CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended June 30, 2015.
Recent key corporate and clinical developments include:
- Reported record patient enrollment
numbers in April with 31 patients, 26 patients in May and 25
patients in June in the Phase 3 head and neck cancer trial.
- A total of five hundred twenty one
(521) patients have been enrolled in the Phase 3 study as of July
31, 2015 after new record patient enrollment of 33 in July.
- Completed expansion of the Phase 3
trial to 24 countries - received clearance in Spain, Italy, and
Thailand.
- Added several clinical trial sites for
the Phase 3 trial, among them Aintree University Hospital in the
UK. This site is headed by Professor Richard Shaw, a leading
European head and neck cancer key opinion leader.
- Added a second clinical site and key
opinion leader to the Phase 1 trial in HIV/HPV co-infected men and
women with peri-anal warts. The University of California, San
Francisco (UCSF) was added in July and world renowned key opinion
leader in HPV and anal cancer, Dr. Joel Palefsky joined as a
Principal Investigator.
- Continued patient enrollment in the
Phase 1 trial in at San Diego Naval Medical Center.
- Raised approximately $16 million, prior
to deducting placement agent commissions and offering
expenses.
“We continued to build momentum in both our Phase 3 and Phase 1
trials for Multikine through the addition of new clinical sites and
increased patient enrollment. Multikine offers a different type of
therapy in the fight against cancer, leveraging the body's natural
immune system in the fight against tumors and other infectious
diseases like HPV that can be a precursor to cancer. We are
encouraged by the progress in our clinical trials and look forward
to a strong second half of 2015,” stated CEL-SCI Chief Executive
Officer Geert Kersten.
CEL-SCI's net loss available to common shareholders for the
quarter ended June 30, 2015 was ($4,429,137) or ($0.05) per basic
share, versus ($2,444,480) or ($0.04) per basic share during the
quarter ended June 30, 2014. The net loss available to common
shareholders for the nine months ended June 30, 2015 was
($24,830,691) or ($0.32) per basic share, versus ($21,261,925) or
($0.38) per basic share during the same nine months ended June 30,
2014. The increase in net loss for the three and nine month periods
of 2015 as compared to the same periods in 2014 was primarily
attributable to the increase in operating loss and the non-cash
charge for the loss on a debt extinguishment off-set by the gain
reported of the non-cash charge for the change in value of
derivative instruments caused by a decrease in the Company’s common
stock.
CEL-SCI reported an operating loss of ($8,201,475) for the
quarter ended June 30, 2015 versus an operating loss of
($6,901,329) for the quarter ended June 30, 2014. The operating
loss for the nine months ended June 30, 2015 was ($25,956,559)
versus ($19,062,074) during the nine months ended June 30,
2014.
During the nine and three months ended June 30, 2015, the rise
in operating loss was attributable to an increase in research and
development expenses by approximately $2,956,000 and $1,239,000
compared to the nine and three months ended June 30, 2014. R&D
expenses increased primarily because of the increase in patient
enrollment of the Company’s Phase 3 clinical study for head and
neck cancer.
About Multikine®
Multikine* (Leukocyte Interleukin, Injection) is an
investigational immunotherapeutic agent that is being tested in an
open-label, randomized, controlled, global pivotal Phase 3 clinical
trial as a potential first-line treatment for advanced primary
squamous cell carcinoma of the head and neck. Multikine is designed
to 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.
Multikine is also being tested in a Phase 1 study through two
clinical sites including the U.S. Naval Medical Center, San Diego
under a Cooperative Research and Development Agreement ("CRADA")
and the University of California San Francisco. The Phase 1 study
is evaluating Multikine as a potential treatment for peri-anal
warts in HIV/HPV co-infected men and women. CEL-SCI has also
entered into two co-development agreements with Ergomed Clinical
Research Limited 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 3
clinical trial as a potential neoadjuvant treatment for patients
with squamous cell carcinoma of the head and neck. If the study
endpoint, which is a 10% improvement in overall survival of the
subjects treated with the Multikine treatment regimen plus the
current 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 has been completed
at the University of Maryland. The latter indication is now in a
Phase 1 trial at two clinical sites including the U.S. Naval
Medical Center, San Diego, under a CRADA and the University of
California San Francisco.
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. For more information, please visit
www.cel-sci.com.
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
Corporation'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, 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.
*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 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 have 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 Phase 3 clinical trial of
this investigational therapy that is currently in progress.
CEL-SCI CORPORATION STATEMENTS OF OPERATIONS THREE
MONTHS ENDED JUNE 30, 2015 AND 2014 (unaudited) 2015 2014
GRANT AND OTHER INCOME $ 389,223 $ 15,914 OPERATING
EXPENSES: Research and development (excluding R&D depreciation
of $35,009 and $43,877 respectively, included below) 5,692,568
4,453,730 Depreciation and amortization 50,913 65,042 General &
administrative 2,847,217 2,398,471
Total operating expenses 8,590,698
6,917,243 OPERATING LOSS (8,201,475 ) (6,901,329 )
GAIN ON DERIVATIVE INSTRUMENTS 4,428,780 4,467,776
LOSS ON DEBT EXTINGUISHMENT (641,276 ) - INTEREST INCOME
26,429 30,795 INTEREST EXPENSE (41,595 )
(41,722 ) NET LOSS $ (4,429,137 ) $ (2,444,480 ) NET
LOSS PER COMMON SHARE BASIC $ (0.05 ) $ (0.04 ) DILUTED $
(0.06 ) $ (0.11 ) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC 83,796,311 64,664,274 DILUTED 85,134,107 64,664,274
CEL-SCI CORPORATION STATEMENTS OF OPERATIONS NINE
MONTHS ENDED JUNE 30, 2015 AND 2014 (unaudited) 2015 2014
GRANT INCOME AND OTHER $ 723,681 $ 196,215 OPERATING
EXPENSES: Research and development (excluding R&D depreciation
of $119,053 and $127,268 respectively, included below) 15,582,933
12,627,269 Depreciation and amortization 163,431 173,185 General
& administrative 10,933,876 6,457,835
Total operating expenses 26,680,240
19,258,289 OPERATING LOSS (25,956,559 )
(19,062,074 ) GAIN (LOSS) ON DERIVATIVE INSTRUMENTS
1,808,954 (1,053,755 ) LOSS ON DEBT EXTINGUISHMENT (641,276
) - INTEREST INCOME 83,072 93,434 INTEREST EXPENSE
(124,882 ) (122,083 ) NET LOSS (24,830,691 )
(20,144,478 ) ISSUANCE OF ADDITIONAL SHARES DUE TO RESET
PROVISIONS - (1,117,447 ) NET LOSS
AVAILABLE TO COMMON SHAREHOLDERS $ (24,830,691 ) $ (21,261,925 )
NET LOSS PER COMMON SHARE BASIC AND DILUTED $ (0.32 ) $
(0.38 ) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING BASIC AND
DILUTED 77,625,511 56,343,806
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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