Adial Pharmaceuticals Reports $13.2 Million Net Loss for 2024, Plans Additional Phase 3 Trials for AD04

Adial Pharmaceuticals, Inc. reported a net loss of approximately $13.2 million for the year ended December 31, 2024, compared to a net loss of $5.1 million for the previous year. The company's accumulated deficit increased to approximately $82.0 million as of December 31, 2024, up from $68.8 million in 2023. The increase in losses was primarily attributed to heightened research and development expenses, which surged by 155% to approximately $3.2 million, driven by direct clinical trial costs and chemistry, manufacturing, and controls (CMC) expenses. General and administrative expenses decreased slightly by 9% to approximately $5.1 million, reflecting lower corporate legal expenses and compensation costs.

In terms of strategic developments, Adial has focused on its lead investigational product, AD04, which is being developed for the treatment of alcohol use disorder (AUD). The company recently completed the ONWARD Phase 3 clinical trial, which, despite missing its primary endpoint, showed statistical significance in a predefined patient group. Following positive feedback from the FDA and European regulators, Adial plans to conduct two additional Phase 3 trials to support its regulatory submissions. The estimated cost for these trials is projected to be between $21 million and $29 million, with each trial requiring $8 million to $12 million in direct expenses.

Operationally, Adial's workforce consists of seven employees, including five full-time staff and two consultants. The company has not generated any significant revenue since its inception and continues to rely on financing through equity offerings and warrant exercises. In 2024, Adial raised approximately $7.8 million through various financing activities, including the sale of common stock and the exercise of warrants. However, the company has indicated that its current cash and cash equivalents are insufficient to fund operations for the next twelve months, necessitating additional financing.

Looking ahead, Adial's management is actively pursuing various funding options, including equity and debt financing, to support its ongoing clinical trials and operational needs. The company has expressed confidence in the potential of AD04, particularly given the promising results from the ONWARD trial and the strategic decision to focus on the U.S. market for regulatory approval. However, the company acknowledges the inherent risks and uncertainties associated with drug development, including the need for additional clinical trials and the potential for regulatory challenges.