NAPLES, FL / ACCESS Newswire / November 19, 2025 / Patients battling aggressive blood cancers face limited treatment options and uncertain outcomes. Scientists have increasingly turned to the body's own defenses, developing therapies that empower natural killer (NK) cells to seek and destroy malignant cells. These next-generation approaches combine precision, potency, and the potential for fewer side effects than... Read More

Phase 1 trial evaluating GTB-3650 TriKE ® for relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues to actively enroll with the next update anticipated in Q1 2026 GTB-5550 TriKE ® IND submission for B7H3-expressing solid tumors expected in late December 2025 or January 2026 SAN FRANCISCO, CALIFORNIA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical... Read More

The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple... Read More

The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end Upon... Read More

SAN FRANCISCO, CALIFORNIA, Oct. 06, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE ® platform, today announced that Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma, will be participating in the Centurion One... Read More

The Company is available for one-on-one meetings at the H.C. Wainwright Conference September 8-10, 2025 in New York City Phase 1 trial evaluating GTBP-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues to enroll as expected, and the Company remains on track to release initial results from multiple dose cohorts later in 2025 Company remains on track for GTB-5550 TriKE ®... Read More

GTB-3650 TriKE ® Phase 1 trial has successfully completed Cohort 1 and Cohort 2 dosing, treating a total of four patients; following Cohort 2’s formal safety review, it has advanced into Cohort 3 and initiated dosing of the fifth patient in the study; initial Phase 1 data expected later in 2025 GTB-5550 TriKE ® IND submission for treatment of B7H3 positive solid tumors expected in Q4 2025; recent peer-reviewed publication... Read More

The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observed The company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ:... Read More

SAN FRANCISCO, CALIFORNIA, June 13, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (NK) cell engager platform, today announced the appointment of David C. Mun-Gavin to its Board of Directors. “We are very pleased to welcome David to the Board of... Read More

Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2. The company plans on releasing more detailed results from Phase 1 later in 2025 following completion of additional dose cohorts. SAN FRANCISCO, CALIFORNIA, May 19, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company... Read More

SAN FRANCISCO, CALIFORNIA, May 15, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc . (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (NK) cell engager platform, today announced the appointment of Andrew Ritter to its Board of Directors. Mr. Ritter will be replacing current board member Dr. Rajesh... Read More

SAN FRANCISCO, CALIFORNIA, May 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (NK) cell engager platform, today announced the appointment of Hilary Kramer to its Board of Directors. Mrs. Kramer will be replacing current board member Bruce Wendel, who... Read More

SAN FRANCISCO, CALIFORNIA, March 04, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (NK) cell engager platform, today announced that Jeffrey Miller, MD 1 from the University of Minnesota Medical School 2 will participate as an expert speaker at the 10th... Read More

SAN FRANCISCO, CALIFORNIA, Feb. 25, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (“NK”) cell engager platform, today announced that it has entered into definitive agreements for the exercise of certain existing warrants to purchase an aggregate of... Read More

SAN FRANCISCO, CALIFORNIA, Feb. 25, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE ® natural killer (“NK”) cell engager platform, today announced that it has filed a Request for Withdrawal with the U.S. Securities and Exchange Commission (“SEC”) with respect to the... Read More

Initial data from the Phase 1 trial expected in 2025 SAN FRANCISCO, CALIFORNIA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE ® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650,... Read More

GTB-3650 TriKE ® Phase 1 trial first patient dosed expected in Q4 2024; initial clinical data expected in Q2 2025 GTB-5550 TriKE ® IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025 GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating multiple solid tumor types, including prostate, breast, head and neck, ovarian, lung, liver, and GI GTB-7550 TriKE ® targets CD19 and... Read More

SAN FRANCISCO, CALIFORNIA, Sept. 26, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE ® platform, today announced that Dr. Jeffrey Miller, MD 1 , from the University of Minnesota Medical School 2 and GT Biopharma’s Consulting Senior Medical... Read More

SAN FRANCISCO, CALIFORNIA, Sept. 24, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE ® platform, today announced it will host a virtual KOL event on Thursday, October 10, 2024 at 12:00 PM ET. To register, click here. The event will feature... Read More

GTB-3650 TriKE ® Phase 1 trial initiation expected in 2H 2024; initial clinical data expected in 1H 2025 GTB-5550 TriKE ® IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025 GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating six solid tumor types, including prostate, breast, head and neck, ovarian, lung, and GI GTB-7550 TriKE ® is in preclinical development for... Read More

GTB-3650 Phase 1 trial initiation expected in H2 2024; initial clinical data expected in H1 2025 GTB-5550 TriKE ® IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025 GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating GTB-5550 in six solid tumor cancers, including prostate, breast, head and neck, ovarian, lung, and GI Cash runway anticipated to be sufficient to fund... Read More

BRISBANE, CALIFORNIA, May 21, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP) (the “Company”), today announced that it has entered into a definitive securities purchase agreements for the purchase and sale of 740,000 shares of the Company’s common stock at a purchase price of $4.35 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement,... Read More

