Processa Pharmaceuticals, Inc. (PCSA) Initiation Report

October 28, 2020 Processa Pharmaceuticals, Inc. Page 8 of 16 ALPHA SELECT LIST Institutional Research Figure 5: Clinical Trial and Study Design Phase II Study of PCS499 in NL Aim To evaluate safety and tolerability of PCS499 in NL and inform the design of future studies Design Open label, single group assignment Dosing PCS499 900mg twice a day Endpoints Primary: evaluation of adverse events (AE) over 6 months Patients Approximately 12 NL patients (6-9 patients without ulceration and 3-6 patients with ulceration) with biopsy- confirmed diagnosis of NL and reference lesion with a score of 2 or greater on the Investigator Global Assessment: Necrobiosis Lipoidica (IGA:NL) Activity scale and surface area with minimum size of 10 cm 2 Safety Most common AE was gastrointestinal symptoms in four patients, all of which were mild in severity and resolved within 1-2 weeks of starting dosing Results ▪ 2/2 patients with severe NL had complete closing of the ulceration at Month 2 and Month 9/extension of treatment o Ulcers occurring from physical contact during the study also completely closed ▪ 10 patients with mild-moderate NL and no ulceration had more limited improvement in their lesions Dates Nov 2018 – Feb 2020 Source: Clinicaltrials.gov and Company filing. The Company began enrollment for a Phase II multicenter, open-label prospective study to determine the safety and tolerability of PCS499 in patients with NL in January 2019. PCSA and the FDA agreed in advance that 1.8 grams/day would be the maximum dose for the study based on toxicology studies and prior healthy human volunteer studies. This dose is 50% greater than the maximum tolerated dose of pentoxifylline, and was well tolerated with no serious adverse events (AEs) reported. All AEs reported in the study were mild in severity, with gastrointestinal symptoms being the most common in four patients, all of which were mild in severity and resolved within 1-2 weeks of starting dosing. Two of the 12 patients in the study presented with more severe ulcerated NL and had ulcers for more than two months prior to dosing. At baseline, the reference ulcer in one of the two patients measured 3.5 cm 2 and completely closed by Month 2 of treatment. The second patient had a baseline reference ulcer of 1.2 cm 2 , which completely closed by Month 9 during the patient’s treatment extension period. In addition, while in the trial, both patients also developed small ulcers at other sites, possibly related to contact trauma, and these ulcers resolved within one month. However, the other ten patients with mild to moderate NL and no ulceration had more limited improvement of the NL lesions during treatment. PCS6422 for Oncology Processa Pharmaceuticals’ (NASDAQ: PCSA) PCS6422 is eniluracil, an oral, irreversible dihydropyrimidine dehydrogenase (DPD) selective inhibitor for use with the chemotherapy medication capecitabine (brand name Xeloda ) for metastatic colorectal or breast cancer patients. Fluoropyrimidines (e.g., capecitabine or its metabolite, 5-FU) are still the cornerstone of treatment for many different cancers, treating an estimated two million patients annually. Xeloda is an oral pro-drug of 5-FU and is approved as first-line therapy for metastatic colorectal and breast cancer. PCS6422 addresses the ~55k new metastatic colorectal cancer cases (incidence of 74/100k and 25% metastatic) and ~17k new metastatic breast cancer cases (incidence of ~279k and 6% metastatic) diagnosed each year in the US. Worldwide there may be ~200k new diagnoses in these indications each year. Xeloda ’s use is limited by AEs, such as the development of HFS, in up to 60% of patients. PCS6422 reduces the adverse events often experienced by patients receiving capecitabine chemotherapy, while improving