CEL-SCI Corporation (NYSE American: CVM) reported
financial results today for the fiscal year ended September 30,
2017. The Company also reported key clinical and corporate
developments achieved during and subsequent to fiscal 2017.
Clinical and Corporate Developments included:
- Full enrollment was achieved in
CEL-SCI’s pivotal Phase 3 head and neck cancer study. The study's
Independent Data Monitoring Committee (IDMC) completed its most
recent review of the data from all 928 patients enrolled in the
study and recommended continuing the study as constituted, as there
was no evidence of any significant safety questions.
- CEL-SCI’s LEAPS vaccine for the
treatment of rheumatoid arthritis received a $1.5 million grant
from the U.S. National Institutes of Health (NIH). The grant
provides funding for CEL-SCI to advance its first LEAPS product
candidate, CEL-4000, towards an Investigational New Drug (IND)
application. Preclinical data on CEL-4000 were presented at several
scientific conferences and published in a scientific journal during
fiscal 2017.
- In the $50 million arbitration suit
brought by CEL-SCI against its former clinical research
organization (CRO), the testimony phase of the arbitration has
concluded, and all that remains at the trial level are closing
statements and post-trial submissions.
- CEL-SCI raised approximately $14.7
million gross proceeds during fiscal 2017.
“While we went through a challenging period during fiscal 2017,
we are pleased to move forward with the achievement of our biggest
milestone to date, completion of enrollment and treatment of all
928 patients in the world’s largest head and neck cancer study,”
stated CEL-SCI CEO, Geert Kersten. “The study is now fully
enrolled. Per the recommendation of the study’s IDMC to continue
the study, in accordance with the study protocol, the enrolled
patients are being followed for survival outcome. After 298 patient
deaths have occurred in the two comparator arms of the study the
company will be able to determine if the study’s endpoint is
achieved.”
CEL-SCI reported a net loss of ($14.36) million in fiscal year
2017 versus a net loss of ($11.51) million in fiscal 2016.
The Company’s audited financial statements contained an audit
opinion from its independent registered public accounting firm that
included an explanatory paragraph related to the Company’s ability
to continue as a going concern.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. 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 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.
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. CEL-SCI has patents
on Multikine from the US, Europe, China, and Japan.
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 CORPORATIONSTATEMENTS OF
OPERATIONSYEARS ENDED SEPTEMBER 30, 2017 and 2016
2017 2016 Grant and other income $ 69,020 $ 285,055
Operating expenses: Research and development 15,606,985
17,445,382 General & administrative 5,800,348 6,486,501
Total operating expenses 21,407,333 23,931,883 Operating
loss (21,338,313) (23,646,828) Gain on derivative
instruments 11,007,215 14,013,726 Interest expense, net
(4,032,189) (1,879,390) Net loss (14,363,287) (11,512,492)
Modification of warrants (63,768) - Net loss
available to common shareholders $ (14,427,055) $ (11,512,492)
NET LOSS PER COMMON SHARE BASIC $ (1.83) $ (2.37) DILUTED $
(1.91) $ (2.37) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC 7,891,843 4,866,204 DILUTED 7,902,647 4,866,204
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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