LANGHORNE, Pa. and
SAN FRANCISCO, Oct. 12, 2018 /PRNewswire/ -- Alliqua
BioMedical, Inc. (Nasdaq:ALQA) and Adynxx, Inc., a privately held
biopharmaceutical company, today announced that they have entered
into a definitive merger agreement under which the stockholders of
Adynxx would become the majority owners of Alliqua's outstanding
common stock on a fully-diluted basis. The proposed merger will
create a public clinical-stage pharmaceutical company focused on
developing a platform of first-in-class, disease-modifying,
non-opioid therapies for the treatment of pain. Adynxx's lead
product candidate, brivoligide for the reduction of postoperative
pain, is intended to provide long-term pain relief and reduced
opioid usage with a single administration at the time of surgery in
a group of patients with a greater risk of experiencing increased
and prolonged pain following surgery.
"We are excited about creating multiple ways for our
shareholders to maximize value with Alliqua," said Dave Johnson, CEO of Alliqua. "First, as
announced in May, we intend to make a special cash dividend to our
stockholders before the merger. Second, following an extensive
review of strategic alternatives, Alliqua's Board of Directors has
determined that the signing of our definitive agreement with Adynxx
will allow our stockholders the opportunity to enjoy value
appreciation in their equity holdings. Finally, we are currently
exploring alternatives for our 16,500 square foot GMP custom
hydrogel manufacturing facility in Langhorne, Pa. to maximize
value for our shareholders."
"With the ongoing opioid crisis in the
United States, there is a critical need for novel and
effective non-opioid therapeutics to treat pain and reduce opioid
usage," noted Rick Orr, CEO of
Adynxx. "Following this transaction, our goal is to accelerate the
development of brivoligide to benefit patients that would otherwise
experience greater pain and higher levels of opioid usage following
surgery. We also plan to build a robust pipeline of novel
therapeutics for pain and inflammation through development of our
earlier-stage internal programs, our ongoing discovery
collaboration leveraging artificial intelligence, and additional
in-licensing activities."
"We believe moving into the public markets will allow Adynxx to
rapidly advance brivoligide and create significant value for
shareholders," added Dennis
Podlesak, Adynxx Chairman and Partner of Domain Associates.
"The benefits of the merger, combined with the strength of the
management team, will also position the company to create
additional value through potential pipeline expansion with a
strategic focus on pain and inflammatory diseases."
The results of Adynxx's Phase 2 studies conducted in patients
undergoing total knee arthroplasty suggest that a single
administration of brivoligide prior to surgery can reduce both pain
with walking and pain at rest following surgery, shorten the period
of time needed to achieve mild postoperative pain and reduce the
need for postoperative opioids in subjects that are high scorers on
the pain catastrophizing scale (PCS), all with a very favorable
safety profile. The clinical profile of brivoligide in high
scorers on the PCS will be prospectively evaluated in upcoming
Phase 2 clinical studies in total knee arthroplasty and mastectomy.
Each trial will involve approximately 130 subjects scoring 16 or
greater on the PCS. Both studies are designed to provide
guidance for the planned Phase 3 pivotal studies to be initiated
after meetings with regulatory authorities. The proposed indication
for brivoligide is the treatment of postoperative pain in patients
that score 16 or greater on the PCS.
The proposed merger remains subject to certain conditions,
including approval by Alliqua's and Adynxx's stockholders.
About the Proposed Merger
The merger is structured as a stock-for-stock transaction
whereby all of Adynxx's outstanding shares of common stock and
securities convertible into or exercisable for Adynxx's common
stock will be converted into Alliqua common stock and securities
convertible into or exercisable for Alliqua common stock.
Under the exchange ratio formula in the merger agreement,
immediately after the merger the former Adynxx securityholders are
expected to own approximately 86% of the aggregate number of shares
of the Alliqua common stock issued and outstanding following the
consummation of the merger, and the existing stockholders of
Alliqua are expected to own approximately 14% of the aggregate
number of shares of the Alliqua common stock issued and outstanding
following the consummation of the merger. Under certain
circumstances further described in the merger agreement, the
exchange ratio may be adjusted in a manner that would reduce the
percentage of the aggregate number of post-merger shares of Alliqua
common stock held by the existing stockholders of Alliqua.
Upon closing of the transaction, Alliqua will be renamed Adynxx,
Inc. and will be headquartered in San
Francisco under the leadership of Adynxx's current
management team. Prior to closing, Alliqua will seek stockholder
approval to conduct a reverse split of its outstanding shares to
satisfy listing requirements of the Nasdaq Capital Market. The
combined company is expected to trade on the Nasdaq Capital Market
under a new ticker symbol. The merger agreement has been
unanimously approved by the board of directors of each company. The
transaction is expected to close by the first quarter of 2019,
subject to approvals by the stockholders of each company and other
customary closing conditions.
H.C. Wainwright & Co. is acting as Alliqua's financial
advisor in the transaction and MTS Securities, LLC is acting as
financial advisor to Adynxx. Haynes and Boone, LLP is serving
as legal counsel to Alliqua and Cooley LLP is serving as legal
counsel to Adynxx with respect to the transaction.
About Alliqua BioMedical, Inc.
Alliqua can provide a custom manufacturing solution to partners
in the medical device; cosmetics; and OTC industry, utilizing its
proprietary hydrogel technology. Alliqua's electron beam production
process, located at its 16,500 square foot GMP manufacturing
facility in Langhorne, Pa., allows
Alliqua to custom manufacture a wide variety of hydrogels.
Alliqua's hydrogels can be customized for various transdermal
applications to address market opportunities in the treatment of
wounds as well as the delivery of numerous drugs or other agents
for pharmaceutical and cosmetic industries.
