GT Biopharma Announces Sponsored Research Agreement With Dr. Jeffrey S. Miller Of The University Of Minnesota

TriKE™ monotherapy has demonstrated in its first-in-class clinical trial the ability to revive the patient's exhausted/inhibited NK cells, significantly reduce cancer cell numbers, and to do so without any toxicities including no cytokine release syndrome (CRS). Highlights to date from patients treated with GTB-3550 TriKE™ monotherapy in the dose escalation Phase 1 clinical trial for the treatment of high-risk MDS and refractory/relapsed AML:

• 57% of patients experienced significant reduction in AML/MDS cancer cell burden when treated with doses of GTB-3550 ranging from 25mcg/kg/day to 150mcg/kg/day.
• Up to 63.7% reduction in bone marrow blast levels observed in some patients.
• GTB-3550 was well tolerated by all patients with no cytokine release syndrome observed.
• Restoration of patient's endogenous NK cell function, proliferation and immune surveillance observed in all patients – No progenitor-derived or autologous/allogenic cell therapy required.

"We have now completed treatment of eleven patients.  In addition to strong safety results, we have seen significant reductions in CD33+ cancer cells," stated Anthony Cataldo, Chairman and Chief Executive Officer of GT Biopharma. "We are pleased to sponsor additional TriKE™ research in Dr. Miller's laboratory in support of our TriKE™ clinical development programs," Mr. Cataldo further stated.

About GTB-3550 TriKE™ Clinical Trial

Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE™. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE™ NK cell engager platform. Our TriKE™ platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE™ technology. For more information, please visit gtbiopharma.com.

Forward-Looking Statements

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We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act, to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.

TriKE™ is a trademark of GT Biopharma, Inc.

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