Microcap biotech's shares crater on a PhIII failure for heavy drinking drug
Shares of microcap biotech Adial Pharmaceuticals cratered Wednesday after the company conceded its experimental therapy for heavy drinkers had failed the primary endpoint in the Phase III test.
Hope springs eternal at Adial, though, and the company insists that it has plenty of positive things to say about the data, including a win (p=0.03) when researchers carved out a large subgroup of heavy drinkers in the patient population. It believes that could be persuasive in pushing the FDA to look favorably on the drug, which is a highly uncertain proposition.
Investors seemed to doubt the position, as Adial shares lost about 20% of their value after the data hit. The market cap sits at $35 million. Year-to-date shares are down 46%.
Company execs said the primary endpoint flop could be attributed to a sharp drop in drinking among patients in the placebo group.
Adial reported $12.7 million in cash on hand 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 results in heavy drinking patients that have the target genetics, and the fact that AD04 demonstrated an exceptional safety profile, and was well-tolerated during the trial, we intend to advance AD04,” noted CEO William Stilley in a prepared statement. “We will work with regulatory authorities in Europe and the U.S. to achieve this goal. We also plan to explore strategic partnerships.”