CEL-SCI Reports Fiscal 2021 Financial Results and Clinical & Corporate Developments
23 December 2021 - 1:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) reported
financial results for the fiscal year ended September 30, 2021, as
well as key clinical and corporate developments.
Clinical and Corporate Developments included:
- On October 22, 2021, CEL-SCI announced it completed the
commercial scale expansion of its dedicated current Good
Manufacturing Practice (cGMP) facility in which it manufactures its
immunotherapy Multikine® (Leukocyte Interleukin, Injection)*. The
construction, which began in 2020, was designed to ensure it will
be compliant with all requirements of the U.S. Food and Drug
Administration’s (FDA) and European cGMP regulations as the
facility’s production capacity has been doubled to meet anticipated
market demand for Multikine once it receives regulatory
approval.
- On June 28, 2021, CEL-SCI announced top line results from its
9.5 year global pivotal Phase 3 study for Multikine 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 (two-sided p=0.0236,
HR=0.68), 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): the Multikine treatment arm showed 62.7% overall
survival versus the control arm which showed only 48.6% overall
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 in the
protocol. The results from the Phase 3 cancer study proved that
Multikine met all of 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 the FDA for
approval of the Multikine treatment regimen in advanced primary
squamous cell carcinoma of the head and neck patients scheduled to
receive surgery and radiation as their primary treatments.
CEL-SCI’s trial was conducted in over 20 countries in which
marketing clearance applications may also be filed subsequent to
FDA filing and/or approval.
- CEL-SCI raised net proceeds of approximately $54.1 million
during fiscal 2021 through the sale of common stock and the
exercise of warrants and options. As of September 30, 2021, CEL-SCI
had $42.2 million in cash, cash equivalents and U.S. Treasury
Bills.
“Having conducted and completed the largest ever study in head
and neck cancer, we are filing for regulatory approval with
confidence that Multikine extends life in this severely unmet
medical need. Our team has delivered and continues to work hard at
preparing our BLA filing, validating and preparing our
manufacturing facility for commercial production and publishing our
data in peer reviewed journals. With a solid cash runway, we are
optimistic about the future and the potential for Multikine to
improve the lives of head and neck cancer patients and their
families,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net loss of $36.4 million in fiscal year 2021
versus a net loss of $30.3 million in fiscal year 2020. The
increase in net loss was predominantly due to an increase in
research and development expenses by approximately $5.3 million, or
30%, and an increase in general and administrative expenses by
approximately $1.4 million, or 12%, compared to the year ended
September 30, 2020. With the conclusion of the Phase 3 study, the
expenditures for fiscal 2022 are expected to be lower.
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 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 groups.
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
the Multikine treatment regimen plus surgery and radiation. When
chemotherapy was added to the radiotherapy, the survival benefit
was negated.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis. 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, 2021. 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
STATEMENTS OF
OPERATIONS
YEARS ENDED SEPTEMBER 30, 2021
and 2020
2021
2020
Grant income
$
-
$
558,664
Operating expenses:
Research and development
23,108,897
17,840,290
General and administrative
13,085,232
11,703,429
Total operating expenses
36,194,129
29,543,719
Operating loss
(36,194,129
)
(28,985,055
)
Other (expense) income
(8,213
)
38,763
Loss on derivative instruments
(694,858
)
(349,078
)
Warrant inducement expense
-
(805,753
)
Other non-operating gain
1,685,379
887,604
Interest expense, net
(1,149,288
)
(1,041,725
)
Net loss
(36,361,109
)
(30,255,244
)
Modification of warrants
(350,861
)
(21,734
)
Net loss available to common
shareholders
$
(36,711,970
)
$
(30,276,978
)
Net loss per common share - basic
$
(0.90
)
$
(0.82
)
Weighted average common shares outstanding
- basic
40,662,137
36,759,115
Net loss per common share - diluted
$
(0.93
)
$
(0.82
)
Weighted average common shares outstanding
- diluted
40,694,248
36,759,115
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version on businesswire.com: https://www.businesswire.com/news/home/20211222005097/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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