Adynxx Stock to Move to OTC Market Following Receipt of Nasdaq Delisting Notice
June 12 2019 - 12:32PM
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 that it has received written
notification from The Nasdaq Stock Market affirming
the delisting of the company's shares from The
Nasdaq Capital Market due to noncompliance with the
minimum round lot stockholders and the
minimum stockholders’ equity requirement for an
initial listing.
The notification indicates that Nasdaq will complete the
delisting process by filing a Form 25 “Notification of
Delisting” with the SEC after all applicable Nasdaq
review and appeal periods have lapsed. In accordance
with Nasdaq’s Listing Rules, Adynxx has 15 days to
decide whether to appeal the delisting determination,
and the company is considering an appeal of the
determination. Any such appeal would not stay the suspension
of trading in the company’s common stock on Nasdaq.
Adynxx expects its common stock to begin trading on
the OTC Markets Pink market tier at the open of trading on
June 13, 2019 under its current trading symbol
“ADYX.” The company will continue to file periodic
reports that will be available on the SEC's website,
www.sec.gov.
“The transition to the OTC Market does not affect
our business operations or clinical development plans for
our lead product candidate, brivoligide for postoperative pain,
which we are advancing with the support of the National Institute
on Drug Abuse,” said Rick Orr, CEO of Adynxx. “At the same time, we
are diligently pursuing courses of action intended to comply with
Nasdaq’s initial listing requirements.”
As previously announced, 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 support clinical
development of brivoligide. The grant award will provide Adynxx
with $5.7 million over a two-year period to complete a Phase 2
study of brivoligide in patients undergoing mastectomy. Following
completion of milestones related to the Phase 2 mastectomy study,
Adynxx can receive an additional award of up to $9 million for a
Phase 3 study of brivoligide.
Adynxx plans to initiate two Phase 2 studies
of brivoligide this year. 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.
About Adynxx
Adynxx is a clinical stage biopharmaceutical company focused on
the development of transcription factor decoy technology and
bringing to market novel, disease-modifying products to address
unmet needs in the treatment of pain and inflammation. Since its
founding in 2007, Adynxx has leveraged the AYX platform of
proprietary transcription factor decoys to identify and develop
first-in-class product candidates to modify the course of pain.
Adynxx believes that its transcription factor decoy technology can
transform the treatment of pain, and going forward has the
potential to be applied to additional disease states. Adynxx plans
to continue advancing the AYX platform programs while
simultaneously generating new transcription factor decoy
candidates, collaborating with its artificial intelligence-driven
drug discovery partner, and evaluating in-licensing opportunities
in order to expand its pipeline and leverage its business
development, clinical development, and regulatory expertise.
About Brivoligide
Clinical studies suggest that a single administration of
brivoligide at the time of surgery could reduce pain for weeks,
shorten the time needed to achieve mild pain and reduce the need
for opioid use during recovery, in each case in a population of
patients at greater risk of experiencing increased and prolonged
pain following surgery. Brivoligide is an
intrathecally-administered, 23 base-pair, double-stranded DNA
transcription factor decoy oligonucleotide. It inhibits the
transcription factor Early Growth Response 1, or EGR1, in the
dorsal root ganglia, or DRG, and spinal cord at the time of
surgery. By inhibiting the function of EGR1 in people undergoing
surgery, Adynxx believes brivoligide prevents the production
of new proteins that start and maintain the increased sensitivity
to pain that some patients experience following surgery. These
patients, who are at greater risk of experiencing increased and
prolonged pain following surgery, are readily identified prior to
surgery using the Pain Catastrophizing Scale, or PCS, and represent
approximately one-third of the surgical population.
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; 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 http://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