THE WOODLANDS, Texas--(BUSINESS WIRE)--
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 has filed a registration statement with the Securities and
Exchange Commission (SEC) for a proposed rights offering of subscription
rights to purchase units comprised of a share of Opexa common stock and
warrants to purchase an additional share of Opexa common stock. Holders
of Opexa’s common stock and holders of Series L warrants as described
below on the record date for the rights offering would be eligible to
participate.
Under the proposed rights offering, Opexa would distribute one
non-transferable subscription right for each share of common stock held
on the record date. Each right would entitle the holder to purchase one
unit, composed of one share of common stock and a warrant to purchase
one share of common stock, at a subscription price to be determined
prior to the effective date of the registration statement. The
subscription price is expected to be between $0.65 and $0.75 per unit.
The three-year warrant would entitle the holder to purchase one share of
common stock at an exercise price of (i) $0.50 per share from the date
of issuance through June 30, 2022, and (ii) $1.50 per share from July 1,
2016 through the warrant expiration date. The warrants would be listed
on NASDAQ and would be redeemable if Opexa’s common stock closes above
$2.50 per share for 10 consecutive trading days.
Opexa also intends to distribute the non-transferable subscription
rights to holders of its Series L warrants who are entitled to
participate in the rights offering pursuant to the terms of the warrants
held by them. Each such Series L warrant holder will receive one
subscription right for each share of common stock into which the Series
L warrants are exercisable as of the record date.
Holders who fully exercise their basic subscription rights will be
entitled, if available, to subscribe for an additional number of units
that are not purchased by other shareholders or holders of Series L
warrants, on a pro rata basis and subject to ownership limitations.
The record, commencement and expiration dates for the rights offering
will be determined and announced after the registration statement
relating to the rights offering becomes effective.
Opexa plans to use the proceeds from the rights offering primarily to
complete funding the ongoing Phase IIb “Abili T” clinical study of
Tcelna in patients with secondary progressive multiple sclerosis (SPMS)
through completion and data release, expected in the second half of 2016.
In addition, Opexa plans to continue preclinical and manufacturing
activities for OPX-212 in development for patients with neuromyelitis
optica (NMO), and if such activities are successful, to file an
investigational new drug application with the U.S. Food and Drug
Administration to initiate a Phase 1/2 proof-of-concept study. The
financing will also provide for other general corporate purposes
(including working capital, research and development, business
development and operational purposes).
Opexa has engaged Maxim Group LLC as lead dealer-manager and National
Securities Corporation as co-dealer-manager for the rights offering.
Questions about the rights offering may be directed to Advantage Proxy,
Inc., the Company's information agent for the rights offering, by
calling (877) 870-8565 (toll-free) or emailing ksmith@advantageproxy.com.
The registration statement on Form S-1 filed by Opexa with the
Securities and Exchange Commission has not yet become effective. These
securities may not be sold nor may offers to buy be accepted prior to
the time the registration statement becomes effective. The rights
offering, which is expected to commence immediately following the
effectiveness of the registration statement, will only be made by means
of a prospectus. A preliminary prospectus relating to and
describing the proposed terms of the rights offering has been filed with
the SEC as a part of the registration statement and is available on the
SEC’s web site at http://www.sec.gov.
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 would be unlawful prior to registration
or qualification under the securities laws of any such state or
jurisdiction.
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 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.
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 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,” “potential,” “possibly,” “estimates,”
“may,” “could” and “intends,” as well as similar expressions, are
intended to identify forward-looking statements. These forward-looking
statements do not constitute guarantees of future performance. Investors
are cautioned that statements which are not strictly historical
statements, including, without limitation, statements regarding plans
and objectives for product development (including for Tcelna
(imilecleucel T) and OPX-212), 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, without
limitation, risks associated with the following: market conditions; our
capital position; our ability to compete with larger, better financed
pharmaceutical and biotechnology companies; new approaches to the
treatment of our targeted diseases such as MS and NMO; 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, to complete preclinical
development activities and potentially file an IND for OPX-212, and
potentially to conduct a Phase 1/2 proof-of-concept study for OPX-212 in
NMO); 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), a wholly owned subsidiary of
Merck Serono S.A., elects to exercise its option (Option) to acquire an
exclusive, worldwide (excluding Japan) license of our Tcelna program for
the treatment of MS); the success of our development programs (including
the preclinical development activities with respect to OPX-212); 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 FDA
regulations; our ability to obtain, maintain and protect intellectual
property rights (including for Tcelna and future pipeline candidates
such as OPX-212); the risk of litigation regarding our intellectual
property rights or the rights of third parties; our limited
manufacturing capabilities; our dependence on third-party suppliers and
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 or revise any
forward-looking statements contained herein to reflect any changes in
our 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 for this offering that has been filed with the
SEC, as well as our Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K.

Source: Opexa Therapeutics, Inc.