Correspondence 0001193125-23-251486 from Capstone Dental Pubco, Inc. (CIK 0001989397)
Capstone Dental Pubco, Inc. (CIK 0001989397)
Date: Oct. 5, 2023 · CIK: 0001989397 · Accession: 0001193125-23-251486
AI Filing Summary & Sentiment
File numbers found in text: 333-274297
Referenced dates: September 29, 2023
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CORRESP 1 filename1.htm CORRESP VIA EDGAR October 5, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Benjamin Richie Lauren Nguyen Julie Sherman Terence O’Brien Re.: Capstone Dental Pubco, Inc. Registration Statement on Form S-4 Filed September 1, 2023 File No. 333-274297 To Whom it May Concern: Capstone Dental Pubco, Inc. (the “Company”) hereby submits the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission,” or the “SEC”) dated September 29, 2023, relating to the above referenced Registration Statement on Form S-4 (File 333-274297) filed by the Company on September 1, 2023 (the “Form S-4”). Concurrent with the submission of this letter, the Company is filing via EDGAR Amendment No. 1 to the Form S-4 (“Amendment No. 1”), which reflects the Company’s responses to the comments received by the Staff and certain updated information. For ease of review, we have set forth below each of the numbered comments of your letter and the Company’s responses thereto. *** Registration Statement on Form S-4 Cover Page 1. You disclose that New Parent will submit an application for Nasdaq listing and that 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 is a condition to the consummation of the Business Combination. Please update this disclosure, as appropriate, and disclose whether you will file the initial listing application prior to mailing the materials to shareholders. Response: On September 27, 2023, New Parent filed an application for listing on Nasdaq. In response to the Staff’s comment, the Company has revised its disclosure on the cover page and on pages 1, 18, 93, 162, 304 and 323 of Amendment No. 1. 2. We note disclosure that New Parent may qualify as a “controlled company” and is subject to reduced public company disclosure standards. Please revise your “controlled company” disclosures to indicate that Accelmed will be your controlling shareholder and will own a majority of your outstanding common stock following the completion of the Business Combination. Response: In response to the Staff’s comment, the Company has revised its disclosure on the cover page and page 21 of Amendment No. 1. 3. Revise to describe the exchange ratio to provide additional context for shareholders instead of referring to the definition in the Business Combination Agreement. Response: In response to the Staff’s comment, the Company has revised its disclosure on the cover page of Amendment No. 1. Q: What happens if the Business Combination is not consummated?, page 3 4. Please revise to clarify whether Check-Cap will remain a public reporting company and Check-Cap shareholders will continue to hold equity in Check-Cap if the Business Combination is not consummated. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 4 of Amendment No. 1. Q: What are the conditions to the consummation of the Business Combination?, page 3 5. Please revise to clarify whether the U.S. Merger and Israeli Merger are conditioned upon each other. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 3 of Amendment No. 1. Questions and Answers 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, page 4 6. Revise to expand your disclosure to highlight the material conflicts of interests. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 5 of Amendment No. 1. Summary, page 8 7. We note your statement that Keystone develops and offers “effective and high-quality” technologies for dental practitioners. You also state elsewhere that certain technology can “accurately scan,” “significantly reduce procedural complexity,” and “implant data with high levels of accuracy.” Please revise these and all similar statements in your registration statement to eliminate conclusions or predictions that your device in development is effective, implicitly or impliedly, as determinations of safety and efficacy are solely within the authority of the FDA and comparable regulatory bodies. We do not object to the presentation of objective data resulting from your trials without conclusions related to efficacy. Response: In response to the Staff’s comment, the Company has revised its disclosure throughout Amendment No. 1. 8. We note that you state that C-Scan is the first and only “patient-friendly preparation-free” test designed to detect polyps. Please further explain what you mean by both “patient-friendly” and “preparation-free.” Please revise or also provide support for your statement that the test is the first and only of its kind, as you also disclose that Check-Cap expects to continue to generate losses for at least the next several years as it continues its investment in research and development and clinical trials in order to complete the development of C-Scan and to attain regulatory approvals. 2 Response: In response to the Staff’s comment, the Company respectfully notes that it has removed the relevant disclosure from Amendment No. 1. Risk Factors, page 24 9. We note your disclosure on page 248 that Keystone may be exposed to inflation risk in the United States and in some of the areas in which the company has international operations. Please describe this risk in the Risk Factors section. Response: In response to the Staff’s comment, the Company has described this risk in the risk factor entitled “Conditions in the global economy, the particular markets Keystone serves and the financial markets may adversely affect Keystone’s business and financial statements” on page 44 of Amendment No. 1. Background of the Business Combination, page 107 10. Please revise this section to provide additional details regarding the negotiations that led to the finalization of the key terms of the proposed business combination between the companies. For example, it is not clear how the parties determined the amount of consideration, relative valuations of the companies, or which parties was negotiating on a certain side of a material term or provision. Also expand your discussion of the initial term sheet and the ancillary agreements to identify the material terms negotiated and how they evolved. For example, where you disclose statements such as “GT, GGS and SL exchanged multiple drafts of the ancillary agreements,” describe the terms, negotiations, each party’s position on these issues, and ultimately how the parties came to a final agreement. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 114, 115 and 116 of Amendment No. 1. 11. We note that on March 13, 2023, Mr. Ovadia and the management team delivered to the Board three proposed courses of action for the Company. We further note that following this meeting, and the announcement that Check-Cap did not meet their efficacy goal, the company adopted Plan A, to conduct additional clinical data analysis and amend the pivotal study protocol. Please revise to describe Check-Cap’s rationale behind the adoption of Plan A and the Board’s initial response to these proposals. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 111 of Amendment No. 1. 