Market Overview

CEL-SCI Corporation Releases Letter to Shareholders


The following letter was sent by CEL-SCI Corporation (NYSE American: CVM) to its shareholders for the upcoming annual meeting:

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

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.

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.


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

View Comments and Join the Discussion!