CEL-SCI Corporation (NYSE MKT: CVM) announced today financial
results for the fiscal quarter ended June 30, 2012.
CEL-SCI reported that net loss available to common shareholders for the
quarter ended June 30, 2012 was $(835,446) versus $(3,114,255) during
the same quarter ended June 30, 2011. The loss during the quarter ended
June 30, 2012 was reduced because of the increased gain on derivative
instruments and an overall reduction in operating expenses versus the
quarter ended June 30, 2011. Net loss per common share, (basic) was
$(0.00) for the quarter ended June 30, 2012 versus $(0.01) during the
same quarter ended June 30, 2011. The operating loss for the quarter
ended June 30, 2012 was $(4,213,098) versus $(4,845,744) during the same
quarter ended June 30, 2011. Net loss available to common shareholders
for the nine months ended June 30, 2012 was $(15,079,238) versus
$(24,463,180) during the same nine months ended June 30, 2011. Net loss
per common share, (basic) was $(0.06) for the nine months ended June 30,
2012 versus $($0.12) during the same nine months ended June 30, 2011.
The operating loss for the nine months ended June 30, 2012 was
$(12,918,731) versus $(14,258,774) during the same nine months ended
June 30, 2011.
R&D expenses for the quarter ended June 30, 2012 totaled $2,469,166
versus R&D expenses of $2,924,771 for the quarter ended June 30, 2011.
R&D expenses for the nine months ended June 30, 2012 totaled $7,519,586
versus R&D expenses of $9,231,296 for the nine months ended June 30,
2011. R&D expenses related to the running of the Company’s Phase III
clinical trial declined because of lower Multikine manufacturing
expenditures and the reduction in site initiation expenses since most
clinical sites were already initiated prior to the quarter ending June
30, 2012.
"Our Phase III study is continuing to enroll patients on a continuous
basis on three continents around the world. We recently presented
CEL-SCI and the Multikine head and neck cancer Phase III study at the 8th
International Head and Neck Cancer conference in Toronto, Canada and
interest was high among clinical investigators in joining our study. We
continue to believe that adding our Multikine immunotherapy to the
existing head and neck cancer treatments will create a new paradigm for
the treatment of head and neck cancer," said Geert Kersten, CEO of
CEL-SCI Corporation.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving
the treatment of cancer and other diseases by utilizing the immune
system, the body's natural defense system. Its lead investigational
therapy is Multikine (Leukocyte Interleukin, Injection), currently being
studied in a pivotal global Phase III clinical trial. CEL-SCI is also
developing (and investigating) an immunotherapy (LEAPS-H1N1-DC) as a
possible treatment for H1N1 hospitalized patients and as a vaccine
(CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform.
The LEAPS drug candidates are currently in preclinical testing. The
investigational immunotherapy 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 possible
emergence of a new more virulent hybrid virus through the combination of
H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in
Vienna, Virginia, and in/near Baltimore, Maryland.
Multikine is the trademark that CEL-SCI has registered for this
investigational therapy, and this proprietary name is subject to FDA
review in connection with our future anticipated regulatory submission
for approval.Multikine has not been licensed or approvedfor
sale, barter or exchangeby the FDA or any other regulatory
agency. Similarly, its safety or efficacy has not been established for
any use. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational therapy
Multikine (Leukocyte Interleukin, Injection). Further research is
required, and early-phase clinical trial results must be confirmed in
the well-controlled, Phase III clinical trial of this investigational
therapy that is currently in progress.
When used in this report, the words "intends," "believes,"
"anticipated", “plans” and "expects" and similar expressions are
intended to identify forward-looking statements. Such statements are
subject to risks and uncertainties which could cause actual results to
differ materially from those projected. Factors that could cause or
contribute to such differences include, an inability to duplicate the
clinical results demonstrated in clinical studies, timely development of
any potential products that can be shown to be safe and effective,
receiving necessary regulatory approvals, difficulties in manufacturing
any of the Company's potential products, inability to raise the
necessary capital and the risk factors set forth from time to time in
CEL-SCI Corporation's SEC filings, including but not limited to its
report on Form 10- K for the year ended September 30, 2011. The Company
undertakes no obligation to publicly release the result of any revision
to these forward-looking statements which may be made to reflect the
events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events.
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2012 AND 2011
(UNAUDITED)
2012
2011
GRANT INCOME AND OTHER
$
35,000
$
77,403
OPERATING EXPENSES:
Research and development (excluding R&D depreciation of $109,867
and $123,519 respectively, included below)
2,469,166
2,924,771
Depreciation and amortization
109,718
148,148
General & administrative
1,669,214
1,850,228
Total operating expenses
4,248,098
4,923,147
OPERATING LOSS
(4,213,098
)
(4,845,744
)
GAIN ON DERIVATIVE INSTRUMENTS
3,390,389
1,763,311
INTEREST INCOME
28,665
34,416
INTEREST EXPENSE
(41,402
)
(66,238
)
NET LOSS
(835,446
)
(3,114,255
)
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS
$
(835,446
)
$
(3,114,255
)
NET LOSS PER COMMON SHARE
BASIC
$
(0.00
)
$
(0.01
)
DILUTED
$
(0.00
)
$
(0.02
)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC
258,467,582
208,402,408
DILUTED
258,467,582
208,402,408
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2012 AND 2011
(UNAUDITED)
2012
2011
GRANT INCOME AND OTHER
$
146,567
$
784,036
OPERATING EXPENSES:
Research and development (excluding R&D depreciation of $338,350
and $359,343 respectively, included below)
7,519,586
9,231,296
Depreciation and amortization
391,571
434,436
General & administrative
5,154,141
5,377,078
Total operating expenses
13,065,298
15,042,810
OPERATING LOSS
(12,918,731
)
(14,258,774
)
OTHER EXPENSES
-
(12,000,000
)
GAIN ON DERIVATIVE INSTRUMENTS
142,532
2,879,003
INTEREST INCOME
86,393
134,002
INTEREST EXPENSE
(220,812
)
(149,042
)
NET LOSS
(12,910,618
)
(23,394,811
)
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS