Processa Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on utilizing its regulatory science approach, including the principles associated with food and drug administration (FDA’s) Project Optimus Oncology initiative and the related FDA Draft Guidance, in the development of Next Generation Chemotherapy (NGC) oncology drug products. The three NGC treatments in its pipeline are NGC-Capecitabine (NGC-Cap), PCS3117, also referred to as NGC-Gemcitabine (NGC-Gem) and PCS11T, also referred to as NGC-Irinotecan (NGC-Iri). NGC-Cap is a combination of PCS6422 and capecitabine, capecitabine being the oral prodrug of the cancer drug 5-fluorouracil. PCS3117 is an oral analog of gemcitabine that is converted to its active metabolite by a different enzyme system than gemcitabine, resulting in a positive response in gemcitabine patients and some gemcitabine treatment-resistant patients. PCS11T is a prodrug of the active metabolite of irinotecan (SN-38).