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

CEL-SCI Corporation (CVM) is the definition of a high-risk, high-reward biotech play, but how does a company with a market capitalization of approximately $52.92 million in November 2025 continue to fund its core investigational drug, Multikine, which could radically change cancer treatment? You see the headlines-a net loss of $6.6 million in the second fiscal quarter of 2025-but you also see the clinical data showing a 73% five-year survival rate in a key patient population versus 45% for the control arm, which is a massive 28 percentage-point difference. We'll cut through the volatility to map out CEL-SCI's unique history, its mission to use the body's own immune system to fight disease, and the core mechanics of how it actually works and makes money-or, more defintely, how it plans to.

CEL-SCI Corporation (CVM) History

Given Company's Founding Timeline

Year established

CEL-SCI Corporation was established in 1983, a time when the concept of leveraging the immune system to fight cancer was still largely theoretical, rooted in research that began a few years earlier at the Max Planck Institute in Germany.

Original location

The company's initial operations were set up in the Washington, D.C. area, specifically near Alexandria, Virginia, before the headquarters eventually settled in Vienna, Virginia. The early science, though, had a European start.

Founding team members

The company was founded by Maximilian de Clara, a Swiss entrepreneur who was the driving force and president until his resignation in 2016. Geert Kersten, his stepson, took on the CEO role in 1995 and has been the long-tenured leader, guiding the company through its decades-long clinical development path.

Initial capital/funding

Specific initial seed capital from 1983 isn't public, but like many early biotechs, the company went public (IPO) soon after its founding in the mid-1980s to secure the substantial capital required for long-term research and development (R&D). This early access to public markets was defintely crucial for survival.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's history is really a story of persistent R&D funding, which is typical for a clinical-stage biotech. You look at their financials for the fiscal year 2024, and you see annual revenue of nearly $0.0, but a net loss of around -$26.9 million, reflecting the cost of advancing their pipeline. That's the high-stakes reality of drug development.

The most transformative moment wasn't a single success, but the complex outcome of the 2021 Phase 3 trial. While the study missed the broad primary endpoint, the data revealed a compelling signal in a specific, high-need population: PD-L1 low, node-negative head and neck cancer patients.

Here's the quick math: In this target group, Multikine showed a 5-year survival rate of 73% compared to 45% in the control arm, cutting the risk of death in half. This finding fundamentally shifted the company's strategy from a broad application to a targeted, neoadjuvant (pre-surgery) immunotherapy approach, positioning them for the current 212-patient Confirmatory Registration Study.

The recent 1-for-30 reverse stock split in May 2025 was a necessary financial action to maintain listing compliance, but the real value driver remains the regulatory path. The completion of their manufacturing facility commissioning in 2024 was a quiet, non-clinical win, but it removes a major regulatory hurdle for a future Biologics License Application (BLA). The entire company is now focused on the Confirmatory Study, which is expected to enroll fully by the second quarter of 2026.

• Securing the FDA's agreement on the Confirmatory Study design was the ultimate vote of confidence in the subgroup data.
• The company's market capitalization stands at approximately $51.96 million as of November 2025, reflecting the high-risk, high-reward nature of this single-asset focus.
• The focus on the neoadjuvant approach aims to establish a new standard of care for a patient population that hasn't seen a new treatment in over 50 years.

To be fair, the long-term success of the company hinges entirely on the outcome of this new trial and the ultimate regulatory decision. You can read more about what guides their decision-making in the Mission Statement, Vision, & Core Values of CEL-SCI Corporation (CVM).

CEL-SCI Corporation (CVM) Ownership Structure

CEL-SCI Corporation's (CVM) ownership structure is highly concentrated in the hands of public and individual investors, a common trait for a clinical-stage biotechnology company with a market capitalization of just over $52.92 million as of November 2025. This means the retail investor base, not large institutions, holds the vast majority of the shares and therefore carries the most influence in the aggregate, which can lead to higher stock price volatility.

Given Company's Current Status

CEL-SCI Corporation is a publicly traded company, listed on the NYSE American stock exchange under the ticker symbol CVM. This public status subjects the company to all the regulatory oversight of the U.S. Securities and Exchange Commission (SEC), including the filing of quarterly and annual financial statements, which is how we know the net loss for the fiscal third quarter of 2025 was $5.7 million. To be fair, a small-cap biotech with a lead candidate like Multikine still in the regulatory pathway often sees this kind of ownership profile. You can dig deeper into the company's financial health and performance in Breaking Down CEL-SCI Corporation (CVM) Financial Health: Key Insights for Investors.

