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Adial Pharmaceuticals Provides Business Update for the Third Quarter of 2018
CHARLOTTESVILLE, Va., Nov. 14, 2018 — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided a business update for the third quarter 2018, as well as recent activities, and has filed its Current Report on Form 10-Q for the quarter ended September 30, 2018, which is available at www.sec.gov
- Completed IPO in July for gross proceeds of $7.32 million
- Appointed Monika Z. Rogozinska as Senior Vice President of Drug and Business Development
- Reported successful results related to the stability testing of the clinical trial material for AD04
- Passed the patent opposition period in Europe without any challenges on its patent for AD04
- Received Notice of Allowance from the Canadian Intellectual Property Office on its patent for AD04
William Stilley, CEO of Adial Pharmaceuticals, stated, “This has been a very active period for the Company following our successful IPO in July. In addition to the funding we received through the IPO, we are also exploring a variety of non-dilutive funding options that we believe may help to accelerate our activities. In the meantime, we are rapidly moving forward on our clinical activities related to our Phase 3 trial for AD04 and look forward to providing further updates in the very near term. Towards this end, we have expanded our senior management team with the addition of Monika Z. Rogozinska, who is helping spearhead many of our initiatives.”
“We are also making tremendous progress expanding our IP portfolio. We recently announced that we passed the patent opposition period in Europe, an important milestone that provides us broad coverage in 36 European countries through at least 2031. We also received a Notice of Allowance from the Canadian Intellectual Property Office, which provides us coverage through 2029 with additional Canadian patents pending that are expected to extend our protection through 2032. In addition to these patents, we are actively pursuing additional patents in the U.S. and around the world, that will not only strengthen our coverage for AD04 in alcohol use disorder (AUD), but also expand our coverage into other indications, based on the mechanism of action for AD04.”
“As recently reported in the The Lancet, one of the world’s leading medical journals, alcohol is the number one cause of death globally among both men and women ages 15 to 49 years. AUD is an enormous and underserved market with an estimated 35 million people in the U.S. and 55 million people in Europe suffering from this terrible disease. Moreover, there are very limited options for these individuals and current therapeutic options have limited efficacy and present major barriers to patient adoption. Assuming we can replicate our prior results in the Phase 3 trial, we believe our genetically target approach would provide a safe and convenient treatment option for patients, which in turn has to potential to provide hope to millions of individuals worldwide, suffering from this deadly disease.”
“Finally, we are encouraged by the recent stability testing results, which exceeded our expectations. Additionally, the drug was manufactured through a process and at a scale that we believe could be used to support a commercial product.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug candidate, AD04, is a genetically targeted therapeutic agent for the treatment of alcohol use disorder (AUD). A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity.
About Alcohol Use Disorder
According to an article in the widely respected publication The Lancet, alcohol is the number one cause of death globally among both men and women ages 15 to 49 years. In the United States alone, approximately 35 million people have AUD resulting in significant health, social and financial costs (NIAAA Alcohol Facts & Statistics). AUD contributes to over 200 different diseases, and 10% of children live with a person that has an alcohol problem. According to the American Society of Clinical Oncologists, 5-6% of new cancers and cancer deaths globally are directly attributable to alcohol. The Centers for Disease Control (CDC) has reported that AUD costs the U.S. economy about $250 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. In addition, according to the NIAAA, the problem in the United States appears to be growing with an approximately 50% increase in AUD prevalence between 2002 and 2013.
Despite the high prevalence and high costs, according to an article in the JAMA 2015 publication, only 7.7% of patients (i.e., approximately 2.7 million people) with AUD are estimated to have been treated in any way and only 3.6% by a physician (i.e., approximately 1.3 million people). The most common treatments for AUD are directed at achieving abstinence and typical treatments include psychological and social interventions. Most therapies require abstinence even prior to initiating therapy. Abstinence requires dramatic lifestyle changes often with serious work and social consequences. Significant side effects of current pharmacologic therapies include mental side effects such as psychiatric disorders and depressive symptoms and physical side effects such as nausea, dizziness, vomiting, abdominal pain, arthritis and joint fitness. These problems with the currently available therapies appear to limit the willingness of people with AUD to seek treatment and then to limit compliance with treatment requirements and, therefore, the ultimate results for many people attempting currently available therapies.
Forward Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements are based upon current beliefs, expectations and assumptions and include statements regarding non-dilutive funding options helping to accelerate our activities, the patent providing patent protection in Europe for AD04 for the treatment of alcohol use disorder through 2031, already issued U.S. patents providing coverage through 2032, plus expected patent expansion into other indications, our genetically targeted approach providing a safe and convenient treatment option for patients, recent stability testing results indicating AD04 could be used as the clinical trial material in the planned clinical trials and could be manufactured through a process and at a scale to support a commercial product and plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, the ability of our patent portfolio to provide protection in Europe through 2031 and in the U.S. patents through 2032, plus expected patent term extensions, our ability to continue to further expand our patent portfolio by prosecuting patent applications related to our proprietary companion diagnostic genetic test and the use of AD04 in other addictive disorders, the ability of AD04 therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, our ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, our ability to manufacture AD04 through a process and at a scale to support a commercial product, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 that we have filed with the SEC. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Crescendo Communications, LLC
David Waldman / Natalya Rudman