VIENNA, Va., Jan. 13 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM) reports financial results for the fiscal year ended September 30, 2009.
CEL-SCI reported an operating loss for fiscal year 2009 of $ (12,100,550) versus an operating loss of $ (9,517,358) in fiscal year 2008. Included in this operating loss in 2009 were non-cash expenditures that added up to approximately $5.5 million. In addition, CEL-SCI also incurred a $28.5 million non-cash loss related to derivative accounting. This loss was primarily a result of the significant increase in the Company's share price. CEL-SCI expects to report a substantial gain related to derivative accounting in the quarter ending December 31, 2009.
The operating loss included research and development (R&D) expenses of $ 6.0 million in fiscal 2009 compared to $4.1 million in fiscal 2008. 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 fiscal year 2009 in the strongest financial condition ever, with more than $33,550,000 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.
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 to treat H1N1 hospitalized patients using its L.E.A.P.S. technology platform. This investigational 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 .
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2009 and 2008
RENT INCOME AND OTHER
Research and development (excluding
R&D depreciation of $329,866 and $91,292
respectively, included below)
Depreciation and amortization
General & administrative
Total operating expenses
(LOSS)/GAIN ON DERIVATIVE INSTRUMENTS
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS
NET LOSS PER COMMON SHARE
BASIC AND DILUTED
WEIGHTED AVERAGE COMMON SHARES
BASIC & DILUTED
SOURCE CEL-SCI Corporation