Adial Pharmaceuticals Reports 2024 Fiscal Year Financial Results and Provides Business Update

Core Insights - Adial Pharmaceuticals achieved significant milestones in 2024, receiving positive feedback from the FDA on its 505(b)(2) bridging strategy and initiating clinical supply manufacturing for its upcoming Phase 3 trial [3] - The completion of the pharmacokinetics (PK) study for AD04, an investigational drug for Alcohol Use Disorder (AUD), confirmed the FDA's bridging requirements and supported the planned micro-dosing regimen for future trials [3] - The company strengthened its regulatory strategy by partnering with Boudicca Dx to develop a companion diagnostic genetic test for AD04, which is crucial for FDA discussions [3] Business Developments - The appointment of Vinay Shah as Chief Financial Officer was announced, bringing over 25 years of experience in the pharmaceutical and healthcare sectors [4] - Adial secured several foundational patents to enhance its intellectual property portfolio, including new patents for genetic-based approaches to treating AUD and opioid-related disorders [4][5][6][7] Financial Performance - As of December 31, 2024, cash and cash equivalents were $3.8 million, an increase from$2.8 million in 2023, expected to fund operations into the second half of 2025 [13] - Research and development expenses rose by approximately $1.9 million (155$13.2 million, compared to a net loss of $5.1 million in 2023, driven by non-cash charges and increased R&D spending [13]