Opexa Therapeutics Reports Second Quarter 2014 Financial Results and Provides Corporate Update

  Opexa Therapeutics Reports Second Quarter 2014 Financial Results and
  Provides Corporate Update

Business Wire

THE WOODLANDS, Texas -- August 14, 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 reported financial results for the second
quarter endedJune 30, 2014and provided an overview of the Company’s recent
corporate developments.

Recent highlights include:

  *Clinical

       *Opexa reached the 180-patient targeted enrollment in the Phase IIb
         “Abili-T” clinical study of Tcelna (imilecleucel-T) in patients with
         Secondary Progressive Multiple Sclerosis as of May 13, 2014 and
         subsequently closed enrollment with a total of 190 patients
         randomized. The Abili-T clinical trial is a randomized, double-blind,
         placebo-controlled study at approximately 35 leading clinical sites
         in the U.S. andCanada. The Company expects to report top-line
         results during the second half of 2016.

  *Financial

       *Reported cash and cash equivalents of$16,214,690as ofJune 30,
         2014.
       *Based on the current clinical activities for the Abili-T trial, Opexa
         believes it has sufficient capital to support its current clinical
         activities for the Abili-T trial and general operations of the
         Company into the fourth quarter of 2015.

“We are pleased to close the first half of 2014 in a strong position to
continue developing Tcelna for the treatment of patients with Secondary
Progressive Multiple Sclerosis,” saidNeil K. Warma, Opexa’s President and
Chief Executive Officer. “Completion of enrollment in the Phase IIb Abili-T
trial during this past quarter represents an important milestone in the
development of our personalized immunotherapy for the Secondary Progressive MS
community. We remain committed to our goal in developing Tcelna for this
patient population.”

As ofJune 30, 2014, Opexa’s cash and cash equivalents totaled
approximately$16,214,690 and the Company’s monthly burn rate for the six
months endingJune 2014was approximately$1.2 million. Based on the current
clinical activities for the Abili-T trial, Opexa believes it has sufficient
liquidity to support its current clinical activities for the Abili-T trial and
general operations to sustain itself into the fourth quarter of 2015.

Second Quarter Financial Results

Opexa reported revenue of$307,686for the three months endedJune 30, 2014,
compared to$348,837for the three months endedJune 30, 2013. The revenue is
related to the recognized portion of the$5 millionupfront payment received
from Merck Serono in conjunction with the Option and License Agreement entered
into between Opexa and Merck Serono duringFebruary 2013.

Research and development expenses were$3,409,210 for the three months
endedJune 30, 2014, compared with $2,223,030 for the three months endedJune
30, 2013. The increase in expenses is primarily due to the increasing
enrollment of patients for the ongoing clinical trial of Tcelna in SPMS, an
increase in the procurement and use of supplies for product manufacturing and
development, and increases in the number of employees to support the ongoing
clinical trial, employee compensation expense and stock compensation expense.

General and administrative expenses for the three months endedJune 30,
2014were$967,367, compared with $750,605 for the three months endedJune 30,
2013. The increase in expense is due to increases in employee compensation and
stock compensation expenses, and was partially offset by decreases in legal
and professional fees related to financing activities.

Depreciation and amortization expenses for the three months endedJune 30,
2014were$98,658, compared with $88,898for the three months endedJune 30,
2013. The increase in expense is due to increases in depreciation for
laboratory, manufacturing and computer equipment acquired during 2013 and 2014
and leasehold improvements during 2013 and 2014 to support increased
development activities.

Opexa reported a net loss for the three months ended June 30, 2014 of
$4,163,259, or $0.15 loss per share (basic and diluted), compared with a net
loss of $2,996,430 or $0.37 loss per share (basic and diluted) for the three
months ended June 30, 2013. The increased net loss is primarily related to a
decrease in revenue and an increase in research and development expenses,
higher general and administrative expenses and higher depreciation expense for
the quarter ending June 30, 2014.

Cash and cash equivalents were$16,214,690as ofJune 30, 2014, compared
to$5,028,280as ofJune 30, 2013.

For additional information please see Opexa’s Quarterly Report on Form 10-Q
filed today with theSEC.

Conference Call and Webcast Details

Opexa will conduct a conference call and webcast to provide a corporate update
and discuss the financial results at 5:00 p.m. Eastern Timetoday. To
participate in the conference call, dial in approximately ten minutes before
the scheduled5:00 p.m.time to (253) 237-1170 or toll free at (877) 372-0867.
Please reference conference ID 81938581 or the Opexa Therapeutics Earnings
Call.

A live webcast of the call can also be accessed here or on the Investor
Relations page of Opexa’s website (www.opexatherapeutics.com).

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 being conducted at approximately 35 leading
clinical sites in the U.S. andCanada 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 theOpexa Therapeuticswebsite
atwww.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 earnings 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,” “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)), 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
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 whetherAres Trading SA (Merck), a wholly owned subsidiary ofMerck
Serono S.A., elects to exercise its option (Option) to acquire an exclusive,
worldwide (excludingJapan) 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 allFood and Drug Administrationregulations; 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
theSecurities 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 our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with
theSEC.

                                                 
OPEXA THERAPEUTICS, INC.
                                                                                   
Statement of
Operations
Data:
                  Three Months                      Six Months
                   Ended June 30,                    Ended June 30,                
                   2014           2013            2014           2013         
Revenue:
Option revenue     $ 307,686        $ 348,837        $ 656,523        $ 568,937
                                                                                   
Research and         3,409,210        2,223,030        6,220,349        3,844,396
development
General and          967,367          750,605          2,070,247        1,853,040
administrative
Depreciation
and                 98,658         88,898         194,244        167,209    
amortization
Operating loss       (4,167,549 )     (2,713,696 )     (7,828,317 )     (5,295,708 )
Interest             4,290            3,066            9,484            4,940
income
Other income,        -                -                -                37,910
net
Interest            -              (285,800   )    -              (1,921,054 )
expense
Net loss           $ (4,163,259 )   $ (2,996,430 )   $ (7,818,833 )   $ (7,173,912 )
                                                                                   
Basic and
diluted loss       $ (0.15      )   $ (0.37      )   $ (0.28      )   $ (0.94      )
per share
                                                                                   
Weighted
average shares
outstanding -        27,661,675       7,991,559        27,623,358       7,617,409
Basic and
diluted
                                                                                   

                                              
Selected Balance Sheet Data:
                                   June 30,          December 31,
                                   2014              2013
                                   (unaudited)
Cash and cash equivalents        $ 16,214,690      $ 23,644,542
Other current assets               1,481,526         1,122,576
Fixed assets, net                  1,234,826         1,295,024
Other long term assets             162,045           177,666
Total assets                       19,093,087        26,239,808
Total current liabilities          3,693,587         3,324,493
Deferred revenue                   1,846,120         2,338,041
Total stockholders’ equity         13,553,380        20,577,274

Contact:

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