CEL-SCI Corporation Receives $10 Million Through Warrant Exercises
June 30 2020 - 8:30AM
Business Wire
Portion of funds to be invested in expanding
Multikine manufacturing facility in anticipation of marketing
approval
CEL-SCI Corporation (NYSE American: CVM) announced today
that, during the quarter ending June 30, 2020 it has received
approximately $10 million from the exercise of warrants. These
funds will allow the Company to complete the expansion of its
Multikine* (Leukocyte Interleukin, Inj.) cancer immunotherapy
manufacturing facility near Baltimore, MD in anticipation of BLA
submission and subsequent marketing approval.
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, 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 believes that this 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 were treated
with the Multikine treatment regimen for 3 weeks prior to receiving
the Standard of Care (SOC), which involves surgery, radiation or
concurrent radiochemotherapy. 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. 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. This study milestone occurred
in late April 2020. The study is currently in preparation for the
data lock/analysis phase.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment of COVID-19 in hospitalized
and at-high-risk patients. 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, including statements with respect to Multikine and the
Phase 3 clinical trial of Multikine in patients with advanced
primary squamous cell carcinoma of the head and neck. 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 trials or nonclinical
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 amended report on Form 10-K/A for the year ended
September 30, 2019. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200630005188/en/
COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460 www.cel-sci.com
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