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CEL-SCI Reports Fiscal 2014 Financial Results and Clinical & Corporate DevelopmentsCEL-SCI Corporation (NYSE MKT: CVM) reported financial results today for the fiscal year ended September 30, 2014. The Company also reported key clinical and corporate developments achieved during, and subsequent to, fiscal 2014. Corporate Developments Included:
Clinical Developments Included:
CEL-SCI reported an operating loss of ($27.57) million in fiscal year 2014 versus an operating loss of ($19.87) million in fiscal year 2013. The rise in operating loss was attributable to an increase in research and development expenses to $17.0 million in fiscal year 2014 compared to $12.68 million in fiscal year 2013. This expense increased based on the additional activity level of the Phase III clinical trial. It was also attributable to an increase in general and administrative expenses to $10.6 million in fiscal year 2014 compared to $6.98 million in fiscal year 2013. This increase is primarily due to equity based compensation costs of approximately $1.48 million for restricted stock issued, increased public relations cost of $440,000 and legal fees of $1.67 million. Public relations costs increased to support the progression of the products through clinical trials. Legal fees increased primarily as a result of arbitration with the Company's former CRO. CEL-SCI's net loss available to common shareholders for the fiscal year 2014 was ($28.48) million, or ($0.48) per share, versus a loss of ($9.23) million, or ($0.30) per share for the fiscal year 2013. The change in net loss available to common shareholders in fiscal year 2014 was primarily due to the gain on derivative instruments of $0.25 million for fiscal year 2014 versus a gain on derivative instruments of $10.75 million for fiscal year 2013 and an increase in total operating expenses of $27.84 million for fiscal year 2014 versus $20.03 million for fiscal year 2013. Geert Kersten, CEL-SCI's Chief Executive Officer said, "Fiscal 2014 was a pivotal year for us. The accelerated pace of our Phase III trial with our two new CROs affirms the strength of our study and the potential of Multikine. We also made advancements in two new indications for Multikine in HIV/HPV co-infected patients with cervical dysplasia and anal-warts. These two indications have the potential for Multikine to produce data and move towards marketing approvals at a faster pace than our large Phase III trial." "We believe fiscal 2015 is a year in which we will achieve and report several significant milestones," Kersten concluded. About Multikine Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in over 20 countries. About CEL-SCI Corporation 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 therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include 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 I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA. CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. The Company has recently received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for RA with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. For more information, please visit www.cel-sci.com. * Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with its 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 (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress. When used in this release, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which 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 Corporation's SEC (News - Alert) filings, including but not limited to its report on Form 10-K for the year ended September 30, 2014. 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.
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