VIENNA, Va., Jan. 14 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (Amex: CVM) reports financial results for the fiscal year ending September 30, 2007.
CEL-SCI reports a net operating loss for fiscal year 2007 of $9,352,209 versus a net operating loss of $5,349,196 in fiscal year 2006. The loss per share for fiscal year 2007 was unchanged at $(0.10) compared to fiscal year 2006.
The cash from operating activities used during the year was about $4,890,100. CEL-SCI's assets during the year grew from $9.6 million in fiscal year 2006 to $20.7 million in fiscal year 2007.
Geert Kersten, Chief Executive Officer said, "CEL-SCI had a very successful year in that it received FDA go-ahead for a Phase III clinical trial with its cancer drug Multikine, raised substantial amounts of money and began building a dedicated manufacturing facility for Multikine. We are looking forward to taking over the completed facility in 2008 and starting the global Phase III trial."
About CEL-SCI's Phase III Cancer Drug Multikine:
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.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS". Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also 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.
The Company has operations in Vienna, Virginia and Baltimore, Maryland.
CEL-SCI's other products, which are currently in pre-clinical stage, have
shown protection against a number of diseases in animal tests and are being
tested against diseases associated with bio-defense.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2007 and 2006
GRANT REVENUE AND OTHER $ 57,043 $ 125,457
Research and development (excluding
R&D depreciation of $91,292, $74,043
and $96,442 respectively, included
below) 2,528,528 1,896,976
Depreciation and amortization 176,186 170,903
General & administrative 6,704,538 3,406,774
Total operating expenses 9,409,252 5,474,653
NET OPERATING LOSS (9,352,209) (5,349,196)
GAIN ON DERIVATIVE INSTRUMENTS 868,182 2,325,784
COSTS ASSOCIATED WITH CONVERTIBLE DEBT - (4,791,548)
OTHER INCOME - -
INTEREST INCOME 562,973 92,487
INTEREST EXPENSE (1,708,603) (216,737)
NET LOSS $ (9,629,657) $ (7,939,210)
NET LOSS PER COMMON SHARE
BASIC $ (0.10) $ (0.10)
DILUTED $ (0.10) $ (0.11)
WEIGHTED AVERAGE COMMON SHARES
BASIC 97,310,488 78,971,290
DILUTED 97,310,488 93,834,078
|SOURCE CEL-SCI Corporation|
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