Given Company's Ownership Breakdown

The ownership breakdown for CEL-SCI is unusual because of the high percentage held by individual investors, or retail. This group includes you and any other non-professional investor, and they collectively own a massive stake. Insider ownership is relatively low, but still significant, and institutional holdings are minimal. Here's the quick math on the approximate split as of late 2025:

What this estimate hides is the power of the largest institutional holders, even with a small percentage. For instance, Vanguard Group Inc. and BlackRock, Inc. are consistently listed among the top institutional owners, holding shares for their various mutual funds and ETFs. Still, the retail base is defintely the driving force here.

Given Company's Leadership

The company is steered by a seasoned, albeit small, executive team with long tenures, which is typical for a company focused on a single long-term drug development program like Multikine. The average tenure for the management team is quite high, suggesting deep institutional knowledge and commitment to the product pipeline.

• Geert Kersten, Esq.: Director and Chief Executive Officer (CEO), a role he has held since 1995. He also serves as the Principal Accounting Officer and Treasurer.
• Patricia B. Prichep: Chief Financial Officer (CFO) and Chief Operations Officer (COO), having assumed the dual role in November 2024.
• Dr. Eyal Talor, PhD: Chief Scientific Officer (CSO).
• John Cipriano: Senior Vice President of Regulatory Affairs.
• Dr. Daniel H. Zimmerman, PhD: Senior Vice President of Research, Cellular Immunology.

The CEO, Geert Kersten, has been with CEL-SCI Corporation since 1987, showing a multi-decade commitment to the company's mission. The board is led by an Independent Chairman, Bruno Baillavoine, which separates the CEO and Chairman roles, a good governance practice. Finance: look for the next SEC filing on insider trading activity to track management's conviction.

CEL-SCI Corporation (CVM) Mission and Values

CEL-SCI Corporation's mission is fundamentally about disrupting the standard of care for serious diseases, primarily cancer, by harnessing the body's own immune system. This patient-centric purpose is backed by a core set of values that demand rigorous, data-driven science and a long-term, ethical commitment to all stakeholders.

CEL-SCI Corporation's Core Purpose

You're looking at a company that is defintely driven by an audacious goal: to change how we treat cancer. They are a clinical-stage biotech, which means their whole operation is currently focused on proving their lead drug, Multikine (Leukocyte Interleukin, Injection), works and getting it approved. That is where all the capital goes.

For example, during the three months ended June 30, 2025, the company reported a net loss available to common shareholders of $5.7 million, reflecting the high cost of this critical research and development. But still, the CEO is working without a salary, which shows a deep commitment to the mission over personal gain.

Official mission statement

The company's formal mission is a dual commitment to patients and investors, which is typical for a publicly traded biotech focused on unmet medical needs:

• Improve the treatment of cancer and other diseases by utilizing the immune system; the body's natural defense system.
• Create real value for stakeholders by developing unique therapies that address unmet medical needs.

Here's the quick math on the potential impact: their Phase 3 trial for head and neck cancer showed a significant 5-year overall survival (OS) benefit of 62.7% versus 48.6% in the study arm that received only radiation following surgery. That's a massive 14.1% absolute advantage, which is the kind of data that can truly change a treatment paradigm.

Vision statement

CEL-SCI Corporation's vision is simple and powerful, reflecting the potential of their pre-surgical immunotherapy approach:

• Change the way cancer is treated.

This vision is what drives their strategy to boost a patient's immune system while it is still intact-before the patient is weakened by standard-of-care treatments like surgery, radiation, and chemotherapy. That is the core difference in their approach. If you want to dive deeper into who is betting on this vision, you should read Exploring CEL-SCI Corporation (CVM) Investor Profile: Who's Buying and Why?

CEL-SCI Corporation slogan/tagline

While the company does not use a single, formal marketing slogan in the traditional sense, their core philosophy acts as a functional tagline:

• Use your immune system to fight disease.

The company's core values translate this philosophy into daily action. They stress a 'no-shortcuts' approach to drug development, which is critical in a high-stakes, highly regulated field. Plus, they strive to be economical in their day-to-day operations, which is important when capital is scarce; for example, they raised gross proceeds of approximately $5.7 million in July 2025 to fund the continued development of Multikine.

