VIENNA, Va., May 16 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION
(Amex: CVM) reports financial results for the three and six months ended
March 31, 2008.
Geert Kersten, Chief Executive Officer of CEL-SCI Corporation said, "We
are completely focused on getting our cancer therapy Multikine(R) into its
pivotal Phase III clinical trial. We were unable to start the Phase III
study until the completion of our dedicated manufacturing facility for
Multikine from which we can supply the Phase III study and subsequent sale
of the drug. This facility is expected to be completed in the 3rd quarter
of 2008. The Phase III study is designed to replicate the safety and
efficacy results seen in the earlier studies and lead to an approval to
sell Multikine."
Mr. Kersten continued, "Our financial results reflect our primary focus
on the facility and preparation for the Phase III trial. Our Phase III
trial is the first Phase III trial to test the theory that immune
stimulation before surgery, radiation and/or chemotherapy will increase
survival of cancer patients."
About 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.
CEL-SCI is currently building a manufacturing facility for Multikine
close to Baltimore, MD. Upon completion of the facility in the 3rd quarter
of 2008, CEL-SCI will commence the Phase III clinical trial. Multikine
appears to be the first non-toxic cancer drug.
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's loss from operations for the quarter ended March 31, 2008
was $2,085,098 versus a loss from operations of $2,012,605 during the same
quarter in 2007. The net loss per common share for the quarter ended March
31, 2008 was $0.03 which was unchanged from the same quarter in 2007. The
Company's loss from operations for the six months ended March 31, 2008 was
$4,952,536 versus a net loss from operations of $3,592,516 during the same
six months in 2007. The Company's net loss per common share for the six
months ended March 31, 2008 was $0.05 which was unchanged from the same six
month period in 2007.
During the three month period ended March 31, 2008, research and
development charges were $1,037,063 compared to $678,865 during the same
period in 2007. During the six month period ended March 31, 2008, research
and development expenses were $2,066,029 compared to $1,185,023 during the
same period in 2007.
During the three month period ended March 31, 2008, general and
administrative expenses were $968,820 compared to $1,316,146 during the
same period in 2007. During the six month period ended March 31, 2008,
general and administrative expenses were $2,754,569 compared to $2,368,850
during the same period in 2007.
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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended
March 31,
2008 2007
REVENUE:
Grant revenue $- $17,917
Rent income - 6,805
Other income - -
Total Revenue - 24,722
EXPENSES:
Research and development, excluding
depreciation of $97,035 and
$20,832 included below 1,037,063 678,865
Depreciation and amortization 79,215 42,316
General and administrative 968,820 1,316,146
Total Expenses 2,085,098 2,037,327
LOSS FROM OPERATIONS (2,085,098) (2,012,605)
LOSS ON DERIVATIVE INSTRUMENTS (1,160,937) (447,356)
INTEREST INCOME 157,256 77,114
INTEREST EXPENSE (121,515) (341,038)
NET LOSS BEFORE INCOME TAXES 3,210,294) (2,723,885)
INCOME TAX PROVISION - -
NET LOSS $(3,210,294) $(2,723,885)
DIVIDENDS (424,815) -
NET LOSS AVAILABLE TO COMMON
SHAREHOLDERS $(3,635,109) $(2,723,885)
NET LOSS PER COMMON SHARE (BASIC) $(0.03) $(0.03)
NET LOSS PER COMMON SHARE (DILUTED) $(0.03) $(0.03)
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING 116,312,378 83,836,076
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Six Months Ended
March 31,
2008 2007
REVENUE:
Grant revenue $- $31,779
Rent income 1,530 12,895
Other income - 841
Total Revenue 1,530 45,515
EXPENSES:
Research and development, excluding
depreciation of $97,856 and
$41,794 included below 2,066,029 1,185,023
Depreciation and amortization 133,468 84,158
General and administrative 2,754,569 2,368,850
Total Expenses 4,954,066 3,638,031
LOSS FROM OPERATIONS (4,952,536) (3,592,516)
GAIN (LOSS) ON DERIVATIVE INSTRUMENTS (170,949) 271,891
INTEREST INCOME 335,987 172,665
INTEREST EXPENSE (265,531) (688,284)
NET LOSS BEFORE INCOME TAXES (5,053,029) (3,836,244)
INCOME TAX PROVISION - -
NET LOSS $(5,053,029) $(3,836,244)
DIVIDENDS (424,815) -
NET LOSS AVAILABLE TO COMMON
SHAREHOLDERS $(5,477,844) $(3,836,244)
NET LOSS PER COMMON SHARE (BASIC) $(0.05) $(0.05)
NET LOSS PER COMMON SHARE (DILUTED) $(0.05) $(0.05)
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING 116,008,631 83,377,267
SOURCE CEL-SCI Corporation
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Related links:
http://www.cel-sci.com
CONTACT:
Gavin de Windt of CEL-SCI Corporation,
+1-703-506-9460
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