CEL-SCI Corporation Releases Letter to Shareholders
08 May 2019 - 10:00PM
Business Wire
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:
- 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.
- 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 KerstenChief 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190508005162/en/
Gavin de WindtCEL-SCI Corporation(703) 506-9460
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