CEL-SCI Corporation (CVM) How It Works

CEL-SCI Corporation is a clinical-stage biotechnology company that doesn't sell products yet; instead, it creates value by advancing its lead immunotherapy drug, Multikine, through rigorous clinical trials and regulatory processes to eventually establish a new, first-line treatment standard for certain cancers.

The company's entire business model revolves around research, development, and securing regulatory approval, which is a high-risk, high-reward proposition. You can see the full investor profile and the speculation around this Exploring CEL-SCI Corporation (CVM) Investor Profile: Who's Buying and Why?

CEL-SCI Corporation's Product/Service Portfolio

CEL-SCI Corporation's Operational Framework

As a clinical-stage firm, CEL-SCI's operations are a cycle of research, clinical testing, and capital raising, not product sales. For instance, the company reported a net loss of $6.6 million for the fiscal second quarter of 2025 (ended March 31, 2025), which is typical for a company at this stage. Here's the quick math on their focus:

• Clinical Development: The primary value driver is the 212-patient Confirmatory Registration Study for Multikine, which the FDA concurred with. Full enrollment is expected by the second quarter of 2026. This is the defintely most critical near-term operational milestone.
• Manufacturing Readiness: They own a dedicated, current Good Manufacturing Practice (cGMP) facility near Baltimore, Maryland. This facility is designed to support potential commercial scale-up, with a capacity to produce over 12,000 Multikine treatments annually. Having this in-house reduces future commercialization risk.
• Funding Operations: Operations are financed through capital raises. In 2025, the company secured $5.7 million in July and $5 million in May through at-the-market offerings to fund the clinical and regulatory path. The company has also been focused on efficiency, reducing R&D expenses by 19% and general and administrative costs by 9% in the second quarter of fiscal 2025 compared to the prior year.

CEL-SCI Corporation's Strategic Advantages

The company's competitive edge is built on its unique scientific approach and strategic readiness for commercialization, which is crucial in the crowded oncology market.

• Unique Mechanism of Action: Multikine is administered as a first-line treatment, before surgery, radiation, or chemotherapy. This is a critical advantage because it activates the patient's immune system while it is still relatively intact, which CEL-SCI believes provides the greatest possible impact on survival.
• Targeted Patient Population: Multikine is uniquely positioned to treat the estimated 70% of head and neck cancer patients who have low PD-L1 expression. This is the patient group that typically does not respond well to the widely used checkpoint inhibitors like Keytruda, creating a distinct, underserved market opportunity.
• Regulatory Head Start: The company has received concurrence from the U.S. FDA on the design and patient selection criteria for its confirmatory trial. This significantly de-risks the trial's path to a Biologics License Application (BLA). Also, the application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) in 2025 could fast-track initial international commercialization.
• Vertical Integration: Owning and operating its cGMP manufacturing facility provides control over the supply chain and quality, a significant advantage over competitors who rely solely on third-party contract manufacturing organizations.

CEL-SCI Corporation (CVM) How It Makes Money

CEL-SCI Corporation is a clinical-stage biotechnology company whose current financial engine is fueled almost entirely by equity financing, not commercial product sales, as its flagship drug, Multikine, is still an investigational product. The company's business model is a high-risk, high-reward bet: spend capital on research and development (R&D) to secure regulatory approval, and then generate revenue through sales or licensing agreements for its cancer immunotherapy.

Given Company's Revenue Breakdown

As of the 2025 fiscal year, CEL-SCI Corporation operates as a pre-commercial entity, meaning it has not yet generated significant revenue from product sales. The company's reported revenue for the trailing twelve months is negligible, effectively $0.00B. The minimal revenue that does appear on the income statement comes from non-core activities like interest income or government grants, which is why the breakdown is heavily skewed.

Business Economics

The economics of CEL-SCI Corporation are typical for a late-stage biotech: a high burn rate driven by R&D expenses with no corresponding product revenue. The entire operation is a capital-intensive investment in a single asset, Multikine, with the goal of capturing a multi-billion dollar market. That's the simple, brutal math of drug development.

