CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended March 31, 2015.
Recent key clinical developments include:
- Reported new record high patient
enrollment numbers - 24 patients in January, 25 patients in
February and 29 patients in March in the Phase III head and neck
cancer trial; with continued increase post-Q2 of 31 patients in
April
- A total of four hundred thirty-seven
(437) patients have been enrolled in the Phase III study as of
April 30, 2015.
- Trial received clearance in Romania,
the Philippines, Malaysia and Belarus.
- Reached milestone of trial approval in
21 countries as originally planned; trial to expand into additional
countries based on strong interest.
- Continued patient enrollment in the
Phase I trial in HIV/HPV co-infected men and women with peri-anal
warts at San Diego Naval Medical Center.
“We have enrolled approximately half of the 880 patients planned
for our Phase III head and neck cancer trial. Twenty-one countries
have cleared the trial and clinical centers around the world are
actively recruiting patients. We are pleased with the progress we
have made. Our CROs are putting forth their best efforts to
complete patient recruitment by the end of 2015. We are
conservatively estimating completion in the first quarter of 2016,”
stated CEL-SCI Chief Executive Officer Geert Kersten.
CEL-SCI reported an operating loss of ($7,759,343) for the
quarter ended March 31, 2015 versus an operating loss of
($6,226,435) for the quarter ended March 31, 2014. The operating
loss for the six months ended March 31, 2015 was ($17,755,084)
versus ($12,160,745) during the six months ended March 31, 2014.
The rise in operating loss was attributable to an increase in
research and development expenses of approximately $1,717,000 in
the first half of fiscal year 2015 compared to the first half of
fiscal year 2014. R&D expenses increased primarily because of
the increase in patient enrollment in the Company’s Phase 3
clinical study for head and neck cancer. In addition, the general
and administrative expenses increased by approximately $4,027,000
for the first half of fiscal year 2015 compared to the first half
of fiscal year 2014. G&A expenses increased primarily because
of an increase of approximately $3,043,000 in employee compensation
costs related to the issuance of shareholder approved shares of
restricted stock and an increase in legal fees of approximately
$872,000 primarily related to the arbitration with the Company’s
former clinical research organization (CRO).
CEL-SCI's net loss available to common shareholders for the
quarter ended March 31, 2015 was ($12,556,236) or ($0.17) per basic
share, versus ($13,365,580) or ($0.24) per basic share during the
quarter ended March 31, 2014. The net loss available to common
shareholders for the six months ended March 31, 2015 was
($20,401,554) or ($0.27) per basic share, versus ($18,817,445) or
($0.36) per basic share during the same six months ended March 31,
2014. The increase in net loss for the three and six month periods
of 2015 as compared to the same periods in 2014 was primarily
attributable to the increase in operating loss off-set by the
reduced loss reported of the non-cash charge for the change in
value of derivative instruments caused by a decrease in the
Company’s common stock.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an
investigational 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. The trial is expected to expand into a total of
approximately 100 clinical centers in about 25 countries.
Multikine is also being tested in a Phase I study under a CRADA
(Cooperative Research and Development Agreement) with the U.S.
Naval Medical Center, San Diego as a potential treatment for
peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has
entered into two co-development agreements with Ergomed to further
the development of 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 plus SOC as compared to
subjects treated with current SOC 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 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 and
10-K/A 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 MARCH 31, 2015 AND 2014 (unaudited) 2015
2014 GRANT AND OTHER INCOME $ 197,620 $
67,157 OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $40,885 and $41,718, respectively, included
below)
5,035,544 4,153,998 Depreciation and amortization 55,905 51,444
General & administrative 2,865,514
2,088,150 Total operating expenses 7,956,963
6,293,592 OPERATING LOSS (7,759,343 )
(6,226,435 ) LOSS ON DERIVATIVE INSTRUMENTS (4,782,796 )
(7,132,348 ) INTEREST INCOME 27,531 30,882 INTEREST
EXPENSE (41,628 ) (37,679 ) NET LOSS $
(12,556,236 ) $ (13,365,580 ) NET LOSS PER COMMON SHARE
BASIC $ (0.17 ) $ (0.24 ) DILUTED $ (0.17 ) $ (0.24 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC AND DILUTED 75,847,869 56,239,562 CEL-SCI
CORPORATION STATEMENTS OF OPERATIONS SIX MONTHS ENDED MARCH 31,
2015 AND 2014 (unaudited) 2015 2014
GRANT INCOME AND OTHER $ 334,458 $ 180,301
OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $84,044 and $83,391 respectively, included
below)
9,890,365 8,173,539 Depreciation and amortization 112,518 108,143
General & administrative 8,086,659
4,059,364 Total operating expenses 18,089,542
12,341,046 OPERATING LOSS (17,755,084 )
(12,160,745 ) LOSS ON DERIVATIVE INSTRUMENTS (2,619,826 )
(5,521,531 ) INTEREST INCOME 56,643 62,639 INTEREST
EXPENSE (83,287 ) (80,361 ) NET LOSS
(20,401,554 ) (17,699,998 ) ISSUANCE OF ADDITIONAL SHARES
DUE TO RESET PROVISIONS - (1,117,447 )
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (20,401,554 ) $
(18,817,445 ) NET LOSS PER COMMON SHARE BASIC $ (0.27 ) $
(0.36 ) DILUTED $ (0.27 ) $ (0.36 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC AND DILUTED 74,540,112 52,183,654
CEL-SCI CorporationGavin de Windt, 703-506-9460
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