UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On February 7, 2024, Inhibikase Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary outcomes of its pre-new drug application meeting held on January 19, 2024 with the U.S. Food and Drug Administration on the pathway for approval for IkT-001Pro, the Company’s prodrug of the anticancer agent imatinib mesylate, in blood and gastrointestinal cancers. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause the Company’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete the 201 Trial evaluating risvodetinib in untreated Parkinson’s disease, our ability to successfully apply for and obtain FDA approval for IkT-001Pro in blood cancers and whether the FDA’s signed meeting minutes differ from written pre-meeting comments or oral discussion that occurred during our pre-NDA meeting for IkT-001Pro. Additional factors include our ability to successfully conduct pre-clinical and clinical studies, and whether results of our animal studies translate to a clinical benefit in humans, as well as our need for additional financing and other such factors that are discussed in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this report speaks only as of the date of this report. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Number | Description | |
| 99.1 | Press Release dated February 7, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 7, 2024 | INHIBIKASE THERAPEUTICS, INC. | |||||
| By: | /S/ MILTON H. WERNER | |||||
| Milton H. Werner, Ph.D. | ||||||
| President and Chief Executive Officer | ||||||
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