GT Biopharma, Inc. is a Delaware-incorporated biotechnology firm focusing on developing therapeutics, with active licensing, clinical, and research collaborations, and a market valuation around $5.1 million as of June 2024.

# Company Summary – GT Biopharma, Inc.

**Overview:**
GT Biopharma, Inc. is a biotechnology company incorporated in Delaware, with IRS organization number 94-1620407. It is publicly traded under the symbol **GTBP** on the Nasdaq Capital Market, with par value of $0.001 per share.

**Business Focus:**
The company operates in the biotechnology sector, focusing on developing and commercializing therapeutics and treatment options, as evidenced by its licensing agreements with the Regents of the University of Minnesota and other research collaborations. It has intellectual property related to its treatments, including various certificates of incorporation and amendments, as well as licensing agreements for specific research and development activities.

**Operational Details:**
- **Number of Employees:** The specific number of employees is not provided.
- **Number of Customers:** The company does not specify its customer base.
- **Revenue and Income:** There are no financial figures such as revenue or net income included in this document.
- **Market Capitalization:** As of June 30, 2024, the company's estimated market value held by non-affiliates was approximately **$5.1 million**.
- **Shares Outstanding:** As of February 19, 2025, there were **2,234,328** shares of common stock issued and outstanding.

**Corporate Structure & Filings:**
- The company has multiple amendments to its certificate of incorporation and bylaws, reflecting ongoing organizational and structural changes.
- It has various agreements related to licensing, clinical trials, securities purchase, and employment, indicating active research and financing activities.
- Its corporate governance includes certifications under Sarbanes-Oxley, with principal executive and financial officers named, including Michael Breen (Executive Chairman and Interim CEO) and Alan Urban (CFO).

**Key Activities:**
- Licensing agreement with the University of Minnesota for research and development.
- Multiple securities and convertible note agreements with investors.
- Ongoing clinical trial collaborations.
- Management contracts and employment agreements with key personnel.
- The company has transitioned to a fully remote working model as of July 1, 2024.

**Regulatory and Disclosure:**
- Filed its annual report (Form 10-K/A) with the SEC, including various exhibit filings such as certificates, agreements, and policies.
- Does not appear to be a large accelerated or accelerated filer; it is classified as a smaller reporting company and emerging growth company.

*Note:* No specific financial data such as revenue, net income, or detailed operational metrics beyond market valuation, shares outstanding, and employee count are available in this document.

GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing novel immuno-oncology products using its proprietary TriKE technology platform.

# GT Biopharma, Inc. Overview

## Company Background
GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel immuno-oncology products using its proprietary Tri-specific Killer Engager (TriKE®) technology platform. The company was formerly known as OXIS International, Inc. and has undergone several name changes and organizational shifts since its inception in 1965.

## Business Focus
GT Biopharma specializes in harnessing the power of natural killer (NK) cells to treat a variety of hematologic malignancies and solid tumors. The TriKE® technology utilizes a specially designed fusion protein to enhance the cytotoxic effect of NK cells against cancer cells and virus-infected cells. The key features of the TriKE® platform include:

- **Targeting Ability:** TriKE® can target multiple tumor antigens simultaneously, applicable to both hematologic malignancies and solid tumors.
- **Non-Customization:** Unlike some personalized therapies, TriKE® products do not require patient-specific customization, allowing for scalable production.
- **Combination Therapy Potential:** TriKE®s may function as standalone therapies or in conjunction with existing treatments.

## Product Candidates

1. **GTB-3550 TriKE®**
   - Initially developed for treating CD33-expressing high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
   - Phase 1 clinical trial started in September 2019; completed enrollment in September 2021.

2. **GTB-3650 TriKE®**
   - A next-generation product candidate derived from GTB-3550.
   - Targets CD33 on relapsed/refractory AML and high-risk MDS, demonstrating enhanced potency in preclinical studies.
   - An IND application was filed in December 2023, with anticipated enrollment beginning in the second half of 2024.

3. **GTB-5550 TriKE®**
   - Targets B7-H3 on solid tumors, with a focus on various cancers including head and neck, breast, and lung cancers.
   - Pre-IND packet filed with the FDA in October 2023, with plans to initiate clinical studies in the first half of 2025.

## Operational Details

- **Employees:** The company has 2 full-time employees and utilizes the services of 8 consultants.
- **Revenue:** As of December 31, 2023, GT Biopharma reported no revenue generated to date.
- **Net Income/Loss:** For the year ended December 31, 2023, the company reported a net loss of $7.6 million and has an accumulated deficit of $682.1 million.

## Customer Base
While specific customer numbers are not detailed, GT Biopharma focuses on collaborations with research institutions and potential partnerships with larger pharmaceutical companies to commercialize its immuno-oncology products.

## Manufacturing and Compliance
GT Biopharma relies on third-party manufacturers to produce its clinical product candidates, ensuring compliance with FDA’s current Good Manufacturing Practices (cGMP).

## Clinical Trials
The company conducts clinical trials to demonstrate the safety and efficacy of its product candidates, addressing significant medical needs in the oncology space, particularly for hematologic malignancies and solid tumors.

## Conclusion
GT Biopharma, Inc. aims to become a leader in immuno-oncology therapies, focusing on the development of innovative treatments based on its proprietary TriKE® technology platform, with a commitment to extending its product pipeline and achieving regulatory approvals.

GT Biopharma, Inc.

10-K / April 14, 2025

10-K / March 26, 2024

10-K / April 14, 2025

Company Summary – GT Biopharma, Inc.