THE WOODLANDS, Texas--(BUSINESS WIRE)--
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company
developing Tcelna®, a patient-specific T-cell immunotherapy for the
treatment of multiple sclerosis (MS), today announced the closing of the
previously announced underwritten public offering of 12,000,000 shares
of its common stock at a price to the public of $1.50 per share. The
gross proceeds to Opexa from this offering were $18 million, before
deducting underwriting discounts and commissions and other estimated
offering expenses. All of the shares in the offering were sold by Opexa.
Opexa has also granted the underwriters a 30-day option to purchase up
to an additional 1,800,000 shares of common stock to cover
over-allotments, if any.
Opexa intends to use the net proceeds from the offering to fund further
clinical development of Tcelna in an ongoing Phase IIb clinical study of
patients with Secondary Progressive MS as well as the expenses of its
operations during such development and for general corporate purposes.
Opexa may also use a portion of the net proceeds to repay all or a
portion of its outstanding convertible secured promissory notes.
Aegis Capital Corp. acted as sole book-running manager for the offering.
A registration statement relating to these securities was declared
effective by the Securities and Exchange Commission on August 7, 2022.
The offering was made only by means of a prospectus. Copies of
the prospectus relating to the offering are available on the SEC’s
website at http://www.sec.gov.
Copies of the prospectus may also be obtained from the offices of
Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th
Floor, New York, NY, 10019, via telephone at (212) 813-1010, or via
email at prospectus@aegiscap.com.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor will there be any
sale of these securities in any state or other jurisdiction in which
such offer, solicitation or sale is not permitted.
About Opexa
Opexa’s mission is to lead the field of Precision Immunotherapy™ by
aligning the interests of patients, employees and shareholders. 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 is
derived from T-cells isolated from the patient’s peripheral blood,
expanded ex vivo, and reintroduced into the patients via subcutaneous
injections. This process triggers a potent immune response against
specific subsets of autoreactive T-cells known to attack myelin.
About Multiple Sclerosis (MS)
Multiple Sclerosis is a chronic, inflammatory condition of the central
nervous system and is the most common, non-traumatic, disabling
neurological disease in young adults. It is estimated that approximately
two million people have MS worldwide.
While symptoms can vary, the most common symptoms of MS include blurred
vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common. The
Secondary Progressive form of MS represents about a third of the MS
patient population.
About Tcelna
Tcelna® is a potential personalized therapy that is under development to
be specifically tailored to each patient's disease profile. Tcelna is
manufactured using ImmPath™, Opexa's proprietary method for the
production of a patient-specific T-cell immunotherapy, which encompasses
the collection of blood from the MS patient, isolation of peripheral
blood mononuclear cells, generation of an autologous pool of
myelin-reactive T-cells (MRTCs) raised against selected peptides from
myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG)
and proteolipid protein (PLP), and the return of these expanded,
irradiated T-cells back to the patient. These attenuated T-cells are
reintroduced into the patient via subcutaneous injection to trigger a
therapeutic immune system response.
Opexa is currently conducting a Phase IIb study of Tcelna. Named
“Abili-T,” the trial is a randomized, double-blind, placebo-controlled
clinical study in patients who demonstrate evidence of disease
progression with or without associated relapses. The trial is expected
to enroll 180 patients at approximately 30 leading clinical sites in the
U.S. and Canada with each patient receiving two annual courses of Tcelna
treatment consisting of five subcutaneous injections per year. The
trial’s primary efficacy outcome is the percentage of brain volume
change (atrophy) at 24 months. Study investigators will also measure
several important secondary outcomes commonly associated with MS,
including disease progression as measured by the Expanded Disability
Status Scale (EDSS), annualized relapse rate and changes in disability
as measured by EDSS and the MS Functional Composite.
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
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Statements contained in this release, other than
statements of historical fact, constitute "forward-looking statements."
The words "expects," "believes," "anticipates," "estimates," "may,"
"could," "intends," and similar expressions are intended to identify
forward-looking statements. The forward-looking statements in this
release do not constitute guarantees of future performance. Investors
are cautioned that statements in this report which are not strictly
historical statements, including, without limitation, statements
regarding the intention to use a portion of the net proceeds to repay
outstanding convertible secured promissory notes and the development of
the Company's product candidate, Tcelna (imilecleucel-T), constitute
forward-looking statements. Such forward-looking statements are subject
to a number of risks and uncertainties that could cause actual results
to differ materially from those anticipated. These risks and
uncertainties include, but are not limited to, risks associated with:
market conditions; our capital position; the rights and preferences
provided to the Series A convertible preferred stock and investors in
the convertible secured notes we issued in July 2012 (including a
secured interest in all of our assets); our ability to compete with
larger, better financed pharmaceutical and biotechnology companies; new
approaches to the treatment of our targeted diseases; our expectation of
incurring continued losses; our uncertainty of developing a marketable
product; our ability to raise additional capital to continue our
development programs (including to undertake and complete any ongoing or
further clinical studies for Tcelna), including in this regard our
ability to satisfy various conditions required to access the financing
potentially available under the purchase agreements with Lincoln Park
Capital Fund, LLC (“Lincoln Park”) (such as the minimum closing price
for our common stock and the requirement for an ongoing trading market
for our stock); our ability to raise additional capital through the sale
of shares of our common stock under the purchase agreements with Lincoln
Park or under our at-the-market (ATM) facility; our ability to maintain
compliance with NASDAQ listing standards; the success of our clinical
trials (including the Phase IIb trial for Tcelna in secondary
progressive MS which, depending upon results, may determine whether Ares
Trading SA (“Merck”) elects to exercise its option for an exclusive
license to Tcelna for the treatment of MS (the “Option”)); whether Merck
exercises its Option and, if so, whether we receive any development or
commercialization milestone payments or royalties from Merck pursuant to
the Option; our dependence (if Merck exercises its Option) on the
resources and abilities of Merck for the further development of Tcelna;
the efficacy of Tcelna for any particular indication, such as for
relapsing remitting MS or secondary progressive MS; our ability to
develop and commercialize products; our ability to obtain required
regulatory approvals; our compliance with all Food and Drug
Administration regulations; our ability to obtain, maintain and protect
intellectual property rights (including for Tcelna); the risk of
litigation regarding our intellectual property rights or the rights of
third parties; the success of third party development and
commercialization efforts with respect to products covered by
intellectual property rights that we may license or transfer; our
limited manufacturing capabilities; our dependence on third-party
manufacturers; our ability to hire and retain skilled personnel; our
volatile stock price; and other risks detailed in our filings with the
SEC. These forward-looking statements speak only as of the date made. We
assume no obligation or undertaking to update any forward-looking
statements to reflect any changes in expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statement is based. You should, however, review additional disclosures
we make in our Registration Statement on Form S-1 declared effective by
the SEC on August 7, 2022, as well as in our Annual Reports on Form
10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K
filed with the SEC.
Source: Opexa Therapeutics, Inc.