CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended June 30, 2014.
Recent key corporate and clinical developments include:
- Enrolled 54 patients in the Company’s
Phase III head and neck cancer trial during the quarter, a 93%
increase in sequential quarterly patient enrollment; Subsequently
in July, achieved milestone of total 232 patients enrolled to date,
representing over one-quarter of the total enrollment for the
study.
- Added four clinical sites in the U.S.
and additional clinical centers around the world for Multikine, an
investigational immunotherapy being studied in a global pivotal
Phase III head and neck cancer trial.
- Expanded the Phase III head and neck
cancer trial into the United Kingdom during the quarter, with
additional expansions post-quarter into Austria, Sri Lanka, Turkey
and France.
- Raised approximately $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.
CEL-SCI reported an operating loss of ($6,901,329) for the
quarter ended June 30, 2014 versus an operating loss of
($5,513,199) for the quarter ended June 30, 2013. The operating
loss for the nine months ended June 30, 2014 was ($19,062,074)
versus ($14,796,535) during the nine months ended June 30, 2013.
The rise in operating loss was mostly attributable to an increase
in research and development expenses to $12,627,269 in the nine
month ended June 30, 2014 compared to $9,208,900 in the nine months
ended June 30, 2013. R&D expenses increased because of the
expansion of the Company’s Phase III clinical study for head and
neck cancer and an associated increase in patient enrollment.
CEL-SCI's net loss available to common shareholders for the
quarter ended June 30, 2014 was ($2,444,480) or ($0.04) per basic
share, versus ($4,507,074) or ($0.15) per basic share during the
quarter ended June 30, 2013. The net loss available to common
shareholders for the nine months ended June 30, 2014 was
($21,261,925) or ($0.38) per basic share, versus ($7,530,621) or
($0.25) per basic share during the same nine months ended June 30,
2013. The increase in net loss for the three and nine 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 the fluctuation in the Company’s
common stock share price.
During the nine months ended June 30, 2014, the Company raised
approximately $31.5 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 enrolled 54 patients in our Phase III head and neck cancer
trial for the quarter ended June 30, 2014 which was the best
quarter ever for us. Since the end of June, we have added four
countries to the study, including two in Western Europe, and added
more clinical sites in order to continue building patient
enrollment. With the progress being made expanding the study by our
partners and CROs, we believe our Phase III study will reach full
enrollment by the end of 2015,” stated CEL-SCI Chief Executive
Officer Geert Kersten.
Mr. Kersten continued, “We are also working closely with our
partners, Ergomed and the U.S. Navy, to complete patient enrollment
in our Phase I study for HIV/HPV co-infected men and women with
peri-anal warts.”
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an
investigational immunotherapeutic agent that is being tested in a
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’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 (Cooperative Research and Development
Agreement).
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 NIH to develop LEAPS as a
potential treatment for RA with Rush University researchers. 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 JUNE 30, 2014 AND 2013 (unaudited) 2014 2013
OTHER INCOME $ 15,914 $ 113,728 OPERATING EXPENSES:
Research and development (excluding R&D depreciation of $43,877
and $47,931, respectively, included below) 4,453,730 3,769,538
Depreciation and amortization 65,042 79,008 General &
administrative 2,398,471 1,778,381
Total operating expenses 6,917,243
5,626,927 OPERATING LOSS (6,901,329 ) (5,513,199 )
GAIN ON DERIVATIVE INSTRUMENTS 4,467,776 1,079,392
INTEREST INCOME 30,795 29,027 INTEREST EXPENSE
(41,722 ) (42,763 ) NET LOSS (2,444,480 ) (4,447,543
) MODIFICATION OF WARRANTS - (59,531 )
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (2,444,480 ) $
(4,507,074 ) NET LOSS PER COMMON SHARE BASIC $ (0.04 ) $
(0.15 ) DILUTED $ (0.11 ) $ (0.18 ) WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING BASIC 64,664,274 30,930,650
DILUTED 64,664,274 30,930,650 CEL-SCI CORPORATION
STATEMENTS OF OPERATIONS NINE MONTHS ENDED JUNE 30, 2014 AND 2013
(unaudited) 2014 2013 OTHER INCOME $ 196,215 $
144,133 OPERATING EXPENSES: Research and development
(excluding R&D depreciation of $127,268 and $208,750
respectively, included below) 12,627,269 9,208,900 Depreciation and
amortization 173,185 302,871 General & administrative
6,457,835 5,428,897 Total operating
expenses 19,258,289 14,940,668
OPERATING LOSS (19,062,074 ) (14,796,535 ) (LOSS) GAIN ON
DERIVATIVE INSTRUMENTS (1,053,755 ) 7,363,854 INTEREST
INCOME 93,434 89,394 INTEREST EXPENSE (122,083 )
(127,803 ) NET LOSS (20,144,478 ) (7,471,090 )
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS (1,117,447 )
- MODIFICATION OF WARRANTS - (59,531 )
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (21,261,925 ) $
(7,530,621 ) NET LOSS PER COMMON SHARE BASIC $ (0.38 ) $
(0.25 ) DILUTED $ (0.38 ) $ (0.50 ) WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING BASIC 56,343,806 30,038,324
DILUTED 56,343,806 30,038,324
COMPANY CONTACT:CEL-SCI CorporationGavin de Windt,
703-506-9460
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