CEL-SCI Advances Multikine® Immunotherapy for Head and Neck Cancer Through Dual U.S. Registration Study and Saudi Market Entry Strategy

Key Terms

confirmatory registration study regulatory

A confirmatory registration study is a large, carefully designed clinical trial intended to prove a drug or medical product works and is safe enough for regulators to grant full marketing approval. Investors care because the study’s outcome often determines whether the product can be sold widely, what claims can be made about it, and how much revenue the company can expect—think of it as the final exam that decides whether a product can enter the market and earn money.

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PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.

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Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

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Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

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U.S. Confirmatory Registration Study expected to begin Summer 2026

Multikine achieved a 73% five-year survival rate versus 45% for standard of care alone in the target patient population and improved quality of life

Saudi partnership includes a 50%/50% net revenue share and supports potential patient access in one of the Middle East's largest oncology markets

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today highlighted its dual-track strategy to bring Multikine® (Leukocyte Interleukin, Injection)* to patients with newly diagnosed locally advanced head and neck cancer through parallel regulatory initiatives in the U.S. and Saudi Arabia.

The Company plans to commence its Confirmatory Registration Study of Multikine this summer while simultaneously advancing regulatory and commercialization activities in Saudi Arabia through its strategic partnership with Saudi Amarox.

“Following extensive clinical development and close engagement with regulators, we are excited to begin our final Confirmatory Registration Study, aiming to extend lives and improve the quality of life for head and neck cancer patients,” said Geert Kersten, Chief Executive Officer of CEL-SCI. “We are also looking forward to participating in next week's signing ceremony at BIO with Amarox, our Saudi partner, as we advance a second pathway to bring Multikine to patients.”

U.S. Registration Pathway

CEL-SCI's Confirmatory Registration Study will enroll 212 newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low PD-L1 tumor expression and no lymph node involvement—the patient population that demonstrated the greatest benefit in the Company's completed Phase 3 study.

In that study, patients treated with Multikine before surgery and standard of care therapy achieved a 73% five-year overall survival rate compared to 45% for patients receiving standard of care alone. The confirmatory study is designed to show, among other things, significant improvement in overall survival and support potential registration of Multikine in the United States.

Saudi Market Entry Pathway

CEL-SCI has a strategic partnership with Amarox to support regulatory approval, commercialization and distribution of Multikine in Saudi Arabia. Under the agreement, Amarox is leading local regulatory activities and will be the exclusive distributor of Multikine in the Kingdom upon approval.

The partnership provides a 50%/50% revenue share for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation. Amarox is ranked #1 for Saudi-FDA (SFDA) applications for critical and unavailable medicine for 3 consecutive years. CEL-SCI retains ownership of all Multikine intellectual property, manufacturing know-how and global rights. The agreement also includes the option for Amarox to distribute Multikine throughout the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

CEL-SCI and Amarox will conduct a formal signing ceremony during the BIO International Convention in San Diego on June 22, 2026 to highlight their collaboration and commitment to advancing Multikine in the region.

Addressing a Significant Unmet Need

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need. The target population of the U.S. Confirmatory Registration Study represents approximately 100,000 newly diagnosed head and neck cancer patients annually. Based on CEL-SCI’s completed Phase 3 study of 928 patients, approximately 70% of head and neck cancer patients are estimated to have low or zero PD-L1 tumor expression, a population for whom currently available checkpoint inhibitors may offer only limited benefit with no definitive overall survival benefit.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a 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), given right after diagnosis and before surgery, 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.

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, inability to finalize a partnering agreement 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, 2025. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260616491572/en/

COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460

Source: CEL-SCI Corporation