parent and made available to fund Keystone’s business, thereby alleviating this condition in the short term. Keystone believes that this amount, together with its existing cash and cash equivalents, will be sufficient to meet its capital requirements and fund its operations through at least the next 12 months from the date of this prospectus. However, Keystone has based these estimates on assumptions that may prove to be wrong, and it could utilize its available capital resources sooner than it currently expects. Changing circumstances could result in lower revenues or cause Keystone to consume capital significantly faster than it currently anticipates, and it may need to raise capital sooner or in greater amounts than currently expected because of circumstances beyond its control.

Keystone may require additional capital in the future as it expects to continue to invest in expanding its sales and marketing organization, research and development of product improvements and future products, and clinical studies designed to support the adoption and utilization of its products. Moreover, Keystone expects to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and SEC compliance, investor relations and other expenses. To the extent additional capital is necessary, there are no assurances that Keystone will be able to raise additional capital on favorable terms or at all, and therefore it may not be able to execute its business plan. Keystone’s future funding requirements will depend on many factors, including:

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New Parent may seek to raise additional capital through equity offerings or debt financings and such additional financing may not be available to New Parent on acceptable terms, or at all. In addition, any additional equity or debt financing that it raises may contain terms that are not favorable to New Parent or its stockholders. For example, if New Parent raises funds by issuing equity or equity-linked securities, the issuance of such securities could result in dilution to our stockholders. Any equity securities issued may also provide for rights, preferences or privileges senior to those of holders of our common stock. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our common stock to decline, and the price per share at which we sell additional shares of our common stock, or securities convertible into or exercisable or exchangeable for shares of our common stock, in future Business Combination may be higher or lower than the price per share of New Parent’s common stock in the Business Combination.

In addition, the terms of debt securities issued or borrowings could impose significant restrictions on Keystone’s operations including restrictive covenants, such as limitations on New Parent’s ability to incur additional debt or issue additional equity, limitations on its ability to pay dividends, limitations on its ability to acquire or license intellectual property rights, and other operating restrictions that could adversely affect Keystone’s ability to conduct its business. For example, Keystone’s current credit agreement prohibits Keystone from incurring certain additional indebtedness without the consent of its lender. In the event that Keystone enters into collaborations or licensing arrangements to raise capital, it may be required to accept unfavorable terms, such as relinquishment or licensing of certain technologies or products that Keystone otherwise would seek to develop or commercialize itself, or reserve for future potential arrangements when it might otherwise be able to achieve more favorable terms. In addition, Keystone may be forced to work with a partner on one or more of its products or market development programs, which could lower the economic value of those programs to Keystone.

If Keystone is unable to obtain adequate financing on terms satisfactory to it when Keystone requires it, Keystone may be required to terminate or delay the development of one or more of its products, delay clinical trials necessary to market its products, or delay establishment of sales and marketing capabilities or other activities necessary to commercialize its products. If this were to occur, Keystone’s ability to grow and support its business and to respond to market challenges could be significantly limited, which could have a material adverse effect on Keystone’s business, financial condition and results of operations.

The commercial success of our products and technologies will depend upon the degree of market acceptance of them by dental practitioners.

Keystone’s success will depend, in large part, on the acceptance of its products as effective, reliable, easy to use and cost-effective. Keystone believes that market acceptance will be driven primarily by dental practitioners, and if they do not adopt its implants and other products as having significant advantages over other alternatives, patients will be less likely to accept or be offered Keystone products and it will fail to meet its business objectives. Dental practitioners’ perceptions of such technology having significant advantages are likely to be based on a determination that, among other factors, Keystone’s products are safe, effective, cost-effective and represent acceptable methods of treatment. Even if Keystone can prove the effectiveness of its products through in vitro and clinical trials, positive results are not guaranteed, there may not be broad adoption and use of its products and dental practitioners may elect not to use its products for any number of other reasons, including:

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Keystone believes that educating notable industry key opinion leaders and dental practitioners about the merits and benefits of its tooth replacement solutions, such as safety, performance and ease of use, is one of the key elements of increasing the adoption of its products. If they do not adopt Keystone’s products for any reason, including those listed above, Keystone’s ability to execute its growth strategy will be impaired, and it will negatively affect Keystone’s business, financial condition, prospects and results of operations.

Even if Keystone’s tooth replacement solutions achieve widespread market acceptance, it may not maintain such level of market acceptance over the long term if competing products or technologies, which are more cost-effective or received more favorably, are introduced. In addition, Keystone’s limited commercialization experience makes it difficult to evaluate its current business and predict its future prospects. Keystone cannot predict how quickly, if at all, dental practitioners and patients will accept its tooth replacement solutions or, if accepted, how frequently it will be used. Failure to achieve or maintain market acceptance and/or market share could materially and adversely affect Keystone’s ability to generate revenues and would have a material adverse effect on its business, financial condition and results of operations.

Keystone’s growth depends in part on the timely development and commercialization, and customer acceptance, of new and enhanced products and services based on technological innovation.

Keystone generally sells its products and services in an industry that is characterized by rapid technological changes, frequent new product introductions and changing industry standards. If Keystone does not develop innovative new and enhanced products and services on a timely basis, its offerings will become obsolete over time and its competitive position and financial statements will suffer. Keystone’s success will depend on several factors, including its ability to:

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If Keystone fails to accurately predict future customer needs and preferences or fails to produce viable technologies, it may invest heavily in research and development of products and services that do not lead to significant sales, which would adversely affect its profitability.

In addition, there can be no assurance that other companies will not succeed in developing or marketing devices or products that are more effective than Keystone’s products or that would render its products obsolete or noncompetitive. Accordingly, Keystone’s success will depend in part on its ability to respond quickly to medical and other changes through the development and introduction of new products. Product development involves a high degree of risk, and there can be no assurance that Keystone’s new product development efforts will result in any commercially successful products.

New product development involves a lengthy and complex process and Keystone may be unable to develop or commercialize products on a timely basis, or at all. In addition, Keystone may expend its limited resources to pursue particular products while failing to capitalize on other products that may be more profitable or for which there is a greater likelihood of commercial success.

Products from Keystone’s research and development programs will take time and considerable resources to develop, and may include improvements or changes to its current products, and Keystone may not be able to complete development and commercialization of new or enhanced products on a timely basis, or at all. There can be no assurance that Keystone’s research and development efforts will produce commercially viable products and technologies. Commercializing new products requires expending significant funds to, for example:

Keystone’s product development processes involve a high degree of risk, and these efforts may be delayed or fail for many reasons, including failure of the product to perform as expected and failure to reliably demonstrate the advantages of the product.

Even if Keystone successfully innovates and develops new and enhanced products and services, it may incur substantial costs in doing so, and its profitability may suffer. In addition, promising new offerings may fail to reach the market or realize only limited commercial success because of real or perceived efficacy or safety concerns, failure to achieve positive clinical outcomes, uncertainty over third-party reimbursement or entrenched patterns of clinical practice. For additional information on third-party reimbursement of dental products, please refer to the section entitled “Keystone Business—Government Regulation—Coverage and Reimbursement.”

In addition, Keystone may expend its limited resources to pursue particular products while failing to capitalize on other products that may be more profitable or for which there is a greater likelihood of commercial

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success. As a result, it may forego or delay pursuit of opportunities with other products that later prove to have greater commercial potential. Keystone’s resource allocation decisions may cause it to fail to timely capitalize on viable commercial products or profitable market opportunities. Its spending on current and future product may not yield any commercially viable products. If Keystone does not accurately evaluate the commercial potential or target market for a particular product, it may relinquish valuable rights to that product through collaboration, licensing, or other royalty arrangements when it would have been more advantageous for Keystone to retain sole development and commercialization rights to such product.

The continuing acceptance of Keystone’s products depends upon maintaining strong working relationships with its existing dental customers. Keystone may be unable to continue to successfully demonstrate to dental practitioners or key opinion leaders the merits of its products and technologies compared to those of its competitors, which may make it difficult to establish its products and technologies as a standard of care and achieve market acceptance.

The development, marketing, and sale of Keystone’s products depends upon Keystone’s ability to maintain strong working relationships with dental practitioners and other key opinion leaders. Keystone relies on these professionals’ knowledge and experience for the development and sale of its products. Among other things, dental practitioners assist Keystone in product development matters and provide public presentations at trade conferences regarding its products. If Keystone cannot maintain its strong working relationships with these professionals and continue to receive their advice and input, the development and marketing of Keystone’s products could suffer, which could harm Keystone’s business, financial condition and results of operations.

Dental practitioners play the primary role in determining the course of treatment and, ultimately, the type of products that will be used to treat a patient. As a result, Keystone’s success depends, in large part, on its ability to effectively market and demonstrate to dental practitioners the merits of its products and methodologies compared to those of its competitors. Acceptance of Keystone’s products and methodologies depends on educating dental practitioners as to the distinctive characteristics, clinical benefits, safety and cost-effectiveness of its products, procedures and technologies as compared to those of its competitors, and on training dental practitioners in the proper use of its products. If Keystone is not successful in convincing dental practitioners of the merits of its products and methodologies or educating them on the use of its products, they may not use Keystone products or may not use them effectively and Keystone may be unable to increase its sales, sustain its growth or achieve and sustain profitability.

Keystone may not be able to establish or strengthen its brand.

Keystone believes that establishing and strengthening its various dental implant brands is important to achieving widespread acceptance of its products and technology, particularly because of the highly competitive nature of the market for similar products. Keystone believes the quality and reliability of its products is critical to building support of dental practitioners for its products and solutions in the United States and abroad, and any negative publicity regarding the quality or reliability of its products and procedures could significantly damage Keystone’s reputation in the market. In the course of conducting its business, Keystone must adequately address quality issues that may arise with its products, including defects in third-party components included in its products. Although Keystone has established internal procedures designed to minimize risks that may arise from quality issues, Keystone may not be able to eliminate or mitigate occurrences of these issues and associated liabilities. In addition, even in the absence of quality issues, Keystone may be subject to claims and liability if the performance of its products do not meet the expectations of dental practitioners or patients.

In addition, promoting and positioning Keystone’s brand will depend largely on the success of its dental education efforts and its ability to educate dental practitioners and patients. These brand promotion activities may not yield increased sales and, even if they do, any sales increases may not offset the expenses Keystone incurs to promote its brand. If Keystone fails to successfully promote and maintain its brand, or if it incurs substantial expenses in an unsuccessful attempt to promote and maintain its brand, its dental implant products and other

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solutions may not be accepted by dental practitioners or patients, which would adversely affect Keystone’s business, results of operations and financial condition.

Keystone may not generate sufficient cash flow to service its debt, pay its contractual obligations, and operate its business.

Keystone’s ability to make payments on its indebtedness and contractual obligations, and to fund its operations, depends on its future performance and financial results, which, to a certain extent, are subject to general economic, financial, competitive, regulatory, interest rate, and other factors that are beyond Keystone’s control. Although senior management believes that Keystone has and will continue to have sufficient liquidity, there can be no assurance that Keystone’s business will generate sufficient cash flow from operations in the future to service our debt, pay its contractual obligations, and operate its business. In addition, the breach of certain covenants or restrictions in certain of Keystone’s debt instruments would permit the lenders to declare all borrowings thereunder to be immediately due and payable and, if provided for in the future, cross default provisions may entitle its other lenders to accelerate their loans.

In order to service its indebtedness, Keystone needs to generate cash from its operating activities or additional equity or debt financing. Keystone estimates that its annual debt service requirement for the year ended December 31, 2023 will be approximately $40.0 million. Keystone cannot assure you that its business will be able to generate sufficient cash flow from operations or that future borrowings or other financings will be available to it in an amount sufficient to enable it to service its indebtedness and fund its other liquidity needs. In addition, all of Keystone’s assets have been pledged as collateral to secure its Midcap Credit Agreement. To the extent Keystone is required to use cash from operations or the proceeds of any future financing to service its indebtedness instead of funding working capital, capital expenditures or other general corporate purposes, it will be less able to plan for, or react to, changes in its business, industry and in the economy generally. This may place Keystone at a competitive disadvantage compared to its competitors that have less indebtedness.

The industries that Keystone serves have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, which could adversely affect Keystone’s financial statements.

The industries that Keystone serves have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, including the following:

These changes as well as other impacts from market demand, government regulations, third-party coverage and reimbursement policies and societal pressures have started changing the way health care is delivered,

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reimbursed and funded and may cause participants in the health care industry and related industries that Keystone serves to purchase fewer of Keystone’s products and services, reduce the prices they are willing to pay for its products or services, reduce the amounts of reimbursement and funding available for its products and services from governmental agencies or third-party payors, heighten clinical data requirements, reduce the volume of medical procedures that use its products and services, affect the acceptance rate of new technologies and products and increase its compliance and other costs. In addition, it may be excluded from important market sectors or unable to enter into contracts with group purchasing organizations and integrated health networks on terms acceptable to it, and even if it does enter into such contracts they may be on terms that negatively affect its current or future profitability. All of the factors described above could adversely affect Keystone’s business and financial statements.

Keystone may not be able to achieve or maintain satisfactory pricing and margins for its products. Industry trends have also resulted in increased downward pricing pressure on medical services and products, which may affect Keystone’s ability to sell its products at prices necessary to support its current business strategy.

Manufacturers of dental implants and related products have a history of price competition, and Keystone can give no assurance that it will be able to achieve satisfactory prices for its current or any new products or maintain prices at the levels it has historically achieved. For example, any decline in the amount that payors reimburse clinicians for Keystone’s products could make it difficult for them to continue using, or to adopt, Keystone’s products and could create additional pricing pressure for Keystone. If Keystone is forced to lower the price it charges for its products, its gross margins will decrease, which will adversely affect its ability to invest in and grow its business. If Keystone is unable to maintain its prices, including during any international expansion, or if its costs increase and it is unable to offset such increase with an increase in prices, its margins could erode.

Additionally, some parts of the dental market continue to be impacted by price competition which are driven in part by the consolidation of dental practices, innovation and product advancements, and the price sensitivity of consumers and patients. Keystone will continue to be subject to significant pricing pressure, which could harm negatively affect its business, financial condition and results of operations.

Keystone’s growth could suffer if the markets into which it sells its products and services decline, do not grow as anticipated or experience cyclicality.

Keystone’s growth depends in part on the growth of the markets which it serves, and visibility into its markets is limited (particularly for markets into which it sells through distribution). Any decline or lower than expected growth in Keystone’s served markets could diminish demand for its products and services, which would adversely affect its financial statements. Keystone’s quarterly sales and profits depend substantially on the volume and timing of orders received during the fiscal quarter, which are difficult to forecast. Certain of Keystone’s businesses operate in industries that may also experience periodic, cyclical downturns.

Keystone’s success will depend upon its ability to increase its market penetration. It cannot guarantee that it will be able to further penetrate its existing markets or that these markets will be able to sustain our current and future product and technology offerings. Obstacles to market penetration include high costs, limited insurance coverage, longer treatment times, procedure complexity and lack of qualified practitioners. Any failure to increase penetration in our existing markets would adversely affect Keystone’s ability to improve its operating results.

In addition, in certain of Keystone’s businesses, demand depends on customers’ capital spending budgets as well as government funding policies, and matters of public policy and government budget dynamics as well as product and economic cycles can affect the spending decisions of these entities. Further, consumer spending habits are affected by, among other things, pandemics, prevailing economic conditions, levels of employment, salaries and wage rates, debt obligations, discretionary income, consumer confidence and consumer perception of current and future economic conditions. A decrease in United States or certain international economies or an

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uncertain economic outlook, both of which occurred as a result of the COVID-19 pandemic and could occur as a result of another pandemic, would adversely affect consumer spending habits which may, among other things, result in reduced patient traffic in dental practitioners’ offices or a reduction in the demand for dental services generally, which may result in dental practitioners postponing investments in our solutions, which would adversely affect Keystone’s sales and operating results.

Demand for Keystone’s products and services is also sensitive to changes in customer order patterns, which may be affected by announced price changes, marketing or promotional programs, new product introductions, the timing of industry trade shows and changes in distributor or customer inventory levels due to distributor or customer management thereof or other factors. Any of these factors could adversely affect Keystone’s growth and results of operations in any given period.

Keystone has limited experience in training and marketing and selling its products and it may provide inadequate training, fail to increase its sales and marketing capabilities or fail to develop and maintain broad brand awareness in a cost-effective manner.

Keystone currently relies on its direct sales force to sell its products in the United States and Israel and intends to expand its direct sales force in the United States. The members of its direct sales force are adequately trained and possess technical expertise, which Keystone believes is critical in driving the awareness and adoption of its products. The members of Keystone’s sales force are at-will employees. The loss of these personnel to competitors, or otherwise, could materially harm Keystone’s business. If Keystone is unable to retain its direct sales force personnel or replace them with individuals of comparable expertise and qualifications, or if it is unable to successfully instill such expertise in replacement personnel, its product sales, revenues and results of operations could be materially harmed.

In order to generate future growth, Keystone plans to continue to significantly expand and leverage its commercial infrastructure to increase its base of dental customers and increase awareness and adoption by existing dental customers to drive its growth. Identifying and recruiting qualified sales and marketing professionals and training them on our products, on applicable federal and state laws and regulations and on our internal policies and procedures requires significant time, expense and attention. It can take several months or more before a sales representative is fully trained and productive. Keystone’s sales force may subject it to higher fixed costs than those of companies with competing products or treatments that can utilize independent third parties, placing Keystone at a competitive disadvantage. Keystone’s business may be harmed if its efforts to expand and train its sales force do not generate a corresponding increase in product sales and revenues, and its higher fixed costs may slow its ability to reduce costs in the face of a sudden decline in demand for its products. Any failure to hire, develop and retain talented sales personnel, to achieve desired productivity levels in a reasonable period of time or timely reduce fixed costs, could have material adverse effect on Keystone’s business, financial condition and results of operations.

Keystone’s ability to increase its base of clinicians and achieve broader market acceptance of its products will depend, to a significant extent, on its ability to expand its sales and marketing and educational efforts. Keystone plans to dedicate significant resources to its sales and marketing and educational programs. Its business may be harmed if these efforts and expenditures do not generate a corresponding increase in revenues.

In addition, Keystone believes that developing and maintaining broad awareness of its products is critical to achieving broad acceptance of its products and reaching new dental practitioners and patients. Promotion and educational activities may not generate dental practitioner awareness or increase revenues, and even if they do, any increase in revenues may not offset the costs and expenses Keystone incurs. If Keystone fails to successfully promote its products in a cost-effective manner, it may fail to attract or retain the market acceptance necessary to realize a sufficient return on its promotional and educational efforts, or to achieve broad adoption of its products.

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Keystone faces intense competition and if it is unable to compete effectively, it may experience decreased demand and decreased market share. Even if it competes effectively, Keystone may be required to reduce prices for its products and services.

Keystone’s businesses operate in industries that are intensely competitive and have been subject to increasing consolidation. Because of the range of the products and services Keystone sells and the variety of markets it serves, Keystone encounters a wide variety of competitors. See “Keystone Business–Competition.” In order to compete effectively, Keystone must retain longstanding relationships with major customers and continue to grow its business by establishing relationships with new customers, continually developing new products and services to maintain and expand its brand recognition and leadership position in various product and service categories and penetrating new markets, including high-growth markets. In addition, significant shifts in industry market share have occurred and may in the future occur in connection with product problems, safety alerts and publications about products, reflecting the competitive significance of product quality, product efficacy and quality systems in its industry. Keystone’s failure to compete effectively and/or pricing pressures resulting from competition may adversely impact Keystone’s financial statements, and its expansion into new markets may result in greater-than-expected risks, liabilities and expenses. In addition, Keystone is exposed to the risk that its competitors or its customers may introduce private label, generic, or low-cost products that compete with our products at lower price points. If these competitors’ products capture significant market share or result in a decrease in market prices overall, this could have an adverse effect on Keystone’s business, results of operations, and financial condition.

Many of Keystone’s competitors have longer, more established operating histories, and significantly greater name recognition and financial, technical, marketing, sales, distribution and other resources, which may prevent Keystone from achieving significant market penetration or improved operating results. These companies may enjoy several other competitive advantages, including established relationships with dental practitioners who are familiar with other alternatives of dental implants, additional lines of products, and the ability to offer rebates or bundle products to offer greater discounts or incentives to gain a competitive advantage and established sales, marketing and worldwide distribution networks.

The results of Keystone’s operations will be materially harmed if Keystone is unable to accurately forecast demand for, and utilization of, its products and manage its inventory.

To ensure adequate inventory supply, Keystone must forecast inventory needs and manufacture its products based on its estimates of future demand and utilization. Its ability to accurately forecast demand and utilization could be negatively affected by many factors, including its failure to accurately manage its expansion strategy, product introductions by competitors, an increase or decrease in demand for its products or for products of its competitors, failure to accurately forecast acceptance of new products, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions. Inventory levels in excess of demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely affected and could impair the strength of Keystone’s brand. Conversely, if Keystone underestimates demand and utilization, its supply chain, manufacturing partners and/or internal manufacturing team may not be able to deliver components and products to meet its requirements, and this could result in damage to its reputation and relationships with clinicians and dental practitioners. In addition, if Keystone experiences a significant increase in demand or utilization, additional supplies of off-the-shelf materials, sub-assemblies, parts and other components or additional manufacturing capacity may not be available when required on terms that are acceptable to Keystone, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet Keystone’s increased requirements, which will adversely affect its business, financial condition and results of operations.

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The sizes of the addressable markets for Keystone’s products have not been established with precision and its potential market opportunity may be smaller than it estimates and may decline.

Keystone’s estimates of the potential annual total addressable market for its implants, prosthetic solutions, biomaterial solutions and digital dentistry solutions are based on a number of internal and third-party estimates, including, without limitation, the assumed prices at which Keystone can sell its products. While Keystone believes its assumptions and the data underlying its estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting its assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, Keystone’s estimates of the annual total addressable market for its implants, prosthetic solutions, biomaterial solutions and digital dentistry solutions may prove to be incorrect. If the actual number of dental practitioners in its target markets, the price at which it can sell its products, or the total addressable market for its implants, prosthetic solutions, biomaterial solutions and digital dentistry solutions is smaller than Keystone has estimated, it may impair Keystone’s sales growth and materially and adversely affect its business, financial condition and results of operations.

In addition, Keystone’s growth strategy involves launching new products or features and expanding sales of existing products into new markets and geographies in which it has limited experience. Sales of new or existing products into new market opportunities may take several years to develop and mature, and Keystone cannot be certain that these market opportunities will develop as it expects. As a result, the sizes of the annual total addressable market for new markets and new products are even more difficult to predict.

Defects and unanticipated use or inadequate disclosure with respect to Keystone’s products or services (including software), or allegations thereof, could adversely affect its business, reputation and financial statements.

Manufacturing or design defects or “bugs” in, unanticipated use of, safety or quality issues (or the perception of such issues) with respect to, “off label” use of, or inadequate disclosure of risks relating to the use of products and services that Keystone makes or sells (including items that its sources from third parties) can lead to personal injury, death, property damage, loss of profits or other liability. These events could lead to recalls or safety alerts, result in the removal of a product or service from the market and result in product liability or similar claims being brought against Keystone. Recalls, removals and product liability and similar claims (regardless of their validity or ultimate outcome) can result in significant costs, as well as negative publicity and damage to Keystone’s reputation that could reduce demand for its products and services. Its business can also be affected by studies of the utilization, safety and efficacy of medical device products and components that are conducted by industry participants, government agencies and others. Any of the above can result in the discontinuation of marketing of such products in one or more countries, and may give rise to claims for damages from persons who believe they have been injured as a result of product issues, including claims by individuals or groups seeking to represent a class.

Conditions in the global economy, the particular markets Keystone serves and the financial markets may adversely affect Keystone’s business and financial statements.

Keystone’s business is sensitive to general economic conditions. Slower global economic growth, actual or anticipated default on sovereign debt, volatility in the currency and credit markets, high levels of unemployment or underemployment, reduced levels of capital expenditures, changes or anticipation of potential changes in government trade, fiscal, tax and monetary policies, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration, austerity measures and other challenges that affect the global economy may adversely affect Keystone and its distributors, customers and suppliers.

Keystone may also be exposed to inflation risk in the United States as well as in some of Keystone’s international operations, particularly in developing countries, and may be subject to increased costs as a result of higher inflation. Because Keystone competes on a global basis, Keystone’s customers would not expect, and may not be willing, to pay for any cost increases from inflation.

Keystone’s success also depends upon the continued strength of the markets it serves. In many markets, dental reimbursement is largely out of pocket for the consumer and thus utilization rates can vary significantly

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depending on economic growth. Consumer spending habits are affected by, among other things, pandemics, prevailing economic conditions, levels of employment, salaries and wage rates, debt obligations, discretionary income, consumer confidence and consumer perception of current and future economic conditions. While many of Keystone’s products are considered necessary by patients regardless of the economic environment, certain products and services that support discretionary dental procedures may be susceptible to changes in economic conditions. The above factors can have the effect of:

There can be no assurances that the capital markets will be available to Keystone or that the lenders participating in any credit facilities Keystone may enter into will be able to provide financing in accordance with their contractual obligations. If growth in the global economy or in any of the markets Keystone serves slows for a significant period, if there is significant deterioration in the global economy or such markets or if improvements in the global economy do not benefit the markets Keystone serves, Keystone’s business and financial statements could be adversely affected.

Keystone received a Paycheck Protection Program loan, and its application for the PPP Loan could in the future be determined to have been impermissible or could result in damage to its reputation

In April 2020, Keystone applied for and received an unsecured $2.2 million loan under the Paycheck Protection Program (the “PPP Loan”). In June 2021, Keystone received full forgiveness for this PPP Loan. The Paycheck Protection Program was established under the Coronavirus Aid, Relief, and Economic Security Act, and is administered by the United States Small Business Administration (the “SBA”).

Keystone’s receipt of the PPP Loan or the forgiveness of the PPP Loan could result in adverse publicity. In addition, if Keystone is later determined to have been ineligible to receive the PPP Loan or loan forgiveness, it may be subject to significant penalties, including significant civil, criminal and administrative penalties, it could be required to repay the PPP Loan in its entirety, and its reputation could suffer. A review or audit by the SBA or other government entity or claims under the United States False Claims Act could consume significant financial and management resources.

Changes in the method for determining SOFR or the elimination of SOFR could affect Keystone’s business, financial condition, results of operations and prospects.

Keystone’s Midcap Credit Agreement provides that interest may be indexed to the Secured Overnight Financing Rate (“SOFR”), which is a broad measure of the cost of borrowing cash overnight collateralized by U.S. Treasury securities. Keystone cannot predict the impact of any changes in the methods by which SOFR is determined or any regulatory activity related to a potential phase out of SOFR on its Midcap Credit Agreement and interest rates. It is not possible to predict the establishment of alternative reference rates in the United States or elsewhere. The establishment of alternative reference rates or implementation of any other potential changes may materially and adversely affect Keystone’s business, results of operations or financial condition.

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Changes in Keystone’s tax rates or exposure to additional income tax liabilities or assessments could affect its profitability.

Keystone is subject to income taxes in the United States and in numerous non-U.S. jurisdictions. The United States Congress may enact additional tax legislation (including proposed changes to United States tax laws by the Biden administration and the United States House of Representatives), which could have an impact on Keystone. It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof. We urge our investors to consult with their legal and tax advisors with respect to possible changes in United States tax law and the potential tax consequences of investing in New Parent common stock.

Changes in tax law relating to multinational corporations could adversely affect Keystone’s tax position.

The United States Congress, government agencies in non-U.S. jurisdictions where Keystone and its affiliates do business, and the Organisation for Economic Co-operation and Development (“OECD”) have been focused on issues related to the taxation of multinational corporations. One example is in the area of “base erosion and profit shifting,” where profits are claimed to be earned for tax purposes in low-tax jurisdictions, or payments are made between affiliates from a jurisdiction with high tax rates to a jurisdiction with lower tax rates. The OECD has released several components of its comprehensive plan to create an agreed set of international rules for addressing base erosion and profit shifting. As a result, the tax laws in the United States and other countries in which Keystone does business could change on a prospective or retroactive basis, and any such changes could adversely affect its business and financial statements.

Keystone’s ability to use net operating losses (“NOLs”) to offset future taxable income may be subject to certain limitations.

As of December 31, 2022, Keystone had United States federal and state net operating loss carryforwards of approximately $211.8 million and $108.4 million, respectively, available to offset future taxable income, if any. The United States federal net operating losses began to expire in 2021, if not utilized, while the state net operating losses began to expire in 2023, if not utilized. As of December 31, 2022, Keystone also had United States federal and state research and development credit carryforwards of approximately $0.9 million and $1.0 million, respectively, which began to expire in 2022 if not utilized.

Keystone’s ability to use its United States federal and state net operating losses to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon its generation of future taxable income, and Keystone cannot predict with certainty when, or whether, it will generate sufficient taxable income to use all of its net operating losses.

Under current law, unused United States federal net operating losses generated for tax years beginning after December 31, 2017, are not subject to expiration and may be carried forward indefinitely. Such United States federal net operating losses generally may not be carried back to prior taxable years, except that, net operating losses generated in 2018, 2019 and 2020 may be carried back to each of the five tax years preceding the tax years of such losses. Additionally, for taxable years beginning after December 31, 2020, the deductibility of such United States federal net operating losses is limited to 80% of our taxable income in any future taxable year. In addition, both Keystone’s current and future unused United States federal net operating losses and research and development tax credits may be subject to limitation under Sections 382 and 383 of the Code, and corresponding provisions of state law, if we undergo or have undergone an “ownership change,” generally defined as a cumulative change of more than 50 percentage points (by value) in our equity ownership by certain stockholders over a three-year period. There have been one or more ownership changes that will limit the amount of NOLs and research and development tax credits that we can utilize annually to offset future taxable income and tax,

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respectively. Keystone, however, has not completed a study to assess the ownership change identified, or whether there have been multiple ownership changes since our formation, due to the significant complexity and related costs with such study. Keystone may experience ownership changes in connection with the Business Combination or as a result of future shifts in our equity ownership, some of which may be outside our control. As a result, Keystone’s ability to use our pre-change United States federal NOLs and other tax attributes to offset future taxable income and taxes could be subject to limitations. For these reasons, Keystone may not be able to utilize a material portion of the NOLs, even if it achieves profitability, which could result in increased tax liability and adversely affect its business, financial condition and cash flows. Keystone believes that it is more likely than not that the NOLs and research and development tax credits will not be fully realizable in the future. Accordingly, Keystone has provided a full valuation against such tax attributes.

