CEL-SCI Corporation (CVM): History, Ownership, Mission, How It Works & Makes Money

What drives a clinical-stage biotechnology company like CEL-SCI Corporation (CVM) to invest millions, reporting research and development expenses of $5.5 million in just the first quarter of fiscal year 2024, despite a net loss of $9.2 million during the same period? This entity stands distinctively positioned, primarily focused on advancing its lead immunotherapy candidate, Multikine, through the final, rigorous stages of clinical trials aimed at treating head and neck cancer. Understanding its journey, operational mechanics, and the path it carves towards potential revenue generation is crucial for anyone tracking the biopharma landscape. Are you ready to delve deeper into the history, ownership structure, and innovative approach that defines this company's pursuit of breakthrough cancer treatments?

CEL-SCI Corporation (CVM) History

CEL-SCI Corporation's Founding Timeline

Year established

CEL-SCI Corporation was founded in 1983.

Original location

The company was initially established in the Alexandria, Virginia area, later moving its headquarters to Vienna, Virginia.

Founding team members

While specific roles evolved, Maximilian de Clara is associated with the company's early conceptual stages. Geert Kersten has served as CEO for a significant portion of the company's history, guiding its clinical development strategy.

Initial capital/funding

Details on the precise initial seed capital from 1983 are not commonly disclosed in recent public filings. Like many biotechs founded decades ago, early funding often came from private investors before accessing public markets.

CEL-SCI Corporation's Evolution Milestones

The company's journey has been heavily focused on advancing its immunotherapy platform.

CEL-SCI Corporation's Transformative Moments

Initiation of the Multikine Phase III Trial

Launching the global Phase III trial in 2007 (with treatment starting later) represented a massive commitment of resources and focus. This decision locked the company into a long, high-stakes development path centered on proving Multikine's efficacy in head and neck cancer, shaping its identity for over a decade and a half.

Completion and Reporting of Phase III Trial Data

Concluding the enrollment and eventually reporting top-line data (2016-2021) were pivotal. The results, indicating benefit in a subgroup but missing the broader primary endpoint, created a complex situation, fundamentally altering the narrative and requiring a strategic pivot towards seeking approval based on specific patient populations identified in the analysis.

Sustained Fundraising for Long-Term R&D

Throughout its history, particularly during the lengthy Phase III trial, CEL-SCI relied heavily on raising capital through stock offerings and warrants. Successfully securing funding, often in challenging market conditions for clinical-stage biotechs, was crucial for survival and continued operations. For instance, various registered direct offerings and private placements occurred through the 2010s and into the 2020s to fund the trial and operations, demonstrating a persistent effort critical to reaching data readout. This long-term vision is often reflected in the Mission Statement, Vision, & Core Values of CEL-SCI Corporation (CVM).

CEL-SCI Corporation (CVM) Ownership Structure

CEL-SCI Corporation operates as a publicly traded entity, meaning its shares are available for purchase by the general public, institutions, and insiders. Understanding who holds these shares provides insight into the company's governance and potential influences on its strategic direction.

CEL-SCI Corporation's Current Status

As of the end of 2024, CEL-SCI Corporation is a publicly listed company. Its common stock trades on the NYSE American stock exchange under the ticker symbol CVM.

CEL-SCI Corporation's Ownership Breakdown

The ownership structure reflects a mix of different shareholder types. Examining this breakdown is crucial for anyone interested in Breaking Down CEL-SCI Corporation (CVM) Financial Health: Key Insights for Investors. Based on data available towards the end of the 2024 fiscal year, the approximate distribution is as follows:

CEL-SCI Corporation's Leadership

The strategic direction and day-to-day operations of the company are guided by its executive leadership team and board of directors. As of late 2024, key figures steering the organization include:

• Geert Kersten: Chief Executive Officer and Director
• Patricia Prichep: Senior Vice President of Operations

The Board of Directors provides oversight, ensuring alignment with shareholder interests and corporate governance standards.

CEL-SCI Corporation (CVM) Mission and Values

CEL-SCI Corporation is fundamentally driven by a commitment to advancing immune system treatments for critical diseases. Their core purpose revolves around developing innovative therapies aimed at improving patient outcomes in areas like cancer and infectious diseases.

CEL-SCI's Core Purpose

Understanding the foundational principles guiding a company like CEL-SCI offers insight into its long-term strategy and operational focus. These statements articulate the company's aspirations and the values underpinning its research and development efforts.

Official mission statement

CEL-SCI's stated mission is generally focused on the discovery, development, and commercialization of novel immunotherapy products for the treatment of cancer and other diseases by utilizing the patient's own immune system.

Vision statement

The company envisions becoming a leader in the field of immunotherapy, aiming to provide effective treatments that address significant unmet medical needs, particularly through its lead investigational therapy Multikine (Leukocyte Interleukin, Injection).

Company slogan

While CEL-SCI may not have a widely publicized, distinct slogan like consumer brands, its communications consistently emphasize themes of activating the immune system to fight disease. The focus remains squarely on the potential of their immunotherapies. Exploring who invests in this vision can be revealing; find out more here: Exploring CEL-SCI Corporation (CVM) Investor Profile: Who’s Buying and Why?

CEL-SCI Corporation (CVM) How It Works

CEL-SCI Corporation operates as a clinical-stage biotechnology company focused on advancing immunotherapy treatments. Its core activity revolves around research and development, particularly large-scale clinical trials aimed at securing regulatory approval for its lead drug candidate.

