Gt Biopharma Inc Stock Price, News & Analysis

GT Biopharma (NASDAQ: GTBP) has advanced to Cohort 3 in its Phase 1 clinical trial of GTB-3650, following successful safety reviews of Cohorts 1 and 2. GTB-3650, a second-generation TriKE® natural killer cell engager, is being evaluated for treating relapsed/refractory CD33-expressing hematologic malignancies.

The trial's first four patients have shown encouraging early results, demonstrating GTB-3650's ability to activate and expand NK cells, with multiple blood biomarker assays indicating heightened immune activity. The study plans to enroll up to 14 patients across seven cohorts, with dosing in two-week cycles for up to four months. Initial Phase 1 results are expected later in 2025.

GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, has appointed David C. Mun-Gavin to its Board of Directors. Mun-Gavin brings decades of executive leadership experience, having served as Client Director in International Private Banking at institutions including Credit Suisse, Swiss Bank Corporation Investment Banking, and Bankers Trust International. He also held the CEO position at Vanol Group, an international oil trading company, and is a qualified Chartered Accountant. The appointment comes as GT Biopharma approaches its first data readout for GTBP-3650 and plans to expand its NK-engager pipeline into broader indications in 2026.

GT Biopharma (NASDAQ: GTBP) has announced significant progress in its Phase 1 trial of GTB-3650, a second-generation TriKE® natural killer cell engager, for treating relapsed/refractory CD33 expressing hematologic malignancies. The company has successfully completed Cohort 1 with no safety or tolerability issues and has initiated Cohort 2. Early results from Cohort 1 showed promising signs of increased immunologic activity, demonstrating GTB-3650's ability to activate and expand NK cells. The trial aims to evaluate approximately 14 patients across seven cohorts, with dosing administered in two-week cycles for up to four months. Complete results are expected later in 2025 after additional cohort completions.

GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, has announced the appointment of Andrew Ritter to its Board of Directors, replacing Dr. Rajesh Shrotriya. Ritter brings over 20 years of leadership experience in biotechnology and healthcare technology to GTBP's board.

Currently serving as CEO of Cairns Health, Ritter's track record includes successful leadership roles at Docbot and Ritter Pharmaceuticals. At Ritter Pharmaceuticals, which he founded and led for nearly 17 years, he guided the company through clinical trials and achieved a NASDAQ listing. He holds a B.A. from USC and an MBA from Wharton.

GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, has appointed Hilary Kramer to its Board of Directors, replacing Bruce Wendel. Kramer, the Founder and Chief Investment Officer of GreenTech Research, brings extensive experience in investment management and corporate governance. She previously served as Senior Managing Director and CIO for a $12 billion family office portfolio and held board positions at several public companies. Her background includes roles at Lehman Brothers, Morgan Stanley, and General Mills. Kramer holds a B.A. from Wellesley College and an MBA from Wharton School.

GT Biopharma (NASDAQ: GTBP) announced its participation in the 10th Anniversary of the Innate Killer Summit in San Diego from March 3-5, 2025. Dr. Jeffrey Miller from the University of Minnesota Medical School will present as an expert speaker, discussing tri-specific engagers' mechanisms in enhancing NK cell activity.

The company's second-generation TriKE®, GTB-3650, is currently in a Phase 1 dose escalation study for patients with hematological malignancies. The trial will evaluate:

• Up to 14 patients across seven cohorts
• Focus on relapsed or refractory CD33 expressing hematologic malignancies
• Including refractory acute myeloid leukemia (AML)
• High-risk myelodysplastic syndrome (MDS)

Enrollment is progressing as planned, with initial data expected in 2025. The trial is registered on clinicaltrials.gov under identifier NCT06594445.

GT Biopharma (NASDAQ: GTBP) has announced agreements for the exercise of existing warrants to purchase 302,069 shares of common stock. The warrants, originally issued in May 2024 with a $4.35 exercise price, will now be exercised at $2.27 per share, generating approximately $0.7 million in gross proceeds before fees.

In exchange for the immediate exercise, the company will issue new unregistered warrants to purchase 604,138 shares at $2.02 per share. Half of these new warrants have a five-year term, while the other half expire in eighteen months. The offering, with H.C. Wainwright & Co. as exclusive placement agent, is expected to close around February 27, 2025.

The proceeds will be used for working capital and general corporate purposes. The new warrants are being offered through private placement and the company will file a registration statement for the resale of shares issuable upon exercise.

GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company developing therapeutics based on their proprietary TriKE® natural killer (NK) cell engager platform, has filed a Request for Withdrawal with the SEC regarding their Form S-1 Registration Statement (File No. 333-284032).

The Registration Statement, originally filed on December 23, 2024, had not been declared effective by the SEC, and no securities were sold in connection with the offering described in the document. The company clarified that this announcement does not constitute an offer to sell or solicitation to buy the Company's common stock or any securities.

GT Biopharma further emphasized that no offer, solicitation, or sale of securities mentioned would occur in any state or jurisdiction where such actions would be unlawful prior to proper registration or qualification under applicable securities laws.

GT Biopharma (NASDAQ: GTBP) has announced the dosing of its first patient in a Phase 1 trial of GTB-3650, its second-generation TriKE therapy, for treating relapsed or refractory CD33 expressing hematologic malignancies. The trial will evaluate up to 14 patients across seven cohorts, focusing on conditions including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

GTB-3650, utilizing camelid nanobody technology, will be administered in two-week blocks (two weeks on, two weeks off) for up to four months. The study aims to assess safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity. Initial data from this Phase 1 trial is expected in 2025.