If Keystone receives a significant number of warranty claims or its implant products require significant amounts of service after sale, Keystone’s operating expenses may substantially increase and its business and financial results will be adversely affected.

Keystone currently warrants its implant products that it sells directly against defects in materials for an indefinite period from the time of placement of its implant products by a customer, provided the implant fails to osseointegrate in the patient’s mouth. Keystone also expects to provide technical and other services to customers throughout the warranty period. Keystone has a limited history of commercial placements from which to judge its rate of warranty claims, and it expects that the number of warranty claims it receives may increase as it scales its operations and as its existing commercial placements age. If product returns or warranty claims are significant or exceed Keystone’s expectations, Keystone could incur unanticipated reductions in sales or additional operating expenditures for parts and service. In addition, Keystone’s reputation could be damaged and its products may not achieve the level of market acceptance that Keystone is targeting in order to achieve and maintain profitability. Unforeseen warranty exposure could negatively impact Keystone’s business and financial results.

Product liability lawsuits against Keystone could cause it to incur substantial liabilities and to limit commercialization of any products that it may develop.

Keystone faces an inherent risk of product liability exposure related to the testing of its current product candidate or future product candidates in human clinical trials and will face an even greater risk if it commercially sells any products that it may develop. Product liability claims may be brought against Keystone by subjects enrolled in its clinical trials, patients, healthcare providers or others using, administering or selling Keystone products. If Keystone cannot successfully defend itself against claims that its product candidate or product caused injuries, it could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

Prior to engaging in future clinical trials, Keystone intends to obtain product liability insurance coverage at a level that it believes is customary for similarly situated companies and adequate to provide it with insurance

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coverage for foreseeable risks; however, it may be unable to obtain such coverage at a reasonable cost, if at all. If Keystone is able to obtain product liability insurance, it may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise and such insurance may not be adequate to cover all liabilities that it may incur. Furthermore, Keystone intends to expand its insurance coverage for products to include the sale of commercial products if it obtains regulatory approval for its product candidate in development, but it may be unable to obtain commercially reasonable product liability insurance for any products that receive regulatory approval. Large judgments have been awarded in class action lawsuits based on devices that had unanticipated side effects. A successful product liability claim or series of claims brought against Keystone, particularly if judgments exceed its insurance coverage, could decrease its cash and adversely affect its business.

Risks Related to Manufacturing and Distribution of Keystone’s Products and Supply Chain

The majority of Keystone’s products are produced at one facility, and a significant disruption or disaster at such facility could have a material adverse effect on its results of operations.

Keystone has four manufacturing facilities, located in each of Israel, Australia, Japan and France. Its primary manufacturing facility is its Israel facility and thus Keystone is dependent upon the continued safe operation of this facility. This facility is subject to various hazards associated with the manufacturing, handling, storage, and transportation of chemical materials and products, including human error, leaks and ruptures, explosions, floods, fires, inclement weather and natural disasters, power loss or other infrastructure failures, mechanical failure, unscheduled downtime, regulatory requirements, the loss of certifications, technical difficulties, labor disputes, inability to obtain material, equipment or transportation, environmental hazards such as remediation, chemical spills, discharges or releases of toxic or hazardous substances or gases, and other risks. Many of these hazards could cause personal injury and loss of life, severe damage to, or destruction of, property and equipment and environmental contamination. In addition, the occurrence of material operation problems at the facility due to any of these hazards could cause a disruption in the production of Keystone’s products. Keystone may also encounter difficulties or interruption as a result of the application of enhanced manufacturing technologies or changes to production lines to improve throughout or to upgrade or repair our production lines. Keystone’s insurance policies have coverage in case of significant damage to the manufacturing facility but may not fully compensate Keystone for the cost of replacement for any such damage and any loss from business interruption. As a result, Keystone may not be adequately insured to cover losses resulting from significant damage to the manufacturing facility. Any damage to the facility or interruption in manufacturing could result in production delays and delays in meeting contractual obligations which could have a material adverse effect on Keystone’s relationship with its customers and on the results of its operations, financial condition or cash flows in any given period.

The establishment and operation of a new manufacturing facility involves significant risks and challenges.

Keystone is currently in the process of searching for the location of a new manufacturing facility in order to produce Osteon’s Nexus iOS products in the United States, contingent upon FDA approval, which approval is not guaranteed and may take longer than expected. With this search comes certain risks including, but not limited to, difficulties finding an appropriate location, potential design and construction delays and cost overruns; issues in installing and qualifying new equipment and ramping production; poor production process yields and reduced quality control; and insufficient personnel with requisite expertise and experience to operate a device fabrication facility. As a result, delays may occur, which can materially impact Keystone’s ability to meet its desired timelines, thereby increasing its costs and reducing its ability to generate revenues.

Keystone’s success depends on market reception and acceptance for its technology products.

Keystone’s ability to generate revenues will depend significantly on its ability to attract a sufficient number of users of Osteon’s Nexus iOS products. If Keystone is unable to successfully market its products to its target

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markets and gain a sufficient number of users, any future revenues will be significantly impacted. In addition, any factors adversely affecting the demand for, or market acceptance of, Nexus iOS could materially reduce Keystone’s revenues and result in adverse market perceptions of Keystone and Nexus iOS.

Keystone relies on complex machinery for its operations, and production of its products involves a significant degree of risk and uncertainty in terms of operational performance and costs.

Keystone relies on complex machinery for its operations, and the production of its products involves a significant degree of risk and uncertainty in terms of operational performance and costs. Its manufacturing facilities consist of large-scale machinery combining many components. These components are likely to suffer unexpected malfunctions from time to time and will require repairs and spare parts to resume operations, which may not be available when needed. Unexpected malfunctions of these components may significantly affect the intended operational efficiency of Keystone’s manufacturing facilities. Operational performance and costs can be difficult to predict and will be influenced by factors outside of Keystone’s control, such as, but not limited to, the scarcity of natural resources, environmental hazards and remediation, costs associated with the decommissioning of machines, labor disputes and strikes, difficulty or delays in obtaining governmental permits, damages or defects in electronic systems, industrial accidents, pandemics, fire, and seismic activity and natural disasters. Should operational risks materialize, they may result in personal injury to or death of workers, the loss of production equipment, damage to manufacturing facilities, monetary losses, delays and unanticipated fluctuations in production, environmental damage, administrative fines, increased insurance costs and potential legal liabilities, all which could have a material adverse effect on Keystone’s business, prospects, financial condition, and results of operations.

The manufacture of many of Keystone’s products is a highly exacting and complex process, and if it directly or indirectly encounters problems manufacturing products, its reputation, business and financial statements could suffer.

The manufacture of many of Keystone’s products is a highly exacting and complex process, due in part to strict regulatory requirements. Problems may arise during manufacturing for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, problems with raw materials, natural disasters and environmental factors, and if not discovered before the product is released to market could result in recalls and product liability exposure. Because of the time required to approve and license certain regulated manufacturing facilities and other stringent regulations of the FDA and similar agencies regarding the manufacture of certain of Keystone’s products, an alternative manufacturer may not be available on a timely basis to replace such production capacity. Any of these manufacturing problems could result in significant costs, liability and lost sales, loss of market share as well as negative publicity and damage to Keystone’s reputation that could reduce demand for its products.

Keystone has limited experience manufacturing its products in large-scale commercial quantities and it faces a number of manufacturing risks that may adversely affect its manufacturing abilities which could delay, prevent or impair its growth.

Keystone’s growth strategy depends on its ability to manufacture its current and future products in sufficient quantities and on a timely basis to meet demand, while adhering to product quality standards, complying with regulatory quality system requirements and managing manufacturing costs in its current manufacturing facility or any future manufacturing facilities.

As demand for Keystone’s products increases, Keystone will have to invest additional resources to purchase components, sub-assemblies and materials, hire and train employees and enhance its manufacturing processes. If it fails to increase its production capacity efficiently, Keystone may not be able to fill orders on a timely basis, its sales may not increase in line with its expectations and its operating margins could fluctuate or decline. In addition, although some future products may share product features, components, sub-assemblies and materials

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with Keystone’s existing products, the manufacture of these products may require modification of Keystone’s current production processes or unique production processes, the hiring of specialized employees, the identification of new suppliers for specific components, sub-assemblies and materials or the development of new manufacturing technologies. It may not be possible for Keystone to manufacture these products at a cost or in quantities sufficient to make these products commercially viable or to maintain current operating margins, all of which could have a material adverse effect on Keystone’s business, financial condition and results of operations.

As Keystone continues to scale the commercial production of its products and increase its manufacturing capacity, it may encounter quality issues that could result in product defects, errors or recalls. Manufacturing delays related to quality control could negatively impact Keystone’s ability to bring its products to market, harm its reputation and decrease its revenues. Any defects, errors, recalls or other replacement of products could be expensive and generate negative publicity, which could impair its ability to market or sell its products, and adversely affect its results of operations.

Shipping is a critical part of Keystone’s business and any changes in its shipping arrangements or damages or losses sustained during shipping could adversely affect its business, financial condition, results of operations and prospects.

Keystone currently relies on third-party vendors for its shipping. If Keystone is not able to negotiate acceptable pricing and other terms with these entities or they experience performance problems or other difficulties, it could negatively impact its operating results and the experience of its clinical and dental customers. Additionally, Keystone’s manufacturing operations and growing business may require global shipping services which are subject to certain factors outside of its control, such as delays passing through customs and disruptions to global shipping routes. Keystone has also experienced shipping delays and difficulties due to the COVID-19 pandemic and may again experience such delays or difficulties due to future quarantines, shelter-in-place and similar government orders related to the COVID-19 pandemic or other infectious disease outbreaks or natural disasters. Moreover, there is no guarantee that Keystone’s products will not become damaged or lost in transit, and Keystone has experienced, and expects to continue to experience, delivery difficulties. If a product is damaged in transit, it may result in a substantial delay in the fulfillment of the order, and depending on the type and extent of the damage and whether the incident is covered by insurance, it may result in clinician dissatisfaction and a substantial financial loss for Keystone. If Keystone’s products are not delivered in a timely fashion or are lost during the delivery process, clinicians could also become dissatisfied and cease using its products or services, which would adversely affect its business, financial condition, results of operations and prospects.

Inventories maintained by Keystone’s distributors and customers may fluctuate from time to time.

Keystone relies in part on its distributor and customer relationships and predictions of distributor and customer inventory levels in projecting future demand levels and financial results. These inventory levels may fluctuate, and may differ from Keystone’s predictions, resulting in its projections of future results being different than expected. These changes may be influenced by changing relationships with the distributor and customers, economic conditions and end-user preference for particular products. There can be no assurance that Keystone’s distributors and customers will maintain levels of inventory in accordance with its predictions or past history, or that the timing of distributors’ or customers’ inventory build or liquidation will be in accordance with Keystone’s predictions or past history.

Supply chain interruptions may increase costs or reduce revenues.

Keystone depends on the effectiveness of its supply chain management to assure reliable and sufficient supply of quality products, on favorable terms. Although many of the products Keystone sells are sourced from a variety of suppliers, certain products, have limited suppliers, which may increase its reliance on those suppliers. Supply chain interruptions, including as a result of shortages and transportation issues or unexpected increases in demand, and

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price increases can adversely affect Keystone as well as its suppliers, whose performance may have a significant impact on Keystone’s results. Such shortages or disruptions could be caused by factors beyond the control of Keystone’s suppliers or us. If Keystone experiences interruptions in its supply chain, as it experienced on occasion during the COVID-19 pandemic, or if contingency planning (such as increasing inventory or adding secondary supply sources, as Keystone did during the COVID-19 pandemic) is not effective, Keystone’s costs could increase and it could limit the availability of products that are a critical part of Keystone’s offerings to customers.

The failure of Keystone’s service providers and suppliers to supply quality services and materials in sufficient quantities, at a favorable price, and in a timely fashion could adversely affect the results of its operations.

Keystone buys raw materials for its products from a limited number of key suppliers. The loss of any of its major suppliers or of any supplier who provides materials that are hard to obtain elsewhere at the same quality could adversely affect Keystone’s business operations. Although Keystone believes it could establish alternate manufacturers and sources for most of its raw materials, any delay in locating and establishing relationships with other sources could result in shortages of products it manufactures from such raw materials, with a resulting loss of sales and customers. In certain situations it may need to alter its products or with its customer’s consent to substitute different materials from alternative sources. A shortage of raw materials or an unexpected interruption of supply could also result in higher prices for those materials. Keystone has experienced increases in various raw material costs, transportation costs and the cost of packaging supplies used in its business. Increasing cost pricing pressures on raw materials and other products have continued throughout fiscal year 2022 and fiscal year 2023 as a result of limited supplies of various ingredients and the effects of higher labor and transportation costs. Keystone expects these upward pressures to continue through the near future. Although Keystone may be able to raise its prices in response to significant increases in the cost of raw materials, it may not be able to raise prices sufficiently or quickly enough to offset the negative effects such cost increases could have on results of its operations or financial condition.

There can be no assurance suppliers will provide the quality raw materials Keystone needs in the quantities requested or at a price Keystone is willing to pay. Because Keystone does not control the actual production of these raw materials, it is also subject to delays caused by interruption in production of materials including but not limited to those resulting from conditions outside of Keystone’s control, such as pandemics, weather, transportation interruptions, strikes, terrorism, natural disasters, and other catastrophic events.

Keystone is dependent upon a limited number of distributors for a significant portion of its sales, and loss of a key distributor could result in a loss of a significant amount of Keystone’s sales. In addition, adverse changes in Keystone’s relationships with, or the financial condition, performance, purchasing patterns or inventory levels of, key distributors and other channel partners could adversely affect its financial statements.

Historically, a substantial portion of Keystone’s international sales have come from a limited number of distributors. There can be no assurance that any particular distributor will purchase any particular quantity of products from Keystone or continue to purchase any products at all. If any distributor significantly reduces the volume of products purchased from Keystone, it would have an adverse effect on Keystone’s financial statements.

Keystone’s key distributors and other channel partners typically have valuable relationships with customers and end-users. Some of these distributors and other partners also sell Keystone’s competitors’ products or compete with Keystone directly, and if they favor competing products for any reason they may fail to market Keystone’s products effectively. Adverse changes in Keystone’s relationships with these distributors and other partners, reduction or discontinuation of their purchases from Keystone or adverse developments in their financial condition, performance or purchasing patterns, could cause a loss of resources and adversely affect Keystone’s business and financial statements. The levels of inventory maintained by Keystone’s distributors and other channel partners, and changes in those levels, can also significantly impact Keystone’s results of operations in any given period. In addition, the consolidation of distributors and customers in certain of Keystone’s served industries could adversely impact Keystone’s business and financial statements.

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If Keystone cannot adjust its manufacturing capacity or the purchases required for its manufacturing activities to reflect changes in market conditions and customer demand, its profitability may suffer. In addition, its reliance upon sole or limited sources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies

Keystone purchases materials, components and equipment from third parties for use in its manufacturing operations, including metallic-based components, plastics, zirconia and other petroleum-based products. Keystone’s profitability could be adversely impacted if it is unable to adjust its purchases to reflect changes in customer demand and market fluctuations, including those caused by seasonality or cyclicality. During a market upturn, suppliers may extend lead times, limit supplies or increase prices. If Keystone cannot purchase sufficient products at competitive prices and quality and on a timely enough basis to meet increasing demand, it may not be able to satisfy market demand, product shipments may be delayed, its costs may increase or it may breach its contractual commitments and incur liabilities. Conversely, in order to secure supplies for the production of products, Keystone sometimes enters into non-cancelable purchase commitments with vendors, which could impact its ability to adjust its inventory to reflect declining market demands. If demand for Keystone’s products is less than Keystone expects, Keystone may experience additional excess and obsolete inventories and be forced to incur additional charges and its profitability may suffer.

In addition, some of Keystone’s businesses purchase certain requirements from sole or limited source suppliers for reasons of quality assurance, regulatory requirements, cost effectiveness, availability or uniqueness of design. If these or other suppliers encounter financial, operating or other difficulties or if Keystone’s relationship with them changes, Keystone might not be able to quickly establish or qualify replacement sources of supply. The supply chains for Keystone’s businesses could also be disrupted, as Keystone experienced on occasion during the COVID-19 pandemic, by supplier capacity constraints, bankruptcy or exiting of the business for other reasons, decreased availability of key raw materials or commodities and external events such as natural disasters, pandemic health issues, war, terrorist actions, governmental actions and legislative or regulatory changes. Any of these factors could result in production interruptions, delays, extended lead times and inefficiencies.

Although Keystone believes that it has stable relationships with its existing suppliers, it cannot assure you that it will be able to secure a stable supply of components or materials going forward. In the event that any adverse developments occur with Keystone’s suppliers, in particular for those components that are single or sole sourced, or if any of Keystone’s suppliers modifies any of the components they supply, Keystone’s ability to supply its products may be temporarily or permanently interrupted. Obtaining substitute components could be difficult, time and resource consuming and costly. Also, there can be no assurance that Keystone will be able to secure a supply of alternative components at reasonable prices without experiencing interruptions in its business operations. In addition, quarantines, shelter-in-place and similar government orders related to the COVID-19 pandemic or other infectious disease outbreaks, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, could impact the suppliers upon which Keystone relies, or the availability or cost of materials, which could disrupt the supply chain for Keystone’s products, as Keystone experienced on occasion during the COVID-19 pandemic.

Keystone’s dependence on third parties subjects it to a number of risks that could impact its ability to manufacture its products and harm its business, including:

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Although Keystone requires its third-party suppliers and providers to provide components and services that meet Keystone’s specifications and other applicable legal and regulatory requirements in its agreements and contracts, and Keystone performs incoming inspection, testing or other acceptance activities to ensure the components meet its requirements, there is a risk that these third parties will not always act consistent with Keystone’s best interests, and may not always supply components or provide services that meet Keystone’s requirements or in a timely manner. In addition, Keystone cannot assure you that its suppliers have obtained and will be able to obtain or maintain all licenses, permits, clearances and approvals necessary for their operations or comply with all applicable laws and regulations, and failure to do so by them may lead to interruption in their business operations, which in turn may result in shortages of components supplied to Keystone.

Further, because Keystone cannot always immediately adapt its production capacity and related cost structures to changing market conditions, its manufacturing capacity may at times exceed or fall short of its production requirements. Any or all of these problems could result in the loss of customers, provide an opportunity for competing products to gain market acceptance and otherwise adversely affect Keystone’s financial statements.

The availability of third-party reimbursement for Keystone’s products is uncertain, which may limit consumer use and the market for its products.

In the United States and elsewhere, sales of medical products are dependent, in part, on the ability of consumers of these products to obtain reimbursement for all or a portion of their cost from third-party payors, such as government and private insurance plans. Any inability of patients, physicians and other users of its products to obtain sufficient reimbursement from third-party payors for Keystone’s products, or adverse changes in relevant governmental policies or the policies of private third-party payors regarding reimbursement for these products, could limit our ability to sell Keystone’s products on a competitive basis. Keystone is unable to predict what changes will be made in the reimbursement methods used by third-party health care payors. Moreover, third- party payors are increasingly challenging the prices charged for medical products and services, and some health care providers are gradually adopting a managed care system in which the providers contract to provide comprehensive health care services for a fixed cost per person. Patients and physicians may not be able to justify the use of Keystone’s products by the attendant cost savings and clinical benefits that Keystone believes will be derived from the use of its products, and therefore may not be able to obtain third party reimbursement.

Reimbursement and health care payment systems in international markets vary significantly by country and include both government-sponsored health care and private insurance. Keystone may not be able to obtain approvals for reimbursement from these international third-party payors in a timely manner, if at all. Any failure to receive international reimbursement approvals could have an adverse effect on market acceptance of Keystone’s products in the international markets in which approvals are sought.

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Keystone’s financial results are subject to fluctuations in the cost and availability of commodities that it uses in its operations.

Keystone’s manufacturing and other operations employ a wide variety of components, raw materials and other commodities, including metallic-based components, plastics, zirconia and other petroleum-based products. Prices for and availability of these components, raw materials and other commodities have fluctuated significantly in the past. Any sustained interruption in the supply of these items could adversely affect Keystone’s business. In addition, due to the highly competitive nature of the industries that Keystone serves, the cost-containment efforts of its customers and the terms of certain contracts to which it is party, if commodity prices rise Keystone may be unable to pass along cost increases through higher prices. If Keystone is unable to fully recover higher commodity costs through price increases or offset these increases through cost reductions, or if there is a time delay between the increase in costs and Keystone’s ability to recover or offset these costs, its margins and profitability could decline and its financial statements could be adversely affected.

Risks Related to Governmental Regulation

If Keystone fails to obtain or maintain approvals, clearances or certifications from the FDA or other applicable foreign regulatory authorities to market and sell its products, or are granted de novo classification, or if such approval or de novo classification is delayed, Keystone’s business will be materially harmed.

In the United States, before it can market a new medical device, or a new use of, new claim for or significant modification to an existing product, Keystone must first receive either clearance under Section 510(k) of the United States Food, Drug, and Cosmetic Act (the “FDCA”) or approval of a Premarket Approval (“PMA”) from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the United States market pursuant to an approved PMA and later down-classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data may be required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life- supporting or implantable devices. To date, our products have received marketing authorization pursuant to the 510(k) clearance process.

Therefore, Keystone must obtain certain regulatory approvals and marketing clearances from governmental authorities, including the FDA, to market and sell its products. Various states also impose similar marketing regulations. The FDA approval process requires an applicant to demonstrate the safety and effectiveness based, in part, on extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data. The de novo classification process requires an applicant to demonstrate that general controls, or general and special controls, are sufficient to provide reasonable assurance of safety and effectiveness and that the probable benefits of the device outweigh the probable risks. The de novo request is supported by performance data, which may include clinical data. The FDA can delay, limit or deny approval of a device for many reasons, including:

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Obtaining approval, clearance or granted de novo classification from the FDA or any foreign regulatory authority is not guaranteed, could take longer than expected, and could result in unexpected and significant costs for us and consume management’s time and other resources. The FDA could ask Keystone to supplement our submissions, collect additional non-clinical data, conduct additional clinical trials, prepare additional manufacturing data or information or engage in other time-consuming actions, or it could simply deny our applications. In addition, if approved or granted approval to market, Keystone will be required to obtain additional FDA approvals or clearances prior to making certain modification to our devices, and the FDA may revoke the approval or clearance or impose other restrictions if post-market data demonstrates safety issues or lack of effectiveness. If Keystone is unable to obtain and maintain the necessary regulatory approvals and clearances to market its products, its financial condition may be adversely affected, and its ability to grow domestically and internationally would likely be limited. Additionally, even if approved or granted de novo classification, Keystone’s products may not be approved or a de novo classification request may not be granted for the indications that are necessary or desirable for successful commercialization or profitability.

The FDA, applicable foreign regulatory entity or notified body can delay, limit or deny clearance, approval or certification of a device for many reasons, including:

Per FDA regulations, the scope of marketing claims Keystone can make about a cleared device is limited to the indications that were previously 510(k)-cleared. Other countries have similar laws and regulations restricting marketing to cleared indications. If a regulatory agency determines that any of Keystone’s marketing claims exceed the cleared indications in a particular country, Keystone may be subject to enforcement action and/or it may be required to cease making the challenged marketing claims, issue corrective communications, pay fines or stop selling products until the incorrect claims have been corrected.

In addition, if any regulatory agency determines that its marketing claims are false or misleading, or suggest a clinical benefit that is not supported in the studies applicable to such products, Keystone may be required to cease making the challenged marketing claims, issue corrective communications, pay fines or stop selling products until the objectionable claims have been corrected, which could harm its business, financial condition and results of operations. Any regulatory action or penalty could lead to private party actions, or private parties could seek to challenge Keystone’s claims even in the absence of formal regulatory actions, which could also harm its business, financial condition and results of operations.

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To the extent Keystone intends to sell its products in member states of the EU, its products must comply with the general safety and performance requirements of the EU Medical Devices Regulation (“EU MDR”) (Regulation (EU) No 2017/745). Compliance with these requirements is a prerequisite to be able to affix the European Conformity, or CE, mark to its products, without which they cannot be sold or marketed in the EU. All medical devices placed on the market in the EU must meet the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. Medical devices must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and—where applicable—other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

To demonstrate compliance with the general safety and performance requirements Keystone must undergo a conformity assessment procedure, which varies according to the type of medical device and its risk classification. Except for low-risk medical devices (Class I), where the manufacturer can self-assess of the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. See “Keystone Business—Government Regulation—Regulation of Medical Devices in the European Union.”

Sales of Keystone’s products outside the United States are subject to foreign regulatory requirements that vary widely from country to country, and such regulatory requirements have been changing and increasing in some countries. Complying with international regulatory requirements can be an expensive and time-consuming process and obtaining regulatory clearance, approvals or certifications is not certain. Keystone may be unable to maintain regulatory qualifications, clearances, approvals or certifications in these countries or to obtain clearances, approvals or certifications in other countries. It may incur significant costs in attempting to obtain, renew, or modify foreign regulatory clearances or approvals, qualifications or certifications. If Keystone experiences difficulties in receiving, maintaining, renewing or modifying necessary qualifications, clearances, approvals or certifications to market our products outside the United States, or if it fails to receive, renew, modify or maintain those qualifications, clearances, approvals or certifications, it may be unable to market its products or enhancements in certain international markets effectively, or at all.

Regulatory clearance or approval by the FDA, which is not guaranteed and could take longer than expected, does not ensure marketing authorization or similar registration, clearance, approval or certification by regulatory authorities in other countries, and such marketing authorization, registration, clearance, approval, or certification by one or more foreign regulatory authorities does not ensure marketing authorization or similar registration, clearance, approval, or certification by regulatory authorities in other foreign countries or by the FDA. However, a failure or delay in obtaining marketing authorization, registration, clearance, approval, or certification in one country, state or other location may have a negative effect on the regulatory process in others. Keystone may occasionally rely on vendors, partners, affiliates, or other third parties to seek marketing approval of one or more products in certain jurisdictions, and it is possible that such other third parties may proceed to sell products in jurisdictions despite the absence of required approvals.

Keystone’s future success depends on Keystone’s ability to develop, receive regulatory clearance or approval for, and introduce new products that will be accepted by the market in a timely manner. There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of Keystone’s future products on a timely basis, if at all, and failure to obtain necessary clearances or approvals for its future products would adversely affect Keystone’s ability to grow its business.

It is important to Keystone’s business that Keystone builds a pipeline of product offerings. As such, Keystone’s success will depend in part on Keystone’s ability to develop and introduce new products. However, it may not be able to successfully develop and obtain regulatory clearance or approval for product enhancements,

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or new products for any number of reasons, including due to the cost associated with certain regulatory approval requirements, or these products may not be accepted by dental practitioners or users.

The success of any new product offering or enhancement to an existing product will depend on a number of factors, including Keystone’s ability to, among others:

If Keystone does not develop new products or product enhancements in time to meet market demand, or if there is insufficient demand for these products or enhancements, or if its competitors introduce new products with functionalities that are superior to Keystone’s, Keystone’s results of operations will suffer.

Some of Keystone’s future products will require FDA clearance of a 510(k). Other products may require the approval of a PMA. In addition, some of its future products may require clinical trials to support regulatory approval and it may not successfully complete these clinical trials. There is no guarantee that such trials will produce positive results or that the results will support Keystone’s claims. The FDA may not approve or clear these products for the indications that are necessary or desirable for successful commercialization. Indeed, the FDA may refuse our requests for 510(k) clearance or PMA of new products. Failure to receive clearance or approval for Keystone’s new products would have an adverse effect on its ability to expand its business.

Healthcare reform measures could hinder or prevent the commercial success of Keystone’s products.

In the United States, there have been, and Keystone expects there will continue to be, a number of legislative and regulatory changes to the healthcare system in ways that may harm its future revenues and profitability and the demand for our products. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. Current and future legislative and regulatory proposals to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for the procedures associated with the use of Keystone’s products. The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in the future could impact Keystone’s revenue from the sale of its products.

By way of example, in the United States, the Affordable Care Act (the “ACA”) was enacted in March 2010 and substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts our industry. The ACA contained a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which have impacted existing government healthcare programs and will result in the development of new programs. Since its enactment, there have been numerous amendments to the ACA and revisions to implementing regulations, along with judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the Supreme Court ruled that states and individuals lacked standing to challenge the constitutionality of the ACA’s individual mandate, post-repeal of its associated tax penalty. Additionally, on February 15, 2021, President Biden issued an executive order that initiated a special enrollment period for

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purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. Additional legislative changes, regulatory changes and judicial challenges related to the ACA remain possible. Keystone cannot predict what effect further changes related to the ACA, including under the Biden administration, will have on its business.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare may harm:

The current presidential administration and Congress may continue to pursue significant changes to the current healthcare laws. Keystone cannot predict what other laws and regulations will ultimately be enacted and implemented at the federal or state level or the effect of any future legislation or regulation in the United States on our business, financial condition, and results of operations. Future changes in healthcare policy could increase Keystone’s costs and subject it to additional requirements that may interrupt commercialization of its current and future solutions, decrease its revenue and impact sales of and pricing for its current and future products.

New legislation and regulations and legislative and regulatory reforms may make it more difficult and costly for Keystone to obtain regulatory clearance or approval of its new and modified products, or to manufacture, market and distribute its products after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in the legislative bodies of the countries in which Keystone sells or intends to sell its products to revise the process for regulatory approval, clearance, authorization, certification, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA, EU and other applicable foreign regulations and guidance are often revised or reinterpreted by the applicable competent authority in ways that may significantly affect its business and its products. For example, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products. In November 2018, FDA officials announced forthcoming steps that the FDA intended to take to modernize the premarket notification pathway under Section 510(k) of the FDCA. Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public feedback on these proposals. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation. Accordingly, it is unclear the extent to which any proposals, if adopted, could impose additional regulatory requirements on Keystone that could delay its ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict its ability to maintain its current clearances, or otherwise create competition that may negatively affect Keystone’s business.

