CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended March 31, 2021, as well as
key clinical and corporate developments.
Clinical and Corporate Developments include:
- In December 2020, CEL-SCI stated that its pivotal Phase 3 head
and neck cancer study completed database lock and entered the
statistical analysis phase. CEL-SCI remains blinded to the study
data and is not involved in the analysis process which is conducted
by independent contractors. The statistical analysis plan follows
the protocol stated objectives and is designed to meet FDA
requirements to define safety and efficacy, those clinical benefits
that Multikine might provide for patients newly diagnosed with
advanced primary (not yet treated) squamous cell carcinoma of the
head and neck.
- In preparation for the anticipated commercial launch of
Multikine, CEL-SCI has been expanding and upgrading its dedicated
cGMP manufacturing facility for Multikine. The construction, which
began in 2020, is expected to be completed soon and will double the
facility’s capacity to accommodate two shifts for increased
production of Multikine.
“We believed in cancer immunotherapy when few did. We were the
first to administer an immunotherapy drug right after diagnosis,
ahead of surgery, radiation and chemotherapy, because we believe
that the activation of an anti-tumor response by the immune system
is best achieved before standard therapies damage it. We believe
that it is possible to develop a non-toxic cancer drug. Our Phase 3
study took years longer than expected because it took longer than
expected to reach the required number of events (patient deaths) in
the comparator arms of the study. It is all about the final data,”
stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $17.3 million for the six
months ended March 31, 2021 versus an operating loss of $13.6
million for the six months ended March 31, 2020. CEL-SCI reported
an operating loss of $8.5 million for the quarter ended March 31,
2021 versus an operating loss of $6.7 million for the quarter ended
March 31, 2020.
During the six and three months ended March 31, 2021, CEL-SCI
incurred approximately $6.9 million and $3.3 million, respectively,
in capitalized costs to upgrade its manufacturing facility to
prepare for the potential commercial production of Multikine. Total
estimated costs of this upgrade are approximately $10.6 million, of
which approximately $9.5 million has been incurred through March
31, 2021. The landlord of the property has agreed to finance the
final $2.4 million of costs and allow for the repayment through
increased lease payments beginning March 1, 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, are treated with the
investigational product Multikine first, BEFORE they received
surgery, radiation or chemoradiotherapy (the current standard of
care [SOC] 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), has received Orphan Drug designation from
the FDA for the 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 better be able to mount an attack on
the tumor. The aim of treatment with Multikine is to boost the
body’s immune system prior to SOC to attack the cancer. The Phase 3
study completed enrollment with 928 patients in September 2016. To
prove an overall survival benefit, the study required CEL-SCI to
wait until 298 (death) events have occurred among the two main
comparator groups. This study milestone occurred in late April
2020. The study is currently in the statistical analysis phase.
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. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational
therapy Multikine. Further research is required, and early-phase
clinical trial results must be confirmed in the Phase 3 clinical
trial of this investigational therapy that is in progress.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
SIX MONTHS ENDED MARCH 31, 2021
AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
334,232
Operating Expenses:
Research and development
10,636,274
8,711,360
General and administrative
6,627,640
5,197,418
Total operating expenses
17,263,914
13,908,778
Operating loss
(17,263,914)
(13,574,546)
Other income
-
36,896
Loss on derivative instruments
(2,108,181)
(2,282,518)
Other non-operating gains
675,236
1,725,180
Interest expense, net
(521,125)
(504,190)
Net loss
(19,217,984)
(14,599,178)
Modification of warrants
(85,779)
(21,734)
Net loss available to common
shareholders
$
(19,303,763)
$
(14,620,912)
Net loss per common share - basic and
diluted
$
(0.49)
$
(0.41)
Weighted average common shares outstanding
- basic and diluted
39,351,194
35,621,711
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED MARCH 31, 2021
AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
298,726
Operating Expenses:
Research and development
5,221,514
4,458,547
General and administrative
3,311,484
2,558,522
Total operating expenses
8,532,998
7,017,069
Operating loss
(8,532,998)
(6,718,343)
Other income
-
18,448
Loss on derivative instruments
(3,041,017)
(3,049,027)
Other non-operating gains
553,630
934,511
Interest expense, net
(260,735)
(253,407)
Net loss
(11,281,120)
(9,067,818)
Modification of warrants
-
(21,734)
Net loss available to common
shareholders
$
(11,281,120)
$
(9,089,552)
Net loss per common share - basic and
diluted
$
(0.28)
$
(0.25)
Weighted average common shares outstanding
- basic and diluted
40,047,273
36,165,050
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version on businesswire.com: https://www.businesswire.com/news/home/20210518005360/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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