12. We note the disclosure that 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 the company adopted. Please revise to include additional details to explain why a reverse triangular merger was deemed to provide higher value compared to other alternatives. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 112 of Amendment No. 1. 3 13. We note that between June 12 and June 15, 2023 Check-Cap exchanged drafts of nonbinding term sheets with four companies, including Keystone. Please specify the industries in which these companies operated, summarize the material discussions held between May 30 and June 1, 2023, and state why each of the companies, other than Keystone, were not as strong of a candidate to participate in a strategic merger with Check-Cap. Please provide the same information for the third party inquiry considered in July 2023. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 113 and 114 of Amendment No. 1. 14. Revise to clarify whether Check-Cap received any non-binding offers from the four candidates after receipt of the draft term sheets. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 114 of Amendment No. 1. 15. Please clarify the FDA’s position taken in the written feedback regarding Check-Cap’s proposed alternative approaches as part of the Sprint process. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 113 and 114 of Amendment No. 1. 16. You disclosed that in late July, 2023, in response to the receipt of an unsolicited inquiry from a third party, 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 this inquiry, and Keystone subsequently permitted Check-Cap to do so. You further disclose that notwithstanding these interactions, the Check-Cap Board determined that the best course of action for Check-Cap’s shareholders was to proceed with the contemplated transaction with Keystone. Revise to disclose whether Check-Cap received any non-binding offers from this third party and discuss the reasons why the Check-Cap Board determined that the best course of action for Check-Cap’s shareholders was to proceed with the contemplated transaction with Keystone. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 117 of Amendment No. 1. 17. Based on press reports, Symetryx Corporation provided a non-binding offer, which was subsequently increased, to purchase Check-Cap. Please revise to disclose the reasons why the Check-Cap board did not accept the Symetryx Corporation offer and proceeded with the Keystone transaction. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 13, 116, 117 and 118 of Amendment No. 1. Check-Cap’s Reasons for Approving the Business Combination, page 114 18. We note that at the August 15, 2023 board meeting, where the Check-Cap Shareholder Transaction Matters were unanimously approved, one director was absent. Please disclose whether this director voted, abstained, and or held a personal interest in the outcome of vote. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 10 and 119 of Amendment No. 1. Opinion of Check-Cap’s Financial Advisors Discounted Cash Flow Analysis, page 127 4 19. We note your statements that “Keystone’s future financial results may materially differ from those expressed in the projections” and “[n]one of Check-Cap, Keystone, Ladenburg or any other person assumes responsibility if future results are materially different from those projected.” It is not appropriate to directly or indirectly disclaim liability for statements in your registration statement. Accordingly, please delete these statements, and those similar, or revise to specifically state that you take liability for these statements. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 132 of Amendment No. 1. 20. Revise to disclose with greater specifically the “potential market for the Keystone portfolio,” “competitive landscape” and “data from various databases” that the Check-Cap board of directors considered in formulating the financial projections. Please provide additional details and explain how the “revenue forecasts were modeled based on NORAM and the rest of world (RoW) sales.” Response: In response to the Staff’s comment, the Company has revised its disclosure on page 132 and 133 of Amendment No. 1. 21. We note the statement that “The projections included below are not being included herein to influence Check-Cap’s shareholders’ decision on whether to vote in favor of any proposal.” However, we note that you have used and included the projections in this registration statement. Please revise to remove any implication that shareholders may not consider or rely on the disclosures. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 132 of Amendment No. 1. Opinion of Check-Cap’s Financial Advisors Discounted Cash Flow Analysis, page 127 22. We see that you have provided projections of estimated annual revenues, cost of sales, research & development, other expenses, EBITDA and Unlevered cash flow for the years ended December 31, 2023 through 2033 and operating profit, income taxes, depreciation, capital expenditures and available cash flow through 2024. Please revise your disclosure to provide more specific assumptions to enhance an investors understanding of the basis for your projections. Please also specifically discuss your ability, and the related limitations with projections as far as 10 years out. We refer you to the Commissions guidance regarding projections provided in Item 10(b)(3) of Regulation S-K. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 132 and 133 of Amendment No. 1. 23. We also see that you present EBITDA and Unlevered Cash Flow. The presentation of projections that include a non-GAAP financial measures should include a clear definition or explanation of the measure, a description of the GAAP financial measure to which it is most closely related, and an explanation why the non-GAAP financial measure was used instead of a GAAP measure. Please revise. Response: In response to the Staff’s comment, the Company has revised its disclosure on page 133 of Amendment No. 1. Regulatory Approvals, page 137 24. We note that, in order to make a distribution, Check-Cap must request approval for the distribution from a applicable Israeli District Court and that the court “may approve the distribution if it is convinced that there is no reasonable concern that the payment of a dividend will prevent Check-Cap from satisfying its existing and foreseeable obligations as they become due.” We further note 5 disclosure on page 275 noting that Check-Cap expects that it will continue to generate losses from its research and development and clinical trials, regulatory activities, manufacturing infrastructure and commercialization efforts of C-Scan, which will result in a negative cash flow from operating activity. You further disclose that Check-Cap anticipates that it will need to raise substantial additional financing in the future to fund its operations. Please disclose any existing and foreseeable obligations that Check-Cap may be required to pay or, if there are none, please so state. Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 13, 142 and 290 of Amendment No. 1. Material U.S. Federal Income Tax Consequences of the Business Combination for Holders of Keystone Securities, page 138 25. We note your statement that this section is a “discussion of certain U.S. federal income tax consequences” and that the section is “necessarily general...” Please