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8-K - CURRENT REPORT - Acer Therapeutics Inc. | opxa_8k.htm |
Exhibit 99.1
Opexa Therapeutics Reports 2016 Year End Financial Results and
Provides Corporate Update
THE WOODLANDS, TX / ACCESSWIRE / March 28, 2017 / Opexa
Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company
developing personalized immunotherapies for autoimmune
disorders, today reported
financial results for the year ended December 31,
2016, and provided an update on the Company's
recent corporate developments.
“During
2016, the focus of our efforts was on conducting and completing the
Abili-T study, the Phase 2b clinical trial in patients with
Secondary Progressive Multiple Sclerosis (SPMS) using Opexa’s
T-cell immunotherapy, Tcelna®,” said
Neil K. Warma, President and Chief Executive Officer of Opexa.
“We reported the top-line results of this study in Q4 2016
and were disappointed by the outcome, which showed that the trial did not meet the
predefined endpoints. We were pleased to have signed an agreement
with KBI Biopharma in February 2017, whereby Opexa assigned its
facility lease and a related lease on a major piece of
equipment to KBI. KBI also paid Opexa a lump sum for
Opexa’s manufacturing and laboratory equipment. In
addition to providing us some cash, it also eliminated key
liabilities for Opexa. We are focused on cash preservation as we
evaluate our strategic opportunities and have conducted two
reductions in head count over the past several
months.”
Corporate Activities
●
On October 28,
2016, Opexa announced that the Phase 2b Abili-T clinical trial
designed to evaluate the efficacy and safety of Tcelna
(imilecleucel-T) in
patients with SPMS did not meet its primary endpoint of reduction
in brain volume change (atrophy), nor did it meet the secondary
endpoint of reduction of the rate of sustained disease progression.
Tcelna did show a favorable safety and tolerability profile.
Further details regarding the Abili-T trial results can be found in
Opexa’s 2016 Annual Report on Form 10-K, filed today with the
Securities and Exchange Commission.
●
The Company is
conducting a review of its other research and development programs,
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. The Company is also
exploring its strategic alternatives.
●
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 November 2,
2016, Opexa announced a reduction in workforce of 40% of the
Company’s then 20 full-time employees while the Company
evaluated its programs and various strategic alternatives. The
Company incurred incremental aggregate cash charges of
approximately $95,000 associated with this workforce reduction.
Additionally, on January 31, 2017, Opexa further reduced its
workforce by terminating the employment of seven full-time
employees, incurring additional costs of approximately $219,000
associated with this workforce reduction.
Financial Results for the Year Ended December 31, 2016
●
Cash position: Cash and cash
equivalents were $3,444,952 as of December 31, 2016, compared to
$12,583,764 as of December 31, 2015.
●
R & D Expense: Research and
development expenses were $6,497,531 for the year ended December
31, 2016, compared to $10,039,496 for the year ended December 31,
2015. The decrease in expenses was primarily due to decreases in
the need for supplies used both in research and clinical trial
product manufacturing operations and decreased clinical
investigator costs associated with a decreased number of patients
in the Abili-T clinical study. Also, contributing to this decrease
was the reduction in staff compensation expenses due to the
reductions-in-force implemented during 2016. Offsetting these
decreases in research and development expense was an increase in
the stability testing of our custom reagent during 2016. We expense
research and development costs as incurred. Property and equipment
for research and development that has an alternative future use is
capitalized and the related depreciation is expensed.
●
G & A Expense: Our general and
administrative expenses were $3,122,337 for the year ended December
31, 2016, compared to $4,258,147 for the year ended December 31,
2015. The decrease is mainly due to a reduction in professional
service fees, corporate governance expenses and a decrease in staff
compensation due to the 2016 workforce reductions. Further reducing
our general and administrative expense is the decrease in our
option expense, driven by the factors used to evaluate the Black
Scholes pricing model. These decreases were partially offset by an
increase in directors’ fees and the valuation of their
stock-based compensation.
●
Net loss: We had a net loss for the
year ended December 31, 2016 of $7,980,114, or $1.13 per share
(basic and diluted), compared with a net loss of $12,019,278, or
$2.05 per share (basic and diluted), for the year ended December
31, 2015.
For
additional information please see Opexa’s Annual Report on
Form 10-K 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 report, 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
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. 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
|
Twelve
Months
Ended
December 31,
|
|
|
2016
|
2015
|
Revenue:
|
|
|
Option
revenue
|
$2,905,165
|
$2,556,329
|
Expenses:
|
|
|
Research and
development
|
6,497,531
|
10,039,496
|
General and
administrative
|
3,122,337
|
4,258,147
|
Depreciation and
amortization
|
238,127
|
351,403
|
Impairment
loss
|
1,036,467
|
--
|
Loss on disposal of
fixed assets
|
2,320
|
1,167
|
|
|
|
Operating
loss
|
(7,991,617)
|
(12,093,884)
|
Interest income,
net
|
874
|
5,911
|
Other income,
net
|
10,629
|
68,695
|
Net
loss
|
$(7,980,114)
|
$(12,019,278)
|
|
|
|
Basic and diluted
loss per share
|
$(1.13)
|
$(2.05)
|
|
|
|
Weighted average
shares outstanding - Basic and diluted
|
7,048,661
|
5,854,438
|
Selected
Balance Sheet Data:
|
|
|
|
December
31,
2016
|
December
31,
2015
|
Cash and cash
equivalents
|
$3,444,952
|
$12,583,764
|
|
|
|
Other current
assets
|
371,562
|
498,798
|
Fixed assets,
net
|
50,000
|
837,867
|
Other long term
assets
|
--
|
496,269
|
Total
assets
|
3,866,514
|
14,416,698
|
Total current
liabilities
|
1,160,488
|
4,801,436
|
Total long-term
liabilities
|
--
|
--
|
Total
stockholders’ equity
|
2,706,026
|
9,615,262
|
Total liabilities
and stockholders’ equity
|
$3,866,514
|
$14,416,698
|
Company Contact:
Neil K.
Warma
President
& CEO
Opexa
Therapeutics, Inc.
281.775.0600
nwarma@opexatherapetics.com
###