More recently, in September 2019, the FDA finalized guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance

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process. The FDA has developed and maintains a list of device types appropriate for the “safety and performance based” pathway and announced that it intends to continue to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible. The FDA may establish performance criteria for classes of devices for which Keystone or its competitors seek or currently have received clearance, and it is unclear the extent to which such performance standards, if established, could impact Keystone’s ability to obtain new 510(k) clearances or otherwise create competition that may negatively affect its business.

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect Keystone’s business and its products. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute Keystone’s products. Keystone cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on its business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance or approval; changes to manufacturing methods; recall, replacement or discontinuance of its products; or additional record keeping.

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay regulatory clearance or approval of Keystone’s product candidates. Keystone cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Keystone is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if it is not able to maintain regulatory compliance, it may lose any marketing approval that it may have obtained and it may not achieve or sustain profitability.

In addition, the EU landscape concerning medical devices in the EU recently evolved. On May 25, 2017, the EU MDR entered into force, which repeals and replaces the EU Medical Devices Directive and the Active Implantable Medical Devices Directive. The EU MDR, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices and ensure a high level of safety and health while supporting innovation.

The EU MDR became effective on May 26, 2021. The new regulation among other things:

These modifications may have an effect on the way Keystone intends to develop its business in the EU and European Economic Area (the “EEA”). For example, as a result of the transition towards the new regime,

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notified body review times have lengthened, and product introductions could be delayed or canceled, which could adversely affect Keystone’s ability to grow its business.

Keystone sells its products to licensed practitioners, including dentists and endodontists. Current laws and regulations could change at any time, disallowing sales of our products to dentists or endodontists and other non- physician providers, imposing additional educational or regulatory requirements on dentists and endodontists and other non-physician providers and limiting the ability of a dentist, endodontist, and non-physicians to operate our products, which could adversely affect Keystone’s business, financial condition and results of operations.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products or limit Keystone’s ability to sell to clinicians. It is impossible to predict whether legislative changes will be enacted or if regulations, guidance or interpretations will change and what the impact of such changes, if any, may be.

Keystone is subject to federal and state health care fraud and abuse laws, false claims laws, physician payment transparency laws and other health care laws and regulations. If Keystone or its employees, independent contractors, consultants, commercial partners, or vendors violate these laws, it could face substantial penalties.

Keystone is subject to federal, state, local and foreign laws, rules, regulations, self-regulatory codes, circulars and orders relating to health care fraud, including, but not limited to, the United States Federal Anti-Kickback Statute (the “AKS”), false claims laws, transparency laws with respect to payments and other transfers of value made to physicians and other licensed health care professionals, and other health care laws and regulations. In particular, the promotion, sales and marketing of health care items and services is subject to extensive laws and regulations designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive and other business arrangements. The United States health care laws and regulations that may affect Keystone’s ability to operate include, but are not limited to:

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Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of Keystone’s business activities, patient outreach programs or its arrangements with independent sales representatives and customers could be subject to challenge under one or more of such laws. The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different and difficult compliance and reporting requirements, increases the possibility that Keystone may run afoul of one or more laws. The costs to comply with these regulatory requirements are becoming more expensive and will also impact Keystone’s profitability. It is not always possible to identify and deter employee misconduct or business noncompliance, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If Keystone or its employees, agents, independent contractors, consultants, commercial partners and vendors violate these laws, it may be subject to investigations, enforcement actions and/or significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal health care programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and/or oversight if Keystone becomes subject to a corporate

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integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and/or curtailment of its operations, any of which could adversely affect our ability to operate its business and its results of operations.

In addition, any government investigation, even if Keystone is able to successfully defend against it, will require the expenditure of significant resources, is likely to generate negative publicity, harm Keystone’s reputation and potentially its financial condition and divert the attention of its management. Moreover, any investigation into Keystone’s practices could cause adverse publicity and require a costly and time-consuming response. If its operations are found to be in violation of any of these laws or any other governmental regulations that may apply to Keystone, it may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment of individuals, exclusion from government funded healthcare programs, such as Medicare and Medicaid, imposition of compliance obligations and monitoring, and the curtailment or restructuring of our operations. Any of the foregoing consequences could seriously harm Keystone’s business and its financial results.

Keystone could be adversely affected by violations of the Foreign Corrupt Practices Act (the “FCPA”) and similar worldwide anti-bribery laws and any investigation, and the outcome of any investigation, by government agencies of possible violations by it of the FCPA could have a material adverse effect on Keystone’s business.

The FCPA and similar worldwide anti-bribery laws prohibit companies and their intermediaries from corruptly providing any benefits to government officials for the purpose of obtaining or retaining business. Keystone is in the process of further enhancing policies and procedures intended to help ensure compliance with these laws. In the future, it may operate in parts of the world that have experienced governmental corruption to some degree. Moreover, because of the significant role government entities play in the regulation of many foreign healthcare markets, it may be exposed to heightened FCPA and similar risks arising from our efforts to seek regulatory approval of and reimbursement for our products in such countries. Keystone cannot assure you that its internal control policies and procedures will protect it from improper acts committed by its employees or agents. Violations of these laws, or allegations of such violations, would significantly disrupt its business and have a material adverse effect on its business, financial condition, and results of operations.

Certain of Keystone’s businesses are subject to extensive regulation by the FDA and by comparable agencies of other countries, as well as laws regulating fraud and abuse in the health care industry and the privacy and security of health information. Failure to comply with those regulations could adversely affect Keystone’s reputation, ability to do business and financial statements.

Most of Keystone’s products are medical devices subject to regulation by the FDA, by other federal and state governmental agencies, by comparable agencies of other countries and regions, by certain accrediting bodies and by regulations governing hazardous materials (or the manufacture and sale of products containing any such materials). The FDA and these other regulatory authorities enforce additional regulations regarding the safety of X-ray emitting devices. The global regulatory environment has become increasingly stringent and unpredictable. Several countries that did not have regulatory requirements for medical devices have established such requirements in recent years, and other countries have expanded, or plan to expand, their existing regulations. For example, the EU has Regulation (EU) 2017/745 on medical devices, which went into effect on May 26, 2021. The EU MDR, which was adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EU authorities in the assessment of certain categories of products. The EU MDR imposes stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. If Keystone fails to meet these requirements, its business in the EU and other regions could be adversely affected.

To varying degrees, these regulators require Keystone to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution and post-marketing surveillance of our

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products. Keystone cannot guarantee that it will be able to obtain regulatory clearance (such as 510(k) clearance) or approvals for our new products or modifications to (or additional indications or uses of) existing products within our anticipated timeframe or at all, and if it does obtain such clearance or approval it may be time-consuming, costly and subject to restrictions. Keystone’s ability to obtain such regulatory clearances or approvals will depend on many factors and the process for obtaining such clearances or approvals could change over time. Even after initial regulatory clearance or approval, Keystone is subject to periodic inspection by these regulatory authorities, and if safety issues arise it may be required to amend conditions for use of a product, such as providing additional warnings on the product’s label or narrowing its approved intended use, which could reduce the product’s market acceptance. Failure to obtain required regulatory clearances or approvals before marketing our products (or before implementing modifications to or promoting additional indications or uses of our products), other violations of these regulations, failure to remediate inspectional observations to the satisfaction of these regulatory authorities and real or perceived efficacy or safety concerns or trends of adverse events with respect to our products (even after obtaining clearance for distribution) can lead to FDA Form 483 Inspectional Observations, warning letters, notices to customers, declining sales, loss of customers, loss of market share, remediation and increased compliance costs, recalls, seizures of adulterated or misbranded products, injunctions, administrative detentions, refusals to permit importations, partial or total shutdown of production facilities or the implementation of operating restrictions, narrowing of permitted uses for a product, suspension or withdrawal of approvals and pre-market notification rescissions. Keystone is also subject to various laws regulating fraud and abuse, pricing and sales and marketing practices in the health care industry and the privacy and security of health information as well as manufacturing and quality standards, including the federal regulations described in the section entitled “Business–Government Regulation.” Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that government authorities will conclude that Keystone’s business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

Noncompliance with these standards can result in, among other things, fines, expenses, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to grant 510(k) clearance of devices, withdrawal of marketing approvals, criminal prosecutions and other adverse effects referenced below under “Our businesses are subject to extensive regulation; failure to comply with those regulations could adversely affect our financial statements and our business, including our reputation.” Further defending against any such actions can be costly and time-consuming and may require significant personnel resources. Therefore, even if Keystone is successful in defending against any such actions that may be brought against it, its business may be impaired.

Any product Keystone develops may cause or contribute to adverse medical events, which could interrupt, delay, or prevent its continued development. If certain events occur after marketing authorization or certification, Keystone may be required to report them to the FDA or comparable regulatory authority, and if it fails to do so, it would be subject to sanctions that could harm its reputation, business, financial condition and results of operations. In addition, the discovery of serious safety issues with its products, or a recall of its products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on Keystone.

Keystone is subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require it to report to the FDA or comparable regulatory authorities when it receives or becomes aware of information that reasonably suggests that one or more of its products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date Keystone becomes aware of the event as well as the nature of the event. Keystone may fail to report events of which it becomes aware within the prescribed timeframe. It may also fail to recognize that it has become aware of a reportable event, especially if it is not reported to it as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If Keystone fails to comply with its reporting obligations, the FDA or comparable

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regulatory authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our marketing authorizations, seizure of Keystone’s products or delay in obtaining marketing authorizations or certifications for Keystone’s product candidates.

The FDA and foreign regulatory bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. Keystone may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by Keystone could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. For example, in each of July 2021 and March, June, September and November 2019, Keystone initiated voluntary recalls of (i) several lots of dental impression components after identifying certain assembly issues, (ii) several lots of screw driver-type instruments after identifying issues related to the fit of such instruments, (iii) one lot of implants after identifying certain surface treatment issues, (iv) one lot of implants that were packaged with an incorrect cover screw and (v) one lot of implants that were packaged with an incorrect cover screw, respectively. The recalls affected approximately 2,500 products, and there were no patient safety issues reported or any reports to any of these issues, which all have been corrected. Product defects or other errors may occur in the future.

Depending on the corrective action Keystone takes to redress a product’s deficiencies or defects, the FDA or foreign regulatory authorities or bodies may require, or Keystone may decide, that Keystone will need to obtain new clearances, approvals or certifications for the device before it may market or distribute the corrected device. Seeking such clearances, approvals or certifications may delay Keystone’s ability to replace the recalled devices in a timely manner. Moreover, if it does not adequately address problems associated with its devices, Keystone may face additional regulatory enforcement action, including FDA or foreign regulatory bodies warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA or foreign regulatory bodies. Keystone may initiate voluntary withdrawals or corrections for its products in the future that it determines do not require notification of the FDA or foreign regulatory bodies. If the FDA or foreign regulatory bodies disagree with Keystone’s determinations, it could require Keystone to report those actions as recalls and Keystone may be subject to enforcement action. A future recall announcement could harm Keystone’s reputation with clinicians and dental practitioners, potentially lead to product liability claims against it and negatively affect its sales. Any corrective action, whether voluntary or involuntary, as well as defending itself in a lawsuit, will require the dedication of Keystone’s time and capital, distract management from operating Keystone’s business and may harm Keystone’s reputation and financial results.

In the future, certain of Keystone’s products may be subject to clinical trials, the results of which may be unexpected, may not be positive, may not support Keystone’s claims, or may be perceived as unfavorable by the market, and could have a material adverse effect on Keystone’s business, financial condition or results of operations. Clinical trials may also be necessary to support a 510(k) clearance, comparable marketing authorization, or certification. Such trials may require the enrollment of large numbers of patients and suitable patients may be difficult to identify and recruit. Delays or failures in Keystone’s clinical trials may prevent it from commercializing modified or new products and may adversely affect its business, financial condition and results of operations.

As a part of the regulatory process of obtaining marketing clearance for new products and new indications for existing products, Keystone may conduct and participate in clinical trials. Unexpected or inconsistent clinical data from existing or future clinical trials, or a regulator’s or the market’s perception of this clinical data, may adversely impact Keystone’s ability to obtain product approvals, its position in, and share of, the markets in which it participates and its business and financial statements.

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Initiating and completing the clinical trials necessary to support Keystone’s current and future products will be time consuming and expensive and the outcome of any such clinical trials is uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product Keystone advances into clinical trials may not have favorable results in later clinical trials and such trials may not support Keystone’s claims. Regulatory authorities or bodies may disagree with Keystone’s interpretation of data and results from Keystone’s clinical trials, and data are often susceptible to various interpretations and analyses. Many companies that have believed their products performed satisfactorily in preclinical studies and earlier clinical trials have nonetheless failed to replicate results in later clinical trials. Failure can occur at any stage of clinical testing. Keystone’s clinical studies may produce negative or inconclusive results, and it may decide, or regulators may require it, to conduct additional clinical and non-clinical testing in addition to those it has planned.

The initiation and completion of any of Keystone’s clinical studies may be prevented, delayed, or halted for numerous reasons. Keystone may experience delays in our clinical trials for a number of reasons, which could adversely affect the costs, timing or successful completion of Keystone’s clinical trials, including related to the following:

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Any of these occurrences may significantly harm Keystone’s business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing authorization of our product candidates.

Moreover, conducting successful clinical studies will require the enrollment of large numbers of patients and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators and support staff, the proximity of patients to clinical trial sites, the availability of patients meeting the eligibility and exclusion criteria for participation in the clinical trial and patient compliance with the trial protocol. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post- treatment procedures or follow-up to assess the performance of our products, or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts.

Patients may also not participate in Keystone’s clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to the products being tested.

Clinical trials must be conducted in accordance with the laws and regulations of the FDA and/or other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject to oversight by these governmental agencies and IRBs or ethics committees at the medical institutions where the clinical trials are conducted. In addition, clinical trials must be conducted with supplies of our devices produced under current good manufacturing practice (“cGMP”), requirements and other regulations. Keystone depends on our collaborators and on medical institutions and CROs to conduct our clinical trials in compliance with good clinical practice (“GCP”), requirements. To the extent our collaborators or the CROs fail to enroll participants for our clinical trials, fail to conduct the study to GCP standards or are delayed for a significant time in the execution of trials, including achieving full enrollment, Keystone may be affected by increased costs, program delays or both. In addition, clinical trials that are conducted in countries outside the United States may subject us to further delays and expenses as a result of increased shipment costs, additional regulatory requirements and the engagement of non-U.S. CROs, as well as expose us to risks associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care.

Even if Keystone’s clinical trials are completed as planned, Keystone cannot be certain that their results will support our product claims or that the FDA, other foreign regulatory authorities, or our notified body will agree with its conclusions regarding such trials. The clinical trial process may fail to demonstrate that Keystone’s products are safe and effective for the proposed indications for use, or patients enrolled in the clinical trials may experience unanticipated adverse side effects, either of which could cause Keystone to abandon or delay further development of a proposed product and may delay the development of other products. Furthermore, any delay or

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termination of Keystone’s clinical trials will delay the filing of its product submissions to the relevant regulatory authorities or to its notified body and, ultimately, its ability to commercialize such product and generate revenues. In addition, despite considerable time and expense invested in its clinical trials, the FDA, foreign regulatory authorities, or its notified body may not consider Keystone’s data adequate to support regulatory clearance, approval, certification of its products, or other required regulatory authorizations, as applicable. Such increased costs and delays or failures to complete Keystone’s clinical trials or obtain the results we expect, delays in its ability to commercialize its products or the abandonment of proposed product lines in response to clinical trial results could adversely affect its business, financial condition and results of operations.

Keystone has limited clinical data on its product candidates to indicate whether they are safe or effective for long- term use in humans and the absence of long-term clinical data might limit sales, and Keystone’s products might therefore prove to be less safe or effective than initially thought.

Keystone has limited clinical data on its product candidates and it has not conducted any studies to evaluate whether they are safe or effective for long-term use in humans, including its Osteon products. While Keystone has not observed any serious adverse events as a result of these preclinical studies or clinical trial, it has not widely tested the Osteon products in humans and cannot be certain how the Osteon products will perform when more widely tested in humans in any later clinical trials.

If treatment with any of its product candidates in its ongoing or future clinical trials results in concerns about their safety or efficacy, Keystone and its collaboration partners may be unable to successfully develop or commercialize any or all of its product candidates or enter into collaborations with respect to its product candidates.

Given the foregoing regulatory environment in which Keystone operates, it lacks the breadth of published long- term clinical data supporting the safety and efficacy of its products and the benefits may slow the adoption of its products, significantly reduce its ability to achieve expected sales and could prevent it from achieving and maintaining profitability.

Keystone’s facilities and those of its suppliers and contract manufacturers are subject to regulation under the Federal Food, Drug and Cosmetic Act and FDA implementing regulations as well as potential inspections by foreign regulatory authorities and audits.

The methods used in, and the facilities used for, the manufacture of Keystone’s products must comply with the FDA’s QSR, which is a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices. Furthermore, Keystone is required to verify that its suppliers maintain facilities, procedures and operations that comply with its quality standards and applicable regulatory requirements. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Keystone’s products are also subject to similar state regulations and various laws and regulations of foreign countries governing manufacturing.

Keystone’s operations could be harmed if regulatory authorities make determinations that it, or its vendors, are not in compliance with these regulations. If the FDA finds a violation of cGMPs, it may enjoin Keystone’s manufacturing operations, seize product, restrict importation of goods, and impose administrative, civil or criminal penalties or take other enforcement actions, such as requesting or requiring recalls. Similar requirements may apply in foreign jurisdictions. If Keystone or its contract manufacturers or suppliers fails to comply with applicable regulatory requirements, it or they could be required to take costly corrective actions, including suspending manufacturing operations, changing product designs, suspending sales, or initiating product recalls or market withdrawals. In addition, compliance with these regulations has increased and may further increase the cost of manufacturing certain of Keystone’s products to ensure and maintain compliance. Any of these outcomes could have a material adverse effect on Keystone’s business, financial condition and results of operations.

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Even after clearance, approval or certification for Keystone’s products is obtained, it and its contract manufacturers are subject to extensive post-market regulation by the FDA and foreign regulatory authorities and the notified body. Keystone’s failure to meet strict regulatory requirements could result in its being required to stop sales of its products, conduct voluntary or mandatory product recalls, pay fines, incur other costs or even close its facilities.

Even after a device is cleared, approved, certified or authorized, there are significant post-market regulations with which Keystone must comply. For example, it is required to comply with the FDA’s QSR, which covers the methods used in, and the facilities and controls used for, the design, manufacture, quality assurance, labeling, packaging, sterilization, storage, shipping, installation, distribution and servicing of its marketed products. The FDA enforces the QSR through periodic announced and unannounced inspections of manufacturing facilities. Any failure by Keystone or its contract manufacturers to take satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions against Keystone or its contract manufacturers.

In the EU, if Keystone were authorized to market, it would also be required to demonstrate compliance with similar quality system requirements which are laid down in the relevant Annexes to the EU MDR. Such compliance can be supported by, among other things, a certificate of compliance with ISO 13485:2016. Demonstration of compliance with the ISO 13485:2016 standard permits manufacturers to benefit from a presumption of conformity with the corresponding quality system requirements laid down in such Annexes to EU MDR. Failure to comply with such standards could adversely impact Keystone’s business.

Later discovery of previously unknown problems with Keystone’s products, including unanticipated adverse events, adverse events of unanticipated severity or frequency, or manufacturing problems, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, a requirement to repair, replace or refund the cost of any medical device that Keystone manufactures or distributes, fines, import refusals, product seizures, injunctions, the suspension, variation or withdrawal of regulatory clearances, approvals, certifications or other regulatory authorizations or the imposition of civil, administrative or criminal penalties or other enforcement or regulatory actions, each of which could adversely affect Keystone’s business, financial condition and results of operations.

The FDA and similar foreign governmental authorities and the authorities of the EU member states, also have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses an unacceptable risk to health. Moreover, Keystone’s notified body has the power to suspend, vary or withdraw our certifications in such circumstances. Manufacturers may, on their own initiative, recall a product if any material deficiency in a device is found or conduct a market withdrawal such as the correction or removal of a device to reduce a risk to health posed by the device, to remedy a minor violation of law or even if no violation of law has occurred. A government-mandated or voluntary recall by Keystone or one of its distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, manufacturing errors, other problems with design or labeling, packaging defects or other deficiencies or failures to comply with applicable regulations.

Depending on the corrective action Keystone takes to redress a product’s deficiencies or defects, the FDA, other applicable foreign regulatory authorities or Keystone’s notified body may require, or it may decide, that it will need to obtain new approvals, clearances, or certifications for the product before it may market or distribute the corrected product. Seeking such approvals, clearances or certifications may delay Keystone’s ability to replace the recalled or withdrawn products in a timely manner. Moreover, if Keystone does not adequately address problems associated with its products, it may face additional regulatory enforcement action, including warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines. Companies often are required to maintain certain records of recalls and withdrawals, even if they are not reportable to the applicable regulatory authority. Keystone may initiate voluntary withdrawals for its products in the future that it determines do not require notification of the FDA or other applicable foreign regulatory authorities. If such

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regulatory authority disagrees with our determinations, it could require Keystone to report those actions as recalls and it may be subject to enforcement action.

Any future recalls or market withdrawals of any of Keystone’s products would divert managerial and financial resources and have an adverse effect on our reputation, business, financial condition and results of operations, which could impair Keystone’s ability to produce its products in a cost-effective and timely manner in order to meet demands. It may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits. A future recall announcement could also potentially lead to product liability claims against Keystone.

The FDA’s medical device reporting regulations and similar foreign regulations require Keystone to report to the FDA and other foreign governmental authorities when it receives or becomes aware of information that reasonably suggests that one or more of its products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of Keystone’s obligation to report is triggered by the date it becomes aware of the adverse event as well as the nature of the event. It may fail to report adverse events of which it becomes aware within the prescribed timeframe. It may also fail to recognize that it has experienced a reportable adverse event, especially if it is not reported to Keystone as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If Keystone fails to comply with its reporting obligations, or any other requirements of the FDA or other regulatory requirements, the FDA and other foreign governmental authorities or bodies could take action, including by issuing warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of a device clearance, approval or certification or failure to grant new clearances, approvals or certifications, seizure of our products or delay in clearance, approval or certification of future products, recalls, requirements for customer notifications or repairs, operating restrictions or partial suspension or total shutdown of production. Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on Keystone’s reputation, business, financial condition and results of operations.

Disruptions at the FDA and foreign regulatory agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact Keystone’s business.

The ability of the FDA, foreign regulatory agencies and the notified body, to review and clear, approve or certify new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees and statutory, regulatory and policy changes. Average review times at these organizations have fluctuated in recent years as a result. In addition, government funding of other government agencies that oversee clearances and approvals and that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at these agencies and bodies may slow the time necessary for new devices to be reviewed and/ or cleared, approved or certified, which would adversely affect our business. For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA, other foreign regulatory authorities and certification bodies from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA, other regulatory authorities and certification bodies to timely review and process our regulatory submissions, which could have a material adverse effect on Keystone’s business.

For instance, in the EU notified bodies must be officially designated to certify products and services in accordance with the EU MDR. While several notified bodies have been designated, the COVID-19 pandemic significantly slowed down their designation process and the current designated notified bodies are facing a large

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amount of requests with the new regulation, resulting in longer notified body review times. The EU notified bodies have currently extended their timeline for audit, testing, and certification in order to account for these longer review times. This situation could impact Keystone’s ability to grow its business in the EU and EEA.

The FDA and other regulatory enforcement agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If Keystone is found to have improperly promoted off-label uses, it may become subject to significant liability.

The FDA strictly regulates the promotional claims that may be made about approved or cleared products. For example, devices authorized for marketing pursuant to a 510(k) clearance cannot be marketed for any intended use beyond the cleared indications. Dentists nevertheless may use Keystone products on their patients in a manner that is inconsistent with the indications for use cleared by the FDA. The FDA does not restrict or regulate a dental practitioner’s use of a medical product within the practice of medicine, and Keystone cannot prevent a dental practitioner from using our products for an off-label use. However, Keystone cannot market for these off-label uses and it trains its marketing personnel and direct sales force to not promote its devices for uses outside of the FDA- cleared indications.

The use of Keystone’s products for indications other than those for which its products have been cleared by the FDA or approved, authorized or certified by a notified body or foreign regulatory enforcement authorities may not effectively treat the conditions not referenced in product indications, which could harm Keystone’s reputation in the marketplace among dental practitioners and patients. If Keystone is found to have promoted such “off-label” uses, it may become subject to significant government fines and other related liability. For example, if the FDA or any foreign regulatory body determines that Keystone’s promotional materials or training constitute promotion of an off-label use, it could request that Keystone modifies our training or promotional materials or subject Keystone to regulatory or enforcement actions, including the issuance or imposition of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as false claims laws, if they consider Keystone’s business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion from participation in government healthcare programs and the curtailment of Keystone’s operations. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

In addition, dentists may misuse Keystone products or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk of product liability. If Keystone’s products are misused or used with improper technique, Keystone may become subject to costly litigation by dental practitioners or their patients. As described above, product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizeable damage awards against it that may not be covered by insurance.

Keystone may request additional label indications for its current products, and the FDA may deny those requests outright, require additional expensive performance or clinical data to support any additional indications or impose limitations on the intended use of any cleared products as a condition of clearance. Any of these events could significantly harm Keystone’s business and results of operations and cause its stock price to decline.

Certain modifications to Keystone’s products may require new 510(k) clearances or other marketing authorizations and may require Keystone to recall or cease marketing our products.

Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device.

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Manufacturers determine in the first instance whether a change to a product requires a new premarket submission, but the FDA may review any manufacturer’s decision. The FDA may not agree with Keystone’s decisions regarding whether new clearances are necessary. It has made modifications to its products in the past and have determined based on its review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required. It may make similar modifications or add additional features in the future that it believes do not require a new 510(k) clearance. If the FDA disagrees with Keystone’s determinations and requires it to submit new 510(k) notifications, Keystone may be required to cease marketing or to recall the modified product until it obtains clearance, and it may be subject to significant regulatory fines or penalties. Similar requirements may apply in foreign jurisdictions.

Clinical trials in support of such clearances, approvals and certifications by Keystone’s notified body may be costly and time-consuming. In the event that Keystone does not obtain additional clearances or approvals from the FDA or foreign regulatory authorities or certifications from its notified body, such approvals, clearances, or certifications not being guaranteed or guaranteed in a timely manner, its ability to market products in the United States, Israel, Australia and the EU and EEA and revenue derived therefrom may be adversely affected. Medical devices subject to premarket review may be marketed only for the indications for which they are approved, cleared, or assessed, and if Keystone is found to be marketing its products for off-label uses or indications for use that have not received the requisite clearances, approvals, certifications or assessments, it might be subject to FDA and other competent authorities’ enforcement action or have other resulting liability. In addition, if the FDA or the competent authorities in Israel, Australia and the EU member states and EEA countries determine that its promotional materials or training constitute promotion of a use which is unapproved, not cleared or not covered by the CE mark or in compliance with other regulatory authorities’ requirements, they could request that Keystone modifies its training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, an injunction, product seizures, consent decrees, civil fines, criminal penalties or import detention.

Significant developments or uncertainties stemming from the United States administration, including changes in United States trade policies, tariffs and the reaction of other countries thereto, could have an adverse effect on Keystone’s business.

Changes, potential changes or uncertainties in United States social, political, regulatory and economic conditions or laws and policies governing foreign trade, the health care system, manufacturing, and development and investment in the territories and countries where Keystone or its customers operate, stemming from the United States administration, could adversely affect our business and financial statements. Keystone is required to comply with various United States export/import control and economic sanctions laws, including the regulations administered by the United States Department of Treasury, Office of Foreign Assets Control, which implement economic sanctions imposed against designated countries, governments and persons based on United States foreign policy and national security considerations, and the import regulatory activities of the United States Customs and Border Protection. For example, the United States administration has increased tariffs on certain goods imported into the United States, raised the possibility of imposing significant, additional tariff increases and called for substantial changes to trade agreements. These factors have adversely affected, and in the future could further adversely affect, Keystone’s operating results and its business.

Keystone’s reputation, ability to do business and financial statements may be impaired by improper conduct by any of its employees, agents or business partners.

Keystone cannot provide assurance that its internal controls and compliance systems will always protect it from acts committed by its employees, agents or business partners of (or of it we acquires or partners with) that would violate United States and/or non-U.S. laws, including the laws governing payments to government officials, bribery, fraud, kickbacks and false claims, pricing, sales and marketing practices, conflicts of interest, competition, employment practices and workplace behavior, export and import compliance, economic and trade sanctions, money laundering and data privacy. In particular, the FCPA, the UK Bribery Act and similar anti-bribery laws in

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other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business, and Keystone operates in many parts of the world that have experienced governmental corruption to some degree. Any such improper actions or allegations of such acts could damage Keystone’s reputation and subject it to civil or criminal investigations in the United States and in other jurisdictions and related stockholder lawsuits, could lead to substantial civil and criminal, monetary and non-monetary penalties and could cause Keystone to incur significant legal and investigatory fees. In addition, the government may seek to hold Keystone liable for violations committed by companies in which it invests or that it acquires. Keystone also relies on its suppliers to adhere to its supplier standards of conduct, and material violations of such standards of conduct could occur that could have a material effect on Keystone’s business, reputation and financial statements.

Keystone’s businesses are subject to extensive regulation; failure to comply with those regulations could adversely affect its financial statements and its business, including its reputation.

In addition to the environmental, health, safety, health care, medical device, anticorruption, data privacy and other regulations noted elsewhere in this prospectus, Keystone’s businesses are subject to extensive regulation by United States and non-U.S. governmental and self-regulatory entities at the supranational, federal, state, local and other jurisdictional levels, including various import laws and export control and economic sanctions laws, which may affect our Business Combination with certain customers, business partners and other persons and dealings between our employees and between our subsidiaries. In certain circumstances, export control and economic sanctions regulations may prohibit the export of certain products, services and technologies. In other circumstances, Keystone may be required to obtain an export license before exporting the controlled item. Compliance with the various import laws that apply to Keystone’s businesses can restrict our access to, and increase the cost of obtaining, certain products and at times can interrupt Keystone’s supply of imported inventory.

