Opexa Therapeutics Reports First Quarter 2013 Financial Results and Provides
THE WOODLANDS, Texas -- May 14, 2013
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a leader in developing a patient
specific T-cell immunotherapy for multiple sclerosis (MS), today reported
financial results for the quarter ended March 31, 2013 and provided an
overview of recent corporate developments.
“Opexa executed on its key strategic initiative through the signing of an
Option and License Agreement with Merck Serono in February 2013,” commented
Neil K. Warma. “Given Merck Serono’s long-term strategic commitment to, and
existing franchise position in, the field of multiple sclerosis, I am very
pleased to enter into this option and license agreement and believe that the
continued development of Tcelna™ in Secondary Progressive Multiple Sclerosis
(SPMS) will be enhanced,” added Mr. Warma.
Recent highlights include:
*Enrolled 48 patients as of April 30, 2013 in the Phase IIb ‘Abili-T’
clinical study of Tcelna™ (imilecleucel-T) in patients with SPMS. The
Abili-T clinical trial is a randomized, double-blind, placebo controlled
study that is expected to enroll 180 patients through approximately 30
leading clinical sites in the U.S. and Canada.
*Initiated an immune monitoring program on a blinded basis to gather
comprehensive biomarker data for patients in conjunction with the Abili-T
trial. The goal of the program is the potential identification of
biomarkers for SPMS and further understanding of the immunopathology of
*Opexa reported revenue of $220,100 for the three months ended March 31,
2013. The revenue is related to the recognized portion of the $5 million
upfront payment received from Merck Serono in conjunction with the Option
and License Agreement. No revenues were recognized during the three months
ended March 31, 2012.
*Potential milestone payments to Opexa if Tcelna is successfully
commercialized, aggregated with the upfront payment of $5 million and an
option exercise fee of up to $25 million, could total up to $225 million.
Additionally, Opexa is eligible to receive tiered royalties on commercial
sales at rates ranging from 8% to 15% of annual net sales.
*Opexa reported research and development expenses of $1,621,366 for the
three months ended March 31, 2013, compared to $1,490,097 for the three
months ended March 31, 2012.
*General and administrative expenses were $1,102,435 for the three months
ended March 31, 2013, as compared to $816,196 for the three months ended
March 31, 2012.
*Interest expense was $1,635,254 for the three months ended March 31, 2013,
compared to $487 for the three months ended March 31, 2012. The increase
in interest expense was primarily related to the amortized debt discount
and interest on both the July 25, 2012 convertible secured promissory
notes and the January 23, 2013 convertible promissory notes and the
amortization of the financing fees over the life of the notes. Interest
expense for the three months ended March 31, 2012 related solely to the
financing of insurance premiums.
*Other income of $37,910 for the three months ended March 31, 2013 was
related to the extinguishment of membership interests in the mutual
insurance company that we participated in for our product liability
insurance through January 1, 2013. We recorded no other income for the
three months ended March 31, 2012.
*Opexa reported a net loss for the three months ended March 31, 2013 of
$4,177,482, or $0.58 per share, compared with a net loss of $2,373,999, or
$0.41 per share for the three months ended March 31, 2012.
*Raised $3.25 million of gross proceeds through a registered offering of
common stock and warrants in February 2013 following the execution of the
Option and License Agreement with Merck Serono.
*Sold an aggregate of 167,618 shares of common stock under the
at-the-market (ATM) agreement with Brinson Patrick Securities Corporation
for gross proceeds of $536,417.
*Closed a private offering of convertible notes and warrants to purchase
common stock for gross proceeds of approximately $650,000 in January 2013.
The note offering provided a cash bridge in order to complete the Option
and License Agreement with Merck Serono. In February 2013, Opexa repaid
$550,000 of the notes and converted a $100,000 note into shares of common
*Raised an aggregate of $142,400 gross proceeds through the sale of 125,000
shares of common stock to Lincoln Park Capital Fund, LLC under the $1.5
million purchase agreement.
*Cash and cash equivalents were $7,834,336 as of March 31, 2013.
For additional information please see Opexa’s Quarterly Report on Form 10-Q
filed today with the SEC.
*Appointed Karthik Radhakrishnan, previously Vice President at ING
Investment Management, as Chief Financial Officer.
*Appointed Donna R. Rill, previously Opexa’s Senior Vice President of
Operations and Quality Systems, as Chief Development Officer.
*Appointed Don Healey, previously Opexa’s Vice President of Manufacturing
and Scientific Development, as Chief Scientific Officer.
*Strengthened the senior management team with the appointment of Kenny
Frazier, previously Head of Clinical Operations at Lexicon
Pharmaceuticals, as Vice President of Clinical Development and Regulatory
Conference Call and Webcast Information:
Opexa will conduct a conference call and webcast to provide a corporate update
and discuss the financial results at 8 A.M. Eastern Time. To participate in
the conference call, dial in approximately ten minutes before the scheduled
8:00 A.M. time to (253) 237-1170 or toll free at (877) 372-0867. Please
reference conference ID # 70924987 while dialing into the call. A live webcast
of the call can also be accessed via the webcast link on our website
(www.opexatherapeutics.com) or by going to the following URL:
Opexa’s mission is to lead the field of Precision Immunotherapy^TM 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 Multiple Sclerosis. 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.
For more information visit the Opexa Therapeutics website at
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 over a 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.
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.
Cautionary Statement Relating to Forward-Looking Information for the Purpose
of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of
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 report, 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 report 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 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 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
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 Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K
filed with the SEC.
OPEXA THERAPEUTICS, INC.
(a development stage company)
Statements of Operations Data:
Three Months Ended
Option revenue $ 220,100 $ -
Research and development 1,621,366 1,490,097
General and administrative 1,102,435 816,196
Depreciation and amortization 78,311 67,355
Operating loss (2,582,012 ) (2,373,648 )
Interest income 1,874 136
Other income and expense, net 37,910 -
Interest expense (1,635,254 ) (487 )
Net loss $ (4,177,482 ) $ (2,373,999 )
Basic and diluted loss per share $ (0.58 ) $ (0.41 )
Weighted average shares outstanding 7,239,102 5,762,028
Selected Balance Sheet Data:
March 31, December 31,
Cash and cash equivalents $ 7,834,336 $ 592,004
Other current assets 1,166,430 1,077,546
Fixed assets, net 1,189,328 1,265,041
Restricted cash 500,000 1,000,000
Deferred financing costs, net 158,540 211,479
Other long-term assets 104,027 -
Total assets 10,952,661 4,146,070
Total current liabilities 3,157,125 885,975
Notes payable, net 376,627 376,763
Deferred revenue 3,384,552 -
Total stockholders' equity 4,034,357 2,883,332
Opexa Therapeutics, Inc.
Chief Financial Officer
The Trout Group
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