IND clearance for GTB-3650, a 2 nd generation nanobody TriKE ® for treatment of CD33+ leukemia expected in Q2 2024 Phase 1 trial initiation with GTB-3650 expected in 2H 2024 Anticipate IND submission for GTB-5550 TriKE ® for treatment of B7H3 positive solid tumors in Q4 2024 Plan to initiate a Phase 1 dose escalation basket trial evaluating GTB-5550 in six solid tumor cancers – prostate, breast, head and neck, ovarian, lung,... Read More

Remain in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2 nd generation nanobody TriKE ® for treatment of CD33+ leukemia Phase 1 trial with GTB-3650 anticipated to start in 2H 2024 Anticipate submitting an IND for GTB-5550 targeting B7H3 for multiple solid tumors, including prostate and breast, in Q4 2024 Cash of approximately $14 million as of December 31, 2023, provides sufficient runway to fund... Read More

BRISBANE, CALIFORNIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP) (the “Company”), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, announced today that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-30. The reverse stock... Read More

The deadline for stockholders to vote (or change their vote) is 11:59 p.m. EST on Sunday, December 17, 2023 BRISBANE, California, Dec. 06, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (Nasdaq: GTBP) (the “Company”), announced that the two leading independent proxy advisory firms, Institutional Shareholder Services Inc. (“ISS”) and Glass Lewis & Co. (“Glass Lewis”), have recommended GT Biopharma stockholders entitled to vote... Read More

BRISBANE, CALIFORNIA, Dec. 04, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, today announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of GTB-3650, a... Read More

BRISBANE, CALIFORNIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, today announced positive preclinical data in highlighting GTB-5550’s potential in prostate cancer. Martin Felices, PhD, Associate Professor of Medicine at the... Read More

IND submission for GTB-3650, 2 nd generation nanobody TriKE ® for treatment of CD33+ leukemia, expected in Q4 2023 Phase 1 clinical trial initiation evaluating GTB-3650 for treatment of CD33+ leukemia anticipated in 2024 Cash of approximately $16 million as of September 30, 2023, provides ample runway to fund operations into 2H 2024; anticipated to be sufficient to initiate clinical trial activities on GTB-3650 BRISBANE,... Read More

Cash of approximately $18.0 million as of June 30, 2023, provides ample runway to fund operations into Q3 2024; anticipated to be sufficient to achieve IND clearance for GTB-3650 and initiate clinical trial activities on GTB-3650. BRISBANE, CALIFORNIA, Aug. 07, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics... Read More

BRISBANE, CALIFORNIA, Aug. 03, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, today announced that Dr. Jeffrey Miller, MD, GT Biopharma’s Consulting Chief Medical Officer and Consulting Chief Scientific Officer, will participate in a... Read More

Cash of approximately $19.9 million as of March 31, 2023, provides ample runway to fund operations into Q2 2024; anticipated to be sufficient to achieve IND clearance for GTB-3650 and GTB-5550, and initiate clinical trial activities on GTB-3650. BRISBANE, CALIFORNIA, May 15, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative... Read More

BRISBANE, CALIFORNIA, May 04, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE ® platform, has named Charles J. Casamento to fill a vacant seat on the Board and to serve as a member of the Audit Committee of the Board, the Compensation... Read More

Proforma cash of approximately $23.0 million includes $16.5 million in cash as of December 31, 2022, plus $6.5 million in gross proceeds received from a registered direct offering priced at a premium to market on January 4, 2023. Cash on hand, coupled with significant recent cost reduction efforts, is expected to provide ample runway to fund operations into Q2 2024; anticipated to be sufficient to achieve IND clearance for... Read More

BRISBANE, CALIFORNIA, Feb. 24, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, today announced that Dr. Jeffrey Miller, MD, GT Bipharma’s Consulting Chief Medical Officer and Chief Scientific Officer, will present a corporate overview at H.C.... Read More

BRISBANE, CALIFORNIA, Feb. 02, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, issued an open letter from the CEO to shareholders, detailing the Company’s recent activities. The full letter is published below: Dear GT... Read More

BRISBANE, CALIFORNIA, Dec. 30, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, today announced that it has entered into a definitive securities purchase agreement for the purchase and sale of 6,500,000 shares of the... Read More

BRISBANE, CALIFORNIA, Dec. 14, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE ® platform, has named Dr. Jeff Miller, renowned NK Cell Cancer Specialist as Consulting Chief Medical Officer. Dr. Miller* is currently Professor of... Read More

Presentation shows the therapeutic potential of combining iPSC-derived CAR NK cells and NK cell engagers to overcome the clinical heterogeneity of AML BRISBANE, CALIFORNIA, Dec. 12, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (NASDAQ: GTBP) today announced the presentation of new preclinical data at the American Society of Hematology's 64th Annual Meeting (ASH 2022). The presentation highlights the potential of a novel dual... Read More