Opexa Therapeutics Reports Third Quarter 2008 Financial Results

THE WOODLANDS, Texas--(Business Wire)--
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company dedicated to the
development of patient-specific cellular therapies for the treatment
of autoimmune diseases such as multiple sclerosis (MS) and diabetes,
today reported financial results for the quarter ended September 30,
2008, and provided an update on its recent accomplishments.

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Recent Highlights:

-- Completed first-in-class Phase IIb TERMS (Tovaxin(R) for Early
Relapsing Multiple Sclerosis) clinical study evaluating Tovaxin, a
novel patient-specific treatment for MS. Top-line findings, which
were reported in September 2008 at the World Congress on Treatment
and Research in Multiple Sclerosis include:

-- Annualized relapse rate (ARR) of 0.214 for patients treated
with Tovaxin, which compares favorably to the lowest ARRs
reported in studies of any MS therapy on the market or in
development.

-- Excellent safety with no serious adverse events attributed to
Tovaxin.

-- Additional data analysis, which focused on patients with the
most active disease (prospectively defined ARR greater than 1
population) provided the following findings:

-- Tovaxin-treated patients experienced a statistically
significant improvement in disability as measured by the
Expanded Disability Status Scale (EDSS) (p=0.045) as compared
to placebo.

-- Tovaxin-treated patients experienced an improvement in brain
atrophy and in the number of Gadolinium enhanced (Gd) lesions
as well as in T-2 lesion volumes, as compared to patients
receiving placebo.

-- Tovaxin-treated patients had less T-cell reactivity and
experienced fewer relapses as compared to patients on placebo
suggesting that Tovaxin may lower the risk of relapse for
patients in this population.

-- Completed enrollment of one-year open label extension study of
Tovaxin. Approximately 90 percent of patients in the Phase IIb
TERMS study elected to participate.

-- Completed a private placement financing with gross proceeds of
approximately $3 million.
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"Opexa's Phase IIb TERMS study provided important data which
highlighted Tovaxin's potential therapeutic benefit to those patients
suffering with more active disease and most in need of treatment,"
commented Neil K. Warma, president and chief executive officer of
Opexa. "Earlier today, we were pleased to report Tovaxin's positive
results with the prospectively defined ARR greater than 1 population
as evidenced by a statistically significant reduction in disability,
improvements with respect to brain atrophy and lesions, and an
important reduction in T-cell reactivity. Previously, we reported that
Tovaxin demonstrated a reduction in ARR to levels on par with the most
efficacious currently available MS treatments, as well as an
impressive safety and tolerability profile. We are aggressively
pursuing the ongoing interest of potential strategic partners to
further advance this innovative therapy."

Third Quarter Financial Results

Opexa recorded no revenues for the three months ended September
30, 2008 or in the comparable prior-year period.

Research and development expenses were approximately $2.4 million
for the three months ended September 30, 2008, compared to
approximately $3.2 million for the three months ended September 30,
2007. The decrease in expenses was primarily due to a wind down of
costs of conducting the Phase IIb clinical trial for Tovaxin recorded
in 2008 offset in part by costs associated with enrollment of the
one-year Phase IIb extension study of Tovaxin.

General and administrative expenses were approximately $0.7
million for the three months ended September 30, 2008, as compared to
approximately $0.8 million for the three months ended September 30,
2007. The decrease in expenses is primarily due to a decrease in stock
compensation expense in the current period.

Opexa reported a net loss for the three months ended September 30,
2008, of approximately $3.1 million, or $0.28 per share, compared with
a net loss of approximately $2.4 million, or $0.35 per share, for the
three months ended September 30, 2007.

The company had cash and cash equivalents of approximately $4.0
million as of September 30, 2008, compared with approximately $2.6
million as of December 31, 2007.

Year-to-Date Financial Results

Opexa reported no revenues in the nine months ended September 30,
2008, or in the comparable prior-year period.

Research and development expenses were approximately $7.1 million
for the nine months ended September 30, 2008, compared to
approximately $10.1 million for the nine months ended September 30,
2007. The decrease in expenses was primarily due to a decrease in
activities related to the Phase IIb clinical trial for Tovaxin in 2008
as compared to 2007 and a reduction in stock compensation expense
recorded in 2008.

General and administrative expenses were approximately $2.7
million for the nine months ended September 30, 2008, as compared to
approximately $2.6 million for the nine months ended September 30,
2007. The increase in expenses is primarily due to an increase in
stock compensation expense during the current period.

