UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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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. ☐
| Item 8.01. | Other Events. |
FDA Clearance of IND Application
On June 27, 2024, GT Biopharma, Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for GTB-3650, allowing the Company to proceed with a Phase 1 clinical trial.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Fully Remote Company
Effective as of July 1, 2024, the Company will become a fully remote company. Accordingly, it will not maintain a principal executive office. For purposes of compliance with applicable requirements of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, any stockholder communication required to be sent to the Company’s principal executive offices may be directed to 315 Montgomery Street, 10th Floor, San Francisco, California 94104, or by email to [email protected].
| Item 9.01. | Financial Statements and Exhibits |
| (d) | Exhibits. |
| Exhibit Number | Description | ||
| 99.1 | Press Release issued June 27, 2024, entitled “GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia”. | ||
| 104 | Cover Page Interactive Data File (embedded as 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.
| GT BIOPHARMA, INC. | ||
| Date: June 27, 2024 | By: | /s/ Alan Urban |
| Alan Urban | ||
| Chief Financial Officer | ||