CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the
"Company") reported financial results today for the fiscal year
ended September 30, 2015. The Company also reported key clinical
and corporate developments achieved during and subsequent to fiscal
2015.
Clinical and Corporate Developments Included:
- CEL-SCI raised net proceeds of
approximately $21.15 million during fiscal 2015 and an additional
$10.6 million subsequent to the end of the fiscal year, to finance
its expanding Phase 3 trial in the treatment of head and neck
cancer.
- During fiscal year 2015 we added 7
countries to our Phase 3 study and we enrolled another 304 patients
in the study. This represented a 115% increase in enrollment over
fiscal year 2014. We are continuing this trend in the first quarter
fiscal 2016.
- We had 2 very important corporate
developments that suggest our Phase 3 trial is going well and that
we have a strong case in our $50+ million arbitration against the
former Clinical Research Organization ("CRO"):
- In October 2015 Ergomed, the new CRO
running our Phase 3 trial, added another $2 million to its existing
$10 million investment in our Phase 3 clinical trial, for a total
investment of $12 million. Ergomed will receive its funds back only
from a successful drug.
- Also in October 2015, we signed a
funding agreement with Lake Whillans, a firm that specializes in
litigation funding. Pursuant to the agreement, CEL-SCI will receive
up to $5.0 million in funding for litigation expenses to support
arbitration claims against the former CRO. This case is scheduled
for “hearing” (trial) in the spring of 2016. Lake Whillans will get
its funds back only from the proceeds derived from the arbitration.
CEL-SCI now spends $0 on this arbitration.
- CEL-SCI expanded the ongoing Phase 1
study with Multikine in HIV/HPV co-infected men and women by adding
a another clinical site and a world renowned key opinion leader in
the field. Dr. Joel Palefsky of the University of California, San
Francisco (UCSF) joined the study in July 2015 as a Principal
Investigator. The study is also being conducted under a Cooperative
Research and Development Agreement (CRADA) with the U.S. Navy at
the San Diego Naval Medical Center.
CEL-SCI reported an operating loss of ($34.30) million in fiscal
year 2015 versus an operating loss of ($27.57) million in fiscal
year 2014. Of the 2015 fiscal operating loss, the cash used by the
company totaled $23.8 million. The legal expenses for the
arbitration were $3.6 million and those expenses will not be
repeated in 2016 since the company signed an agreement with the
litigation funding firm Lake Whillans to fund any remaining
arbitration legal fees. This will allow CEL-SCI to focus its
expenditures on the Phase 3 trial.
The rise in operating loss was largely attributable to an
increase in research and development expenses to $20.95 million in
fiscal year 2015 compared to $17.0 million in fiscal year 2014.
This expense increased based on the additional activity level of
the Phase 3 clinical trial, including more clinical centers joining
the study and more patients enrolled.
Geert Kersten, CEL-SCI’s Chief Executive Officer said, “We are
rapidly enrolling patients in our Phase 3 trial in head and neck
cancer and the trial date for our arbitration is near. Both of
these efforts are proceeding well, and we look forward to a
positive 2016.”
About Multikine
Multikine* (Leukocyte Interleukin, Injection) 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
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 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 at UCSF.
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 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 (Leukocyte Interleukin,
Injection). 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
YEARS ENDED SEPTEMBER 30, 2015 and 2014 2015 2014
GRANT INCOME AND OTHER $ 657,377 $ 264,033 OPERATING
EXPENSES:
Research and development (excluding
R&D depreciation of $148,939, $172,442 and $253,072
respectively, included below)
20,949,208 17,000,145 Depreciation and amortization 206,750 231,752
General & administrative 13,797,964
10,606,248 Total operating expenses 34,953,922
27,838,145 OPERATING LOSS (34,296,545 )
(27,574,112 ) GAIN ON DERIVATIVE INSTRUMENTS 282,616 248,767
LOSS ON DEBT EXTINGUISHMENT (641,276 ) - INTEREST
INCOME 110,544 122,854 INTEREST EXPENSE (129,985 )
(163,774 ) NET LOSS (34,674,646 ) (27,366,265 )
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS -
(1,117,447 ) MODIFICATION OF WARRANTS - -
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $
(34,674,646 ) $ (28,483,712 ) NET LOSS PER COMMON SHARE
BASIC $ (0.42 ) $ (0.48 ) DILUTED $ (0.42 ) $ (0.49 )
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC and DILUTED 82,519,027 58,804,622
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version on businesswire.com: http://www.businesswire.com/news/home/20151211005879/en/
CEL-SCI CorporationGavin de Windt, 703-506-9460
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