These are not the only regulations that Keystone’s businesses must comply with. The regulations to which it is have tended to become more stringent over time and may be inconsistent across jurisdictions. Keystone, its representatives and the industries in which it operates may at times be under review and/or investigation by regulatory authorities. Compliance with these and other regulations may also affect Keystone’s returns on investment, require it to incur significant expenses or modify its business model or impair its flexibility in modifying product, marketing, pricing or other strategies for growing its business. Keystone’s products and operations are also often subject to the rules of industrial standards bodies such as the International Standards Organization, and failure to comply with these rules could result in withdrawal of certifications needed to sell our products and services and otherwise adversely impact our business and financial statements. Non-compliance with applicable requirements (or any alleged or perceived failure to comply) could result in import detentions, fines, damages, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, recall or seizure of products, operating restrictions, refusal of the government to approve product export applications or allow Keystone to enter into supply contracts, disbarment from selling to certain governmental agencies or exclusion from government funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, disruption of our business, limitation on our ability to manufacture, import, export and sell products and services, loss of customers, significant legal and investigatory fees, disgorgement, individual imprisonment, reputational harm, contractual damages, diminished profits, curtailment or restricting of business operations, criminal prosecution and other monetary and non-monetary penalties. For additional information regarding these risks, please refer to the section entitled “Keystone Business–Government Regulation.”

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Risks Related to Keystone’s Recent and Future Acquisitions

Any inability to consummate acquisitions at its historical rate and at appropriate prices, and to make appropriate investments that support its long-term strategy, could negatively impact Keystone’s growth rate and stock price.

Keystone’s ability to grow sales, earnings and cash flow at or above its historic rates depends in part upon our ability to identify and successfully acquire and integrate businesses at appropriate prices and realize anticipated synergies, and to make appropriate investments that support its long-term strategy. It may not be able to consummate acquisitions at rates similar to the past, which could adversely impact its growth rate and our stock price. Promising acquisitions and investments are difficult to identify and complete for a number of reasons, including high valuations, competition among prospective buyers, the availability of affordable funding in the capital markets and the need to satisfy applicable closing conditions and obtain applicable antitrust and other regulatory approvals on acceptable terms. In addition, competition for acquisitions and investment may result in higher purchase prices. Changes in accounting or regulatory requirements or instability in the credit markets could also adversely impact Keystone’s ability to consummate acquisitions and investments.

Keystone’s acquisition of businesses, investments, joint ventures and other strategic relationships could negatively impact its business and financial statements. In the future, Keystone may seek strategic alliances, joint ventures or collaborations, or enter into licensing or partnership arrangements and may not be successful in doing so, and even if it is, it may not realize the benefits or costs of such relationships.

As part of Keystone’s business strategy, it acquires businesses, makes investments and enters into joint ventures and other strategic relationships in the ordinary course; please refer to the section entitled “Information about Keystone – Keystone Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this prospectus for additional details. Keystone’s most recent acquisition activity includes the 2019 acquisition of Paltop and the August 2021 acquisition of Osteon. Acquisitions, investments, joint ventures and strategic relationships involve a number of financial, accounting, managerial, operational, legal, compliance and other risks and challenges, including the following, any of which could adversely affect our business and our financial statements:

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Further, Keystone may not be successful in its efforts to establish such collaborations. Any of these relationships may require Keystone to incur non-recurring and other charges, increase its near and long-term expenditures, issue securities that dilute its existing stockholders or disrupt its management and business. In addition, Keystone faces significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, it may not be successful in its efforts to establish a strategic alliance or other alternative arrangements for its products. Keystone cannot be certain that, following a strategic alliance or similar arrangement, it will achieve the revenues or specific net income that justifies such transaction. In addition, any potential future collaborations may be terminable by Keystone’s collaborators, and Keystone may not be able to adequately protect its rights under these agreements. Any termination of collaborations Keystone enters into in the future, or delays in entering into new strategic partnership agreements could delay Keystone’s sales and marketing efforts, which would harm its business prospects, financial condition and results of operations.

Additionally, Keystone may not be in a position to exercise sole decision-making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on decisions, and its collaborators may have economic or business interests or goals that are, or that may become, inconsistent with Keystone’s business interests or goals. It is possible that conflicts may arise with Keystone’s collaborators, such as conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations or the ownership or control of intellectual property developed during the collaboration. If any conflicts arise with Keystone’s current or future collaborators, they may act in their self-interest, which may be adverse to Keystone’s best interest, and they may breach their obligations to Keystone. In addition, Keystone has limited control over the amount and timing of resources that its current collaborators or any future collaborators devote to its collaborators’ or its future products and technologies.

Keystone acquired Osteon in 2021 and it may not successfully integrate this or future acquisitions.

In August 2021, Keystone acquired Osteon. Keystone may not be able to successfully integrate this acquisition and it may not perform as Keystone or the market expects. Risks associated with acquisitions include:

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The indemnification provisions of acquisition agreements by which Keystone has acquired companies may not fully protect it and as a result it may face unexpected liabilities.

Certain of the acquisition agreements by which Keystone has acquired companies require the former owners to indemnify it against certain liabilities related to the acquired company before Keystone acquired it. In most of these agreements, however, the liability of the former owners is limited and certain former owners may be unable to meet their indemnification responsibilities. Keystone cannot assure you that these indemnification provisions will protect it fully or at all, and as a result it may face unexpected liabilities that adversely affect its financial statements.

Divestitures or other dispositions could negatively impact Keystone’s business, and contingent liabilities from businesses that it or its predecessors have sold could adversely affect Keystone’s financial statements.

Keystone continually assess the strategic fit of its existing businesses and may divest, spin-off, split-off or otherwise dispose of businesses that are deemed not to fit with Keystone’s strategic plan or are not achieving the desired return on investment. These Business Combination pose risks and challenges that could negatively impact our business and financial statements. For example, when Keystone decides to sell or otherwise dispose of a business or assets, it may be unable to do so on satisfactory terms within its anticipated timeframe or at all, and even after reaching a definitive agreement to sell or dispose a business the sale is typically subject to satisfaction of pre-closing conditions which may not become satisfied. In addition, divestitures or other dispositions may dilute Keystone’s earnings per share, have other adverse tax, financial and accounting impacts and distract management, and disputes may arise with buyers. In addition, Keystone has retained responsibility for and/or have agreed to indemnify buyers against some known and unknown contingent liabilities related to certain businesses or assets it or its predecessors have sold or disposed. The resolution of these contingencies has not had a material effect on Keystone’s financial statements but it cannot be certain that this favorable pattern will continue.

Keystone may be required to recognize impairment charges for its goodwill and other intangible assets.

As of June 30, 2023, the net carrying value of Keystone’s goodwill and other intangible assets totaled approximately $69.4 million. In accordance with generally accepted accounting principles, Keystone periodically assesses these assets to determine if they are impaired. Significant negative industry or economic trends, disruptions to its business, inability to effectively integrate acquired businesses, unexpected significant changes or planned changes in use of its assets, changes in the structure of its business, divestitures, market capitalization declines, or increases in associated discount rates may impair its goodwill and other intangible assets. Any charges relating to such impairments would adversely affect Keystone’s results of operations in the periods recognized.

Risks Related to Keystone’s Intellectual Property and Cybersecurity

If Keystone or its current or future licensors are unable to obtain and maintain patent or other intellectual property protection for any products Keystone develops or for its technology, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, Keystone’s competitors could develop and commercialize products and technology similar or identical to Keystone’s, and its ability to successfully commercialize any products it may develop, and its technology, may be harmed.

In order to remain competitive, Keystone, and its current or future licensors, must develop, maintain, and protect the proprietary aspects of its brands, technologies, data, and products. Keystone relies on a combination

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of contractual provisions, confidentiality procedures, patent, copyright, trademark, trade secret, and other intellectual property laws to protect the proprietary aspects of its brands, technologies, data, and products. These legal measures afford only limited protection, and competitors or others may gain access to or use its intellectual property and proprietary information. Any failure to obtain or maintain patent and other intellectual property protection with respect to Keystone’s products could harm its business, financial condition and results of operations.

As of July 31, 2023, Keystone owned or licensed 24 issued or pending United States patents, 47 issued or pending European (EP and EU) patents, 17 issued or pending Asian patents and applications, and additional patents issued or applications pending in Australia, Brazil, Canada, Colombia, Israel, Mexico, and New Zealand, and Keystone had one pending Patent Cooperation Treaty (“PCT”) application. Keystone cannot assure you that its intellectual property position will not be challenged or that all patents for which Keystone has applied will be granted. As with other medical device companies, Keystone’s success depends, in part, on its and its current or future licensors’ ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property portfolio or other proprietary rights, including the amount and timing of any payments Keystone and its current or future licensors may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights. The process of applying for and obtaining a patent is expensive, time consuming and complex, and Keystone may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patents or patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous, or it may not be able to protect its proprietary rights at all. Although Keystone enters into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of its research and development output, such as its employees, corporate collaborators, outside scientific collaborators, suppliers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing Keystone’s ability to seek and obtain patent protection. Keystone may choose not to seek patent protection for certain innovations and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope. It is also possible that Keystone will fail to identify patentable aspects of its research and development results before it is too late to obtain patent protection. In addition, Keystone’s ability to obtain and maintain valid and enforceable patents depends in part on whether the differences between its inventions and the prior art allow its inventions to be patentable over the prior art. Furthermore, the publication of discoveries in scientific literature often lags behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until eighteen (18) months after filing, or in some cases not at all. Therefore, Keystone cannot be certain that it was the first to file for patent protection of such inventions. Despite Keystone’s efforts to protect its proprietary rights, unauthorized parties may be able to obtain and use information that it regards as proprietary. In addition, the issuance of a patent is not conclusive as to its inventorship, validity or enforceability, and its patents may be challenged in the courts or patent offices in the United States and abroad, so even if it obtains patents, they may not provide Keystone with adequate proprietary protection or competitive advantage against its competitors with similar products. Keystone’s patent applications may not result in issued patents and its patents may not be sufficiently broad to protect its technology. In addition, the laws of foreign jurisdictions may not protect its rights to the same extent as the laws of the United States. For example, certain countries outside of the United States do not allow patents for methods of treating the human body. This may preclude Keystone from obtaining method patents outside of the United States having similar scope to those we have obtained or may obtain in the future in the United States. Changes in either the patent laws or their interpretation in the United States and other countries may diminish its ability to protect our inventions, obtain, maintain, and enforce its intellectual property rights and, more generally, could affect the value of its intellectual property or narrow the scope of its patent protection. Additionally, Keystone cannot predict whether the patent applications it is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors or other third parties.

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Keystone relies on Politecnico di Milano, of Milan Italy, NanoSurfaces S.r.l., of Granarolo Dell’Emilia, Italy, and SAMO of Granarolo Dell’Emilia, Italy, and SeaSpine, of Carlsbad, California, to maintain the patents and otherwise protect the intellectual property it licenses directly from them pursuant to the related licensing agreements. Keystone’s current or future licensors may not successfully prosecute the intellectual property applications, including patent applications that it has licensed or may license in the future, may fail to maintain these patents, or may determine not to pursue litigation against other companies that are infringing this intellectual property, or may pursue such litigation less aggressively than Keystone would. If, in the future, Keystone no longer has rights to one or more of these licensed patents or other licensed intellectual property, its intellectual property coverage may be compromised, which, in turn, could affect its ability to protect its products and defend them against competitors. Without protection for the intellectual property Keystone licenses, other companies might be able to offer substantially identical products for sale, which could adversely affect Keystone’s competitive business position and harm its business prospects.

Moreover, even if Keystone is able to obtain patent protection, such patent protection may be of insufficient scope to achieve its business objectives. The strength of patent rights generally, and particularly the patent position of medical device companies, involves complex legal, factual and scientific questions and can be uncertain, and has been the subject of much litigation in recent years. This uncertainty includes changes to the patent laws through either legislative action to change statutory patent law or court action that may reinterpret existing law or rules in ways affecting the scope or validity of issued patents. Even if patents do successfully issue from Keystone’s patent applications, third parties may challenge the validity, enforceability, or scope of such patents, which may result in such patents being narrowed, invalidated, or held unenforceable. Decisions by courts and governmental patent agencies may introduce uncertainty in the enforceability or scope of patents owned by or licensed to Keystone. Furthermore, the issuance of a patent does not give Keystone the right to practice the patented invention. Third parties may also have blocking patents that could prevent Keystone from marketing its own products and practicing its own technology. It may not be aware of all third-party intellectual property rights potentially relating to our products, product candidates or their intended uses, and as a result the impact of such third-party intellectual property rights upon the patentability of its own patents and patent applications, as well as the impact of such third-party intellectual property upon our freedom to operate, is highly uncertain. Keystone cannot ensure that it does not infringe any patents or other proprietary rights held by others. If Keystone’s products were found to infringe any proprietary right of another party, it could be required to pay significant damages or license fees to such party and/or cease production, marketing and distribution of those products. Litigation may also be necessary to defend infringement claims of third parties or to enforce patent rights Keystone holds or protect trade secrets or techniques it owns. Further, third parties may seek approval to market their own products similar to or otherwise competitive with Keystone’s products. In these circumstances, Keystone may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or agency with jurisdiction may find Keystone’s patents invalid, unenforceable, or not infringed; competitors may then be able to market products and use manufacturing and analytical processes that are substantially similar to Keystone’s. Even if Keystone has valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve Keystone’s business objectives.

Keystone’s success will also depend, in part, on preserving its trade secrets, maintaining the security of our data and know-how and obtaining and maintaining other intellectual property rights. Keystone relies on trade secret protection and confidentiality agreements for strategic purposes, to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Keystone may also rely on trade secret protection as temporary protection for concepts that may be included in a future patent filing. There can be no assurances that Keystone can meaningfully protect or maintain intellectual property, trade secrets or other unpatented proprietary rights necessary to its business or in a form that provides it with a competitive advantage, or that others will not independently develop substantially equivalent proprietary products or processes or otherwise gain access to our proprietary technology. In addition, Keystone’s trade secrets, data, and know-how could be subject to unauthorized use, misappropriation, or

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disclosure to unauthorized parties, despite its efforts to enter into confidentiality agreements with its employees, consultants, clients, and other vendors who have access to such information, and could otherwise become known or be independently developed or discovered by third parties. Keystone’s intellectual property, including trademarks, could be challenged, invalidated, infringed, and circumvented by third parties, and its trademarks could also be diluted, declared generic or found to be infringing on other marks. If any of the foregoing occurs, Keystone could be forced to re-brand its products, resulting in loss of brand recognition, and requiring it to devote resources to advertising and marketing new brands, and suffer other competitive harm. Third parties may also adopt trademarks similar to Keystone’s, which could harm its brand identity and lead to market confusion. Failure to obtain and maintain intellectual property rights necessary to Keystone’s business and failure to protect, monitor and control the use of its intellectual property rights could negatively impact its ability to compete and cause it to incur significant expenses. The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions Keystone depends upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of our trademarks, data, technology and other intellectual property and services, and may not provide an adequate remedy if its intellectual property rights are infringed, misappropriated, or otherwise violated.

Additionally, Keystone may find it necessary or prudent to acquire or obtain licenses from third-party intellectual property holders. However, Keystone may be unable to acquire or secure such licenses to any intellectual property rights from third parties that it identifies as necessary for its products or any future products it may develop. The acquisition or licensing of third-party intellectual property rights is a competitive area, and its competitors may pursue strategies to acquire or license third-party intellectual property rights that it may consider attractive or necessary, and its competitors could market competing products and technology. Keystone’s competitors may have a competitive advantage over it due to their size, capital resources and greater development and commercialization capabilities. In addition, companies that perceive it to be a competitor may be unwilling to assign or license rights to Keystone. Keystone also may be unable to acquire or license third- party intellectual property rights on terms that would allow us to make an appropriate return on its investment or at all. If Keystone is unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights it has, it may have to abandon development of the relevant product, and its customers may be forced to stop using the relevant product, which could harm its business, financial condition, and results of operations.

Keystone may, in the future, be a party to intellectual property litigation or administrative proceedings that are very costly and time-consuming and could interfere with its ability to sell and market its products.

The medical device industry is highly competitive and has been characterized by extensive litigation regarding patents, trademarks, trade secrets, and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. It is possible that United States and foreign patents, along with pending patent applications or trademarks controlled by third parties may be alleged to cover our products, or that Keystone may be accused of misappropriating third parties’ trade secrets. Additionally, Keystone’s products include components that it purchases from vendors, and may include design components that are outside of Keystone’s direct control. Keystone’s competitors, many of which have substantially greater resources and have made substantial investments in patent portfolios, trade secrets, trademarks, and competing technologies, may have applied for or obtained, or may in the future apply for or obtain, patents or trademarks that will prevent, limit or otherwise interfere with Keystone’s ability to make, use, sell and/or export its products or to use its technologies or product names.

Third parties, including Keystone’s competitors, may currently have patents or obtain patents in the future and claim that the manufacture, use or sale of our products infringes upon these patents. Keystone has not conducted an extensive search of patents issued or assigned to other parties, including its competitors, and no assurance can be given that patents containing claims covering our products, parts of its products, technology or methods do not exist, have not been filed or could not be filed or issued. In addition, because patent applications can take many years to issue and because publication schedules for pending applications vary by jurisdiction,

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there may be applications now pending of which we are unaware and which may result in issued patents which Keystone’s current or future products infringe. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that Keystone infringes. As the number of competitors in its market grows and the number of patents issued in this area increases, the possibility of patent infringement claims against us escalates. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that Keystone’s products and business operations infringe or violate the intellectual property rights of others. The defense of these matters can be time consuming, costly to defend in litigation, divert management’s attention and resources, damage Keystone’s reputation and brand and cause Keystone to incur significant expenses or make substantial payments. Vendors from whom Keystone purchases hardware or software may not indemnify Keystone in the event that such hardware or software is accused of infringing a third-party’s patent or trademark or of misappropriating a third-party’s trade secret. Since patent applications are confidential for a period of time after filing, Keystone cannot be certain that it was the first to file any patent application related to its products. Competitors may also contest its or its current or future licensors’ patents in court, and administrative agency, or at the patent office, if issued, by proving that the invention was not original, was not novel, was obvious, or was obtained without disclosing all pertinent material prior art information to the patent office, among other reasons. For example, in litigation, a competitor could claim that Keystone’s patents, if issued, are not valid for a number of reasons or are unenforceable due to inequitable conduct. If a court agrees, Keystone would lose its rights to those challenged patents.

In addition, Keystone may in the future be subject to claims by its former employees or consultants asserting an ownership right in its patents or patent applications, as a result of the work they performed on Keystone’s behalf. Although Keystone generally requires its all of our employees and consultants and any other partners or collaborators who have access to its proprietary know-how, information or technology to assign or grant similar rights to their inventions to Keystone, it cannot be certain that it has executed such agreements with all parties who may have contributed to its intellectual property, nor can it be certain that its agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which Keystone may not have an adequate remedy.

Further, if third party claims of patent or trademark infringement or trade secret misappropriation are successfully asserted against Keystone, such claims may harm Keystone’s business, result in injunctions preventing Keystone from selling our products, and require payment of license fees, damages, attorney fees, and court costs, which may be substantial and have a material adverse impact on Keystone’s business. In addition, if Keystone is found to willfully infringe third-party patents or trademarks or to have misappropriated trade secrets, it could be required to pay treble damages in addition to other penalties. Although patent, trademark, trade secret, and other intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties that may substantially erode Keystone’s margins. Further, Keystone may be unable to obtain necessary licenses on satisfactory terms, if at all. If Keystone does not obtain necessary licenses, it may not be able to redesign its products to avoid infringement, and as such may need to stop selling the infringing products, which would have a significant adverse impact on its business, financial condition, and results of operations.

Similarly, interference or derivation proceedings provoked by third parties or brought by the United States Patent and Trademark Office (the “USPTO”) may be necessary to determine priority with respect to Keystone’s patents, patent applications, trademarks, or trademark applications. Keystone may also become involved in other proceedings, such as reexamination, inter-partes review, post-grant review, derivation, interference or opposition proceedings before the USPTO or other jurisdictional body relating to our intellectual property rights or the intellectual property rights of others. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit its ability to stop others from using or commercializing similar or identical products and techniques without payment to

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Keystone, or limit the duration of the patent protection of its technology. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent Keystone from manufacturing its products or using product names, which would have a significant adverse impact on its business, financial condition, and results of operations.

Additionally, Keystone may file lawsuits or initiate other proceedings to protect or enforce its patents, trademarks, or other intellectual property rights, which could be expensive, time consuming and unsuccessful. Former, current, or future licensees may violate the terms of their licenses and thereby infringe Keystone’s intellectual property. Competitors may infringe Keystone’s issued patents, trademarks, or other intellectual property. To counter infringement or unauthorized use by licensees, competitors, or other parties, Keystone may be required to file infringement or misuse claims, which can be expensive and time-consuming. Any claims it asserts against perceived infringers could provoke these parties to assert counterclaims or file administrative actions against it alleging that it infringes their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of Keystone’s is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that its patents do not cover the technology in question. Furthermore, even if Keystone’s patents or trademarks are found to be valid and infringed, a court may refuse to grant injunctive relief against the infringer and instead grant Keystone monetary damages and/or ongoing royalties. Such monetary compensation may be insufficient to adequately offset the damage to Keystone’s business caused by the infringer’s competition in the market, and an adverse result in any litigation proceeding or administrative action could put one or more of Keystone’s patents at risk of being invalidated or interpreted narrowly, which could adversely affect its competitive business position, financial condition, and results of operations.

Even if Keystone is successful in defending against intellectual property claims, litigation or other legal proceedings relating to such claims may cause Keystone to incur significant expenses and could distract its technical and management personnel from their normal responsibilities. Protracted litigation to defend or prosecute Keystone’s intellectual property rights could also result in its customers or potential customers deferring or limiting their purchase or use of the affected products until resolution of the litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial negative impact on the price of Keystone’s common stock. Such litigation or proceedings could substantially increase its operating losses and reduce its resources available for development activities. Keystone may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of Keystone’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than it can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of litigation or other intellectual property related proceedings could harm Keystone’s business, financial condition, and results of operations.

In addition, third parties may assert infringement claims against Keystone’s customers. These claims may require Keystone to initiate or defend protracted and costly litigation on behalf of its customers or indemnify its customers for any costs associated with their own initiation or defense of infringement claims, regardless of the merits of these claims. If any of these claims succeed or settle, Keystone may be forced to pay damages or settlement payments on behalf of its customers or may be required to obtain licenses for the products they use. If Keystone cannot obtain all necessary licenses on commercially reasonable terms, its customers may be forced to stop using its products.

Obtaining and maintaining intellectual property, including patent protection, depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, and Keystone’s intellectual property, including patent protection, could be reduced or eliminated for non-compliance with these requirements.

The USPTO, United States Copyright Office (the “USCO”) and various foreign governmental agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during

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the application process. In addition, periodic maintenance fees, renewal fees, annuity fees and various other government fees often must be paid to the USPTO, USCO and foreign agencies over the lifetime of any registered or applied-for intellectual property rights Keystone may obtain in the future. While an unintentional lapse of an intellectual property registration or application can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the registration or application, resulting in partial or complete loss of intellectual property rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a registration or application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If Keystone or its current or future licensors’ fail to maintain the intellectual property registrations and applications covering its products, it may not be able to stop a competitor from developing or marketing products that are the same as or similar to its products, which would have a material adverse effect on Keystone’s business.

Patent terms may be inadequate to protect Keystone’s competitive position on its products for an adequate amount of time.

Patents have a limited lifespan. The terms of individual patents depend upon the legal term for patents in the countries in which they are granted. In most countries, including the United States, if all maintenance fees are timely paid, the natural expiration of a utility patent is generally 20 years from its earliest non-provisional filing date in the applicable country. However, the actual protection afforded by a patent varies from country to country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering Keystone’s products are obtained, once the patent life has expired, Keystone may be open to competition from competitive products, which may harm its business prospects. In addition, although upon issuance in the United States a patent’s term can be extended based on certain delays caused by the USPTO, this extension can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. If Keystone does not have sufficient patent terms to protect its products, proprietary technologies and their uses, its business would be seriously harmed. As its patents expire, the scope of its patent protection will be reduced, which may reduce or eliminate any competitive advantage afforded by Keystone’s patent portfolio. As a result, Keystone’s patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to Keystone’s.

Changes in United States or foreign patent laws or their interpretations could diminish the value of patents in general, thereby impairing Keystone’s ability to protect its existing and future products.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. In 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and also affect patent litigation. These also include provisions that switched the United States from a “first-to-invent” system to a “first-to-file” system, allow third-party submission of prior art to the USPTO during patent prosecution and set forth additional procedures to attack the validity of a patent by the USPTO administered post grant proceedings. Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The USPTO recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. A third-party that files a patent application in the USPTO after March 2013, but before Keystone could therefore be awarded a patent covering an invention of Keystone’s even if Keystone had made

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the invention before it was made by such third-party. This will require Keystone to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, Keystone cannot be certain that it was the first to file any patent application related to its products or invent any of the inventions claimed in its patents or patent applications.

The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third-party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third-party may attempt to use the USPTO procedures to invalidate Keystone’s or its current or future licensors’ patent claims that would not have been invalidated if first challenged by the third-party as a defendant in a district court action. Therefore, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of Keystone’s patent applications and the enforcement or defense of our issued patents. In addition, future actions by the United States Congress, the federal courts and the USPTO could cause the laws and regulations governing patents to change in unpredictable ways. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on Keystone’s business, financial condition, and results of operations.

In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement and defense of our patents and applications. Furthermore, the United States Supreme Court and the United States Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. Keystone cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies. Those changes may materially affect Keystone’s patents or patent applications and its ability to obtain additional patent protection in the future.

Keystone’s or its current or future licensors’ patent rights and other intellectual property may be subject to priority, ownership or inventorship disputes, interferences, and similar proceedings.

Keystone or its current or future licensors’ may also be subject to claims that former employees, collaborators, or other third parties have an interest in Keystone’s or its current or future licensors’ patents and patent applications or other intellectual property as an inventor or co-inventor. If Keystone is unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents and patent applications, such co-owners rights may be subject, or in the future subject, to assignment or license to other third parties, including Keystone’s competitors. In addition, Keystone may need the cooperation of any such co-owners to enforce any such patents and any patents issuing from such patent applications against third parties, and such cooperation may not be provided to Keystone. Additionally, Keystone may be subject to claims from third parties challenging its ownership interest in or inventorship of intellectual property it regards as its own, for example, based on claims that its agreements with employees or consultants obligating them to assign intellectual property to it are ineffective or in conflict with prior or competing contractual obligations to assign inventions to another employer, to a former employer, or to another person or entity, despite Keystone’s inclusion of valid, present-tense intellectual property assignment obligations. Litigation may be necessary to defend against claims, and it may be necessary or it may desire to enter into a license to settle any such claim.

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If Keystone or its current or future licensors are unsuccessful in any priority, validity (including any patent oppositions), ownership or inventorship disputes to which it or they are subject, it may lose valuable intellectual property rights through the loss of one or more of its patents, or such patent claims may be narrowed, invalidated, or held unenforceable, or through loss of exclusive ownership of or the exclusive right to use its owned or in-licensed patents. In the event of loss of patent rights as a result of any of these disputes, it may be required to obtain and maintain licenses from third parties, including parties involved in any such interference proceedings or other priority or inventorship disputes. Such licenses may not be available on commercially reasonable terms or at all, or may be non-exclusive. If Keystone or its current or future licensors are unable to obtain and maintain such licenses, it may need to cease the development, manufacture, and commercialization of one or more of the product candidates it may develop. An inability to incorporate technologies, features or other intellectual property that are important or essential to Keystone’s products could have a material adverse effect on our business and competitive position. The loss of exclusivity or the narrowing of it or its current or future licensors patent claims could limit its ability to stop others from using or commercializing similar or identical technology and product candidates. Even if Keystone is successful in priority, inventorship or ownership disputes, it could result in substantial costs and be a distraction to management and other employees. Any litigation or the threat thereof may adversely affect Keystone’s ability to hire employees or contract with independent sales representatives. Any of the foregoing could result in a material adverse effect on Keystone’s business, financial condition, results of operations or prospects.

If Keystone fails to comply with its obligations in its intellectual property licenses, including its agreements with SeaSpine, of Carlsbad, California and NanoSurfaces S.r.l., of Granarolo Dell’Emilia, Italy, Keystone could lose rights that are important to its business.

Keystone is party to a license agreement with SeaSpine, of Carlsbad, California. Pursuant to this license agreement, it is granted a fully paid and royalty-free, exclusive, world-wide license in the dental field for certain patents, trade secrets, trademarks, and other intellectual property rights relating to natural and synthetic bone regeneration products. Keystone is also party to a sublicense agreement with NanoSurfaces S.r.l., of Granarolo Dell’Emilia, Italy in which they sublicense to Keystone a family of patents that they license from Politecnico di Milano, of Milan Italy. Pursuant to this sublicense agreement, Keystone is granted a fully paid and royalty-free, exclusive, world-wide sublicense relating to osteo-integration interfaces for dental implants, which cover the BioSpark, BioRough, and TiCare surface enhancement technologies as well as various titanium anodization technologies, and Keystone is also granted a royalty-free, world-wide sublicense relating to color anodization technologies used for color coding of dental implant system components. These agreements impose, and Keystone expects that any future license agreements will impose, certain notice, confidentiality and other obligations on it. If it fails to comply with the terms and obligations of its intellectual property agreements, including the obligations described above, its rights may be reduced and terminated, in which event it may not be able to develop and market any product that is covered by its intellectual property agreements.

Keystone may be subject to claims that its employees, consultants, advisors, or contractors have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of a non-competition or non-solicitation agreement with its competitors and third parties may claim an ownership interest in intellectual property Keystone regards as its own. Such claims could harm its business, financial condition, and results of operations.

