CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2021, as well as
key clinical and corporate developments.
Clinical and Corporate Developments include:
- On June 28, 2021, CEL-SCI announced top line results from its
9.5 year global pivotal Phase 3 study for its immunotherapy
Multikine® (Leukocyte Interleukin, Injection)* in head and neck
cancer. The Phase 3 results showed a long-term 5-year overall
survival (OS) benefit in the treatment arm receiving Multikine
treatment regimen followed by surgery and radiation. This survival
benefit was statistically significant, robust and durable, with no
safety issues, something not commonly seen with cancer drugs. In
fact, the survival benefit increased over time and at 5-years the
overall survival benefit reached an absolute 14.1% advantage for
the Multikine treated arm over control (n=380, total study patients
treated with surgery plus radiation): Multikine arm 62.7%, control
arm 48.6% survival.
- The OS benefit of 14.1% at 5 years for this treatment arm
exceeded the >10% OS benefit set
out for the study population as a whole in the protocol. The OS
results for this treatment arm were significant (two-sided
p=0.0236, HR=0.68) and the survival effect increased over time. The
results from the Phase 3 cancer study proved that Multikine met all
of the protocol required benefits stated in the study protocol in
patients in the treatment arm receiving surgery and radiation as
their standard therapies. Based on the results of this pivotal
Phase 3 study, CEL-SCI intends to file a Biologic License
Application with U.S. Food and Drug Administration (FDA) for
approval of this indication. We are assembling the information
required to request a pre-BLA (Biologics License Application)
meeting with the FDA to discuss the adequacy of the study results
to support a license application and receive FDA input on any other
issues that would have to be addressed for an approval to be
granted.
- Worldwide there are approximately 890,000 newly diagnosed head
and neck cancer patients of which CEL-SCI’s target population when
filing for FDA approval is about 210,000 patients. That would mean
that approximately 29,000 patients could be alive at 5-years if all
210,000 eligible patients received the Multikine treatment regimen
followed by surgery and radiation compared to receiving surgery and
radiation alone, the current treatment paradigm/SOC for these
patients.
- CEL-SCI is near completion of the expansion of its existing
dedicated cGMP manufacturing facility for Multikine. The
construction, which began in 2020, will double the current
facility’s capacity to accommodate two shifts for increased
production of Multikine.
CEL-SCI raised net proceeds of $53.6 million during the nine
months ended June 30, 2021 through the sale of common stock and the
exercise of warrants and options. As of June 30, 2021, CEL-SCI had
$47.1 million in cash, cash equivalents and U.S. Treasury
Bills.
“The results of this 10-year landmark study proved our novel
concept of cancer treatment, 1) that the use of our investigational
cancer immunotherapy Multikine before
the usual first cancer treatments (as neoadjuvant treatment) should
significantly increase survival and 2) that a cancer drug can have
a very favorable safety profile. Our Phase 3 study results are the
first sign of real progress in the treatment of advanced primary
head and neck cancer in many decades. We estimate about 210,000
patients per year globally who could potentially benefit from this
drug once approved. Our goal is to seek FDA approval based on the
data from our recently concluded pivotal Phase 3 study,” stated
CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $27.7 million for the nine
months ended June 30, 2021, versus an operating loss of $20.5
million for the nine months ended June 30, 2020. CEL-SCI reported
an operating loss of $10.5 million for the quarter ended June 30,
2021, versus an operating loss of $7.0 million for the quarter
ended June 30, 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 with the investigational product
Multikine first, BEFORE they received surgery and radiotherapy or
surgery plus concurrent radiotherapy and 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), 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 pivotal Phase 3 study is the largest Phase 3
study in the world for the treatment of advanced primary head and
neck cancer.
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 be better able to mount an attack on the tumor.
The Phase 3 study was started in early 2011 and was fully enrolled
with 928 patients in September 2016. To prove an overall survival
benefit, the study required CEL-SCI to wait until at least 298
(deaths) events had occurred among the two main comparator arms of
the study. This study milestone occurred in late April 2020 and
database lock occurred in December 2020. The study results
announced in June 2021 showed excellent survival benefit for those
patients who received Multikine treatment regimen plus surgery and
radiation. When chemotherapy was added to radiotherapy following
surgery the survival benefit was negated.
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.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
NINE MONTHS ENDED JUNE 30, 2021
AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
530,106
Operating Expenses:
Research and development
17,818,373
12,680,430
General and administrative
9,902,120
8,389,821
Total operating expenses
27,720,493
21,070,251
Operating loss
(27,720,493
)
(20,540,145
)
Other income
(8,213
)
38,741
Loss on derivative instruments
(991,562
)
(3,565,347
)
Warrant inducement expense
-
(805,753
)
Other non-operating gains
1,436,473
774,245
Interest expense, net
(872,457
)
(777,898
)
Net loss
(28,156,252
)
(24,876,157
)
Modification of warrants
(350,861
)
(21,734
)
Net loss available to common
shareholders
$
(28,507,113
)
$
(24,897,891
)
Net loss per common share - basic
$
(0.71
)
$
(0.69
)
Weighted average common shares outstanding
- basic
39,907,624
36,230,092
Net loss per common share - diluted
$
(0.74
)
$
(0.69
)
Weighted average common shares outstanding
- diluted
40,158,321
36,230,092
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED JUNE 30, 2021
AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
195,874
Operating Expenses:
Research and development
7,182,099
3,969,070
General and administrative
3,274,480
3,192,403
Total operating expenses
10,456,579
7,161,473
Operating loss
(10,456,579
)
(6,965,599
)
Other (expense) income
(8,213
)
1,845
Gain (loss) on derivative instruments
1,116,619
(1,282,829
)
Warrant inducement expense
-
(805,753
)
Other non-operating gains (losses)
761,237
(950,935
)
Interest expense, net
(351,332
)
(273,708
)
Net loss
(8,938,268
)
(10,276,979
)
Modification of warrants
(265,082
)
-
Net loss available to common
shareholders
$
(9,203,350
)
$
(10,276,979
)
Net loss per common share - basic
$
(0.22
)
$
(0.27
)
Weighted average common shares outstanding
- basic
41,020,485
37,453,539
Net loss per common share - diluted
$
(0.25
)
$
(0.27
)
Weighted average common shares outstanding
- diluted
41,231,082
37,453,539
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version on businesswire.com: https://www.businesswire.com/news/home/20210816005105/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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