CEL-SCI Corporation Releases Letter to Shareholders
October 19 2015 - 9:00AM
Business Wire
The following letter is being released by CEL-SCI Corporation
(NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholder:
We are pleased to report significant steps forward for our most
important clinical program, the ongoing Phase 3 clinical trial with
our investigational cancer immunotherapy drug Multikine* (Leukocyte
Interleukin, Injection) against advanced primary head and neck
cancer. We also recently received a very important endorsement for
our $50 million arbitration against the former Clinical Research
Organization (CRO) that used to run this trial.
In our Phase 3 cancer immunotherapy trial, Multikine is given
for 3 weeks right after cancer has been diagnosed and before any
standard of care treatments, like surgery, radiation and/or
chemotherapy. This trial is about proving that it should be more
beneficial to cancer patients if we stimulate their immune systems
before their immune systems are severely weakened by standard of
care cancer treatments. It seems logical to us that this immune
therapy approach should give better results than today’s standard
approach of treating cancer patients after radiation and chemo have
left their immune systems severely weakened. Our goal is to make
the very first cancer treatment more successful.
While at this time we cannot report clinical results in the
ongoing Phase 3 trial, we can point to rapidly increasing
enrollment and to many more of the world’s leading doctors
participating and enrolling patients in this study. When we
dismissed the former CRO we were enrolling about one patient per
month. Last month, with the new CRO, we basically enrolled one
patient per day.
In early October 2015 we had another development that we think
is quite telling. The new CRO running our Phase 3 trial, Ergomed,
has increased its co-development agreement, the amount it
contributes to the Phase 3 study, from $10 to $12 million. If
Multikine is not successful, Ergomed will get nothing back from its
$12 million Multikine co-development investment. If it is
successful, Ergomed will be repaid in the form of a royalty on
sales with a cap. Ergomed runs the Phase 3 study and its employees
are in contact with all the study sites and treating physicians on
a regular basis. We believe Ergomed’s choice to increase its
investment in the trial is important.
Another very important event is the $50 million arbitration
against the CRO that used to run our Phase 3 study, until we
dismissed them in or about April 2013. The arbitration against this
company was filed in October 2013 and is drawing closer to trial.
Remember, this is an arbitration which is generally much faster
than litigation. This arbitration is very important to CEL-SCI
because it offers us the opportunity to prove that the CRO
significantly harmed CEL-SCI’s efforts to conduct the Phase 3
clinical trial. The trial, under the new CRO, has been going well
since we dismissed the former CRO. If the arbitrator agrees with
us, and based on the evidence we have assembled we strongly believe
that he will, CEL-SCI will collect damages that could be
significant.
Further strengthening our position in the case, we just
announced that Lake Whillans, a firm specialized in financing
litigation, has committed $5 million to fully fund the arbitration
expenses against the former CRO. This amount is larger than we
think is needed, but we wanted to make sure that the other side
clearly understands that we are more than prepared to represent and
protect our rights in this case. The $5 million will be used to pay
for the arbitration costs; CEL-SCI will no longer pay any
arbitration costs. This money is non-recourse, meaning that Lake
Whillans’ return can only come from the proceeds of the arbitration
award or the proceeds from the settlement of the arbitration. If we
do not win or if we only win a small amount, then Lake Whillans
will receive nothing or just a small amount. Prior to committing to
fund our arbitration against the former CRO, Lake Whillans, under
strict confidentiality, conducted extensive and detailed due
diligence of all of the records in this case.
The bottom line is:
- The Phase 3 trial is progressing well
and we feel that the new Ergomed co-development investment confirms
this.
- We feel that our case in the
arbitration is strong and that the Lake Whillans arbitration
funding agreement confirms this too.
- The arbitration, which had been a
substantial financial burden in the past, is no longer costing
CEL-SCI money.
We will keep you updated as matters progress in both the global
Phase 3 study and the arbitration.
Sincerely,
Geert KerstenChief Executive Officer
Forward-Looking Statements
This press release 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
Corporation's filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-K and 10-K/A for
the year ended September 30, 2014. 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 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 have 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 (Leukocyte Interleukin,
Injection). 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 currently in progress.
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version on businesswire.com: http://www.businesswire.com/news/home/20151019005445/en/
CEL-SCI CorporationGavin de Windt, (703)-506-9460
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