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Washington, D.C. 20549







Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934


Date of Report:

(Date of earliest event reported)


June 27, 2024




GT Biopharma, Inc.

(Exact name of registrant as specified in its charter)



(State or other Jurisdiction of Incorporation)



(Commission File Number)



(IRS Employer Identification No.)


8000 Marina Blvd., Suite 100

Brisbane, CA 94005

(Address of Principal Executive Offices and zip code)


(800) 304-9888

(Registrant’s telephone number, including area code)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


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   GTBP   The Nasdaq Stock Market LLC


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).


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. ☐







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 auditcommittee@gtbiopharma.com.


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).







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: June 27, 2024 By: /s/ Alan Urban
    Alan Urban
    Chief Financial Officer