Form 8-K Opexa Therapeutics, Inc. For: Oct 31
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (date of earliest event reported): October 31,
2016
OPEXA THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
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Texas
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001-33004
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76-0333165
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(State
or other jurisdiction ofincorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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2635 Technology Forest Blvd., The Woodlands, Texas
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77381
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (281) 272-9331
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N/A
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(Former name or
former address, if changed since last report)
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Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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☐
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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Item
2.05 Costs Associated with Exit or Disposal
Activities.
On
November 2, 2016, Opexa Therapeutics, Inc. (the
“Company”) announced an approximately 40% reduction to
the Company’s then-current workforce in light of the negative
Phase 2b Abili-T clinical trial top-line results announced on
October 28, 2016. Following further analysis of the Phase 2b
Abili-T clinical trial top-line results and in order to reduce
operating expenses and conserve cash resources, on October 26,
2016, the Company’s Board of Directors approved reduction of
the Company’s 20 current full-time employees. The workforce
reduction is effective immediately. The Company estimates that it
will incur incremental aggregate cash charges of approximately
$95,000 associated with this workforce reduction.
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain
Officers.
On
October 31, 2016, Scott Seaman, a member of the Board of Directors,
informed the Board of his decision to resign from the Board,
effective immediately. Mr. Seaman’s resignation was not in
connection with any known disagreement with the Company on any
matter.
On
November 2, 2016, the Company also announced that it had accepted
the resignation of Donna Rill, the Company’s Chief
Development Officer, with such resignation to be effective as of
November 4, 2016.
Item
9.01 Financial Statements and Exhibits.
A
copy of the press release issued by the Company on November 2, 2016
is attached hereto as Exhibit 99.1 and
is incorporated herein by reference.
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
reduction-in-workforce and the anticipated future reduction in
operating expenses and cash conservation benefits associated
therewith, and the future charges expected to be incurred,
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
possible changes in the magnitude 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, and the
Company’s ability to reduce its operating expenses and
conserve cash on a net basis as a result of the workforce
reduction. 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 June 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.
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SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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Dated:
November 2, 2016 |
OPEXA THERAPEUTICS,
INC.
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By:
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/s/
Neil K.
Warma
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Neil K.
Warma
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President, Chief
Executive Officer and Acting Chief Financial Officer
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3
EXHIBIT 99.1
Opexa
Announces Reduction in Workforce in Light of Top-Line Results from
Phase 2b Abili-T Trial of Tcelna® (imilecleucel-T) in Secondary
Progressive Multiple Sclerosis
THE WOODLANDS, Texas (November 2, 2016) –
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company
developing personalized immunotherapies for autoimmune disorders,
including multiple sclerosis (MS) and neuromyelitis optica (NMO),
today announced that it was
implementing an approximately 40% reduction to the Company’s
current workforce in order to reduce operating expenses and
conserve cash resources. The move comes as the Company recently
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.
The Company estimates that it will incur incremental aggregate cash
charges of approximately $95,000 associated with this current
workforce reduction. Moreover, the Company expects that additional
restructuring will occur by year-end.
Additionally, the Company has accepted the resignations of Ms.
Donna Rill, Opexa’s Chief Development Officer, and Mr. Scott
Seaman, a member of the Company’s Board of Directors. Ms.
Rill, who is leaving to pursue other career opportunities, will
depart as of November 4, 2016.
“This reduction in force is a difficult but necessary step as
a result of the disappointing results of our lead product
candidate, Tcelna, announced last week,” said Neil K. Warma,
President and Chief Executive Officer of Opexa. “I would like
to personally express my appreciation to each of the employees
impacted by this decision for their commitment to Tcelna and Opexa.
The Opexa team has endeavored to increase the understanding of
secondary progressive multiple sclerosis, and we hope our work will
contribute to the development of a safe and effective therapy for
this devastating disease. I would also like to thank Scott Seaman
for his long-time service as a Director of Opexa and note our
special heartfelt appreciation of Donna Rill who has dedicated over
15 years to Opexa.”
About
Opexa Therapeutics
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, please visit 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
reduction-in-workforce and the anticipated future reduction in
operating expenses and cash conservation benefits associated
therewith, and the future charges expected to be incurred,
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
possible changes in the magnitude 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, and the
Company’s ability to reduce its operating expenses and
conserve cash on a net basis as a result of the workforce
reduction. 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 June 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.
Company Contact:
Neil K.
Warma
Opexa
Therapeutics, Inc.
Chief
Executive Officer
281-775-0600
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