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

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

Business Wire

THE WOODLANDS, Texas -- August 13, 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 closing of the previously announced
underwritten public offering of 12,000,000 shares of its common stock at a
price to the public of $1.50 per share. The gross proceeds to Opexa from this
offering were $18 million, before deducting underwriting discounts and
commissions and other estimated offering expenses. All of the shares in the
offering were sold by Opexa. Opexa has also granted the underwriters a 30-day
option to purchase up to an additional 1,800,000 shares of common stock to
cover over-allotments, if any.

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. acted as sole book-running manager for the offering.

A registration statement relating to these securities was declared effective
by the Securities and Exchange Commission on August 7, 2013. The offering was
made only by means of a prospectus. Copies of the prospectus relating to the
offering are available on the SEC’s website at http://www.sec.gov. Copies of
the prospectus may also be obtained from the offices of Aegis Capital Corp.,
Prospectus Department, 810 Seventh Avenue, 18^th Floor, New York, NY, 10019,
via telephone at (212) 813-1010, or via email at prospectus@aegiscap.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 is not permitted.

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 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
(“Lincoln Park”) (such as the minimum closing price for our common stock and
the requirement for an ongoing trading market for our stock); our ability to
raise additional capital through the sale of shares of our common stock under
the purchase agreements with Lincoln Park or under our at-the-market (ATM)
facility; 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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