Exhibit 99
CEL-SCI CORPORATION RELEASES LETTER TO SHAREHOLDERS
Vienna, VA, May 8, 2019 -- The following letter was sent by
CEL-SCI Corporation (NYSE American: CVM) to its
shareholders:
Dear
CEL-SCI Shareholders:
The
first 4 months of this year have already been very positive for us.
Our Phase 3 head and neck cancer study is continuing and we are
moving forward with our Rheumatoid Arthritis product development.
Since January 1, we have received about $9.6 million from the
conversion of warrants to finance our ongoing
projects.
We
believe the following developments with regard to the Multikine*
Phase 3 trial have contributed to additional investments in our
Company:
1.
Length of Phase 3 study could be a
sign of Multikine’s efficacy:
We have
not yet hit the primary endpoint of our 928 patient Phase 3 study
with our investigational cancer immunotherapy drug Multikine. That
endpoint will be reached when 298 events (deaths) have occurred and
are recorded in the two main comparator arms of the study. Since
the scientific literature does not suggest an improvement in the
survival rates for oral head and neck cancer patients receiving
standard of care only, we believe a delay in reaching these 298
events could be a good sign for the potential effectiveness of
Multikine.
2.
The IDMC recommended to continue the
Phase 3 cancer study after their review of our
data:
At the
end of March 2019, we had an official review of the Phase 3 study
by the IDMC (Independent Data Monitoring Committee). The IDMC
recommended to “continue the trial until the appropriate
number of events has occurred”. The IDMC reviews all the
study results at the time of each IDMC meeting. Had the study
results indicated that meeting the primary survival endpoint of the
study would no longer be possible, the study could have been deemed
futile. The IDMC recommended to continue the study. In our Phase 3
trial the primary endpoint is met by reaching a 10% improvement in
the overall survival of the group of patients receiving the
Multikine treatment regimen plus the Standard of Care versus the
overall survival of the group of patients receiving the Standard of
Care only. Futility has been on the minds of investors a lot more
recently, because finding futility in the case of a Phase 3
Alzheimer study by Biogen in March 2019 resulted in a loss to
shareholders of close to $30 billion.
Our
goal is to use Multikine immunotherapy to 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. In short, our goal is to use the immune system,
while it is still strong, to make the first cancer treatment more
successful so that patients do not progress and become terminal
cancer patients. This approach is unique to CEL-SCI.
I have
been traveling extensively since the beginning of the year to
communicate to the investment community our new way of treating
cancer, administrating cancer immunotherapy right after diagnosis
and BEFORE surgery. When we started the Phase 3 study over eight
years ago, hardly anyone believed that cancer immunotherapy would
ever be successful. Now just about everyone I meet with sees cancer
immunotherapy as the future of cancer treatment. Only a few years
ago investors told me that it was not necessary to treat before
surgery, radiation and chemotherapy because the immune system
recovers. Now investors appear to agree that activating the immune
system to fight cancer before surgery, radiation and chemotherapy
have severely compromised the immune system, should be the most
effective way of treating cancer.
What
few of these investors understood is that existing cancer drugs,
even the newly approved immunotherapy drugs you read about in the
news almost every week, cannot be given right after diagnosis and
before the first “intent to cure” treatment of surgery.
Delay of surgery is not allowed and that leaves only three weeks
for treatment between diagnosis and surgery. Multikine fits into
this three week treatment schedule and that makes Multikine
immunotherapy unique. The other cancer immunotherapies require
months of treatments. In addition, given the horrible toxicities
from radiochemotherapy, which often follows surgery in head and
neck cancer and also other cancers, any drug added must not add
toxicity to the already toxic treatment. Multikine, as we learned
from prior studies, satisfies this requirement as
well.
We are
benefiting from renewed interest in CEL-SCI’s Multikine
cancer immunotherapy by meeting with new investors weekly. What is
striking is that hardly any of them have ever heard of CEL-SCI,
even though we have been running the largest study ever in head and
neck cancer. We think that the absence of new clinical data for
over 8 years (we are blinded to the Phase 3 results and therefore
could not announce clinical data) is probably the reason for
CEL-SCI being virtually unknown. But, while that presented a
problem in the past, it now represents a fantastic opportunity. New
investors are very interested for two reasons: 1) during our Phase
3 study cancer immunotherapy has become accepted as a new treatment
modality for cancer; and 2) investors prefer investing near the end
of this long trial.
It has
taken decades to get to this point in time, but we are finally near
the end, and we feel good about it. Each of the last few years I
have purchased more CEL-SCI stock. And I did so again this week
when I purchased $100,000 worth of restricted CEL-SCI stock at
$6.86 directly from the Company at the full market price. Several
others from our senior management team and one member of the Board
of Directors have joined me and purchased another $110,000 worth of
CEL-SCI stock on the same terms.
One
last point: We have our Annual Shareholder Meeting on May 20, 2019.
Please participate by voting your shares. If you are having
problems voting or have not received a proxy from your broker,
please call Advantage Proxy at 1-877-870-8565 and talk to
them.
WE
BELIEVE! We believed when there was little data supporting our
belief. We believe now even more than before. Thank you very much
for your support.
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, 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.