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... Read More

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... Read More

VIENNA, Va. / Mar 18, 2025 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: 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... Read More

VIENNA, Va. / Mar 17, 2025 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: 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... Read More

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 VIENNA, Va. / Mar 17, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan... Read More

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... Read More

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 VIENNA, Va. / Feb 20, 2025 / Business Wire / CEL-SCI... Read More

VIENNA, Va. / Feb 18, 2025 / Business Wire / 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... Read More

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... Read More

VIENNA, Va. / Dec 31, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: 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... Read More

VIENNA, Va. / Dec 27, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: 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... Read More

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... Read More

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 VIENNA, Va. / Nov 07, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced... Read More

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... Read More

As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery VIENNA, Va. / Oct 01, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: 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,... Read More

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... Read More

Data to be presented on Saturday, September 14 and published via a press release before the open of market on Monday, September 16 VIENNA, Va. / Sep 10, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: 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... Read More

VIENNA, Va. / Sep 04, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be... Read More

VIENNA, Va. / Aug 15, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments. Clinical and Corporate Developments include: In July 2024, following the end of the third fiscal quarter, CEL-SCI... Read More

VIENNA, Va. / Jul 29, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 10,845,000 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 $1.00 per... Read More

VIENNA, Va. / Jul 26, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the pricing of a best-efforts offering of 10,845,000 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 an offering price of $1.00 per share (inclusive of... Read More

Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study Detailed data on parameters including patient age, sex,... Read More

VIENNA, Va. / Jul 08, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: 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... Read More

Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors 73% survival for Multikine vs 45% in the control arm at 5 years Statistically significant log rank p = 0.0015 5-year risk of death cut in half from 55% to 27% Hazard ratio... Read More

Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo for Bristol Myers Squibb CEL-SCI’s Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50% FDA has given... Read More

VIENNA, Va. / May 16, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments. Clinical and Corporate Developments include: In May 2024, CEL-SCI received the go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of... Read More

Critical milestone achieved—the FDA accepted CEL-SCI’s selection criteria defining the Multikine target population before surgery Selected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial 212-patient confirmatory study is de-risked, backed by robust efficacy and safety data from completed Phase 3 trial, the largest in... Read More

VIENNA, Va. / Apr 23, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: 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... Read More

CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may VIENNA, Va. / Mar 19, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced the peer reviewed scientific journal Frontiers in Immunology published an article regarding CEL-SCI’s Ligand Epitope... Read More

VIENNA, Va. / Mar 06, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting. Dear CEL-SCI Shareholders: Last year we successfully moved our investigational Multikine ® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and... Read More

VIENNA, Va. / Feb 15, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments. Clinical and Corporate Developments include: CEL-SCI identified the target head and neck cancer patient population for Multikine ® (Leukocyte Interleukin, Injection)* that will be the basis for the Company’s... Read More

VIENNA, Va. / Feb 13, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 3,875,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the... Read More

VIENNA, Va. / Feb 09, 2024 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being... Read More

Marks key achievement that is a prerequisite to filing a Biologics License Application with the FDA and other regulators for marketing approval VIENNA, Va. / Feb 06, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine ® (Leukocyte Interleukin, Injection)* cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed. “This is a very significant milestone... Read More

CEL-SCI has cleared a significant hurdle that mandates cancer drugs in Europe comply with strict requirements for pediatric usage and clinical evidence VIENNA, Va. / Jan 31, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted... Read More

VIENNA, Va. / Dec 22, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments. Clinical and Corporate Developments: CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance. The new... Read More

VIENNA, Va. / Dec 04, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine* (Leukocyte Interleukin, Injection) to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK’s National Institute for... Read More

VIENNA, Va. / Nov 20, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM) , a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 2,490,000 shares of its common stock to a single investor at a public offering price of $2.00 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and... Read More

VIENNA, Va. / Nov 16, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 2,490,000 shares of its common stock to a single investor at an offering price of $2.00 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and offering expenses. All of the... Read More

View the letter: Click Here VIENNA, Va. / Oct 30, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today released a letter to shareholders from the Company’s CEO, Geert Kersten. The very comprehensive letter details the data reported on the efficacy of Multikine (Leukocyte Interleukin, Injection)* in the head and neck cancer target patient population as well as CEL-SCI’s plan to file for immediate regulatory... Read More

