GT Biopharma Inc (GTBP)

GT Biopharma Inc. (NASDAQ: GTBIO): A Comprehensive Overview

Company Profile

Detailed History and Background:

GT Biopharma Inc. (GT Biopharma) was founded in 2002 as Graviton Technologies, Inc. with a focus on developing protein-based therapeutics. In 2010, the company shifted its focus to the development of orally administered small molecule therapies for NASH (Non-alcoholic steatohepatitis) and viral infections.

Core Business Areas:

• Hepatitis B Virus (HBV) Cure: GT Biopharma's lead program is GTL-001, an oral capsid assembly modulator (CAM) designed to eliminate the Hepatitis B virus from infected individuals.
• Non-Alcoholic Steatohepatitis (NASH): The company is developing GTL-003, an oral ASK1 inhibitor, for the treatment of NASH.

Leadership and Corporate Structure:

• Timothy C. Rodell, Ph.D.: President, Chief Executive Officer, and Chairman of the Board of Directors
• Dr. Gary Glick: Chief Medical Officer
• Dr. Kevin Poulin: Chief Scientific Officer
• Dr. John B. Crittenden, CFA: Chief Financial Officer

Top Products and Market Share:

Top Products:

• GTL-001 (ViroPharma): An oral CAM in Phase 2b clinical trial for the treatment of chronic HBV infection.
• GTL-003 (GTx-003): An oral ASK1 inhibitor in Phase 2a clinical trial for the treatment of NASH.

Market Share:

• Neither GTL-001 nor GTL-003 are currently marketed, so they do not hold a market share.

Total Addressable Market (TAM):

The global market for HBV therapeutics is estimated to reach $2.6 billion by 2027, while the global NASH treatment market is projected to reach $35 billion by 2028.

Financial Performance:

• Revenue: GT Biopharma does not currently generate revenue as it is in the clinical development stage.
• Net Income: The company has consistently incurred net losses, with a net loss of $31.4 million in 2022.
• EPS: EPS for 2022 was -$0.78.
• Cash Flow: The company's cash flow from operations was negative $27.5 million in 2022.
• Balance Sheet: The company has a cash and cash equivalents balance of $33.2 million as of December 31, 2022.

Dividends and Shareholder Returns:

• Dividends: GT Biopharma does not pay dividends as it is a clinical-stage company reinvesting its resources into R&D.
• Shareholder Returns: Total shareholder return for the last year has been negative.

Growth Trajectory:

• GT Biopharma is in the early stages of clinical development for GTL-001 and GTL-003. Success in the clinic and potential regulatory approval would drive future growth.
• The company has a pipeline of other preclinical programs, which could contribute to future growth.

Market Dynamics:

• The market for HBV therapeutics is competitive, with established players such as Gilead Sciences (GILD) and Bristol Myers Squibb (BMY).
• The NASH treatment market is also competitive, with several companies developing new therapies.

Competitors:

• HBV Treatment: Gilead Sciences (GILD), Bristol Myers Squibb (BMY), Intercept Pharmaceuticals (ICPT)
• NASH Treatment: Intercept Pharmaceuticals (ICPT), Genfit (GNFT), NGM Biopharmaceuticals (NGM)

Competitive Advantages and Disadvantages:

• Advantages: Novel therapeutic approaches with GTL-001 and GTL-003, experienced management team.
• Disadvantages: No approved products, relatively early-stage clinical development pipeline.

Potential Challenges and Opportunities:

• Challenges: Competition in the HBV and NASH markets, potential delays in clinical development, regulatory hurdles.
• Opportunities: Success in clinical trials and regulatory approval of GTL-001 and GTL-003, potential partnerships or acquisitions to expand pipeline.

Recent Acquisitions:

GT Biopharma has not made any acquisitions in the last 3 years.

AI-Based Fundamental Rating:

Based on current financial metrics, market position, and future potential, GT Biopharma receives a speculative rating of 5/10. This rating is subject to change based on future developments.

Sources and Disclaimers:

• Company website: https://gtbiopharma.com/
• SEC filings: https://www.sec.gov/edgar/search/
• Financial data: Yahoo Finance

This overview is for informational purposes only and should not be construed as investment advice. Please conduct your own due diligence before making any investment decisions.