• Plans to file for approval with Breakthrough Therapy Designation in Saudi Arabia based on completed Phase 3 results

VIENNA, Va. / May 15, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended March 31, 2025, as well as key recent clinical and corporate developments.

“We are highly encouraged about the latest development for the commercialization of Multikine in global markets. Based on guidance from the Saudi Food and Drug Authority (SFDA), we intend to file for drug approval based on the wealth of data from our completed Phase 3 study,” stated CEL-SCI CEO, Geert Kersten.

Corporate and Clinical Developments include:

• Multikine resulted in up to 95% improvement in quality of life. CEL-SCI published new data from its Phase 3 study of Multikine in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR). The article titled “Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study” included a comprehensive presentation of results from CEL-SCI’s Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer. The new, previously unpublished findings included the following patient quality of life data:
  • Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites.
  • QoL improvements in Multikine treated patients included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing.
  • 95.1% of complete responders to Multikine reported improved QoL.
  • Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures.
  • 89.4% of partial responders to Multikine reported improved quality of life measures.

• CEL-SCI is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients, reviewed and concurred to by the U.S. Food and Drug Administration (FDA). This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI’s previously completed randomized controlled Phase 3 trial.

• CEL-SCI is in talks with potential partners. Given Multikine’s excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, as well as its favorable safety profile, CEL-SCI is pursuing discussions with key parties that may be interested in partnering with CEL-SCI.

Financial Results

During the three months ended March 31, 2025, net loss was $6.6 million compared to $7.2 million in the prior year period. Basic and diluted net loss per common share increased to $0.08 for the three months ended March 31, 2025, compared to $0.14 for the three months ended March 31, 2024. The Company has instituted several cost-cutting measures including reductions in salaries. 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.