As is common in the medical device industry, Keystone’s employees, consultants, and advisors may be currently or previously employed or engaged at universities or other medical device or healthcare companies, including our competitors and potential competitors. Some of these employees, consultants, advisors, and contractors, may have executed proprietary rights, non-disclosure, and non-competition agreements in connection with such previous employment. Although Keystone tries to ensure that its employees, consultants, advisors, and contractors do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for Keystone, it may in the future become subject to claims that it or these individuals have, inadvertently or otherwise, misappropriated the intellectual property, including trade secrets or other proprietary

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information, of their current or former employers, competitors or other third parties. Also, it may in the future be subject to claims that these individuals are violating non-compete agreements with their former employers. Litigation may be necessary to defend against these claims. If Keystone fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights or personnel, which could harm its business, financial condition and results of operations. Even if Keystone is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

In addition, while it is Keystone’s policy to require its employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Keystone, it may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Keystone regards as its own. The assignment of intellectual property rights may not be self- executing, or the assignment agreements may be breached, and it may be forced to bring claims against third parties, or defend claims that they may bring against Keystone, to determine the ownership of what it regards as its intellectual property. Such claims could harm its business, financial condition, and results of operations.

If Keystone fails to validly execute invention assignment agreements with its employees and contractors involved in the development of intellectual property or is unable to protect the confidentiality of its trade secrets and other proprietary information, the value of its products, its business and competitive position may be harmed.

In addition to patent protection, Keystone also relies on other proprietary rights, including protection of trade secrets, know-how, and other confidential and proprietary information that is not patentable or that it elects not to patent. However, trade secrets can be difficult to protect, and some courts are less willing or unwilling to protect trade secrets. To maintain the confidentiality of its trade secrets and proprietary information, Keystone generally has confidentiality and invention assignment provisions in contracts with its employees, consultants, suppliers, contract manufacturers, collaborators, and others upon the commencement of their relationship with Keystone. However, Keystone may not enter into such agreements with each party that may have or have had access to its trade secrets or proprietary technology and processes. It may not be able to prevent the unauthorized disclosure or use of its technical knowledge or other trade secrets by such third parties, despite the existence generally of these confidentiality restrictions. These contracts may not provide meaningful protection for its trade secrets, know-how, or other proprietary information in the event of any unauthorized use, misappropriation, or disclosure of such trade secrets, know-how, or other confidential or proprietary information. There can be no assurance that such third parties will not breach their agreements with Keystone, that Keystone will have adequate remedies for any breach, or that Keystone’s trade secrets or proprietary technology and processes will not otherwise become known or independently developed by competitors. Keystone may need to share its proprietary information, including trade secrets, with future business partners, collaborators, contractors, and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. Despite the protections Keystone does place on its intellectual property or other confidential and proprietary rights, monitoring unauthorized use and disclosure of our intellectual property is difficult, and it does not know whether the steps it has taken to protect its intellectual property or other proprietary rights will be adequate. In addition, the laws of many foreign countries will not protect Keystone’s intellectual property or other proprietary rights to the same extent as the laws of the United States. Consequently, Keystone may be unable to prevent our proprietary technology from being exploited abroad, which could affect its ability to expand to international markets or require costly efforts to protect its technology.

To the extent its intellectual property or other proprietary information protection is incomplete, Keystone is exposed to a greater risk of direct competition. A third-party could, without authorization, copy or otherwise obtain and use its products or technology, or develop similar technology. Its competitors could purchase its products and attempt to replicate some or all of the competitive advantages Keystone derives from its development efforts or design around its protected technology. Keystone’s failure to secure, protect and enforce

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its intellectual property rights could substantially harm the value of its products, brand, and business. The theft or unauthorized use or publication of its trade secrets and other confidential business information could reduce the differentiation of our products and harm its business, the value of its investment in research and development or acquisitions could be reduced, and third parties might make claims against it related to losses of their confidential or proprietary information. Any of the foregoing could materially and adversely affect Keystone’s business, financial condition, and results of operations.

Further, it is possible that others will independently develop the same or similar technology or otherwise obtain access to our unpatented technology, and in such cases, Keystone could not assert any trade secret rights against such parties. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our products that Keystone considers proprietary. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our trade secret rights and related confidentiality and nondisclosure provisions. If Keystone fails to obtain or maintain trade secret protection, or if its competitors obtain its trade secrets or independently develop technology similar to Keystone’s or competing technologies, Keystone’s competitive market position could be materially and adversely affected. In addition, some courts are less willing or unwilling to protect trade secrets and agreement terms that address non-competition are difficult to enforce in many jurisdictions and might not be enforceable in certain cases. Even though Keystone uses commonly accepted security measures, trade secret violations are often a matter of state law, and the criteria for protection of trade secrets can vary among different jurisdictions.

Keystone also seeks to preserve the integrity and confidentiality of its data and other confidential information by maintaining physical security of its premises and physical and electronic security of its information technology systems. While it has confidence in these individuals, organizations and systems, agreements or security measures may be breached and detecting the disclosure or misappropriation of confidential information and enforcing a claim that a party illegally disclosed or misappropriated confidential information is difficult, expensive, and time-consuming, and the outcome is unpredictable. Further, Keystone may not be able to obtain adequate remedies for any such breach. It may not be able to protect our intellectual property rights throughout the world.

Keystone or its current or future licensors may not be able to enforce its intellectual property rights throughout the world.

Filing, prosecuting, and defending patents or trademarks on Keystone’s current and future products in all countries throughout the world would be prohibitively expensive. The requirements for patentability and trademarking may differ in certain countries, particularly developing countries. The laws of some foreign countries do not protect intellectual property rights to the same extent as laws in the United States. Consequently, Keystone or its current or future licensors may not be able to prevent third parties from utilizing its inventions and trademarks in all countries outside the United States. Competitors may use Keystone’s technologies or trademarks in jurisdictions where Keystone has not obtained patent or trademark protection to develop or market their own products and further, may export otherwise infringing products to territories where Keystone has patent and trademark protection, but enforcement on infringing activities is inadequate. These products or trademarks may compete with Keystone’s current or future products or trademarks, and its patents, trademarks or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, may not favor the enforcement of patents, trademarks, and other intellectual property protection, which could make it difficult for us to stop the infringement of Keystone’s patents and trademarks or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce Keystone’s patent and trademark rights in foreign jurisdictions could result in substantial costs and divert Keystone’s efforts and attention from other aspects of its business, could put its patents and trademarks at risk of being invalidated or interpreted narrowly, and could provoke third parties to assert claims against it. Keystone may not prevail in any

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lawsuits that it initiates, and the damages or other remedies awarded, if any, may not be commercially meaningful. In addition, certain countries in Europe and certain developing countries, including India and China, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, Keystone may have limited remedies if its patents are infringed or if it is compelled to grant a license to our patents to a third-party, which could materially diminish the value of those patents. This could limit its potential revenue opportunities. Accordingly, Keystone’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that it owns or licenses. Finally, Keystone’s ability to protect and enforce its intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws.

If Keystone’s trademarks and trade names are not adequately protected, then it may not be able to build name recognition in its markets of interest and its business may be adversely affected.

Keystone relies on trademarks and trade names to build brand recognition and to promote, distinguish and market its products and services. Its current or future registered and unregistered trademarks or trade names may be challenged, opposed, infringed, circumvented or declared generic or descriptive, determined to be not entitled to registration, or determined to be infringing on other marks. Keystone may not be able to protect its rights to these trademarks and trade names or may be forced to stop using these names, which it needs for name recognition by potential partners or customers in its markets of interest. During trademark registration proceedings, it may receive rejections of its applications by the USPTO or in other foreign jurisdictions. Although Keystone would be given an opportunity to respond to those rejections, it may be unable to overcome such rejections. In the event that its trademarks are successfully challenged, Keystone could be forced to rebrand its products, which could result in loss of brand recognition, and could require Keystone to devote resources to advertising and marketing new brands. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against Keystone’s trademarks, and its trademarks may not survive such proceedings. If Keystone is unable to establish name recognition based on its trademarks and trade names, it may not be able to compete effectively, and its business may be adversely affected. It may in the future license its trademarks and trade names to third parties. Although these license agreements may provide guidelines for how its trademarks and trade names may be used, a breach of these agreements or misuse of its trademarks and tradenames by Keystone’s licensees may jeopardize Keystone’s rights in or diminish the goodwill associated with its trademarks and trade names. Keystone’s efforts to enforce or protect its proprietary rights related to trademarks, trade names, and service marks may be ineffective and could result in substantial costs and diversion of resources and could adversely affect its financial condition or results of operations.

Trademark litigation can be expensive, and the outcome can be highly uncertain. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. At times, competitors or other third parties may adopt trade names or trademarks similar to Keystone’s, thereby impeding Keystone’s ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of its registered or unregistered trademarks or trade names. If Keystone asserts trademark infringement claims, a court may determine that the marks it have asserted are invalid or unenforceable, or that the party against whom Keystone has asserted trademark infringement has superior rights to the marks in question. In this case, Keystone could ultimately be forced to cease use of such trademarks.

If Keystone is unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with its obligations under such agreements, its business could be harmed.

It may be necessary for Keystone to use the patented or proprietary technology of third parties to commercialize our products, in which case it would be required to obtain a license from these third parties. The

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licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that Keystone may consider attractive or necessary. These established companies may have a competitive advantage over Keystone due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive Keystone to be a competitor may be unwilling to assign or license rights to it. If Keystone is unable to license such technology, or if it is forced to license such technology, on unfavorable terms, its business could be harmed. If Keystone is unable to obtain a necessary license, it may be unable to develop or commercialize the affected product candidates, which could harm its business, and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on Keystone’s part to pay royalties and/or other forms of compensation. Even if Keystone is able to obtain a license, it may be non-exclusive, thereby giving its competitors access to the same technologies licensed to Keystone.

Moreover, some of Keystone’s patents and patent applications in the future may be jointly owned with third parties. If Keystone is unable to obtain an exclusive license to any such third party joint owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including its competitors, who could market competing products and technology. In addition, Keystone may need the cooperation of any such joint owners in order to enforce such patents against third parties, and such cooperation may not be provided to it. Any of the foregoing could harm Keystone’s business, financial condition and results of operations.

Intellectual property rights do not necessarily address all potential threats, and limitations in intellectual property rights could harm Keystone’s business, financial condition, and results of operations.

The degree of future protection afforded by Keystone’s intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect Keystone’s business or permit it to maintain its competitive advantage. For example:

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Any of the foregoing could harm Keystone’s business, financial condition, and results of operations.

A significant disruption in, or breach in security of, Keystone’s information technology systems, such as its enterprise resource planning system, or data or violation of data privacy laws could adversely affect its business, reputation and financial statements.

Keystone is planning to launch a new Enterprise Resource Planning system to manage its business data. Keystone also relies on other information technology systems, some of which are provided and/or managed by third parties, to process, transmit and store electronic information (including sensitive data such as confidential business information and personal data relating to employees, customers, other business partners and patients), and to manage or support a variety of critical business processes and activities (such as receiving and fulfilling orders, billing, collecting and making payments, shipping products, providing services and support to customers and fulfilling contractual obligations). In addition, some of Keystone’s software products and services incorporate information technology that may house personal data and some products or software we sell to customers may connect to Keystone’s systems for maintenance or other purposes. These systems, products and services (including those we acquire through business acquisitions) may be damaged, disrupted or shut down due to attacks by computer hackers, computer viruses, ransomware, human error or malfeasance, power outages, hardware failures, telecommunication or utility failures, catastrophes or other unforeseen events, and in any such circumstances Keystone’s system redundancy and other disaster recovery planning may be ineffective or inadequate. Attacks may also target hardware, software and information installed, stored or transmitted in our products after such products have been purchased and incorporated into third-party products, facilities or infrastructure. Security breaches of our systems, regardless of whether the breach is attributable to a vulnerability in Keystone’s products or services, or security breaches of third parties’ systems, which Keystone relies upon to process, store, or transmit electronic information, could result in the misappropriation, destruction or unauthorized disclosure of confidential information or personal data belonging to us or to our employees, partners, customers, patients or suppliers. Like most multinational corporations, Keystone’s information technology systems have been subject to computer viruses, malicious codes, unauthorized access and other cyber-attacks and Keystone expects the sophistication and frequency of such attacks to continue to increase. Unauthorized tampering, adulteration or interference with Keystone’s products may also adversely affect product functionality and result in loss of data, risk to patient safety and product recalls or field actions. Any of the attacks, breaches or other disruptions or damage described above could interrupt Keystone’s operations or the operations of its customers and partners, delay production and shipments, result in theft of Keystone’s and its customers’ intellectual property and trade secrets, damage customer, patient, business partner and employee relationships and Keystone’s reputation or result in defective products or services, legal claims and proceedings, liability and penalties under privacy laws and increased costs for security and remediation, each of which could adversely affect Keystone’s business, reputation and financial statements.

If Keystone is unable to maintain reliable information technology systems and appropriate controls with respect to global data privacy and security requirements and prevent data breaches, it may suffer adverse

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regulatory consequences, business consequences and litigation. As a global organization, it is subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of its business. For example, in the United States, the HIPAA privacy and security rules require certain of Keystone’s operations to maintain controls to protect the availability and confidentiality of patient health information, individual states regulate data breach and security requirements and multiple governmental bodies assert authority over aspects of the protection of personal privacy. Entities that are found to be in violation of HIPAA as the result of a breach of unsecured patient health information, a complaint about privacy practices or an audit by the Department of Health and Human Services (“HHS”), may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. The EU General Data Protection Regulation (“GDPR”), which became effective in May 2018, has imposed significantly stricter requirements in how Keystone collects, transmits, processes and retains personal data, including, among other things, a requirement for almost immediate notice of data breaches to supervisory authorities in certain circumstances and prompt notice to data subjects in certain circumstances with significant fines for non-compliance. Failure to comply with the requirements of GDPR and the applicable national data protection laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. Several other countries such as China and Russia have passed, and other countries are considering passing, laws that require personal data relating to their citizens to be maintained on local servers and impose additional data transfer restrictions. Lastly, a broad privacy law in California, the California Consumer Privacy Act (“CCPA”), which came into effect in January 2020 has some of the same features as the GDPR, and has already prompted several other states to follow with similar laws, including Colorado, Connecticut, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah and Virginia. Government enforcement actions can be costly and interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect Keystone’s business, reputation and financial statements. Also, the manufacturer may be subject to significant regulatory fines or penalties. In addition, compliance with the varying data privacy regulations across the United States and around the world have required significant expenditures and may require additional expenditures, and may require changes in our products or business models that increase competition or reduce sales.

Keystone’s software and its internal computer systems, or those used by its contractors or consultants, may fail or suffer security breaches, and such failure could negatively affect Keystone’s business, financial condition and results of operations.

The continued development, maintenance and operation of Keystone’s software are important factors impacting the success of our offerings and level of market acceptance and adoption of products. These efforts are expensive and complex and may involve unforeseen difficulties, including material performance problems and undetected defects or other technical or human errors. Keystone may encounter technical obstacles, and it is possible that it may discover additional problems that prevent its software and technologies from operating properly. If its software or technologies, individually or collectively, do not function reliably or fail to meet clinician, payor or patient expectations of performance or outcomes, then clinicians may stop using or offering Keystone’s solutions, payors could attempt to cancel their contracts with Keystone and patients may generate negative publicity about their experience or Keystone’s products.

Proprietary software development is time-consuming, expensive and complex, and may involve unforeseen difficulties. Keystone’s software may contain errors or vulnerabilities. Any real or perceived errors, failures, bugs or other vulnerabilities discovered in its existing or new software could result in negative publicity and damage to its reputation, loss of customers, loss of or delay in market acceptance of our products, loss of competitive position, loss of revenues or liability for damages, overpayments and/or underpayments, any of which could harm Keystone’s business and results of operation.

In the ordinary course of Keystone’s business, Keystone collects, uses, discloses, transfers, processes and stores sensitive data, including legally protected individually identifiable health information in the United States,

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credit card, and other financial information, insurance information, and other potentially personally identifiable information. It also processes and stores, and uses additional third parties to process and store, sensitive intellectual property and other proprietary business information, including that of its customers.

Keystone depends on its information technology systems for the efficient functioning of its business, including the manufacture, distribution and maintenance of its products, as well as for accounting, data storage, compliance, purchasing, inventory management and other related functions. Keystone does not have redundant information technology in all aspects of its systems at this time. Despite the implementation of security and back-up measures, its internal computer, server, and other information technology systems as well as those of its third-party consultants, contractors, suppliers, and service providers, may be vulnerable to damage from physical, electronic or technical break-ins, accidental or intentional exposure of its data by employees or others with authorized access to its networks, computer viruses, malware, ransomware, supply chain attacks, natural disasters, terrorism, war, telecommunication and electrical failure, denial of service, “phishing attacks” and other cyberattacks or disruptive incidents that could result in unauthorized access to, use or disclosure of, corruption of, or loss of sensitive, and/or proprietary data, including personal information, including health-related information, and could subject us to significant liabilities and regulatory and enforcement actions, and reputational damage. Additionally, theft of its intellectual property or proprietary business information could require substantial expenditures to remedy. Such theft could also lead to loss of intellectual property rights through disclosure of our proprietary business information, and such loss may not be capable of remedying. Keystone has also outsourced elements of its information technology infrastructure, and as a result a number of third- party vendors may or could have access to our confidential information. If Keystone or its third-party consultants, contractors, vendors, suppliers, or service providers were to suffer an attack or breach, for example, that resulted in the unauthorized access to or use or disclosure of personal or health information, Keystone may have to notify consumers, partners, collaborators, government authorities, and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions, and litigation, any of which could harm its business and reputation. Likewise, Keystone relies on third parties to conduct clinical trials, and similar events relating to their computer systems and networks could also have a material adverse effect on our business. The COVID-19 pandemic generally increased the risk of cybersecurity intrusions. Keystone’s reliance on internet technology and the number of our employees who are working remotely may create additional opportunities for cybercriminals to exploit vulnerabilities. For example, there was an increase in phishing and spam emails as well as social engineering attempts from “hackers” hoping to use the COVID-19 pandemic to their advantage. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, Keystone may be unable to anticipate these techniques or implement adequate preventative measures. It may also experience security breaches that may remain undetected for an extended period. If its systems are damaged or cease to function properly due to any number of causes, ranging from catastrophic events to power outages to security breaches, and its business continuity plans do not effectively compensate timely, Keystone may suffer interruptions in its ability to manage operations, and would also be exposed to a risk of loss, including financial assets or litigation and potential liability. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or systems or data or systems of our commercial partners, or inappropriate or unauthorized access to or disclosure or use of confidential, proprietary, or other sensitive, personal, or health information, Keystone could incur liability and suffer reputational harm. Failure to maintain or protect its information technology systems effectively could negatively affect its business, financial condition and results of operations.

Keystone cannot assure you that any limitations of liability provisions in its contracts would be enforceable or adequate or would otherwise protect us from any liabilities or damages with respect to any particular claim relating to a security lapse or breach. While Keystone maintains certain insurance coverage, our insurance may be insufficient or may not cover all liabilities incurred by such attacks. It also cannot be certain that our insurance coverage will be adequate for data handling or data security liabilities actually incurred, that insurance will continue to be available to Keystone on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any future claim. The successful assertion of one or more large claims against Keystone that exceeds available insurance coverage, or the occurrence of changes in our insurance policies, including premium

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increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on its business, including its financial condition, operating results and reputation.

Actual or perceived failure to comply with data protection, privacy and security laws, regulations, standards and other requirements could negatively affect Keystone’s business, financial condition or results of operations.

Keystone may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy laws, and consumer protection laws and regulations that govern the collection, processing, use, disclosure, and protection of health-related and other personal information could apply to Keystone’s operations or the operations of its partners. For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations implemented thereunder, or collectively, HIPAA, imposes obligations on “covered entities,” including certain health care providers, health plans, and health care clearinghouses, and their respective “business associates” that create, receive, maintain or transmit individually identifiable protected health information (“PHI”), for or on behalf of a covered entity, as well as their covered subcontractors with respect to safeguarding the privacy, security and transmission of individually identifiable health information. Entities that are found to be in violation of HIPAA, whether as the result of a breach of unsecured PHI, a complaint about privacy practices, or an audit by the Department of Health and Human Services, or HHS, may be subject to significant civil, criminal, and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. Depending on the facts and circumstances, Keystone could be subject to penalties if it violates HIPAA.

Even when HIPAA does not apply, according to the Federal Trade Commission, or the FTC, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of the Federal Trade Commission Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards.

In addition, certain state laws govern the privacy and security of health-related and other personal information in certain circumstances, some of which may be more stringent, broader in scope or offer greater individual rights with respect to protected health information than HIPAA, many of which may differ from each other, thus, complicating compliance efforts. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. For example, California enacted the CCPA, which creates individual privacy rights for California consumers (as defined in the law), including the right to opt out of certain disclosures of their information, and places increased privacy and security obligations on entities handling certain personal data of consumers or households and may apply to us in the future. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. Further, the California Privacy Rights Act (the “CPRA”), recently passed in California. The CPRA will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions went into effect on January 1, 2023, with the remainder scheduled to go into effect in March 2024, and additional compliance investment and potential business process changes may be required. The CCPA and CPRA could mark the beginning of a trend toward more stringent privacy legislation

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in the United States, as other states or the federal government may follow California’s lead and increase protections for United States residents. For example, on March 2, 2021, the Virginia Consumer Data Protection Act, which took effect on January 1, 2023, was signed into law. The CCPA has already prompted a number of proposals for new federal and state privacy legislation that, if passed, could increase our potential liability, add layers of complexity to compliance in the United States market, increase its compliance costs and adversely affect its business.

Foreign data protection laws, including the GDPR, may also apply to Keystone’s processing of health-related and other personal data regardless of where the processing in question is carried out. The GDPR imposes stringent requirements for controllers and processors of personal data of individuals within the EEA. The GDPR applies to any company established in the EEA as well as to those outside the EEA if they collect, process, and use personal data in connection with the offering of goods or services to individuals in the EEA or the monitoring of their behavior. The GDPR, together with national legislation, regulations and guidelines of the EEA Member States, govern the processing of personal data, and impose strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including health data from clinical trials and adverse event reporting. In particular, these obligations and restrictions involve the consent of the individuals to whom the personal data relates, the information provided to the individuals, the transfer of personal data out of the EEA to jurisdictions deemed to have inadequate, security breach notifications, security and confidentiality of the personal data and imposition of substantial potential fines for breaches of the data protection obligations. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. Further, from January 1, 2021, companies have to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR, e.g., fines up to the greater of €20 million (£17.5 million) or 4% of global turnover. The relationship between the UK and the European Union in relation to certain aspects of data protection law remains unclear, and it is unclear how UK data protection laws and regulations will develop in the medium to longer term. The European Commission has adopted an adequacy decision in favor of the UK, enabling data transfers from EU member states to the UK without additional safeguards. However, the UK adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews/extends that decision. Implementing mechanisms that endeavor to ensure compliance with the GDPR and relevant local legislation in EEA Member States and the UK, if necessary, may be onerous and may interrupt or delay our development activities, and adversely affect our business, financial condition, results of operations, and prospects. While Keystone has taken steps to comply with the GDPR where applicable, including by reviewing its security procedures, and entering into data processing agreements with relevant contractors, our efforts to achieve and remain in compliance may not be fully successful.

Compliance with applicable United States and foreign data protection, privacy and security laws, regulations and standards could require Keystone to take on more onerous obligations in our contracts, require it to engage in costly compliance exercises, restrict its ability to collect, use and disclose data, or in some cases, impact its or its partners’ or suppliers’ ability to operate in certain jurisdictions. Each of these constantly evolving laws can also be subject to varying interpretations. Any failure or perceived failure to comply could result in government investigations and enforcement actions (which could include civil or criminal penalties), fines, private litigation, and/or adverse publicity, and could negatively affect Keystone’s operating results and business. Moreover, patients about whom Keystone or its partners obtain information, as well as the providers who share this information with Keystone, may contractually limit Keystone’s ability to use and disclose the information. Claims that Keystone have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if it is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm Keystone’s business.

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Risks Related to Ownership of New Parent Common Stock

There is no current trading market for New Parent common stock and an active market may never develop or be sustained.

Until now, there has been no public market for New Parent common stock. An active public trading market may not develop after completion of the Business Combination or, if developed, may not be sustained. The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. An inactive market may also impair our ability to raise capital by selling shares and may impair our ability to acquire other businesses or assets using our shares as consideration. Furthermore, although New Parent has applied to list the New Parent common stock to be issued in the Business Combination on the Nasdaq Capital Market under the symbol “KSD” there can be no guarantee that we will continue to satisfy the continued listing standards of Nasdaq. If we fail to satisfy the continued listing standards, we could be de-listed, which would have a negative effect on the price of New Parent common stock.

The market and trading volume of New Parent common stock may be volatile, and you could lose all or part of your investment.

The market price of New Parent common stock may fluctuate or decline significantly in the future. Some of the factors that could negatively affect our share price or result in fluctuations in the price or trading volume of New Parent common stock include those listed in “—Risks Related to our Business, Financial Condition and Capital Requirements,” and the following, some of which are beyond our control:

Certain broad market and industry factors may decrease the market price of New Parent common stock, regardless of our actual operating performance. The stock market in general has from time to time experienced

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extreme price and volume fluctuations, including in recent months. In addition, in the past, following periods of volatility in the overall market and the market price of a company’s securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.

Future sales of shares by existing stockholders could cause our stock price to decline.

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of New Parent common stock in the public market after the lock-up and legal restrictions on resale discussed in this prospectus lapse, the trading price of New Parent common stock could decline. At the Closing of the Business Combination, we will have outstanding a total of 37,412,245 shares of common stock. Accelmed, AGP, our CEO Melker Nilsson and directors and officers of Check-Cap are subject to lock-up and market standoff agreements that restrict their ability to, among other things and subject to certain exceptions, sell or transfer their shares for a period of 180 days after the date of this prospectus subject to certain exceptions. After the lock-up agreements expire, all shares outstanding will be eligible for sale in the public market, of which the shares held by directors, executive officers and other affiliates may be resold immediately thereafter pursuant to the registration rights agreements we have entered into with Accelmed, AGP and Melker Nilsson in connection with the Business Combination. Sales of a substantial number of such shares upon expiration of the lock-up and market stand-off agreements, the perception that such sales may occur or early release of these agreements, could cause our market price to fall or make it more difficult for you to sell New Parent common stock at a time and price that you deem appropriate.

In addition, 4,977,346 shares of New Parent common stock are issuable upon the exercise of options and warrants outstanding as of July 31, 2023. These shares will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements, the lock-up agreements and Rules 144 and 701 of the Securities Act of 1933 (the “Securities Act”). We intend to file a registration statement on Form S-8 under the Securities Act covering all the shares of common stock subject to stock options outstanding and reserved for issuance under our stock plans. That registration statement will become effective immediately on filing, and shares covered by that registration statement will be eligible for sale in the public markets, subject to Rule 144 limitations applicable to affiliates and the lock-up agreement described above. If these additional shares are sold, or if it is perceived that they will be sold in the public market, the trading price of New Parent common stock could decline.

If our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of New Parent common stock may decline.

We may, but are not obligated to, provide public guidance on our expected operating and financial results for future periods. Any such guidance will be comprised of forward-looking statements subject to the risks and uncertainties described in this prospectus and in our other public filings and public statements. Our actual results may not always be in line with or exceed any guidance we have provided, especially in times of economic uncertainty. If, in the future, our operating or financial results for a particular period do not meet any guidance we provide or the expectations of investment analysts, or if we reduce our guidance for future periods, the market price of New Parent common stock may decline. Even if we do issue public guidance, there can be no assurance that we will continue to do so in the future.

If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, our share price and trading volume could decline.

The trading market for New Parent common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business, our market and our competitors. We do not have any control over these analysts. If one or more of the analysts who cover us downgrade our shares or change their opinion of our business, our share price would likely decline. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.

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The future issuance of additional common stock in connection with our incentive plans, acquisitions or otherwise will dilute all other stockholdings.

After the Business Combination, we will have an aggregate of [●] shares of common stock authorized but unissued and not reserved for issuance under our incentive plans. We may issue all of these shares of common stock without any action or approval by our stockholders, subject to certain exceptions. We also intend to continue to evaluate acquisition opportunities and may issue common stock in connection with these acquisitions. Any common stock issued in connection with our incentive plans, acquisitions or otherwise would dilute the percentage ownership held by our other shareholders.

We have no current plans to pay cash dividends on New Parent common stock; as a result, you may not receive any return on investment unless you sell New Parent common stock for a price greater than that which you paid for it.

We have no current plans to pay dividends on New Parent common stock. Any future determination to pay dividends will be made at the discretion of our board of directors, subject to applicable laws, and will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual, legal, tax and regulatory restrictions, general business conditions, and other factors that our board of directors may deem relevant. In addition, our ability to pay cash dividends is currently restricted under our debt financing arrangements and may be restricted by the terms of any of our future debt financing arrangements, which may contain terms restricting or limiting the amount of dividends that may be declared or paid on New Parent common stock. As a result, you may not receive any return on an investment in New Parent common stock unless you sell your New Parent common stock for a price greater than that which you paid for it.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our operating results could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of New Parent common stock.

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenues and expenses that are not readily apparent from other sources. It is possible that interpretation, industry practice and guidance involving estimates and assumptions may evolve or change over time. If our assumptions change or if actual circumstances differ from our assumptions, our operating results may be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of New Parent common stock.

Risks Related to Being a Public Company

We will incur increased costs and become subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business.

As a public company, we will incur significant legal, accounting, and other expenses that we have not incurred as a private company, including costs associated with public company reporting requirements. We also have incurred and will continue to incur costs associated with the Sarbanes-Oxley Act, and related rules implemented by the Commission and Nasdaq. The expenses generally incurred by public companies for reporting and corporate governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. These laws and regulations also could make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability

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insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on our board committees, or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of New Parent common stock, fines, sanctions, other regulatory action, and potentially civil litigation.

In addition, as a public company we will be required to incur additional costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, beginning with our second annual report on Form 10-K after we become a public company, we will be required to make a formal assessment of the effectiveness of our internal control over financial reporting, and once we cease to be an emerging growth company or a smaller reporting company, we will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaging in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting.

