Slide 1: Processa Pharmaceuticals, Inc. Update
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) , Update / August 11, 2022 @ Processa Pharmaceuticals
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements The following summary is provided for informational purposes only and does not constitute an offer or solicitation to acquire interests in the investment or any related or associated company. The information contained here is general in nature and is. not inten
Slide 3: Our People Lead to Success
Our People Lead to Success Management Team David Young, PharmD. PhD in Bigora, PharmD. Michael Floyd President and Chief Executive Officer Chief Development Officer Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business - Strategy Officer Chief Financial Officer Chief Admini
Slide 4: Processa Pharmaceuticals Highlights
Processa Pharmaceuticals, Inc (NASDAQ: PCSA) Highlights v v v Development Company Focused on Improving the Quality of Life (QOL) and/or Survival of Patients with an Unmet Medical Need Condition Management & Development Team with Track Record of Success Regulatory Science Approach to Drug Development
Slide 5: Processa's Risk Abated Approach and Criteria for Drug Selection
Processa’s Risk Abated Approach and Criteria for Drug Selection Experience in Adding Value to Companies: > 30 FDA Approvals & Regulatory Science Contracts from FDA = o% eo DEVELOP NOT DISCOVER e— REGULATORY SCIENCE PLATFORM ey Capital Efficiency + [mel iniellVaattelan sie) Unmet Medical Need + Effic
Slide 6: Pipeline of Five Drugs Each with $1B Market Opportunity
Pipeline of Five Drugs Each with $1B Market Opportunity >» 4 Drugs in Clinical Stage of Development and 1 in Pre-IND = 3 Drugs Targeting the Treatment of Cancer (Phase 1B, Phase 2B, Pre-IND Stage) (Blue Box, Blue Arrows) * 1 Drug in Phase 2B Targeting an Orphan Condition with no Approved Treatments
Slide 7: Pipeline Milestones During the Next Months
Pipeline Milestones During the Next 12 Months Drug Disease Target Status and Milestones Next Generation Capecitabine Phase 1B (PCS6422) Metastatic Colorectal, Other Cancers Cohort 1 and 2A Completed, 1 Pt in Cohort 2B completed, 1 Site being Added (Total of 6 Sites) Complete Enrollment and Interim A
Slide 8: Questions and Answers
Questions and Answers > What is Management doing to deal with the progress of the programs, especially enrollment in 499 and 6422? Has Processa considered that the eligibility requirements to enroll in their trials may be too stringent? Is it possible that Processa is splitting resources across the
Slide 9: Pipeline Background Slides
@ Processa Pharmaceuticals Pipeline Background Slides
Slide 10: Next Generation Capecitabine
@ Processa Pharmaceuticals Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Metastatic Colorectal Cancer, Breast Cancer, Pancreatic Cancer, Other Cancers
Slide 11: Next Generation Capecitabine Improves Safety/Efficacy Profile of Capecitabine
Next Generation Capecitabine Improves Safety/Efficacy Profile of Capecitabine (Combination of PCS6422 and Capecitabine) PCS6422 Irreversibly Inhibits Dihydropyrimidine Dehydrogenase (DPD) Enzyme 6422 Inhibits DPD Allowing Two Ways to Win Capecitabine > Lower Side Effects by Lowering 5-FU Metabolite
Slide 12: Unmet Medical Need and Evidence of Clinical Benefit
Unmet Medical Need and Evidence of Clinical Benefit > Safety Differentiation of 6422 + Capecitabine vs Existing Chemotherapy a 384) FBAL Side Effects mma()) Revollo et al. 2008 Clin Cancer Res; Masuda et al. 2017. NEJM. + 50-70% of capecitabine patients have adverse events from FBAL resulting in dec
Slide 13: Next Generation Capecitabine Phase 1B Interim Results
ee Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) ¥ Response Rate Survival Time v HFS Rate &/or Severity ¥ % Treatment Resist. Pts nen, v v Phase 1B Next Generation Capecitabine Cohort 1 and 2 Interim Results No DLTs, no drug-related adverse events greater than Grade 1, and n
Slide 14: PCS499 Ulcerative Necrobiosis Lipoidica (uNL)
@ Processa Pharmaceuticals PCS499 Ulcerative Necrobiosis Lipoidica (uNL)
Slide 15: PCS499: Would be the First Drug Approved to Treat uNL
