CEL-SCI Corporation Reports Third Quarter Fiscal 2022 Financial Results
15 Août 2022 - 3:00PM
Business Wire
CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2022, as well as
key clinical and corporate developments.
Clinical and Corporate Developments include:
- The American Society of Clinical Oncology (ASCO) published two
abstracts related to CEL-SCI’s pivotal randomized controlled 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.” -
https://meetings.asco.org/abstracts-presentations/207202
- “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.” -
https://meetings.asco.org/abstracts-presentations/207201
- Multikine is given for three weeks after cancer diagnosis, but
before surgery and other treatments. In the peer-reviewed abstract
presented at ASCO, a clear survival advantage for patients treated
with Multikine prior to surgery in the surgery-plus-radiation arm
of the IT-MATTERS study was described. The survival advantage was
driven by objective data derived from patients in the
intent-to-treat (ITT) population who had a significant number of
early complete and partial tumor responses which occurred prior to
surgery. Five patients in the study had their tumors completely
disappear (confirmed by pathology) before surgery. In the ITT
population as a whole, 8.5% of all Multikine-treated patients had a
tumor response before surgery, but not a single tumor response
before surgery was seen in the ITT control group before surgery,
statistically a highly significant finding (p-value of less than
0.00000000001). This indicates that the likelihood of seeing these
results by chance is less than 1 in ten billion. These results
confirm findings from the Phase 1 and 2 studies with Multikine and
provide direct evidence of Multikine’s anticancer activity.
- 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 was designed
to ensure the facility will be compliant with all U.S. Food and
Drug Administration’s (FDA) GMP and European regulations.
“Advanced primary squamous cell carcinoma (cancer) of the head
and neck is a horrible disease for which FDA has not approved a new
treatment in many decades. Many leading drugs have failed in
studies for the treatment of advanced primary head and neck cancer.
Our Phase 3 study shows an almost 4-year median survival benefit
for the patients who received Multikine treatment before surgery
and radiation. We believe that this represents a meaningful
clinical impact for those patients for whom no treatment has
imparted a significant survival benefit in decades. We are looking
forward to additional peer-reviewed publications of this data,”
stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $27.1 million for the nine
months ended June 30, 2022 versus an operating loss of $27.7
million for the nine months ended June 30, 2021. Net cash used
during the nine months ended June 30, 2022 was $13.3 million. This
represents a decrease of $0.7 million compared to the nine months
ended June 30, 2021. CEL-SCI reported an operating loss of $8.7
million for the three months ended June 30, 2022 versus an
operating loss of $10.5 million for the three months ended June 30,
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 radiochemotherapy (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 study results announced showed almost 4-year 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. 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
NINE MONTHS ENDED JUNE 30, 2022
AND 2021
(UNAUDITED)
2022
2021
Operating expenses:
Research and development
$
18,893,857
$
17,818,373
General and administrative
8,220,768
9,902,120
Total operating expenses
27,114,625
27,720,493
Operating loss
(27,114,625
)
(27,720,493
)
Gain (loss) on derivative instruments
366,791
(991,562
)
Other non-operating (loss) gain
(30,793
)
1,428,260
Interest expense, net
(1,460,055
)
(872,457
)
Net loss
(28,238,682
)
(28,156,252
)
Modification of warrants
(294,409
)
(350,861
)
Net loss available to common
shareholders
$
(28,533,091
)
$
(28,507,113
)
Net loss per common share - basic
$
(0.66
)
$
(0.71
)
Weighted average common shares outstanding
- basic
43,124,972
39,907,624
Net loss per common share - diluted
$
(0.66
)
$
(0.74
)
Weighted average common shares outstanding
- diluted
43,124,972
40,158,321
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED JUNE 30, 2022
AND 2021
(UNAUDITED)
2022
2021
Operating Expenses:
Research and development
$
6,286,873
$
7,182,099
General and administrative
2,432,518
3,274,480
Total operating expenses
8,719,391
10,456,579
Operating loss
(8,719,391
)
(10,456,579
)
Gain on derivative instruments
-
1,116,619
Other non-operating gains
-
753,024
Interest expense, net
(913,193
)
(351,332
)
Net loss
(9,632,584
)
(8,938,268
)
Modification of warrants
(294,409
)
(265,082
)
Net loss available to common
shareholders
$
(9,926,993
)
$
(9,203,350
)
Net loss per common share - basic
$
(0.23
)
$
(0.22
)
Weighted average common shares outstanding
- basic
43,174,775
41,020,485
Net loss per common share - diluted
$
(0.23
)
$
(0.25
)
Weighted average common shares outstanding
- diluted
43,174,775
41,231,082
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version on businesswire.com: https://www.businesswire.com/news/home/20220815005121/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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