CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended December 31, 2015.
Key corporate and clinical developments during first quarter
fiscal year 2016 include:
- Enrolled an additional 98 patients in
the global pivotal Phase 3 head and neck cancer trial. As of
January 31, 2016, 697 patients have been enrolled in the
study.
- Raised net proceeds of approximately
$10.6 million to finance the Phase 3 head and neck cancer
trial.
- Increased Ergomed’s investment in our
Phase 3 head and neck cancer trial. Ergomed added another $2
million to its existing $10 million investment for a total
investment of $12 million. Ergomed will receive its funds back only
from future sales of Multikine* (Leukocyte Interleukin,
Injection).
- Secured litigation funding for our
ongoing arbitration against the former CRO of our Phase 3 trial
from Lake Whillans, a firm that specializes in litigation funding.
Pursuant to the agreement, CEL-SCI will receive up to $5.0 million
in funding and Lake Whillans will get its funds back only from the
proceeds derived from the arbitration.
- Granted a new European patent on
Multikine. The patent is important because it recites a mechanism
of action of Multikine by which Multikine changes the type of T
cells that enter the tumor microenvironment. This change results in
the tumor becoming "visible" to the immune system, resulting in a
robust and sustainable anti-tumor immune response.
- Received acceptance into a new program
for technology commercialization and niche analysis of our LEAPS
rheumatoid arthritis vaccine candidate from the U.S. National
Institutes of Health (NIH).
- Continued patient enrollment in the
Phase 1 trial of Multikine in HIV/HPV co-infected men and women
with peri-anal warts at San Diego Naval Medical Center and
University of California, San Francisco (UCSF). The study in
expected to be complete in the second half of 2016.
“During the first quarter of fiscal 2016 we received funding
from two strategic sources, Ergomed and Lake Whillans, which we
believe affirm the strength of both our Phase 3 trial and our
arbitration claims against the former CRO. We are confident in our
partners as we move towards the completion of enrollment in our
Phase 3 trial,” stated CEL-SCI Chief Executive Officer Geert
Kersten.
CEL-SCI reported an operating loss of ($5,783,132) for the
quarter ended December 31, 2015 versus an operating loss of
($9,995,741) for the quarter ended December 31, 2014. Research and
development expenses remained relatively consistent and increased
by approximately $286,000 compared to the three months ended
December 31, 2014. General and administrative expenses decreased by
approximately $4,560,000 compared to the three months ended
December 31, 2014. Major components of the decrease include
approximately $2,296,000 in a gain on the derecognition of legal
fees recognized pursuant to the agreement with Lake Whillans offset
by approximately $316,000 net increase in other general and
administrative expenses. Also during the quarter ended December 31,
2014, there was approximately $2,620,000 in additional employee
compensation costs related to the issuance of shareholder approved
shares of restricted stock released upon meeting predetermined
milestones.
CEL-SCI's net income (loss) available to common shareholders for
the quarter ended December 31, 2015 was $2,341,813 or $0.02 per
basic share, versus ($7,845,318) or ($0.11) per basic share during
the quarter ended December 31, 2014. The income was primarily
attributable to an unrealized gain on the fair value of warrants,
as a result of the change in the stock price between reporting
periods.
About Multikine
Multikine 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.
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 standard of care (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 in conjunction with the U.S. Naval Medical
Center, San Diego, under a CRADA and UCSF.
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.
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 for the year
ended September 30, 2015. 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 (Leukocyte Interleukin, Injection) 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. 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 DECEMBER 31, 2015 AND 2014 (UNAUDITED) 2015
2014 GRANT INCOME AND OTHER $ 20,976 $ 136,838
OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $28,309 and $43,159 respectively, included
below)
5,141,198 4,854,821 Depreciation and amortization 41,741 56,613
General & administrative 621,169 5,221,145
Total operating expenses 5,804,108
10,132,579 OPERATING LOSS (5,783,132 )
(9,995,741 ) GAIN ON DERIVATIVE INSTRUMENTS 8,122,960
2,162,970 INTEREST INCOME (EXPENSE), NET 1,985
(12,547 ) NET INCOME (LOSS) AVAILABLE TO COMMON
SHAREHOLDERS $ 2,341,813 $ (7,845,318 ) NET INCOME
(LOSS) PER COMMON SHARE BASIC $ 0.02 $ (0.11 ) DILUTED $
0.02 $ (0.14 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 109,768,502 73,260,783 DILUTED 111,639,785 73,260,783
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version on businesswire.com: http://www.businesswire.com/news/home/20160209006598/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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