THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical
company developing personalized immunotherapies for autoimmune disorders
including multiple sclerosis (MS) and neuromyelitis optica (NMO), today
announced that the Company has entered into a stock purchase agreement
with a private investor to fund the Company’s NMO program, including its
planned Phase I/II trial, for up to $5 million, upon achievement of
certain pre-specified milestones.
The funding is to be provided in five tranches, based on the successful
completion of milestones, with the first tranche having been delivered
today, the effective date of this agreement. For the first tranche, the
company issued shares priced at $0.55 per share for a purchase amount of
$500,000. The total number of shares delivered in the first tranche was
909,090. The first tranche also included a warrant to acquire an equal
number of shares with an initial exercise price of $0.50 until June 30,
2016, and an exercise price of $1.50 through its expiration on April 9,
2018.
Subsequent tranches totaling a possible $4.5 million are based on the
completion of the ongoing preclinical activities and subsequent
submission of an IND for OPX-212 in NMO no later than February 15, 2022;
the review and acceptance of the IND by the U.S. Food and Drug
Administration (FDA) no later than May 15, 2022; enrollment of the first
patient in a planned Phase I/II study no later than August 30, 2022; and
enrollment of 30% of the patients in the same Phase I/II study no later
than December 31, 2021. Each subsequent tranche will include the sale of
common stock only (i.e., no additional warrants will be issued), with
such shares priced at 90% of the 10-day volume weighted average price of
Opexa’s common stock immediately preceding the occurrence of the related
milestone. The Company has filed a Current Report on Form 8-K with the
U.S. Securities and Exchange Commission, which includes a copy of the
stock purchase agreement. No bank was used in this transaction.
“We are pleased as this financing gives us the potential to fully fund
the Phase I/II clinical trial we are planning for OPX-212 in NMO,” said
Neil K. Warma, President and Chief Executive Officer of Opexa. “OPX-212
is Opexa’s second development program and offers what we believe to be a
promising therapy for individuals with NMO. Currently there are no
approved treatments for NMO, a debilitating disease in which the
patients suffer attacks that can lead to blindness and paralysis. Having
secured the financing to get through a first-in-man or proof-of-concept
study is significant. Our next step in the OPX-212 development program
is to complete the IND-enabling studies over the next several months
such that we can file our IND with the FDA by the end of the year and be
in a position to commence our Phase I/I trial by mid-2016. We are
grateful to the patients and the NMO community who have supplied us with
blood samples enabling us to proceed with our pre-IND work, to the
thought leaders and nurse coordinators at UT Southwestern and
Johns Hopkins for being open and receptive to Opexa’s approach to NMO,
and to our investors for enabling Opexa to potentially move forward with
the planned clinical study with OPX-212.”
Mr. Warma added, “Earlier this year we secured financing to fully fund
our landmark Phase IIb Abili-T trial with Tcelna® in
secondary progressive multiple sclerosis, which is expected to read out
in the second half of 2016, and now, with today’s announcement, we have
secured financing to possibly fully fund the first clinical study in our
orphan disease program. Both of these programs, if successful, have the
potential to provide significant improvements to the quality of life of
many individuals suffering from debilitating diseases. In 2013, we
secured an option and license agreement with Merck Serono for a
potential partnership with Tcelna in multiple sclerosis. We do, though,
currently own 100% of the rights to OPX-212 and all other possible drug
candidates developed off of our proprietary T-cell immunotherapy
platform and, therefore, maintain all future partnering rights for these
candidates.”
NMO, also known as neuromyelitis optica spectrum disorder (NMOSD), is a
rare autoimmune disorder, which is designated as an Orphan Disease by
the U.S. Food and Drug Administration. It is a relapsing inflammatory
demyelinating disease that most commonly affects optic nerves and the
spinal cord. There is currently no cure and there are no approved
therapies for this disease, worldwide.
About OPX-212
OPX-212 is Opexa’s personalized T-cell immunotherapy in development for
the treatment of NMO. It will be specifically tailored to each patient’s
immune response to aquaporin-4. In NMO, the immune system recognizes
aquaporin-4 as foreign, thus triggering an attack on myelin cells in the
optic nerves and the spinal cord leading to demyelination and loss of
axons. Symptoms of the attack include blindness in one or both eyes
followed within days or weeks by varying degrees of paralysis in the
arms and legs. OPX-212 has an hypothesized mechanism of action to reduce
the number and/or regulate aquaporin-4 reactive T-cells (ARTCs), thereby
reducing the frequency of clinical relapses and subsequent progression
in disability. OPX-212 will be manufactured using ImmPath®,
Opexa Therapeutics’ proprietary T-cell immunotherapy platform technology.
About Opexa
Opexa is a biopharmaceutical company developing a personalized
immunotherapy with the potential to treat major illnesses, including
multiple sclerosis (MS) as well as other autoimmune diseases such as
neuromyelitis optica (NMO). These therapies are based on Opexa’s
proprietary T-cell technology. The Company’s leading therapy candidate,
Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb
clinical development program (the Abili-T trial) for the treatment of
secondary progressive MS. Tcelna consists of myelin-reactive T-cells,
which are expanded ex vivo from the patient’s peripheral blood and
reintroduced into the patient in an attenuated form via subcutaneous
injections. This process triggers a potent immune response against
specific subsets of autoreactive T-cells known to attack myelin for each
individual patient.
For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com
or follow company news on Twitter
via @OpexaCEO.
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 the safety, efficacy
and projected development timeline of drug candidates such as Tcelna®
and OPX-212, 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 (including to achieve the specified milestones and
raise the related capital for the development of OPX-212 in NMO), our
ability to successfully develop potential products such as Tcelna and
OPX-212, our 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 our
SEC filings, including our Annual Report on Form 10-K for the year ended
December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022. 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.

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Source: Opexa Therapeutics, Inc.