Gt Biopharma Inc Stock Price, News & Analysis

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.

GT Biopharma (NASDAQ: GTBP) reported Q3 2024 financial results with a net loss of $3.4 million, compared to $2.4 million in Q3 2023. The company maintains $6.5 million in cash, expected to fund operations into Q2 2025. R&D expenses remained flat at $1.3 million, while SG&A expenses increased to $2.3 million from $1.2 million year-over-year.

The company expects to dose its first patient in the GTB-3650 Phase 1 trial in Q4 2024, with initial clinical data expected in Q2 2025. Additionally, GTB-5550 IND submission for B7H3 positive solid tumors is planned for 1H 2025, with phase 1 trials expected to begin in 2025.

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.