VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) reports financial results for the fiscal quarter ended March 31, 2013.
CEL-SCI reported that net loss available to common shareholders for the quarter ended March 31, 2013 was ($713,371) versus ($10,086,959) during the same quarter ended March 31, 2012. Net loss per common share, (basic) was ($0.00) for the quarter ended March 31, 2013 versus ($0.04) during the same quarter ended March 31, 2012. The operating loss for the quarter ended March 31, 2013 was ($4,239,824) versus ($4,262,357) during the same quarter ended March 31, 2012. Net loss available to common shareholders for the six months ended March 31, 2013 was ($3,023,617) versus ($14,243,792) million during the same six months ended March 31, 2012. Net loss per common share, (basic) was ($0.01) for the six months ended March 31, 2013 versus ($0.06) during the same six months ended March 31, 2012. The operating loss for the six months ended March 31, 2013 was ($9,283,337) versus ($8,705,633) during the same six months ended March 31, 2012.
R&D expenses for the quarter ended March 31, 2013 totaled $2,515,585 versus R&D expenses of $2,594,235 for the quarter ended March 31, 2012. R&D expenses for the six months ended March 31, 2013 totaled $5,439,363 versus R&D expenses of $5,050,420 for the six months ended March 31, 2012. R&D expenses are mostly related to the running of the Company’s Phase III clinical trial.
Geert Kersten, Chief Executive Officer said, “We are fortunate that we were able to bring in a new partner to help us expand the Phase III clinical trial to about 100 clinical sites worldwide. The new partner, Ergomed, will contribute up to $10 million towards this expanded clinical trial and will be responsible for most of the enrollment. We feel very good about this new development.”
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, 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.
| CEL-SCI CORPORATION | ||||||||||
| STATEMENTS OF OPERATIONS | ||||||||||
| THREE MONTHS ENDED MARCH 31, 2013 AND 2012 | ||||||||||
| (unaudited) | ||||||||||
| 2013 | 2012 | |||||||||
| GRANT INCOME AND OTHER | $ | 15,405 | $ | 106,543 | ||||||
| OPERATING EXPENSES: | ||||||||||
|
Research and development (excluding R&D depreciation of $55,957 and $108,531, respectively, included below) |
2,515,585 | 2,594,235 | ||||||||
| Depreciation and amortization | 90,413 | 143,428 | ||||||||
| General & administrative | 1,649,231 | 1,631,237 | ||||||||
|
Total operating expenses |
4,255,229 | 4,368,900 | ||||||||
| OPERATING LOSS | (4,239,824 | ) | (4,262,357 | ) | ||||||
| GAIN (LOSS) ON DERIVATIVE INSTRUMENTS | 3,538,264 | (4,204,327 | ) | |||||||
| INTEREST INCOME | 30,952 | 28,673 | ||||||||
| INTEREST EXPENSE | (42,763 | ) | (55,948 | ) | ||||||
| NET LOSS | (713,371 | ) | (8,493,959 | ) | ||||||
| INDUCEMENT WARRANTS | - | (1,593,000 | ) | |||||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (713,371 | ) | $ | (10,086,959 | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||
| BASIC | $ | (0.00 | ) | $ | (0.04 | ) | ||||
| DILUTED | $ | (0.01 | ) | $ | (0.04 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
||||||||||
| BASIC | 309,011,767 | 247,369,587 | ||||||||
| DILUTED | 309,011,767 | 247,369,587 | ||||||||
| CEL-SCI CORPORATION | ||||||||||
| STATEMENTS OF OPERATIONS | ||||||||||
| SIX MONTHS ENDED MARCH 31, 2013 AND 2012 | ||||||||||
| (unaudited) | ||||||||||
| 2013 | 2012 | |||||||||
| GRANT INCOME AND OTHER | $ | 30,405 | $ | 111,567 | ||||||
| OPERATING EXPENSES: | ||||||||||
|
Research and development (excluding R&D depreciation of $160,820 and $225,282, respectively, included below) |
5,439,363 | 5,050,420 | ||||||||
| Depreciation and amortization | 223,863 | 281,853 | ||||||||
| General & administrative | 3,650,516 | 3,484,927 | ||||||||
| Total operating expenses | 9,313,742 | 8,817,200 | ||||||||
| OPERATING LOSS | (9,283,337 | ) | (8,705,633 | ) | ||||||
| GAIN (LOSS) ON DERIVATIVE INSTRUMENTS | 6,284,462 | (3,247,857 | ) | |||||||
| INTEREST INCOME | 60,367 | 57,728 | ||||||||
| INTEREST EXPENSE | (85,109 | ) | (179,410 | ) | ||||||
| NET LOSS | (3,023,617 | ) | (12,075,172 | ) | ||||||
| ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS | - | (250,000 | ) | |||||||
| MODIFICATIONS OF WARRANTS | - | (325,620 | ) | |||||||
| INDUCEMENT WARRANTS | - | (1,593,000 | ) | |||||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (3,023,617 | ) | $ | (14,243,792 | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||
| BASIC | $ | (0.01 | ) | $ | (0.06 | ) | ||||
| DILUTED | $ | (0.03 | ) | $ | (0.06 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
||||||||||
| BASIC | 295,921,608 | 237,912,177 | ||||||||
| DILUTED | 295,921,608 | 237,912,177 | ||||||||
