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8-K - CURRENT REPORT - Acer Therapeutics Inc. | opxa_8k.htm |
Opexa Therapeutics Reports First Quarter 2017 Financial Results and
Provides Corporate Update
THE WOODLANDS, Texas (May 12, 2017) - Opexa Therapeutics,
Inc. (NASDAQ: OPXA), a biopharmaceutical company developing
personalized immunotherapies for autoimmune disorders, today
reported financial results for the quarter ended March 31,
2017, and
provided an update on the Company’s recent corporate
developments.
“The
first quarter saw us continuing with our analysis and progress of
identifying and advancing on strategic options for the Company,
following the announcement last quarter of disappointing results
from the Phase 2b clinical trial of our lead product candidate
Tcelna (imilecleucel-T) in patients with secondary progressive
multiple sclerosis (SPMS),” said Neil K. Warma, President and
Chief Executive Officer of Opexa. “We have been focused on
defining an appropriate path forward for the Company, as well as
managing our cash during this process. As previously reported, Opexa was able
to eliminate the liabilities for the ongoing operation of its
facility and equipment by assigning the facility and equipment
leases to KBI Biopharma in the first
quarter.”
Corporate Activities
●
On February 1,
2017, Opexa entered into an assignment and assumption of lease with
KBI Biopharma, Inc. for Opexa’s 10,200 square foot corporate
headquarters facility located in The Woodlands, Texas, and
a related assignment of a
lease on a major piece of equipment. Opexa also sold certain
furniture, fixtures and equipment, as well as its laboratory
supplies, located at its corporate headquarters to KBI for a lump
sum cash consideration.
●
On January 31,
2017, Opexa implemented a reduction of its workforce by terminating
the employment of seven full-time employees, incurring costs of
approximately $219,000 associated with this workforce
reduction.
●
In addition to
assessing strategic options, the Company is conducting a review of
its research and development programs other than Tcelna, including
its preclinical program for OPX-212 for the treatment of
neuromyelitis optica (NMO), to assess the viability of continuing
to pursue one or more of these programs.
Financial Results for the Quarter Ended March 31, 2017
●
Cash position: Cash and cash
equivalents were $2,822,677 as of March 31, 2017, compared to
$3,444,952 as of December 31, 2016.
●
R & D Expense: Research and
development expenses were $206,024 for the three months ended March
31, 2017, compared with $1,829,062 for the three months ended March
31, 2016. 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. The reduction in
expense was slightly offset by the severance accrual for our former
Chief Scientific Officer.
●
G & A Expense: General and
administrative expenses were $719,869 for the three months ended
March 31, 2017, compared with $987,248 for the three months ended
March 31, 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 March 31, 2017 of $926,272, or $0.12 loss per
share (basic and diluted), compared with a net loss of
approximately $2.2 million or $0.31 loss per share (basic and
diluted) for the three months ended March 31, 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
continued development of Tcelna or NMO or any other drug candidate
and the Company’s evaluation of its research and development
programs, the Company’s evaluation of various strategic
options or alternatives, the anticipated reduction in operating
expenses and cash conservation benefits associated with recent
workforce reductions, the elimination of future lease liabilities
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
the Company’s ability to raise additional capital to continue
any of its development programs and support its operations, 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 on a net
basis as a result of recent workforce reductions and other
cost-cutting measures that are
implemented, the
ability to obtain, maintain and protect intellectual property
rights (including for Tcelna and OPX-212), 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 March 31, 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
|
Three
Months
Ended
March 31,
|
|
|
|
|
|
|
|
|
2017
|
2016
|
Revenue:
|
|
|
Option
revenue
|
$—
|
$726,291
|
|
|
|
Research and
development
|
206,024
|
1,829,062
|
General and
administrative
|
719,869
|
987,248
|
Depreciation and
amortization
|
—
|
72,589
|
Operating
loss
|
(925,893)
|
(2,162,608)
|
Interest income
(expense), net
|
(846)
|
108
|
Other income
(expense), net
|
467
|
2,106
|
Net
loss
|
$(926,272)
|
$(2,160,394)
|
|
|
|
Basic and diluted
loss per share
|
$(0.12)
|
$(0.31)
|
|
|
|
Weighted average
shares outstanding - Basic and diluted
|
7,597,769
|
6,982,909
|
Selected
Balance Sheet Data:
|
|
|
|
March
31,
2017
|
December
31,
2016
|
Cash and cash
equivalents
|
$2,822,677
|
$3,444,952
|
|
|
|
Other current
assets
|
237,331
|
371,562
|
Fixed assets,
net
|
--
|
50,000
|
Total
assets
|
3,060,008
|
3,866,514
|
Total current
liabilities
|
818,315
|
1,160,488
|
Total
stockholders’ equity
|
2,241,693
|
2,706,026
|
Total liabilities
and stockholders’ equity
|
$3,060,008
|
$3,866,514
|
Company Contact:
Neil K.
Warma
President
& CEO
Opexa
Therapeutics, Inc.
nwarma@opexatherapetics.com
###