VIENNA, Va. / Oct 24, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today released a video presentation in which the Company’s CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data’s impact on propelling the Company’s immunotherapy drug Multikine* (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of... Read More

Target patient population for regulatory submissions finalized: Patients with low PD-L1 , in contrast to current checkpoint inhibitors which work best with high PD-L1. Addressing unmet need in ~145,000 head and neck cancer patients per year worldwide. Routine cancer screening tests can readily identify patients for Multikine... Read More

Achieves significant milestones toward commissioning of manufacturing facility in preparation for Biologics License Application for regulatory approval submissions VIENNA, Va. / Oct 19, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine* (Leukocyte Interleukin, Injection) cGMP state-of-the-art dedicated manufacturing facility commissioning is substantially complete, a... Read More

CEL-SCI will present the MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously, as a result of an improved selection algorithm that more accurately predicts the patients who would benefit most from the Multikine therapy UK has about 12,500 new head & neck cancer cases each year VIENNA, Va. / Oct 05, 2023 / Business Wire /... Read More

Europe has 150,000 new head & neck cancer cases each year, more than twice the incidence in the U.S. VIENNA, Va. / Sep 26, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with... Read More

VIENNA, Va. / Aug 11, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2023, as well as key clinical and corporate developments. Clinical and Corporate Developments this quarter include: CEL-SCI had a productive pre-submission meeting with Canada’s regulator, Health Canada, to determine the best regulatory path toward market approval. Health... Read More

VIENNA, Va. / Jul 20, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 2,500,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $5,000,000, before deducting underwriting discounts and offering expenses. The Company... Read More

VIENNA, Va. / Jul 17, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM) , a Phase 3 cancer immunotherapy company, today announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $5,000,000, before deducting underwriting discounts, and offering expenses. All of the shares of... Read More

VIENNA, Va. / Jul 17, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. The Company expects to grant the underwriter a 45-day option to purchase up to an additional 15% of the number of shares of common stock sold in this offering... Read More

FDA acknowledges the great need for improved treatments for head and neck cancer, particularly the locally advanced oral cavity that CEL-SCI is targeting and is open to a close collaboration with CEL-SCI to help demonstrate that Multikine could be such a therapy Approval is being pursued in other markets including Europe, the United Kingdom, and Canada, where commercialization could possibly begin as early as 2024 if Health... Read More

Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression Combination therapy could boost patient outcomes CEL-SCI has filed a patent for the use of Multikine in tumor expressing low levels of PD-L1 VIENNA, Va. /... Read More

VIENNA, Va. / Jun 22, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s ( AHNS ) 11 th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in... Read More

Histopathology analysis confirmed improved 5-year survival in Multikine-treated subjects, showed improved progression free survival and improved local regional control, and significantly lowered death rate compared to control subjects who received standard of care alone VIENNA, Va. / May 15, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced that the latest results from its pivotal Phase 3 study... Read More

VIENNA, Va. / May 12, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2023, as well as key clinical and corporate developments. Clinical and Corporate Developments include: In addition to pursuing approval by the US Food and Drug Administration (FDA), CEL-SCI is also pursuing marketing approval for Multikine in the treatment of head and neck... Read More

VIENNA, Va. / Apr 27, 2023 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of its underwritten confidentially marketed public offering of 794,117 shares of common stock at an offering price of $1.70 per share. The closing of the offering is expected to take place on or about May 2, 2023, subject to the satisfaction of... Read More

Follows pre-submission meeting with Canada’s regulator Health Canada Plans to pursue marketing approval in other countries while preparing its BLA application for U.S. FDA VIENNA, Va. / Apr 19, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced it has held a productive pre-submission meeting with Canada’s regulator to determine the best regulatory path toward market approval. Based on the... Read More

VIENNA, Va. / Mar 08, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN). A poster presentation titled “Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment naïve locally... Read More

VIENNA, Va. / Mar 03, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced it will present new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), on March 8, 2023 at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. CEL-SCI will publish a summary of the findings shortly... Read More

VIENNA, Va. / Feb 15, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2022, as well as key clinical and corporate developments. Clinical and Corporate Developments include: Multikine completely cleared cancer in 5 people with advanced head and neck cancer (locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN)) and 40... Read More

CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2022, as well as key clinical and corporate developments. Clinical and Corporate Developments: CEL-SCI’s main focus throughout fiscal year 2022 has been to complete and submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Multikine®* (Leukocyte Interleukin,... Read More