CEL-SCI Corporation engages in the research and development of immunotherapy for the treatment of cancer and infectious diseases. The company's lead investigational immunotherapy is Multikine, which is under phase III clinical trial for the treatment of head and neck cancer. Its Ligand Epitope Antigen Presentation System (LEAPS), a pre-clinical patented T-cell modulation process that stimulates the human immune system to fight bacterial, viral, and parasitic infections, as well as autoimmune diseases, allergies, transplantation rejections, and cancer. The company also develops LEAPS-H1N1-DC; CEL-2000 and CEL-4000 are product candidates for the treatment of rheumatoid arthritis; and LEAPS COV-19, a product candidate to treat COVID-19 coronavirus. CEL-SCI Corporation has a collaboration agreement with the University of Georgia's Center for Vaccines and Immunology to develop LEAPS COVID-19 immunotherapy. The company was founded in 1983 and is headquartered in Vienna, Virginia.
IPO Year: 1997
Exchange: AMEX
Website: cel-sci.com
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
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
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 ("CEL-SCI" or the "Company") (NYSE:CVM), a cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 16,130,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) was sold at an offering price of $0.31 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of approximately $5,000,000, before deducting placement agent fees and other offering expenses. 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 f
CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of a best-efforts public offering of 16,130,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at a public offering price of $0.31 per share (inclusive of the Pre-Funded Warrant exercise price). Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $5,000,000. The offering is expected to close on December 31, 2024, subject to satisfaction of customary closing condi
CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a clinical stage cancer immunotherapy company, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants in lieu thereof) in a best efforts public offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital. ThinkEquity is acting as sole placement agent for the offering. The securities will b
Multikine is the first cancer immunotherapy to show pre-surgical tumor regression in head and neck cancer in just 3 weeks - confirmed by pathology at surgery Factors supporting the go-ahead for the 212-person registration study in the target population include: Multikine led to significant rates of tumor regression Pre-surgical tumor regressions were confirmed at surgery and forecast survival benefit Target population is likely to show significant survival prolongation in the confirmatory study Confirmatory study target population selection is based on: Strong statistical significance in a large subgroup of 114 patients Subgroup analysis was pre-defined in the statist
Biomarker used to select patients who are more likely have favorable outcomes, supporting a successful confirmatory Registration Study Patients with low PD-L1 expression treated with Multikine in the target population had a 5-year survival of 73% vs. 45% in the control group in the prior randomized controlled Phase 3 study CEL-SCI Corporation (NYSE:CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company's approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. This study will focus on the treatment of newly diagnosed locally adva
Oncologic Drugs Advisory Committee (ODAC) determines risks outweigh benefits in some cancers for frontline immune checkpoint inhibitors, including blockbuster drugs such as Keytruda and Opdivo, in patients with low PD-L1 expression Multikine has shown survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression Multikine has potential as a combination drug with current checkpoint inhibitors such as Keytruda which is projected to be the top selling drug in the world with $27 billion in 2024 sales To the Company's knowledge, Multikine is the only neoadjuvant
As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery CEL-SCI Corporation (NYSE:CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer. Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market. This partnership marks a con
5-year survival rate of 82.6% and 73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery Data provide further evidence that the selection criteria for CEL-SCI's upcoming confirmatory Registration Study may yield improved clinical outcomes Future advances in diagnostic technologies that improve patient selection, such as PET scans (which will be used in the confirmatory study), may fur
Data to be presented on Saturday, September 14 and published via a press release before the open of market on Monday, September 16 CEL-SCI Corporation (NYSE:CVM) today reported it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain. A poster titled "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy" will be presented by the study's co-author József Tímár MD, PhD, DSc, a p
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
4 - CEL SCI CORP (0000725363) (Issuer)
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