• Cost Structure: The primary cost is R&D, which was approximately $4.4 million in the first quarter of fiscal year 2025 (ended December 31, 2024), representing the bulk of the company's operating expenses.
• Pricing Strategy (Future): While Multikine has no current price, its future pricing will be a premium, specialty drug price. It is a first-in-class neoadjuvant (pre-surgical) immunotherapy for head and neck cancer patients with low PD-L1 expression, a group where it showed a 28% absolute survival benefit at five years in its Phase 3 trial. This strong efficacy data in a specific, underserved population of an estimated 145,000 global patients annually gives it significant pricing power.
• Path to Revenue: Near-term revenue opportunity is tied to a commercialization and regulatory partnership agreement in Saudi Arabia, which was poised for signing in the second half of 2025. This could lead to the sale and reimbursement of Multikine in Saudi Arabia, a crucial first step for global expansion. You can learn more about the capital structure that supports this growth in Exploring CEL-SCI Corporation (CVM) Investor Profile: Who's Buying and Why?

Given Company's Financial Performance

The company's financial health is measured by its cash runway and its ability to raise capital, not by traditional profitability metrics like Gross Margin or P/E ratio, which are not applicable yet. The key is managing the net loss while advancing the drug.

• Net Loss: The net loss for the fiscal third quarter ended June 30, 2025, was $5.7 million, a notable reduction from the $7.5 million loss in the same period a year prior.
• Cash Flow: The trailing twelve months (LTM) operating cash flow was a negative $17.27 million, which shows the capital drain from ongoing operations and clinical trials.
• Liquidity and Solvency: The Current Ratio as of November 2025 is low at 0.47, indicating that current liabilities exceed current assets. The Debt/Equity ratio is 1.42, showing a significant reliance on debt relative to shareholder equity.
• Financing Activities: The company successfully raised gross proceeds of approximately $5.7 million in July 2025 through an at-the-market stock offering, plus another $5 million in May 2025. This equity financing is the lifeblood of the operation.
• Market Valuation: As of November 2025, the company's market capitalization stands at approximately $51.96 million, reflecting the highly speculative nature of a pre-commercial biotech with a binary outcome.

Here's the quick math: The quarterly net loss is around $5.7 million, so the combined $10.7 million raised in May and July 2025 effectively bought the company less than two quarters of operating runway, excluding any additional capital needs for the Confirmatory Registration Study.

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

CEL-SCI Corporation's near-term outlook is a high-stakes binary bet, hinging entirely on the regulatory and commercial success of its lead asset, Multikine (Leukocyte Interleukin, Injection), which targets a specific, unmet need in head and neck cancer (HNC). The company is currently pre-revenue, operating with a net loss of $5.7 million for the fiscal third quarter of 2025, but a potential commercial launch in the Middle East in 2025 could be the defintely needed first revenue catalyst.

Competitive Landscape

You need to understand that CEL-SCI is not competing on market share right now; it's competing on a novel mechanism of action against established, multi-billion-dollar blockbusters. The global HNC therapeutics market is valued at about $2.27 billion in 2025, and the immunotherapy segment is heavily dominated by PD-1/PD-L1 inhibitors.

Opportunities & Challenges

The company's strategy is to exploit the clinical gap left by checkpoint inhibitors, plus securing early international approval to shore up its balance sheet. The key is execution on the confirmatory trial and the Saudi partnership. Exploring CEL-SCI Corporation (CVM) Investor Profile: Who's Buying and Why?

Industry Position

CEL-SCI Corporation holds a unique, but precarious, position in the oncology landscape. It's a clinical-stage biotech focused on a first-in-class neoadjuvant (pre-surgery) immunotherapy, Multikine, a strategy that contrasts sharply with the post-surgery or metastatic use of mainstream checkpoint inhibitors like Keytruda and Opdivo.

• Niche Specialist: The company is carving out a niche in the HNC market, specifically targeting the low PD-L1 expressing, node-negative patient population, which represents a significant unmet medical need that the current PD-1/PD-L1 inhibitors do not adequately address.
• Financial Fragility: Despite raising $10.7 million in gross proceeds from stock offerings in May and July 2025, the company's financial health is typical of a high-burn biotech, with a net loss of $5.7 million in Q3 2025.
• Potential Disruptor: If Multikine secures regulatory approval, it could unlock a $1 billion to $2 billion market opportunity by offering a paradigm shift in the initial treatment of locally advanced HNC.

The next concrete step is clear: Monitor the Saudi Food and Drug Authority (SFDA) for the Breakthrough Medicine Designation decision, which is expected soon. This will signal the first potential commercial revenue stream and a critical proof-of-concept for global regulatory efforts.