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 the
completion of its merger with Alliqua BioMedical, Inc.
In connection with the merger, Alliqua has changed its name to
Adynxx, Inc. The combined organization will commence trading on May
6, 2019 on the Nasdaq Capital Market under the symbol “ADYX.” The
company is based in San Francisco and now operating under the
leadership of the Adynxx management team in place prior to the
merger, including Rick Orr, Chief Executive Officer; Donald C.
Manning, M.D., Ph.D., Chief Medical Officer; and Julien Mamet,
Ph.D., founder and Chief Scientific Officer. In conjunction with
the closing, Pierre Legault and Matthew Ruth have joined as
directors.
“The closing of this transaction represents another significant
milestone for Adynxx and reflects the unwavering support of our
investors who share our commitment to the development of
life-improving therapies for patients with unmet or underserved
medical needs,” said Rick Orr. “With the access to public
markets, we plan to rapidly advance the development of our AYX
platform of transcription factor decoys, including the initiation
of two Phase 2 studies of brivoligide, our lead product candidate
for postoperative pain, and create additional value through
pipeline expansion to establish Adynxx as a leading developer of
treatments for pain and inflammatory diseases.”
“Speaking on behalf of our board of directors, we have
tremendous confidence in Rick and his team, especially given Rick’s
outstanding track record of building successful biopharmaceutical
companies that have brought multiple new drug products to market
and delivered strong returns for shareholders,” said Dennis
Podlesak, Partner, Domain Associates and Adynxx’s Chairman. “Today
we are also pleased to announce the addition to the board of Pierre
Legault and Matt Ruth, two accomplished pharmaceutical industry
leaders. Their guidance and expertise will be instrumental as we
focus on building Adynxx and rapidly advancing the development of
our novel, non-opioid pain therapeutics to address one of our
country’s most significant health crises.”
Podlesak continued, “Pierre is a highly accomplished global
pharmaceutical executive who has a proven history of building world
class companies, both as a senior executive and board member. With
the addition of Pierre to the board of directors, we benefit not
only from his highly distinguished experience and operational
expertise, but also from the recent relevant experience I shared
with him and fellow Adynxx board member Eckard Weber on the board
of Tobira Therapeutics. Tobira went public through the acquisition
of Regado Biosciences in 2015 and was subsequently acquired by
Allergan, creating significant value for the Tobira
shareholders.”
“Matt joins the Adynxx board after having played key senior
executive roles in successfully building multiple biopharmaceutical
companies, all of which were acquired for significant premiums.
Most recently Matt led the highly successful launch and
commercialization of Narcan nasal spray at Adapt Pharmaceuticals,”
Podlesak added. “Narcan, a product that can reverse the effects of
opioid and heroin overdoses, has had a critical impact on the
effort to combat the opioid epidemic, and we welcome Matt’s highly
relevant insights and expertise as we work to develop therapeutics
to reduce the need for opioid-based pain therapies.”
On May 3, 2019, prior to the consummation of the
merger, Alliqua effected a one-for-six reverse stock split.
All issued and outstanding Alliqua shares were subject to the
reverse stock split. No fractional shares will be issued in
connection with the reverse stock split. Instead, cash will be paid
in lieu of fractions of shares. Upon completion of the merger,
taking into consideration the reverse stock split, the holders of
shares of Adynxx capital stock outstanding immediately prior to the
merger received 0.0359 shares of Alliqua common stock in
exchange for each share of Adynxx capital stock.
Following the reverse stock split and merger, the combined
organization is expected to have approximately 5.8 million shares
outstanding.
Adynxx will pay the previously announced special cash dividend
of $1.05 per share as soon as practicable following consummation of
the reverse stock split and merger. In addition, Adynxx intends to
consummate the previously announced distribution of shares of
AquaMed Technologies, Inc., currently 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, and in any
event, no later than June 21, 2019.
Adynxx expects to receive a written notification from the
Listing Qualifications Department of Nasdaq notifying the company
that Nasdaq has determined, among other things, that the company’s
stockholders’ equity does not comply with the minimum stockholders’
equity requirement for initial listing on the Nasdaq Capital
Market, as set forth in Nasdaq Listing Rule 5505. Adynxx expects to
submit a plan to Nasdaq to regain compliance with Nasdaq Listing
Rule 5505.
Biographies of the New Board Members
Pierre Legault
In addition to his membership on the Adynxx board of directors,
Pierre Legault, MBA, CPA is the Chairman of Bicycle Therapeutics, a
pharmaceutical company developing a new class of versatile,
chemically synthesized medicines to address therapeutic needs
unreachable with any other existing modality; Poxel, a
biopharmaceutical company developing innovative drugs for metabolic
diseases, including type 2 diabetes and non-alcoholic
steatohepatitis; and Artios, a DNA damage repair company. Legault
is also a member of the board of Clementia Pharmaceuticals, Urovant
Sciences and Syndax Pharmaceuticals. In the past, he was a board
member of Forest Laboratories, Tobira Therapeutics, NPS
Pharmaceuticals, Regado Biosciences, Armo Biosciences, Iroko
Pharmaceuticals, Cyclacel Pharmaceuticals, Eckerd Pharmacy and
Nephrogenex, where he also served as the Chairman and Chief
Executive Officer from 2012 to 2016. From 2010 to 2012, he served
as the CEO of Prosidion. From 2009 to 2010, he was the CFO and
Treasurer of OSI Pharmaceuticals. Legault also served as the CEO of
Eckerd Pharmacy and Senior Executive Vice President and CAO of the
Rite Aid Corporation. Between 1989 and 2005, he held various global
roles such as President, CEO and CFO of a global group at Sanofi
and legacy companies.
Matthew Ruth
In addition to his membership on the Adynxx board of directors,
Matt Ruth is currently Senior Vice President, U.S. Chief Commercial
Officer for Adapt Pharma, a division of Emergent Bio Solutions
commercializing Narcan Nasal Spray, a product that can reverse the
effects of opioid and heroin overdoses. Following a successful
launch of Narcan in 2016, Adapt was acquired by Emergent
BioSolutions for up to $735 million. From 2012 to 2015, Ruth was
Chief Operating Officer for RightCare Solutions, a medical
technology company that was acquired by NaviHealth in 2015. From
2007 to 2012, he was Vice President of Azur Pharma which was
acquired by Jazz Pharma in 2012. From 2006 to 2007, he served as
Vice President of Avanir Pharmaceuticals responsible for the
commercial operation along with M&A activities, including the
acquisition of Alamo Pharma and the sale of the CNS franchise to
Azur. From 2000 to 2006, he held positions of increasing
responsibility at Allergan.
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 company(415)
513-1284patti.bank@westwicke.com
Media: David SchullPresidentRusso Partners(858)
717-2310david.schull@russopartnersllc.com