CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended March 31, 2018. The Company
also reported key clinical and corporate developments achieved
during the quarter.
Clinical and Corporate Developments included:
- CEL-SCI’s Phase 3 head and neck cancer
study has been fully enrolled since September 2016. All 928
patients are being followed per the protocol. The primary endpoint
of the study, a 10% improvement in overall survival of the
Multikine treatment regimen plus Standard of Care (SOC) vs.
Standard of Care alone, will be determined after a total of 298
deaths have occurred in the two main comparator arms of the study
and have been recorded in the study database. All that remains to
be done in this pivotal Phase 3 study is to continue to track
patient survival until the 298 deaths have occurred and it can be
determined if the primary endpoint has been met.
- Closing arguments in the arbitration
against the former clinical research organization (CRO) for the
Phase 3 trial concluded on April 25, 2018. The parties are now
awaiting a decision from the arbitrator.
- The U.S. Patent and Trademark Office
allowed a patent for CEL-SCI’s LEAPS technology for methods of
inducing immune responses.
“We expect two significant and material outcomes in the near
term. In the very near term we are awaiting a decision from the
arbitrator in our case against our former CRO. The read out of the
Phase 3 study is expected to take longer than the decision by the
arbitrator, however, based on overall survival data available in
the scientific literature for the study's patient population and
the fact that the last patient was enrolled in the study over 1.5
years ago, we believe that the end of the Phase 3 trial is
approaching as well,” said CEL-SCI’s Chief Executive Officer, Geert
Kersten. “Separately, we continue to advance our LEAPS technology
through preclinical studies in preparation for human clinical
studies. The current work with the Rheumatoid Arthritis vaccine is
funded by a $1.5 million grant from the National Institutes of
Health.”
During the six months ended March 31, 2018, CEL-SCI’s cash
increased by approximately $0.7 million. Significant components of
this increase include net proceeds from the sale of CEL-SCI’s
common stock of approximately $7.1 million offset by net cash used
to fund the Company’s regular operations, including its Phase 3
clinical trial, of approximately $6.4 million.
CEL-SCI reported an operating loss of ($4,205,745) for the
quarter ended March 31, 2018 versus an operating loss of
($7,906,557) for the quarter ended March 31, 2017. The operating
loss was ($9,117,175) for the six months ended March 31, 2018
versus an operating loss of ($12,844,565) for the six months ended
March 31, 2017.
The research and development expenses decreased by approximately
$4.8 million compared to the six months ended March 31, 2017. The
majority of CEL-SCI’s research and development expense relates to
its on-going Phase 3 clinical trial. Clinical trial costs tend to
be higher during the enrollment phase of the study and because the
study is fully enrolled, the expenses incurred over the last six
months have decreased. The general and administrative expenses
increased by approximately $1.3 million compared to the six months
ended March 31, 2017. This increase is primarily due to an increase
of approximately $1.0 million in equity based compensation related
to the Company’s shareholder approved 2014 Incentive Stock Bonus
Plan, and a net increase of approximately $0.3 million in other
general and administrative expenses primarily for accounting fees
and public relations services.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3
study is fully enrolled with 928 patients. When it comes to cancer
immunotherapy, CEL-SCI believes it is most logical to boost the
patient’s immune system while it is still intact in order to have
the greatest possible impact on survival. Therefore, CEL-SCI treats
patients who are newly diagnosed with head and neck cancer with its
lead investigational immunotherapy Multikine* (Leukocyte
Interleukin, Injection), BEFORE they have received surgery,
radiation and/or chemotherapy. This approach is unique. Most other
cancer immunotherapies are used only after conventional therapies
have been tried and/or failed. Head and neck cancer represents
about 6% of all cancers. Multikine has received Orphan Drug
designation from the FDA for the treatment of head and neck cancer
patients with advanced squamous cell carcinoma. CEL-SCI has
received patents for Multikine from the US, Europe, China and
Japan.
The Company’s LEAPS technology is being developed as a
therapeutic vaccine for rheumatoid arthritis and is supported by
grants from the National Institutes of Health. 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’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, 2017. 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 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. 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 in progress.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2018 AND
2017
(UNAUDITED)
2018 2017 Grant and other income $ 245,859 $ 34,433
Operating Expenses: Research and development 5,288,311
10,126,875 General & administrative 4,074,723
2,752,123 Total operating expenses
9,363,034 12,878,998 Operating loss
(9,117,175 ) (12,844,565 ) Gain on derivative instruments
196,585 8,879,612 Interest expense, net (1,975,375 )
(940,385 ) Net loss available to common shareholders
$ (10,895,965 ) $ (4,905,338 ) Net loss per common
share Basic $ (0.81 ) $ (0.74 ) Diluted $ (0.81 ) $ (0.78 )
Weighted average common shares outstanding Basic 13,403,878
6,649,814 Diluted 13,403,878 6,682,592
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2018 AND
2017
(UNAUDITED)
2018 2017 Grant and other income $ 131,962 $ 17,175
Operating Expenses: Research and development 2,962,297
6,578,618 General & administrative 1,375,410
1,345,114 Total operating expenses
4,337,707 7,923,732 Operating loss
(4,205,745 ) (7,906,557 ) Gain (loss) on derivative
instruments 1,154,815 (48,700 ) Interest expense, net
(1,657,205 ) (471,234 ) Net loss available to common
shareholders $ (4,708,135 ) $ (8,426,491 ) Net loss
per common share Basic and diluted $ (0.31 ) $ (1.15 )
Weighted average common shares outstanding Basic and diluted
15,210,296 7,319,761
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version on businesswire.com: https://www.businesswire.com/news/home/20180515006513/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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