Opexa Therapeutics Joins Russell Microcap Index

  Opexa Therapeutics Joins Russell Microcap Index

Business Wire

THE WOODLANDS, Texas -- June 30, 2014

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing
Tcelna^® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of
multiple sclerosis (MS), today announced its addition to the Russell
Microcap^® Index. Effective today, Opexa joins the index following an annual
reconstitution of the 4,000 largest U.S. stocks as of the end of May.

Russell indexes are widely used by investment managers and institutional
investors for index funds and as benchmarks for active investment strategies.
Russell calculates more than 700,000 benchmarks daily covering approximately
98 percent of the investable market globally, 80 countries and more than
10,000 securities. Approximately $5.2 trillion in assets are benchmarked to
the Russell Indexes.

“We are pleased to be joining the Russell Microcap Index and look forward to
increased exposure to the investment community,” said Neil K. Warma, President
and Chief Executive Officer of Opexa. “This listing provides an additional
opportunity to generate interest in Opexa as we continue to make progress on
our Abili-T clinical trial and leverage our T-cell immunotherapy platform.”

Members of the Russell Microcap Index are automatically included in the
appropriate growth and value style indexes. Russell determines membership for
its equity indexes primarily by objective, market-capitalization rankings and
style attributes.

About Opexa

Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning
the interests of patients, employees and shareholders. The Company’s leading
therapy candidate, Tcelna^®, is a personalized T-cell immunotherapy that is in
a Phase IIb clinical development program (the Abili-T trial) for the treatment
of Secondary Progressive MS. Tcelna is derived from T-cells isolated from a
patient’s peripheral blood, expanded ex vivo, and reintroduced into the
patient via subcutaneous injections. This process triggers a potent immune
response against specific subsets of autoreactive T-cells known to attack
myelin.

About Multiple Sclerosis (MS)

MS is a chronic, inflammatory condition of the central nervous system and is
the most common, non-traumatic, disabling neurological disease in young
adults. It is estimated that approximately two million people have MS
worldwide.

While symptoms can vary, the most common symptoms of MS include blurred
vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common. The Secondary
Progressive form of MS represents about a third of the MS patient population.

About Tcelna

Tcelna^® is a potential personalized therapy that is under development to be
specifically tailored to each patient's disease profile. Tcelna is
manufactured using ImmPath^®, Opexa's proprietary method for the production of
a patient-specific T-cell immunotherapy, which encompasses the collection of
blood from the MS patient, isolation of peripheral blood mononuclear cells,
generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised
against selected peptides from myelin basic protein (MBP), myelin
oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the
return of these expanded, irradiated T-cells back to the patient. These
attenuated T-cells are reintroduced into the patient via subcutaneous
injection to trigger a therapeutic immune system response.

Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,”
the trial is a randomized, double-blind, placebo-controlled clinical study in
patients who demonstrate evidence of disease progression with or without
associated relapses. The trial is being conducted at approximately 35 leading
clinical sites in the U.S. and Canada with each patient receiving two annual
courses of Tcelna treatment consisting of five subcutaneous injections per
year. The trial’s primary efficacy outcome is the percentage of brain volume
change (atrophy) at 24 months. Study investigators will also measure several
important secondary outcomes commonly associated with MS, including disease
progression as measured by the Expanded Disability Status Scale (EDSS),
annualized relapse rate and changes in disability as measured by EDSS and the
MS Functional Composite.

For more information visit the Opexa Therapeutics website at
www.opexatherapeutics.com.

Cautionary Statement Relating to Forward-Looking Information for the Purpose
of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of
1995

This press release contains forward-looking statements which are made pursuant
to the safe harbor provisions of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Statements contained in this press release, other than statements of
historical fact, constitute “forward-looking statements.” The words “expects,”
“believes,” “potential,” “possibly,” “estimates,” “may,” “could” and
“intends,” as well as similar expressions, are intended to identify
forward-looking statements. These forward-looking statements do not constitute
guarantees of future performance. Investors are cautioned that statements
which are not strictly historical statements, including, without limitation,
statements regarding plans and objectives for product development (including
for Tcelna (imilecleucel T) ) and for potential expansion of the T-cell
platform into other disease indications, constitute forward-looking
statements. Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ materially from
those anticipated. These risks and uncertainties include, without limitation,
risks associated with the following: market conditions; our capital position;
our ability to compete with larger, better financed pharmaceutical and
biotechnology companies; new approaches to the treatment of our targeted
diseases such as Multiple Sclerosis (MS); our expectation of incurring
continued losses; our uncertainty of developing a marketable product; our
ability to raise additional capital to continue our development programs
(including to undertake and complete any ongoing or further clinical studies
for Tcelna or clinical studies related to our T-cell platform); our ability to
maintain compliance with NASDAQ listing standards; the success of our clinical
trials (including the Phase IIb trial for Tcelna in secondary progressive MS
which, depending upon results, may determine whether Ares Trading SA (Merck),
a wholly owned subsidiary of Merck Serono S.A., elects to exercise its option
(Option) to acquire an exclusive, worldwide (excluding Japan) license of our
Tcelna program for the treatment of MS); whether Merck exercises its Option
and, if so, whether we receive any development or commercialization milestone
payments or royalties from Merck pursuant to the Option; our dependence (if
Merck exercises its Option) on the resources and abilities of Merck for the
further development of Tcelna; the efficacy of Tcelna for any particular
indication, such as for relapsing remitting MS or secondary progressive MS;
our ability to develop and commercialize products; our ability to obtain
required regulatory approvals; our compliance with all Food and Drug
Administration regulations; our ability to obtain, maintain and protect
intellectual property rights (including for Tcelna and future pipeline
candidates); the risk of litigation regarding our intellectual property rights
or the rights of third parties; the success of third party development and
commercialization efforts with respect to products covered by intellectual
property rights that we may license or transfer; our limited manufacturing
capabilities; our dependence on third-party suppliers and manufacturers; our
ability to hire and retain skilled personnel; our volatile stock price; and
other risks detailed in our filings with the Securities and Exchange
Commission. These forward-looking statements speak only as of the date made.
We assume no obligation or undertaking to update or revise any forward-looking
statements contained herein to reflect any changes in its expectations with
regard thereto or any change in events, conditions or circumstances on which
any such statement is based. You should, however, review additional
disclosures we make in the reports we file with the SEC.

Contact:

Company Contact:
Karthik Radhakrishnan
Opexa Therapeutics, Inc.
Chief Financial Officer
281-775-0600
or
Investor Relations:
The Trout Group
Adam Cutler
646-378-2936
opexa@troutgroup.com
 
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