CEL-SCI Reports Fiscal 2020 Financial Results and Clinical & Corporate Developments
December 30 2020 - 8:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) reported
financial results for the fiscal year ended September 30, 2020, as
well as key clinical and corporate developments.
Clinical and Corporate Developments included:
- During fiscal 2020, the Independent Data Monitoring Committee
(IDMC) for the Company's pivotal Phase 3 head and neck cancer study
of Multikine* (Leukocyte Interleukin, Injection) conducted an
official review of the study data in October 2019 and April 2020,
and recommended in each case that the trial continue until the
appropriate number of events has occurred. CEL-SCI announced in
early May 2020 that the study reached the targeted threshold of 298
events (deaths) required to conduct the data evaluation and the
process of data lock commenced. In December 2020, the study entered
its final stage of statistical analysis of all study data.
- In preparation for potential marketing clearance, CEL-SCI began
expanding and upgrading its dedicated cGMP facility in which it
manufactures Multikine. The construction will double the facility’s
capacity, accommodating two shifts for increased production of
Multikine.
- CEL-SCI initiated the development of an immunotherapy with the
potential to treat COVID-19 using the Company’s patented LEAPS
peptide technology and signed a collaboration agreement with the
University of Georgia (UGA) Center for Vaccines and Immunology to
develop its LEAPS COV-19 immunotherapy during fiscal 2020.
Following the end of fiscal 2020, 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 models
as compared to 0% survival in the two control groups in studies
conducted at UGA Center for Vaccines and Immunology.
- The LEAPS platform technology was issued a patent from the
European Patent Office titled “Method of Preparation and
Composition of Peptide Constructs for Treatment of Rheumatoid
Arthritis”. In addition to the treatment of COVID-19, the LEAPS
platform technology is being developed as a potential therapeutic
vaccine for rheumatoid arthritis supported by grants from the U.S.
National Institutes of Health (NIH).
- CEL-SCI raised net proceeds of approximately $25.8 million
during fiscal 2020 through the sale of common stock and the
exercise of warrants and options. In December 2020, following the
end of the 2020 fiscal year, CEL-SCI raised an additional $14.7
million.
“The aim of our Phase 3 pivotal study is to show that our
immunotherapy Multikine can help head and neck cancer patients when
administered right after diagnosis, before surgery, radio and
chemotherapy have weakened the immune system. After a decade of
running the world’s largest Phase 3 study in head and neck cancer,
we are looking forward to hearing the final study results which
will hopefully prove our concept. We are grateful to all the
stakeholders who have patiently been on this long journey with us,”
stated CEL-SCI CEO, Geert Kersten.
“While Multikine in the treatment of head and neck cancer is our
immediate focus and opportunity, based on Phase 3 results, we may
evaluate Multikine for the treatment of other cancers, concurrent
with advancing our LEAPS therapeutic vaccine platform in COVID-19
and rheumatoid arthritis,” Kersten concluded.
CEL-SCI reported a net loss of $30.3 million in fiscal year 2020
versus a net loss of $22.1 million in fiscal year 2019. The
increase in net loss was predominantly due to an increase in
research and development expenses by approximately $5.2 million, or
41%, and an increase in general and administrative expenses by
approximately $3.7 million, or 46%, compared to the year ended
September 30, 2019.
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 with the investigational product
Multikine* first, BEFORE they received surgery, radiation and/or
chemotherapy. 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 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.
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.
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
STATEMENTS OF
OPERATIONS
YEARS ENDED SEPTEMBER 30, 2020
and 2019
2020
2019
Grant income
$
558,664
$
462,754
Operating expenses:
Research and development
17,840,290
12,659,287
General and administrative
11,703,429
7,998,573
Total operating expenses
29,543,719
20,657,860
Operating loss
(28,985,055
)
(20,195,106
)
Other income
38,763
73,022
Loss on derivative instruments
(349,078
)
(760,603
)
Warrant inducement expense
(805,753
)
-
Other non-operating gain
887,604
545,528
Interest expense, net
(1,041,725
)
(1,797,481
)
Net loss
(30,255,244
)
(22,134,640
)
Modification of warrants
(21,734
)
-
Net loss available to common
shareholders
$
(30,276,978
)
$
(22,134,640
)
Net loss per common share, basic and
diluted
$
(0.82
)
$
(0.71
)
Weighted average common shares
outstanding, basic and diluted
36,759,115
31,174,394
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version on businesswire.com: https://www.businesswire.com/news/home/20201230005016/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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