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Opexa Therapeutics Announces Changes to Senior Management Team



  Opexa Therapeutics Announces Changes to Senior Management Team

Business Wire

THE WOODLANDS, Texas -- April 01, 2013

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a leader in developing a patient
specific T-cell immunotherapy for multiple sclerosis (MS) is pleased to
announce the strengthening of its management team through the appointment of
several key individuals. Karthik Radhakrishnan has been appointed Chief
Financial Officer, Kenny Frazier has been appointed Vice President of Clinical
Development and Regulatory Affairs and Maryann Murray has been appointed as
Clinical Development Manager.

Mr. Radhakrishnan joins Opexa as CFO with over 10 years of healthcare capital
markets experience and most recently was a Vice President at ING Investment
Management in New York. While at ING, he was responsible for healthcare
investments in the small & small-mid cap core/growth products that are part of
the Fundamental Equity product line. Previously he was the senior analyst at
Eagle Asset Management, responsible for large cap growth healthcare. Prior to
this, Mr. Radhakrishnan started his financial career at The Dow Chemical
Company. Mr. Radhakrishnan is a CFA charterholder and has an MBA degree from
the University of Michigan, a Masters in Engineering from the State University
of New York and a Bachelors degree from the Indian Institute of Technology. He
replaces David Jorden, Opexa’s Acting CFO, who will continue to serve as a
Director of the Company.

Mr. Frazier joins as Vice President of Clinical Development and Regulatory
Affairs and was previously at Lexicon Pharmaceuticals, where he was a Senior
Director of Clinical Operations. At Lexicon, Mr. Frazier was responsible for
overseeing activities including project/program management, clinical research
monitoring, drug supply management, data management, biostatistics, clinical
trial associates, meeting planning and medical writing. His responsibilities
included worldwide management and conduct of all clinical trials across six
therapeutic areas. Previously he was Director of Clinical Operations at Tanox,
Inc. and was responsible for the management and conduct of Phase I-IV clinical
trials across all therapeutic disciplines. Prior to this he was Director of
Clinical Operations at DuPont Pharmaceuticals. Mr. Frazier has a Bachelor of
Science degree in Biology from Texas Tech University. Mr. Frazier replaces
Jaye L. Thompson, who has left the Company but will continue to serve in a
consulting capacity.

Ms. Murray joins Opexa as the Clinical Development Manager and was previously
at The University of Texas Health Science Center as a Research Coordinator.
She has many years experience as a Clinical Research Manager at several
neurology centers across Texas including the site that conducted Opexa’s Phase
I clinical studies with Tcelna. Ms. Murray has a Bachelor of Science degree in
Microbiology from Michigan State University.

“We are very pleased to be strengthening the Opexa team with such highly
qualified individuals,” commented Neil K. Warma, President and Chief Executive
Officer of Opexa. “Karthik’s financial expertise and understanding of the
investment environment will be a tremendous asset to help us realize the full
value of our clinical programs. He has a wealth of experience and a strong
network from which to draw, having spent several years in the center of New
York City’s investment hub. He and his family will be relocating to The
Woodlands area. We would also like to thank David for his recent oversight of
the finance function, and we look forward to his continued contribution on our
Board,” added Mr. Warma.

“It is with great pleasure that I am joining Opexa at this value inflection
stage of its growth. Opexa is working towards providing the MS community an
elegant and safe patient-specific immunotherapy that is a badly needed option
in the treatment regimen toolkit. Present therapies are broadly
immunosuppressive while Tcelna is a targeted patient-specific approach to
regulate the immune system. As the CFO, my priority will be to help Opexa
unlock the promise behind Tcelna and the broader T-cell platform while
creating value for the shareholders,” commented Mr. Radhakrishnan.

“The addition of Kenny and Maryann is also very timely to Opexa as we are in
the ramp-up stage of the enrollment for our Phase IIb Abili-T clinical trial
in secondary progressive MS. Kenny brings extensive clinical expertise from
roles at Lexicon and Tanox where he was responsible for the execution of large
clinical trials in various stages and indications. We are happy to have
Maryann be part of the clinical team especially given her prior experience
with a principal investigator of Tcelna while it was in Phase I development.
We would also like to thank Jaye for her solid contributions over the past
several years in support of the development of Tcelna,” commented Mr. Warma.

“With the signing of the option and license agreement with Merck Serono in
February 2013 and recent additions to the management team, we believe Opexa is
well-positioned to execute on its clinical development strategy,” highlighted
Mr. Warma.

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 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.

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.

Contact:

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