CEL-SCI Corporation (NYSE AMEX: CVM) announced today financial results for the fiscal quarter ended March 31, 2012.
CEL-SCI reported that net loss available to common shareholders for the quarter ended March 31, 2012 was $(10,086,959) versus $(15,097,973) during the same quarter ended March 31, 2011. Net loss per common share, (basic) was $(0.04) for the quarter ended March 31, 2012 versus $(0.07) during the same quarter ended March 31, 2011. The operating loss for the quarter ended March 31, 2012 was $(4,262,357) versus $(5,096,996) during the same quarter ended March 31, 2011. Net loss available to common shareholders for the six months ended March 31, 2012 was $(14,243,792) versus $(21,348,925) million during the same six months ended March 31, 2011. Net loss per common share, (basic) was $(0.06) for the six months ended March 31, 2012 versus $($0.10) during the same six months ended March 31, 2011. The operating loss for the six months ended March 31, 2012 was $(8,705,633) versus $(9,413,030) during the same six months ended March 31, 2011.
R&D expenses for the quarter ended March 31, 2012 totaled $2,594,235 versus R&D expenses of $3,042,097 for the quarter ended March 31, 2011. R&D expenses for the six months ended March 31, 2012 totaled $5,050,420 versus R&D expenses of $6,306,525 for the six months ended March 31, 2011. R&D expenses related to the running of the Company's Phase III clinical trial declined because of lower Multikine manufacturing expenditures and lower costs related to the set-up of the clinical sites that had been present in the same period last year.
Geert Kersten, Chief Executive Officer, said, "Our global Phase III clinical trial for our investigational cancer drug Multikine is moving forward as anticipated. We continue to believe that we will end up being successful in this trial and that we will develop a paradigm shift in the way that head and neck cancer is treated."
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 approvedfor sale, barter or exchangeby 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.
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| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| THREE MONTHS ENDED MARCH 31, 2012 and 2011 | ||||||||
| (UNAUDITED) | ||||||||
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| Â | 2012 | Â | Â | 2011 | Â | |||
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| GRANT INCOME AND OTHER | $ | 106,543 | $ | 43,815 | ||||
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| OPERATING EXPENSES: | ||||||||
Research and development (excluding R&D depreciation of $108,531 and $119,633 respectively, included below) | 2,594,235 | 3,042,097 | ||||||
| Depreciation and amortization | 143,428 | 145,141 | ||||||
| General & administrative | Â | 1,631,237 | Â | Â | 1,953,573 | Â | ||
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| Total operating expenses | Â | 4,368,900 | Â | Â | 5,140,811 | Â | ||
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| OPERATING LOSS | (4,262,357 | ) | (5,096,996 | ) | ||||
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| OTHER EXPENSES | - | (12,000,000 | ) | |||||
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| (LOSS) GAIN ON DERIVATIVE INSTRUMENTS | (4,204,327 | ) | 3,062,087 | |||||
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| INTEREST INCOME | 28,673 | 46,707 | ||||||
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| INTEREST EXPENSE | Â | (55,948 | ) | Â | (41,402 | ) | ||
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| NET LOSS | (8,493,959 | ) | (14,029,604 | ) | ||||
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| MODIFICATIONS OF WARRANTS | - | (1,068,369 | ) | |||||
| INDUCEMENT OF WARRANTS | Â | (1,593,000 | ) | Â | - | Â | ||
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| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (10,086,959 | ) | $ | (15,097,973 | ) | ||
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| NET LOSS PER COMMON SHARE | $ | (0.04 | ) | $ | (0.07 | ) | ||
| BASIC | ||||||||
| $ | (0.04 | ) | $ | (0.09 | ) | |||
| DILUTED | ||||||||
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WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||||||||
| BASIC | 247,369,587 | 207,089,841 | ||||||
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| DILUTED | 247,369,587 | 207,089,841 | ||||||
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| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| SIX MONTHS ENDED MARCH 31, 2012 and 2011 | ||||||||
| (UNAUDITED) | ||||||||
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| Â | 2012 | Â | Â | 2011 | Â | |||
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| GRANT INCOME AND OTHER | $ | 111,567 | $ | 706,633 | ||||
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| OPERATING EXPENSES: | ||||||||
Research and development (excluding R&D depreciation of $225,282 and $235,824 respectively, included below) | 5,050,420 | 6,306,525 | ||||||
| Depreciation and amortization | 281,853 | 286,288 | ||||||
| General & administrative | Â | 3,484,927 | Â | Â | 3,526,850 | Â | ||
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| Total operating expenses | Â | 8,817,200 | Â | Â | 10,119,663 | Â | ||
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| OPERATING LOSS | (8,705,633 | ) | (9,413,030 | ) | ||||
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| OTHER EXPENSES | - | (12,000,000 | ) | |||||
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| (LOSS) GAIN ON DERIVATIVE INSTRUMENTS | (3,247,857 | ) | 1,115,692 | |||||
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| INTEREST INCOME | 57,728 | 99,586 | ||||||
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| INTEREST EXPENSE | Â | (179,410 | ) | Â | (82,804 | ) | ||
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| NET LOSS | (12,075,172 | ) | (20,280,556 | ) | ||||
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| ISSUANCE OF ADDITIONAL SHARES | (250,000 | ) | - | |||||
| MODIFICATIONS OF WARRANTS | (325,620 | ) | (1,068,369 | ) | ||||
| INDUCEMENT OF WARRANTS | Â | (1,593,000 | ) | Â | - | Â | ||
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| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (14,243,792 | ) | $ | (21,348,925 | ) | ||
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| NET LOSS PER COMMON SHARE | ||||||||
| BASIC | $ | (0.06 | ) | $ | (0.10 | ) | ||
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| DILUTED | $ | (0.06 | ) | $ | (0.10 | ) | ||
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WEIGHTED AVERAGE COMMON SHARES OUTSTANDING | ||||||||
| BASIC | 237,912,177 | 206,090,265 | ||||||
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| DILUTED | 237,912,177 | 206,090,265 | ||||||
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Contacts:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
