CEL-SCI Reports Fiscal Third Quarter 2025 Financial Results

CEL-SCI to sign partnership agreement in Saudi Arabia—Potential for patient access and reimbursement/sale of Multikine in Saudi Arabia within approximately 60 days following filing for Breakthrough Medicine Designation

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended June 30, 2025, as well as key recent clinical and corporate developments.

“Commercial and regulatory momentum for Multikine is accelerating due to three driving factors—our partnership negotiations in Saudi Arabia, the increasing interest in CEL-SCI from investors in the Middle East, and continued recognition in the global scientific and regulatory community that PD-L1 is a valuable predictive marker for head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We are particularly encouraged about the potential for Multikine to become commercially available in Saudi Arabia in 2025. Should this happen, we believe it could support our regulatory and commercial efforts worldwide.”

Corporate and Clinical Developments include:

• CEL-SCI’s CEO and a Director of the Company each purchased a combined total of 32,116 shares of restricted common CEL-SCI stock in July 2025.
• Gross proceeds of approximately $5.7 million were raised by CEL-SCI in July 2025 through the sale of 1,500,000 shares of common stock at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. In May of 2025, the Company raised gross proceeds of $5 million through the sale of 2,000,000 shares of common stock priced at $2.50 per share.
• CEL-SCI is set to sign a commercialization and regulatory partnership agreement with a leading Saudi Arabian pharmaceutical company for Multikine* (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in the Kingdom of Saudi Arabia. A Breakthrough Medicine Designation application for Multikine was filed by the pharma partner with the Saudi Food and Drug Authority (SFDA). According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.
• Several leading Saudi funds have expressed interest in investing in CEL-SCI, Multikine and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI’s offering with Multikine is in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s 60-day timeline to make Multikine potentially available, in-country investors have expressed interest in bringing a much-needed cancer treatment to market while also supporting their nation’s health-tech goals.
• A new study supports CEL-SCI’s strategy to seek early approval in the U.S. CEL-SCI is in final preparations before starting enrollment of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. CEL-SCI plans to seek early approval based on early tumor responses. A third-party study recently published in Cancer Cell titled “Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies” provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The third-party study published in Cancer Cell gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
• More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PLD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June, the FDA approved Merck’s KEYTRUDA® (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine in PD-L1 low and negative patients. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by only 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.

Financial Results

During the three months ended June 30, 2025, net loss available to common shareholders was $5.7 million compared to $7.5 million in the prior year period. Basic and diluted net loss per common share was $1.36 for the three months ended June 30, 2025, compared to $4.18 for the three months ended June 30, 2024. In demonstration of his deep commitment to the Company and Multikine’s potential to significantly improve patient outcomes, CEO Geert Kersten has been and is currently working without taking a salary.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

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COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation