CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended December 31, 2014.
Key corporate and clinical developments during Q1 fiscal year
2015 include:
- Enrolled an additional 63 patients with
advanced primary, not yet treated, head and neck cancer into the
global pivotal Phase III trial. As of January 31, 2015, 352
patients have been enrolled in the study.
- Expanded the Phase III trial to more
clinical sites.
- Began screening patients at new
clinical centers in France, Turkey, Poland, Sri Lanka, Russia and
Taiwan. As of December 31, 2014, 17 countries have cleared our
Phase III study to allow patient enrollment. In January 2015,
Romania became the 18th country to clear our Phase III study.
- Continued patient enrollment in the
Phase I trial of Multikine* (Leukocyte Interleukin, Injection) in
HIV/HPV co-infected men and women with peri-anal warts at San Diego
Naval Medical Center. The study in expected to be complete in the
second half of 2015 and is being conducted under a Cooperative
Research and Development Agreement (CRADA) with the U.S. Navy.
- Raised gross proceeds of approximately
$7,000,000 through public and private offerings.
CEL-SCI reported an operating loss of ($9,995,741), of which
approximately $3,346,000 were non-cash related expenses, for the
quarter ended December 31, 2014 versus an operating loss of
($5,934,310), of which approximately $820,000 were non-cash related
expenses, for the quarter ended December 31, 2013. Research and
development expenses increased by approximately $835,000 compared
to the three months ended December 31, 2013 due to the increased
level of activity associated with conducting the Company’s Phase
III clinical study for head and neck cancer. General and
administrative expenses increased by approximately $3,250,000
compared to the three months ended December 31, 2013. The major
components of the increase include approximately $2,605,000
(non-cash) in employee compensation costs related to the issuance
of shareholder approved shares of restricted stock, increased legal
fees of approximately $503,000 as a result of the arbitration with
the Company’s former Clinical Research Organization (CRO), and
approximately $122,000 in increased accounting fees.
CEL-SCI's net loss available to common shareholders for the
quarter ended December 31, 2014 was ($7,845,318) or ($0.09) per
basic share, versus ($5,451,865) or ($0.11) per basic share during
the quarter ended December 31, 2013.
“We believe that 2015 can be a very successful year for CEL-SCI.
We expect 3 major events to come to the forefront: 1) The full
enrollment of the Phase III clinical trial for Multikine, something
that 18 months ago seemed not possible since the prior CRO was
enrolling so few patients every month. Now patient enrollment in
the study is hitting new monthly records and is up over 1,000% from
the time we dismissed the prior CRO, 2) the $50 million arbitration
against the prior CRO should reach its final conclusion, and 3) we
expect to have data from our study with the U.S. Navy of Multikine
in HIV/HPV co-infected patients with anal warts, potentially a
faster way to market,” stated CEL-SCI Chief Executive Officer Geert
Kersten.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an
investigational immunotherapeutic agent that is being tested in a
global pivotal Phase III clinical trial as a potential first-line
treatment for advanced primary head and neck cancer. If approved
for use following completion of CEL-SCI's clinical development
program for head and neck cancer, Multikine would be a different
type of therapy in the fight against cancer; one that appears to
have the potential to work with the body's natural immune system in
the fight against tumors. CEL-SCI is aiming to complete enrollment
of subjects to the Phase III head and neck cancer study by the end
of 2015.
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 therapy Multikine (Leukocyte Interleukin,
Injection) is currently being studied in a pivotal Phase III
clinical trial against head and neck cancer. If the study endpoint,
which is a 10% improvement in overall survival of the subjects
treated with Multikine treatment regimen as compared to subjects
treated with current standard of care only is satisfied, the study
results will be used to support applications which will be
submitted to regulatory agencies in order to receive from these
agencies commercial marketing approvals for Multikine in major
markets around the world. Additional clinical indications for
Multikine which are being investigated include 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 I trial of the former
indication has been completed at the University of Maryland. The
latter indication is now in a Phase I trial in conjunction with the
U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the
treatment of pandemic influenza and as a potential therapeutic
vaccine against rheumatoid arthritis. The Company has recently
received a Phase I SBIR Grant from the National Institutes of
Health to develop LEAPS as a potential treatment for RA with
researchers from Rush University Medical Center in Chicago,
Illinois. 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, 2014. 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 STATEMENTS OF OPERATIONS THREE MONTHS
ENDED DECEMBER 31, 2014 AND 2013 (UNAUDITED) 2014
2013 GRANT INCOME AND OTHER $ 136,838 $ 113,144
OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $43,159 and $41,673 respectively, included
below)
4,854,821 4,019,541 Depreciation and amortization 56,613 56,699
General & administrative 5,221,145
1,971,214 Total operating expenses 10,132,579
6,047,454 OPERATING LOSS (9,995,741 )
(5,934,310 ) GAIN ON DERIVATIVE INSTRUMENTS 2,162,970
1,610,817 INTEREST INCOME 29,112 31,757 INTEREST
EXPENSE (41,659 ) (42,682 ) NET LOSS
(7,845,318 ) (4,334,418 ) ISSUANCE OF ADDITIONAL SHARES DUE
TO RESET PROVISIONS - (1,117,447 ) NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (7,845,318 ) $ (5,451,865 )
NET LOSS PER COMMON SHARE BASIC $ (0.09 ) $ (0.11 )
DILUTED $ (0.11 ) $ (0.15 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 88,960,783 48,215,919 DILUTED 88,960,783 48,215,919
CEL-SCI CorporationGavin de Windt, 703-506-9460
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