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CEL-SCI
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August
2018
Dear
CEL-SCI Shareholders:
Our
singular goal right now is to reach the final data readout of the
Phase 3 trial to establish the utility of our investigational
immunotherapy Multikine* (Leukocyte Interleukin, Injection) in the
treatment of head and neck cancer. 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.
The
results of the Phase 3 study, if positive, will form the basis of
our regulatory submissions for marketing applications worldwide to
commercially market and distribute Multikine. The U.S. FDA has not
approved a new drug for advanced primary squamous cell carcinoma
(cancer) of the head and neck in about 60 years, a clear unmet
medical need. The FDA has granted Multikine Orphan Drug status in
this indication.
If we
receive FDA approval, we believe that Multikine should become part
of the standard of care (SOC) because the study endpoint of
“improvement in overall survival” is the gold standard
for cancer drug approval. Since our Phase 3 head and neck cancer
study is the largest head and neck cancer study ever conducted, we
expect data from it should be sufficiently robust and highly
regarded to support our belief. Multikine should then become the
recommended first treatment to be administered following diagnosis
of cancer and before SOC is administered, for a cancer that affects
about 650,000 patients per year.
This
key inflection point is on the near term horizon. CEL-SCI is a
cancer immunotherapy company that has a market cap of about $20
million. That makes little sense. We think that this is in large
part due to the fact that we have all been waiting for Phase 3 data
for 8.5 years. That is a long time. But, the last patients were
enrolled almost two years ago and the final read out of the Phase 3
study is near. In the past 18 months, several successful Phase 3
cancer immunotherapy companies were sold for $7 billion to almost
$12 billion. They had positive survival data from their pivotal
studies, but had not yet received FDA approval. In addition,
recently one cancer immunotherapy company with Phase 3 studies that
were not yet complete was sold for about $1.6 billion.
CEL-SCI’s
Multikine Phase 2 open label “Proof of Concept” study
used the same three week Multikine treatment regimen prior to SOC
that is being used in the current Phase 3 study. The effects of a 3
week Multikine treatment regimen on the tumors that were removed at
surgery (per SOC) following the Multikine treatment regimen was
examined and evaluated by pathology. The findings were published in
the Journal of Clinical Oncology and presented at American Society
of Clinical Oncology. The pathologists found that about 10% of
patients had no tumor cells remaining after a three week Multikine
treatment, and the remaining patients had only about 50% of their
tumor cells remaining. In a survival follow-up study of patients
from the same Phase 2 study, it was determined that there was a 33%
overall survival benefit compared to results obtained in 55
clinical trials reported in the scientific literature between 1987
and 2007 in the same patient population (Advanced Primary Squamous
Cell Carcinoma of the Head and Neck). Our pivotal Phase 3 study is
designed to prove a 10% overall survival benefit in a prospectively
controlled study in a statistically significant
manner.
Our
idea and aim is to help cancer patients by boosting their immune
system BEFORE the ravages of surgery, radiation and chemotherapy.
We believe that boosting a cancer patient's immune system while it
is still intact, before surgery and/or radiation/chemotherapy,
should provide the greatest possible impact on survival. Our Phase
3 study is meant to prove this. This is a logical concept and one
that made sense to 24 regulatory agencies, including the FDA, when
we applied to them to conduct this global Phase 3 study. This idea
is now gaining traction among oncologists. If we are successful in
head and neck cancer, we hope to expand this concept to other
cancers.
-- more
--
CEL-SCI
Corporation
August
2018
Page
2
We
recently completed and won the arbitration against the clinical
research organization (CRO) that ran our 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 us. Many investment
funds and analysts did not like the legal risk of this arbitration
and now that the arbitration has been resolved in our favor, this
should no longer be an impediment to investors and should result in
renewed investment interest in CEL-SCI. With the arbitration behind
us, we move forward with a clean slate.
Investors,
new and old, can now focus on the achievements that establish the
true value of our Company: 1) a fully enrolled cancer Phase 3
clinical trial awaiting final top line data readout; and 2) a very
promising rheumatoid arthritis treatment vaccine candidate, based
on our LEAPS technology, funded by a large U.S. government
grant.
Moving
forward to a promising future, we plan to meet with and provide an
update to interested investors, many of whom will be looking at
CEL-SCI for the first time.
Sincerely,
Geert
Kersten
Chief
Executive Officer
Forward-Looking Statements
This
shareholder letter 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.
