Vienna, VA, United States
Vienna, VA, United States

Time filter

Source Type

News Article | April 24, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation releases letter to shareholders.


News Article | February 27, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) announces that the NYSE MKT (the “Exchange”) has accepted the Company’s plan to bring itself into compliance with the Exchange's continued listing standards. The Company previously received notice from the Exchange on December 9, 2016, indicating the Company is below compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii) since it reported a stockholders’ equity deficit as of June 30, 2016 and had a net losses in its 5 most recent fiscal years ended September 30, 2015. The Company was afforded the opportunity to submit a plan to regain compliance, and on January 9, 2017 the Company submitted its plan to the Exchange. On February 24, 2017 the Exchange notified the Company that it accepted the Company's plan of compliance and granted the Company until June 11, 2018 to regain compliance with the continued listing standards. The Company will be subject to periodic review during this period. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the period could result in the Company being delisted from the NYSE MKT. The Company may then appeal a staff determination to initiate such proceedings in accordance with the exchange's Company Guide. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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 and 10-K/A for the year ended September 30, 2016. 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.


News Article | February 17, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced it has entered into a definitive agreement with institutional investors for an offering of shares of common stock with gross proceeds of approximately $1.0 million in a registered direct offering. The closing of the offering is expected to take place on or about February 23, 2017, subject to the satisfaction of customary closing conditions. In connection with the offering, the CEL-SCI will issue approximately 10 million registered shares of common stock at a purchase price of $0.10 per share. Concurrently in a private placement, the Company will issue warrants to purchase up to shares of its common stock. For each share of common stock purchased by an investor, such investor in the private placement will receive from the CEL-SCI an unregistered warrant to purchase one share of common stock. The warrants have an exercise price of $0.12 per share, will be exercisable upon the 6 month anniversary of the issue date, and will expire five and a half years from the issue date. Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with the offering. CEL-SCI intends to use the net proceeds from the offering for the Phase 3 clinical study and general corporate purposes. The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a “shelf” registration statement (File No. 333-205444). Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. A prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the prospectus supplement, when filed with the SEC, and accompanying prospectus relating to this offering may also be obtained from H.C. Wainwright & Co., LLC, by emailing placements@hcwco.com or by calling 646-975-6996. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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 and 10-K/A for the year ended September 30, 2016. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold on enrollment of additional new patients.


News Article | December 9, 2016
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) reported on a communication received today from the staff of the NYSE MKT, its current listing exchange, that it considered the Company to be noncompliant with certain listing requirements based on its quarterly report for the period ended June 30, 2016. The Company has been given the opportunity to maintain its listing by submitting a plan of compliance by January 9, 2017. This plan must advise of actions the company has taken or will take to regain compliance with the continued listing standards by June 11, 2018. The Company intends to submit such a plan by January 9, 2017. Based on the Company’s quarterly report on Form 10-Q for the period ended June 30, 2016, the Company is below compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii) since it reported a stockholders’ equity deficit as of June 30, 2016 and had a net losses in its 5 most recent fiscal years ended September 30, 2015. Additional information and provisions regarding the NYSE MKT requirements are found in Part 10 of its Company Guide. Geert Kersten, CEO of CEL-SCI said: “Noncompliance with the rules cited above came about a result of our total market capitalization having fallen below $50 million. The Exchange will not normally consider suspending dealings in, or removing from listing, the securities of an issuer which is otherwise below the stockholders’ equity criteria in the sections noted above but has a market capitalization of at least $50 million. Therefore one of the ways we can regain compliance is by achieving and maintaining market capitalization of at least $50 million.” The communication and compliance plan has no current effect on the listing of the Company's shares on the exchange. If the plan is not acceptable or the Company does not make sufficient progress under the plan or reestablish compliance by June 11, 2018, then staff of the exchange may initiate proceedings for delisting from the NYSE MKT. The Company may then appeal a staff determination to initiate such proceedings in accordance with the exchange's Company Guide. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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, 2015. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold on enrollment of additional new patients.


