Company on Track with All Business Operations and Clinical Development Plans for Brivoligide While Pursuing Options to Comply with Nasdaq’s Initial Listing Requirements
SAN FRANCISCO, June 12, 2019 (GLOBE NEWSWIRE) -- 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.
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.
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.
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.
Westwicke, an ICR company
Source: Adynxx, Inc.