For additional information, please visit http://www.alliqua.com.
To receive future press releases via email, please visit
https://ir.stockpr.com/alliqua/email-alerts.
About Adynxx
Adynxx, Inc., located in San
Francisco, is a clinical-stage pharmaceutical company
developing a potentially transformative technology platform
addressing pain at its molecular roots – treating the development
of pain following surgery or trauma and established chronic pain
syndromes. Adynxx`s approach is to transform pain management by
approaching pain as a disease rather than a symptom. For more
information, visit www.adynxx.com.
About Brivoligide
Brivoligide (AYX1) is an investigational drug intended to reduce
acute post-surgical pain with a single administration at the time
of surgery. It acts by locally inhibiting EGR1 activity at the time
of surgery or trauma in neurons critical to pain sensation,
switching off the sequence of events leading to exacerbated pain
after surgery, including pain with movement. EGR1 is a
transcription factor transiently upregulated in the spinal cord and
dorsal root ganglia at the time of surgery or trauma. During this
short period of upregulation, EGR1 triggers waves of gene
transcription and subsequent protein expression that change
neuronal properties, establishing mechanical hypersensitivity and
leading to long-term pain arising from a single traumatic
incident.
About the Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a validated and
sensitive 13-item clinical tool, developed in 1995, which assesses
the three domains of the catastrophizing construct: rumination,
helplessness and magnification. Each item is rated on a zero to
four-point scale, with the total score ranging from zero to
52. Patients with a score of 16 or higher on the PCS are more
likely to experience inadequate pain relief following surgery and
represent 25-35% of all patients undergoing surgery. The
relationship between PCS score and pain has been extensively
documented and more than 600 papers have been published on use of
the PCS in acute and chronic pain populations. Elevated
scores on the PCS may reflect altered descending pain modulation
neuronal networks associated with enhanced postoperative pain. The
PCS can be provided to patients well in advance of surgery and
easily integrated into the patient assessment and education flow to
reliably identify patients suitable for brivoligide treatment. PCS
data were collected in all three Phase 2 studies of brivoligide and
show consistent effects in subjects with high PCS scores.
Safe Harbor Statements
Additional Information about the Proposed Merger and Where
to Find It
In connection with the proposed merger, Alliqua intends to file
relevant materials with the Securities and Exchange Commission, or
the SEC, including a proxy statement. Investors and security
holders of Alliqua and Adynxx are urged to read these materials
when they become available because they will contain important
information about Alliqua, Adynxx and the proposed merger. The
proxy statement and other relevant materials (when they become
available), and any other documents filed by Alliqua with the SEC,
may be obtained free of charge at the SEC web site at www.sec.gov.
In addition, investors and security holders may obtain free copies
of the documents filed with the SEC by Alliqua by directing a
written request to: Alliqua, Inc., Inc. 2150 Cabot Blvd West, Suite
B, Langhorne, Pa. 19047, Attn:
Investor Relations. Investors and security holders are urged to
read the proxy statement and the other relevant materials when they
become available before making any voting or investment decision
with respect to the proposed merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Participants in the Solicitation
Alliqua and its directors and executive officers and Adynxx and
its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Alliqua in connection with the proposed transaction. Information
regarding the special interests of these directors and executive
officers in the proposed merger will be included in the proxy
statement referred to above. Additional information regarding the
directors and executive officers of Alliqua is also included in
Alliqua's Annual Report on Form 10-K for the year ended
December 31, 2017 and the proxy
statement for Alliqua's 2018 Annual Meeting of Stockholders. These
documents are available free of charge at the SEC web site
(www.sec.gov) and from Investor Relations at Alliqua at the address
described above.
Forward Looking Statements
Alliqua cautions you that statements in this press release that
are not a description of historical fact are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements may be identified by
the use of words referencing future events or circumstances such as
"expect," "intend," "plan," "anticipate," "believe," and "will,"
among others. Such statements include, but are not limited to,
statements regarding the structure, timing and completion of our
proposed merger with Adynxx; our continued listing on the Nasdaq
Capital Market prior to and after the proposed merger; our
expectations regarding the capitalization, resources and ownership
structure of the combined organization; our expectations regarding
the sufficiency of the combined organization's resources to fund
the advancement of any development program or the completion of any
clinical trial; the nature, strategy and focus of the combined
organization; the safety, efficacy and projected development
timeline and commercial potential of any product candidates; the
executive officer and board structure of the combined organization;
and the expectations regarding voting by Alliqua and Adynxx
stockholders. Alliqua and/or Adynxx may not actually achieve the
proposed merger, or any plans or product development goals in a
timely manner, if at all, or otherwise carry out the intentions or
meet the expectations or projections disclosed in our
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. These forward-looking statements are based upon
Alliqua's and Adynxx's current expectations and involve assumptions
that may never materialize or may prove to be incorrect. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with stockholder approval of and
the ability to consummate the proposed merger through the process
being conducted by Alliqua and Adynxx, the ability to project
future cash utilization and reserves needed for contingent future
liabilities and business operations, the availability of sufficient
resources for combined company operations and to conduct or
continue planned clinical development programs, the timing and
ability of Alliqua or Adynxx to raise additional equity capital to
fund continued operations; the ability to successfully develop any
of Adynxx's product candidates, and the risks associated with the
process of developing, obtaining regulatory approval for and
commercializing drug candidates that are safe and effective for use
as human therapeutics. Risks and uncertainties facing Alliqua are
described more fully in Alliqua's periodic reports filed with the
SEC available at www.sec.gov. You are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the
date on which they were made. Alliqua undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made,
except as may be required by law.
Contact:
William Martin
1-415-512-7740 ext 205
wmartin@adynxx.com
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SOURCE Adynxx, Inc.