GT Biopharma funds $3.8M trial with Minnesota

GT Biopharma, Inc. entered into an Investigator Initiated Clinical Trial Agreement with the Regents of the University of Minnesota on April 3, 2026.

Rhea-AI Filing Summary

GT Biopharma, Inc. entered into an Investigator Initiated Clinical Trial Agreement with the Regents of the University of Minnesota on April 3, 2026. Under this pact, the University will sponsor an Investigational New Drug application for IND 169118 GTB-5550 and act as sponsor investigator for a phase 1a/1b trial in select advanced solid tumors that have failed prior therapy.

The study budget provides for up to approximately $3.8 million over three years, to be borne by GT Biopharma. Both parties retain rights to publish the study results, and the agreement includes mutual termination rights, including 30 days’ notice provisions and immediate termination by the University for health, welfare, or safety reasons.

Insights

Biotech equity analyst

GT Biopharma commits up to $3.8M to an early-stage oncology trial run by the University of Minnesota.

GT Biopharma is funding an investigator-initiated phase 1a/1b trial of GTB-5550 for advanced solid tumors that have failed prior therapy. The University of Minnesota sponsors the IND and serves as sponsor investigator, which can reduce GT Biopharma’s operational burden while still advancing its asset.

The company expects to bear up to $3.8 million in study costs over three years, a modest but real cash commitment for an early-stage program. Flexible termination rights for both parties and the University’s ability to halt for health or safety reasons provide structured risk controls. Future disclosures on enrollment progress and results will shape the program’s importance in GT Biopharma’s pipeline.

8-K Event Classification

2 items: 1.01, 9.01

2 items

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Study budget: $3.8 million IND number: IND 169118 Study phase: Phase 1a/1b +1 more

4 metrics

Study budget $3.8 million Budget for the GTB-5550 study over three years borne by GT Biopharma

IND number IND 169118 Investigational New Drug application sponsored by the University of Minnesota

Study phase Phase 1a/1b Clinical trial stage for GTB-5550 in select advanced solid tumors

Notice period 30 days Termination notice period available to either party under the agreement

Key Terms

Investigator Initiated Clinical Trial Agreement, Investigational New Drug, phase 1a/1b clinical trial, Camelid Nanobody, +1 more

5 terms

Investigator Initiated Clinical Trial Agreement regulatory

"entered into an Investigator Initiated Clinical Trial Agreement (the “Agreement”) with the Regents of the University of Minnesota"

Investigational New Drug regulatory

"the University shall sponsor an Investigational New Drug (“IND”) application for IND 169118 GTB-5550"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

phase 1a/1b clinical trial medical

"serve as a sponsor investigator for a phase 1a/1b clinical trial entitled, “GTB-5550"

Camelid Nanobody medical

"GTB-5550, a Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®)"

A camelid nanobody is a very small, naturally occurring antibody fragment derived from animals such as llamas and camels; think of it as a compact, highly focused version of a conventional antibody that can bind a target like a molecular Velcro. Investors should care because these tiny biologics often enter tissues more easily, can be cheaper and faster to manufacture, and open different drug or diagnostic paths than traditional antibodies, affecting R&D value and partnering potential.

Tri-Specific Killer Engager medical

"a Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®)"

A tri-specific killer engager is a lab-made protein that simultaneously binds three things—typically a marker on a cancer cell, a receptor on an immune “killer” cell (like a T cell or natural killer cell), and often a third molecule that boosts the interaction—forcing the immune cell to recognize and destroy the tumor cell. For investors, it matters because this design aims to increase precision and potency of cancer immunotherapy but also brings higher scientific, manufacturing and regulatory risks compared with simpler drugs.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What agreement did GTBP’s GT Biopharma sign with the University of Minnesota?

GT Biopharma signed an Investigator Initiated Clinical Trial Agreement with the Regents of the University of Minnesota. The University will sponsor an Investigational New Drug application for IND 169118 GTB-5550 and run a phase 1a/1b trial in advanced solid tumors that failed prior therapy.

How much will GT Biopharma (GTBP) fund for the GTB-5550 clinical study?

GT Biopharma will fund a study budget of up to approximately $3.8 million over three years. This amount covers funding and resources for the investigator-initiated phase 1a/1b trial of GTB-5550 in advanced solid tumors at the University of Minnesota.

What is the focus of GTBP’s GTB-5550 phase 1a/1b trial?

The GTB-5550 phase 1a/1b trial targets select advanced solid tumors that have failed prior therapy. It evaluates GTB-5550, a Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®), under an investigator-initiated study sponsored and led by the University of Minnesota.

Who sponsors the IND for GTBP’s GTB-5550 program with the University of Minnesota?

The Regents of the University of Minnesota will sponsor the Investigational New Drug application for IND 169118 GTB-5550. They also act as sponsor investigator for the phase 1a/1b trial, while GT Biopharma provides funding and resources under the clinical trial agreement.

Can GT Biopharma or the University terminate the GTB-5550 trial agreement?

Yes. Either GT Biopharma or the University may terminate the agreement at any time with thirty days’ written notice. The University may terminate immediately for health, welfare, or safety reasons, and either party can end it for an uncured material breach within a thirty-day cure period.

Do GT Biopharma and the University of Minnesota share publication rights for GTB-5550 results?

Yes. Both GT Biopharma and the University of Minnesota retain the right to publish the results of the GTB-5550 phase 1a/1b study. This structure lets each party independently disseminate clinical findings while operating under the terms of the Investigator Initiated Clinical Trial Agreement.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 04/07/2026 - 07:05 AM EDT Learn about SEC filing dates

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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: 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

Filing Exhibits & Attachments

5 documents

Agreements & Contracts

• EX-10.1 EX-10.1 176.3 KB

Other Documents

• EX-10 GRAPHIC 5.0 KB
• EX-101 XBRL SCHEMA FILE 3.0 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB