Shuttle Pharmaceuticals Holdings Inc
For the period ended Dec 31, 2023. Filed Mar 21, 2024.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 21, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
For the fiscal year ended December 31,2023
or
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______________ to ______________
Commission file number:001-41488
(Exact name of registrant as specified in its charter)
| Delaware | 82-5089826 |
|---|---|
| State or other jurisdiction of | (I.R.S. Employer |
| incorporation or organization | Identification Number) |
401 Professional Drive, Suite 260
**Gaithersburg, MD 20879 **
(Address of principal executive offices) (Zip Code)
(240) 403-4212
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock | SHPH | The Nasdaq Stock Market LLC |
Securities registered pursuant to section 12(g) of the Act: NONE
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an 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.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☒ | ||
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 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☒
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No☒
The aggregate market value of the registrant’s common stock, par value $0.00001 per share, held by non-affiliates of the registrant, as computed by reference to the June 30, 2023 closing price reported by Nasdaq, was approximately $11,712,797.
The number of shares outstanding of the registrant’s common stock on March 20, 2024, was 16,794,893
TABLE OF CONTENTS
| Page No. | |||
|---|---|---|---|
| PART I | |||
| Item 1. | Business | 4 | |
| Item 1A. | Risk Factors | 24 | |
| Item 1B. | Unresolved Staff Comments | 52 | |
| Item 1C. | Cybersecurity | 52 | |
| Item 2. | Properties | 53 | |
| Item 3. | Legal Proceedings | 53 | |
| Item 4. | Mine Safety Disclosures | 53 | |
| PART II | |||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 54 | |
| Item 6. | [Reserved] | 55 | |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 55 | |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 60 | |
| Item 8. | Financial Statements and Supplementary Data | 61 | |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 62 | |
| Item 9A. | Controls and Procedures | 62 | |
| Item 9B. | Other Information | 62 | |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 62 | |
| PART III | |||
| Item 10. | Directors, Executive Officers and Corporate Governance | 63 | |
| Item 11. | Executive Compensation | 72 | |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 75 | |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 76 | |
| Item 14. | Principal Accountant Fees and Services | 77 | |
| PART IV | |||
| Item 15. | Exhibit and Financial Statement Schedules | 78 | |
| Item 16. | Form 10–K Summary | 80 | |
| SIGNATURES | 81 | ||
FORWARD LOOKING STATEMENTS
This Annual Report on Form 10-K (including the section regarding Management’s Discussion and Analysis and Results of Operations, the “Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements are based on our management’s beliefs and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical facts contained in this Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “project,” “continue,” “potential,” “ongoing” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
| ● | the initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and INDs, NDAs other regulatory submissions; |
| ● | our expected dependence on third party collaborators for developing, obtaining regulatory approval for and commercializing product candidates; |
| ● | our receipt and timing of any milestone payments or royalties under any research collaboration and license agreement we enter into; |
| ● | our ability to identify and develop product candidates; |
| ● | our or a collaborator’s ability to obtain and maintain regulatory approval of any of our product candidates; |
| ● | the rate and degree of market acceptance of any approved products candidates; |
| ● | the commercialization of any approved product candidates; |
| ● | our ability to establish and maintain additional collaborations and retain commercial rights for our product candidates subject to collaborations; |
| ● | the implementation of our business model and strategic plans for our business, technologies and product candidates; |
| ● | our estimates of our expenses, ongoing losses, future revenue and capital requirements; |
| ● | our ability to obtain additional funds for our operations; |
| ● | our ability to obtain and maintain intellectual property protection for our technologies and product candidates and our ability to operate our business without infringing the intellectual property rights of others; |
| ● | our reliance on third parties to conduct our preclinical studies or any future clinical trials; |
| ● | our reliance on third party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development, preclinical and clinical trial drug supplies; |
| ● | our ability to attract and retain qualified key management and technical personnel; |
| ● | our use of net proceeds received by us from our initial public offering, or IPO, or any subsequent private placement; |
| ● | our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
| ● | our financial performance; and |
| ● | developments relating to our competitors or our industry. |
You should not place undue reliance on forward-looking statements, because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed in the reports we filed with the Securities and Exchange Commission (the “SEC”). Actual events or results may vary significantly from those implied or projected by the forward-looking statements due to these risk factors. No forward-looking statement is a guarantee of future performance. You should read this Annual Report, the documents that we reference in this Annual Report and the documentation we have filed as exhibits thereto with the SEC, with the understanding that our actual future results and circumstances may be materially different from what we expect.
Unless the context otherwise requires, the terms “the Company,” “Shuttle Pharma,” “we,” “us,” and “our” in this Annual Report refer to Shuttle Pharmaceuticals Holdings, Inc.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.