CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended December 31, 2016.
CEL-SCI reported the net income available to common shareholders
for the quarter ended December 31, 2016 was $3,536,802 or $0.02 per
basic share, versus $2,341,813 or $0.02 per basic share during the
quarter ended December 31, 2015. CEL-SCI reported an operating loss
of ($5,414,607) for the quarter ended December 31, 2016 versus an
operating loss of ($5,783,132) for the quarter ended December 31,
2015.
CEL-SCI’s net income for the quarter ending December 31, 2016
and 2015 was largely attributable to the gain on derivative
instruments of approximately $8.9 million and $8.1 million,
respectively, which was the result of the change in fair value of
the derivative liabilities during the quarter. This change was
caused by decreases in the share price of CEL-SCI’s common
stock.
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate
the immune system to fight cancer and infectious diseases. Its lead
investigational immunotherapy, Multikine* (Leukocyte Interleukin,
Injection), is currently being studied in a pivotal Phase 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. Subject to the
partial clinical hold, the study was designed with the objective
that, if the study endpoint, which is an improvement in overall
survival of the subjects treated with the Multikine treatment
regimen plus the current standard of care (SOC) as compared to
subjects treated with the current SOC only, is satisfied, the study
results will be used to support applications that the Company plans
to submit to regulatory agencies in order to seek commercial
marketing approvals for Multikine in major markets around the
world. Additional clinical indications for Multikine that are being
investigated include the treatment of cervical dysplasia in HIV/HPV
co-infected women, and the treatment of peri-anal warts in HIV/HPV
co-infected men and women. A Phase 1 trial of the former indication
(treatment of cervical dysplasia in HIV/HPV co-infected women) has
been completed at the University of Maryland. The latter indication
(treatment of peri-anal warts in HIV/HPV co-infected men and women)
is being studied in a Phase 1 trial at the University of
California, San Francisco. CEL-SCI has patents on Multikine from
the US, Europe, China, and Japan.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) technology for the potential
treatment of pandemic influenza in hospitalized patients and as a
potential vaccine for the treatment of rheumatoid arthritis.
The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press release, 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 that 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’s filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K and 10-K/A for
the year ended September 30, 2016. 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.
* Multikine (Leukocyte Interleukin, Injection) is the trademark
that CEL-SCI has registered for this investigational therapy, and
this proprietary name is subject to FDA review in connection with
the Company's 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. Further research is required, and early-phase
clinical trial results must be confirmed in the Phase 3 clinical
trial of this investigational therapy that is in progress and that
is currently subject to a clinical hold on enrollment of additional
new patients.
CEL-SCI CORPORATION
STATEMENTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2016 AND
2015
(UNAUDITED)
2016 2015 GRANT INCOME AND OTHER $ 17,258 $ 20,976
OPERATING EXPENSES: Research and development 4,024,856
5,169,507 General & administrative 1,407,009
634,601 Total operating expenses
5,431,865 5,804,108 OPERATING LOSS
(5,414,607 ) (5,783,132 ) GAIN ON DERIVATIVE INSTRUMENTS
8,928,312 8,122,960 INTEREST INCOME, NET 23,097
1,985 NET INCOME AVAILABLE TO COMMON
SHAREHOLDERS $ 3,536,802 $ 2,341,813
NET INCOME PER COMMON SHARE BASIC $ 0.02 $ 0.02 DILUTED $ 0.01 $
0.02 WEIGHTED AVERAGE COMMON SHARES OUTSTANDING BASIC
149,860,777 109,768,502 DILUTED 152,117,711 111,639,785
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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