PCS499: Would be the First Drug Approved _____ to Treat Ulcerative Necrobiosis Lipoidica (uNL) or Any Form of NL Skin and tissue below the skin become necrotic forming open ulcers; can last from months to years with complications such as infections, amputation, and cancer Severe NL v > Literature re
Slide 16: Unmet Medical Need, Evidence of Clinical Efficacy
Unmet Medical Need, Evidence of Clinical Efficacy >» No FDA approved treatment for uNL or NL, no standard of care, all treatments are inadequate > Drugs have been used off-label with mixed success (e.g., pentoxifylline (PTX)); provide poor safety profile given their limited efficacy Vv PCS499 is the
Slide 17: PCS499 in 2020 - 2021
PCS499 in 2020 - 2021 > 1.8 gm/d of 499 has a better safety profile than 1.2 gm of PTX in animal tox studies and Phase 1 healthy human volunteer studies > Determined 1.8 gm/d of 499 was safe in 12 NL patients and effective in closing the open ulcers of the 2 patients with uNL in an open-labeled Phas
Slide 18: PCS12852 Gastroparesis
@ Processa Pharmaceuticals PCS12852 Gastroparesis
Slide 19: Gastroparesis
Gastroparesis PCS12852 is a More Potent and More Selective 5HT4 Agonist than Previous 5HT4 Agonists > Target Indication: 80 + Treatment of moderate to severe gastroparesis > Target Claims: + Improves gastric emptying rate and the symptoms associated with moderate to severe gastroparesis (e.g., bloat
Slide 20: Treatment of Gastroparesis (> $1.5B Market)
Treatment of Gastroparesis (> $1.5B Market) >» Existing FDA approved drugs and off-labeled prescribed drugs are mainly used for the treatment of diabetic gastroparesis > All these drugs have a poor side effect profile limiting their use > Present market size for gastroparesis is estimated to be over
Slide 21: PCS3117
@ Processa Pharmaceuticals PCS3117 Metastatic Pancreatic Cancer, Biliary Cancer, Other Cancers
Slide 22: 1H'22 - PCS3117 Biomarker Assay Development Completed
1H’22 - PCS3117 Biomarker Assay Development Completed NH NH2 NH SS SS Ox LA ( e ON ro} 6. N ‘0 HO. A oN oO HO, 0. = OH OH OH Fe RX-3117 Gemcitabine (dFdC) OH OH Oral Administration WV Administration Cytidine (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) (Cytosine + Ribose Ring) » Gemcitabi
Slide 23: PCS3117 for Cancer Patients Resistant to Gemcitabine
rr PCS3117 for Cancer Patients Resistant to Gemcitabine > PCS3117 has a similar structure to gemcitabine but is activated through a different pathway and causes cancer cell apoptosis in more ways than gemcitabine > PCS3117 has been shown in gemcitabine resistant cancer patients and tumor animal mode
Slide 24: PCS3117 Prior Evidence of Clinical Efficacy and Safety in Cancer Patients
PCS3117 Prior Evidence of Clinical Efficacy and Safety in Cancer Patients > PCS3117 monotherapy Phase 2A trial as second or third-line therapy in patients with progressive metastatic pancreatic cancer after 1-5 previous therapies of chemotherapy (93% (40/43) refractory to gemcitabine) * 31% (14 pati
Slide 25: PCS11T
@ Processa Pharmaceuticals PCS11T Small Cell Lung, Pancreatic, Colorectal, Other Cancers
Slide 26: PCS11T: Lipophilic Prodrug of SN-38
PCS11T: Lipophilic Prodrug of SN-38 (Irinotecan Active Metabolite) > Pro-drug of SN-38 linking SN-38 to a molecular nano-motor (MNM), a proprietary compound, which interacts with cell membranes preferentially accumulating in the membrane of tumor cells and the tumor core more than normal cells >» Cr
Slide 27: Higher and More Selective Tumor Exposure to SN38 with PCS11T
Higher and More Selective Tumor Exposure to SN38 with PCS11T (formerly ATT-11T) versus Irinotecan Tumor-bearing mice had 200x higher drug in tumor vs muscle compared to 15x with lrinotecan an 120 art eae = 100 me Plasma 400: a cestinss etme ey 0 2 20 | 3 =| & Tumor/muscle = 200 c my Tumor/muscle = 1
Slide 28: Efficacy Maintained at Lower Doses of PCS11T Compared to Irinotecan
Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model MTD %MTD % MTD Tumor volume, mm? Spat contd 1000 || —e—srp#2: 07-11 00rehg ip seer Grp ATTATT 150mg/A epi: Controt 1000 | -='9~ Geol: C9T-11 Somer iP a 66: ATT 11T Smale, ip =e Gpwts c