CEL-SCI Corporation Reports First Quarter Fiscal 2021 Financial Results
February 16 2021 - 9:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended December 31, 2020, as well
as key clinical and corporate developments.
Clinical and Corporate Developments include:
- In December 2020, CEL-SCI updated the status of its pivotal
Phase 3 head and neck cancer study of Multikine* (Leukocyte
Interleukin, Injection). Data lock has been completed, and the
study entered its final stage of statistical analysis. CEL-SCI
remains blinded to the study data and is not involved in this
process which is conducted by independent contractors. The
statistical analysis plan follows the protocol stated objectives
and is designed to meet FDA requirements to define the clinical
benefits that Multikine might provide for patients newly diagnosed
with advanced primary (not yet treated) squamous cell carcinoma of
the head and neck. The analysis looks at multiple parameters to
gain the most information on the possible benefits of using
Multikine immunotherapy as a first line treatment before standard
of care for these patients.
- CEL-SCI continued expanding and upgrading its dedicated cGMP
facility in which it manufactures Multikine. The construction,
which began in 2020, is expected to be completed in the coming
months and will double the facility’s capacity to accommodate two
shifts for increased production of Multikine.
- In December 2020, CEL-SCI announced that its LEAPS COV-19
peptides, delivered as a therapeutic treatment following SARS-CoV-2
virus challenge, achieved a 40% survival rate in human ACE2
transgenic mouse model as compared to 0% survival in the two
control groups. These studies were conducted at the University of
Georgia Center for Vaccines and Immunology. As COVID-19 mutations
increase, LEAPS COV-19’s mechanism of action which targets the
non-mutating part of the SARS-CoV-2 virus is becoming more
important.
- In December 2020, CEL-SCI sold 1,000,000 shares of common stock
at a public offering price of $14.65 per share and received
aggregate proceeds of approximately $13.6 million. On December 31,
2020, CEL-SCI’s cash position was approximately $21.9 million.
After December 31, 2020, CEL-SCI has received approximately $3.9
million through the exercise of warrants and stock options.
“As the data analysis for our Phase 3 trial is being conducted,
we are focused on expanding manufacturing of Multikine so that we
will be ready to produce significant commercial quantities for this
unmet medical need. We believe that Multikine may add substantial
clinical benefit and help these patients.” stated CEL-SCI CEO,
Geert Kersten.
CEL-SCI reported a net loss of approximately $7.9 million for
the quarter ended December 31, 2020 versus net loss of
approximately $5.5 million for the quarter ended December 31,
2019.
During the three months ended December 31, 2020, CEL-SCI
incurred approximately $3.6 million in costs to upgrade its
manufacturing facility to prepare for the potential commercial
production of Multikine. Total estimated costs of this upgrade are
approximately $10.5 million, of which approximately $6.7 million
has been incurred through December 31, 2020.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while
it is still intact should provide the greatest possible impact on
survival. Therefore, in the Phase 3 study CEL-SCI treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck, are treated with the
investigational product Multikine first, BEFORE they received
surgery, radiation and/or chemotherapy (the current standard of
care for these patients). This approach is unique. Most other
cancer immunotherapies are administered only after conventional
therapies have been tried and/or failed. Multikine (Leukocyte
Interleukin, Injection), has received Orphan Drug designation from
the FDA for the neoadjuvant therapy in patients with squamous cell
carcinoma (cancer) of the head and neck.
CEL-SCI believes that this Phase 3 study is the largest Phase 3
study in the world for the treatment of head and neck cancer. Per
the study’s protocol, newly diagnosed patients with advanced
primary squamous cell carcinoma of the head and neck were treated
with the Multikine treatment regimen right after diagnosis and
prior to receiving the Standard of Care (SOC), which involves
surgery, radiation or concurrent radiochemotherapy. Multikine is
designed to help the immune system “see” the tumor at a time when
the immune system is still relatively intact and thereby thought to
better be able to mount an attack on the tumor. The aim of
treatment with Multikine is to boost the body’s immune system prior
to SOC to attack the cancer. The Phase 3 study is fully enrolled
with 928 patients and the last patient was treated in September
2016. To prove an overall survival benefit, the study requires
CEL-SCI to wait until 298 (death) events have occurred among the
two main comparator groups. This study milestone occurred in late
April 2020. The study is currently in the statistical analysis
phase.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment for COVID-19 infection. The
Company has operations in Vienna, Virginia, and near/in 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.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. 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, 2020. 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
THREE MONTHS ENDED DECEMBER 31,
2020 AND 2019
(UNAUDITED)
2020
2019
Grant income
$
-
$
35,506
Operating Expenses:
Research and development
5,414,760
4,252,813
General and administrative
3,316,156
2,638,896
Total operating expenses
8,730,916
6,891,709
Operating loss
(8,730,916
)
(6,856,203
)
Other income
-
18,448
Gain on derivative instruments
932,836
766,509
Other non-operating gains
121,606
790,669
Interest expense, net
(260,390
)
(250,783
)
Net loss
(7,936,864
)
(5,531,360
)
Modification of warrants
(85,779
)
-
Net loss available to common
shareholders
$
(8,022,643
)
$
(5,531,360
)
Net loss per common share
BASIC
$
(0.21
)
$
(0.16
)
DILUTED
$
(0.21
)
$
(0.16
)
Weighted average common shares
outstanding
BASIC
38,670,247
35,084,279
DILUTED
38,767,286
35,098,608
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version on businesswire.com: https://www.businesswire.com/news/home/20210216005197/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
www.cel-sci.com
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