VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) reported financial results today for the fiscal year ended September 30, 2012.
CEL-SCI’s net loss available to common shareholders for the fiscal year 2012 was ($17.6) million, or ($0.07) per share, versus a loss of ($26.8) million, or ($0.13) per share for the fiscal 2011 year. CEL-SCI reported an operating loss of ($17,243,000) in fiscal year 2012 versus an operating loss of ($17,986,000) in fiscal year 2011. The change in net loss available to common shareholders in fiscal year 2012 was primarily due to a $12 million one-time expense for the settlement of a lawsuit from 2011. Subsequent to the end of its fiscal year, CEL-SCI completed a Registered Direct Offering, where it sold its common stock and warrants, raising gross proceeds of $10.5 million.
The operating loss included research and development (R&D) expenses of $10.4 million in fiscal 2012 compared to $11.7 million in fiscal 2011. The operating loss also included the general and administrative (G&A) expenses of $6.6 million in fiscal 2012 compared to $6.7 million in fiscal 2011.
Geert Kersten, Chief Executive Officer said, “We made good progress in our very large Phase III head and neck cancer clinical trial this year. In the fall of 2012 we were able to announce the first positive safety review by the Data Safety Monitoring Board, composed of independent leading experts in the head and neck cancer space, letting the global Phase III clinical continue to enroll patients. We feel good about what are seeing and are expanding the study further to include more US and European clinical sites.”
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. 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 our 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 report, 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 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 filings, including but not limited to its report on Form 10- K for the year ended September 30, 2012. 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2012 and 2011
|GRANT INCOME AND OTHER||$||254,610||$||956,154|
Research and development (excluding R&D depreciation of $445,710, $438,738 and $434,030 respectively, included below)
|Depreciation and amortization||533,468||531,316|
|General & administrative||6,595,287||6,664,883|
|Total operating expenses||17,497,450||18,941,828|
|GAIN ON DERIVATIVE INSTRUMENTS||1,911,683||4,432,148|
|NET (LOSS) INCOME||(15,477,310||)||(25,712,343||)|
|ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS||(250,000||)||-|
|MODIFICATIONS OF WARRANTS||(325,620||)||(1,068,369||)|
|NET (LOSS) INCOME AVAILABLE TO COMMON SHAREHOLDERS||$||(17,645,930||)||$||(26,780,712||)|
|NET (LOSS) INCOME PER COMMON SHARE|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING