- \n
- Peer-reviewed study in Oral Oncology identified prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine in upcoming Confirmatory Head & Neck Cancer Registration Study<\/i><\/li>\n
- Dual track commercialization strategy includes the global Confirmatory Registration study to commence enrollment in the U.S., Europe, Asia and South America for U.S. FDA approval, with a parallel process in Saudi Arabia for Breakthrough Designation which could make Multikine commercially available in the near term<\/i><\/li>\n
- Signed key partnership with Amarox to advance Multikine approval and commercialization in Saudi Arabia<\/i><\/li>\n<\/ul>\n
VIENNA, Va.–(BUSINESS WIRE<\/a>)–CEL-SCI Corporation<\/a>(NYSE American: CVM) <\/b>today reported financial results for three months ended June 30, 2026, as well as key recent corporate, commercial, regulatory, and clinical developments for Multikine (Leukocyte Interleukin, Injection)*.<\/p>\n
\n\u201cThis was a quarter of important progress across our clinical, regulatory and commercialization programs as we move Multikine closer to patients,\u201d stated CEL-SCI CEO Geert Kersten. \u201cOur recently published peer-reviewed data identified the biomarkers that allow us to prospectively select the patients most likely to benefit from Multikine\u2014the same population in which our Phase 3 study demonstrated a 73% five-year survival rate compared with 45% for standard of care alone. By focusing our 212-patient Confirmatory Registration Study on this biomarker-selected population, we believe we have substantially increased the likelihood of confirming Multikine\u2019s survival benefit and achieving a successful trial outcome. At the same time, our partnership with Amarox is advancing a potential near-term path to commercial availability in Saudi Arabia. With enrollment in our registration study set to commence globally, we believe we have never been better positioned to bring Multikine to patients and advance it toward commercialization.\u201d<\/p>\n
Clinical and Corporate Developments:<\/b><\/p>\n
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- A leading peer-reviewed journal, <\/b>Oral Oncology<\/b><\/i><\/a>, published biomarker selected population and survival data from CEL-SCI\u2019s Phase 3 clinical study, the largest trial of its kind in the world. The article provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study. Low and zero (0%) tumor PD-L1 expression and no lymph node involvement were identified as biomarkers for selecting patients most likely to benefit from Multikine pre-surgery treatment. The published study concludes that Multikine represents the first neoadjuvant treatment in decades to demonstrate an overall survival benefit in biomarker-selected patients with locally advanced resectable oral cancer. Multikine neoadjuvant treatment also demonstrated a statistically significant improvement in progression-free survival with a 49% reduction in the risk of disease progression in the same biomarker-selected patients.\n<\/li>\n
- CEL-SCI is set to commence enrollment in its 212-patient U.S. FDA Confirmatory Registration Study<\/b> evaluating Multikine in newly diagnosed, locally advanced head and neck cancer patients at clinical sites in the U.S., Europe, Asia and South America. Because Multikine is administered for a short period before surgery, pre-surgical tumor responses can be evaluated within weeks following full enrollment, providing an early assessment of Multikine\u2019s anti-tumor activity. CEL-SCI plans to use these early tumor response data to pursue potential accelerated approval in the U.S. while patients continue to be followed for overall survival.\n<\/li>\n
- CEL-SCI entered a strategic partnership with <\/b>Amarox<\/b><\/a>, one of Saudi Arabia\u2019s <\/b>fastest growing<\/b><\/a> pharmaceutical companies <\/b>to pursue regulatory approval, marketing and commercialization of Multikine for head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.Amarox will support and coordinate the regulatory process with the Saudi Food and Drug Authority (SFDA), including pursuit of Breakthrough Medicine Designation\u2014the granting of which could lead to immediate availability of Multikine for reimbursement\/sale in Saudi Arabia. Amarox has ranked #1<\/a> for SFDA applications for critical and unavailable medicines for 3 consecutive years. CEL-SCI and Amarox will share net revenue from Saudi Arabian Multikine sales on a 50%\/50% basis.\n<\/li>\n
- Gross proceeds of approximately $9.7 million<\/b> were raised by CEL-SCI during the quarter.\n<\/li>\n<\/ul>\n
Financial Results<\/b><\/p>\n
\nDuring the three months ended June 30, 2026, research and development expenses were $3.6 million compared to $3.7 million for the three months ended June 30, 2025. General and administrative expenses for the three months ended June 30, 2026 were $1.9 million compared to $1.7 million for the three months ended June 30, 2025. Cash used for operating activities during the three months ended June 30, 2026 was $4.0 million. Net loss was $5.7 million for the three months ended June 30, 2026, unchanged from the second quarter of 2025. Basic and diluted net loss per common share was $0.47 for the three months ended June 30, 2026, compared to $1.36 for the three months ended June 30, 2025.<\/p>\n
About Multikine<\/b><\/p>\n
\nMultikine 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\u2019s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world\u2019s 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%.<\/p>\n
About CEL-SCI Corporation<\/b><\/p>\n
\nCEL-SCI believes that boosting a patient\u2019s 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 \u201ctarget\u201d 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.<\/p>\n
\nMultikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been administered to over 740 patients and has an excellent safety profile compared to other cancer drugs. It has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.<\/p>\n
\nThe Company has operations in Vienna, Virginia, and near\/in Baltimore, Maryland.<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
\nThis 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 \u201cintends,\u201d \u201cbelieves,\u201d \u201canticipated,\u201d \u201cplans\u201d and \u201cexpects,\u201d 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.<\/p>\n
* 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.<\/i><\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260817887056\/en\/<\/a><\/span><\/p>\n
\nGavin de Windt
\n
CEL-SCI Corporation
\n
<\/b>(703) 506-9460<\/p>\nKEYWORDS:<\/b> Virginia United States Saudi Arabia North America Middle East<\/p>\n
INDUSTRY KEYWORDS:<\/b> Research Surgery FDA Clinical Trials Other Health Biotechnology Pharmaceutical Health Science Oncology<\/p>\n
- CEL-SCI is set to commence enrollment in its 212-patient U.S. FDA Confirmatory Registration Study<\/b> evaluating Multikine in newly diagnosed, locally advanced head and neck cancer patients at clinical sites in the U.S., Europe, Asia and South America. Because Multikine is administered for a short period before surgery, pre-surgical tumor responses can be evaluated within weeks following full enrollment, providing an early assessment of Multikine\u2019s anti-tumor activity. CEL-SCI plans to use these early tumor response data to pursue potential accelerated approval in the U.S. while patients continue to be followed for overall survival.\n<\/li>\n
- Dual track commercialization strategy includes the global Confirmatory Registration study to commence enrollment in the U.S., Europe, Asia and South America for U.S. FDA approval, with a parallel process in Saudi Arabia for Breakthrough Designation which could make Multikine commercially available in the near term<\/i><\/li>\n
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