VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) reports financial results for the fiscal quarter ended December 31, 2010.
CEL-SCI reported that net income available to shareholders for the quarter ended December 31, 2010 was a loss of ($6,250,952) versus a gain of $19,159,517 during the same quarter ended December 31, 2009. Net income per share, basic was a loss of ($0.03) for the quarter ended December 31, 2010 versus a gain of $0.10 during the same quarter ended December 31, 2009. The change from a substantial net income in the quarter ending December 31, 2009 to a loss in the quarter ending December 31, 2010 was primarily due to a derivative gain of $23,340,267 million in the 2009 quarter versus a derivative loss of ($1,946,395) million for the 2010 quarter. The operating loss for the quarter ended December 31, 2010 was ($4,316,034) versus an operating loss of ($4,252,849) during the same quarter ended December 31, 2009. The net cash used during the quarter ending December 31, 2010 was about $3.6 million.
R&D expenses for the quarter ended December 31, 2010 totaled $3,264,428 versus R&D expenses of $2,805,127 for the same quarter in fiscal year 2010. R&D expenses increased due to higher costs associated with the start up of the Company’s Phase III clinical trial of its cancer drug Multikine® which commenced in December 2010. As of December 31, 2010, CEL-SCI had cash, cash equivalents and prepaid expenditures of $23 million.
Geert Kersten, Chief Executive Officer said, “Last quarter we started our Phase III clinical trial for head and neck cancer in the US. We are currently in the process of adding clinical sites in another eight countries. This study, if successful, should make our Multikine cancer drug part of the new standard of care treatment for newly diagnosed head and neck cancer patients.”
CEL-SCI’s Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only. CEL-SCI’s 880 patient trial is expected to be the largest clinical study of head and neck cancer ever conducted. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional therapy weakens the immune system, and likely compromises the benefits of immunotherapy.
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.
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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|For the Three Months Ended|
|Grant and other income||662,818||-|
Research and development, excluding depreciation of $116,191 and $99,583 included below
|Depreciation and amortization||141,147||119,581|
|General and administrative||1,573,277||1,358,141|
|LOSS FROM OPERATIONS||(4,316,034||)||(4,252,849||)|
|(LOSS) GAIN ON DERIVATIVE INSTRUMENTS||(1,946,395||)||23,340,267|
|NET (LOSS) INCOME BEFORE INCOME TAXES||(6,250,952||)||19,159,517|
|INCOME TAX PROVISION||-||-|
|NET (LOSS) INCOME AVAILABLE TO COMMON SHAREHOLDERS||$||(6,250,952||)||$||19,159,517|
|NET (LOSS) INCOME PER COMMON SHARE-BASIC||$||(0.03||)||$||0.10|
|NET (LOSS) INCOME PER COMMON SHARE-DILUTED||$||(0.03||)||$||0.02|
|WEIGHTED AVERAGE COMMON|
|WEIGHTED AVERAGE COMMON|
Gavin de Windt, 703-506-9460
KEYWORDS: United States North America Virginia
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Oncology Pharmaceutical Research Science