SAN FRANCISCO, CALIFORNIA — August 14, 2025 — Leads & Copy — GT Biopharma, Inc. (NASDAQ: GTBP) announced its second quarter 2025 financial results and provided an update on its clinical trials. The company’s GTB-3650 TriKE® Phase 1 trial has completed Cohort 1 and Cohort 2 dosing, treating four patients. Following a safety review, it has advanced into Cohort 3 and initiated dosing of the fifth patient. Initial Phase 1 data is expected later in 2025.
GT Biopharma anticipates submitting an IND for GTB-5550 TriKE® for treating B7H3 positive solid tumors in Q4 2025. A recent peer-reviewed publication highlighted the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer.
The company reported cash of approximately $5.3 million as of June 30, 2025, which is expected to fund operations into Q1 2026.
Michael Breen, Executive Chairman and Chief Executive Office of GT Biopharma, said the company is pleased with the enrollment momentum in the Phase 1 clinical trial evaluating GTB-3650 in cancer patients. Breen added that moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650.
The Phase 1 dose escalation study is evaluating GTB-3650 in 12 patients with relapsed or refractory CD33 expressing hematologic malignancies. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. GT Biopharma plans to release more detailed results later in 2025 following enrollment and completion of additional dose cohorts.
R&D expenses for the second quarter ended June 30, 2025 were approximately $400,000 compared to $1.8 million for the same comparable quarter of 2024. SG&A expenses for the second quarter ended June 30, 2025 were approximately $1.1 million compared to $2.0 million for the same comparable quarter of 2024. The Company reported a net loss of approximately $1.4 million for the second quarter ended June 30, 2025 compared to a net loss of $3.7 million for the same comparable quarter in 2024.
Investor Relations Contact:
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
212-915-2577
Source: GT Biopharma, Inc.
