false
0000109657
0000109657
2026-04-03
2026-04-03
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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: April 3, 2026
(Date
of earliest event reported)
GT
Biopharma, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other Jurisdiction of Incorporation)
| 1-40023 |
|
94-1620407 |
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
N/A1
(Address
of Principal Executive Offices and zip code)
(415)
919-4040
(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. ☐
1
Effective as of July 1, 2024, the Company became a fully remote company. We do 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 505 Montgomery
Street, 10th Floor, San Francisco, California 94111, or by email to auditcommittee@gtbiopharma.com.
Item
1.01 Entry into a Material Definitive Agreement.
On
April 3, 2026, GT Biopharma, Inc., a Delaware corporation (the “Company”), entered into an Investigator Initiated Clinical
Trial Agreement (the “Agreement”) with the Regents of the University of Minnesota (the “University”), pursuant
to which, the University shall sponsor an Investigational New Drug (“IND”) application for IND 169118 GTB-5550 (the “Research
Program”) and shall serve as a sponsor investigator for a phase 1a/1b clinical trial entitled, “GTB-5550, a Camelid Nanobody
B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy,” designed by
University (the “Study”). The Research Program is being conducted for clinical research use. The budget for the Study, including
without limitations, funding and resources, provides for up to approximately $3.8 million over the course of three years borne by the
Company. The University and the Company will each have the right to publish the Study results. The Agreement may be terminated by the
Company or the University at any time upon thirty days’ written notice to the other party, by the University immediately for health,
welfare and safety reasons, or by either party if the other party materially breaches the Agreement, provided that the breaching party
fails to cure such breach within thirty days.
The
foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text
of the Agreement attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated by reference into this Item 1.01.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
Number |
|
Description |
| |
|
|
| 10.1* |
|
Investigator Initiated Clinical Trial Agreement, dated as of April 3, 2026, by and between GT Biopharma, Inc. and the Regents of the University of Minnesota. |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File, formatted in Inline XBRL |
*
Certain exhibits and schedules to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby
undertakes to furnish copies of any of the omitted schedules and exhibits upon request by the U.S. Securities and Exchange Commission.
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:
April 7, 2026 |
By: |
/s/
Alan Urban |
| |
|
Alan
Urban |
| |
|
Chief
Financial Officer |
