Opexa Therapeutics Reports Year End 2012 Financial Results and Provides Corporate Update

  Opexa Therapeutics Reports Year End 2012 Financial Results and Provides
  Corporate Update

Business Wire

THE WOODLANDS, Texas -- March 28, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing a
novel T-cell therapy for multiple sclerosis (MS), today reported financial
results for the year ended December 31, 2012 and provided an overview of
recent corporate developments.

2012 and recent highlights include:

  *Clinical

       *Commenced a Phase IIb clinical study of Tcelna™ (imilecleucel-T) in
         patients with Secondary Progressive Multiple Sclerosis (SPMS). The
         randomized, double-blind, placebo controlled study is titled the
         “Abili-T” trial and will enroll 180 patients through approximately 30
         leading clinical sites in the U.S. and Canada;
       *Gained approval from Health Canada to expand the Abili-T clinical
         trial to include several renowned sites in Canada; and
       *Initiated a comprehensive Immune Monitoring Program to capture
         valuable information from the Abili-T trial, including the potential
         identification of biomarkers for SPMS and further understanding of
         the immunopathology of SPMS.

  *Financial/Operational

       *Closed a private offering of convertible secured notes and warrants
         to purchase common stock for gross proceeds of approximately $4.1
         million in July 2012;
       *Entered into two stock purchase agreements with Lincoln Park Capital
         Fund LLC in November 2012 in which Opexa may sell up to an aggregate
         of $16.5 million of shares of common stock to Lincoln Park subject to
         certain limitations and conditions over a 30-month period;
       *Executed a key strategic option and license agreement with Merck
         Serono in February 2013 for the development and commercialization of
         Tcelna in patients with MS. If Merck Serono exercises the licensing
         option, Merck would be solely responsible for funding development,
         regulatory and commercialization activities for Tcelna in MS.
         Potential milestone payments to Opexa if Tcelna is successfully
         commercialized could total $225 million. Additionally, Opexa is
         eligible to receive tiered royalties on commercial sales at rates
         ranging from 8% to 15% of annual net sales;
       *Raised $3.25 million of gross proceeds through a registered offering
         of common stock and warrants in February 2013; and
       *Strengthened our expertise in cell therapy through the hiring of
         several cell therapy experts in the areas of manufacturing, quality
         assurance, quality control and R&D.

“2012 was a transformative year for Opexa as we commenced the Abili-T clinical
trial for Tcelna in patients with SPMS,” commented Neil K. Warma, President
and Chief Executive Officer of Opexa. “The enthusiastic response from
physicians and patients alike to the Abili-T study has resulted in us being
able to sign on some of the leading institutions and physician practices
across the U.S. to enroll patients. We expect to further enhance our
enrollment with recently activated sites who serve large MS populations.
Overall, the Abili-T clinical study is expected to enroll 180 patients at
approximately 30 clinical sites and top-line data is expected during the first
half of 2016.”

“Our active strategic development discussions which progressed well in 2012
culminated with the signing of an option and license agreement with Merck
Serono in February 2013,” added Mr. Warma. “We are very pleased to have
entered into an option and license agreement with Merck Serono given their
long-term strategic commitment to, and existing franchise position in, the
field of multiple sclerosis.”

“The team at Opexa performed exceptionally well in 2012, hitting their key
target which was to get back into the clinic with the initiation of a well
designed MS clinical trial. Modifications and improvements to ImmPath^TM,
Tcelna’s manufacturing process, and to the clinical trial protocol were
submitted to the FDA in 2012. This enabled a smooth and uninterrupted
transition into the Abili-T trial. We had increased staff levels throughout
the first half of 2012 in anticipation of the trial’s start and now have a
very experienced group of people well qualified to manage the clinical
development of a personalized immune therapy,” continued Mr. Warma.

"As of December 31, 2012, our cash and cash equivalents totaled approximately
$592,000,” noted Mr. Warma. “Our monthly burn rate for the twelve months
ending December 2012 was approximately $830,000. During the first quarter of
2013, we raised approximately $9.5 million in additional capital through
financing transactions and the $5 million upfront payment from Merck Serono.
We will need to raise additional capital to fund our current business plan and
support our clinical trial operations. Based on our current burn rate, we
believe we have sufficient liquidity to support our current clinical trial
activities into the fourth quarter of 2013.”

