Latest news with #GeertKersten
Yahoo
19-05-2025
- Business
- Yahoo
CEL-SCI Announces Combination of Common Stock
VIENNA, Va., May 19, 2025--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) announced today that during its annual Shareholder's Meeting on May 19, 2025, a combination was authorized for its outstanding shares of common stock. On May 19, 2025, the Board of Directors approved a 1 for 30 combination of common stock. CEL-SCI expects the combination to be implemented on May 20, 2025. When the market opens on May 20, 2025, the common stock will trade under a new CUSIP number 150837 706, but the Company's ticker symbol, CVM, will remain unchanged. When the combination of stock becomes effective, every 30 shares of common stock will be converted into 1 share of common stock. The combination of common stock will not eliminate any shareholders of record since any fractional share resulting from the combination of common stock will be rounded to the nearest whole share. The exercise price of all outstanding warrants and options, as well as the shares issuable upon the exercise of the outstanding warrants and options, will also be proportionately adjusted. "We believe that the next few months may present us with a number of major catalysts. Hopefully this will lead to more interest from investors. The combination of common stock is needed for two reasons: 1) our low stock price prohibits many funds from investing in CEL-SCI and 2) the major US stock exchanges have made it clear that they want listed companies to have a higher share price. Therefore we believe that this is an appropriate time to implement a combination that will bring our share price to levels where more investors, as well as funds, can buy and trade our stock. We appreciate the continued support of our shareholders as we advance our investigational drug and drug candidates through our clinical development program with a goal towards delivering better treatment alternatives for cancer, autoimmune and infectious diseases," stated CEL-SCI CEO Geert Kersten. It is not necessary for stockholders to exchange their existing stock certificates for new stock certificates in connection with the combination of common stock although stockholders may do so if they wish. Please direct any questions you might have concerning the combination of common stock to your broker or our transfer agent Computershare Trust Company by calling (800) 962-4284. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's 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 "target" 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. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, 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, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve 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. 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, 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. View source version on Contacts COMPANY CONTACT:Gavin de WindtCEL-SCI Corporation(703) 506-9460
Business Wire
19-05-2025
- Business
- Business Wire
CEL-SCI Announces Combination of Common Stock
When the combination of stock becomes effective, every 30 shares of common stock will be converted into 1 share of common stock. The combination of common stock will not eliminate any shareholders of record since any fractional share resulting from the combination of common stock will be rounded to the nearest whole share. The exercise price of all outstanding warrants and options, as well as the shares issuable upon the exercise of the outstanding warrants and options, will also be proportionately adjusted. 'We believe that the next few months may present us with a number of major catalysts. Hopefully this will lead to more interest from investors. The combination of common stock is needed for two reasons: 1) our low stock price prohibits many funds from investing in CEL-SCI and 2) the major US stock exchanges have made it clear that they want listed companies to have a higher share price. Therefore we believe that this is an appropriate time to implement a combination that will bring our share price to levels where more investors, as well as funds, can buy and trade our stock. We appreciate the continued support of our shareholders as we advance our investigational drug and drug candidates through our clinical development program with a goal towards delivering better treatment alternatives for cancer, autoimmune and infectious diseases,' stated CEL-SCI CEO Geert Kersten. It is not necessary for stockholders to exchange their existing stock certificates for new stock certificates in connection with the combination of common stock although stockholders may do so if they wish. Please direct any questions you might have concerning the combination of common stock to your broker or our transfer agent Computershare Trust Company by calling (800) 962-4284. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's 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 "target" 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. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, 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, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve 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. 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, 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.
Business Wire
15-05-2025
- Business
- Business Wire
CEL-SCI Reports Fiscal Second Quarter 2025 Financial Results
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended March 31, 2025, as well as key recent clinical and corporate developments. 'We are highly encouraged about the latest development for the commercialization of Multikine in global markets. Based on guidance from the Saudi Food and Drug Authority (SFDA), we intend to file for drug approval based on the wealth of data from our completed Phase 3 study,' stated CEL-SCI CEO, Geert Kersten. Corporate and Clinical Developments include: Multikine resulted in up to 95% improvement in quality of life. CEL-SCI published new data from its Phase 3 study of Multikine in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR). The article titled 'Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study' included a comprehensive presentation of results from CEL-SCI's Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer. The new, previously unpublished findings included the following patient quality of life data: Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites. QoL improvements in Multikine treated patients 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. 95.1% of complete responders to Multikine reported improved QoL. 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. CEL-SCI is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients, reviewed and concurred to by the U.S. Food and Drug Administration (FDA). This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI's previously completed randomized controlled Phase 3 trial. CEL-SCI is in talks with potential partners. Given Multikine's excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, as well as its favorable safety profile, CEL-SCI is pursuing discussions with key parties that may be interested in partnering with CEL-SCI. Financial Results During the three months ended March 31, 2025, net loss was $6.6 million compared to $7.2 million in the prior year period. Basic and diluted net loss per common share increased to $0.08 for the three months ended March 31, 2025, compared to $0.14 for the three months ended March 31, 2024. The Company has instituted several cost-cutting measures including reductions in salaries. In demonstration of his deep commitment to the Company and Multikine's potential to significantly improve patient outcomes, CEO Geert Kersten has been and is currently working without taking a salary. 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. 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.
Business Wire
23-04-2025
- Business
- Business Wire
CEL-SCI to File for Regulatory Approval of Multikine in Saudi Arabia—Pursuing Local Partnerships for Commercialization and Manufacturing to Serve Middle East and North Africa Market
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: 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 pathways to a marketing application in Saudi Arabia. Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data. Share Based on discussions with the SFDA, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI's concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation. The SFDA's usual response time for a complete submission for such an application is thought to be approximately 60 days after filing. 'Our data was well received by the SFDA in a recent meeting. In consideration of their response, our intention is to file for Conditional Approval of Multikine with Breakthrough Therapy designation based on our completed Phase 3 data,' stated CEL-SCI CEO Geert Kersten. 'In alignment with the Saudi Kingdom's Vision 2030 initiatives, we are currently evaluating potential partnerships with local Saudi companies to commercialize Multikine, conduct clinical trials in Saudi hospitals and to establish a local Multikine manufacturing facility that would serve the entire Middle East and North Africa (MENA) market. We envision such a partnership encompassing funding, regulatory support, post-approval commercial launch, and distribution,' Kersten concluded. The Kingdom of Saudi Arabia's Vision 2030 includes a National Biotechnology Strategy, which is poised to position the Kingdom as a regional and global biotech hub with a far-reaching impact in biomanufacturing and medical innovation. The National Biotechnology Strategy aims to establish an advanced local bio-manufacturing platform to boost the Kingdom's self-sufficiency in producing biologics and biosimilars, enable global export opportunities, drive growth of the broader biotech sector in the Kingdom, and reduce healthcare costs. The incidence of head and neck cancer in the MENA region is expected to double by 2030, from incidence levels cited in a 2012 study. This rate of increase is two times higher than that of the projected worldwide incidence rate. In the Gulf Cooperation Council countries (GCC) of Saudi Arabia, Bahrain, Oman, Kuwait, Qatar, and the United Arab Emirates, the incidence risk of head and neck cancer is estimated to be 1.6%. About CEL-SCI Corporation CEL-SCI believes that boosting a patient's 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 "target" 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. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, 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, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve 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. 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, 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.
