Adial Pharmaceuticals (ADIL) investor relations material

Executive summary

• Focused on developing AD04 for alcohol use disorder, targeting specific genetic subgroups and advancing toward late-stage development, supported by regulatory and strategic progress.

• Entered a collaboration framework with Molteni Farmaceutici for potential exclusive commercialization of AD04 in Europe, with possible milestone and royalty payments up to $60 million, though no definitive agreement yet.

• No products approved for sale and no significant revenue generated since inception; operations funded primarily through equity and debt offerings.

• Strengthened intellectual property with an international patent application that could extend AD04 protection through at least 2045.

• FDA policy shift may allow approval with one pivotal study plus confirmatory evidence, potentially reducing costs and accelerating NDA submission.

Financial highlights

• Net loss for Q1 2026 was $2.0 million, an improvement from $2.2 million in Q1 2025, mainly due to lower R&D spending.

• Research and development expenses decreased 42% year-over-year to $433,000.

• General and administrative expenses increased 3% year-over-year to $1.57 million.

• Cash and cash equivalents at March 31, 2026 were $4.6 million, expected to fund operations into the second half of 2026.

• Accumulated deficit reached $92 million as of March 31, 2026.

Outlook and guidance

• Current cash is only sufficient to fund operations into the second half of 2026; additional capital is required to continue development and operations.

• Plans to begin a Phase 3 study of AD04 in 2026, contingent on securing adequate funding.

• Commercialization of AD04 is not expected before 2028.

• Actively pursuing additional equity or debt financing, strategic alternatives, or collaborations.

• Regulatory and policy trends support non-abstinence endpoints and harm reduction, aligning with AD04's clinical profile.