Blueprint
EXHIBIT 99.1
Opexa
Therapeutics Reports Third Quarter 2016 Financial Results
and
Provides
Corporate Update
THE WOODLANDS, Texas (November 14, 2016) - Opexa Therapeutics,
Inc. (NASDAQ: OPXA), a biopharmaceutical company developing
personalized immunotherapies for autoimmune disorders, today
reported financial results for the quarter ended September 30,
2016, and provided an update on the Company’s clinical
development and corporate activities.
“Over
the past several years, Opexa has dedicated itself to developing
therapies to treat patients with high unmet medical needs, such as
those with secondary progressive multiple sclerosis,” stated
Neil K. Warma, President and Chief Executive Officer of Opexa.
“We are extremely disappointed that the Abili-T trial did not
meet the predefined endpoints, and we are evaluating strategic
alternatives for the Company in order to determine the best path
forward.”
Clinical 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 secondary progressive multiple sclerosis (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
surrounding the Abili-T trial results can be found in Opexa’s
3rd
Quarter Form 10-Q, filed this morning with the Securities and
Exchange Commission.
●
Opexa is currently
analyzing the complete data set from the Abili-T trial. However,
based on the top-line results, it is unlikely that the Company will
continue with further development of Tcelna.
●
The Company is
conducting a review of its other research and development programs,
including the preclinical program for OPX-212 in neuromyelitis
optica (NMO), to assess the viability of continuing to pursue one
or more of these programs.
Corporate Activities
●
On November 2, 2016, Opexa announced a
reduction in workforce of 40% of the Company’s then 20
full-time employees while the Company evaluates its programs
and various strategic alternatives in light of the disappointing
Abili-T study data. The
Company estimates that it will incur incremental aggregate cash
charges of approximately $95,000 associated with workforce
reduction. The Company expects that additional restructuring will
occur by year-end.
●
On November 2, 2016, Opexa announced that the Company had accepted
the resignations of Ms. Donna Rill, Opexa’s Chief Development
Officer, and Mr. Scott Seaman, a member of Opexa’s Board of
Directors.
Financial Results for the Quarter Ended September 30,
2016
●
Cash position: Cash and cash equivalents
were $5,814,300 as of September 30, 2016, compared to $12,583,764
as of December 31, 2015. As of September 30, 2016, the Company had
accounts payable and accrued expenses of $2,121,043.
●
R & D Expense: Research and
development expenses were $2,165,728 for the three months ended
September 30, 2016, compared with $2,420,220 for the three months
ended September 30, 2015. 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 site expenses as well
as additional expense reduction due to a pause in NMO study
development cost. Additionally, there was a decrease in legal
patent protection expenses, and the March 2016 workforce reduction
further reduced third quarter expenses. These reductions were
almost completely offset by the increase in monthly expenses to
Pharmaceutical Research Associates, Inc. (PRA), as well as an
execution payment and additional milestone payments relating to an
amendment entered into for a change order relating to the clinical
trials management services agreement for the Abili-T
study.
●
G & A Expense: General and
administrative expenses were $512,727 for the three months ended
September 30, 2016, compared with $1,023,848 for the three months
ended September 30, 2015.
●
Net loss: Net loss reported for the
three months ended September 30, 2016 was approximately $2.0
million, or $0.28 loss per share (basic and diluted), compared with
a net loss of approximately $2.8 million or $0.42 loss per share
(basic and diluted) for the three months ended September 30,
2015.
Financial
Guidance
●
Based on the
current activities of the Company and projected burn, Opexa
believes it has sufficient liquidity to support current activities
in winding down the Abili-T trial and for general operations to
sustain the Company and support such activities into the first
quarter of 2017.
For
additional information please see Opexa’s Quarterly Report on
Form 10-Q filed today with the SEC.
About Opexa
Opexa
Therapeutics is a biopharmaceutical company developing personalized
immunotherapies based on ImmPath®, its proprietary T-cell
technology, with the potential to treat autoimmune diseases.
Opexa’s staff of cell therapy experts operates in a
stand-alone facility located on one acre in the Woodlands, Texas.
The facility is comprised of over 10,000 sq. ft. of state of the
art space for cGMP manufacturing suites, a quality control
laboratory, a research and development laboratory, quality
assurance, specialized flow cytometry, a microscopy lab and
clinical and regulatory affairs, as well as warehouse space for
materials management. Opexa’s patent estate is currently
comprised of over 160 issued patents (domestic and
international).
For more information, visit the Opexa Therapeutics website
at
www.opexatherapeutics.com or follow company news on
Twitter via
@OpexaCEO or
LinkedIn.
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 anticipation of additional workforce
restructuring, the anticipated current and future reduction in
operating expenses and cash conservation benefits associated
therewith, and the future charges expected to be incurred, 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, possible changes in the
magnitude or timing of the planned workforce reduction, including
as a result of changes that may occur in the Company’s
operations or operating plan, or other reasons or events, possible
changes in the amount of charges and cash payments associated with
the workforce reduction, including the possibility that the Company
may incur unanticipated charges or make cash payments that are not
currently contemplated, the Company’s ability to reduce its
operating expenses and conserve cash on a net basis as a result of
the workforce reduction or any 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, 2015 and its
Quarterly Report on Form 10-Q for the quarter ended September 30,
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
(Unaudited)
|
Three
Months Ended
September 30,
|
Nine Months
Ended September 30,
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Option
revenue
|
$726,291
|
$726,291
|
$2,178,873
|
$1,830,036
|
|
|
|
|
|
Research and
development
|
2,165,728
|
2,420,220
|
5,809,730
|
7,853,076
|
General and
administrative
|
512,727
|
1,023,848
|
2,453,557
|
3,375,602
|
Loss on disposition
of assets
|
---
|
1,167
|
---
|
1,167
|
Depreciation and
amortization
|
52,045
|
89,018
|
190,287
|
280,003
|
Operating
loss
|
(2,004,209)
|
(2,807,962)
|
(6,274,701)
|
(9,679,812)
|
Interest income,
net
|
686
|
2,222
|
1,208
|
5,290
|
Other income
(expense), net
|
(2,381)
|
11,760
|
2,474
|
32,781
|
Net
loss
|
$(2,005,904)
|
$(2,793,980)
|
$(6,271,019)
|
$(9,641,741)
|
|
|
|
|
|
Basic and diluted
loss per share
|
$(0.28)
|
$(0.42)
|
$(0.89)
|
$(1.75)
|
|
|
|
|
|
Weighted average
shares outstanding - Basic and diluted
|
7,073,703
|
6,709,251
|
7,017,638
|
5,498,228
|
|
|
|
Cash and cash
equivalents
|
$5,814,300
|
$12,583,764
|
Other current
assets
|
224,806
|
498,798
|
Property and
equipment, net
|
648,801
|
837,867
|
Other long term
assets
|
489,517
|
496,269
|
Total
assets
|
7,177,424
|
14,416,698
|
Total current
liabilities
|
2,847,335
|
4,801,436
|
Total
stockholders’ equity
|
4,330,089
|
9,615,262
|
Total liabilities
stockholders’ equity
|
7,177,424
|
14,416,698
|
Company
Contact:
Opexa
Therapeutics, Inc.
Camilla
Zuckero
281.775.0609
czuckero@opexatherapeutics.com
###