Year Ended December 31, 2012 Financial Results

Opexa reported no commercial revenues in the year ended December 31, 2012 or
in the comparable prior-year period.

Research and development expenses were $6,318,476 for the year ended December
31, 2012, compared to $3,340,038 for the year ended December 31, 2011. The
increase in expenses was primarily due to increases in staff to conduct
increased development activities, the procurement and use of supplies used in
both our laboratory and product manufacturing operations, the engagement of
consultants, the costs of subject participation in our Phase IIb clinical
study, facilities costs and stock compensation expense, and was partially
offset by a decrease in legal costs.

General and administrative expenses were $2,508,541 for the year ended
December 31, 2012, as compared to $2,406,269 for the year ended December 31,
2011. The increase in expense is due to increases in legal expense, capital
financing activities, stock compensation expense and facilities costs, and was
partially offset by a reduction in professional service fees.

Depreciation and amortization expenses were $303,677 for the year ended
December 31, 2012, as compared to $210,252 for the year ended December 31,
2011. The increase in expense is due to an increase in depreciation for
facility build-out costs incurred during the first half of 2011, an increase
in depreciation for laboratory and manufacturing equipment acquired during
2011 and 2012 to support increased development activities and an increase in
depreciation for information technology equipment to replace and upgrade
obsolete equipment.

Interest expense was $350,300 for the year ended December 31, 2012, compared
to $3,135 for the year ended December 31, 2011. The increase in interest
expense was primarily related to the non-cash amortized debt discount and
interest on the July 25, 2012 convertible notes and the amortization of the
financing fees over the life of the notes. Interest expense for the year ended
December 31, 2011 related solely to the financing costs on insurance policies
and the loan payable on an equipment line.

Opexa reported a net loss for the year ended December 31, 2012 of $8,930,833,
or $1.54 per share (basic and diluted), compared with a net loss of
$5,968,448, or $1.06 per share (basic and diluted), for the year ended
December 31, 2011. The increase in net loss is primarily due to increases in
research and development, general and administrative, depreciation and
interest expenses.

Cash and cash equivalents were $592,004 as of December 31, 2012 compared to
$7,109,215 as of December 31, 2011. Our financing activities generated
approximately $4.0 million in net proceeds for the year ended December 31,
2012.

For additional information please see Opexa’s Annual Report on Form 10-K filed
today with the SEC.

About Multiple Sclerosis (MS)

MS 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.

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 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.

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.

                                                     
OPEXA THERAPEUTICS, INC.

(a development stage company)
             
Statements of Expenses Data:
                                        Twelve Months Ended

                                        December 31,
                                        2012               2011
Research and development                $ 6,318,476        $ 3,340,038
General and administrative                2,508,541          2,406,269
Depreciation and amortization             303,677            210,252
Loss on disposal of assets               3,097            9,686      
             Operating loss               (9,133,791 )       (5,966,245 )
                                                           
Interest income                           280                932
Gain on derivative instruments            552,978            -
Interest expense                         (350,300   )      (3,135     )
             Net loss                   $ (8,930,833 )     $ (5,968,448 )
                                                           
Basic and diluted loss per share        $ (1.54      )     $ (1.06      )
                                                           
Weighted average shares outstanding       5,785,372          5,633,124
                                                           
                                                           
                                                           
                                                           
Selected Balance Sheet Data:
                                        2012               2011
Cash and cash equivalents               $ 592,004          $ 7,109,215
Other current assets                      1,077,546          124,773
Fixed assets, net                         1,265,041          1,029,236
Restricted cash                           1,000,000          -
Deferred financing costs, net             211,479            -
Total assets                              4,146,070          8,263,224
Total current liabilities                 885,975            1,067,860
Total long term liabilities               376,763            -
Total stockholders' equity                2,883,332          7,195,364

Contact:

Company 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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