CEL-SCI Corporation Releases Letter to Shareholders

VIENNA, Va.–(BUSINESS WIRE)–The following letter was sent by CEL-SCI Corporation (NYSE American:
CVM) to its shareholders for the upcoming annual meeting:

Dear CEL-SCI Shareholders:

The enrollment of 928 patients in our Phase 3 clinical trial of Advanced
Primary (just diagnosed and not yet treated) Head and Neck Cancer was
completed in September of 2016. For the study to end we have to wait for
298 events (deaths) in the two main groups to show a survival benefit.
Based on published survival data, we had already expected to have
reached the 298 events. Instead, we had to extend the contracts with the
Clinical Research Companies (CROs) running the Phase 3 study because we
had not yet reached the required number of events in the study. While we
do not like waiting, we also recognize that this may be a positive
development for our Phase 3 study since Multikine may be the reason for
not yet having reached 298 events. Let us explain to you why.

The primary objective of our Phase 3 study is to demonstrate that, by
administering the Multikine treatment regimen prior to the current
standard of care therapy (SOC), surgery followed by radiotherapy or
followed by combined radiochemotherapy, we can achieve a 10% increase in
overall survival of the Multikine treated head and neck cancer patients.
In a much smaller uncontrolled Phase 2 study Multikine appeared to
increase overall survival even more. If Multikine does increase overall
survival in our well controlled Phase 3 study by 10%, it will likely
take longer to reach 298 events.

Our ultimate goal is to show that Multikine, when given before surgery,
radiation and chemotherapy have weakened the immune system, improves the
cancer patients’ survival and confers clinical benefit. Should we be
successful in reaching this goal, we hope to extend the use of Multikine
to treat other cancers and maybe even other diseases.

Think of family and/or friends who have undergone cancer treatments.
Usually the first treatments consist of surgery, radiation and
chemotherapy, or any combination thereof. If these treatments “cured”
the patient, the issue was resolved. However, if there is a recurrence
of the tumor, more treatments follow, and the outcome is generally not
good. Life may be extended for only a short time, with many horrible
side effects along the way.

The most common misconception with respect to the use of Multikine is
that it is in competition with all of the recently FDA approved
immunotherapies (e.g., Keytruda, Opdivo, CAR-T) that have been in the
news. However those treatments are NOT in competition with Multikine
because they are not intended for use in the same head and neck cancer
patient population we are targeting for Multikine. Multikine is given to
advanced primary head and neck cancer patients who are newly diagnosed,
before they receive their first SOC treatment, which is surgery. These
other immunotherapies are indicated only for patients whose cancers have
recurred following SOC, those patients with metastatic cancer, and
patients where surgery is not an option.

Multikine is given in combination with SOC treatments that are called
“intent to cure” because doctors expect that these first cancer
treatments will cure a certain percentage of patients. Surgery, the
first component of SOC, is usually performed within 3-4 weeks of
diagnosis. A delay in an “intent to cure” SOC treatment is not permitted
because that delay may lead to a patient’s death sooner than if
treatment had not been delayed. Multikine also is not allowed to delay
the surgery, hence Multikine is administered for only 3 weeks prior to
surgery. The use of the previously mentioned cancer immunotherapies
(e.g., Keytruda, Opdivo, CAR-T) in the same patient population being
treated with Multikine would be both inappropriate and unethical because
they are administered over many months, which would cause a delay in
surgery. Further, the toxicities that may be associated with these other
cancer immunotherapies may also preclude their use in patients who are
potentially curable by the current SOC.

We chose to explore advanced primary head and neck cancer as a lead
indication for Multikine for the following reasons:

1. Advanced primary head and neck cancer makes up about 2/3 of the
   650,000 head and neck cancer patients per year.
2. On average, about half of these patients will die within 3 years; and
   there is only one standard of care for this disease.
3. The last FDA approval for this indication was about 60 years ago.
   These patients have a clear unmet medical need.

If we are successful in significantly improving the overall survival for
these patients, we will have made a great advance in the treatment of
this cancer. However, as noted, we believe that Multikine may be a
useful agent to add to therapies currently used to treat other cancers
too.

Years ago, when we started developing Multikine cancer immunotherapy,
the scientific community did not believe that the immune system could
ever be used to fight cancer. Even when we initiated our Phase 3
clinical trial, the attitude was still very critical of cancer
immunotherapy. Today cancer immunotherapy is thought to be the future of
successful cancer treatments. Our premise all along was that the immune
system is incredibly powerful. It needs to be activated in the right way
to fight cancer before it is destroyed by surgery, radiation and/or
chemotherapy. We believe we found a way to do so with the Multikine
treatment regimen. That is the basic belief that guides us every day.

Our Phase 3 study in head and neck cancer has taken eight years.
Throughout all of these years, due to the study design of the Phase 3
clinical trial, we had no clinical data to report while the trial was
ongoing. That is akin to an eight year drought. However, we are now
finally at the end of the study and investors are becoming interested
again. Our valuation was a mere $20 million when we sent you a
shareholder letter in July 2018. Now, in March 2019, it is approximately
$90 million. We had many millions of dollars in warrant exercises
providing the company over $12 million of cash in the past 10 months. We
have a clean balance sheet with no debt. Several large and well known
funds have returned to our stock. New investors in the US, Canada, and
Europe are taking positions. We are on the right path. Of course, our
success rests on the Phase 3 clinical trial data.

In the past 2 years, several successful Phase 3 cancer companies were
sold for multi-billion dollars, most of them before FDA approval, and a
few right afterwards. The most recent acquisition was by Eli Lilly who
bought Loxo Oncology for about $8 billion. The key to that kind of a
valuation lies in providing clinical benefit to cancer patients.
Remember, the last FDA approval in this cancer was well over 50 years
ago and, as far as we know, Multikine is the only drug being evaluated
for use in treating advanced primary head and neck cancer.

In summary, we want to give you the details of when patients were
enrolled and the survival assumptions for the SOC group in our Phase 3
study:

• Approximately 135 patients were enrolled in the study from 2011 to
  2013, about 195 were enrolled in 2014, about 340 in 2015, and about
  260 in 2016
• The last patient was enrolled in the study in September 2016
• The study protocol assumes an overall survival rate of about 55% at 3
  (three) years for the SOC treatment group alone, but obviously the
  event rate in patients who have been in the study longer than 3 years
  will be higher

Some people have wondered if somehow the SOC treatment for advanced
primary head and neck cancer has become more successful in increasing
the overall survival of these patients during our eight year clinical
trial. We have seen no evidence of this, and do not believe this to be
the case. A recent scientific article on essentially the same patient
population as treated in our Phase 3 study, during almost the same time
as our Phase 3 study (European Journal of Otolaryngology (2017)
274:2567-2572 https://slideheaven.com/treatment-outcome-of-advance-staged-oral-cavity-cancer-concurrent-chemoradiother.html),
appears to confirm our belief. The survival curves in this publication
do not look different to us than did the survival curves from the
published studies we used to design our Phase 3 clinical trial.

We have managed to undertake a massive cancer study of eight years, a
huge feat for a small company. We have reached the point where we will
soon have data that could prove our concept for an improved way of
treating newly diagnosed cancer. We continue to believe that we will be
successful.

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

COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703)
506-9460