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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 Or 15(d) of the
Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): November 1,
2018
GT Biopharma, Inc.
(Exact
name of Registrant as specified in its charter)
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Delaware
(State
or other Jurisdiction of Incorporation or
organization)
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000-08092
(Commission
File Number)
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94-1620407
(IRS
Employer I.D. No.)
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310 N. Westlake Blvd
Suite 206
Westlake Village, CA 91362
Phone: (800) 304-9888
(Address,
including zip code, and telephone number, including area code,
of
registrant’s
principal executive offices)
(Former
name, former address and former fiscal year, if changed since last
report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐
Soliciting material
pursuant to Rule l 4a- l 2 under the Exchange Act (17 CFR 240. l
4a- l 2)
☐
Pre-commencement
communications pursuant to Rule l 4d-2(b) under the Exchange Act
(17 CFR 240. l 4d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240. l 3e-4(c))
ITEM 8.01 Other Events
On November 1, 2018, GT Biopharma announced that in reference to
the Investigational New Drug Application submitted under section
505(i) of the Federal Food, Drug, and Cosmetic Act for GTB-3550
(OXS-3550), the Food and Drug Administration has completed its
review and concluded that the clinical investigation of protocol
HM2015-39: “CD16/IL-15/CD33 (161533) Tri-Specific Killer
Engagers (TriKEs) for the Treatment of High Risk Myelodysplastic
Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced
Systemic Mastocytosis” may be initiated.
ITEM 9.01 Exhibits.
Letter from Food and Drug Administration indicating authorization
to initiate clinical investigation
SIGNATURE PAGE
Pursuant
to the requirement of the Securities and Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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GT Biopharma, Inc.
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Dated:
November 1, 2018
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By:
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/s/
Raymond W. Urbanski
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Raymond
W. Urbanski
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Chairman and Chief
Executive Officer
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