Business
Adial Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update
Reported Positive Feedback from US and EU Regulatory Meetings Sale of Purnovate Significantly Reduces Cash Burn Rate Charlottesville, Va., Aug. 21, 2023
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Reported Positive Feedback from US and EU Regulatory Meetings Sale of Purnovate Significantly Reduces Cash Burn Rate Charlottesville, Va., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the second quarter of 2023. Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We continue to advance AD04 to meaningful inflection points and recently received favorable feedback from our US and EU regulatory meetings. Following the feedback, we made a strategic decision to focus our efforts on obtaining FDA approval, as the US standard should translate to acceptance in other international markets. In addition, the FDA confirmed the primary endpoint based on Percentage of No Heavy Drinking Days (PNHDD)-patients who reduced their alcohol consumption to zero heavy drinking days in the last two months of a six-month study. Furthermore, the FDA acknowledged that our post hoc analysis showing a statistically and clinical meaningful effect in specific genetic subtypes was positive and promising but requested additional data to support an NDA submission. As a result, we are currently planning to conduct two Phase 3 trials with AD04 in parallel to support potential approval in the shortest timeframe possible. Toward this end, and now having received regulatory feedback, we are progressing our partnering discussions and intend to provide further updates as appropriate. Overall, we remain confident in AD04’s ability to address a significant unmet need for patients suffering from alcohol use disorder, representing an addressable market of approximately $40 billion in the U.S. alone. Moreover, the sale of our Purnovate business during the quarter provided non-dilutive funding and significantly reduced our current cash burn rate. Overall, we believe we are well positioned to execute on our development strategy, as well as reach meaningful milestones that we believe will drive significant value for shareholders.” Other Recent Developments Purnovate On May 16, 2023, Adovate, LLC, exercised its option for the purchase of the assets and business of the Company’s wh...