Opexa Therapeutics, Inc. Announces Pricing of Public Offering of Common Stock

  Opexa Therapeutics, Inc. Announces Pricing of Public Offering
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Business Wire

THE WOODLANDS, Texas -- August 7, 2013

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a biotechnology company developing
Tcelna®, a patient-specific T-cell immunotherapy for the treatment of multiple
sclerosis (MS), today announced the pricing of an underwritten public offering
of 12 million shares of its common stock at a price to the public of $1.50 per
share. The gross proceeds to Opexa from this offering are expected to be
approximately $18 million, before deducting underwriting discounts and
commissions and other estimated offering expenses. All of the shares in the
offering are to be sold by Opexa. Opexa has also granted the underwriters a
30-day option to purchase up to an additional 1.8 million shares of common
stock to cover over-allotments, if any. The offering is expected to close on
or about August 13, 2013, subject to customary closing conditions.

Opexa intends to use the net proceeds from the offering to fund further
clinical development of Tcelna in an ongoing Phase IIb clinical study of
patients with Secondary Progressive MS as well as the expenses of its
operations during such development and for general corporate purposes. Opexa
may also use a portion of the net proceeds to repay all or a portion of its
outstanding convertible secured promissory notes.

Aegis Capital Corp. is acting as sole book-running manager in this offering.

A registration statement on Form S-1 relating to these securities was declared
effective by the Securities and Exchange Commission on August 7, 2013. A
preliminary prospectus relating to and describing the terms of the offering
has been filed with the SEC and is available on the SEC’s website at
http://www.sec.gov. Copies of the preliminary prospectus may also be obtained
from the offices of Aegis Capital Corp., Prospectus Department, 810 Seventh
Avenue, 18th Floor, New York, NY, 10019, via telephone at (212) 813-1010, or
via email at prospectusaegiscap.com.

This press release does not constitute an offer to sell or the solicitation of
an offer to buy these securities, nor will there be any sale of these
securities in any state or other jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state or jurisdiction.

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 the
patient’s 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.

About Multiple Sclerosis (MS)

Multiple Sclerosis 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 expected to enroll 180 patients at
approximately 30 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 release, other than statements of historical
fact, constitute "forward-looking statements." 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 report
which are not strictly historical statements, including, without limitation,
statements regarding the intention to sell shares of common stock in an
underwritten public offering, to use a portion of the net proceeds to repay
outstanding convertible secured promissory notes and 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 and the requirement
for an ongoing trading market for our stock); 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”) elects
to exercise its option for an exclusive license to Tcelna for the treatment of
MS (the “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 SEC. These forward-looking statements speak
only as of the date made. We assume no obligation or undertaking to update any
forward-looking statements to reflect any changes in 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 our Registration Statement on Form S-1 declared effective by the SEC on
August 7, 2013, as well as in our Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, and Current Reports on Form 8-K filed with the SEC.

Contact:

Company Contact:
Opexa Therapeutics, Inc.
Karthik Radhakrishnan
281.775.0600
kradhakrishnan@opexatherapeutics.com
 
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