Exhibit 99.1
Opexa
Therapeutics Reports First Quarter 2014 Financial Results and Provides
Corporate Update
THE WOODLANDS, Texas--(BUSINESS WIRE)--May 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 first quarter ended March 31, 2014 and provided an overview of
the Company’s recent corporate developments.
Recent highlights include:
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Clinical
-
As of May 13, 2014, Opexa reached the targeted enrollment of 180
patients in the Phase IIb “Abili-T” clinical study of Tcelna
(imilecleucel-T) in patients with Secondary Progressive Multiple
Sclerosis. The Abili-T clinical trial is a randomized,
double-blind, placebo-controlled study at approximately 35 leading
clinical sites in the U.S. and Canada.
-
The Company will also allow patients who are currently in the
screening process to enroll in the Abili-T clinical study should
they meet the trial’s entry criteria. The Company expects to
report the top-line results of the Abili-T clinical study in
mid-2016.
-
Operations
-
In March, Opexa appointed two highly experienced individuals to
join the Company’s Board of Directors - Hans-Peter Hartung, M.D.,
Ph.D., FRCP, a world leading clinician and expert in the treatment
of Multiple Sclerosis and other neurological diseases, and Timothy
Barabe, a proven CFO with global operational and financial
expertise.
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Financial
-
Reported cash and cash equivalents of $19,659,525 as of March 31,
2014.
-
Opexa believes it has sufficient liquidity to support its current
clinical activities for the Abili-T trial and general operations
to sustain the Company and support such trial into the fourth
quarter of 2015.
“Reaching our clinical trial enrollment target of 180 patients in the
Phase IIb Abili-T trial in Secondary Progressive Multiple Sclerosis
represents an important milestone in the development of our personalized
immunotherapy for this unmet medical need,” said Neil K. Warma, Opexa’s
President and Chief Executive Officer. “MS patients are in dire need of
a product to treat the progressive form of the disease. With so few
treatment options for Secondary Progressive MS patients, we remain
committed in our efforts to develop Tcelna for this patient group.”
During the first quarter of 2014, Hans-Peter Hartung and Tim Barabe
joined Opexa’s Board of Directors. They bring with them deep experience
in the areas of clinical development, neurology, finance and operations.
As of March 31, 2014, Opexa’s cash and cash equivalents totaled
approximately $19.7 million and our monthly burn rate for the three
months ending March 2014 was approximately $1.3 million. Based on the
cash position, the Company 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.
First Quarter Financial Results
Opexa reported revenue of $348,837 for the three months ended March 31,
2014, compared to $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 entered into between Opexa and Merck Serono
during February 2013.
Research and development expenses were $2,811,139 for the three months
ended March 31, 2014, compared with $1,621,366 for the three months
ended March 31, 2013. The increase in expenses is primarily due to
increased costs in connection with the enrollment of patients for the
ongoing clinical trial of Tcelna in Secondary Progressive Multiple
Sclerosis, the procurement and use of supplies for product manufacturing
and development, the number of employees to support the ongoing clinical
trial and stock compensation expense.
General and administrative expenses for the three months ended March 31,
2014 were $1,102,880, compared with $1,102,435 for the three months
ended March 31, 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.
Depreciation and amortization expenses for the three months ended March
31, 2014 were $95,586, compared with $78,311 for the three months ended
March 31, 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.
Interest expense of $1,635,254 for the three months ended March 31, 2013
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. No interest expense was
recorded for the three months ended March 31, 2014.
Opexa reported a net loss for the three months ended March 31, 2014 of
approximately $3.7 million, or $0.13 loss per share (basic and diluted),
compared with a net loss of approximately $4.2 million or $0.58 loss per
share (basic and diluted) for the three months ended March 31, 2013. The
decrease in net loss is primarily due to a decrease in interest expense
and an increase in revenue, and was partially offset by increases in
research and development, general and administrative and depreciation
costs.
Cash and cash equivalents were $19,659,525 as of March 31, 2014,
compared to $23,644,542 as of December 31, 2013.
For additional information please see Opexa’s Quarterly Report on Form
10-Q filed today with the SEC.
