Core Insights - GT Biopharma is advancing its clinical trials, with the first patient for the GTB-3650 TriKE® Phase 1 trial expected to be dosed in Q4 2024, and initial clinical data anticipated in Q2 2025 [1][2] - The company plans to submit an IND for GTB-5550 for treating B7H3 positive solid tumors in the first half of 2025, with a Phase 1 dose escalation trial expected to start in 2025 [1][2] - GTB-7550 TriKE® is in preclinical development targeting CD19 for autoimmune diseases [1][3] - As of September 30, 2024, the company has approximately $6.5 million in cash, expected to fund operations into Q2 2025 [1][5] Financial Performance - R&D expenses for Q3 2024 were $1.3 million, unchanged from Q3 2023, attributed to lower raw material costs but offset by increased scientific research costs [6] - SG&A expenses for Q3 2024 increased to $2.3 million from $1.2 million in Q3 2023, primarily due to higher legal and professional fees [7] - The company reported a net loss of $3.4 million for Q3 2024, compared to a net loss of $2.4 million in Q3 2023, with the increase mainly due to higher SG&A expenses and a reduction in the fair value of warrant liability [9][15] Research and Development - The company received FDA clearance for the IND application for GTB-3650 in June 2024, with expectations for increased clinical and preclinical expenses as trials progress [6] - The focus remains on the development of GTB-3650 and GTB-5550, with plans for further exploration of the TriKE platform technology for various indications [3][6] Market Position and Strategy - GT Biopharma is positioned in the immuno-oncology sector, leveraging its proprietary TriKE® NK cell engager platform to enhance the immune system's ability to target cancer [10] - The company is exploring combination therapies with NK cell therapies, indicating a strategic approach to broaden its therapeutic applications [3]

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 myel ...

As filed with the Securities and Exchange Commission on June 27, 2024 Registration No. 333-280326 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO THE FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 2834 94-1620407 State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer incorporation or organization Classification Code Number) Identification Number) ...

About GT Biopharma, Inc. Forward-Looking Statements be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-lo ...

"FDA clearance for GTB-3650 is a tremendous accomplishment and we look forward to submitting our next IND in the first quarter of 2025 for GTB-5550, which will target multiple solid tumors", said Michael Breen, Executive Chairman and Interim Chief Executive Officer of GT Biopharma. "As we ramp up our clinical activities, we plan to start the Phase 1 trial with GTB-3650 in the coming months followed by multiple data readouts in 2025. We also expect to start a basket trial with GTB-5550 for multiple solid tum ...

As filed with the Securities and Exchange Commission on June 18, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) incorporation or organization Classification Code Number) Identification Number) Delaware 2834 94-1620407 State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer 8000 Marina Blvd., Suite 100 ...

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, the Company will issue warrants to purchase up to 740,000 shares of common stock. Th ...

Group 1 - GT Biopharma (NASDAQ:GTBP) stock is experiencing significant trading activity, with over 10.6 million shares changing hands, far exceeding its daily average of approximately 10,000 shares [1][2] - The company's market capitalization is reported at $4.308 million, categorizing it as a penny stock, which is characterized by low trading volume [2] - As of Monday morning, GTBP stock has surged by 143%, indicating a substantial increase in value [3] Group 2 - The rise in GTBP stock is occurring without any accompanying news, press releases, or analyst coverage, suggesting that the movement may not be based on fundamental developments [2][3] - The penny stock status of GTBP raises concerns about potential market manipulation, as such stocks can be susceptible to traders who artificially inflate prices before selling for profit [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2024. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 94-1620407 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number: 001-40023 GT BIOPHARMA, INC. (Exact name of Registrant as specified in its charter) | Delaware | 94-1620407 ...