CEL-SCI presented the data for the first time at the European Society for Medical Oncology (ESMO) Congress in Spain on October 22, 2023. The selection criteria for this target population were developed based on the completed Phase 3 randomized controlled trial, advice from regulators, and advice from physician consultants associated with the University of California San Diego Cancer Center and Yale Medical School, recognized as among the nation's most esteemed immuno-oncologists in head and neck cancer. This is a new sign of hope for head and neck cancer patients and a critical milestone for Multikine towards achieving regulatory approval.

Because Multikine is a neoadjuvant (pre-surgical) immunotherapy, identifying patients who benefit from Multikine upon diagnosis was very difficult, and welcomed the assistance of regulators and expert physician consultants to help. Patients with this disease have a clear unmet medical need for better outcomes. Multikine's demonstrated effects in the new intended target population are overwhelmingly large and strong as a statistical matter and support the observed Multikine efficacy.

While Multikine has not yet been tested prospectively in the new target population, the Phase 3 data present a compelling case for immediate patient access to Multikine because the Phase 3 study results showed prospectively that Multikine led to pre-surgical responses which in turn led to longer life. Regulators understand that patients should not have to wait before gaining access to these benefits, particularly given Multikine's safety profile and data that mechanistically and empirically supports the target population definition. There are specific pathways in Europe, the UK, Canada, and the U.S. for such approvals, and are currently working towards this goal.

Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. 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.

CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds, use of proceeds and closing of the offering.

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, 2022. 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 unmet medical need for the approval of Multikine.