Company Ends Fiscal Year in Strong Financial Condition
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) reported financial results today for the fiscal year ended September 30, 2010.
CEL-SCI’s net income for the fiscal year 2010 was $10.48 million, or $0.04 per share, versus a loss of ($40.9) million, or ($0.31) per share for the fiscal 2009 year. CEL-SCI reported an operating loss for the fiscal 2010 year of ($18,560,000) versus an operating loss of ($12,020,000) in fiscal year 2009. The improvement in net income in fiscal year 2010 was primarily due to a derivative gain of $28.8 million, versus a derivative loss of ($28.5) million for 2009.
The operating loss included research and development (R&D) expenses of $11.9 million in fiscal 2010 compared to $6.0 million in fiscal 2009. R&D expenses increased due to higher costs associated with preparing for the Company’s upcoming Phase III clinical trial of its cancer drug Multikine®. As of September 30, 2010, CEL-SCI had cash and cash equivalents of $26.5 million.
Geert Kersten, Chief Executive Officer said, “We have spent the whole year preparing for the global Phase III trial which we expect to commence shortly. For this trial we have pursued important initiatives related to trial design, manufacturing and enrollment to enhance the chances of success. We feel that CEL-SCI is in a unique position in that it was able to build a dedicated manufacturing facility where it could control the production of its cancer drug Multikine and has the money to support broad enrollment in its clinical trial.”
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. The pivotal Phase III study will involve about 48 clinical centers in nine countries on three continents and will be the biggest head and neck cancer Phase III trial ever conducted.
Multikine is the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is Combination Immunotherapy in that Multikine contains both active and passive immunity. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The 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 creation 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.
When used in this report, the words "intends," "believes," "anticipated" 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, 2010. 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, 2010 and 2009 | ||||||||
| 2010 | 2009 | |||||||
| RENT INCOME AND OTHER | $ | 153,300 | $ | 80,093 | ||||
| OPERATING EXPENSES: | ||||||||
|
Research and development (excluding R&D depreciation of $434,030 and $329,866 respectively, included below) |
11,911,626 | 6,011,750 | ||||||
| Depreciation and amortization | 516,117 | 417,205 | ||||||
| General & administrative | 6,285,810 | 5,671,595 | ||||||
| Total operating expenses | 18,713,553 | 12,100,550 | ||||||
| OPERATING LOSS | (18,560,253 | ) | (12,020,457 | ) | ||||
| GAIN (LOSS) ON DERIVATIVE INSTRUMENTS | 28,843,772 | (28,491,650 | ) | |||||
| INTEREST INCOME | 362,236 | - | ||||||
| INTEREST EXPENSE | (162,326 | ) | (397,923 | ) | ||||
| NET INCOME (LOSS) | 10,483,429 | (40,910,030 | ) | |||||
| MODIFICATIONS OF WARRANTS | (1,532,456 | ) | (490,728 | ) | ||||
| NET INCOME (LOSS) AVAILABLE TO COMMON SHAREHOLDERS | $ | 8,950,973 | $ | (41,400,758 | ) | |||
| NET INCOME (LOSS) PER COMMON SHARE | ||||||||
| BASIC | $ | 0.04 | $ | (0.31 | ) | |||
| DILUTED | $ | (0.05 | ) | $ | (0.31 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES | ||||||||
| OUTSTANDING | ||||||||
| BASIC | 202,102,859 | 133,535,050 | ||||||
| DILUTED | 226,277,913 | 133,535,050 | ||||||
CONTACT:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
KEYWORDS: United States North America Virginia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Research Science
MEDIA:
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