The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation to meet the detailed standards under the rules. During the course of its testing, our management may identify material weaknesses or deficiencies which may not be remedied in time to meet the deadline imposed by the Sarbanes- Oxley Act. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls, we may not be able to produce timely and accurate financial statements. If that were to happen, the market price of our stock could decline and we could be subject to sanctions or investigations by the stock exchange on which New Parent common stock is listed, the Commission or other regulatory authorities.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Upon the completion of the Business Combination, we will become subject to the periodic reporting requirements of the Exchange Act. We must design our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Commission. Any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement causing us to fail to make a required related party transaction disclosure. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

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We are an “emerging growth company” and a “smaller reporting company” and we cannot be certain if the reduced disclosure requirements applicable to us will make New Parent common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition, as an “emerging growth company” the JOBS Act allows us to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. We have elected to use this extended transition period under the JOBS Act. As a result, our financial statements and interim financial statements may not be comparable to issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make comparison of our financials to those of other public companies more difficult. To the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, we will continue to be permitted to make certain of the same reduced disclosures in our periodic reports and other documents that we file with the Commission. We cannot predict if investors will find New Parent common stock less attractive because we will rely on these exemptions. If some investors do find New Parent common stock less attractive, there may be a less active trading market for New Parent common stock and our stock price may be more volatile or may decline.

We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of our initial public offering, (2) the last day of the fiscal year in which we have total annual revenue of more than $1.235 billion, (3) the date on which we are deemed to be a large accelerated filer, which means the market value of New Parent common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We will remain a smaller reporting company for so long as the market value of our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter.

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against companies following a decline in the market price of its securities. This risk is especially relevant for us because medical technology companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of New Parent common stock.

If, after listing, we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist New Parent common stock. Such a delisting would likely have a negative effect on the price of New Parent common stock and would impair your ability to sell or purchase New Parent common stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing

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requirements would allow New Parent common stock to become listed again, stabilize the market price or improve the liquidity of New Parent common stock, prevent New Parent common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with the listing requirements of Nasdaq.

Risks Related to Our Corporate Structure and Ownership

We expect to be a “controlled company” within the meaning of the Nasdaq corporate governance standards and would qualify for exemptions from certain corporate governance requirements.

Because Accelmed will own a majority of our outstanding common stock following the completion of the Business Combination, we expect to be a “controlled company” as that term is set forth in the Nasdaq corporate governance standards. Under these rules, a company of which more than 50% of the voting power is held by another person or group of persons acting together is a “controlled company” and may elect not to comply with certain corporate governance requirements, including:

These requirements will not apply to us as long as we remain a “controlled company.” As a result, you may not have the same protections afforded to stockholders of companies that are subject to all of the Nasdaq corporate governance requirements. Accelmed’s significant ownership interest could adversely affect investors’ perceptions of our corporate governance.

After the Business Combination, our principal stockholders and management will own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.

As of July 31, 2023, our executive officers, directors and 10% stockholders beneficially owned approximately 85% of the outstanding shares of Keystone common stock, and, as of the effective time of the Business Combination, that same group will hold approximately 68% of the outstanding shares of New Parent common stock. Therefore, even after the Business Combination, these stockholders will have the ability to influence us through this ownership position.

If the ownership of New Parent common stock continues to be highly concentrated, it may prevent minority stockholders from influencing significant corporate decisions and may result in conflicts of interest.

Following the completion of the Business Combination, Accelmed will own approximately 60% of our outstanding common stock. As a result, Accelmed will own shares sufficient for the majority vote over all matters requiring a stockholder vote, including the election of directors; Business Combinations, consolidations and acquisitions; the sale of all or substantially all of our assets and other decisions affecting our capital structure; the amendment of our existing amended and restated certificate of incorporation and our existing bylaws; and our winding up and dissolution. This concentration of ownership may delay, deter or prevent acts that would be favored by our other stockholders. The interests of Accelmed may not always coincide with our interests or the interests of our other stockholders. This concentration of ownership may also have the effect of

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delaying, preventing or deterring a change in control. As a result, the market price of New Parent common stock could decline or stockholders might not receive a premium over the then-current market price of New Parent common stock upon a change in control. In addition, this concentration of share ownership may adversely affect the trading price of New Parent common stock because investors may perceive disadvantages in owning shares in a company with significant stockholders.

Certain of our stockholders have the right to engage or invest in the same or similar businesses as us.

Accelmed has other investments and business activities in addition to their ownership of us. Accelmed has the right, and has no duty to abstain from exercising such right, to engage or invest in the same or similar businesses as us, do business with any of our customers or suppliers or employ or otherwise engage any of our officers, directors or employees. If Accelmed or any of its officers, directors or employees acquire knowledge of a potential transaction that could be a corporate opportunity, they have no duty, to the fullest extent permitted by law, to offer such corporate opportunity to us, our stockholders or our affiliates. This right could adversely impact our business, prospects, financial condition or results of operations if attractive business opportunities are procured by Accelmed or another party for their own benefit rather than for ours.

In the event that any of our directors and officers who is also a director, officer or employee of Accelmed acquires knowledge of a corporate opportunity or is offered a corporate opportunity, such person is deemed to have fully satisfied such person’s fiduciary duties owed to us and is not liable to us, to the fullest extent permitted by law, if Accelmed pursues or acquires the corporate opportunity or does not present the corporate opportunity to us, provided that this knowledge was not acquired solely in such person’s capacity as our director or officer and such person acts in good faith.

General Risks

Keystone’s insurance policies are expensive and protect it only from some business risks, which leaves it exposed to significant uninsured liabilities.

Keystone does not carry insurance for all categories of risk that its business may encounter. Although it has general and product liability insurance that it believes is appropriate, this insurance is subject to deductibles and coverage limitations. Keystone’s current product liability insurance may not continue to be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate to protect us against any future product liability claims. Similarly, it has limited insurance coverage regarding hazardous waste and cybersecurity events. If it is unable to obtain insurance at an acceptable cost or on acceptable terms or otherwise protect against potential product liability claims, it could be exposed to significant liabilities. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could negatively affect its business, financial condition and results of operations.

Keystone also expects that operating as a public company will make it more difficult and more expensive for it to obtain director and officer liability insurance, and it may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for it to attract and retain qualified people to serve on its board of directors, on its board committees or as executive officers. Keystone does not know, however, if it will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require it to pay substantial amounts, which would negatively affect its business, financial condition and results of operations.

Foreign currency exchange rates may adversely affect Keystone’s financial statements.

Sales and purchases in currencies other than the United States dollar expose Keystone to fluctuations in foreign currencies relative to the United States dollar and may adversely affect its financial statements. Increased strength of the United States dollar increases the effective price of Keystone’s products sold in United States

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dollars into other countries, which may require Keystone to lower its prices or adversely affect sales to the extent it does not increase local currency prices. Decreased strength of the United States dollar could adversely affect the cost of materials, products and services Keystone purchases overseas. Sales and expenses of its non-U.S. businesses are also translated into United States dollars for reporting purposes and the strengthening or weakening of the United States dollar could result in unfavorable translation effects. In addition, certain of our businesses may invoice customers in a currency other than the business’ functional currency, and movements in the invoiced currency relative to the functional currency could also result in unfavorable translation effects. Keystone also faces exchange rate risk from its investments in subsidiaries owned and operated in foreign countries.

Keystone is subject to a variety of litigation and other legal and regulatory proceedings in the course of its business that could adversely affect its business and financial statements.

Keystone is subject to a variety of litigation and other legal and regulatory proceedings incidental to our business (or the business operations of previously owned entities), including claims or counterclaims for damages arising out of the use of products or services and claims relating to intellectual property matters, employment matters, tax matters, commercial disputes, breach of contract claims, competition and sales and trading practices, environmental matters, personal injury, insurance coverage and acquisition-related matters, as well as regulatory subpoenas, requests for information, investigations and enforcement. Keystone may also become subject to lawsuits as a result of past or future acquisitions or as a result of liabilities retained from, or representations, warranties or indemnities provided in connection with, businesses divested by us or our predecessors. The types of claims made in lawsuits include claims for compensatory damages, punitive and consequential damages (and in some cases, treble damages) and/or injunctive relief. The defense of these lawsuits may divert Keystone’s management’s attention, Keystone may incur significant expenses in defending these lawsuits, and it may be required to pay damage awards or settlements or become subject to equitable remedies that could adversely affect its operations and financial statements. Moreover, any insurance or indemnification rights that it may have may be insufficient or unavailable to protect it against such losses. In addition, developments in proceedings in any given period may require Keystone to adjust the loss contingency estimates that it has recorded in its financial statements, record estimates for liabilities or assets previously not susceptible of reasonable estimates or pay cash settlements or judgments. Any of these developments could adversely affect Keystone’s financial statements in any particular period. Keystone cannot assure you that its liabilities in connection with litigation and other legal and regulatory proceedings will not exceed its estimates or adversely affect its financial statements and business. However, based on our experience, current information and applicable law, Keystone does not believe that it is reasonably possible that any amounts it may be required to pay in connection with litigation and other legal and regulatory proceedings in excess of its reserves as of the date of this prospectus will have a material effect on its financial statements.

Keystone’s operations, products and services expose it to the risk of environmental, health and safety liabilities, costs and violations that could adversely affect its business, reputation and financial statements.

Keystone’s operations, products and services are subject to environmental laws and regulations, which impose limitations on the discharge of pollutants into the environment, establish standards for the use, generation, treatment, storage and disposal of hazardous and non-hazardous wastes and impose end-of-life disposal and take- back programs. Keystone must also comply with various health and safety regulations in the United States and abroad in connection with our operations. It cannot assure you that our environmental, health and safety compliance program (or the compliance programs of businesses we acquire) have been or will at all times be effective. Failure to comply with any of these laws could result in civil and criminal, monetary and non-monetary penalties and damage to our reputation. In addition, Keystone cannot provide assurance that its costs of complying with current or future environmental protection and health and safety laws will not exceed its estimates or adversely affect its financial statements.

In addition, Keystone may incur costs related to remedial efforts or alleged environmental damage associated with past or current waste disposal practices or other hazardous materials handling practices. Keystone

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is also from time to time party to personal injury, property damage or other claims brought by private parties alleging injury or damage due to the presence of or exposure to hazardous substances. It may also become subject to additional remedial, compliance or personal injury costs due to future events such as changes in existing laws or regulations, changes in agency direction or enforcement policies, developments in remediation technologies, changes in the conduct of our operations and changes in accounting rules. Keystone cannot assure you that its liabilities arising from past or future releases of, or exposures to, hazardous substances will not exceed its estimates or adversely affect its reputation and financial statements or that it will not be subject to additional claims for personal injury or remediation in the future based on its past, present or future business activities. However, based on the information it currently has, Keystone does not believe that it is reasonably possible that any amounts it may be required to pay in connection with environmental matters in excess of its reserves as of the date of this prospectus will have a material effect on its financial statements.

Changes in governmental regulations may reduce demand for Keystone’s products or services or increase its expenses.

Keystone competes in markets in which it and its customers must comply with supranational, federal, state, local and other jurisdictional regulations, such as regulations governing health and safety, the environment, food and drugs and privacy. Keystone develops, configures and markets its products and services to meet customer needs created by these regulations. These regulations are complex, change frequently, have tended to become more stringent over time and may be inconsistent across jurisdictions. Any significant change in any of these regulations (or in the interpretation or application thereof) could reduce demand for, increase Keystone’s costs of producing or delay the introduction of new or modified products and services, or could restrict its existing activities, products and services.

International economic, political, legal, compliance and business factors could negatively affect Keystone’s financial statements.

For the year ended December 31, 2022, approximately 28% of Keystone’s sales were derived from customers outside the United States. In addition, many of its manufacturing operations, suppliers and employees are located outside the United States. Since Keystone’s growth strategy depends in part on its ability to further penetrate markets outside the United States and increase the localization of its products and services, Keystone expects to continue to increase its sales and presence outside the United States, particularly in the high-growth markets. Its international business (and particularly its business in high growth markets) is subject to risks that are customarily encountered in non-U.S. operations, including:

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Any of these risks could negatively affect Keystone’s financial statements, business, growth rate, competitive position, results of operations and financial condition.

The ongoing military conflict between Russia and Ukraine could adversely affect Keystone’s financial condition and results of operations.

On February 24, 2022, Russian military forces commenced military operations in Ukraine. The military conflict has continued since then and sustained conflict and disruption in the region is likely. Although the length, impact and outcome of the ongoing military conflict is highly unpredictable, the conflict could lead to significant market and other disruptions, including significant volatility in commodity prices and supply of resources, resulting in increases in the cost of shipping and transportation, instability in financial markets, supply chain interruptions, political and social instability and changes in consumer or purchaser preferences. Russia’s military action against Ukraine has led to an unprecedented expansion of sanction programs imposed by the United States, the European Union, the United Kingdom, Canada, Switzerland, Japan and other countries against Russia, Belarus, the Crimea Region of Ukraine, the so-called Donetsk People’s Republic and the so-called Luhansk People’s Republic.

We are actively monitoring the military conflict and will continue to assess any impact it may have on Keystone’s financial condition and results of operations. Revenues from sales of Keystone’s products in Russia were $744,267 and $997,113 for the years ended December 31, 2021 and 2022, respectively, and $482,563 for the six-months ended June 30, 3023. Although the conflict has not yet had any impact on Keystone’s operations and sales in Russia through our distributors there, Keystone has no way to predict the progress or outcome of the conflict or its impacts in Russia, as the conflict and any resulting government reactions are rapidly developing and beyond Keystone’s control. The extent and duration of the military action, sanctions and resulting market disruptions could be significant and could potentially have substantial impact on the global economy and Keystone’s business for an unknown period of time. Any of the abovementioned factors could have a material adverse effect on Keystone’s financial condition and results of operations.

Political, economic and military instability in Israel may impede Keystone’s ability to operate and harm its financial results.

A large portion of Keystone’s products are manufactured in Israel. Accordingly, political, economic, and military conditions in Israel and the surrounding region may directly affect its business and operations. In recent years, Israel has been engaged in sporadic armed conflicts with various militant groups and state actors, including Iran and Syria. In addition, Iran has threatened to attack Israel and may be developing nuclear weapons. Some of these hostilities were accompanied by missiles being fired from the Gaza Strip against civilian targets in various parts of Israel, including areas in which our employees and some of our manufacturers are located, and negatively affected business conditions in Israel. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations.

Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, Keystone cannot assure you that this government coverage will be maintained or that it will sufficiently cover Keystone’s potential damages. Any losses or damages incurred by keystone could have a material adverse effect on its business. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm its results of operations.

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Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on Keystone’s operating results, financial condition or the expansion of its business. A campaign of boycotts, divestment and sanctions has been undertaken against Israel, which could also adversely impact Keystone’s business.

In addition, many Israeli citizens are obligated to perform several days, and in some cases more, of annual military reserve duty each year until they reach the age of 40 (or older, for reservists who are military officers or who have certain occupations) and, in the event of a military conflict, may be called to active duty. In response to increases in terrorist activity, there have been periods of significant call-ups of military reservists. It is possible that there will be military reserve duty call-ups in the future. Keystone’s operations could be disrupted by such call-ups, which may include the call-up of employees key to production and manufacturing of our products. Such disruption could materially adversely affect Keystone’s business, prospects, financial condition and results of operations.

If Keystone suffers loss to its facilities, supply chains, distribution systems or information technology systems due to catastrophe or other events, its operations could be seriously harmed.

Keystone’s facilities, supply chains, distribution systems and information technology systems are subject to catastrophic loss due to fire, flood, earthquake, hurricane, public health crisis, war, terrorism or other natural or man-made disasters. If any of these facilities, supply chains or systems were to experience a catastrophic loss, it could disrupt Keystone’s operations, delay production and shipments, result in defective products or services, damage customer relationships and Keystone’s reputation and result in legal exposure and large repair or replacement expenses. The third-party insurance coverage that Keystone maintains will vary from time to time in both type and amount depending on cost, availability and our decisions regarding risk retention, and may be unavailable or insufficient to protect it against such losses.

Keystone’s ability to attract, develop and retain talented executives and other key employees is critical to its success.

Keystone’s future performance is dependent upon its ability to attract, motivate and retain executives and other key employees. The loss of services of executives and other key employees or the failure to attract, motivate and develop talented new executives or other key employees could prevent it from successfully implementing and executing business strategies, and therefore adversely affect its financial statements. Keystone’s success also depends on its ability to attract, develop and retain a talented employee base. Certain employees could leave it given uncertainties relating to the Business Combination, resulting in the inability to operate its business with employees possessing the appropriate expertise, which could have an adverse effect on Keystone’s performance.

Keystone depends on key personnel.

Keystone’s success depends to a significant degree upon the contributions of certain key personnel that would be difficult to replace. If any of its key personnel were to cease employment with Keystone, Keystone’s operating results could suffer. Further, the process of attracting and retaining suitable replacements for key personnel whose services it may lose would result in transition costs and would divert the attention of other members of its senior management from its existing operations. The loss of services from key personnel or a limitation in their availability could materially and adversely impact Keystone’s business, prospects, liquidity, financial condition, and results of operations. Further, such a loss could be negatively perceived in the capital markets. Keystone has not obtained and does not expect to obtain key person life insurance that would provide it with proceeds in the event of death or disability of any of our key personnel.

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Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws, as well as Delaware law, could discourage a change in control of New Parent or a change in our management.

Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws will contain, and Delaware law contains, provisions that might discourage, delay or prevent a Business Combination, acquisition, or other change in control that stockholders may consider favorable, including Business Combination in which you might otherwise receive a premium for your shares of New Parent common stock. These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. These provisions include:

These provisions might discourage, delay or prevent a change in control of New Parent or a change in our management. For example, because Accelmed will own a majority of the voting power of New Parent common stock upon the completion of the Business Combination, it could prevent a third party from acquiring us, even if the third party’s offer may be considered beneficial by many of our stockholders. The existence of these provisions could adversely affect the voting power of holders of common stock and limit the price that investors might be willing to pay in the future for shares of New Parent common stock

Risks Related to Check-Cap

If Check-Cap does not complete the Business Combination in a timely manner or at all, its board of directors may decide to pursue its dissolution and liquidation. In such an event, the amount of cash available for distribution to its shareholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

There can be no guarantee that Check-Cap will complete the Business Combination in a timely manner or at all. If no transaction is completed, the Check-Cap board may decide that it is in the best interest of its shareholders to dissolve the company and liquidate its assets. In that event, the amount of cash available for distribution to its shareholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution continues to decrease as Check-Cap funds its operations and transaction expenses. In addition, Check-Cap may be subject to litigation or other claims related to its dissolution and liquidation. Accordingly, holders of Check-Cap ordinary shares could lose all or a significant portion of their investment in the event of a dissolution, liquidation or winding up of Check-Cap.

Check-Cap is substantially dependent on its remaining employees to facilitate the consummation of a strategic transaction. Check-Cap could lose such key employees.

As part of its cash conservation activities, Check-Cap implemented a 90% reduction in workforce plan. Check-Cap’s ability to successfully complete the Business Combination depends in large part on its ability to retain certain personnel, particularly Alex Ovadia, its Chief Executive Officer, and Mira Rosenzweig, its Chief Financial Officer. Despite Check-Cap’s efforts to retain these employees, one or more may terminate their employment on short notice. The loss of the services of any of these employees could potentially harm Check-Cap’s ability to complete the Business Combination, run its day-to-day business operations as well as fulfill its reporting obligations as a public company.

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If the Business Combination is not completed, and Check-Cap does not pursue an alternative strategic option or liquidation, Check-Cap expects that it will require significant additional funding in order to complete the development, scale up manufacturing and commercialization of C-Scan. If additional capital is not available, Check-Cap may have to cease operations.

Check-Cap is a clinical and development-stage medical diagnostics company with a limited operating history. Check-Cap has incurred net losses in each fiscal year since it commenced operations in 2009. Check-Cap incurred net losses of $11.3 million in the first six months of 2023, $19.1 million in 2022, $17.2 million in 2021. As of June 30, 2023, Check-Cap’s accumulated deficit was $138.6 million. Check-Cap expects its losses to continue for the foreseeable future. If the Business Combination is not completed, and Check-Cap does not pursue an alternative strategic option or liquidation, Check-Cap expects that it will need to raise and spend substantial amounts in order to complete the clinical development, regulatory approval and commercialization of C-Scan. Check-Cap may seek additional funding through equity offerings, debt financings, collaborations, licensing arrangements or any other means to conduct clinical trials and develop, manufacture and market C-Scan or for our general corporate purposes. If adequate additional financing on acceptable terms is not available, Check-Cap may have to cease operations.

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INFORMATION ABOUT THE CHECK-CAP SHAREHOLDER MEETING

In order for the Israeli Merger to become effective, certain matters related to the Israeli Merger must be approved by the shareholders of Check-Cap at a general special meeting of Check-Cap’s shareholders.

The Check-Cap Shareholder Meeting

Pursuant to Section 320 of the Companies Law, Check-Cap will convene the Check-Cap Shareholder Meeting, to consider and approve the Check-Cap Shareholder Transaction Matters. The Check-Cap Shareholders Meeting will be held on ●], 2023 beginning at [●]:00 p.m., Israel time, [at the offices of Check-Cap’s Israeli legal counsel, [●], located at [●].

The Check-Cap board of directors has fixed the close of business on [●], [●] [●]], 2023, as the Check-Cap record date for determination of Check-Cap shareholders entitled to vote at the Check-Cap Shareholder Meeting. Accordingly, only holders of record of shares of Check-Cap ordinary shares at the close of business on [●] [●], 2023 will be entitled to vote at the Check-Cap Shareholder Meeting. Check-Cap shareholders are also entitled to notice of and to vote at the Check-Cap Shareholder Meeting if they held Check-Cap ordinary shares through a bank, broker or other nominee that is one of Check-Cap’s shareholders of record at the close of business on the record date, or which appeared in the participant listing of a securities depository on that date. Each holder of record of Check-Cap ordinary shares on the Check-Cap record date is entitled to cast one vote per share, in person or by a properly executed proxy, at the Check-Cap Shareholder Meeting. As of the Check-Cap record date, there were [●] Check-Cap ordinary shares outstanding and entitled to vote at the Check-Cap Shareholder Meeting.

Voting at the Check-Cap Shareholder Meeting

The presence, in person or by proxy, of two or more shareholders possessing at least 25% of Check-Cap’s voting power will constitute a quorum at the Check-Cap Shareholder Meeting. No business will be considered or determined at the Check-Cap Shareholder Meeting unless the requisite quorum is present within half an hour from the time designated for the meeting. In the absence of a quorum within 30 minutes of the scheduled time for the Check-Cap Shareholder Meeting, the meeting will be adjourned until the same day of the following week ([●], [●], 2023) at the same time and place. At such adjourned meeting, the presence of any two shareholders in person or by proxy will constitute a quorum.

Abstentions and broker non-votes will be considered present at the Check-Cap Shareholder Meeting for the purpose of calculating a quorum. Broker non-votes occur for a particular proposal when brokers that hold their customers’ shares in street name sign and submit proxies for such shares (in which case they are considered present for purposes of determining presence of a quorum at the Check-Cap Shareholder Meeting) but do not have the discretionary authority to vote on such particular proposal. This occurs when brokers have not received any voting instructions from their customers, in which case the brokers, as the holders of record, are permitted to vote on “routine” matters, but not on non-routine matters. All proposals to be voted on at the Check-Cap Shareholder Meeting are non-routine matters. Unsigned or unreturned proxies, including those not returned by banks, brokers, or other record holders, will not be counted for quorum or voting purposes.

Pursuant to the Check-Cap Articles of Association and Section 320 of the Companies Law, the affirmative vote of the holders of a majority of the Check-Cap ordinary shares present at the Check-Cap Shareholder Meeting (or any adjournment or postponement thereof), in person or by proxy, is required to approve and adopt the Check-Cap Shareholder Transaction Matters, excluding abstentions and broker non-votes and excluding any Check-Cap ordinary shares that are held by (a) New Parent, Keystone, Israeli Merger Sub or by any person holding, directly or indirectly, 25% or more of the voting power or the right to appoint 25% or more of the directors of New Parent, Keystone or Israeli Merger Sub, (b) a person or entity acting on behalf of New Parent, Keystone or Israeli Merger Sub or a person or entity described in clause (a) above, or (c) a family member of an

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individual contemplated by either of clause (a) or (b) above, or an entity controlled by, New Parent, Keystone, Israeli Merger Sub or any of the foregoing.

Forms of proxies of holders of Check-Cap ordinary shares for the Check-Cap Shareholder Meeting must be received by Check Cap’s transfer agent or at its registered office in Israel no later than forty-eight (48) hours prior to the designated time for the Check-Cap Shareholder Meeting, i.e., prior to [●], 2023, at [●]. Forms of proxies not so returned may be valid if handed to the chairman prior to the start of the Check-Cap Shareholder Meeting, at the discretion of the chairman. If a shareholder is a beneficial owner and holds it Check-Cap ordinary shares in “street name” through a bank, broker or other nominee on Nasdaq, such shareholder should instruct their bank, broker or other nominee of how they wish to vote its Check-Cap ordinary shares using the instructions provided by their bank, broker or other nominee. A shareholder may also vote in person at the Check-Cap Shareholder Meeting if it obtains a “legal proxy” from its bank, broker or other nominee. Under applicable stock exchange rules, such banks, brokers or other nominees have the discretion to vote on routine matters. The proposals to be considered at the Check-Cap Shareholder Meeting are non-routine matters, and such banks, brokers and other nominees cannot vote on these proposals without the shareholder instructions.

If a Check-Cap shareholder is a shareholder of record on the record date, it may change its vote at any time prior to the exercise of authority granted in the proxy by delivering a written notice of revocation to Check-Cap’s Chief Financial Officer, by granting a new proxy bearing a later date, or by attending the Check-Cap Shareholder Meeting and voting in person. Attendance at the Check-Cap Shareholder Meeting will not cause a shareholder’s previously granted proxy to be revoked unless such shareholder specifically so requests. If a Check-Cap shareholder’s ordinary shares are held in “street name,” it may change its vote by submitting new voting instructions to its broker, bank, trustee or nominee or, if it has obtained a legal proxy from its broker, bank, trustee or nominee giving them the right to vote their shares, by attending the Check-Cap Shareholder Meeting and voting in person.

Pursuant to Section 323 of the Companies Law, if the appropriate majority is obtained at the Check-Cap Shareholder Meeting in favor of the Israeli Merger, a minimum of 30 days must elapse from the date of the approval of the Israeli Merger by the shareholders of Check-Cap (and Israeli Merger Sub) before the Israeli Merger can become effective.

At the time of the Check-Cap Shareholder Meeting, holders of Check-Cap ordinary shares will not know the exact ownership percentage that they will be entitled to in New Parent.

Solicitation of Proxies

This prospectus, the Check-Cap proxy statement and its accompanying forms of proxy are being mailed by Check-Cap to Check-Cap shareholders in connection with the solicitation of proxies by Check-Cap for the Check-Cap Shareholders Meeting. The cost of soliciting proxies in the accompanying forms will be borne by Check-Cap. Check-Cap intends to retain an independent soliciting agent. Proxies may be solicited in person or by telephone or electronic communication by the directors, executive officers and employees of Check-Cap, who will not receive additional compensation for such activities.

Upon request and in accordance with customary U.S. practice, brokers, nominees and other similar record holders will be requested to forward proxy solicitation material to beneficial owners and, upon request and in accordance with customary practice, will be reimbursed by Check-Cap for their out-of-pocket expenses.

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THE BUSINESS COMBINATION

This section describes the Business Combination and the other transactions contemplated by the Business Combination Agreement. The description in this section and elsewhere in this prospectus is qualified in its entirety by reference to the complete text of the Business Combination Agreement, a copy of which is attached as Annex A to this prospectus. This summary does not purport to be complete and may not contain all of the information about the Business Combination and the other transactions contemplated by the Business Combination Agreement that is important to you. You are encouraged to read the Business Combination Agreement carefully and in its entirety. This section is not intended to provide you with any factual information about Keystone or Check-Cap. Such information can be found elsewhere in this prospectus and in the public filings Check-Cap makes with the Commission, as described in the section entitled “Where You Can Find Additional Information” beginning on page 323 of this prospectus.

The Parties

New Parent

New Parent was formed solely for the purpose of effectuating the Business Combination. Upon the closing of the Business Combination, New Parent will become the parent entity of both Keystone and Check-Cap. New Parent was incorporated as a Delaware corporation on July 31, 2023. New Parent has no material assets and does not operate any business. To date, New Parent has not conducted any activities other than those incidental to its formation, the execution of the Business Combination Agreement and the preparation of applicable filings under U.S. securities laws and regulatory filings made in connection with the Business Combination.

The principal executive offices of New Parent are located at 154 Middlesex Turnpike, Burlington, Massachusetts 01803.

Keystone

Keystone was incorporated in the State of Delaware in 2008. Keystone is a global commercial stage medical technology company focused on providing end-to-end solutions for dental practitioners and tooth replacement procedures. Its comprehensive portfolio of tooth replacement solutions is comprised of implants, prosthetic solutions, biomaterial solutions and digital dentistry capabilities. Keystone develops and offers technologies it believes are effective and advanced technologies for dental practitioners, dental laboratories and patients at an attractive price, driving significant value to both practitioners and patients. Keystone believes its products offer strong value proposition for dental practitioners through its innovative products with high quality manufacturing and design at various pricing options. Keystone has premium and high touch customer service with an experienced direct sales force and third-party distributors, simplifying a complex procedure through the digitalization of workflow for multiple clinical indications. Based on Keystone’s estimates, it believes its digital capabilities for dental practices have the potential to reduce the number of office visits and decrease patient chair time per procedure. Keystone’s various brands, including Genesis, Prima, Paltop, Molaris, Dyna, and Nexus iOS, are widely known amongst dental practitioners.

The principal executive offices of Keystone are located at 154 Middlesex Turnpike, Burlington, Massachusetts 01803.

Check-Cap

Check-Cap was formed under the laws of the State of Israel in 2009. 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 cancer to enable early intervention and

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cancer prevention. Check-Cap has generated significant losses to date, and it expects to continue to generate losses as it continues to explore strategic alternatives focused on maximizing stockholder value.

The principal executive offices of Check-Cap are located at 29 Abba Hushi Avenue, Isfiya, 3009000, Israel.

