Microcap biotech shares crater over PhIII failure for high alcohol drug – Endpoints News
Shares of microcap biotech Adial Pharmaceuticals cratered on Tuesday after the company admitted that its experimental therapy for heavy drinkers failed the primary endpoint of the Phase III trial.
Hope is eternal at Adial, however, and the company insists it has plenty of positive things to say about the data, including a win (p=0.03) when researchers cut a large penny -group of heavy drinkers in the patient population. He thinks that might be persuasive to get the FDA to consider the drug favorably, which is a very uncertain proposition.
Investors appeared to be dubious about the position, as shares of Adial lost about 20% of their value after the data was released. The market cap is $35 million. Year-to-date stocks are down 46%.
Company executives said the flop in the primary endpoint could be attributed to a sharp drop in alcohol consumption among patients in the placebo group.
Adial reported $12.7 million in free cash at the end of the last quarter.
“Alcohol use disorder is an unmet medical need that affects tens of millions of people each year, and, based on the strength of these ONWARD findings in heavy drinking patients who have the target genetics , and the fact that AD04 demonstrated an exceptional safety profile, and was well tolerated during the trial, we intend to move AD04 forward,” CEO William Stilley said in a prepared statement. We will work with regulatory authorities in Europe and the US to achieve this goal, and we also plan to explore strategic partnerships.