CEL-SCI Corporation (NYSE American: CVM) today reported financial results for three months ended December 31, 2024, as well as key recent clinical and corporate developments.

“CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year.”

Corporate and Clinical Developments include:

  • The U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated 70% of head and neck patients who have low PD-L1 expression.
  • The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
    • Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery:
      • Multikine led to significant rates of tumor regression prior to surgery.
      • There was no tumor regression observed in the control group that did not receive Multikine.
      • Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
      • The patient population for the Registration Study is likely to show significant survival prolongation.
    • Phase 3 Registration Study patient population selection is based on:
      • Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
      • Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
      • Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
  • Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.

Financial Results

During the three months ended December 31, 2024, research and development expenses were $4.4 million, approximately the same as the three months ended December 31, 2023. General and administrative expenses for the first quarter of fiscal 2025 were $2.5 million compared to $2.1 million in the first quarter of fiscal 2023. Net loss was $7.1 million for three months ended December 31, 2024 compared to $6.7 million in the prior year period. Cash spent during the quarter was $5.1 million. Net loss per common share narrowed by 21% to $0.11 for the three months ended December 31, 2024, compared to $0.14 for the three months ended December 31, 2023.

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. Such statements include, but are not limited to, statements about the terms, expected 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, 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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