Adynxx, Inc., (Nasdaq:ADYX), a clinical-stage biopharmaceutical
company leading the development of transcription factor decoy
technology and first-in-class therapeutics for the treatment of
pain and inflammatory diseases, today announced May 29, 2019 as
payment date for the special cash dividend announced by Alliqua
Biomedical, Inc. (formerly Nasdaq:ALQA) on April 11, 2019.
The special cash dividend entitled each share of Alliqua common
stock outstanding as of the close of business on April 22, 2019 to
receive $1.05 in cash, subject to the consummation of Alliqua’s
previously announced merger transaction with Adynxx. The merger was
consummated on May 3, 2019, immediately prior to which Alliqua
effected a six-for-one reverse stock split. The distribution of the
special cash dividend will be made on a pre-split basis.
In addition to payment of the special cash dividend, Adynxx
intends to consummate the previously announced distribution of
shares of AquaMed Technologies, Inc., now a wholly-owned subsidiary
of Adynxx, as soon as practicable following the satisfaction of all
conditions to closing of the previously announced merger
transaction between AquaMed and TO Pharmaceuticals, LLC. In
the event the closing conditions to the merger between AquaMed and
TO Pharmaceuticals are satisfied, the stock distribution will be
made no later than June 21, 2019.
“With the payment of the special cash dividend, we are excited
to deliver value to the former Alliqua shareholders and look
forward to rapidly advancing our AYX platform of non-opioid pain
therapies to continue to create value for the shareholders of
Adynxx,” said Rick Orr, Chief Executive Officer. “In light of
the ongoing opioid crisis in the United States, we remain dedicated
to developing transformative pain therapies with the potential to
reduce the need for opioid-based analgesics.”
Adynxx plans to initiate two Phase 2 studies this year for the
company’s lead program, brivoligide for postoperative pain, with
data from the first study expected in mid-2020. With a single
administration at the time of surgery, brivoligide is intended to
reduce both the severity and duration of postoperative pain in a
readily-identified group of patients at greater risk of
experiencing increased and prolonged pain following surgery,
relative insensitivity to analgesics and elevated opioid use as a
result. The first study, ADYX-005, will be conducted in subjects
undergoing unilateral total knee arthroplasty or TKA. The second
study, ADYX-006, will be conducted in subjects undergoing
mastectomy with immediate tissue expander or implant placement.
Topline data for both Phase 2 studies are expected in 2020.
In December, 2018, Adynxx received a Notice of Award from the
National Institute on Drug Abuse (NIDA), part of the National
Institutes of Health (NIH), for a grant to provide Adynxx with $5.7
million over a two-year period to complete ADYX-006. Following
completion of milestones related to ADYX-006, Adynxx can receive an
additional award of up to $9 million for a Phase 3 study of
brivoligide.
Adynxx also plans to initiate IND-enabling studies for AYX2 in
the second half of 2019. AYX2 is the second product candidate
originating from the Adynxx AYX platform and is intended to provide
long-term reduction of chronic pain, including both inflammatory
and neuropathic pain, with a single or infrequent dosing
regimen.
Outside of the AYX platform, the company is collaborating with
twoXAR, Inc., an artificial intelligence-driven drug discovery
company, utilizing twoXAR’s proprietary AI technology to identify a
set of medical treatments with the potential to treat and prevent
the recurrence of endometriosis and associated symptoms. Adynxx
also continues to evaluate partnering opportunities to build a
diverse pipeline to address unmet medical needs in pain and
inflammation.
About Adynxx
Adynxx is a clinical-stage biopharmaceutical company focused on
bringing to market novel therapeutics for the treatment of pain and
inflammatory diseases. A leader in transcription factor decoy
technology, Adynxx is utilizing its platform of AYX transcription
factor decoys to create first-in-class therapies with
disease-modifying properties. Transcription factor decoys are
short, synthetic double-stranded DNA oligonucleotides that bind to
transcription factors and prevent their interaction with the
genome, effectively inhibiting a coordinated network of pathologic
gene expression. The AYX platform has applications across multiple
disease states and has initially been leveraged to create novel,
non-opioid therapeutics for the treatment of pain.
About Brivoligide
Clinical studies suggest that a single administration of
brivoligide at the time of surgery can safely reduce pain for
weeks, accelerate the time to achieve mild pain, and substantially
reduce the need for opioid use during recovery specifically in
patients at greater risk of experiencing increased and prolonged
pain following surgery. Brivoligide (formerly AYX1) is an
intrathecally-administered, 23 base-pair, double-stranded DNA
transcription factor decoy oligonucleotide. It inhibits the
transcription factor EGR1 in the dorsal root ganglia and spinal
cord at the time of surgery. EGR1 binds to the promoter regions of
many genes associated with nociceptive sensitization and increased
pain. EGR1 launches waves of gene regulation at the time of surgery
that initiate and maintain neuronal sensitization. This
sensitization may lead to increased and prolonged postoperative
pain in certain patients who are relatively insensitive to
analgesics and may be at high risk for elevated use of rapidly
acting opioids, the type most commonly associated with Opioid Use
Disorder or OUD.
Forward-Looking Statements
Statements contained in this press release that are not purely
historical may be deemed to be forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
Without limiting the foregoing, the use of words such as “may,”
“intends,” “can,” “might,” “will,” “expect,” “plan,” and other
similar expressions are intended to identify forward-looking
statements. The product candidates discussed are in clinic and not
approved and there can be no assurance that the clinical programs
will be successful in demonstrating safety and/or efficacy, that
Adynxx will not encounter problems or delays in clinical
development, or that any product candidate will ever receive
regulatory approval or be successfully commercialized. All
forward-looking statements are based on estimates and assumptions
by Adynxx’s management that, although Adynxx believes to be
reasonable, are inherently uncertain. All forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those that Adynxx
expected. In addition, Adynxx’s business is subject to additional
risks and uncertainties, including among others, the initiation and
conduct of preclinical studies and clinical trials; the timing and
availability of data from preclinical studies and clinical trials;
expectations for regulatory submissions and approvals; potential
safety concerns related to, or efficacy of, Adynxx’s product
candidates; the availability or commercial potential of product
candidates; the ability to maintain continued listing of Adynxx’s
common stock on The Nasdaq Stock Market or any national securities
exchange; the consummation of the Special Dividend or the
Distribution; and Adynxx’s and its partners’ ability to perform
under their license, collaboration and manufacturing arrangements.
These statements are also subject to a number of material risks and
uncertainties that are described in the definitive proxy statement
filed by Alliqua BioMedical, Inc. with the Securities and Exchange
Commission on January 24, 2019, as updated by Adynxx’s subsequent
filings with the Securities and Exchange Commission. Any
forward-looking statement speaks only as of the date on which it
was made. Adynxx undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise, except as required under
applicable law.
View source version on https://ir.adynxx.com/press-releases
Source: Adynxx, Inc.
Investors: Patti BankManaging
DirectorWestwicke, an ICR
company415-513-1284patti.bank@westwicke.com
Media:David SchullPresidentRusso
Partners858-717-2310david.schull@russopartnersllc.com