Acer Therapeutics Inc. (ACER) Accused of Misleading Investors
Since the Company’s founding in 2013, Acer has allocated much of its resources into EDSIVO, including funding research and clinical studies into the efficacy of the drug in the hopes of obtaining U.S. Food and Drug Administration (“FDA”) approval for the drug. To help fund this research, Acer conducted two secondary public offerings in December 2017 and August 2018. In each of these offerings, Acer touted EDVISO’s future prospects and assured that EDVISO’s New Drug Application (“NDA”) would be approved, citing data gathered from a French clinical trial published in October 2010 involving the use of celiprolol (the “Ong Trial”). However, on June 25, 2019, Acer revealed that the Company had received a response letter from the FDA stating Acer would need to “conduct an adequate and well-controlled trial” to accurately determine the efficacy of EDVISO in treating vEDS to receive FDA approval. Reports later revealed that the small group size of the Ong Trial that supported the NDA raised questions about the adequacy of EDVISO’s trial results. On this news, Acer’s stock price fell nearly 79% to close at $4.12. To date, none of Acer’s drug candidates has received FDA approval.