Core Viewpoint - Adial Pharmaceuticals, Inc. is gaining visibility through CEO Cary Claiborne's appearance on the Big Biz Show, which could enhance the company's profile in the biopharmaceutical industry focused on addiction treatment [1][2]. Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing therapies for addiction and related disorders [3]. - The company's lead product, AD04, is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients [3]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking among heavy drinkers without significant safety or tolerability issues [3]. - The potential applications of AD04 extend to other addictive disorders, including Opioid Use Disorder, gambling, and obesity [3].

Core Insights - Branded Legacy, Inc. has acquired a 22,000-square-foot commercial property in Vancouver, Canada, to establish a state-of-the-art laboratory and manufacturing facility aimed at addressing the opioid crisis [1][2] - The facility is compliant with Good Manufacturing Practices (GMP) and features ISO Class 7 and 8 clean rooms, ensuring high-quality standards for sensitive manufacturing processes [1][3] - The in-house laboratory is equipped to handle a variety of substances, including opioids, and the company has pending applications for Controlled Substances Licenses with Health Canada [4] - The strategic location in Vancouver allows for direct collaboration with local populations affected by the drug crisis, enhancing the relevance of the solutions developed [5] - Company executives emphasize that this acquisition aligns with their vision to create a comprehensive ecosystem for addiction solutions, combining expertise with academic partnerships and advanced manufacturing capabilities [6] Company Overview - Branded Legacy, Inc. focuses on health and wellness, developing innovative solutions to combat addiction, including a patented intranasal naloxone delivery device for opioid overdose treatment [7]

Core Insights - Diamond Equity Research has initiated coverage of BioCorRx®, Inc., highlighting its diversified product pipeline and strategic positioning in the addiction treatment market [1][3]. Company Overview - BioCorRx® Inc. is a biopharmaceutical company focused on developing treatments for substance use disorders, with key products including the implantable naltrexone candidate BICX104 and the commercial drug LUCEMYRA® [3]. Product Pipeline - The company has a strategically diversified product pipeline that includes FDA-approved products and advanced clinical-stage candidates, with LUCEMYRA® being a revenue-generating asset for opioid withdrawal [1]. - BICX104 is an innovative biodegradable naltrexone implant that offers sustained drug release over approximately 84 days, significantly longer than the standard 28-day injections [1]. Financial Backing - BioCorRx® has received substantial federal funding, including an $11 million grant for advancing BICX104 for methamphetamine use disorder, which mitigates clinical development risks [1]. - The company has secured a total of $20 million in non-dilutive grant funding to support the development and clinical research of BICX104 [1]. Market Expansion Opportunities - BioCorRx® is exploring growth opportunities through expanded indications for LUCEMYRA®, international market expansion into Canada, and integration with digital health solutions [1]. - The global opioid use disorder market is projected to reach $10.24 billion by 2030, presenting significant revenue diversification potential for the company [1]. Valuation Insights - The risk-adjusted valuation of BioCorRx® is driven by contributions from BICX104 and LUCEMYRA®, with a projected treatment cost of $15,000 per patient per year for BICX104 [1]. - A discounted cash flow (DCF) analysis estimates a risk-adjusted valuation of $0.80 per share, contingent on successful execution by the company [1].

Core Insights - Branded Legacy, Inc. has formed a strategic partnership with McMaster University to enhance the development of interventions for addiction treatment, leveraging academic research and real-world innovation [1][2][3] Company Overview - Branded Legacy, Inc. is a diversified holdings company focused on health and wellness solutions, particularly in combating addiction and supporting recovery [6] - The company’s subsidiary, Bio-Legacy Evaluative Group, is dedicated to creating innovative products aimed at populations affected by addictions [1][3] Partnership Details - The collaboration combines McMaster University's clinical research expertise with Bio-Legacy Evaluative Group's practical experience in addiction medicine, facilitating rigorous evaluations and clinical trials [2][5] - This partnership aims to develop cost-effective interventions to reduce acute overdose deaths and support long-term recovery for addicted individuals [2][3] Product Innovation - Bio-Legacy Evaluative Group's flagship product is a patented intranasal naloxone delivery device designed to address market limitations such as high costs and inconsistent dosing [4] - The naloxone market is projected to grow from $371 million in 2022 to over $1.16 billion by 2032, with a compound annual growth rate (CAGR) of approximately 11.9% [4] Market Impact - The partnership is expected to create a scalable industry model that meets regulatory requirements while addressing societal needs, ultimately enhancing shareholder value through innovative advancements [5]

Core Insights - Adial Pharmaceuticals has made significant progress in the first quarter of 2025, particularly in advancing its lead investigational drug AD04 for Alcohol Use Disorder (AUD) [2] - The company successfully completed a pharmacokinetics bridging study, confirming favorable bioavailability of AD04, and has begun manufacturing clinical trial supplies [2] - Regulatory alignment with the FDA has been achieved, supporting a streamlined path for the upcoming Phase 3 clinical trial [2] - Adial has strengthened its intellectual property portfolio with multiple granted patents related to AD04 [5] Financial Results - As of March 31, 2025, cash and cash equivalents were $2.4 million, down from $3.8 million as of December 31, 2024 [12] - Research and development expenses increased by approximately $293 thousand (65%) compared to the same period in 2024, driven by increased CMC expenses and consulting [12] - General and administrative expenses rose by approximately $129 thousand (9%) due to higher compensation and consulting [12] - The net loss for the first quarter of 2025 was $2.2 million, a decrease from a net loss of $6.5 million in the same quarter of 2024 [12] Strategic Developments - Adial received a six-figure milestone payment from Adovate, LLC, following the start of a Phase 1 clinical trial for an asthma compound [3] - The company is eligible for over $50 million in commercial milestone payments and an additional $11 million in development and approval milestone payments for the first three compounds [4] - Adial retains over a 10% equity stake in Adovate, allowing participation in the long-term upside as the asthma candidate progresses [4] Intellectual Property - A new patent was issued covering the administration of AD04 as a precision medicine approach for patients with specific genetic markers [5] Future Outlook - The company is preparing for an End of Phase 2 meeting with the FDA in July to finalize the Phase 3 trial design [2][13] - There is confidence in advancing AD04 through late-stage development, with potential applications for other addictive disorders such as Opioid Use Disorder, gambling, and obesity [9][13]

Core Insights - Adial Pharmaceuticals has achieved a milestone by receiving a six-figure payment from Adovate, LLC, following the initiation of a Phase 1 clinical trial for ADO-5030, a novel asthma therapy targeting a significant market with unmet medical needs [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with its lead product AD04 targeting Alcohol Use Disorder (AUD) [4] Financial Aspects - Under the agreement with Adovate, Adial is eligible for over $50 million in commercial milestone payments and an additional $11 million in development and approval milestone payments per compound, totaling up to $83 million for the first three compounds if milestones are achieved [3][7] - Adial retains a significant equity stake of over 10% in Adovate, allowing participation in the long-term upside as the asthma candidate progresses [3][7] Clinical Development - The ongoing Phase 1 study for ADO-5030 is a Single Ascending Dose (SAD) trial aimed at evaluating safety, tolerability, and pharmacokinetics in healthy volunteers, with the potential to shift the treatment paradigm for asthma patients globally [2][3]

As filed with the Securities and Exchange Commission on November 8, 2023. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ADIAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8071 82-3074668 (I.R.S. Employer Identification No.) Adia ...