• Saudi Arabia’s new Breakthrough Medicine Designation, if granted, would make Multikine available for patient access and commercial use
  • Saudi Food and Drug Authority typically responds to Breakthrough Medicine Designation applications within approximately 60 days
  • Multikine increased the 5-year survival rate of the target patient population in head and neck cancer to 73% vs 45% in patients treated with standard of care alone; The 5-year risk of death was halved from 55% to 27%

CEL-SCI Corporation (NYSE American: CVM) today announced it has completed its Breakthrough Medicine Designation application for Multikine* (Leukocyte Interleukin, Injection) for submission to the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer.

The Breakthrough Designation Application is expected to be formally submitted to the SFDA on CEL-SCI’s behalf within the next few weeks by the Company’s prospective Saudi partner, one of the country’s premier pharmaceutical and healthcare companies. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days.

“We are very excited that Multikine could become available to patients in Saudi Arabia as early as this summer,” stated CEL-SCI CEO Geert Kersten. “Based on our recent meeting with the SFDA, we are hopeful for a positive response. In the meeting the SFDA provided guidance and gave encouragement for seeking approval for Multikine in head and neck cancer. Our belief is that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA. Together with our prospective local partner, we are hopeful that we will be able to help patients in Saudi Arabia.”

Under the SFDA’s new Breakthrough Medicine Designation program, Multikine would immediately become available for patient access and reimbursement upon it being granted Breakthrough Medicine Designation. Head and neck cancers constitute approximately 5% of all cancer cases in Saudi Arabia.

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative which seeks to make Saudi Arabia a global biotech hub. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility criteria include all four of the following in order to gain a Breakthrough Medicine Designation:

  • Target serious debilitating or life-threatening conditions with unmet medical need.
  • The medicinal product is likely to offer major advantage over methods currently used.
  • The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
  • The product is not registered at any regulatory authority at the time of submission of the designation request.

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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients.

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, 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.

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

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