CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended June 30, 2018. 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. Enrollment was
completed in September of 2016. Based on published survival data,
we believe top line results may be available as soon as early 2019.
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 has been met. 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 determined after
a total of 298 deaths have occurred in the two main comparator arms
of the study and have been recorded in the study database.
- The US Patent and Trademark Office
allowed two new patents to CEL-SCI for the Company's LEAPS platform
technology. Titled "Method for Inducing an Immune Response and
Formulations Thereof" and " Method for Inducing an Immune Response
against avian, swine, Spanish, H1N1, H5N9 influenza viruses and
formulations", these patents relate to methods for diagnosing,
preventing, and treating disease by generating or modulating the
immune response through the use of specific peptides.
- CEL-SCI won the arbitration against the
clinical research organization (CRO) that ran the Phase 3 head and
neck cancer study from 2011-2013. The arbitrator ruled that the CRO
materially breached its contract with CEL-SCI. The arbitrator’s
decision has vindicated CEL-SCI. Many investment funds and analysts
did not like the legal risk of this arbitration and now that the
arbitration has been resolved in CEL-SCI’s favor, this should no
longer be an impediment to investors and should result in renewed
investment interest in CEL-SCI. With the arbitration completed,
CEL-SCI moves forward with a clean slate.
“We are proud of having run the largest head and neck cancer
Phase 3 study in the world, in an indication that has not seen a
new drug approved by the FDA in over 60 years. This has not been
easy for many reasons, including the fact that our approach to
immunotherapy involves treating the patient when they first get
diagnosed instead of using immunotherapy as a last ditch option for
survival. Our approach meant a longer clinical trial period, with
nearly one thousand patients enrolled. Despite the many challenges
of this study, we believe the potential to bring a new
immunotherapy to help save the lives of newly diagnosed cancer
patients has been worth it,” said CEL-SCI’s Chief Executive
Officer, Geert Kersten. “As we look forward to a readout of the
endpoint data which may happen in early 2019, we also continue to
develop our LEAPS technology platform with the support of the U.S.
National Institutes of Health. Should our Phase 3 results lead to
marketing approval in head and neck cancer, we will also have the
opportunity to purse clinical development and marketing approval of
our immunotherapy in other cancer indications.”
During the nine months ended June 30, 2018, the Company’s cash
remained constant. Cash used in operations of approximately $9.1
million was offset by approximately $9.1 million in cash provided
by financing activities. Sources of financing during the nine
months included approximately $7.0 million in proceeds from the
issuance of common stock and warrants and $2.1 million in proceeds
from the exercise of warrants.
CEL-SCI reported an operating loss of ($4,070,363) for the
quarter ended June 30, 2018 versus an operating loss of
($4,758,719) for the quarter ended June 30, 2017. The operating
loss was ($13,187,538) for the nine months ended June 30, 2018
versus an operating loss of ($17,603,283) for the nine months ended
June 30, 2017.
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 the 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 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 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 Company’s LEAPS technology is currently being developed as a
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.
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, 2017. 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
THREE MONTHS ENDED JUNE 30, 2018 AND
2017
(unaudited)
2018 2017 Grant and other income $ 104,170 $ 17,389
Operating Expenses: Research and development 2,425,562
3,180,401 General & administrative 1,748,971
1,595,707 Total operating expenses
4,174,533 4,776,108 Operating loss
(4,070,363 ) (4,758,719 ) (Loss) gain on derivative
instruments (8,618 ) 790,365 Interest expense, net
(1,935,587 ) (495,709 ) Net loss available to common
shareholders $ (6,014,568 ) $ (4,464,063 ) Net loss
per common share Basic and diluted $ (0.36 ) $ (0.53 )
Weighted average common shares outstanding Basic and diluted
16,651,297 8,405,790
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2018 AND
2017
(unaudited)
2018 2017 Grant and other income $ 350,029 $
51,822 Operating Expenses: Research and development
7,713,873 13,307,275 General & administrative 5,823,694
4,347,830 Total operating expenses
13,537,567 17,655,105 Operating
loss (13,187,538 ) (17,603,283 ) Gain on derivative
instruments 187,967 9,669,977 Interest expense, net
(3,910,962 ) (1,436,095 ) Net loss available to
common shareholders $ (16,910,533 ) $ (9,369,401 )
Net loss per common share Basic $ (1.17 ) $ (1.29 ) Diluted $ (1.17
) $ (1.34 ) Weighted average common shares outstanding Basic
14,486,351 7,235,140 Diluted 14,486,351 7,292,715
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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