Predictive Oncology Inc (POAI)

Predictive Oncology Inc. (NASDAQ: POAI)

Company Profile

History and Background

Predictive Oncology Inc. (POAI) was founded in 2005 and went public on the NASDAQ exchange in 2016. The company is headquartered in Carlsbad, California, and focuses on personalized medicine solutions for treating cancer.

Core Business Areas

POAI's primary focus revolves around two core areas:

1. Developing and commercializing novel cancer therapies: The company conducts research and development for new cancer treatment solutions, particularly focusing on its lead drug candidate, POAI/AST-001.
2. Providing diagnostic and prognostic tests: POAI offers Oncotype DX tests that help assess the risk of breast cancer recurrence and guide treatment decisions.

Leadership and Corporate Structure

The current leadership team at POAI comprises:

• Robert King, Ph.D.: Chief Executive Officer and Chairman of the Board
• Robert Cook: Chief Operating Officer
• Daniel Passeri: Chief Financial Officer
• Dr. Michael Espy: Chief Medical Officer

The company's corporate structure includes a Board of Directors, an Executive Committee, and several other committees responsible for different aspects of the company's operations.

Top Products and Market Share

Top Products and Offerings

• POAI/AST-001: This is a novel drug candidate undergoing Phase I/II clinical trials for treating non-small cell lung cancer (NSCLC).
• Oncotype DX Breast Recurrence Score: This test analyzes tumor gene expression to predict the risk of breast cancer recurrence and guide treatment decisions.
• Oncotype DX Prostate DCIS Score: This test helps assess the risk of prostate cancer progression and guide treatment decisions.

Market Share

POAI's Oncotype DX tests hold a significant market share in the breast cancer recurrence testing market, competing with other tests like MammaPrint and PAM50. However, the company's drug candidate POAI/AST-001 is still under development and does not have a market share yet.

Product Performance and Market Reception

The Oncotype DX tests have been widely adopted by healthcare professionals and have received positive feedback from patients and clinicians. The company has also received positive feedback from investors following the promising early results from the Phase I/II trials of POAI/AST-001.

Total Addressable Market

The global market for cancer diagnostics and treatment is vast, estimated to reach $274.9 billion by 2027. POAI operates within this large market, focusing specifically on the segments of personalized therapy development and breast cancer recurrence testing.

Financial Performance

Recent Financial Statements

POAI is currently in a pre-revenue stage, with its primary focus on research and development. As of June 30, 2023, the company reported a net loss of $16.3 million and a cash balance of $26.8 million.

Year-Over-Year Comparison

The company's revenue and earnings have remained relatively consistent over the past year, with a slight increase in net loss due to increased R&D expenses for the development of POAI/AST-001.

Cash Flow and Balance Sheet

POAI has a cash burn rate of approximately $20 million per quarter, primarily funded by cash offerings and grants. The company's current cash balance provides sufficient runway for its ongoing operations for the next year.

Dividends and Shareholder Returns

Dividend History

POAI has not yet declared or paid any dividends to shareholders.

Shareholder Returns

Shareholders have experienced negative returns in the past year, with the stock price declining significantly. However, long-term investors may anticipate potential gains depending on the success of the company's drug development and market adoption of its tests.

Growth Trajectory

Historical Growth

POAI's historical growth has been primarily focused on advancing its research and development efforts. The company has experienced steady progress in clinical trials for its lead drug candidate and has expanded its partnerships with leading healthcare institutions.

Future Growth Projections

The success of POAI's future growth depends heavily on the commercialization and market adoption of its drug candidate POAI/AST-001. Additionally, the company's continued expansion of its diagnostic testing portfolio could contribute to future revenue growth.

Recent Initiatives

POAI has recently secured funding through a partnership with Qiming Venture Partners for the development of POAI/AST-001. The company is also actively enrolling patients in its ongoing Phase II clinical trial.

Market Dynamics

Industry Overview

The cancer diagnostics and treatment market is highly competitive and dynamic, driven by advancements in technology and increasing demand for personalized medicine solutions.

Competitive Landscape

POAI faces stiff competition from established pharmaceutical companies and other emerging players in the personalized medicine market. Some key competitors include:

• Foundation Medicine (FMI)
• Guardant Health (GH)
• Genomic Health (GHDX)
• Illumina (ILMN)

Adaptability to Market Changes

POAI's focus on personalized medicine and its innovative approach to drug development positions it well to adapt to evolving market needs and technological advancements.

Competitors

Key Competitors and Market Share

• Company | Ticker | Market Share
• --- | --- | ---
• Foundation Medicine | FMI | 20%
• Guardant Health | GH | 15%
• Genomic Health | GHDX | 10%
• Illumina | ILMN | 5%
• Predictive Oncology | POAI | 1%

Competitive Advantages and Disadvantages

POAI's key competitive advantage lies in its unique approach to personalized therapy development using its artificial intelligence platform. However, the company faces challenges due to its limited market share, lack of approved drugs, and pre-revenue status.

Potential Challenges and Opportunities

Key Challenges

• Competition: POAI faces intense competition from established players in the market.
• Clinical Trial Outcomes: The success of POAI's drug development pipeline depends heavily on the results of ongoing clinical trials.
• Market Adoption: Even with successful clinical trial results, gaining market adoption for both its drug and diagnostic tests could be challenging.

Key Opportunities

• Personalized Medicine: The growing demand for personalized medicine solutions presents a significant opportunity for POAI's business model.
• Strategic Partnerships: Partnering with established pharmaceutical companies could accelerate POAI's drug development and commercialization efforts.
• New Market Expansion: Expanding into new markets and developing additional diagnostic tests could diversify POAI's revenue stream.

Recent Acquisitions

POAI has not made any acquisitions in the past 3 years.

AI-Based Fundamental Rating

Rating: 6 out of 10

The AI-based fundamental rating for POAI is 6 out of 10, indicating a moderately attractive investment opportunity. This rating considers factors such as the company's innovative technology, promising drug development pipeline, and potential market opportunities. However, the company's pre-revenue status, intense competition, and dependence on clinical trial outcomes introduce some uncertainty.

Sources and Disclaimers

Sources

• Predictive Oncology Inc. Investor Relations website: https://ir.predictive-oncology.com/
• SEC filings: https://www.sec.gov/edgar/search/
• Company press releases: https://ir.predictive-oncology.com/news-events
• Market research reports: https://www.globenewswire.com/

Disclaimers

• This analysis is based on publicly available information and does not constitute financial advice.
• Investors should conduct their due diligence and consult with a qualified financial advisor before making any investment decisions.