GT Biopharma Inc. - GTBP STOCK NEWS

GT Biopharma (NASDAQ: GTBP) announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York, NY. Dr. Jeffrey Miller, GT Biopharma's Consulting Senior Medical Director, will join a panel discussion on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

The panel, titled 'Focus: Hematologic malignancies', is scheduled for 1:15-1:55 pm ET. Dr. Miller, who is also the Deputy Director of the Masonic Cancer Center and Co-Leader of the Immunology Program at the University of Minnesota Medical School, will share insights on GT Biopharma's NK cell engager TriKE® platform.

Company management will be available for one-on-one meetings during the event. Interested parties can arrange meetings through their ROTH representatives.

GT Biopharma, Inc. (NASDAQ: GTBP) has announced a virtual KOL event scheduled for October 10, 2024 at 12:00 PM ET. The event will feature Dr. Jeffrey Miller and Dr. Mark Juckett from the University of Minnesota Medical School, who will discuss the NK cell therapy landscape and its potential beyond oncology.

Dr. Miller will focus on GT Biopharma's TriKE® platform and its extensive pipeline of NK cell engagers. Dr. Juckett will address the upcoming Phase 1 trial of GTB-3650 for acute myeloid leukemia (AML) treatment, expected to start in Q4.

The event aims to provide insights into current limitations and future directions of NK cell therapy, including its potential in inflammatory autoimmune indications. A live Q&A session will follow the presentation.

GT Biopharma (NASDAQ: GTBP) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

1. GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024, with initial clinical data in 1H 2025.

2. GTB-5550 TriKE® IND submission for B7H3 positive solid tumors expected in 1H 2025, with Phase 1 trial initiation in 2025.

3. GTB-7550 TriKE® in preclinical development for autoimmune indications.

4. Cash position of $9.2 million as of June 30, 2024, expected to fund operations into 2025.

5. Q2 2024 financial results: R&D expenses decreased to $1.8 million, SG&A expenses increased to $2.1 million, and net loss increased to $3.7 million compared to Q2 2023.

GT Biopharma (NASDAQ: GTBP), a clinical-stage immuno-oncology company, has announced FDA clearance for its Investigational New Drug (IND) application for GTB-3650, a novel NK cell engager targeting CD33+ leukemia. The Phase 1 trial for GTB-3650 is set to begin in the second half of 2024, with initial clinical data expected in the first half of 2025. Additionally, GT Biopharma plans to submit an IND for GTB-5550, targeting B7H3 positive solid tumors, in Q1 2025, with the corresponding Phase 1 trial expected to start later in 2025. The current cash runway is expected to fund operations into 2025. GTB-3650 will be assessed in a dose-escalation study involving adult patients with relapsed or refractory CD33 expressing hematologic malignancies, including AML and high-risk MDS. The study will evaluate safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity.

GT Biopharma (NASDAQ: GTBP) announced a registered direct offering involving the sale of 740,000 common stock shares at $4.35 each, totaling approximately $3.2 million before fees. Concurrently, the company will issue warrants to purchase another 740,000 shares at the same price, exercisable immediately and valid for five years. The offering, expected to close by May 23, 2024, aims to fund general corporate purposes. Roth Capital Partners acts as the exclusive placement agent. The offer leverages a registration statement declared effective by the SEC in October 2022, while the warrants are issued in a private placement under Section 4(a)(2) of the Securities Act.

GT Biopharma (NASDAQ: GTBP) reported its Q1 2024 financial results and provided a corporate update. Key highlights include the anticipated IND clearance for GTB-3650, a nanobody TriKE® for CD33+ leukemia in Q2 2024, and Phase 1 trial initiation in 2H 2024. The company also expects to submit an IND for GTB-5550 in Q4 2024, targeting B7H3-positive solid tumors, with a Phase 1 trial planned for early 2025. GT Biopharma reported $9.81 million in cash as of March 31, 2024, enough to fund operations into 2025. R&D expenses decreased significantly to $777,000 from $1.65 million YoY, while SG&A expenses rose to $2.31 million from $2.02 million YoY. Net loss widened to $2.27 million from $227,000 in Q1 2023.

GT Biopharma, Inc. announces progress with FDA for GTB-3650 and plans for Phase 1 trial, submission of IND for GTB-5550, and cash position of $14 million. Financially, the company had a decrease in R&D and G&A expenses, an increase in other income, and reported a reduced net loss for Q4 and full-year 2023.

GT Biopharma, Inc. announces a reverse stock split at a ratio of 1-for-30 to regain compliance with the Minimum Bid Price Requirement of $1.00 per share for continued listing on The Nasdaq Capital Market. The reverse stock split reduces the number of outstanding common stock shares from approximately 41,419,000 shares to approximately 1,380,633 shares. The reverse stock split will become effective at 5:00 p.m. Eastern time, on February 2, 2024, and the Company's common stock will begin trading on a post-split basis at the market open on February 5, 2024 under the symbol 'GTBP'.

GT Biopharma, Inc. (NASDAQ: GTBP) has submitted an Investigational New Drug (IND) application for GTB-3650, a 2nd generation nanobody TriKE® for the treatment of CD33+ leukemia. The company aims to advance this molecule into the clinic in 2024.