CEL-SCI Corporation Reports Second Quarter Fiscal 2022 Financial Results
May 16 2022 - 8:50AM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended March 31, 2022, as well as
key clinical and corporate developments.
Clinical and Corporate Developments include:
- The American Society of Clinical Oncology (ASCO) has accepted
two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine®
(Leukocyte Interleukin, Injection)* head and neck cancer clinical
trial for presentation at the 2022 ASCO Annual Meeting to be held
June 3-7, 2022 in Chicago, Illinois. The abstract titles are:
- “Novel algorithm for assigning risk/disease-directed treatment
(DDT) choice in locally advanced primary squamous cell carcinoma of
the head and neck (SCCHN): Using pretreatment data only.”
- “Leukocyte interleukin injection (LI) immunotherapy extends
overall survival (OS) in treatment-naive low-risk (LR) locally
advanced primary squamous cell carcinoma of the head and neck: The
IT-MATTERS study.”
- 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. CEL-SCI’s
Phase 3 study showed great improvement in survival with no toxicity
issues for these patients with a statistically significant, robust,
and durable survival benefit of 14.1% at 5 years. This is clearly
an unmet medical need for an estimated 211,000 people
globally.
- Additional results from the Phase 3 study of Multikine in
advanced primary head and neck cancer have been submitted to the
U.S. government clinical trial website www.clinicaltrials.gov. That
data is expected to be released to the public in the near
future.
- CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP)
facility in which it manufactures Multikine is now undergoing
validation following the completion of its commercial scale build
out during the first quarter of 2022. 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.
- As of March 31, 2022, CEL-SCI had $34.3 million in cash and
cash equivalents.
“ASCO’s annual meeting in June, with over 40,000 oncology
professionals from over 100 countries expected, is one of the
largest and most prominent oncology conferences. Our scientific
team looks forward to presenting two abstracts there, and we expect
a high level of interest based on Multikine’s results and the fact
that outcomes have not improved for the head and neck cancer
population in decades,” stated CEL-SCI CEO, Geert Kersten. “The
conference is well timed to inform oncologists from around the
world about Multikine ahead of our planned regulatory filing for
approval.”
CEL-SCI reported an operating loss of $18.4 million for the six
months ended March 31, 2022 versus an operating loss of $17.3
million for the six months ended March 31, 2021. CEL-SCI reported
an operating loss of $9.6 million for the three months ended March
31, 2022 versus an operating loss of $8.5 million for the three
months ended March 31, 2021. Net cash used in operating activities
was $7.5 million for the six months ended March 31, 2022 which
represents a decrease of $1.2 million compared to the six months
ended March 31, 2021.
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.
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
SIX MONTHS ENDED MARCH 31, 2022
AND 2021
(UNAUDITED)
2022
2021
Operating expenses:
Research and development
$ 12,606,984
$ 10,636,274
General and administrative
5,788,250
6,627,640
Total operating expenses
18,395,234
17,263,914
Operating loss
(18,395,234)
(17,263,914)
Gain (loss) on derivative instruments
366,791
(2,108,181)
Other non-operating (loss) gain
(30,793)
675,236
Interest expense, net
(546,862)
(521,125)
Net loss
(18,606,098)
(19,217,984)
Modification of warrants
-
(85,779)
Net loss available to common
shareholders
$ (18,606,098)
$ (19,303,763)
Net loss per common share - basic and
diluted
$ (0.43)
$ (0.49)
Weighted average common shares outstanding
- basic and diluted
43,100,070
39,351,194
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED MARCH 31, 2022
AND 2021
(UNAUDITED)
2022
2021
Operating Expenses:
Research and development
$ 6,523,817
$ 5,221,514
General and administrative
3,028,042
3,311,484
Total operating expenses
9,551,859
8,532,998
Operating loss
(9,551,859)
(8,532,998)
Gain (loss) on derivative instruments
2,195
(3,041,017)
Other non-operating gain
-
553,630
Interest expense, net
(273,828)
(260,735)
Net loss
$ (9,823,492)
$ (11,281,120)
Net loss per common share - basic and
diluted
$ (0.23)
$ (0.28)
Weighted average common shares outstanding
- basic and diluted
43,122,671
40,047,273
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version on businesswire.com: https://www.businesswire.com/news/home/20220516005179/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460
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