CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the
"Company") reported financial results today for the fiscal year
ended September 30, 2016. The Company also reported key clinical
and corporate developments achieved during and subsequent to fiscal
2016.
Clinical and Corporate Developments included:
- CEL-SCI raised net proceeds of
approximately $21.42 million during fiscal 2016.
- During fiscal year 2016 CEL-SCI
enrolled another 365 patients in the study before, on September 26,
2016, the FDA placed the study on partial clinical hold. We are
completely focused on working diligently with the FDA to obtain a
release of this partial clinical hold. As of September 26, 2016,
928 patients had been enrolled in the Phase 3 head and neck cancer
study.
- The arbitration hearing on the merits
against the former clinical research organization (CRO) began on
September 26, 2016.
- The ongoing Phase 1 study with
Multikine in HIV/HPV co-infected men and women continues at the
University of California, San Francisco (UCSF). The Principal
Investigator is a world renowned key opinion leader in the field,
Dr. Joel Palefsky.
CEL-SCI reported a net loss of ($11.46) million in fiscal year
2016 versus a net loss of ($34.67) million in fiscal 2015. CEL-SCI
reported an operating loss of ($25.55) million in fiscal year 2016
versus an operating loss of ($34.30) million in fiscal year
2015.
The reduction in operating loss was largely attributable to a
decrease in general and administrative expenses to $6.5 million in
fiscal year 2016 compared to $13.9 million in fiscal year 2015.
Major components of the decrease are 1) Lake Whillans Litigation
Finance took over payment of legal fees which were about $4.4 m in
fiscal year 2015 in the arbitration against the former CRO that
used to run the Company’s Phase 3 trial, 2) a $2.8 million decrease
in share-based employee compensation costs, which relates to the
timing of vesting for the incentive stock bonus plan and 3) other
miscellaneous decreases netting to approximately $200,000.
Geert Kersten, CEL-SCI’s Chief Executive Officer said, “Our full
focus is on two issues very important to our company: 1) the
release of the partial clinical hold on the Company’s Phase 3 trial
and 2) bringing to a successful conclusion the arbitration against
the former CRO that used to run the Phase 3 study. That hearing on
the merits, which is equivalent to a trial in a court case, started
on September 26, 2016 and is ongoing.”
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 immunotherapy, 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. Subject to the
partial clinical hold, the study was designed with the objective
that, if the study endpoint, which is an 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
(treatment of cervical dysplasia in HIV/HPV co-infected women) has
been completed at the University of Maryland. The latter indication
(treatment of peri-anal warts in HIV/HPV co-infected men and women)
is being studied in a Phase 1 trial at the University of
California, San Francisco. CEL-SCI has 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’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, 2016. 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 and that
is currently subject to a clinical hold on enrollment of additional
new patients.
CEL-SCI CORPORATION STATEMENTS OF
OPERATIONS YEARS ENDED SEPTEMBER 30, 2016 and 2015
2016 2015 GRANT INCOME AND OTHER $ 285,055 $
657,377 OPERATING EXPENSES: Research and development
19,351,779 21,098,147 General & administrative 6,486,501
13,855,775 Total operating expenses
25,838,280 34,953,922 OPERATING
LOSS (25,553,225 ) (34,296,545 ) GAIN ON DERIVATIVE
INSTRUMENTS 14,013,726 282,616 LOSS ON DEBT EXTINGUISHMENT -
(620,457 ) INTEREST INCOME (EXPENSE), net 73,001
(40,260 ) NET LOSS (11,466,498 ) (34,674,646 )
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS
- - NET LOSS AVAILABLE TO COMMON
SHAREHOLDERS $ (11,466,498 ) $ (34,674,646 ) NET LOSS PER
COMMON SHARE BASIC $ (0.09 ) $ (0.42 ) DILUTED $ (0.09 ) $ (0.42 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC and DILUTED 121,655,108 82,519,027
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version on businesswire.com: http://www.businesswire.com/news/home/20161214006273/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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