CEL-SCI Corporation (NYSE MKT: CVM) reported financial
results for the quarter ended June 30, 2016 and updates
shareholders in regards to the upcoming date for the Company’s
arbitration hearing against its former Clinical Research
Organization (CRO).
Key corporate and clinical developments during the quarter
include:
- Enrolled an additional 92 patients in
the global pivotal Phase 3 head and neck cancer trial during the
third quarter of FY 2016 which is a 12% increase over the third
quarter of FY 2015.
- Enrolled another 29 patients in July
2016, following the end of the quarter.
- A total of 877 patients have been
enrolled in the study as of July 31, 2016.
- 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).
- Raised $5 million to finance the Phase
3 head and neck cancer trial.
CEL-SCI's net loss for the quarter ended June 30, 2016 was
($3,849,324) or ($0.03) per basic and diluted share, versus
($4,429,137) or ($0.05) per basic share and ($0.06) per diluted
share during the quarter ended June 30, 2015. The net loss for the
nine months ended June 30, 2016 was ($10,352,366) or ($0.09) per
basic and diluted share, versus ($24,830,691) or ($0.32) per basic
and diluted share during the same nine months ended June 30,
2015.
CEL-SCI reported an operating loss of ($6,382,747) for the
quarter ended June 30, 2016 versus an operating loss of
($8,201,475) for the quarter ended June 30, 2015. The operating
loss for the nine months ended June 30, 2016 was ($18,439,482)
versus ($25,956,559) during the nine months ended June 30,
2015.
Geert Kersten, CEL-SCI’s Chief Executive Officer said, “The
current focus remains the completion of the Phase 3 clinical trial
with Multikine and the upcoming arbitration hearing (“trial”)
against the Company’s former CRO scheduled for September 7,
2016.”
About Multikine (Leukocyte Interleukin, Injection)
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 (not yet treated) 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 has issued
patents on Multikine from the US, Europe, China and Japan.
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 JUNE 30, 2016 AND 2015 (unaudited)
2016 2015 GRANT AND OTHER INCOME $ 129,975 $
389,223 OPERATING EXPENSES: Research and development
4,838,108 5,727,577 General & administrative 1,674,614
2,863,121 Total operating expenses
6,512,722 8,590,698 OPERATING
LOSS (6,382,747 ) (8,201,475 ) GAIN ON DERIVATIVE
INSTRUMENTS 2,508,744 4,428,780 LOSS ON DEBT EXTINGUISHMENT
- (641,276 ) INTEREST INCOME (EXPENSE), NET 24,679
(15,166 ) NET LOSS $ (3,849,324 ) $ (4,429,137
) NET LOSS PER COMMON SHARE BASIC $ (0.03 ) $ (0.05 )
DILUTED $ (0.03 ) $ (0.06 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 124,132,500 83,796,311 DILUTED 124,132,500 85,134,107
CEL-SCI CORPORATION STATEMENTS OF OPERATIONS NINE
MONTHS ENDED JUNE 30, 2016 AND 2015 (unaudited)
2016 2015 GRANT INCOME AND OTHER $
183,726 $ 723,681 OPERATING EXPENSES: Research and
development 14,636,197 15,701,986 General & administrative
3,987,011 10,978,254 Total
operating expenses 18,623,208 26,680,240
OPERATING LOSS (18,439,482 ) (25,956,559 )
GAIN ON DERIVATIVE INSTRUMENTS 8,037,974 1,808,954 LOSS ON
DEBT EXTINGUISHMENT - (641,276 ) INTEREST INCOME (EXPENSE),
NET 49,142 (41,810 ) NET LOSS $
(10,352,366 ) $ (24,830,691 ) NET LOSS PER COMMON SHARE
BASIC AND DILUTED $ (0.09 ) $ (0.32 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC AND DILUTED 117,412,443 77,625,511
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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