U.S. Merger Sub

U.S. Merger Sub is a wholly-owned subsidiary of New Parent formed solely for the purpose of effectuating the Business Combination. U.S. Merger Sub was incorporated as a Delaware corporation on July 31, 2023. U.S. Merger Sub has no material assets and does not operate any business. To date, U.S. Merger Sub has not conducted any activities other than those incidental to its formation and the execution of the Business Combination Agreement. After the consummation of the Business Combination, it will cease to exist.

The principal executive offices of U.S. Merger Sub are located at 154 Middlesex Turnpike, Burlington, Massachusetts 01803.

Israel Merger Sub

Israel Merger Sub is a wholly-owned subsidiary of New Parent formed solely for the purpose of effectuating the Business Combination. Israel Merger Sub was organized as a company under the laws of the State of Israel on July 30, 2023. Israel Merger Sub has no material assets and does not operate any business. To date, Israel Merger Sub has not conducted any activities other than those incidental to its formation and the execution of the Business Combination Agreement. After the consummation of the Business Combination, it will cease to exist.

The mailing address of Israel Merger Sub’s registered office is 98 Yigal Alon Street, Tel Aviv 67891, Israel.

The Business Combination

In accordance with the Business Combination Agreement, U.S. Merger Sub will merge with and into Keystone pursuant to the U.S. Merger, with Keystone surviving as a wholly-owned subsidiary of New Parent, and Israel Merger Sub will merge with and into Check-Cap pursuant to the Israeli Merger, with Check-Cap surviving as a wholly-owned subsidiary of New Parent. Check-Cap, as a wholly owned subsidiary of New Parent, will maintain a registered office in the State of Israel. The U.S. Merger will become effective upon the filing of a certificate of merger with the Secretary of State of the State of Delaware executed in accordance with, and in such form as is required by, the relevant provisions of the DGCL, and the Israeli Merger will become effective upon the issuance by the Israeli Companies Registrar of the Certificate of Merger for the Israeli Merger in accordance with Section 323(5) of the Companies Law.

Background of the Business Combination

Overview

Check-Cap is a clinical stage medical diagnostics company engaged in the development of C-Scan^®, a screening test to detect polyps before they may transform into colorectal cancer (CRC). Check-Cap’s Board (“Board”) and executive management regularly review Check-Cap’s operating and strategic plans, both near-term and long-term, in an effort to enhance shareholder value. This review has included consideration of equity financings and strategic transactions, and engaging in discussions with potential strategic partners and investors.

In March, 2023, Check-Cap announced that its most recent efficacy results from its calibration studies did not meet the goal in order to proceed to the powered portion of the U.S. pivotal study for C-Scan, its main product. In June, 2023, after further review of additional data and interaction with the FDA on a revised pivotal study protocol together with consideration of the anticipated time and investment necessary to further develop

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the technology, Check-Cap’s Board determined to pursue strategic options. At such time, Check-Cap’s Board also approved a reduction in its workforce by approximately 90 percent, to reduce its cash burn. In light of these developments, Check-Cap discontinued the calibration studies and determined not to commence the powered portion of its U.S. pivotal study, and to concentrate its resources on its essential research activities and strategic alternatives.

Following the March 2023 announcement regarding the efficacy results from its calibration studies, Check-Cap’s Board commenced a review of strategic alternatives. As part of that review, Check-Cap’s Board considered and evaluated options for enhancing shareholder value. Recognizing that in light of the C-Scan calibration studies’ internal assessment, enhancing shareholder value as a stand-alone entity would be extremely challenging and uncertain, Check-Cap’s Board determined to explore various suitable alternatives, including but not limited to a business combination transaction.

Accordingly, during the second and third quarters of 2023, Check-Cap’s Board conducted a number of discussions with several potential targets concerning an acquisition of, combination with, or investment in, another company or technology, which, upon consummation, would provide Check-Cap with new, active operations. The Check-Cap Board also established a strategic transaction sub-committee comprised of four board members (Mr. Steven Hanley, the Check-Cap Board Chairman, as well as Ms. Clara Ezed, Dr. Mary Jo Gorman, and Mr. Yuval Yanai), which consulted with Check-Cap’s Chief Executive Officer and Chief Financial Officer when appropriate. As part of this initiative, Check-Cap’s Board also began working with Ladenburg as its primary financial advisor to assist the Check-Cap Board in, among other things, identifying and evaluating potential targets. Over the course of this process, Check-Cap’s Board, together with its financial advisor, contacted a total of 150 potential target companies for a proposed merger or acquisition, which were identified based on certain key characteristics that Check-Cap’s Board sought in a target company: (i) favorable technology in an investment-attractive space; (ii) management with strong records in initial public offerings and merger transactions; (iii) investors and/or strategic partners that have the experience and capability of developing products and bringing them to market; and (iv) the potential for achieving a significant return on investment for Check-Cap’s shareholders over the next two to three years based on multiple inflection points and with little remaining regulatory risk to limit the downside of the investment. In general, the potential target companies were private companies at various stages of development that operate in the medical device, pharma or biotechnology industries, similar to the industry in which Check-Cap had operated, and for which Check-Cap’ Board had the optimal experience for selection and evaluation.

The following chronology sets forth a summary of the material events leading up to the execution of the Business Combination Agreement (“BCA”) with Keystone. In addition, throughout the chronology of developments described below, prior to and in between formal Check-Cap Board meetings, the Chairman of the Check-Cap Board, Mr. Hanley and the other members of the strategic transaction sub-committee, updated all of Check-Cap’s Board members on a frequent basis as to the nature and extent of such developments. During this time, Mr. Hanley and Mr. Yanai also continued to engage from time to time in preliminary discussions with third parties concerning potential transactions, although, ultimately, no such discussions advanced beyond preliminary stages. No alternative transaction was identified that was believed by the Check-Cap Board, based on the criteria identified above, to be as attractive to Check-Cap and its shareholders as the proposed transaction with Keystone.

Evaluation of Check-Cap’s Technology and Action Plan

In May 2022, Check-Cap initiated the first part of the U.S. pivotal study of C-Scan, which focused on device calibration and enhancement of C-Scan algorithms among the average risk U.S. population. In parallel, to support the calibration portion of the U.S. pivotal study, Check-Cap continued enrolling average risk patients in its study in Israel. Throughout the study, until March 2023, Check-Cap enrolled more than 300 average risk patients as part of its Israeli study, but only 17 average risk patients in the first part of its U.S. pivotal study. The slower than expected U.S. site recruitment pace was primarily due to state licensing requirements associated with the X-ray technology with a radioactive source within Check-Cap’s C-Scan capsule. While prior C-Scan trial

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performance was based on an enriched population (i.e., subjects with known polyps), the later calibration studies’ target was intended to optimize the C-Scan device for the average risk population prior to commencing the powered portion of the U.S. pivotal study, which aimed to demonstrate C-Scan performance in a statistically significant manner for average risk subjects. The initiation of the powered portion of the U.S. pivotal study was dependent upon successful completion of the Israeli calibration study, as well as the calibration portion of the U.S. pivotal study.

In March 2023, Check-Cap announced that its most recent efficacy results from its calibration studies did not meet the goal in order to proceed to the powered portion of the U.S. pivotal study. Though additional data was expected for additional subjects for C-Scan as well as the corresponding colonoscopy, the time to obtain this data was determined to be longer than expected in the original plan. Consequently, the Check-Cap Board requested that management prepare and present to the Check-Cap Board a plan of action intended to evaluate technology viability. In addition, the Check- Cap Board and management determined to review the most currently available data from past and committed subjects, and to consult with several medical experts to determine if updating algorithms or making other modifications to the study parameters could make the technology viable.

On March 13, 2023, the Check-Cap Board held a meeting in which the Chief Executive Officer of Check-Cap, Mr. Ovadia, advised the Board that following the Board’s request that management present an action plan, management had conducted internal discussions and assessments and prepared three proposed recommendations: (i) Plan A – C-Scan performance validation, to provide a possible path to quantitative validation of C-Scan performance; (ii) Plan B — pivots derived from C-Scan technology, to provide several options to expand Check-Cap’s product portfolio based on its existing intellectual property; and (iii) combined plan – an intermediate option combining aspects of both plans. Following discussion, the Board determined that the potential C-Scan technology pivots relating to other gastro-intestinal applications did not have sufficient clinical evidence to suggest that they were worthy of the necessary substantial investment. The product differentiation and patient and physician benefit were not sufficiently supported to determine that such option would be viable. Accordingly, both Plan B and the combined plan were determined to be too high a risk with insufficient data for investment. It was further determined that it would be appropriate to conduct additional analysis on the existing data and conduct a limited number of additional studies and to retrieve the additional colonoscopy data on past subjects to make a determination if such data would allow Check-Cap to achieve a new end point which would be acceptable to the FDA and still be commercially viable and cost effective. Plan A also involved the continuation of the C-Scan algorithm development relating to the post processing of the data with the goal of improving the results in a manner that would make the product viable. Based on the foregoing considerations, the Board determined to pursue Plan A.

On the same day, a call was held between several members of the Check-Cap Board and management and Ms. Janice Hogan of Hogan Lovells, Check-Cap’s regulatory advisor, to obtain feedback from Ms. Hogan on possible endpoints for C-Scan that could be acceptable to the FDA and their implications. During this call, Mr. Ovadia informed Ms. Hogan that following internal evaluation of results from calibration clinical studies to date, Check-Cap had concluded that C-Scan would likely not achieve the efficacy performance that was previously agreed with the FDA. Ms. Hogan discussed several possible options for Check-Cap to approach the FDA, but was uncertain if these approaches would be successful.

In addition to several internal discussions led by Dr. Mary Jo Gorman, on March 14, 2023, the Check-Cap Board held a meeting with Dr. Jeff Kreikemeier, a private U.S. gastroenterologist who was recruited as a consultant to Check-Cap, regarding the changes proposed to the U.S. pivotal study endpoints. Dr. Kreikemeier provided advice and feedback on the latest practices and the impact of detection of certain polyps sizes on the future use of C-Scan, as well as his understanding of the upcoming technology, including blood biopsies and new stool tests. 

On March 15, 2023, Check-Cap’s Board held a meeting in which Dr. Aasma Shaukat and Dr. Seth Gross of New York University, Coordinating Principal Investigator (CPI) and Principal Investigator (PI) for the U.S.

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pivotal study, respectively, provided their input regarding Check-Cap’s potential plans, as presented to the Board at the meeting held on March 13, 2023. Dr. Shaukat and Dr. Gross commented primarily on the impact of proposed changes to the endpoints for the U.S. pivotal study that were being considered.

On March 21, 2023, Check-Cap announced in an update to its shareholders that following its internal assessment of the clinical data collected from its calibration studies, Check-Cap had determined that the efficacy results did not meet their goal in order to proceed to the powered portion of the U.S. pivotal study. As a result, Check-Cap adopted a plan of action (Plan A) that included conducting additional clinical data analysis and approaching the FDA to make amendments to the U.S. pivotal study protocol that were expected to be part of an IDE supplemental submission to the FDA, and which would be subject to FDA approval. In addition, Check-Cap planned to continue conducting its calibration studies, albeit at a slower pace, to collect additional clinical data and also to implement a cost reduction plan, in order to extend its cash runway. In addition, Check-Cap announced that the initiation of the powered portion of the U.S. pivotal study that was expected in mid-2023 was being postponed. Check-Cap also targeted achieving formal feedback from the FDA to better understand alternative approval options while continuing to enroll subjects both in Israel and the United States, though also at a slower pace. These efforts would continue as additional strategic options for Check-Cap were developed.

Reverse Triangular Merger Transaction

On April 6, 2023, Check-Cap’s Board held a meeting in which it considered three primary strategic options for Check-Cap: (i) continued investment in the development of C-Scan; (ii) liquidation and distribution of Check-Cap’s cash to its shareholders; and (iii) a reverse triangular merger transaction, which was understood to be the most common “reverse merger” structure, and the structure most likely to enable Check-Cap to maintain its Nasdaq listing and to achieve maximum valuation for Check-Cap in a potential business combination transaction. The Board discussed Check-Cap’s strategic options and potential reverse merger scenarios with David Strupp, a managing partner at Ladenburg. Mr. Strupp stated that in recent transactions conducted by Ladenburg, the average value for a public company in a reverse triangular merger was between $12-13 million above the cash value, which premium would not be achievable in a liquidation scenario. Mr. Strupp stated that he expected Ladenburg to receive numerous competitive bids for a reverse triangular merger with Check-Cap. Mr. Strupp noted that the then current market environment was hostile for initial public offerings and that challenges in using a SPAC structure had made the value of a reverse triangular merger higher at that time. Mr. Strupp described the timeline and process for a reverse triangular merger.

On April 11, 2023, Check-Cap’s Board held a meeting to continue the discussion following the presentation by Mr. Strupp of Ladenburg at the meeting of the Board held on April 6, 2023, regarding Check-Cap’s strategic alternatives to create the highest shareholder value, including the possibility of liquidating and returning cash to the shareholders, as well as an analysis of options related to a merger with another company. In addition, the Board discussed the engagement proposal submitted by Ladenburg. Members of the Board expressed their opinion that Ladenburg is a very experienced firm and has a strong reputation in merger transactions, and several Board members stated that they had a positive experience with Ladenburg and particularly with Mr. Strupp. Following discussion, the Check-Cap Board agreed that Check-Cap would research and make contact with other potential advisors, in order to obtain additional perspectives regarding Ladenburg’s proposal as compared to other options.

On April 18, 2023, Check-Cap’s Board held a meeting to discuss and approve the engagement of an investment bank to provide advisory services to Check-Cap in a potential transaction being explored by the Board as an alternative to the C-Scan technology, if such technology was ultimately determined by the Board not to be viable. Mr. Hanley stated that the Board was continuing to explore its options to create the highest shareholder value by understanding potential strategic transactions, including a potential reverse triangular merger with Check-Cap. Mr. Hanley and Mr. Yanai stated that they had approached several investment banks regarding the provision of advisory services to Check-Cap and presented the proposals they received from such investment banks. After reviewing these proposals, and each advisors’ estimated pricing and experience with

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reverse merger transactions, it was determined that Ladenburg had a higher level of experience with this particular type of transaction, and offered the best value and the highest likelihood for success, to assure the optimal outcome to shareholders. After discussion, the Board approved the engagement of Ladenburg. 

On April 24, 2023, the Check-Cap Board held a meeting during which Mr. Ovadia, the CEO, reviewed the latest data from incoming results from previously completed patients. In addition, Mr. Ovadia reported that management was working closely with Ms. Hogan to formally present alternative approaches to the FDA through the FDA’s interactive Sprint methodology (available for companies with Breakthrough Device designation). The Sprint methodology permits qualified companies to ask questions and request feedback from the FDA within a pre-determined response time of 45 days. As part of this process, Check-Cap sought FDA guidance with respect to several alternative approaches with respect to both technology and study design (which would, among other things, allow for the recruitment of additional subjects). Check-Cap also wanted the FDA’s view on the proposed overall sample size of the study, which would have a large impact on timing and cost, as well as feedback on the FDA’s openness to increasing the size of the polyps targeted in the endpoint, which would make it easier for the device to achieve its endpoint with the current design. Check-Cap formally submitted a Sprint request to the FDA in late April 2023 with an expected response in early June. The Check-Cap Board also continued to work in parallel with regulatory experts to determine whether additional data and FDA insight might provide a path forward for investment or at least increase the value of Check-Cap’s assets for monetization if further investment was not determined to be best for Check-Cap’s shareholders.

In parallel to these activities, Check-Cap commenced a bidding process led by its financial advisor, Ladenburg. By early May, Ladenburg had contacted over 150 companies which fit the Check-Cap Board’s criteria for a target company, and by May 16, 2023, Check-Cap had received 42 formal non-binding proposals; these proposals contained, among other things, proposed transaction structures, as well as estimates of each such companies’ valuations, and the percentage ownership that the current Check-Cap shareholders would own in the combined company as a result of the proposed transaction.

On May 18, 2023, the Check-Cap strategic transaction sub-committee held a meeting and discussed the key issues, timing and obligations related to a potential strategic transaction by Check-Cap, including a reverse triangular merger. Mr. Hanley advised the Check-Cap sub-committee that over 40 proposals had been received, and that Check-Cap was working with Ladenburg to review and analyze these proposals. 

On May 23, 2023, the subcommittee met to discuss the pros and cons of each of the proposals received. Among other things, the sub-committee considered the commercial potential, market size, regulatory risk, valuation, financial strength, management and board experience to determine which of these companies offered the best fit for a potential transaction with Check-Cap. After extensive discussions, the sub-committee identified six companies with which it determined to enter into further discussions and diligence and directed Ladenburg to arrange for presentations to be obtained from each of these six companies.

On May 30 and May 31, 2023 and June 1, 2023, the Check-Cap strategic transaction sub-committee met with and received presentations from each of these six participants, including Keystone. These presentations were from top management at each of the six companies and included financial forecasts, business and scientific reviews and justification on valuation and reasons for the reverse merger. No negotiations were undertaken with any of these companies during this time period.

On June 1, 2023, the Check-Cap sub-committee held another meeting to review Ladenburg’s analysis of the six reverse triangular merger candidates interviewed by the sub-committee. The members of the Check-Cap sub-committee expressed that all companies have viable products; however, the sub-committee concurred that the most promising candidates were four companies, including Keystone. Among other things, members of the sub-committee noted that these candidates have minimized their FDA regulatory and commercial risk, while maintaining a good cash position and a strong management team.

On June 3, 2023, Check-Cap received formal written feedback from the FDA regarding the proposed alternative approaches submitted by Check-Cap as part of the Sprint process. In its response, the FDA indicated,

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among other things, concern that increasing the size of the polyp to 10 mm and greater would not reflect the target population for which it is intended. In addition, the FDA stated that “the proposed lower bound sensitivity performance goal of .58 for polyps of at least 6 mm is not sensitive enough to allow C-Scan to be used prior to colonoscopy in patients who are otherwise good candidates for colonoscopy”. Further, the FDA provided feedback that the studies’ positive predictive value and negative predictive value should represent the intended use population and not the age enriched population, which was not a material issue but could impact the marketing of the product. Lastly, the FDA rejected Check-Cap’s proposal to use a 1-sided 95% confidence interval hypothesis test and recommended that the performance goal be compared to the lower limit of the two-sided confidence interval; a 1-sided 95% confidence interval method would have reduced the number of subjects needed in the pivotal study. The FDA feedback validated the Check-Cap board’s view that there would be a high level of risk in achieving the performance goal with the C-Scan system. The feedback also confirmed that regardless of system performance, there would be a significant increase in pivotal study execution timing and cost for the system to achieve FDA approval. The Check- Cap board’s view of the FDA’s feedback was that the current design and algorithm were not performing at a level to achieve the required higher performance and therefore additional capital, time, and research were needed with a high level of risk to achieve the goal. In addition, the higher sensitivity goal would further increase the size and cost of a future proposed pivotal study. On June 5, 2023, Check-Cap’s management held a conference call with the FDA to confirm the FDA’s position.

On June 6, 2023, Check-Cap announced that after further review of additional data and interaction with the FDA on a revised pivotal study protocol, together with the anticipated time and investment necessary to further develop the technology, the Check-Cap Board had determined that it was appropriate to pursue strategic options. In addition, the Check-Cap Board approved a reduction in Check-Cap’s workforce by approximately 90 percent, to reduce its cash burn, after which Check-Cap expected to have eight to nine remaining employees. In light of these developments, Check-Cap discontinued the calibration studies and did not commence the powered portion of its U.S. pivotal study and concentrated its resources on its essential research activities and strategic alternatives.

Subsequently, at the direction of the sub-committee, Ladenburg prepared and delivered non-binding term sheets to each of the four companies, including Keystone, identified at the June 1 sub-committee meeting.

By June 12, 2023, Check-Cap had received a counter-term sheet from each of the four companies, including Keystone. Between June 12 and June 15, 2023 representatives of Check-Cap and such companies, including Keystone, exchanged drafts of non-binding term sheets. While the proposed changes differed from term sheet to term sheet, they primarily focused on relative valuations, net cash requirements and other closing conditions, and the treatment of legacy assets.

During this time, the Check-Cap strategic transaction sub-committee held several diligence meetings with physicians and healthcare contacts to understand the value propositions of the top four companies, including analysis of the regulatory and market adoption risks associated with these companies, each of which were either commercial or pre-commercial medtech companies. The sub-committee also evaluated the experience and track record of the management of the prospective companies.

At a meeting held on June 15, 2023, the Check-Cap strategic transaction sub-committee, with the help of Ladenburg, voted and ranked the remaining four companies based on management quality, commercial opportunity, regulatory risk, financial strength and liabilities, substantiated valuation, financial risks, public readiness related to company structure and accounting practices. Two of the companies presented significant regulatory and commercial risks requiring near-term FDA approval and the uncertainty of a successful commercial launch. Another company indicated some level of execution risk regarding its newly expanded product pipeline into previously failed markets and a potential liability risk requiring a large sum of debt to be paid upon the consummation of a merger. Each of these companies had significant financing risks related to the need to raise a significant amount of capital and provided little visibility on the ability to raise the required capital. During the evaluation process, the sub-committee, assisted by its advisors, had performed due diligence

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regarding Keystone and had obtained a strong degree of comfort regarding Keystone’s business prospects and valuation. The sub-committee was also satisfied that the valuation ascribed to Check-Cap in the Keystone term sheet (in excess of its net cash) was a good result for Check-Cap’s shareholders. Based on these factors, as well as the high quality of management, experienced and successful board of directors, limited regulatory risk, high quality investment base, commercial momentum and public company readiness, Keystone was unanimously chosen as the preferred strategic partner, and Check-Cap’s advisors were directed to finalize negotiations of a non-binding term sheet with Keystone.

The parties exchanged drafts of the term sheet between June 15 and 19. As part of the negotiations leading up to the final term sheet, Keystone agreed to remove the closing condition that Check-Cap have a minimum amount of net cash at closing and Check-Cap agreed to add closing conditions relating to obtaining certain Israeli tax rulings. Negotiation of the term sheet also addressed, among other things, calculation of the fully-diluted equity of Check-Cap, calculation of Check-Cap’s closing net cash and Check-Cap’s ability to sell certain of its legacy assets to third parties prior to closing.

At a meeting with the sub-committee on June 20, 2023, Mr. Hanley presented the term sheet provided by Keystone and Check-Cap’s proposed counteroffer. A discussion ensued, following which the sub-committee agreed on the principal terms for a response to the offer and agreed to have Ladenburg send a non-binding and non-signed response. After further discussions with Keystone leadership, on June 21, 2023, Check-Cap and Keystone entered into a non-binding term sheet.

On June 23, 2023, key members of Keystone management, Board and advisors met with their respective counterparties from Check-Cap to kick off the definitive agreement negotiations. This included action plans for due diligence for both parties, disclosures and consideration of tax and structure of the transaction. Thereafter, representatives of Check-Cap and Keystone continued conducting business, tax and legal diligence on each other, including a review of the Keystone intellectual property portfolio.

On July 13, 2023, Greenberg Traurig, LLP (“GT”), Check-Cap’s U.S. counsel, delivered an initial draft of the BCA to Goldfarb Gross Seligman (“GGS”) and Stevens & Lee (“SL”), Keystone’s Israeli and U.S. counsel, respectively. The terms of the initial draft of the BCA generally aligned with the terms of the term sheet entered into with Keystone and also provided that the business combination transaction would be structured as a “double dummy” transaction pursuant to which (a) Israeli Merger Sub would merge with and into Check-Cap, as a result of which Check-Cap would be the surviving company and become a direct, wholly owned subsidiary of New Parent, and (b) U.S. Merger Sub would merge with and into Keystone, as a result of which Keystone would be the surviving company and become a direct, wholly owned subsidiary of New Parent.

On July 21, 2023, representatives of GGS sent representatives of GT and FISCHER (FBC & Co.) (“FBC”), Check-Cap’s Israeli counsel, a revised draft of the BCA. Among other changes, the revised draft of the Business Combination Agreement, reflected the following additional or modified material terms from the initial draft of the Business Combination Agreement that GT sent to GGS on July 13, 2023: (a) the calculation of net cash for purposes of adjusting the equity value attributed to Check-Cap, (b) the parties would commit to obtain certain additional Israeli tax rulings and the obtaining of such tax rulings would be a condition for Closing, (c) modification of the scope of certain representations and warranties made by Check-Cap and Keystone, (d) modification of the timing of Keystone’s obligation to deliver the written consent of its stockholders approving the Business Combination, and inclusion of the ability of Keystone’s board to make a change in recommendation, and (e) Check-Cap would commit to obtain the approval of Israeli courts to distribute a dividend to New Parent at Closing, and the obtaining of such approval would be a condition for Closing.

Thereafter, through the signing of the Business Combination Agreement on August 16, 2023, representatives of Check-Cap and Keystone held multiple calls to discuss the terms of the Business Combination and the provisions of the BCA. GT and GGS, in collaboration with FBC and SL, exchanged multiple updated drafts of the Business Combination Agreement and certain related documents and agreements during this period.

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Negotiations centered on, among other things, the scope of the representations and warranties, the scope of the definition of “material adverse effect”, interim operating covenants, closing conditions, treatment of transaction expenses, treatment of outstanding securities and the mechanics of payment of consideration in connection with the Mergers given the cross-border implications. Over the same period, the representatives for Check-Cap and Keystone held numerous conference calls and reached agreement on outstanding business issues, including, among others: (i) the ability of Keystone’s Board to make a change in recommendation; (ii) the termination fees payable by each of Check-Cap and Keystone in connection with the potential termination of the Business Combination Agreement; (iii) the scope and components of Check-Cap’s closing net cash at Closing for purposes of adjusting the equity value attributed to Check-Cap; (iv) the terms and conditions under which Check-Cap may undertake a sale of its legacy assets to third parties prior to the Closing, and the distribution of the proceeds of any such sale to Check-Cap’ legacy equity holders; (v) Keystone’s obligation to amend the Keystone 2021 SPA; and (vi) the overall suite of representations, warranties and covenants to be provided by each party under the Business Combination Agreement. The parties worked through each other’s concerns around these issues and achieved a reasonable balance that respected the needs of both Check-Cap and Keystone shareholders. For further information related to the final resolution of items (i) through (vi), please see the section entitled “The Business Combination Agreement.”

On July 26, 2023, representatives of GGS sent representatives of GT initial drafts of the form of Keystone Lock-Up Agreement and Check-Cap Lock-Up Agreement. On July 27, 2023, representatives of SL sent representatives of GT an initial draft of the form of Registration Rights Agreement. On August 1, 2023, representatives of GT sent representatives of GGS and SL an initial draft of the Keystone Stockholder Support Agreement. Between July 26, 2023 and August 15, 2023, representatives of GT, GGS and SL exchanged multiple drafts of the ancillary agreements generally reflecting updates to the negotiated terms of the BCA, with no material discussions or negotiations between the parties regarding the ancillary agreements. For further information related to these agreements, please see the section entitled “The Business Combination Agreement — Ancillary Agreements.”

During this period, Keystone, Check-Cap and their advisors, including GT, FBC and GGS, continued to conduct due diligence of Check-Cap and Keystone, based on materials made available in the parties’ virtual data rooms and diligence sessions with management and advisors, including due diligence of material contracts, corporate matters, real estate, regulatory matters, and financial, tax and accounting matters. Also during this period, Check-Cap, Keystone and their advisors held weekly calls to discuss the status of the Business Combination, including the Business Combination Agreement and related ancillary agreements, the preparation of the registration statement of which this prospectus forms a part and the due diligence process.

On July 18, 2023, Symetryx Corporation, a self-described family office based in Toronto, Canada, issued a press release in which it announced a non-binding proposal to acquire Check-Cap at a price of $4.35 per share in cash. As stated in the press release, the non-binding proposal was contingent upon a number of conditions, including completion of satisfactory due diligence, obtaining satisfactory financing arrangements, entering into a satisfactory purchase and sale agreement and filing and completion of all regulatory matters. The press release further stated that “Symetryx may require additional conditions to complete [their] non-binding proposal that [they] will determine [their] sole discretion.” Symetryx also stated in its press release that it owned less than 5% of Check-Cap’s shares, but that it believed it was the largest Check-Cap shareholder.

On July 25, 2023, Symetryx issued another press release, in which it announced that it was increasing the cash purchase price per share of Check-Cap in its non-binding proposal from $4.35 per share to $4.60 per share in cash. In this press release, Symetryx reiterated that its non-binding proposal was contingent upon a number of conditions. Other than these press releases, Check-Cap did not receive a written proposal directly from Symetryx.

In response to the Symetryx press releases, Check-Cap requested that Keystone release Check-Cap from the exclusivity provisions in the term sheet between the parties, to enable Check-Cap to respond to unsolicited third-party proposals such as the one made by Symetryx, and on July 27, 2023, Keystone agreed to permit Check-Cap to do so.

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On August 1, 2023, Steve Hanley, the board chairman, received an email from the chief executive officer of a private company, which attached a letter in which such company expressed interest in exploring a potential business combination transaction with Check-Cap. The letter, which valued Check-Cap at “more than $30 million,” described a non-binding stock-for-stock transaction subject to several conditions, including a due diligence review and Check-Cap having minimum working capital of $32 million.

On August 2, 2023, David Strupp of Ladenburg had a phone conversation with the chief executive officer of the private company, and thereafter Check-Cap sent to the private company a non-disclosure agreement (which was substantially similar to the non-disclosure agreements utilized in the auction process described above) after the execution of which the parties would be able to exchange non-public information. On this call, the chief executive officer of the private company disclosed that it and/or its affiliates were shareholders in Check-Cap. Further, Symetryx’s website indicates that it is a shareholder in the private company.

On August 8, 2023, following negotiation of a standard engagement letter between Check-Cap’s sub-committee and Variance, the Check-Cap subcommittee engaged Variance to provide an additional independent opinion on the fairness of the Exchange Ratio, from a financial point of view, to the Check-Cap shareholders in connection with the business combination.

On August 9, 2023, Check-Cap received the private company’s proposed revisions to the non-disclosure agreement, which, among other things added an exclusivity provision, and deleted several other provisions, which were present in almost all of the other non-disclosure agreements previously entered into with potential transaction partners.

