CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2020 and provided
an update on clinical developments:
- CEL-SCI reached the targeted threshold of 298 events (deaths)
required to conduct the data evaluation for its global pivotal
Phase 3 head and neck cancer study of Multikine* (Leukocyte
Interleukin, Inj.) immunotherapy. The study is currently in the
database lock and analysis phase. CEL-SCI will be advised of the
results when the analysis is finalized, and the study results will
be announced to the public and investors at that time.
- CEL-SCI initiated the development of an immunotherapy with the
potential to treat the COVID-19 coronavirus using its patented
LEAPS peptide technology. The initial animal experiments showed
that after only one injection, LEAPS COVID-19 conjugates induced
antibody responses faster and in much higher titers than expected
against a non-mutating region of the virus that causes COVID-19.
These animal experiments provide the basis for moving forward into
animal challenge studies with live virus SARS-CoV-2, the causative
agent of COVID-19, at the University of Georgia Vaccine
Center.
- CEL-SCI signed a collaboration agreement with the University of
Georgia’s Center for Vaccines and Immunology to develop the LEAPS
COVID-19 immunotherapy. Initial studies with COVID-19 aim to
replicate prior successful preclinical experiments of LEAPS against
the H1N1pandemic flu virus in mice conducted at and in
collaboration with the National Institutes for Allergies and
Infectious Diseases (NIAID). These studies demonstrated improvement
in both morbidity and mortality of H1N1 infected animals treated
with the LEAPS-H1N1 construct as compared to controls. CEL-SCI
believes its COVID-19 approach is unique for two reasons: 1) LEAPS
focuses on a non-changing part of the virus; and 2) LEAPS has both
anti-viral and anti-inflammatory attributes. The goal is to develop
a more successful treatment for infected patients.
- CEL-SCI raised approximately $27.0 million in gross proceeds
during the nine months ended June 30, 2020 through the sale of
common stock through public offerings and the exercise of
warrants.
“Our goal is to create the first non-toxic cancer drug that is
effective in increasing survival. This is the first cancer drug in
decades that would be used to improve the success rate of the
current first ‘intent to cure’ head and neck cancer standard of
care treatment. Now that the long Phase 3 study is finished, the
organizations who run the study are responsible for cleaning
up/collecting all final data and analyzing it. This is a very big
job since the study ran for 9.5 years in 100 hospitals in 24
countries. Once we know the final study results, we will share them
with our shareholders. We believe that our Multikine will help
these patients,” stated CEL-SCI CEO, Geert Kersten.
During the nine months ended June 30, 2020, the Company’s cash
increased by approximately $11.7 million. Significant components of
this increase include approximately $14.0 million in net proceeds
from the sale of common stock through public offerings,
approximately $12.1 million in proceeds from the exercise of
warrants and options and employee stock purchases of approximately
$0.2 million, offset by net cash used to fund the Company’s regular
operations, including its Phase 3 clinical trial, of approximately
$11.7 million, approximately $1.6 million of equipment and
leasehold improvement expenditures, approximately $0.7 million for
payments of stock issuance costs and approximately $0.6 million in
lease payments.
CEL-SCI reported a net loss of $24.7 million for the nine months
ended June 30, 2020 versus a net loss of $17.3 million for the nine
months ended June 30, 2019. CEL-SCI reported a net loss of $10.2
million for the quarter ended June 30, 2020 versus a net loss of
$12.1 million for the quarter ended June 30, 2019.
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 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
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 first - for 3 weeks 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 database lock and analysis phase.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment of COVID-19 in hospitalized
and at-high-risk patients. 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, including statements with respect to Multikine and the
Phase 3 clinical trial of Multikine in patients with advanced
primary squamous cell carcinoma of the head and neck. 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 trials or nonclinical
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 amended report on Form 10-K/A for the year ended
September 30, 2019. 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
NINE MONTHS ENDED JUNE 30, 2020
AND 2019
(UNAUDITED)
2020
2019
Grant income
$
530,106
$
386,121
Operating Expenses:
Research and development
12,511,830
9,269,772
General and administrative
8,389,821
5,667,510
Total operating expenses
20,901,651
14,937,282
Operating loss
(20,371,545
)
(14,551,161
)
Other income
38,741
54,575
Loss on derivative instruments
(3,565,347
)
(3,316,384
)
Warrant inducement expense
(805,753
)
-
Other non-operating gains
774,245
1,877,197
Interest expense, net
(777,898
)
(1,350,774
)
Net loss
(24,707,557
)
(17,286,547
)
Modification of warrants
(21,734
)
-
Net loss available to common
shareholders
$
(24,729,291
)
$
(17,286,547
)
Net loss per common share - basic and
diluted
$
(0.68
)
$
(0.58
)
Weighted average common shares outstanding
- basic and diluted
36,230,092
30,046,241
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED JUNE 30, 2020
AND 2019
(UNAUDITED)
2020
2019
Grant income
$
195,874
$
108,938
Operating Expenses:
Research and development
3,912,870
2,965,512
General and administrative
3,192,403
2,353,525
Total operating expenses
7,105,273
5,319,037
Operating loss
(6,909,399
)
(5,210,099
)
Other income
1,845
18,448
Loss on derivative instruments
(1,282,829
)
(7,905,519
)
Warrant inducement expense
(805,753
)
-
Other non-operating (losses) gains
(950,935
)
1,455,844
Interest expense, net
(273,708
)
(443,442
)
Net loss available to common
shareholders
$
(10,220,779
)
$
(12,084,768
)
Net loss per common share - basic and
diluted
$
(0.27
)
$
(0.37
)
Weighted average common shares outstanding
- basic and diluted
37,453,539
33,051,888
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Gavin de Windt CEL-SCI Corporation (703) 506-9460
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