VIENNA, Va., Feb. 16 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX: CVM) reports financial results for the quarter ended December 31, 2009.
CEL-SCI reported that net income available to shareholders for the quarter ended December 31, 2009 was $19,159,517 versus a loss of ($2,173,513) during the same quarter in fiscal year 2009. Net income per share, basic was $0.10 for the quarter ended December 31, 2009 versus a loss of ($0.02) during the same quarter in fiscal year 2009. The operating loss for the quarter ended December 31, 2009 was ($4,252,849) versus an operating loss of ($2,551,823) during the same quarter in fiscal year 2009. The gain on net income available to shareholders for the quarter ended December 31, 2009 is due to derivative accounting.
R&D expenses for the quarter ended December 31, 2009 totaled $2,805,127 versus R&D expenses of $1,410,753 for the same quarter in fiscal year 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®.
Geert Kersten, Chief Executive Officer said, "We concluded December 31, 2009 quarter in the strongest financial condition ever, with more than $36 million in cash and cash equivalents, allowing us to self-fund our upcoming pivotal Phase III study with our cancer drug Multikine. We are excited that we are in position to move Multikine through the clinic without losing rights to any of the major markets and to continue to develop our L.E.A.P.S.™ technology platform in areas such as H1N1 and Rheumatoid Arthritis."
Multikine is the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. 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.
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007. Thereafter CEL-SCI built a dedicated manufacturing facility for Multikine which is now completed and fully validated.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global Phase III trial in advanced primary head and neck cancer. 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 L.E.A.P.S. 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. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com .
CEL-SCI CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended December 31, 2009 2008 ---- ---- REVENUE: Rent income $30,000 $- --------- --------- Total revenue 30,000 - EXPENSES: Research and development, excluding depreciation of $99,583 and $64,523 included below 2,805,127 1,410,753 Depreciation and amortization 119,581 85,944 General and administrative 1,358,141 1,055,126 --------- --------- Total expenses 4,282,849 2,551,823 --------- --------- LOSS FROM OPERATIONS (4,252,849) (2,551,823) GAIN ON DERIVATIVE INSTRUMENTS 23,340,267 391,689 INTEREST INCOME 110,219 71,237 INTEREST EXPENSE (38,120) (84,616) ------- ------- NET INCOME (LOSS) BEFORE INCOME TAXES 19,159,517 (2,173,513) INCOME TAX PROVISION - - ------- ------- NET INCOME (LOSS) AVAILABLE TO COMMON SHAREHOLDERS $19,159,517 $(2,173,513) =========== =========== NET INCOME (LOSS) PER COMMON SHARE-BASIC $0.10 $(0.02) ===== ====== NET INCOME (LOSS) PER COMMON SHARE-DILUTED $0.02 $(0.02) ===== ====== WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-BASIC 194,959,814 122,215,334 =========== =========== WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-DILUTED 256,198,162 122,215,334 =========== ===========
SOURCE CEL-SCI Corporation
|SOURCE CEL-SCI Corporation|
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