CEL-SCI Corporation's Product/Service Portfolio

CEL-SCI Corporation's Operational Framework

The company's operations are heavily centered on research and development, clinical trial management, and regulatory affairs. A significant aspect of its operational infrastructure is the dedicated manufacturing facility near Baltimore, Maryland, designed for the production of Multikine. This facility supports the potential commercial scale-up if regulatory approval is achieved. Given its clinical stage, CEL-SCI does not generate revenue from product sales. Operations are funded through capital raises, primarily equity financing. For the fiscal year ending September 30, 2024, research and development expenses were approximately $22.1 million, while general and administrative costs were around $10.5 million, reflecting the focus on advancing its lead candidate through late-stage development and towards potential commercialization.

CEL-SCI Corporation's Strategic Advantages

CEL-SCI possesses several strategic assets that underpin its potential value proposition.

• Its lead candidate, Multikine, targets a significant indication in head and neck cancer where new pre-surgical treatments are sought.
• The company owns and operates its manufacturing facility, ensuring control over production and potentially easing scaling challenges post-approval. This physical asset is a core part of its infrastructure.
• The underlying LEAPS technology platform provides a foundation for developing further drug candidates and potential licensing or partnership opportunities across different therapeutic areas.
• The extensive data generated from the large, multi-year Phase 3 trial for Multikine represents a substantial body of clinical information, crucial for regulatory discussions.

Understanding the company's operational focus and strategic positioning is key for evaluation. Exploring CEL-SCI Corporation (CVM) Investor Profile: Who’s Buying and Why? provides further context on market perception and stakeholder interest based on these factors.

CEL-SCI Corporation (CVM) How It Makes Money

As a clinical-stage biotechnology company, CEL-SCI Corporation currently generates minimal revenue, primarily derived from interest income on its cash reserves rather than product sales or services. Its core focus remains the research and development of its immunotherapy treatments, particularly Multikine, with future revenue contingent upon successful clinical trials, regulatory approvals, and subsequent commercialization.

CEL-SCI Corporation's Revenue Breakdown

Based on filings for the fiscal year ending September 30, 2024, the company reported negligible operating revenue.

CEL-SCI Corporation's Business Economics

The economic model for CEL-SCI Corporation is characteristic of a development-stage biotech firm. Its viability hinges entirely on securing sufficient capital to fund extensive research and development activities, primarily the costly Phase 3 clinical trial for Multikine and manufacturing scale-up.

• Funding Dependency: Operations are financed almost exclusively through equity offerings (selling stock) and occasionally debt instruments. Consistent access to capital markets is critical for survival. Understanding the investor base is key; Exploring CEL-SCI Corporation (CVM) Investor Profile: Who’s Buying and Why? offers insights into this aspect.
• Cost Structure: The largest expense category by far is Research and Development (R&D), encompassing clinical trial costs, contract manufacturing, personnel, and regulatory affairs. General and Administrative (G&A) expenses represent a smaller but significant portion of the cash outflow.
• Future Potential: If Multikine receives market approval, the economic model would shift dramatically towards commercial operations, involving sales, marketing, distribution, and large-scale manufacturing, potentially generating substantial revenue streams offset by significant commercialization costs.

CEL-SCI Corporation's Financial Performance

Financial performance metrics as of the fiscal year ended September 30, 2024, reflect its pre-revenue status and focus on R&D investment. Key indicators include:

• Net Loss: The company reported a net loss of approximately $40.2 million for FY2024, driven primarily by high R&D and G&A spending without corresponding revenue.
• Research & Development Expenses: R&D costs were substantial, amounting to roughly $24.5 million, underscoring the investment in the Multikine Phase 3 trial and related activities.
• General & Administrative Expenses: G&A expenses totaled approximately $15.5 million for the fiscal year.
• Cash Position: As of September 30, 2024, cash and cash equivalents stood at around $12.1 million. This figure is critical for assessing the company's operational runway.
• Cash Burn Rate: The company's operating activities consumed significant cash throughout the year, highlighting the ongoing need for financing to sustain operations until potential revenue generation. The average quarterly burn rate derived from operating cash flow influences funding requirements.

These figures illustrate the financial challenges and investment-heavy nature of bringing a novel therapeutic like Multikine through late-stage development and towards potential market entry.

CEL-SCI Corporation (CVM) Market Position & Future Outlook

CEL-SCI Corporation operates as a clinical-stage biotechnology company focused primarily on its lead investigational immunotherapy, Multikine, positioning it as a potential disruptor in the head and neck cancer treatment landscape pending regulatory approval. The company's future hinges significantly on the successful commercialization of Multikine, representing both a major opportunity and its most substantial risk.

Competitive Landscape

Opportunities & Challenges

Industry Position

CEL-SCI is positioned as a focused, clinical-stage player within the highly competitive oncology and immunotherapy sector. Its differentiation lies in the novel neoadjuvant approach of Multikine, targeting treatment before standard of care interventions like surgery or radiation. Success relies heavily on navigating the final stages of regulatory review and demonstrating clear clinical benefit and market acceptance. The company owns its manufacturing facility near Baltimore, Maryland, viewed as a key asset for potential future production, mitigating certain supply chain risks often faced by smaller biotech firms. Understanding who holds stakes in companies like this is crucial; you can find more details here: Exploring CEL-SCI Corporation (CVM) Investor Profile: Who’s Buying and Why? The company's valuation and future prospects are intrinsically tied to the outcome of the Multikine regulatory process.