VIENNA, Va.–(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 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.
Contacts
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460