Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADIL), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.
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, Inc. (NASDAQ: ADIL; ADILW) will have CEO William Stilley participate in the 2022 Virtual Growth Conference from March 28-30. The event, hosted by Maxim Group LLC and M-Vest, requires prior membership to attend. Stilley's pre-recorded corporate update will be accessible throughout the conference. This event will feature presentations from various sectors, including Biotech and Healthcare. Adial is focused on developing treatments for addiction, with its lead drug AD04 currently in a pivotal Phase 3 trial for Alcohol Use Disorder.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the completion of patient enrollment in its ONWARD™ Phase 3 trial, focusing on AD04 for treating Alcohol Use Disorder (AUD). The trial included 302 participants across 25 sites in Europe, surpassing initial targets. The CEO highlighted the significance of this milestone, emphasizing the need for effective AUD treatments amid rising public health concerns. Topline results are expected in Q2, aiming to demonstrate a statistically significant reduction in heavy drinking days for those treated with AD04 compared to a placebo.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has successfully closed a registered direct offering, generating around $10 million. A single accredited institutional investor purchased approximately 2,322,250 shares of common stock, along with pre-funded warrants and additional warrants to acquire about 3,977,888 shares. The effective purchase price was $2.40 per share/warrant. The net proceeds will enhance Adial's balance sheet as it advances its Phase 3 ONWARD™ trial for AD04, targeting addiction treatments.
Adial Pharmaceuticals has entered into a securities purchase agreement with an institutional investor to raise approximately $10 million through a registered direct offering of common stock and related warrants. The agreement includes the sale of 4,187,250 shares at an effective purchase price of $2.40 per share, alongside warrants for 3,977,888 shares with an exercise price of $2.52. The closing date is anticipated on February 15, 2022, subject to customary conditions. The offering is being facilitated by Maxim Group LLC.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced promising results for its subsidiary, Purnovate's PNV-5032, in treating asthma. The in vivo study showed a 25% reduction in pulmonary flow resistance, which indicates improved airflow in an asthmatic model compared to controls. PNV-5032 exhibited over 1000-fold selectivity for the adenosine A1 receptor and demonstrated significantly higher solubility than similar compounds. The company aims to initiate first-in-human trials in 2023, supported by a patent application extending protection until 2047.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced that the U.S. Patent and Trademark Office has sent a Notice of Allowance for patent application No. 16/784,051 concerning the treatment of opioid use disorder (OUD) using its drug AD04. This application is particularly focused on patients with a genetic biomarker for the serotonin-3 receptor. Currently, AD04 is being evaluated in the ONWARD Phase 3 trial for alcohol use disorder (AUD). The company expects long-term patent protection through 2036, supporting its goal to address the significant market of OUD.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced that CEO William Stilley will present at the H.C. Wainwright BioConnect 2022 Conference from January 10-13, 2022. The presentation will be available on-demand starting January 10 at 7:00 AM ET, accessible for 90 days. Adial is developing AD04, a treatment for Alcohol Use Disorder, currently undergoing a pivotal Phase 3 clinical trial. The company aims to treat various addictions and is working on adenosine analogs for pain management and other disorders.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced it received $720,000 from an $800,000 private placement, originally disclosed on November 10, 2021. The shares, priced at $4.00 each, were fully subscribed with 200,000 shares purchased. This funding was confirmed following the SEC's Notice of Effectiveness for the Form S-3 Registration Statement. Adial is focused on addiction therapies, particularly its lead investigational drug, AD04, which is under evaluation in the ONWARD™ Phase 3 trial aimed at treating Alcohol Use Disorder.
Adial Pharmaceuticals has appointed Cary J. Claiborne as Chief Operating Officer, while he remains on the Board of Directors. Claiborne's role includes overseeing strategic growth initiatives and commercial preparations for AD04, aimed at treating Alcohol Use Disorder (AUD). CEO William Stilley emphasized Claiborne's extensive experience in the biopharmaceutical sector, particularly in addiction treatment. Claiborne expressed enthusiasm for advancing the company’s therapeutic pipeline, including the promising AD04 and Purnovate's adenosine platform, which holds significant market potential.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) reported promising preclinical results for its lead compound PNV2 in treating triple negative breast cancer. The study showcased that PNV2 significantly reduced metastatic tumors in the lungs of mice compared to a control group, with luciferase activity indicating much lower cancer presence. Purnovate, Adial's subsidiary, plans to advance PNV2 to clinical trials in 2022, overcoming past solubility challenges associated with adenosine analogs. The company remains focused on its ongoing Phase 3 trial for its lead drug candidate for Alcohol Use Disorder.
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