Inhibikase Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 27, 2024.
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FY2023 · Filed Mar 27, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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:001-39676
INHIBIKASE THERAPEUTICS, INC.
(Exact name of Registrant as specified in its Charter)
| Delaware | 26-3407249 |
|---|---|
| (State or other jurisdiction ofincorporation or organization) | (I.R.S. EmployerIdentification No.) |
| 3350 Riverwood Parkway SE, Suite 1900Atlanta, GA | 30339 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (678)392-3419
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, $0.001 par value | IKT | 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 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, 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 Exchange Act). Yes ☐ No ☒
The aggregate market value of the common stock, par value $0.001 per share, (“Common Stock”) held by non-affiliates of the Registrant, based on the closing price of the shares of Common Stock on The Nasdaq Stock Market on June 30, 2023 (the last business day of the Registrant's most recently completed second fiscal quarter) was $19.1 million. Shares of the Registrant's common stock held by each executive officer, director and holder of 5% or more of the outstanding Common Stock have been excluded in that such persons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of the registrant for other purposes. The number of shares of the Registrant’s Common Stock outstanding as of March 15, 2024 was 6,476,844.
DOCUMENTS INCORPORATED BY REFERENCE
None
Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 2 |
| Item 1A. | Risk Factors | 26 |
| Item 1B. | Unresolved Staff Comments | 76 |
| Item 1C. | Cybersecurity | 76 |
| Item 2. | Properties | 77 |
| Item 3. | Legal Proceedings | 77 |
| Item 4. | Mine Safety Disclosures | 77 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 78 |
| Item 6. | [Reserved] | 78 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 79 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 88 |
| Item 8. | Financial Statements and Supplementary Data | 88 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 88 |
| Item 9A. | Controls and Procedures | 88 |
| Item 9B. | Other Information | 88 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 88 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 89 |
| Item 11. | Executive Compensation | 98 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 104 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 105 |
| Item 14. | Principal Accounting Fees and Services | 106 |
| PART IV | ||
| Item 15. | Exhibits, Financial Statement Schedules | F-1 |
| Signatures | F-4 | |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
All statements included or incorporated by reference in this Annual Report on Form 10-K, or the Report, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates, approximations and projections about our industry and business, management’s beliefs, and certain assumptions made by us, all of which are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” and similar expressions and variations or negatives of these words. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, some of which are listed under “Risk Factors” in Item 1A of this Report. These forward-looking statements speak only as of the date of this Report. We undertake no obligation to revise or update publicly any forward-looking statement for any reason, except as otherwise required by law. In this Report, unless otherwise indicated, the “Company”, “we,” “us” or “our” refer to Inhibikase Therapeutics, Inc., a Delaware corporation and its subsidiary, IKT Securities Corporation, a Massachusetts corporation.
The sources of industry and market data contained in this financial report primarily include those listed below:
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Ying Zhao, et al., “Progression of Parkinson’s Disease as Evaluated by Hoehn and Yahr Stage
Transition Times.”Movement Disorders 25:710-716 (2010).
Literature References
J.M. Savitt, V.L. Dawson, T. M. Dawson, Diagnosis and treatment of Parkinson disease: molecules to medicine. J Clin Invest. 116, 1744-1754 (2006).
W. Dauer, S. Przedborski, Parkinson’s Disease: mechanisms and models. Neuron. 39, 889-909 (2003).
M. Goedert, α-Synuclein and neurodegenerative diseases. Nat Rev Neurosci. 2, 492-501 (2001).
M. Goedert, M.G. Spillantini, K. Del Tredici, H. Braak, 100 years of Lewy pathology. Nat Rev Neurol. 9, 13-24 (2013).
V.M. Lee, J. Q. Trojanowski, Mechanisms of Parkinson’s Disease linked to pathological alpha-synuclein: new targetsfor drug discovery. Neuron. 52, 33-38 (2006).
A.H.V. Schapira, C.W. Olanow, J. T. Greenamyre, E. Bezard, Slowing of neurodegeneration in Parkinson’s Disease and Huntington’s disease: future therapeutic perspectives. Lancet 384, 545-555 (2014).
Werner MH and Olanow CW. Parkinson’s disease modification through c-Abl inhibition: An Opportunity. Mov. Disorder 2022; 37:6-15.
Karuppagounder, et al. The c-Abl Inhibikase Risvodetinib suppresses neurodegeneration in murine models of heritable and sporadic Parkinson’s disease. Sci. Transl. Med. 2023;15:eabp9352.
Marmion, et al. Viral-based rodent and nonhuman primate models of multiple system atrophy: Fidelity to the human disease. Neuro. Biol. Dis. 2021: 148:105184.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.