VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) announced today financial results for the fiscal quarter ended June 30, 2013.
CEL-SCI reported that net loss available to common shareholders for the quarter ended June 30, 2013 was ($4,507,004) versus ($835,446) during the same quarter ended June 30, 2012. The loss during the quarter ended June 30, 2013 was increased because of the decreased gain on derivative instruments and an overall increase in operating expenses versus the quarter ended June 30, 2012. Net loss per common share, (basic) was ($0.01) for the quarter ended June 30, 2013 versus ($0.00) during the same quarter ended June 30, 2012. The operating loss for the quarter ended June 30, 2013 was ($5,513,199) versus ($4,213,098) during the same quarter ended June 30, 2012. Net loss available to common shareholders for the nine months ended June 30, 2013 was ($7,530,621) versus ($15,079,238) during the same nine months ended June 30, 2012. Net loss per common share, (basic) was ($0.03) for the nine months ended June 30, 2013 versus ($0.06) during the same nine months ended June 30, 2012. The operating loss for the nine months ended June 30, 2013 was ($14,796,535) versus ($12,918,731) during the same nine months ended June 30, 2012.
R&D expenses for the quarter ended June 30, 2013 totaled $3,769,538 versus R&D expenses of $2,469,166 for the quarter ended June 30, 2012. R&D expenses for the nine months ended June 30, 2013 totaled $9,208,900 versus R&D expenses of $7,519,586 for the nine months ended June 30, 2012. R&D expenses related to the running of the Company’s Phase III clinical trial increased because in April 2013 the Company hired two new clinical research organizations to accelerate patient enrollment and expand the clinical trial to another 60-80 additional clinical sites.
Geert Kersten, Chief Executive Officer said, "During the past few months we have worked closely with our new CROs to accelerate enrollment in our Phase 3 head and neck cancer clinical trial. We believe the changes we have made will allow them to enroll patients much faster and more cost-effectively. We are making considerable progress in advancing the study, with the exception of India, where new medical legislation has impacted clinical trial enrollment for all pharmaceutical companies, including the NIH. There are proposals under consideration in the country to amend the law, which would allow CEL-SCI to resume enrollment of new patients there. In the interim, we have begun to develop plans in other Far Eastern countries, such as Thailand, Indonesia, Malaysia, Philippines; key investigators have already been identified in these countries in the event that India does not come on-line in a timely manner. We are also currently in the process of adding over 40 clinical centers around the world, more than doubling the number of clinical trial sites that will be able to enroll subjects in our study. By mid-August we will also have completely redesigned the electronic data software for the study to make it more user friendly to study personnel at the sites. Based on the foregoing we expect enrollment will accelerate beginning in September."
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 JUNE 30, 2013 AND 2012 | ||||||||||
| (UNAUDITED) | ||||||||||
| 2013 | 2012 | |||||||||
| GRANT INCOME AND OTHER | $ | 113,728 | $ | 35,000 | ||||||
| OPERATING EXPENSES: | ||||||||||
|
Research and development (excluding R&D depreciation of $47,931 and $109,867, respectively, included below) |
3,769,538 | 2,469,166 | ||||||||
| Depreciation and amortization | 79,008 | 109,718 | ||||||||
| General & administrative | 1,778,381 | 1,669,214 | ||||||||
| Total operating expenses | 5,626,927 | 4,248,098 | ||||||||
| OPERATING LOSS | (5,513,199 | ) | (4,213,098 | ) | ||||||
| GAIN ON DERIVATIVE INSTRUMENTS | 1,079,392 | 3,390,389 | ||||||||
| INTEREST INCOME | 29,027 | 28,665 | ||||||||
| INTEREST EXPENSE | (42,693 | ) | (41,402 | ) | ||||||
| NET LOSS | (4,447,473 | ) | (835,446 | ) | ||||||
| MODIFICATION OF WARRANTS | (59,531 | ) | - | |||||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (4,507,004 | ) | $ | (835,446 | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||
| BASIC | $ | (0.01 | ) | $ | (0.00 | ) | ||||
| DILUTED | $ | (0.02 | ) | $ | (0.00 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
||||||||||
| BASIC | 309,306,502 | 258,467,582 | ||||||||
| DILUTED | 309,306,502 | 258,467,582 | ||||||||
| CEL-SCI CORPORATION | ||||||||||
| STATEMENTS OF OPERATIONS | ||||||||||
| NINE MONTHS ENDED JUNE 30, 2013 AND 2012 | ||||||||||
| (UNAUDITED) | ||||||||||
| 2013 | 2012 | |||||||||
| GRANT INCOME AND OTHER | $ | 144,133 | $ | 146,567 | ||||||
| OPERATING EXPENSES: | ||||||||||
|
Research and development (excluding R&D depreciation of $208,750 and $338,350, respectively, included below) |
9,208,900 | 7,519,586 | ||||||||
| Depreciation and amortization | 302,871 | 391,571 | ||||||||
| General & administrative | 5,428,897 | 5,154,141 | ||||||||
| Total operating expenses | 14,940,668 | 13,065,298 | ||||||||
| OPERATING LOSS | (14,796,535 | ) | (12,918,731 | ) | ||||||
| GAIN ON DERIVATIVE INSTRUMENTS | 7,363,854 | 142,532 | ||||||||
| INTEREST INCOME | 89,394 | 86,393 | ||||||||
| INTEREST EXPENSE | (127,803 | ) | (220,812 | ) | ||||||
| NET LOSS | (7,471,090 | ) | (12,910,618 | ) | ||||||
| ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS | - | (250,000 | ) | |||||||
| MODIFICATION OF WARRANTS | (59,531 | ) | (325,620 | ) | ||||||
| INDUCEMENT WARRANTS | - | (1,593,000 | ) | |||||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (7,530,621 | ) | $ | (15,079,238 | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||
| BASIC | $ | (0.03 | ) | $ | (0.06 | ) | ||||
| DILUTED | $ | (0.05 | ) | $ | (0.06 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
||||||||||
| BASIC | 300,383,239 | 244,738,972 | ||||||||
| DILUTED | 300,383,239 | 244,738,972 | ||||||||