Opexa reported a net loss for the nine months ended September 30,
2008, of approximately $9.9 million, or $0.99 per share, compared with
a net loss of approximately $10.8 million, or $1.62 per share, for the
nine months ended September 30, 2007.

Conference Call Information

Opexa will host a conference call on Thursday, October 23, 2008,
at 8:30 a.m. Eastern Time to discuss the company's third quarter
results and recent clinical developments.

The conference call can be accessed by dialing (800) 230-1092 from
the U.S. and (651) 291-0618 internationally. Additionally a live
webcast of the call will be available on Opexa's web site at
www.opexatherapeutics.com. The webcast will be archived until November
22, 2008.

Additionally, a replay of the conference call can be accessed
until October 30, 2008, at 11:59 p.m., by dialing (800) 475-6701 from
the U.S. and (320) 365-3844 internationally, and entering the
following access code: 965022.

About Opexa Therapeutics

Opexa Therapeutics is a biotechnology company dedicated to the
development of patient-specific cellular therapies for the treatment
of autoimmune diseases. The company's leading therapies currently in
development have the potential to address significant unmet medical
needs in several large patient populations including multiple
sclerosis (MS) and diabetes. The company's lead product is Tovaxin, a
T-cell therapy for MS which recently completed a Phase IIb trial. The
company also holds an exclusive worldwide license for adult
multi-potent stem cells derived from mononuclear cells of peripheral
blood. The technology provides means to differentiate these stem cells
into other tissue types such as pancreatic islets. By using an
individual's own cells, this approach may minimize threat of treatment
rejection. This technology serves as the basis for Opexa's preclinical
diabetes program, which is focused on the generation of
insulin-secreting pancreatic-like cells. 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 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 current or future financial performance and
position, management's strategy, plans and objectives for future
operations, plans and objectives for product development, plans and
objectives for present and future clinical trials and results of such
trials, plans and objectives for regulatory approval, litigation,
intellectual property, product development, manufacturing plans and
performance, 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, including, without limitation, risks
associated with: the success of collaborative relationships, 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 treatment development programs, the
success of our clinical trials, 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 for our products, the risk of litigation regarding our
intellectual property rights, our limited manufacturing capabilities,
our dependence on third-party manufacturers and value added resellers,
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. We assume no obligation to update any
forward-looking information contained in this press release or with
respect to the announcements described herein.

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OPEXA THERAPEUTICS, INC.
(a development stage company)
Financial Highlights
(Unaudited)

Statements of Three Months Ended Nine Months Ended
Expenses Data: September 30, September 30,
2008 2007 2008 2007
------------- ------------------------- -------------
Research &
development $ 2,429,258 $ 3,189,256 $ 7,134,786 $ 10,148,930
General and
Administrative 660,814 842,079 2,668,511 2,557,609
Depreciation 58,826 50,446 175,896 149,371
Loss on disposal
of assets -- -- 116 4,034
------------- ------------ ------------ -------------

Operating
loss (3,148,898) (4,081,781) (9,979,309) (12,859,944)

Interest Income 23,681 102,292 92,885 423,086
Other income and
expense, net -- 1,612,440 34,901 1,612,440
Interest expense (4,553) (4,731) (15,573) (10,875)
------------- ------------ ------------ -------------

Net loss $(3,129,770) $(2,371,780) $(9,867,096) $(10,835,293)
============= ============ ============ =============

Basic and
diluted loss
per share $ (0.28) $ (0.35) $ (0.99) $ (1.62)

Weighted average
shares
outstanding 11,370,527 6,696,784 9,977,831 6,696,784

Selected Balance September 30, December 31,
Sheet Data: 2008 2007
------------- ------------
Cash and cash
equivalents $ 4,044,082 $ 2,645,482
Other current
assets 180,240 355,266
Fixed assets
(net) 1,225,905 1,370,647
Total assets 5,450,227 4,371,395
Total current
liabilities 2,068,712 2,075,354
Total long term
liabilities 116,131 162,456
Total
stockholders'
equity 3,265,384 2,133,585
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Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Vida Communication
Stephanie Diaz, 415-675-7400 (Investors)
sdiaz@vidacommunication.com
Tim Brons, 415-675-7400 (Media)
tbrons@vidacommunication.com

Copyright Business Wire 2008