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Opexa Therapeutics to Present at the Regenerative Medicine - A Fundamental Shift in Science & Culture Conference

  Opexa Therapeutics to Present at the Regenerative Medicine - A Fundamental
  Shift in Science & Culture Conference

Business Wire

THE WOODLANDS, Texas -- April 04, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing
Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced
that Neil K. Warma, President and Chief Executive Officer, will present at The
Second International Vatican Adult Stem Cell Conference: Regenerative Medicine
— A Fundamental Shift in Science & Culture, taking place from within The
Vatican, April 11-13, 2013.

The conference is part of a five-year collaboration between The Stem for Life
Foundation, a not-for-profit organization devoted to raising global awareness
of the therapeutic potential of adult stem cells, NeoStem, a leader in the
emerging cellular therapy industry and The Vatican's Pontifical Council for
Culture and its foundation, called STOQ International (Science, Theology and
the Ontological Quest). Among the conference goals are to raise awareness of
existing therapies, reduce misperceptions surrounding the field of cellular
research and to foster dialogue among researchers, physicians,
philanthropists, faith leaders and policy makers to identify unmet medical
needs that can benefit from the development of cell therapies.

“Opexa is proud to be a part of this international forum designed to highlight
the important contributions made by the cell therapy industry to date and to
increase awareness of cellular research and the potential of cell therapies to
address unmet medical needs,” commented Neil K. Warma, President and Chief
Executive Officer of Opexa.

Opexa will be included in a special luncheon, Living with Multiple Sclerosis,
featuring Meredith Vieira from NBC news and Richard M. Cohen, journalist and
husband of Ms. Vieira.

About Tcelna

Tcelna is a personalized therapy that is 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, attenuated
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 believes the potential combination of efficacy, superior
safety, excellent tolerability and administration may position Tcelna as the
MS treatment of choice as compared to existing therapeutics.

About Opexa

Opexa is dedicated to the development of patient-specific cellular therapies
for the treatment of autoimmune diseases such as MS. The Company’s leading
therapy candidate, Tcelna™, is a personalized cellular immunotherapy that is
in Phase IIb clinical development for MS. Tcelna is derived from T-cells
isolated from peripheral blood, expanded ex vivo, and reintroduced into the
patients via subcutaneous injections. This process triggers a potent immune
response against specific subsets of autoreactive T-cells known to attack
myelin.

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.
The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,”
“intends,” and similar expressions are intended to identify forward-looking
statements. The forward-looking statements in this release do not constitute
guarantees of future performance. Investors are cautioned that statements in
this press release which are not strictly historical statements, including,
without limitation, statements regarding the development of the Company’s
product candidate, Tcelna (imilecleucel-T), 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, but are not limited
to, risks associated with: market conditions; our capital position; the rights
and preferences provided to the Series A convertible preferred stock and
investors in the convertible secured notes we issued in July 2012 (including a
secured interest in all of our assets); our ability to compete with larger,
better financed pharmaceutical and biotechnology companies; new approaches to
the treatment of our targeted diseases; 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),
including in this regard our ability to satisfy various conditions required to
access the financing potentially available under the purchase agreements with
Lincoln Park Capital Fund, LLC (such as the minimum closing price for our
common stock, the registration of the underlying shares of common stock under
the Securities Act of 1933, as amended, and the requirement for an ongoing
trading market for our stock); our ability to regain and 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 Merck elects to exercise its Option);
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); 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 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 Securities and Exchange Commission.

Contact:

Neil K. Warma
Opexa Therapeutics, Inc.
President & CEO
281-775-0600
or
Investor Relations:
The Trout Group
Adam Cutler
646-378-2936
opexa@troutgroup.com
 
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