News Article | December 14, 2016
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported financial results today for the fiscal year ended September 30, 2016. The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2016. CEL-SCI reported a net loss of ($11.46) million in fiscal year 2016 versus a net loss of ($34.67) million in fiscal 2015. CEL-SCI reported an operating loss of ($25.55) million in fiscal year 2016 versus an operating loss of ($34.30) million in fiscal year 2015. The reduction in operating loss was largely attributable to a decrease in general and administrative expenses to $6.5 million in fiscal year 2016 compared to $13.9 million in fiscal year 2015. Major components of the decrease are 1) Lake Whillans Litigation Finance took over payment of legal fees which were about $4.4 m in fiscal year 2015 in the arbitration against the former CRO that used to run the Company’s Phase 3 trial, 2) a $2.8 million decrease in share-based employee compensation costs, which relates to the timing of vesting for the incentive stock bonus plan and 3) other miscellaneous decreases netting to approximately $200,000. Geert Kersten, CEL-SCI’s Chief Executive Officer said, “Our full focus is on two issues very important to our company: 1) the release of the partial clinical hold on the Company’s Phase 3 trial and 2) bringing to a successful conclusion the arbitration against the former CRO that used to run the Phase 3 study. That hearing on the merits, which is equivalent to a trial in a court case, started on September 26, 2016 and is ongoing.” CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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, 2016. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold on enrollment of additional new patients.


News Article | November 16, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for  Head And Neck Cancer Squamous Cell Carcinoma, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for  Head And Neck Cancer Squamous Cell Carcinoma and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Head and Neck Cancer Squamous Cell Carcinoma - Pipeline Review, H2 2016 addition with 123 market data tables and 18 figures, spread across 722 pages is available at http://www.reportsnreports.com/reports/747734-head-and-neck-cancer-squamous-cell-carcinoma-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis AB Science SA, AbbVie Inc., Accelerated Pharma,Acceleron Pharma, Inc. ,Adaptimmune Therapeutics Plc ,Advaxis, Inc. ,Altor BioScience Corporation ,Amgen Inc. ,AstraZeneca Plc ,AVEO Pharmaceuticals, Inc. ,Bayer AG ,Bionovis SA ,BioNTech AG ,Boehringer Ingelheim GmbH ,Bristol-Myers Squibb Company ,Calithera Biosciences, Inc. ,CEL-SCI Corporation ,Cellceutix Corporation ,Celldex Therapeutics, Inc. ,Centrose LLC Inquire before buying http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=747734this is a premium report price at US$2000 for a single user PDF license).


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced that Dr. Daniel Zimmerman, its Senior V.P of Research, Cellular Immunology, presented data with a LEAPS Rheumatoid Arthritis therapeutic (treatment) vaccine at Madridge‘s International Conference on Vaccines held in Baltimore, MD on February 20-22, 2017. At the conference Dr. Zimmerman presented a potentially novel approach to fighting the inflammation in the joints caused by Rheumatoid Arthritis. He introduced animal data that demonstrates that using CEL-SCI’s L.E.A.P.S CEL-4000 Rheumatoid Arthritis treatment vaccine downregulates pro-inflammatory T-cell responses and upregulates anti-inflammatory T-cell responses. This finding was confirmed by an examination of cytokines in the serum of the animals. This demonstrates that LEAPS CEL-4000 has the potential for use as a therapeutic vaccine to treat certain types of Rheumatoid Arthritis if these results can be confirmed in human studies. The study was conducted in collaboration with Dr. Tibor Glant's research team at Rush University Medical Center. Dr. Glant holds the "Jorge O. Galante, MD" Endowed Chair Professorship in Orthopedic Surgery at Rush. The Proteoglycan induced arthritis (PGIA) animal model was developed and has been studied extensively in Dr. Glant's laboratory at Rush University Medical Center for over 25 years and is considered to be closely related to the human condition of many Rheumatoid Arthritis patients. The PGIA model exhibits rheumatoid factor (Rf) and Rheumatoid Arthritis -specific antibodies not seen in other Rheumatoid Arthritis models. The LEAPS vaccines in this preliminary study consisted of a disease epitope (portion of a disease associated antigen protein) attached to a portion of another very small peptide immune cell binding ligand (ICBL) chosen to promote and direct the immune response away from a Th1 response. When the ICBL and the disease-related Proteoglycan epitope were conjugated to each other, one of the LEAPS vaccines promoted protective immune responses reduced arthritis symptoms in the animals. Rheumatoid arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% of the global population and is associated with significant morbidity and increased mortality. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. 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 and 10-K/A for the year ended September 30, 2016. 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.


NEW YORK, February 16, 2017 /PRNewswire/ -- In today's pre-market research, Stock-Callers.com has issued research reports on Heat Biologics Inc. (NASDAQ: HTBX), PDL BioPharma Inc. (NASDAQ: PDLI), Achaogen Inc. (NASDAQ: AKAO), and CEL-SCI Corp. (NYSE MKT: CVM). These companies belong...


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI reports preclinical data showing LEAPS vaccine is successful in treating Rheumatoid Arthritis.


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI submits response to FDA in connection with partial clinical hold on phase 3 clinical trial.

Loading CEL-SCI collaborators
Loading CEL-SCI collaborators