Concluded a successful meeting with Saudi Food and Drug Authority CEL-SCI was encouraged to apply for Conditional Approval with Breakthrough Therapy Designation based on data from its concluded Phase 3 study Evaluating Saudi Arabia-based partnerships to potentially fund local manufacturing and launch Multikine throughout the region CEL-SCI Corporation (NYSE:CVM) today announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy* (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathway

Head and neck cancer patients treated with Multikine who had complete or partial tumor responses before surgery had improvements in overall survival, suggesting pre-surgical tumor response is a strong indicator of efficacy and leads to improved overall survival A third-party head and neck cancer study published in "Cancer Cell" confirms the observation that pre-surgical tumor responses in head and neck cancer leads to improved survival CEL-SCI Corporation (NYSE:CVM) today announced that a study titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" by Li Housaiyin et. al., Cancer Cell (2025) provides support for CEL-SCI's approach aimed at see

Data published in peer-reviewed scientific journal Pathology and Oncology Research Quality of life improvements 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 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 Multikine is headed into a final confirmatory Registration Study in head and neck

CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, is approximately $2,560,000. All the shares and Pre-Funded Warrants in the offering were offered by the Company The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital. ThinkEquity acted as sole p

CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital. ThinkEq

Growing body of data on PD-L1 as a cancer biomarker spurs interest Working towards partnership for non-dilutive funding of the final confirmatory head and neck cancer Registration Study CEL-SCI Corporation (NYSE:CVM) today announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study's Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no commen

The DEPEND study demonstrates that checkpoint inhibitor nivolumab (Opdivo®) works best with high levels of PD-L1 biomarker, but does not work well with low levels of PD-L1 Multikine* is uniquely positioned in the field as the only oncology drug used as a neoadjuvant that has demonstrated overall survival benefit in head and neck cancer patients whose tumors express low levels of PD-L1 Multikine aims to address a major treatment gap for head and neck cancer patients where about 70% have low PD-L1 expression, in its upcoming confirmatory Registration Trial CEL-SCI Corporation (NYSE:CVM) today announced that a third-party study published on March 6, 2025 in JAMA Oncology titled "Neoadjuvant

Confirmatory Phase 3 Trial Designed to Support Commercialization of Multikine for Head and Neck Cancer Treatment Full enrollment expected by Q2 2026 with plans to seek early approval at that time based on early tumor responses—Potential to set a new standard of care CEL-SCI Corporation (NYSE:CVM) today announced it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI's previously completed randomized

CEL-SCI Corporation (NYSE: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 stati

A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of start-up preparations - full enrollment expected by Q2 2026 Plans to seek early approval based on pre-surgical response rates A positive study outcome will position Multikine as the first treatment in over 50 years for newly diagnosed locally advanced head and neck cancer patients – a population with a severe unmet medical need Development of Multikine in other cancers is planned CEL-SCI Corporation (NYSE:CVM) reported financial results for the fiscal year ended September 30, 2024, as well as key clinical and corporate development

CEL-SCI Corporation (NYSE:CVM) today reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240815767286/en/The table includes detailed results from the bias analysis. (Graphic: Business Wire) Clinical and Corporate Developments include: In July 2024, following the end of the third fiscal quarter, CEL-SCI reported the results of a bias analysis. The bias analysis, a standard process to ensure a trial's findings are reliable, was conducted in preparation for CEL-SCI's upcoming confirmatory Registration Study. This

CEL-SCI Corporation (NYSE:CVM) today announced that Robert ("Bob") Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board. Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt in

CEL-SCI Corporation (NYSE:CVM) today announced the appointment of Mario Gobbo to its Board of Directors. Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. His expertise encompasses venture capital and private equity as well as investment banking and strategic advisory services. He has served as an officer or director for a number of companies including several biotech companies: Xcovery, Ocimum/Genelogic and Helix BioPharma. Prior to that, Mr. Gobbo worked in the financial industry for Lazard LLC, Swiss Bank Corporation, the European Bank for Reconstruction and Development, Natixis Bleichroeder, Inc., and International Finance Corporation

Pioneer in the field of regenerative medicine who brought four products from concept through FDA approval and market launch CEL-SCI Corporation (NYSE:CVM) today announced the appointment of Dr. Gail K. Naughton to its Board of Directors. Dr. Naughton has been a pioneer in the field of regenerative medicine for over 35 years. She was the founder of Advanced Tissue Sciences (NASDAQ:ATIS) where she oversaw the design and development of the world's first up-scaled manufacturing facility for cell-based products, established corporate development and marketing partnerships with companies including Smith & Nephew, Medtronic, and Inamed Corporation, was pivotal in raising over $350 million from t

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