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 Time
today. To participate in the conference call, dial in approximately ten
minutes before the scheduled 5:00 p.m. time to (253) 237-1170 or toll
free at (877) 372-0867. Please reference conference ID 44945084 or the
Opexa Therapeutics Earnings Call.
A live webcast of the call can also be accessed via the webcast link 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. 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.
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 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 whether Ares Trading SA (Merck), a wholly owned
subsidiary of Merck Serono S.A., elects to exercise its option (Option)
to acquire an exclusive, worldwide (excluding Japan) 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 all Food and Drug
Administration regulations; 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 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 our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed
with the SEC.
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OPEXA THERAPEUTICS, INC.
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(a development stage company)
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Statements of Operations Data:
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Three Months Ended
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March 31,
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2014
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2013
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Option revenue
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$
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348,837
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$
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220,100
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Research and development
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2,811,139
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1,621,366
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General and administrative
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1,102,880
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1,102,435
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Depreciation and amortization
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95,586
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78,311
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Operating loss
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(3,660,768
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)
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(2,582,012
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)
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Interest income
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5,194
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1,874
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Other income and expense, net
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-
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37,910
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Interest expense
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-
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(1,635,254
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)
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Net loss
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$
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(3,655,574
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)
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$
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(4,177,482
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)
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Basic and diluted loss per share
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$
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(0.13
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)
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$
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(0.58
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)
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Weighted average shares outstanding
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27,584,615
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7,239,102
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Selected Balance Sheet Data:
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March 31,
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December 31,
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2014
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2013
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Cash and cash equivalents
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$
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19,659,525
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$
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23,644,542
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Other current assets
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1,565,648
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1,122,576
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Fixed assets, net
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1,289,623
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1,295,024
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Other long-term assets
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166,649
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177,666
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Total assets
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22,681,445
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26,239,808
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Total current liabilities
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3,339,334
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3,324,493
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Deferred revenue, net of current portion
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1,989,204
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2,338,041
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Total stockholders' equity
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17,352,907
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20,577,274
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CONTACT:
Company Contact:
Karthik Radhakrishnan
Opexa
Therapeutics, Inc.
Chief Financial Officer
281-775-0600
or
Investor
Relations:
The Trout Group
Adam Cutler
646-378-2936
opexa@troutgroup.com
Forward-Looking
Statements This earnings presentation 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 whether Ares
Trading SA (Merck), a wholly owned subsidiary of Merck Serono S.A.,
elects to exercise its option (Option) to acquire an exclusive,
worldwide (excluding Japan) 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 all Food and
Drug Administration regulations; 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 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 our Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q , and Current Reports on Form 8-K filed
with the SEC. 2
Opexa’s Mission To
lead the field of Precision ImmunotherapyTM by aligning the interests of
patients, employees and shareholders. 3
Abili-T : Phase IIb
clinical trial Enrollment Target Reached FDA Fast Track Designation
Secondary Progressive MS patients only Status –Enrolment target reached:
180 patients Patients currently in screening process still eligible to
enroll Design –Double-blind, 1:1 randomized, placebo-controlled –Trial
fully enrolled at 180 patients –Approximately 35 clinical sites in USA
and Canada –Two annual courses of personalized therapy Key Endpoints
–Whole-brain atrophy –Sustained progression measured by EDSS –Time to
sustained progression Timing −Top-line data expected mid-2016 4
5 Income Statement
Q1 2014 Q1 2013 Option Revenue $0.35 MM $0.22 MM Research & Development
$2.8 MM $1.6 MM General & Administrative $1.1 MM $1.1 MM Depreciation &
Amortization $0.1 MM $0.1 MM Operating Loss $3.7 MM $2.6 MM Interest
Expense - $1.6 MM Net Loss $3.7 MM $4.2 MM Basic and Diluted Loss per
Share $(0.13) $(0.58)
Investment Thesis
T-cell platform company with Fast Track designation in SPMS Strong
Intellectual property with 50 issued patents (domestic and
international) Esteemed Scientific Advisory Board Precision
Immunotherapy potentially optimizes benefit-risk profile Targeting an
unmet medical need in a potentially substantial market Option Agreement
with Merck Serono, a strong potential commercial partner Replacement
value of Company is multiples of present market cap Attractive potential
risk-reward profile for long term/value investors Goal-oriented
management team focused on value creation 7