CEL-SCI Corporation Reports First Quarter Fiscal 2022 Financial Results
February 14 2022 - 9:00AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended December 31, 2021, as well
as key clinical and corporate developments.
Clinical and Corporate Developments include:
- During the first fiscal quarter, CEL-SCI completed the
commercial scale build out of its dedicated current Good
Manufacturing Practice (cGMP) facility in which it manufactures its
investigational immunotherapy Multikine® (Leukocyte Interleukin,
Injection)*. The construction is designed to ensure the facility
will be compliant with all U.S. Food and Drug Administration’s
(FDA) and European cGMP regulations. Production capacity has been
doubled to meet anticipated market demand for Multikine once it
receives regulatory approval.
- Based on the results of its pivotal Phase 3 study, CEL-SCI
intends to file a Biologic License Application (BLA) with the FDA
for approval of the Multikine treatment regimen in locally advanced
primary squamous cell carcinoma of the head and neck in 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.
- The head and neck cancer patients who are scheduled to receive
surgery and radiation as their first treatments have not seen a
marked improvement in their treatment outcome in decades. This is
clearly an unmet medical need. The study showed great improvement
in survival with no noted safety issues for these patients. The
number of patients who could benefit from this treatment annually
is large, estimated at about 211,000 globally.
- As of December 31, 2021, CEL-SCI had $37.1 million in cash and
cash equivalents.
“Our current focus is in three primary areas, all of which are
essential steps towards drug approval. First, we are assembling the
clinical documentation required to obtain FDA approval of a
Biologic Product License which will allow commercial marketing of
Multikine, second, we are preparing and submitting our compelling
data to peer review publications and third, on the production side,
we are preparing the facility for FDA inspection as part of the
Biologic Establishment License Application process. We look forward
to providing updates on these essential steps as we reach
milestones,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net loss available to common shareholders of
approximately $8.8 million for the quarter ended December 31, 2021
versus a net loss of approximately $8.0 million for the quarter
ended December 31, 2020.
During the quarter ended December 31, 2021, CEL-SCI completed a
major upgrade of its leased manufacturing facility to prepare for
the potential commercial production of Multikine. Total costs of
this upgrade were approximately $11.1 million, of which the
landlord of the property agreed to finance $2.4 million. The
landlord financing is being repaid through increased lease payments
over the remaining term of the lease.
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 CONDENSED
STATEMENTS OF OPERATIONS THREE MONTHS ENDED DECEMBER 31, 2021 AND
2020 (UNAUDITED)
2021
2020
Operating expenses:
Research and development
$
6,083,167
$
5,414,760
General and administrative
2,760,208
3,316,156
Total operating expenses
8,843,375
8,730,916
Operating loss
(8,843,375
)
(8,730,916
)
Gain on derivative instruments
364,596
932,836
Other non-operating gains
(30,793
)
121,606
Interest expense, net
(273,034
)
(260,390
)
Net loss
(8,782,606
)
(7,936,864
)
Modification of warrants
-
(85,779
)
Net loss available to common
shareholders
$
(8,782,606
)
$
(8,022,643
)
Net loss per common share
BASIC and DILUTED
$
(0.20
)
$
(0.21
)
Weighted average common shares
outstanding
BASIC
43,077,961
38,670,247
DILUTED
43,083,420
38,767,286
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version on businesswire.com: https://www.businesswire.com/news/home/20220214005134/en/
Gavin de Windt CEL-SCI Corporation (703)
506-9460
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