On August 10, 2023, Mr. Hanley, the Board Chairman, sent an email to Symetryx proposing a conversation. Symetryx did not respond to this email.

On August 10, 2023, Mr. Hanley contacted the chief executive officer of the private company, proposing a non-confidential conversation between Mr. Hanley, Mr. Yanai and the chief executive officer of the private company. The parties spoke later that day and exchanged preliminary non-confidential information about each other.

On August 11, 2023 Mr. Hanley sent to the chief executive officer of the private company an email explaining that additional information, including Check-Cap’s estimated cash at closing, would be provided once a non-disclosure agreement between the parties was in place, and requesting that the private company provide an updated proposal which, given that a stock deal was being proposed, would need to describe the relative ownership ratios between the parties, as well as information regarding the private company. The email attached a process letter prepared by Ladenburg, which was substantially similar to the process letter utilized in the auction process, seeking substantially the same information that had been requested from other potential transaction partners. Mr. Hanley requested that the private company provide its updated proposal, as well as its responses to the process letter, by noon ET on August 15.

Between August 11 and August 14, counsel for the respective parties negotiated the terms of the proposed non-disclosure agreement, which was executed on August 14. Later that day, two phone calls were held between representatives of each of the two companies.

On August 15, Mr. Hanley sent another email to the chief executive officer of the private company, reiterating the need for an updated proposal which would take into account the information provided by Check-Cap, and also include the information previously requested from the private company. No such proposal was received by Check-Cap from the private company.

On August 14, 2023 and August 15, 2023, representatives of Check-Cap, Keystone, GGS, GT and FBC held videoconference calls to discuss material terms in the draft Business Combination Agreement that remained subject to further discussion between Check-Cap and Keystone. On these calls, among other things, the parties

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discussed: (i) the treatment of Check-Cap’s outstanding warrants, (ii) the termination fees payable by each of Check-Cap and Keystone in connection with a potential termination of the BCA and (iii) the terms and conditions with respect to Check-Cap’s obligation to declare a dividend at Closing.

On August 15, 2023, Check-Cap’s Board met via teleconference, with all but one board members present. Also in attendance were representatives of Ladenburg, Variance, GT and FBC. At the meeting, the Check-Cap board discussed both the Symetryx non-binding offer, and the letter and subsequent dialogue with the private company. Regarding the Symetryx proposal, the board noted that the proposal was non-binding and highly conditional (including an apparent need for financing), and further noted that the revised cash purchase price of $4.60 per share was significantly less than the value ascribed to Check-Cap in the proposed Keystone transaction. Regarding the letter from the private company, the board noted that the approximately $30 million valuation was less than the cash amount held by Check-Cap as reflected in its publicly available information at the time the letter was sent and that in the absence of an updated proposal, the board assumed that the valuation would be further adjusted downward based on Check-Cap’s estimated cash at closing. It was also noted that no information had been provided by the private company to support its valuation, and that the private company operated in an industry that was outside of the medical technology industry with which Check-Cap and its board members had the most familiarity. Lastly, members of the board expressed their concern that further delay could result in the loss of the Keystone opportunity. Taking all of these items into account, the board determined that entering into the transaction with Keystone, which was substantially fully-negotiated at this time, was preferable to waiting for further feedback from either Symetryx or the private company.

At the meeting, a representative of FBC reviewed with the directors their fiduciary duties under Israeli law generally and how those fiduciary duties applied in the context of considering the Business Combination and provided an overview of the proposed board resolutions for approving the Israeli Merger, BCA and the transactions to which Check-Cap is a party. Ladenburg presented to the Board the estimated per share value to Check-Cap’s shareholders in the event of the liquidation of Check-Cap as compared to the per share value to Check-Cap’s shareholders in the Business Combination, which demonstrated an increased value to the shareholders in the Business Combination. Check-Cap’s Board and GT then reported on the contemplated timing of the Business Combination and a representative of GT reviewed the terms of the BCA and the other transaction documents with Check-Cap’s Board. At the meeting, members of Check-Cap’s Board discussed among themselves the key terms of the Business Combination. Representatives of Ladenburg and Variance reviewed with Check-Cap’s Board their respective financial analyses, and rendered their respective oral opinions, which were subsequently confirmed by delivery of their respective written opinions, dated August 15, 2023, to the Board that, as of such date, and based upon and subject to the factors and assumptions set forth in their respective opinions, the Exchange Ratio is fair, from a financial point of view, to the Check-Cap shareholders. For a detailed discussion of Ladenburg’s opinion and Variance’s opinion, see “— Opinion of Check-Cap’s Financial Advisors — Fairness Opinion of Ladenburg” and “— Opinion of Check-Cap’s Financial Advisors — Fairness Opinion of Variance,” respectively. Following discussions, including discussing the advantages and risks of the proposed transaction (which are more fully described below under the caption “— Check-Cap’s Reasons for Approving the Business Combination”), Check-Cap’s Board voted unanimously (with one director absent) to approve and declare advisable the BCA and the ancillary transaction agreements and the transactions contemplated thereby, subject to final negotiations, and the submission of the business combination to the approval of the Check-Cap shareholders.

On August 16, 2023, the BCA and ancillary agreements were executed by the parties thereto.

After the market close on August 16, 2023, Check-Cap and Keystone issued a joint press release announcing the execution of the BCA, and Check-Cap filed with the Commission a Current Report on Form 6-K disclosing the execution of the BCA and related matters. During the morning of August 17, 2023, representatives of Check-Cap and Keystone conducted an investor conference call to announce the Business Combination.

On August 17, 2023, Keystone delivered to Check-Cap a copy of the written consent of Keystone stockholders adopting the BCA and approving the Business Combination, including the U.S. Merger.

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Since August 16, 2023, Check-Cap and Keystone, along with their respective counsel and advisors, have worked jointly on the preparation of the registration statement of which this prospectus forms a part.

The parties have continued and expect to continue regular discussions regarding the timing to consummate the Business Combination and necessary preparation in connection therewith.

Recommendation of the Check-Cap Board

At a meeting held on August 15, 2023, the Check-Cap board of directors unanimously (with one director absent) (i) determined that the Israeli Merger and the other transactions to which Check-Cap is a party, are fair to, advisable and in the best interests of Check-Cap and its shareholders, (ii) approved and declared advisable the Check-Cap Shareholder Transaction Matters, (iii) determined that considering the financial position of the merging entities in the Israeli Merger, no reasonable concern exists that, as a result of the Israeli Merger, the Israeli Surviving Company will be unable to fulfill the obligations of Check-Cap to its creditors, and (iv) determined to recommend, upon the terms and subject to the conditions set forth in the Business Combination Agreement, that the Check-Cap shareholders vote to approve the Check-Cap Shareholder Transaction Matters.

Check-Cap’s Reasons for Approving the Business Combination

At its August 15, 2023 meeting, the Check-Cap board of directors unanimously (with one director absent who did not vote, abstain or hold a personal interest in the outcome of vote) determined that the Check-Cap Shareholder Transaction Matters were fair to, and in the best interests of, Check-Cap and its shareholders. Consequently, the Check-Cap board of directors approved the Check-Cap Shareholder Transaction Matters and determined to recommend that the Check-Cap shareholders approve the Check-Cap Shareholder Transaction Matters.

Leading up to such approval, a special committee of independent members of the Check-Cap board of directors and its financial advisor, Ladenburg, undertook a comprehensive and thorough process to review and analyze potential strategic transaction opportunities and merger candidates to identify an opportunity or merger partner that would, in the Check-Cap board’s view, create the most value for the Check-Cap shareholders. In the course of its evaluation of the Business Combination Agreement and Business Combination with Keystone, the special committee held numerous meetings, consulted with Check-Cap’s senior management, Check-Cap’s outside legal counsel and Check-Cap’s financial advisors, and reviewed and assessed a significant amount of information, and considered a number of factors. This information was shared on a regular basis with all members of the Check-Cap board to enable the Check-Cap board to be fully informed to reach its final decisions. The information and factors considered in the evaluation included the following:

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The Check-Cap board also considered the recent results of operations and financial conditions of Check-Cap, including:

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The Check-Cap board also reviewed the terms of the Business Combination Agreement and associated transactions, including:

The Check-Cap board also considered a variety of risks and other countervailing factors related to the Business Combination, including:

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The foregoing information and factors considered by the Check-Cap board are not intended to be exhaustive but are believed to include all of the material factors considered by the Check-Cap board. In view of the wide variety of factors considered in connection with its evaluation of the Business Combination and the complexity of these matters, the Check-Cap board did not find it useful to attempt, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of the Check-Cap board may have given different weight to different factors. The Check-Cap board conducted an overall analysis of the factors described above, including thorough discussions with, and questioning of, Check-Cap management team, members of the special committee and the legal and financial advisors of Check-Cap, and considered the factors overall to be favorable to, and to support, its determination.

Recommendation of the Keystone Board

At a meeting held on August 15, 2023, the Keystone board of directors unanimously (i) determined that the transactions, including the U.S. Merger, are fair to, advisable and in the best interests of Keystone and its stockholders, (ii) approved and declared advisable the Business Combination Agreement and the transactions, including the U.S. Merger and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Business Combination Agreement, that the Keystone stockholders vote to adopt the Business Combination Agreement and approve the Business Combination, including the U.S. Merger.

Keystone’s Reasons for Approving the Business Combination

In approving and authorizing the Business Combination Agreement and the Business Combination, the Keystone board of directors considered a number of factors. Although the following discussion sets forth the material factors considered by the Keystone board of directors in reaching its determination, it may not include all of the factors considered by the Keystone board of directors. In light of the number and wide variety of factors considered in connection with its evaluation of the Business Combination Agreement and the Business Combination, the Keystone board of directors did not consider it practicable to, and did not attempt to, quantify or otherwise assign relative weights to the specific factors it considered in reaching its determination. The Keystone board of directors viewed its position and determinations as being based on all of the information available and the factors presented to and considered by it. In addition, individual directors may have given different weight to different factors.

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In reaching its decision, the Keystone board of directors consulted with Keystone’s management with respect to strategic and operational matters and with Keystone’s legal counsel with respect to the Business Combination Agreement and the transactions contemplated thereby.

Among the factors considered by the Keystone board of directors in its decision to approve the Business Combination Agreement were the following:

In reaching its determination to approve the Business Combination Agreement and the Business Combination, the members of the Keystone board of directors identified and considered a number of the potentially beneficial aspects of the Business Combination, including the following:

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The members of the Keystone board of directors also identified and considered the following material uncertainties and risks:

The Keystone board of directors weighed the benefits, advantages and opportunities of a potential transaction against the negative factors described above, including the possible diversion of management attention for an extended period of time. The Keystone board of directors realized that there can be no assurance about future results, including results expected or considered in the factors listed above. However, the Keystone board of directors concluded that the potential benefits significantly outweighed the potential risks of completing the Business Combination.

After taking into account these and other factors, including the alternatives of pursuing a private financing or an initial public offering, the Keystone board of directors approved and authorized the Business Combination Agreement and the transactions contemplated thereby, including the Business Combination.

Agreements Related to the Business Combination

Registration Rights Agreement

In connection with the transactions contemplated by the Business Combination Agreement, New Parent will enter into a Registration Rights Agreement with Accelmed, AGP and Melker Nilsson, the CEO of New Parent. A copy of the Registration Rights Agreement is attached as Annex F to this prospectus. The following summary of the Registration Rights Agreement does not purport to be complete and may not contain all of the information about the Registration Rights Agreement that is important to you and you are encouraged to read the Registration Rights Agreement carefully and in its entirety.

Demand Registration Rights

Subject to certain limitations, at any time following the execution of the Registration Rights Agreement, Accelmed and AGP may make up to three (3) demands for New Parent to register under the Securities Act registrable securities by delivering to New Parent a written notice of each such demand, provided that the total offering price reasonably expected under each registration is expected to exceed, in the aggregate, $20,000,000.

Piggyback Registration Rights

Subject to certain limitations, if, at any time following the execution of the Registration Rights Agreement, New Parent proposes for any reason to register shares of New Parent common stock under the Securities Act

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with respect to an offering of equity securities, or securities or other obligations exercisable or exchangeable for, or convertible into equity securities, for its own account or for the account of its stockholders, it must at each such time give written notice of such proposed filing to the holders of registrable securities as soon as practicable (but not less than ten (10) days before the anticipated filing date) and include in such registration all registrable securities with respect to which New Parent has received written requests for inclusion therein within five (5) business days after receipt of New Parent’s notice.

Expenses

All fees and expenses incidental to New Parent’s performance of or compliance with its obligations under the Registration Rights Agreement (excluding incremental selling expenses such as underwriting marketing costs, commissions, discounts and brokerage fees) will be borne by New Parent.

Indemnification

The Registration Rights Agreement also includes customary cross-indemnification provisions, under which New Parent is obligated to indemnify the holders of registrable securities, their officers, directors, stockholders, partners, members, affiliates and agents, and the holders’ control persons, in the event of material misstatements or omissions in the registration statement attributable to New Parent, and the holders of registrable securities are obligated to indemnify New Parent, its directors, officers, agents and New Parent’s control persons, for material misstatements or omissions attributable to them.

Support Agreement

Concurrently with the execution of the Business Combination Agreement, Accelmed and AGP entered into a Support Agreement with Keystone and Check-Cap. A copy of the Support Agreement is attached as Annex G to this prospectus. The following summary of the Support Agreement does not purport to be complete and may not contain all of the information about the Support Agreement that is important to you and you are encouraged to read the Support Agreement carefully and in its entirety.

The Support Agreement generally provides, among other things, that Accelmed and AGP will vote all of the shares of common stock of Keystone they own in favor of the approval and adoption of the Business Combination Agreement and the transactions thereunder and against any action, agreement or transaction or proposal that would reasonably be expected to result in the failure of the transactions from being consummated, except in connection with the exercise of any of New Parent’s rights under the Business Combination Agreement.

Lock-up Agreements

Concurrently with the execution of the Business Combination Agreement, Accelmed, AGP, Melker Nilsson and certain directors and officers of Check-Cap entered into Lock-Up Agreements with New Parent. A copy of the form of Lock-Up Agreement is attached as Annex H to this prospectus. The following summary of the Lock-Up Agreements does not purport to be complete and may not contain all of the information about the Lock-Up Agreements that is important to you and you are encouraged to read the Lock-Up Agreement carefully and in its entirety.

The Lock-Up Agreements generally provide that each of Accelmed, AGP, Melker Nilsson and the certain directors and officers of Check-Cap agreed to certain restrictions on transfers of any shares of New Parent’s common stock they own for a period of 180 days following the date of the Closing. Each of the securityholders party to the Lock-Up Agreements agreed that without the prior written consent of New Parent such securityholder will not (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of,

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directly or indirectly, any shares of New Parent common stock or any securities convertible into or exercisable or exchangeable for shares of New Parent common stock, whether then owned or thereafter acquired, or publicly disclose the intention to make such offer, sale, pledge, grant, transfer or disposition (other than as set forth in the Business Combination Agreement or pursuant to the Registration Rights Agreement), (ii) enter into any swap, short sale, hedge or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of New Parent common stock or (iii) make any demand for, or exercise any right with respect to, the registration of any shares of New Parent common stock or any security convertible into or exercisable or exchangeable for shares of New Parent common stock (other than as set forth in the Business Combination Agreement or pursuant to the Registration Rights Agreement).

Consideration to be Received in the Business Combination

Upon consummation of the U.S. Merger, each holder of shares of Keystone common stock will receive, for each share of Keystone common stock, a number of shares of New Parent common stock calculated pursuant to an exchange ratio based on the respective per share valuations of Keystone and Check-Cap, subject to adjustment based on the amount of net cash (as determined pursuant to the Business Combination Agreement) that Check-Cap has as of the close of business on the last business day prior to the anticipated closing date (the “Exchange Ratio”). In addition, each option to purchase shares of Keystone common stock and each warrant to purchase shares of Keystone common stock issued by Keystone will be converted into an option or warrant to purchase shares of New Parent common stock issued by New Parent, as applicable, on substantially similar terms, subject to adjustment in the number of underlying shares and the exercise price in accordance with to the Exchange Ratio (subject to rounding down to the nearest whole number of shares).

Upon consummation of the Israeli Merger, each holder of Check-Cap ordinary shares will receive one share of New Parent common stock for each ordinary share of Check-Cap such stockholder held at the effective time of the Israeli Merger. Each option to purchase Check-Cap ordinary shares (whether vested or unvested) that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each Check-Cap Vested RSU that is outstanding immediately prior to the effective time of the Israeli Merger will be canceled and automatically convert into and represent the right to receive from New Parent the same number of shares of New Parent common stock. Each Check-Cap RSU that is outstanding and unvested immediately prior to the effective time of the Israeli Merger will automatically expire and cease to exist as of immediately prior to the effective time of the Israeli Merger without any assumption or conversion, and no consideration will be delivered in respect thereof. Each Check-Cap CLA Warrant that is outstanding and unexercised immediately prior to the effective time of the Israeli Merger will automatically expire with no consideration delivered in respect thereof. Finally, the Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants may be exercised by the holders thereof following the effective time of the Israeli Merger or, for a period of thirty days following the effective time of the Israeli Merger, redeemed at the election of the holders thereof for cash in an amount determined based on the Black-Scholes valuation model pursuant to the terms of such warrants. As the Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants are “out of the money” relative to the per share valuation of Check-Cap, it is expected that they will be redeemed in full and the calculation of net cash (as determined in accordance with the Business Combination Agreement) includes a reduction for the aggregate cost of the expected redemptions of such Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants. If any Check-Cap Registered Direct Warrants and Check-Cap Placement Agent Warrants are not redeemed by the end of such thirty-day period, the warrantholder will have the right to receive, upon exercise of such warrant, that number of shares of New Parent common stock that could have been acquired if such warrant had been exercised for ordinary shares of Check-Cap prior to the effective time of the Israeli Merger, and an allocable portion of any distributions with respect to the sale of Check-Cap’s legacy assets, as further described herein. There can be no assurance that any such sale or distributions will occur.

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Opinion of Check-Cap’s Financial Advisors

Fairness Opinion of Ladenburg

As stated above, pursuant to an engagement letter dated April 24, 2023 (the “Ladenburg Engagement Letter”), Check-Cap retained Ladenburg to act as its financial advisor in connection with a proposed business combination with an unaffiliated third party and to render an opinion to the Check-cap board of directors as to the fairness of the Exchange Ratio, from a financial point of view, to the holders of Check-Cap ordinary shares. On August 15, 2023, at the request of the Check-Cap board of directors, Ladenburg rendered its oral Ladenburg Opinion to the Check-Cap board of directors, subsequently confirmed in writing, that as of the date of such Ladenburg Opinion and based upon the various assumptions and limitations set forth therein, and such other factors that Ladenburg deemed relevant, the Exchange Ratio (assumed, at the time, to be 2.6656) was fair, from a financial point of view, to the holders of Check-Cap ordinary shares.

The full text of the Ladenburg Opinion is attached as Annex B to this prospectus and is incorporated by reference. The summary of the Ladenburg Opinion set forth herein is qualified by reference to the full text of the Ladenburg Opinion. Ladenburg provided its opinion for the benefit and use by the Check-Cap board of directors in its consideration of the financial terms of the Business Combination. The Ladenburg Opinion is not a recommendation to the Check-Cap board of directors whether or not to approve the Business Combination or to any holder of Check-Cap ordinary shares or any other person as to how to vote with respect to the proposed Business Combination or to take any other action in connection with the Business Combination or otherwise.

In connection with the Ladenburg Opinion, Ladenburg took into account an assessment of general economic, market and financial conditions as well as its experience in connection with similar transactions and securities valuations generally and, among other things:

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In conducting its review and arriving at its opinion, Ladenburg, with the consent of the Check-Cap board of directors, assumed and relied upon, without independent verification or investigation, the accuracy and completeness of all financial and other information provided to or discussed with Ladenburg by Check-Cap and Keystone, respectively (or their respective employees, representatives or affiliates), or which was publicly available or was otherwise made available to it by Check-Cap or Keystone, respectively. Ladenburg did not undertake any responsibility for the accuracy, completeness or reasonableness of, or independent verification of, such information. Ladenburg relied upon, without independent verification, the assessment of the Check-Cap board of directors and Keystone management as to the viability of, and risks associated with, the current and future products and services of Keystone (including without limitation, the development, testing and marketing of such products and services, the receipt of all necessary governmental and other regulatory approvals for the development, testing and marketing thereof, and the life and enforceability of all relevant patents and other intellectual and other property rights associated with such products and services). In addition, Ladenburg did not conduct, nor did it assume any obligation to conduct, any physical inspection of the properties or facilities of Check-Cap or Keystone. Ladenburg, with the Check-Cap board of directors’ consent, relied upon the assumption that all information provided to it by Check-Cap and Keystone was accurate and complete in all material respects. To the extent that such information included estimates and forecasts of future financial performance prepared by or reviewed with the board of directors of Check-Cap or management of Keystone, as applicable, Ladenburg assumed such estimates and forecasts had been reasonably prepared on bases reflecting the best currently available estimates and judgements of Check Cap board of directors or Keystone management.

In its opinion, Ladenburg expressly disclaimed any undertaking or obligation to advise any person of any change in any fact or matter affecting the Ladenburg Opinion of which it becomes aware after the date of the Ladenburg Opinion. For purposes of the Ladenburg Opinion, Ladenburg assumed there were no material changes in the assets, liabilities, financial condition, results of operations, business or prospects of Check-Cap or Keystone since the date of the last financial statements made available to it. Ladenburg did not obtain any independent evaluations, valuations or appraisals of the assets or liabilities of Check-Cap or Keystone, nor was Ladenburg furnished with such materials. In addition, Ladenburg did not evaluate the solvency or fair value of Check-Cap or Keystone under any state or federal laws relating to bankruptcy, insolvency or similar matters. The Ladenburg Opinion does not address any legal, tax or accounting matters related to the Israeli Merger, as to which it assumed that Check-Cap and the Check-Cap board of directors had received such advice from legal, regulatory, tax and accounting advisors as each had determined appropriate. The Ladenburg Opinion addresses only the fairness of the Exchange Ratio, from a financial point of view, to the holders of Check-Cap ordinary shares. Ladenburg expressed no view as to any other aspect or implication of the Israeli Merger or any other agreement or arrangement entered into in connection with the Israeli Merger. The Ladenburg Opinion was necessarily based upon financial, economic and market conditions and other circumstances as they existed and could be evaluated by Ladenburg on the date of the Ladenburg Opinion. Ladenburg cautioned that it should be understood that although subsequent developments may affect the Ladenburg Opinion, Ladenburg does not have any obligation to update, revise or reaffirm the Ladenburg Opinion and Ladenburg expressly disclaimed any responsibility to do so.

Ladenburg did not consider any potential legislative or regulatory changes currently being considered or recently enacted by the United States or any foreign government, or any domestic or foreign regulatory body, or any changes in accounting methods or generally accepted accounting principles that may be adopted by the Securities and Exchange Commission, the Financial Accounting Standards Board, or any similar foreign regulatory body or board. For purposes of rendering the Ladenburg Opinion, Ladenburg assumed in all respects material to its analysis, that the final form of the Business Combination Agreement will not differ from the draft that Ladenburg has reviewed, that the representations and warranties of each party contained in the Business Combination Agreement were true and correct, that each party would perform all of the standards of the

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covenants and agreements required to be performed by it under the Business Combination Agreement and that all conditions to the consummation of the Israeli Merger would be satisfied without waiver or amendment of any term or condition thereof. Ladenburg also assumed that all governmental, regulatory and other consents and approvals contemplated by the Business Combination Agreement or otherwise required for the transactions contemplated thereby would be obtained and that in the course of obtaining any of those consents no restrictions would be imposed or waivers made that would have an adverse effect on Check-Cap, Keystone or the contemplated benefits of the Israeli Merger and the other transactions contemplated under the Business Combination Agreement. Ladenburg assumed that the Israeli Merger would be consummated in a manner that complied with the applicable provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and all other applicable federal and state statutes, rules and regulations.

The Ladenburg Opinion was intended for the benefit and use of the Check-Cap board of directors in its consideration of the financial terms of the Israeli Merger and, except as set forth in the Ladenburg Engagement Letter, could not be used for any other purpose or reproduced, disseminated, quoted or referred to at any time, in any manner or for any purpose without Ladenburg’s prior written consent, except that Ladenburg agreed that the Ladenburg Opinion could be included in its entirety in any filing related to the Israeli Merger to be filed with the Securities and Exchange Commission and the proxy statement to be mailed to the holders of Check-Cap ordinary shares.

The Ladenburg Opinion does not constitute a recommendation to the Check-Cap board of directors of whether or not to approve the Business Combination Agreement, including the Israeli Merger or to any holder of Check-Cap ordinary shares or any other person as to how to vote with respect to the Israeli Merger or to take any other action in connection with the Israeli Merger or otherwise. The Ladenburg Opinion does not address Check-Cap’s underlying business decision to proceed with the Israeli Merger or the relative merits of the Israeli Merger compared to other alternatives available to Check-Cap. Ladenburg expressed no opinion as to the prices or ranges of prices at which shares or the securities of any person, including Check-Cap, will trade at any time, including following the announcement or consummation of the Israeli Merger ,or as to the potential effects of volatility in the credit, financial, and stock markets on Check-Cap, Keystone or the transactions contemplated by the Business Combination Agreement. Ladenburg was not requested to opine as to, and the Ladenburg Opinion does not in any manner address, the fairness in amount or nature of compensation to any of the officers, directors or employees of any party to the Israeli Merger, or any class of such persons, relative to the compensation to be received by the holders of Check-Cap ordinary shares in connection with the Israeli Merger pursuant to the Business Combination Agreement. The Ladenburg Opinion was reviewed and approved by Ladenburg’s fairness opinion committee.

Principal Financial Analyses

The following is a summary of the principal financial analyses performed by Ladenburg to arrive at the Ladenburg Opinion. Some of the summaries of financial analyses include information presented in tabular format. In order to fully understand the financial analyses, the tables must be read together with the text of each summary. The tables alone do not constitute a complete description of the financial analyses. Considering the data set forth in the tables without considering the full narrative description of the financial analyses, including the methodologies and assumptions underlying the analyses, could create a misleading or incomplete view of the financial analyses. Ladenburg performed certain procedures, including each of the financial analyses described below and reviewed with the Check-Cap board of directors the assumptions on which such analyses were based and other factors, including the historical and projected financial results of Check-Cap and Keystone.

Transaction Overview as of the Date of the Ladenburg Opinion

Based upon the Exchange Ratio of 2.6656 at the time of the signing of the Business Combination Agreement, Ladenburg estimated that at the closing of the Israeli Merger and the other transactions contemplated under the Business Combination Agreement: (a) Keystone equity (common stock, options and warrants) holders

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as of immediately prior to the Israeli Merger would own approximately 85.0% of the fully-diluted shares of New Parent common stock at the closing of the Israeli Merger, and (b) the existing Check-Cap equity holders as of immediately prior to the Israeli Merger (excluding for this purpose certain out-of-the-money Check-Cap options) would own approximately 15.0% of the fully-diluted shares of New Parent common stock at the closing of the Israeli Merger.

Implied New Parent Valuation

Ladenburg derived an implied valuation for the combined company by adding the $225 million Keystone equity value (as negotiated in the transaction) to the $39.7 million Check-Cap valuation (as negotiated in the transaction) for a combined New Parent equity value of $264.7 million.

Comparable Company Multiple Analysis

Based on its experience and professional judgment and using financial screening sources and databases to find companies that share similar business characteristics to Keystone within the MedTech industry, Ladenburg selected financial data of 12 publicly traded companies (referred to as the “Selected Publicly Traded Companies”). Each of the Selected Publicly Traded Companies is a revenue-generating company in the Dental and MedTech space developing similar implants and biomaterials that have a comparable growth and profitability profile to Keystone. Although the companies referred to below were used for comparison purposes, none of those companies were directly comparable to Keystone. In its evaluation, Ladenburg did not exercise any judgment or exclusionary practices to add or remove relevant companies that fit within such parameters. Accordingly, an analysis of the results of such a comparison was not purely mathematical but instead involved considerations and judgments concerning differences in historical and projected financial and operating characteristics of the selected companies below. The total enterprise values are based on closing stock prices on August 14, 2023. The Selected Publicly Traded Companies were:

Ladenburg reviewed the enterprise value of each of the Selected Publicly Traded Companies as compared to forecasted 2024 and 2025 revenue estimates, as provided via consensus estimates using Ladenburg’s financial screening sources and databases (CapitalIQ and Bloomberg). Ladenburg divided both the 2024 and 2025 estimated revenue by the enterprise value of each company resulting in an Enterprise Value / Revenue multiple range of 0.9x to 8.1x. Ladenburg then utilized the 25^th and 75^th percentile of Enterprise Value / Revenue multiples to exclude potential outliers and provide a more representable sample of revenue multiples in its analysis. Using the 25^th percentile and the 75^th percentile of the Enterprise Value / Revenue multiples, Ladenburg then calculated a range of implied total equity values for the combined company by multiplying the projected Keystone revenue (as provided by management) in each year by the respective multiple for 2024 and 2025 and then adjusting for the combined company debt ($40.0 million) and the combined company cash ($30.3 million).

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This results in a 2024 equity value range of $179.1 million to $376.0 million and a 2025 equity value range of $208.4 million to $382.9 million compared to the implied combined company valuation of $264.7 million.

Comparable M&A Transaction Multiple Analysis

Ladenburg reviewed the financial terms, to the extent the information was publicly available, of the 9 most recent merger transactions of companies that share similar business characteristics to Keystone within the MedTech industry (referred to as the “Selected Precedent M&A Transactions”). Although the Selected Precedent M&A Transactions were used for comparison purposes, none of the target companies were directly comparable to Keystone. In its evaluation, Ladenburg did not exercise any judgment or exclusionary practices to add or remove relevant companies that fit within such parameters. Accordingly, an analysis of the results of such a comparison was not purely mathematical, but instead involved considerations and judgments concerning differences in historical and projected financial and operating characteristics of the companies involved and other factors that could affect the merger value of such companies and Keystone to which they were being compared. Ladenburg reviewed the total enterprise values of the target companies (including downstream milestone payments). These transactions, including the date each was closed, were as follows:

Selected Precedent M&A Transactions