Adial Pharmaceuticals (ADIL) Investor presentation summary

Market need and challenges

• Alcohol use disorder (AUD) affects about 30 million people in the U.S., with only a small fraction seeking or receiving treatment, leading to significant health, social, and economic burdens estimated at $250 billion annually.

• Existing therapies for AUD are limited by requirements for abstinence, low efficacy, significant side effects, and stigmatization, resulting in over 95% of patients remaining untreated.

Product innovation and differentiation

• AD04 is an oral, genetically targeted therapy designed to reduce heavy drinking without requiring abstinence, aiming to improve patient compliance and reduce stigma.

• The therapy is paired with a genetic biomarker test to identify patients most likely to benefit, supporting a precision medicine approach.

• AD04’s anticipated unique selling points include a novel mechanism of action, oral dosing, and genetic targeting, differentiating it from current market options.

Clinical development and results

• The ONWARD Phase 3 study in Europe used a randomized, double-blind, placebo-controlled design, enrolling patients based on genotype and heavy drinking criteria.

• Post hoc analysis showed that heavy drinkers with the AG+ genotype had a statistically significant reduction in heavy drinking days, with 49% achieving zero heavy drinking days versus 22% for placebo.