Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder “AUD” using its lead investigational new drug product, AD04. A Phase 2b University of Virginia investigator-sponsored clinical trial of AD04 for the treatment of AUD showed promising results 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.
On November 14th, 2018, the Company announced the business update for the third quarter of 2018, as well as recent activities
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.”
Recent developments:
- 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
Additionally, Adial is also making tremendous progress expanding its IP portfolio. ADIL recently announced that it passed the patent opposition period in Europe, an important milestone that provides it broad coverage in 36 European countries through at least 2031. The company also received a Notice of Allowance from the Canadian Intellectual Property Office, which provides its coverage through 2029 with additional Canadian patents pending that are expected to extend its protection through 2032. In addition to these patents, Adial is actively pursuing additional patents in the U.S. and around the world, that will not only strengthen its coverage for AD04 in alcohol use disorder (AUD) but also expand its coverage into other indications, based on the mechanism of action for AD04.”
Analysts Review and Target Price:
Analyst tracking the stock are bullish about the company and are encouraged by the recent stability testing results, which exceeded management’ expectations as well. Additionally, the drug was manufactured through a process and at a scale that could be used to support a commercial product.
Thus, value investors should consider exposure in this sector as the backdrop remains favorable. Per www.marketbeat.com, Their average twelve-month price target is $5.00, suggesting that the stock has a possible upside of 30.21%. The high price target for ADIL is $5.00, and the low-price target for ADIL is $5.00. There are currently two buy ratings for the stock, resulting in a consensus rating of “Buy.”
Below are the excerpts of recent ratings by brokerage house:
Source: marketbeat.com
About the company: 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 the 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.
Clinical studies:
Other recent announcements: Crown CRO (“Crown”) to help oversee the trial.
On Nov. 29, 2018, the company announced that it has established a Scientific Advisory Board (SAB) and has appointed Dr. Giovanni Addolorato, a leading global expert in the field of alcohol use disorder (AUD), as its first member and Chairperson. The SAB will help to guide the Company’s strategy and advance AD04, its lead therapeutic agent for AUD, with Phase 3 trials expected to commence in the first half of 2019.
William Stilley, CEO of Adial Pharmaceuticals, stated, “We are pleased to officially launch our new Scientific Advisory Board to support the development efforts of AD04, our lead product candidate. We welcome Dr. Addolorato as the first member of our SAB, as he brings tremendous knowledge and experience in AUD and is expected to play an integral role as we prepare to begin our Phase 3 clinical trial.”
Industry Potential:
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. Also, 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.
Third Quarter 2018 Highlights:
- Research and Development: R&D expenses increased by approximately $191,000 (147%) during the nine months ended September 30, 2018, as compared to the nine months ended September 30, 2017. The increase was primarily due to increased salaries and headcount of development-directed officers and employees, post-IPO, as well as an increase in development expenses of about $30,000 in the first six months of the year.
- Liquidity: As of September 30, 2018, we had approximately $4,817,000 in cash and cash equivalents and $4,922,000 of working capital, compared to approximately $18,000 in cash and cash equivalents and $(1,005,000) of negative working capital as of December 31, 2017.
Key risk factors and potential stock drivers:
- Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.
- ADIL is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.
- The company’ business risk profile is significantly dependent upon the success of its lead product candidate, AD04, which requires significant additional clinical testing before Adial could seek regulatory approval and potentially launch commercial sales. The company does not have any other products in clinical development.
- ADIL has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.
Stock Performance
Comments:
- On Monday, December 3, 2018, ADIL was at $3.05, with volume of 924K shares exchanging hands. Market capitalization is $18.39 million. The current RSI is 62.19.
- In the past 52 weeks, shares of ADIL have traded as low as $1.11 and as high as $5.00
- At $3.05, shares of ADIL are trading above its 50-day moving average (MA) at $2.17
- The present support and resistance levels for the stock are at $2.67 & $5.59 respectively.
Disclaimer
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.
