CEL-SCI Corporation Announces Fiscal 2011 Financial Results

CEL-SCI Corporation (NYSE AMEX: CVM) reported financial results today for the fiscal year ended September 30, 2011.

CEL-SCI’s net loss available to common shareholders for the fiscal year 2011 was ($26.8) million, or ($0.13) per share, versus an income of $8.9 million, or $0.04 per share for the fiscal 2010 year. CEL-SCI reported an operating loss of ($17,986,000) in fiscal year 2011 versus an operating loss of ($18,560,000) in fiscal year 2010. The change in net income available to common shareholders in fiscal year 2011 was primarily due to a reduction of the gain on derivative instruments of $24.4 million from 2010, and a $12 million one-time expense for the settlement of a lawsuit.

The operating loss included research and development (R&D) expenses of $11.7 million in fiscal 2011 compared to $11.9 million in fiscal 2010. R&D expenses remained constant due to the costs associated with the Company’s ongoing Phase III clinical trial of its investigational cancer therapy, Multikine ® (Leukocyte Interleukin, Injection)*. The report by the Company’s accountants also contained an explanatory paragraph referring to its recurring losses from operations and expressing substantial doubt in the Company’s ability to continue as a going concern. This means that based upon only the existing and committed amount of cash in CEL-SCI today, not taking into consideration management’s ability to raise additional capital, the accountants cannot be sure that CEL-SCI will have enough cash to continue its operations until December 2012. As is clearly explained in the Company’s annual report filing, CEL-SCI’s management is aware of this, expected to receive this and has plans in place. The last time CEL-SCI received this explanatory paragraph was in January 2009. During 2009 CEL-SCI raised in excess of $40 million in equity capital.

Geert Kersten, Chief Executive Officer said, “Our Phase III clinical trial for our investigational cancer drug Multikine is enrolling patients on 3 continents. We plan to further expand this study in 2012 since we are pleased with its progress so far.”

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 developing (and 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, 2011. 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.
 
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2011 and 2010
 
 
    2011     2010
 
GRANT INCOME AND OTHER $ 956,154 $ 153,300
 
OPERATING EXPENSES:

Research and development (excluding R&D depreciation of $438,738, $434,030 and $329,866 respectively, included below)
11,745,629 11,911,626
Depreciation and amortization 531,316 516,117
General & administrative   6,664,883     6,285,810  
 
Total operating expenses   18,941,828     18,713,553  
 
OPERATING LOSS (17,985,674 ) (18,560,253 )
 
OTHER EXPENSES (12,000,000 ) -
 
GAIN ON DERIVATIVE INSTRUMENTS 4,432,148 28,843,772
 
INTEREST INCOME 164,163 362,236
 
INTEREST EXPENSE   (322,980 )   (162,326 )
 
NET (LOSS) INCOME (25,712,343 ) 10,483,429
 
MODIFICATIONS OF WARRANTS   (1,068,369 )   (1,532,456 )
 
NET (LOSS) INCOME AVAILABLE TO COMMON SHAREHOLDERS $ (26,780,712 ) $ 8,950,973  
 
NET (LOSS) INCOME PER COMMON SHARE
BASIC $ (0.13 ) $ 0.04
 
DILUTED $ (0.15 ) $ (0.06 )
 

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC 208,488,987 202,102,859
 
DILUTED 208,488,987 202,102,859
 

Copyright Business Wire 2010

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