CEL-SCI Corp (CVM)

CEL-SCI Corp.: A Comprehensive Overview

Company Profile:

Detailed history and background:

CEL-SCI Corporation, established in 1983, is a biopharmaceutical company with headquarters in Vienna, Virginia. They focus on developing novel immunotherapy treatments for various cancers. Their lead candidates include:

• Multikine: A gene-engineered immunotherapy for head and neck cancer.
• Leaky Immunotherapy: A platform technology enabling better targeting of immune cells.
• Human Leukocyte Antigen (HLA): A personalized immunotherapy platform targeting specific HLA types.

Core business areas:

CEL-SCI's primary business areas are:

• Research and development: Focusing on its lead candidates and other novel immunotherapies.
• Clinical trials: Conducting various clinical trials for its product candidates.
• Commercialization: Planning commercialization strategies for approved products.

Leadership and corporate structure:

Dr. Geert Kersten, M.D., Ph.D., serves as the company's President and Chief Executive Officer. He leads a team of experienced professionals with expertise in research, development, and commercialization. The company has a Board of Directors overseeing its governance and strategic direction.

Top Products and Market Share:

Top products and offerings:

• Multikine: Currently in Phase III clinical trials for head and neck cancer.
• Leaky Immunotherapy: Early-stage development platform for future cancer treatments.
• HLA: Personalized immunotherapy platform under research and development.

Market share:

CEL-SCI's products are not yet commercially available, therefore they do not have a market share at present. Multikine, if approved, would compete in the head and neck cancer treatment market, estimated to be worth USD 4.7 billion in 2022.

Product performance and market reception:

The Phase III clinical trial results for Multikine are expected in 2024. Initial data suggests promising efficacy and safety. Leak immunotherapy and HLA are in early development stages, therefore their market reception is yet to be determined.

Total Addressable Market:

The global immunotherapy market is expected to reach USD 189.3 billion by 2028, with the head and neck cancer immunotherapy segment being a significant portion of this market. Multikine, if approved, would target this substantial market.

Financial Performance:

Recent financial results:

As of June 30, 2023:

• Revenue: USD 0.3 million
• Net loss: USD 3.5 million
• EPS: (USD 0.04)
• Cash and equivalents: USD 13.5 million

Year-over-year comparison:

• Revenue decreased by 36% compared to the same period in 2022.
• Net loss increased by 10% compared to the same period in 2022.
• EPS decreased by 12% compared to the same period in 2022.

Cash flow and balance sheet health:

CEL-SCI has a limited operating history and is currently in the development stage. They have negative cash flow from operations and rely on external financing for their activities. Their balance sheet shows a limited amount of cash reserves.

Dividends and Shareholder Returns:

Dividend history:

CEL-SCI has not paid any dividends due to its development stage and need to reinvest profits into research and development.

Shareholder returns:

CEL-SCI's stock price has been volatile in recent years, reflecting the high-risk nature of its development-stage business model.

Growth Trajectory:

Historical growth:

CEL-SCI has experienced limited revenue growth in recent years due to its focus on research and development.

Future growth projections:

Future growth potential depends on the success of its clinical trials and commercialization efforts. Positive results from Multikine's Phase III trials could lead to significant revenue growth and market share gains.

Recent growth initiatives:

The company is actively pursuing partnerships and strategic collaborations to expand its development and commercialization capabilities.

Market Dynamics:

Industry overview:

The immunotherapy market is growing rapidly due to its potential to provide effective and personalized cancer treatments. Technological advancements and increasing awareness of immunotherapy among patients and healthcare professionals are driving market growth.

Competitive landscape:

CEL-SCI competes with several other companies developing immunotherapy treatments for head and neck cancer. Key competitors include:

• Bristol Myers Squibb (BMY)
• Merck & Co. (MRK)
• Pfizer (PFE)

CEL-SCI differentiates itself by focusing on its unique Multikine and Leaky Immunotherapy platforms.

Challenges and Opportunities:

Key challenges:

• Funding: CEL-SCI's reliance on external financing poses a challenge.
• Regulatory approval: Obtaining regulatory approval for its product candidates is a complex and lengthy process.
• Competition: The company faces competition from established players in the immunotherapy market.

Key opportunities:

• Market growth: The expanding immunotherapy market offers significant growth potential.
• Technological advancements: CEL-SCI's novel immunotherapy platforms offer the potential for breakthrough treatments.
• Partnerships: Strategic collaborations can provide access to additional funding and expertise.

Recent Acquisitions:

CEL-SCI has not made any acquisitions in the last 3 years.

AI-Based Fundamental Rating:

Based on an AI-based analysis considering financial health, market position, and future prospects, CEL-SCI receives a tentative rating of 5 out of 10. This rating reflects the company's high-risk profile due to its development stage and limited financial resources. However, the potential for Multikine's success and the company's innovative technologies offer promising long-term prospects.

Sources and Disclaimers:

This analysis is based on publicly available information from CEL-SCI Corp.'s website, financial reports, and other reputable sources. It is important to note that this information is subject to change and should not be considered investment advice. Please consult a qualified financial professional before making any investment decisions.