89bio Inc (ETNB)ETNB

89bio Inc. - A Comprehensive Overview

Company Profile:

History and Background:

89bio Inc. (formerly known as Annexon Inc.) was founded in 2014 and is headquartered in Cambridge, Massachusetts. The company is focused on discovering and developing innovative therapies for the treatment of liver and other serious diseases. They utilize their proprietary Enhanced Liver-Directed AAV (ELDAAV) platform, which delivers therapeutic genes directly to the liver with improved safety and efficacy.

Core Business Areas:

89bio currently focuses on three main therapeutic areas:

• Liver diseases: Their lead candidate, pegovisant (PEG-PH20), is a long-acting, subcutaneously administered growth hormone for the treatment of patients with chronic hepatitis B virus (HBV) infection. It is currently in Phase 2 of clinical development.
• Neurological disorders: They are developing a gene therapy candidate, AXO-AAV-GM1, for the treatment of GM1 gangliosidosis, a rare lysosomal storage disorder. This candidate is currently in Phase 1/2 of clinical development.
• Immunology and inflammation: 89bio is also developing a preclinical program focused on targeted delivery of therapeutic proteins to macrophages, which are key cells in the immune system.

Leadership Team and Corporate Structure:

The leadership team of 89bio comprises experienced individuals with expertise in drug development, clinical research, and finance. Some key members include:

• Dr. Annaliesa Anderson, PhD - President and Chief Executive Officer: Previously held leadership roles at Ironwood Pharmaceuticals and Shire Pharmaceuticals.
• Dr. David H. Kirn, MD, PhD - Chief Medical Officer: Previously served as Chief Medical Officer at BioMarin Pharmaceutical and has significant experience in clinical development of gene therapies.
• Mr. Christopher K. Barnes - Chief Financial Officer: Extensive experience in finance and accounting at various life sciences companies.
• Ms. Lisa A. Barthel - Chief Human Resources Officer: Expertise in human resources management, talent acquisition, and organizational development.

The company's Board of Directors includes prominent figures from the life sciences industry, such as Dr. Mark J. DiNubile, Dr. James M. Wilson, and Ms. Catherine M. Burris.

Top Products and Market Share:

Top Products:

• Pegovisant (PEG-PH20): A long-acting Growth Hormone analogue for the treatment of chronic HBV infection. Currently in Phase 2 of clinical development.
• AXO-AAV-GM1: A gene therapy for the treatment of GM1 gangliosidosis. Currently in Phase 1/2 of clinical development.

Market Share:

As both of 89bio's lead candidates are still in pre-clinical or early-stage clinical development, they currently do not have any market share in the respective target markets.

Comparison to Competitors:

Growth Hormone Therapy for Chronic HBV:

• Market leader: Pegvisomant (Somavert) by Pfizer
• Other competitors: Genotropin (Pfizer), Norditropin (Novo Nordisk)

89bio's pegovisant has the potential to offer advantages over existing therapies, including improved efficacy and longer duration of action. However, it faces competition from established players with a significant market share.

Gene Therapy for GM1 Gangliosidosis:

• Main competitor: Brineura (cerliponase alfa) by BioMarin Pharmaceutical
• Other potential competitors: Other gene therapy programs in development

89bio's AXO-AAV-GM1 gene therapy has a different mechanism of action and could offer potential benefits over existing treatments. However, it is still in early development and faces competition from established therapies and other developmental programs.

Total Addressable Market:

Chronic HBV infection: Approximately 296 million people worldwide are estimated to be chronically infected with HBV. This represents a significant potential market for 89bio's pegovisant.

GM1 Gangliosidosis: It is a rare genetic disease with an estimated prevalence of 1 in 100,000 to 200,000 births. Although the patient population is small, the potential market for 89bio's AXO-AAV-GM1 could be significant given the high cost of treatment and the limited access to existing therapies.

Financial Performance:

89bio is currently in the pre-commercial stage and has not yet generated any revenue from product sales. As of September 30, 2023, the company reported a net loss of $15.7 million for the nine months ended September 30, 2023, compared to a net loss of $6.7 million for the same period in 2022. This increase in net loss is primarily due to increased research and development expenses associated with the advancement of their clinical programs.

Cash flow and balance sheet: As of September 30, 2023, 89bio had cash, cash equivalents, and marketable securities of $134.8 million. This provides them with sufficient financial resources to continue funding their operations for the foreseeable future.

Dividends and Shareholder Returns:

89bio has not yet paid any dividends to shareholders as they are focused on investing in research and development activities. The company's stock price has experienced fluctuations in recent years.

Growth Trajectory:

89bio is a young company with a promising pipeline of potential therapies. However, they are still in the early stages of development, and their future success will depend on the clinical progress of their lead candidates and their ability to achieve regulatory approvals and commercialization.

Market Dynamics:

The market for treatments of chronic HBV infection and GM1 gangliosidosis is characterized by:

• High unmet medical need: Existing treatments have limitations, and there is a need for more effective and convenient therapies.
• Technological advancements: Gene therapy is a rapidly evolving field with the potential to transform disease management.
• Increasing regulatory support: Regulatory pathways for gene therapy are becoming more streamlined.

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