CEL-SCI Corporation (NYSE MKT: CVM) reported financial results
today for the fiscal year ended September 30, 2012.
CEL-SCI's net loss available to common shareholders for the fiscal year
2012 was ($17.6) million, or ($0.07) per share, versus a loss of ($26.8)
million, or ($0.13) per share for the fiscal 2011 year. CEL-SCI reported
an operating loss of ($17,243,000) in fiscal year 2012 versus an
operating loss of ($17,986,000) in fiscal year 2011. The change in net
loss available to common shareholders in fiscal year 2012 was primarily
due to a $12 million one-time expense for the settlement of a lawsuit
from 2011. Subsequent to the end of its fiscal year, CEL-SCI completed a
Registered Direct Offering, where it sold its common stock and
warrants, raising gross proceeds of $10.5 million.
The operating loss included research and development (R&D) expenses of
$10.4 million in fiscal 2012 compared to $11.7 million in fiscal 2011.
The operating loss also included the general and administrative (G&A)
expenses of $6.6 million in fiscal 2012 compared to $6.7 million in
Geert Kersten, Chief Executive Officer said, "We made good progress in
our very large Phase III head and neck cancer clinical trial this year.
In the fall of 2012 we were able to announce the first positive safety
review by the Data Safety Monitoring Board, composed of independent
leading experts in the head and neck cancer space, letting the global
Phase III clinical continue to enroll patients. We feel good about what
are seeing and are expanding the study further to include more US and
European clinical sites."
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
investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment
for H1N1 hospitalized patients and as a vaccine (CEL-2000) for
Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS
technology platform. 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.
For more information, please visit www.cel-sci.com.
* 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 approved for
sale, barter or exchange by 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, 2012. 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2012 and 2011
Research and development (excluding R&D depreciation of $445,710,
$438,738 and $434,030 respectively, included below)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
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