VIENNA, Va., Jan. 14 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION
(NYSE Alternext US: CVM) reports financial results for the fiscal year ended September 30, 2008.
CEL-SCI reported a net loss for fiscal year 2008 of $(7,703,415) versus a net loss of $(9,629,657) in fiscal year 2007. The loss per share per common share for fiscal year 2008 was $(0.07) compared to a net loss per common share in fiscal year 2007 of $(0.10). Included in the loss in 2008 were non-cash expenditures that added up to approximately $3.3 million, including $1.3 million for employee-stock compensation charges and $1.4 million for various consulting and other related expenses.
The net loss included research and development (R&D) expenses of $4,101,563 in 2008 compared to $2,528,528 in 2007. 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 are pleased by the progress we made in fiscal 2008 in preparing for our pivotal trial of Multikine for head and neck cancer. Expenditures for 2009 are expected to be significantly reduced because of the completion of the manufacturing facility and other material reductions in expenditures. Our focus now is to secure strategic partners to assist us in funding the Phase III study of our cancer drug."
The report by the Company's accountants also contained a "going concern" qualification. This means that based upon only the existing and committed amount of cash in CEL-SCI today, the accountants cannot be sure that CEL-SCI will have enough cash to stay in business until January 2010. As is clearly explained in the Company's 10-K filing, CEL-SCI's management is aware of this, and is currently working on licensing agreements (in addition to the two agreements it currently has with Teva Pharmaceuticals and Orient Europharma), joint ventures and/or financings to start the Phase III clinical trial with its cancer drug Multikine. In addition, in late December 2008 CEL-SCI put in place a $5 million equity line of credit. In the meantime, in light of the challenging capital markets, management has been very successful in reducing its monthly cash expenditures.
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 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.
CEL-SCI CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS YEARS ENDED SEPTEMBER 30, 2008 and 2007 2008 2007 GRANT REVENUE AND OTHER $5,065 $57,043 OPERATING EXPENSES: Research and development (excluding R&D depreciation of $124,705 and $91,292 respectively, included below) 4,101,563 2,528,528 Depreciation and amortization 215,060 176,186 General & administrative 5,200,735 6,704,538 Total operating expenses 9,517,358 9,409,252 NET OPERATING LOSS (9,512,293) (9,352,209) GAIN ON DERIVATIVE INSTRUMENTS 1,799,393 868,182 COSTS ASSOCIATED WITH CONVERTIBLE DEBT - - INTEREST INCOME 483,252 562,973 INTEREST EXPENSE (473,767) (1,708,603) NET LOSS $(7,703,415) $(9,629,657) DIVIDENDS (424,815) - NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $(8,128,230) $(9,629,657) NET LOSS PER COMMON SHARE BASIC $(0.07) $(0.10) DILUTED $(0.07) $(0.10) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING BASIC 117,060,866 97,310,488 DILUTED 117,060,866 97,310,488
|SOURCE CEL-SCI Corporation|
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