Adial Pharmaceuticals, Inc.

We are a clinical-stage biopharmaceutical company focused on developing treatments for addiction and related disorders. Our primary investigational drug candidate, AD04, is being developed to treat alcohol use disorder (AUD). AD04 was studied in a Phase 3 clinical trial, called the ONWARD trial, for AUD in patients with specific genetic profiles identified using our companion diagnostic genetic test. We are now concentrating on completing the clinical development program for AD04 in these genetic subgroups to meet regulatory requirements, primarily in the US and secondarily in Europe/UK. The vast majority of our resources have been dedicated to AD04's development, including preparing for and conducting clinical trials, providing general and administrative support, and protecting our intellectual property. We anticipate these activities will continue to require most of our resources. We do not currently have any products approved for sale and have not generated significant revenue since our inception. Our operations have been funded primarily through private and public placements of debt, equity securities, and an equity line. Our current cash and cash equivalents are not expected to fund operations for the twelve months from the date of filing this Annual Report on Form 10-K. We have incurred net losses every year since inception, including approximately $8.0 million for the year ended December 31, 2025, and $13.2 million for the year ended December 31, 2024. Our accumulated deficits were approximately $90.0 million as of December 31, 2025, and $82.0 million as of December 31, 2024.