CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended March 31, 2020 and provided
an update on clinical developments:
- On May 4, 2020, CEL-SCI announced it has been notified that it
reached the targeted threshold of 298 events (deaths) required to
conduct the data evaluation for its pivotal Phase 3 head and neck
cancer study of Multikine* (Leukocyte Interleukin, Inj.)
immunotherapy. The database is now being prepared for database
lock. Once the database has been locked, the final analysis of the
trial results can be performed.
- In April 2020, the Independent Data Monitoring Committee (IDMC)
for the Company's pivotal Phase 3 head and neck cancer study of its
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) performed a review of the study data and recommended to
continue the trial without change. The data from all 928 enrolled
patients were provided to the IDMC by the clinical research
organization (CRO) responsible for data management of this Phase 3
study.
- In March 2020, CEL-SCI initiated the development of an
immunotherapy with the potential to treat the COVID-19 coronavirus
using its patented LEAPS peptide technology. 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 corona virus aim to
replicate prior successful preclinical experiments of LEAPS against
H1N1pandemic flu in mice conducted with National Institutes for
Allergies and Infectious Diseases (NIAID). These studies
demonstrated improvement in both morbidity and mortality of animals
treated with the LEAPS-H1N1 construct as compared to controls. We
believe that our COVID 19 approach is unique for several reasons:
1) we focus on a non-changing part of the virus and 2) our
immunotherapy has both anti-viral and anti-inflammatory attributes.
The goal is to develop a more successful treatment for infected
patients.
- CEL-SCI raised approximately $16.1 million in gross proceeds
during the six months ended March 31, 2020 through the sale of
common stock through public offerings and the exercise of
warrants.
“We have completed and will soon evaluate data from our pivotal
global Phase 3 study, which is the world’s largest Phase 3 study in
head and neck cancer. A successful study result will provide
definitive proof of the concept established in our Phase 2 head and
neck cancer studies, that immunotherapy should be given as the
initial treatment of cancer right after diagnosis, before surgery,
chemotherapy, and radiation which severely weaken the immune
system. Should the study meet its primary endpoint, we expect
CEL-SCI will gain the first FDA approval for a first-line treatment
for advanced primary squamous cell carcinoma of the head and neck
in about 60 years. We are grateful to all the patients, clinicians
and investigators, clinical sites, and the entire team at CEL-SCI
and our current CROs for completing this very large pivotal Phase 3
global study.” stated CEL-SCI CEO, Geert Kersten.
During the six months ended March 31, 2020, the Company’s cash
increased by approximately $5.9 million. Significant components of
this increase include approximately $12.9 million in net proceeds
from the sale of common stock through public offerings and
approximately $2.1 million in proceeds from the exercise of
warrants and options, offset by net cash used to fund the Company’s
regular operations, including its Phase 3 clinical trial, of
approximately $8.0 million, approximately $0.8 million of equipment
and leasehold improvement expenditures and approximately $0.4
million in lease payments.
CEL-SCI reported a net loss of $14.5 million for the six months
ended March 31, 2020 versus a net loss of $5.2 million for the six
months ended March 31, 2019. CEL-SCI reported a net loss of $9.0
million for the quarter ended March 31, 2020 versus a net loss of
$6.4 million for the quarter ended March 31, 2019. The variance is
largely due to the change in fair value of the derivative
liabilities at the respective period ends. These changes were
caused mainly by fluctuation in the share price of the Company’s
common stock.
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 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. 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.
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
SIX MONTHS ENDED MARCH 31, 2020
AND 2019
(UNAUDITED)
2020
2019
Grant income
$
334,232
$
277,183
Operating Expenses:
Research and development
8,598,960
6,304,260
General and administrative
5,197,418
3,313,985
Total operating expenses
13,796,378
9,618,245
Operating loss
(13,462,146
)
(9,341,062
)
Other income
36,896
36,127
(Loss)/gain on derivative instruments
(2,282,518
)
4,589,135
Other non-operating gains
1,725,180
421,353
Interest expense, net
(504,190
)
(907,332
)
Net loss
(14,486,778
)
(5,201,779
)
Modification of warrants
(21,734
)
-
Net loss available to common
shareholders
$
(14,508,512
)
$
(5,201,779
)
Net loss per common share
BASIC
$
(0.41
)
$
(0.18
)
DILUTED
$
(0.41
)
$
(0.19
)
Weighted average common shares
outstanding
BASIC
35,621,711
28,543,417
DILUTED
35,621,711
28,548,818
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED MARCH 31, 2020
AND 2019
(UNAUDITED)
2020
2019
Grant income
$
298,726
$
150,769
Operating Expenses:
Research and development
4,402,347
2,832,546
General and administrative
2,558,522
1,624,823
Total operating expenses
6,960,869
4,457,369
Operating loss
(6,662,143
)
(4,306,600
)
Other income
18,448
18,216
Loss on derivative instruments
(3,049,027
)
(967,171
)
Other non-operating gains (losses)
934,511
(730,823
)
Interest expense, net
(253,407
)
(461,303
)
Net loss
(9,011,618
)
(6,447,681
)
Modification of warrants
(21,734
)
-
Net loss available to common
shareholders
$
(9,033,352
)
$
(6,447,681
)
Net loss per common share
BASIC
$
(0.25
)
$
(0.22
)
DILUTED
$
(0.25
)
$
(0.22
)
Weighted average common shares
outstanding
BASIC
36,165,050
29,113,910
DILUTED
36,165,050
29,113,910
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version on businesswire.com: https://www.businesswire.com/news/home/20200511005283/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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