CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended March 31, 2014.
Recent key corporate and clinical developments include:
- Reported March and April 2014 as new
record months for patient enrollment in the Company’s Phase III
head and neck cancer trial.
- The Investigational Review Board (IRB)
of the U.S. Naval Medical Center, San Diego approved the start of a
Phase I study of Multikine* (Leukocyte Interleukin, Injection) in
HIV/HPV co-infected men and women with peri-anal warts.
- Added the first expansion site in the
U.S. at 21st Century Oncology in Greenville, North Carolina to the
Phase III head and neck cancer trial.
- Added a large number of clinical
centers to the Phase III head and neck cancer trial around the
world.
- Listed warrants issued in connection
with the October and December 2013 public offerings (NYSE MKT: CVM
WS).
CEL-SCI reported an operating loss of ($6,226,435) for the
quarter ended March 31, 2014 versus an operating loss of
($4,239,824) for the quarter ended March 31, 2013. The operating
loss for the six months ended March 31, 2014 was ($12,160,745)
versus ($9,283,337) during the six months ended March 31, 2013. The
rise in operating loss was mostly attributable to an increase in
research and development expenses to $8,173,539 in the first half
of fiscal 2014 compared to $5,439,363 in the first half of fiscal
year 2013. R&D expenses increased because of the expansion of
the Company’s Phase III clinical study for head and neck cancer to
additional clinical sites and an associated increase in patient
enrollment.
CEL-SCI's net loss available to common shareholders for the
quarter ended March 31, 2014 was ($13,365,580) or ($0.24) per basic
share, versus ($713,371) or ($0.02) per basic share during the
quarter ended March 31, 2013. The net loss available to common
shareholders for the six months ended March 31, 2014 was
($18,817,445) or ($0.36) per basic share, versus ($3,023,617) or
($0.10) per basic share during the same six months ended March 31,
2013. The increase in net loss for the three and six month periods
of 2014 as compared to the same periods in 2013 was primarily
attributable to a non-cash charge for the change in value of
derivative instruments caused by an increase in the Company’s
common stock share price.
On March 31, 2014 the Company had approximately $10,600,000 in
cash and cash equivalents. In April 2014, the Company raised an
additional $9.84 million in net proceeds through the sale of common
stock and warrants in a public offering and from the exercise of
previously issued and outstanding warrants.
“We were again able to strengthen our cash position by securing
an additional $13 million during March and April 2014. In addition,
the enrollment in our Phase III trial continues to increase
rapidly, culminating in a record number of patients enrolled in
March, which was quickly surpassed by another record number
enrolled in April. We expect to continue to build enrollment
through the remainder of 2014. We also anticipate patient
enrollment to begin soon in a Phase I study conducted by the U.S.
Navy to develop Multikine as a potential treatment for HIV/HPV
co-infected men and women with peri-anal warts,” stated CEL-SCI
Chief Executive Officer Geert Kersten.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an
immunotherapeutic agent that is being tested in an open-label,
randomized, controlled, 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. The trial is expected to
expand into a total of approximately 100 clinical centers in about
20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA
(Cooperative Research and Development Agreement) with the U.S.
Naval Medical Center, San Diego, to develop Multikine as a
potential treatment for HIV/HPV co-infected men and women with
peri-anal warts. CEL-SCI also announced that it entered into two
new co-development agreements with Ergomed to further clinically
develop Multikine for cervical dysplasia/neoplasia in women who are
co-infected with HIV and HPV and for peri-anal warts in men and
women who are co-infected with HIV and HPV.
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 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 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, 2013. 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 MARCH 31, 2014 AND 2013 (unaudited) 2014 2013
OTHER INCOME $ 67,157 $ 15,405 OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $41,718 and $55,957, respectively, included
below)
4,153,998 2,515,585 Depreciation and amortization 51,444 90,413
General & administrative 2,088,150
1,649,231 Total operating expenses 6,293,592
4,255,229 OPERATING LOSS (6,226,435 )
(4,239,824 ) (LOSS) GAIN ON DERIVATIVE INSTRUMENTS
(7,132,348 ) 3,538,264 INTEREST INCOME 30,882 30,952
INTEREST EXPENSE (37,679 ) (42,763 ) NET LOSS
$ (13,365,580 ) $ (713,371 ) NET LOSS PER COMMON SHARE BASIC
$ (0.24 ) $ (0.02 ) DILUTED $ (0.24 ) $ (0.14 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 56,239,562 30,901,177 DILUTED 56,239,562 30,901,177
CEL-SCI CORPORATION STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2014 AND 2013 (unaudited) 2014
2013 OTHER INCOME $ 180,301 $ 30,405 OPERATING
EXPENSES:
Research and development (excluding
R&D depreciation of $83,391 and $160,820 respectively, included
below)
8,173,539 5,439,363 Depreciation and amortization 108,143 223,863
General & administrative 4,059,364
3,650,516 Total operating expenses 12,341,046
9,313,742 OPERATING LOSS (12,160,745 )
(9,283,337 ) (LOSS) GAIN ON DERIVATIVE INSTRUMENTS
(5,521,531 ) 6,284,462 INTEREST INCOME 62,639 60,367
INTEREST EXPENSE (80,361 ) (85,109 ) NET LOSS
(17,699,998 ) (3,023,617 ) ISSUANCE OF ADDITIONAL SHARES DUE
TO RESET PROVISIONS (1,117,447 ) - NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (18,817,445 ) $ (3,023,617
) NET LOSS PER COMMON SHARE BASIC $ (0.36 ) $ (0.10 )
DILUTED $ (0.36 ) $ (0.31 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 52,183,654 29,592,161 DILUTED 52,183,654 29,592,161
CEL-SCI CorporationGavin de Windt, 703-506-9460
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