AzurRx BioPharma, Inc. announced that it has signed an exclusive worldwide licensing agreement with First Wave Bio, Inc. for the use of their patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI infections. Niclosamide is a small molecule drug that was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections and is on the World Health Organization’s (WHO) list of essential medicines. It has been safely used by millions of patients and is being investigated as a potential new therapy for inflammatory diseases and viral infections. Founded in 2015, First Wave has invested in translational biology along with process development and manufacturing to develop proprietary oral and rectal gut-targeted formulations of niclosamide for the treatment of ICI-AC, COVID-19 GI-infections, and inflammatory bowel disease (IBD). Under the terms of the agreement, AzurRx is granted a worldwide, exclusive right to develop, manufacture, and commercialize First Wave’s proprietary immediate release oral and enema formulations of niclosamide for the treatment of ICI-AC and COVID-19 GI infections. First Wave will receive an upfront payment of $10.25 million in cash payable $9.0 million at closing and $1.25 million by June 30, 2021 and $3.0 million of Convertible Junior Preferred Stock, which shall be convertible into common stock following shareholder approval, and up to $74.0 million in potential development and commercial milestones, as well as mid single-digit royalties on product sales for the ICI-AC and COVID-19 GI indications. H.C. Wainwright & Co. is acting as financial advisor to AzurRx in connection with the licensing transaction.