Current Report — Form 8-K Filing Table of Contents
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1: 8-K Current Report HTML 28K
2: EX-10.1 Assignment and Assumption of Lease HTML 15K
3: EX-99.1 Press Release HTML 11K
Opexa Facility Becomes Foundation for Contract Manufacturing
and
Development Organization for Cellular Therapies
THE WOODLANDS, Texas (February 1, 2017) - Opexa Therapeutics,
Inc. (NASDAQ: OPXA), a biopharmaceutical company with a
strong history of cellular therapy drug development, today
announced it had assigned its facility lease to KBI Biopharma,
Inc., a global contract development and manufacturing company,
thereby establishing a cellular therapy contract development and
manufacturing organization (CDMO) in the Houston area. Opexa had
leased the facility for over a decade to support GMP manufacturing
for its proprietary cellular therapy platform. The assignment of
Opexa’s facility lease and the related assignment of a lease
on a major piece of equipment to KBI should eliminate key
liabilities for Opexa. The annual lease obligations on the
facility, including property tax and insurance, totaled
approximately $1 million. In addition to assuming the remaining
lease term for the facility and the piece of equipment, KBI paid
Opexa a lump sum for Opexa’s manufacturing and laboratory
equipment. Resulting from this, the employment contract for Donald
Healey, Ph.D., Opexa’s Chief Scientific Officer, has been
terminated as he becomes the Senior VP of Operations and Site Head
for KBI. KBI intends to transition the facility into a world class
manufacturing and development operation, providing contract
services to biopharmaceutical companies developing cellular therapy
products.
“I
am pleased with this transaction for two strategic reasons,”
said Neil K. Warma, President and Chief Executive Officer of Opexa.
“First, it enabled us to eliminate our two major liabilities
for Opexa shareholders, as we continue to assess strategic
opportunities. Opexa had almost four years left on a five-year
building lease, plus over two years remaining on an equipment
lease, so being able to exit from those two leases and the related
future obligations was a priority for us. Second, with an esteemed
group such as KBI assuming the leases and taking over the facility,
we are pleased to see that Opexa’s legacy in cellular therapy
manufacturing will continue under such an experienced group with a
solid history of success. Dr. Healey’s expertise in managing
the operations of the local facility should result in a smooth
transition and provide a solid foundation from which KBI can build
and offer services to cell therapy companies across the
country.”
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 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" 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
Opexa’s elimination of future lease liabilities and
KBI’s development of a cellular therapy contract development
and manufacturing organization, constitute forward-looking
statements. These forward-looking statements are based upon our
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 our ability to
raise additional capital to continue our development programs, our
ability to successfully develop potential products, our ability to
obtain, maintain and protect intellectual property rights , and our
ability to realize the savings anticipated by the lease assignments
and restructuring, 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 our
SEC filings, including our Annual Report on Form 10-K for the year
ended December 31, 2015 and our Quarterly Report on Form 10-Q for
the quarter ended September 30, 2016. All forward-looking
statements contained in this release speak only as of the date on
which they were first made by us, and we undertake no obligation to
update such statements to reflect events that occur or
circumstances that exist after such date.
