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Exhibit
99.1
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Opexa Therapeutics Reports Second Quarter 2017 Financial Results
and Provides Corporate Update
THE WOODLANDS, Texas (August 14, 2017) - Opexa Therapeutics,
Inc. (NASDAQ: OPXA), a biopharmaceutical company developing
personalized immunotherapies for autoimmune disorders, today
reported financial results for the quarter ended June 30,
2017 and
provided an update on the Company’s recent corporate
developments.
“On
July 3rd,
we were pleased to announce the planned merger with Acer
Therapeutics,” said Neil K. Warma, President and Chief
Executive Officer of Opexa. “After a comprehensive evaluation
of strategic alternatives, Acer was selected based on their
technology and stage of development of their lead drug candidate.
Acer’s lead asset,
EDSIVO™, a potential life-saving therapy for patients with
vEDS could be on the market within the next two years, subject to
FDA approval. Opexa shareholders are expected to own
approximately 11.2% of the outstanding common shares in the
combined company. The proposed merger is expected to close
during the third quarter of 2017, subject to the approval of the
stockholders of Acer and the shareholders of
Opexa.”
Corporate Activities
●
On July 3, 2017,
Opexa Therapeutics, Inc.
and Acer Therapeutics Inc., a privately-held pharmaceutical
company, announced that they have entered into a definitive merger
agreement under which the stockholders of Acer (including investors
in a financing that will close concurrently with the merger) are
currently estimated to become holders of approximately 88.8% of
Opexa’s outstanding common stock on a pro forma basis, with
current Opexa shareholders expected to own the remaining 11.2%. The
proposed merger remains subject to certain conditions, including
approval by Opexa’s shareholders and Acer’s
stockholders. In conjunction with the proposed
merger, an
investor syndicate led by TVM Capital Life Sciences and comprised
of existing Acer investors and new investors has committed to
invest approximately $15.7 million in Acer (including through a
conversion of approximately $5.7 million in outstanding convertible
notes) immediately prior to closing of the proposed
merger.
Financial Results for the Quarter Ended June 30, 2017
Cash position. Cash and cash equivalents
were $1,824,355 as of June 30, 2017, compared to $3,444,952 as of
December 31, 2016.
Research and Development Expenses.
Research and development expenses were a credit of $796 for the
three months ended June 30, 2017, compared with $1,814,940 for the
three months ended June 30, 2016. The $796 credit balance was due
to receipt of a credit memo for $8,397 which more than offset the
total expenses of $7,601 for the three months ended June 30, 2017.
The decrease in expenses is primarily due to cost reductions in
connection with the winding down of the clinical trial of Tcelna in
SPMS, including our site expenses as well as additional expense
reduction due to a pause in NMO study development cost.
Additionally, expenses were further reduced due to the workforce
reductions over the past year.
General and Administrative Expenses.
General and administrative expenses were $678,660 for the three
months ended June 30, 2017, compared with $953,582 for the three
months ended June 30, 2016. The decrease in expenses is primarily
due to the workforce reduction over the past year as well as a
reduction in rent and property taxes. These reductions were
slightly offset by an increase in professional services and no
reallocation of general and administrative expenses to research and
development.
Net Loss. We had a net loss for the
three months ended June 30, 2017 of $678,192, or $0.09 loss per
share (basic and diluted), compared with a net loss of
approximately $2.1 million or $0.30 loss per share (basic and
diluted) for the three months ended June 30, 2016. The decrease in
net loss from June 30, 2016 to June 30, 2017 is due to the cost
reduction efforts taken over the last year. The reduction in both
general and administrative expenses as well as research and
development expenses, was offset by the completed term for revenue
recognition of the Option and License Agreement with Merck Serono
in December 2016.
For
additional information please see Opexa’s Quarterly Report on
Form 10-Q filed today with the SEC.
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
Statements contained in this news release, other than statements of
historical fact, constitute “forward-looking
statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. The words “expects,”
“believes,” “may,” “intends,”
“potential,” “should,” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements do not constitute guarantees of
future performance. Investors are cautioned that forward-looking
statements, including without limitation statements regarding the
structure, timing and completion of the proposed merger with Acer
and Acer’s concurrent financing, expectations regarding the
capitalization, resources and ownership structure of the combined
company, the potential for EDSIVO™ (celiprolol) to safely and
effectively target diseases, the adequacy of the combined
company’s capital to support its future operations and its
ability to successfully initiate and complete clinical trials, the
nature, strategy and focus of the combined company, the development
and commercial potential of any product candidates, the
expectations regarding voting by Opexa’s shareholders and
Acer’s stockholders, and the sufficiency of the
Company’s resources constitute forward-looking statements.
These forward-looking statements are based upon the Company’s
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, which include without limitation risks and
uncertainties associated with securityholder approval of and the
ability to consummate the proposed merger through the process being
conducted by Opexa and Acer, the ability to project future cash
utilization and reserves needed for contingent future liabilities
and business operations, the availability of sufficient resources
of the combined company to meet its business objectives and
operational requirements, the protection and market exclusivity
provided by Acer’s intellectual property, risks related to
the drug discovery and regulatory approval process and the impact
of competitive products and technological changes, the
Company’s continued listing on the NASDAQ Capital Market
until closing of the proposed merger, the Company’s ability
to raise additional capital to continue any of its development
programs and support its operations if the proposed merger is not
completed, whether the Company continues development of Tcelna,
OPX-212 or any of its other research and development programs, the
Company’s ability to reduce its operating expenses and
conserve cash, as well as other risks associated with the process
of discovering, developing and commercializing drug candidates that
are safe and effective for use as human therapeutics. These and
other risks are described in detail in the Company’s SEC
filings, including its Annual Report on Form 10-K for the year
ended December 31, 2016 and its Quarterly Report on Form 10-Q for
the quarter ended June 30, 2017. All forward-looking statements
contained in this report speak only as of the date on which they
were first made by the Company, and the Company undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after such date.
OPEXA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three
Months
Ended June
30,
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Six
Months
Ended June
30,
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2017
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2016
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2017
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2016
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Revenue:
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Option
revenue
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$-
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$726,291
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$-
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$1,452,582
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|
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Research and
development
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(796)
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1,814,940
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205,228
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3,644,002
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General and
administrative
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678,660
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953,582
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1,398,529
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1,940,830
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Depreciation and
amortization
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-
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65,653
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-
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138,242
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Operating
loss
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(677,864)
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(2,107,884)
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(1,603,757)
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(4,270,492)
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Interest income
(expense), net
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(302)
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414
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(1,148)
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522
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Other income
(expense), net
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(26)
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2,749
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441
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4,855
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Net
loss
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$(678,192)
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$(2,104,721)
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$(1,604,464)
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$(4,265,115)
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Basic and diluted
loss per share
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$(0.09)
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$(0.30)
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$(0.21)
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$(0.61)
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Weighted average
shares outstanding - Basic and diluted
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7,657,332
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6,995,686
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7,627,715
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6,989,298
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Selected Balance Sheet Data:
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June
30,
2017
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December
31,
2016
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(unaudited)
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Cash and cash
equivalents
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$1,824,355
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$3,444,952
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Other current
assets
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155,970
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371,562
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Fixed assets,
net
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--
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50,000
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Total
assets
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1,980,325
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3,866,514
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Total current
liabilities
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368,547
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1,160,488
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Total
stockholders’ equity
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1,611,778
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2,706,026
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Total liabilities
and stockholders’ equity
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1,980,325
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3,866,514
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Company Contact:
Neil K.
Warma
President
& CEO
Opexa
Therapeutics, Inc.
nwarma@opexatherapetics.com
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