Adial Pharmaceuticals Investor Brief · Q2 · 2026

A Precision Medicine Breakthrough for Addiction.

Adial Pharmaceuticals is pioneering genetically targeted therapies for Alcohol Use Disorder — a global health crisis affecting tens of millions of people with limited effective treatment options. By combining precision medicine, companion diagnostics, and targeted therapeutics, Adial is developing a new generation of addiction treatments designed to improve outcomes and expand access to care.

Listed Nasdaq: ADIL
Lead Asset AD04
Indication Alcohol Use Disorder
Stage Pivotal Ready
Adial Pharmaceuticals — Fighting Alcohol Use Disorder
Fighting Alcohol Use Disorder Combining precision medicine, companion diagnostics, and targeted therapeutics
groups
~30M Americans suffer from Alcohol Use Disorder
medical_services
~2.6M Only ~2.6 million currently receive treatment
coronavirus
200+ Alcohol contributes to over 200 diseases
warning
#1 Risk factor for death among people ages 15–49 globally
01 The Addiction Treatment Gap

Millions Struggle With Addiction. Effective Treatments Remain Limited.

Alcohol Use Disorder (AUD) represents one of the largest unmet medical needs in modern healthcare. Despite its enormous societal and economic impact, most patients receive no treatment and existing therapies often fail to deliver consistent results. Excessive alcohol consumption contributes to more than 200 diseases and health conditions1 and is responsible for 5.3% of deaths worldwide1. The economic impact is staggering. Alcohol misuse costs the U.S. economy approximately $250 billion annually2, yet treatment adoption remains extremely low.

This enormous treatment gap represents both a major public health challenge and a significant pharmaceutical opportunity.

  • World Health Organization, Global Status Report on Alcohol and Health.
  • Centers for Disease Control and Prevention, "Excessive Drinking Costs U.S. $249 Billion."
02 Why Current Treatments Fail

Existing Therapies Leave Millions Without Effective Solutions.

Despite decades of development, currently available medications for Alcohol Use Disorder face major barriers that limit their effectiveness and adoption.

01
Limited Efficacy
Many current therapies fail to significantly reduce heavy drinking across large patient populations.
02
Side Effects
Existing drugs often cause adverse effects including nausea, psychiatric symptoms, and poor tolerability.
03
Abstinence Requirement
Most therapies require patients to stop drinking entirely before beginning treatment — creating a major barrier to adoption.
04
Stigma and Compliance Issues
Traditional addiction treatments often carry social stigma and require difficult lifestyle changes, reducing patient participation.
The Takeaway

The majority of patients with Alcohol Use Disorder remain untreated.

03 A Precision Medicine Platform

Genetically Targeted Therapy Designed for Better Outcomes

Adial's lead investigational drug candidate, AD04, is a genetically targeted serotonin-3 receptor antagonist designed to treat Alcohol Use Disorder in patients with specific genetic markers. The therapy is paired with a proprietary genetic diagnostic test that identifies individuals most likely to respond to treatment.

04 AD04 — Lead Drug Candidate

Designed to Treat Alcohol Use Disorder More Effectively.

Adial's lead drug candidate AD04 is a genetically targeted therapy designed to treat Alcohol Use Disorder in patients with specific genetic markers. AD04 works by modulating serotonin pathways associated with addictive behaviors and alcohol consumption.

  • check_circle Precision medicine approach with companion genetic test
  • check_circle Once-daily oral therapy
  • check_circle No abstinence requirement before treatment
  • check_circle Strong safety and tolerability profile
  • check_circle Designed specifically to reduce heavy drinking
Why It Matters

This differentiated profile could position AD04 as a new standard of care for targeted AUD patients.

Adial genetic companion diagnostic test
05 Clinical Data Demonstrates Strong Results

Promising Results in Genetically Identified Patient Groups.

Clinical analysis of AD04 has demonstrated meaningful improvements in targeted patient populations. In heavy drinkers with the AG+ genotype, AD04 significantly reduced heavy drinking days compared with placebo.3

86% Reduction in heavy drinking days in targeted patient groups
17.2 → 2.4 Heavy drinking reduced from 17.2 days to ~2.4 days per month
vs. Placebo Significant improvement versus placebo in responder populations
The Takeaway

These results demonstrate the potential for precision medicine to dramatically improve addiction treatment outcomes.

  • Adial Pharmaceuticals, ONWARD pivotal Phase 3 clinical trial analysis. AD04 is an investigational drug candidate that has not been approved by the FDA or any other regulatory authority.
06 Market Opportunity

Addressing a Multi-Billion-Dollar Global Health Crisis

Addiction disorders represent one of the largest unmet needs in modern medicine. Alcohol Use Disorder alone represents a multi-billion-dollar global market with significant societal costs and limited effective treatment options. By combining precision medicine with scalable diagnostics, Adial aims to redefine how addiction disorders are treated.

  • check_circle Alcohol Use Disorder affects millions globally
  • check_circle Large global market opportunity for effective treatments
  • check_circle Significant unmet need for targeted therapies
  • check_circle Potential expansion into additional addiction-related disorders
Patient impact — Alcohol Use Disorder
07 Strategic Positioning

Positioned for the Next Phase of Development.

Adial is entering an important phase of development as it prepares for pivotal clinical studies and potential regulatory pathways for AD04. Strategic initiatives are positioning the company for long-term growth and value creation.

01
Precision Medicine Strategy
Adial's integrated drug-and-diagnostic model enables targeted therapy tailored to patient genetics.
02
Strong Intellectual Property
The company continues expanding its patent portfolio, with protections potentially extending to 2045, supporting long-term commercial exclusivity.
03
Manufacturing Readiness
Partnerships with leading pharmaceutical manufacturers such as Thermo Fisher Scientific and Cambrex support scalable production for future commercialization.
04
Regulatory Momentum
Regulatory discussions and evolving FDA frameworks could streamline clinical development requirements for therapies addressing addiction disorders.

Invest in the Future of Precision Addiction Treatment

Adial Pharmaceuticals is advancing a new paradigm in addiction therapy — combining genetics, targeted therapeutics, and precision medicine to improve outcomes for millions of patients worldwide. As the company advances toward pivotal clinical development, investors have the opportunity to participate in a potentially transformative healthcare innovation.

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