On 12/13/19 Processa Pharmaceuticals filed for a $15 million offering of common stock. The Hanover, MD based company focuses on acquiring and developing drugs that already have some proof-of-concept clinical data supporting its clinical use in the indication selected and in 2-4 years after acquisition will either have completed the pivotal study or be ready for a pivotal study and out-licensing. Processa trades on the OTCQB Marketplace under the symbol “PCSA." The company intends to apply to list its common stock on NASDAQ.
Processa's lead product, PCS-499, is an oral tablet that is an analog of an active metabolite of pentoxifylline (PTX) - trade name Trental. According to the company prospectus, "higher exposure of certain active metabolites are seen after PCS-499 administration compared to PTX. Despite the greater exposure to these pharmacologically active molecules, PCS-499 appears to be well tolerated, even at higher doses than the standard dosing of PTX."
The lead indication currently under development for PCS-499 is Necrobiosis Lipoidica (NL). NL is a chronic, disfiguring condition affecting the skin and the tissue under the skin typically on the lower extremities with no currently approved FDA treatments. Approximately 74,000 - 185,000 people in the United States and more than 200,000 – 500,000 people outside the United States are affected by NL. In June of 2018, the company announced that PCS-499 had received Orphan Drug Status from the FDA for Necrobiosis Lipoidica.