Processa Pharmaceuticals, Inc. (PCSA) Initiation Report

October 28, 2020 Processa Pharmaceuticals, Inc. Page 10 of 16 ALPHA SELECT LIST Institutional Research We also note the work of Rivera et al. (2014) that showed a comparative Phase II study in which 10 evaluable metastatic breast cancer patients with rapid disease progression during capecitabine treatment crossed over to take eniluracil 11-16 hours prior to 5-FU and leucovorin. Of these patients, 3 had a partial tumor response, 6 had stable disease, and 4 had >7 months of progression free survival. If the preclinical and clinical data remain consistent through PCSA’s clinical trials, PSC6422 could offer a patient preferred all-oral regimen that will increase quality of life and potentially even improve efficacy. Figure 6: PCS6422 Pre-Treatment Mitigates Adverse Events Source: Company presentation. PCS12852 for Gastrointestinal Diseases PCS12852 is a novel, potent and more selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist that could provide a better safety and efficacy profile for constipation indications than other agonists. Other 5-HT receptor agonists with less 5-HT4 selectivity successfully treat gastrointestinal (GI) motility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis. Less selective 5-HT4 agonists, such as cisapride, have been either removed from the market or not approved because of the cardiovascular side effects associated with the drugs binding to other receptors, especially 5-HT receptors other than 5-HT4. PCSA acquired from Yuhan an exclusive license to develop, manufacture and commercialize PCS12852 in August 2020 in all geographies except South Korea for $2 million of PCSA common stock and development and regulatory milestones. Yuhan also participated in the most recent financing. The Company plans to meet with the FDA in early 2021 to further define the clinical development program and discuss a Phase IIa proof of concept randomized, placebo-controlled study for PCS12852 in a gastrointestinal (GI) motility dysfunction disorder. The Company has suggested the following indications – post-operative ileus, opioid induced constipation, and chronic idiopathic constipation – as possible target indications. The purpose of the Phase IIa trial would be to better define a dosage regimen that could be used in a larger pivotal study.