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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company dedicated to developing treatments for addiction and related disorders. The company's primary focus is on creating personalized therapies that address the unique needs of individuals suffering from substance abuse. Adial's flagship product, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. AD04 has shown promise in reducing excessive drinking in heavy drinking patients and has been investigated in the company's ONWARD™ pivotal Phase 3 clinical trial. The active ingredient in AD04 is ondansetron, which is commonly used to prevent nausea and vomiting, and now brings potential benefits in addiction treatment.
Adial leverages its expertise in pharmacogenomics to develop therapies that are tailored to the genetic makeup of patients. This approach has the potential to revolutionize the treatment of addiction by providing more effective and safer treatment options. The company recently regained compliance with Nasdaq's listing requirements by maintaining a stockholders' equity of at least $2.5 million. Adial has also been active in forming strategic partnerships, including an agreement with Adovate, LLC, which could yield up to $83 million in milestone payments and commercial royalties.
Adial's intellectual property portfolio is robust, with multiple patents protecting the combination of its genetic diagnostics and AD04 for the treatment of AUD, Opioid Use Disorder (OUD), and other dependencies. The company's recent awards include the 2023 Best Practices Technology Innovation Leadership Award from Frost & Sullivan. Financially, Adial is in a stable position, with cash and cash equivalents allowing it to fund operations into the first quarter of 2025. The company's research and development expenses have been judiciously managed, ensuring that resources are effectively utilized.
Recent studies have underscored the safety and efficacy of AD04, highlighting its favorable liver safety profile compared to placebo and its potential to treat other addictive disorders like gambling and obesity. Adial has initiated new activities related to its clinical development plan, including two parallel Phase 3 clinical trials of AD04 to support its approval in the shortest timeframe possible. The company is also engaging with the FDA to refine its study designs and enhance the likelihood of regulatory success.
Adial Pharmaceuticals continues to make significant strides in its mission to develop innovative solutions for addiction treatment, offering hope to millions affected by these disorders worldwide.
Adial Pharmaceuticals, focused on addiction treatments, announced that CEO William Stilley will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 AM Eastern Time. Adial's lead drug, AD04, is being studied in its ONWARD™ Phase 3 trial for Alcohol Use Disorder (AUD) targeting specific genetic profiles, following promising Phase 2b results. The company also explores treatments for other addictions and related disorders.
Adial Pharmaceuticals has successfully closed enrollment for its ONWARD™ Phase 3 trial, achieving 302 patients across 25 clinical sites, exceeding the target of 290. This trial is assessing AD04 for Alcohol Use Disorder (AUD) in patients with specific genetic markers. The company anticipates completing patient dosing by Q1 2022 and looks forward to releasing top-line data shortly thereafter. Preliminary retention rates and safety data indicate AD04 is well-tolerated, potentially positioning it favorably against existing AUD treatments.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has completed enrollment for its ONWARD™ Phase 3 clinical trial, targeting 290 participants with Alcohol Use Disorder (AUD) related to specific genetic markers. The trial is expected to conclude in Q1 2022. CEO William Stilley highlighted strong patient interest, with 33% of screened subjects testing positive for targeted genetics. The market potential for AD04, a novel treatment for AUD, is estimated to exceed $36 billion in the U.S. Additionally, the trial retention rate is high with no serious adverse events reported, enhancing the drug's safety profile.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) will hold a conference call on August 20, 2021, at 11:00 A.M. Eastern Time to discuss clinical updates and business developments. U.S. callers can join by dialing 844-369-8770, while international participants can dial +1 862-298-0840. A webcast will also be available on the Company’s website. An audio replay will be accessible until September 3, 2021. Adial focuses on developing treatments for addiction, with its lead product, AD04, currently in a pivotal Phase 3 trial for Alcohol Use Disorder.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announces a conference call on August 20, 2021, at 11:00 A.M. ET for a clinical update and business developments. The call can be accessed via telephone or webcast. The Company focuses on therapies for addiction, with its lead product, AD04, currently in a pivotal Phase 3 trial targeting Alcohol Use Disorder (AUD). Prior Phase 2b results showed significant reductions in drinking frequency and quantity without major safety concerns. AD04 may also address other addictive disorders.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced recent patent issuances for its lead asset, AD04, aimed at treating Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD). Patents were granted in the U.S., Canada, Israel, and Brazil, protecting the use of AD04 for patients with specific genetic markers. The ONWARD trial, a Phase 3 study for AD04 in AUD, is ongoing across seven countries. The company highlights the potential of AD04 in treating OUD, given the similarities in addiction physiology. CEO William Stilley emphasizes these advancements as significant opportunities.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the completion of a $5,000,002 private placement of 1,666,668 shares at $3.00 each, funding its ONWARD™ Phase 3 trial for AD04, a treatment for Alcohol Use Disorder (AUD). The financing, totaling $7.1 million when combined with a previous round, supports trial completion until data read-out. CEO William Stilley expressed confidence in investor support and business outlook. AD04 aims to target specific genetic profiles in AUD treatment, with prior trials showing significant results without safety concerns.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced that its CEO, William Stilley, has published an op-ed on Nasdaq.com, discussing the importance of addressing Alcohol Use Disorder (AUD). The op-ed highlights that over 30 million people in the U.S. are affected by AUD, leading to more than 95,000 deaths annually, and a cost of $250 billion to the nation. Stilley underscores the positive impact of their investigational drug AD04, currently in a pivotal Phase 3 trial for AUD. The trial's results from a Phase 2b study showed promising reductions in drinking frequency and no significant safety issues.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced promising advancements in its adenosine analog development platform via its acquisition of Purnovate. The compounds developed show potency against targeted adenosine receptors while maintaining high solubility, achieving over 50 times more solubility than similar compounds. Initial studies indicate good oral bioavailability and pharmacological activity, particularly in reducing pain in rodents and demonstrating synergy with morphine and acetaminophen. These findings position Adial to potentially replace opioids and address addiction issues.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has entered into Securities Purchase Agreements for a private placement of 1,666,667 shares at $3.00 each, totaling $5 million. Leading the placement is Bespoke Growth Partners, Inc., contributing $2.5 million. The investment will be funded in two tranches: $500,000 immediately and the remaining $4.5 million following share registration. Adial focuses on addiction treatments, with its lead product AD04 currently in a pivotal Phase 3 trial for Alcohol Use Disorder (AUD), showing promising results in earlier trials.