CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2019. The Company
also reported key clinical and corporate developments achieved
during the quarter.
Clinical and Corporate Developments included:
- CEL-SCI’s Phase 3 head and neck cancer study continued to
follow all 928 patients who were enrolled. The Company is now
awaiting final study results. All that remains to be done in this
pivotal Phase 3 study, the largest in the world in head and neck
cancer, is to continue to track patient survival until it can be
determined if the primary endpoint of the study, a 10% improvement
in overall survival of the Multikine* treatment regimen plus
Standard of Care (SOC) vs. SOC alone will be met. The primary
endpoint will be determined after a total of 298 events (deaths)
have occurred in the two main comparator arms of the study and have
been recorded in the study database. These final results could be
available soon since the last cancer patients were treated in
September 2016, and the first cancer patients in the study were
treated in early 2011.
- On May 11, 2019 and July 3, 2019, new data was presented on
CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment
for rheumatoid arthritis. The work was performed in conjunction
with researchers at Rush University Medical Center, Chicago,
Illinois.
- On June 3-6, 2019, CEL-SCI was an exhibitor and showcased its
presentation at the BIO International Convention. CEL-SCI was
selected to be part of the Innovation Zone sponsored by the U.S.
National Institutes of Health (NIH). The focus was the Company’s
experimental LEAPS platform technology and CEL-SCI’s ongoing
development of a LEAPS based therapeutic antigen-specific treatment
for rheumatoid arthritis. The NIH has funded research studies for
CEL-SCI’s LEAPS technology in the treatment of rheumatoid arthritis
through a $1.5 million grant. There was a lot of corporate interest
in the LEAPS technology for rheumatoid arthritis.
- On June 28, 2019, CEL-SCI joined the broad-market Russell 3000®
Index that was effective after the US market opened on July 1,
2019.
- Following this quarter, between July 1, 2019 and August 13,
2019, the Company received over $2.5 million through the exercise
of warrants to purchase shares of the Company's common stock.
“We look forward to the readout of our Phase 3 data, as we
believe Multikine immunotherapy may increase the success rate of
the first ‘intent to cure’ cancer treatment regimen by adding the
tumor cell killing ability of the still healthy immune system to
the known anti-tumor effects of surgery, radiation and
chemotherapy. Multikine is unique in cancer immunotherapy because
it can potentially be effective when administered for just three
weeks, right after diagnosis and prior to surgery, as compared to
other immuno-oncology drugs on the market today that are used to
treat people with recurrent cancer, or end stage disease,” stated
CEL-SCI CEO, Geert Kersten. “Our experimental LEAPS vaccine
platform continues to show promise as we continue IND-enabling
studies in conjunction with the NIH.”
CEL-SCI reported a net loss of $17.3 million for the nine months
ended June 30, 2019 versus a net loss of $16.9 million for the nine
months ended June 30, 2018. The net loss increase was in large part
due to the change in value of the non-cash derivative instruments
that were caused mainly by fluctuation in the share price of the
Company’s common stock.
During the three months ended June 30, 2019, the Company’s cash
increased by approximately $4.0 million, as compared to the second
quarter of fiscal 2019, to $9.5 million. Significant components of
this increase included net proceeds from the exercise of warrant
and stock options of approximately $8.4 million and the purchase of
common stock by officers and directors of approximately $0.2
million. The increase was offset by net cash used to fund the
Company’s regular operations, including its Phase 3 clinical trial,
of approximately $4.6 million.
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 treats patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with Multikine first, BEFORE they
receive surgery, radiation and/or chemotherapy. 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 neoadjuvant therapy in patients
with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI's Phase 3 study is the largest Phase 3 study in the
world for the treatment of head and neck cancer. Per the study's
protocol, newly diagnosed patients with advanced primary squamous
cell carcinoma of the head and neck are treated with the Multikine
treatment regimen for 3 weeks prior to the Standard of Care (SOC)
which involves surgery, chemotherapy and/or radiation. 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 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.
The Phase 3 study is fully enrolled with 928 patients and the last
patient was treated in September 2016. To prove an overall survival
benefit, the study requires CEL-SCI to wait until 298 events have
occurred among the two main comparator groups.
The Company's experimental LEAPS technology is currently being
developed as a potential therapeutic vaccine for rheumatoid
arthritis and is supported by grants from the National Institutes
of Health. The Company has operations in Vienna, Virginia, and
in/near 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, 2018. 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
NINE MONTHS ENDED JUNE 30, 2019
AND 2018
(UNAUDITED)
2019
2018
Grant income
$
386,121
$
297,045
Operating Expenses:
Research and development
7,956,203
7,713,873
General and administrative
6,981,079
5,823,694
Total operating expenses
14,937,282
13,537,567
Operating loss
(14,551,161)
(13,240,522)
Other income
54,575
52,984
(Loss) gain on derivative instruments
(3,316,384)
187,967
Other non-operating gain (loss)
1,877,197
(171,468)
Interest expense, net
(1,350,774)
(3,739,494)
Net loss available to common
shareholders
$
(17,286,547)
$
(16,910,533)
Net loss per common share
Basic and Diluted
$
(0.58)
$
(1.17)
Weighted average common shares
outstanding
Basic and Diluted
30,046,241
14,486,351
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED JUNE 30, 2019
AND 2018
(UNAUDITED)
2019
2018
Grant income
$
108,938
$
86,459
Operating Expenses:
Research and development
2,298,555
2,425,562
General and administrative
3,020,482
1,748,971
Total operating expenses
5,319,037
4,174,533
Operating loss
(5,210,099)
(4,088,074)
Other income
18,448
17,711
Loss on derivative instruments
(7,905,519)
(8,618)
Other non-operating gain (loss)
1,455,844
(149,359)
Interest expense, net
(443,442)
(1,786,228)
Net loss available to common
shareholders
$
(12,084,768)
$
(6,014,568)
Net loss per common share
Basic and Diluted
$
(0.37)
$
(0.36)
Weighted average common shares
outstanding
Basic and Diluted
33,051,888
16,651,297
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version on businesswire.com: https://www.businesswire.com/news/home/20190814005490/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460
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