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Phase 1 trial evaluating GTB-3650 TriKE ® continues to actively enroll, with the next update anticipated in Q3 2026 following completion of enrollment in dose Cohort 5
SAN FRANCISCO, CALIFORNIA, Feb. 17, 2026 (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 Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma, will be participating in the Centurion One Capital 9th Annual Toronto Growth Conference on Thursday, March 5th, 2026, in Toronto, Ontario.
GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor types known to express B7-H3 Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (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 FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. “FDA clearance of our third TriKE® IND, GTB-5550, represents a defining moment for GT Biopharma as we bring another NK cell engager into the clinic”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.
GT Biopharma targets a portion of the estimated $362 billion global solid tumor market Preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025 anticipated to extend cash runway into Q3 2026 SAN FRANCISCO, CALIFORNIA, Jan. 15, 2026 (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 submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the treatment of B7-H3 expressing solid tumor cancers. “The IND for GTB-5550 represents another NK cell engager we plan to move into clinical development and a tremendous accomplishment for the company”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.
GT Biopharma Inc. (NASDAQ: GTBP) on Thursday said it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE for solid tumors.
VANCOUVER, British Columbia, Dec. 24, 2025 (GLOBE NEWSWIRE) -- Equity Insider News Commentary - The U. S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034[1], driven by a fundamental shift in how physicians combat cancer's most resistant forms.
Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC , Dec. 19, 2025 /PRNewswire/ -- USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2].
/PRNewswire/ -- Triple-therapy immunotherapy approaches are demonstrating complete leukemia elimination in preclinical models by reprogramming how cancer cells
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.
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
SAN FRANCISCO, CALIFORNIA, Aug. 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 natural killer (NK) cell engager TriKE® platform, today announced second quarter 2025 financial results for the period ended June 30, 2025.
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, 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.
Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2.
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 is resigning his position.
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 302,069 shares of its common stock having an exercise price of $4.35 per share, originally issued in May 2024. The resale of the shares of common stock issuable upon exercise of the existing warrants is registered pursuant to an effective registration statement on Form S-1 (File No. 333-280326). The gross proceeds to the Company from the exercise of the existing warrants are expected to be approximately $0.7 million, prior to deducting placement agent fees and offering expenses payable by the Company.
SAN FRANCISCO, CALIFORNIA, Nov. 14, 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 third quarter 2024 financial results for the period ended September 30, 2024.
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, MD1, from the University of Minnesota Medical School2 and GT Biopharma's Consulting Senior Medical Director, will participate in a panel discussion on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 3rd Annual ROTH Healthcare Opportunities Conference taking place October 9, 2024 in New York, NY. Company management will also be participating in 1x1 meetings during the event.
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.
SAN FRANCISCO, CALIFORNIA, June 27, 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 FDA clearance of its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to start in second half of 2024.