CEL-SCI Corporation (NYSE MKT: CVM) today reported
financial results for the quarter ended March 31, 2016.
Key corporate and clinical developments during second quarter
fiscal year 2016 include:
- Enrolled an additional 186 patients in
the global pivotal Phase 3 head and neck cancer trial during the
first six months of FY 2016, a 32% increase in enrollment compared
to the first six months of FY 2015.
- Enrolled a monthly record of 41
patients in April 2016, following the end of Q2.
- A total of 797 patients have been
enrolled in the study as of April 30, 2016.
- The Company’s CEO and CSO provided
informative updates in multiple interviews, including Fox Business
News.
- 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).
- Received significant litigation funding
for arbitration lawsuit against former CRO that led to a narrowing
of G&A expense and operating loss in Q2 FY 2016.
CEL-SCI reported an operating loss of ($6,273,603) for the
quarter ended March 31, 2016 versus an operating loss of
($7,759,343) for the quarter ended March 31, 2015. The operating
loss for the six months ended March 31, 2016 was ($12,056,735)
versus ($17,755,084) during the six months ended March 31, 2015.
The decrease in operating loss in the first half of fiscal 2016 was
mostly attributable to a decrease in general and administrative
expenses of approximately $5,803,000, as compared to the first half
of fiscal 2015. A major component of the decrease is the
approximate $3,254,000 gain on the derecognition of legal fees
recognized pursuant to an agreement with Lake Whillans for funding
litigation expenses in the Company’s arbitration against its former
CRO. Additionally, during the first half of fiscal 2015, there was
approximately $2,726,000 in employee compensation costs related to
the issuance of shareholder approved shares of restricted stock
released upon meeting predetermined milestones. Research and
development expenses remained relatively consistent and decreased
by $176,000 during the six months ended March 31, 2016.
CEL-SCI's net loss available to common shareholders for the
quarter ended March 31, 2016 was ($8,844,855) or ($0.07) per basic
and diluted share, versus ($12,556,236) or ($0.17) per basic and
diluted share during the quarter ended March 31, 2015. The net loss
available to common shareholders for the six months ended March 31,
2016 was ($6,503,042) or ($0.06) per basic and diluted share,
versus ($20,401,554) or ($0.27) per basic and diluted share during
the same six months ended March 31, 2015. The decrease in net loss
for the three and six month periods of 2016 as compared to the same
periods in 2015 was primarily attributable to the decrease in
operating loss and reduced loss and unrealized gain, respectively,
on the fair value of warrants as a result of the change in the
stock price between reporting periods.
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 MARCH 31, 2016 AND 2015 (unaudited) 2016
2015 GRANT AND OTHER INCOME $ 32,775 $
197,620 OPERATING EXPENSES: Research and development
4,628,582 5,076,429 General & administrative 1,677,796
2,880,534 Total operating expenses
6,306,378 7,956,963 OPERATING
LOSS (6,273,603 ) (7,759,343 ) LOSS ON DERIVATIVE
INSTRUMENTS (2,593,730 ) (4,782,796 ) INTEREST INCOME
(EXPENSE), NET 22,478 (14,097 ) NET
LOSS $ (8,844,855 ) $ (12,556,236 ) NET LOSS PER COMMON
SHARE BASIC AND DILUTED $ (0.07 ) $ (0.17 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC AND DILUTED 118,420,327 75,847,869 CEL-SCI
CORPORATION STATEMENTS OF OPERATIONS SIX MONTHS ENDED MARCH 31,
2016 AND 2015 (unaudited) 2016 2015
GRANT INCOME AND OTHER $ 53,751 $ 334,458
OPERATING EXPENSES: Research and development 9,798,089 9,974,409
General & administrative 2,312,397
8,115,133 Total operating expenses 12,110,486
18,089,542 OPERATING LOSS (12,056,735 )
(17,755,084 ) GAIN (LOSS) ON DERIVATIVE INSTRUMENTS
5,529,230 (2,619,826 ) INTEREST INCOME (EXPENSE), NET
24,463 (26,644 ) NET LOSS $ (6,503,042 ) $
(20,401,554 ) NET INCOME (LOSS) PER COMMON SHARE BASIC AND
DILUTED $ (0.06 ) $ (0.27 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC AND DILUTED 114,070,776 74,540,112
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version on businesswire.com: http://www.businesswire.com/news/home/20160510006886/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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