Slide 1: Clinical Pipeline Update
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) ZB Clinical Pipeline Update / May 12, 2022 2D PROSERE) HEE rTeree eT
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 intend
Slide 3: Processa Pharmaceuticals Highlights
Processa Pharmaceuticals, Inc (NASDAQ: PCSA) Highlights >» 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 » In-licensed Five Drugs Each with Potential Sa
Slide 4: 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 = on — DEVELOP NOT DISCOVER a REGULATORY SCIENCE PLATFORM ee -—, Unmet Medical Need + Efficacy Evidence + Regulatory Science Capital Eff
Slide 5: Pipeline With High Value 2022 Milestones
Pipeline With High Value 2022 Milestones 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 Arrows) = 1 Drug in Phase 2B Targeting an Orphan Condition with no A
Slide 6: 1Q2022 Highlights
Processa Pharmaceuticals, Inc (NASDAQ: PCSA) 1Q2022 Highlights > In 102022 each clinical development program has moved closer to obtaining key findings that are needed to design and initiate our pivotal trials and subsequent FDA submission + Next Generation Capecitabine (Combination of PCS6422 and C
Slide 7: 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 > Colorectal cancer: > 145,000 new patients/yr U.S., > 45% of the new patients with colorectal Capecitabi
Slide 8: Next Generation Capecitabine Phase 1B Interim Results
Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Phase 1B Next Generation Capecitabine Cohort 1 and 2 Interim Results INCREASE POTENCY > No DLTs, no drug-related adverse events greater than Grade 1, and no ve, hand-foot syndrome side effects were observed in Cohort 1 and 2 Resp
Slide 9: Next Generation Capecitabine Q1 Achievements and Future Milestones
cc Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Q1 Achievements and Future Milestones Achievements in 102022 > Amended Phase 1B protocol to determine the 6422 regimens that would increase the cancer-killing potency of Next Generation Capecitabine for all 7 days of capecitab
Slide 10: PCS499: Would be the First Drug Approved
cc PCS499: Would be the First Drug Approved to Treat Ulcerative Necrobiosis Lipoidica (uNL) or Any Form of NL » Skin, tissue below the skin become necrotic forming open ulcers; Severe NL Mild NL can last from months to years with complications such asinfections, amputation, and cancer » Literature r
Slide 11: Unmet Medical Need, Evidence of Clinical Efficacy
cc Unmet Medical Need, Evidence of Clinical Efficacy > No FDA approved treatment for uNL or NL, no standard of care, all treatments inadequate (eg, pentoxifylline (PTX) used off-label providing limited efficacy given the safety profile) >» PCS499 is the deuterated analog of a major metabolite of PTX
Slide 12: PCS499: Phase 2B Trial for Ulcerative Necrobiosis Lipoidica
PCS499: Phase 2B Trial for the Treatment of Ulcerative Necrobiosis Lipoidica Q1 Achievements and Future Milestones Achievements in 102022 > 3 patients completed trial; Closed EU sites that were not enrolling > COVID has had an impact on enrollment — Potential patients who have been identified have n
Slide 13: PCS12852: Treatment of Gastroparesis
PCS12852: Treatment of Gastroparesis PCS12852 is a More Potent and More Selective 5HT4 Agonist than Previous 5HT4 Agonists > Target Indication: %0 + Treatment of moderate to severe gastroparesis > Target Claims: " + Improves gastric emptying rate and the symptoms associated with moderate to severe y
Slide 14: PCS12852: Treatment of Gastroparesis (> $1.5B Market)
PCS12852: Treatment of Gastroparesis (> $1.5B Market) >» Existing FDA approved drugs and off-labeled prescribed drugs are mainly used for the treatment of diabetic gastroparesis and not for idiopathic or post-surgical gastroparesis > All these drugs have a poor side effect profile limiting their use
Slide 15: PCS12852 Q1 Achievements and Future Milestones
PCS12852: Treatment of Gastroparesis Q1 Achievements and Future Milestones Achievements in 102022 > 5 patients enrolled out of 24 to be enrolled; 5 in screening; > 50% screening failure rate expected Milestones Mid-2022 > None at this time Milestones 2H2022 > Completion of enrollment expected with t
Slide 16: PCS3117 for Cancer Patients Resistant to Gemcitabine
cc 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 mod
Slide 17: PCS3117 Clinical Status
PCS3117 Clinical Status >» PCS3117 presently has an orphan designation for the treatment of Pancreatic Cancer >» PCS3117 presently has an IND for the treatment of Pancreatic Cancer > Previous Trials = PCS3117 monotherapy Phase 2A trial as second or third-line therapy in patients with progressive met
Slide 18: PCS3117: Treatment of Pancreatic Cancer or Other Cancers
PCS3117: Treatment of Pancreatic Cancer or Other Cancers Q1 Achievements and Future Milestones Achievements in 102022 > Initiated development of assays to determine if biomarkers could be identified that would predict a patient’s response to PCS3117 versus gemcitabine Milestones Mid-2022 > Prelimina
Slide 19: Processa Pipeline Achievements and Future Milestones
cc Processa Pipeline Achievements and Future Milestones > Near Term Milestones (March-August) + Next Generation Capecitabine: Expect interim results on the dosing regimen of PCS6422 (one component of Next Generation Capecitabine) and determine how much the cancer-killing potency of capecitabine will
Slide 20: Our People Lead to Success
Our People Lead to Success Management Team David Young, PharmD. PhD Chief Executive Officer, Chairman of the Sian Bigora, PharmD. Michael Floyd Board Chief Development Officer Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business ~ Strategy Officer Chief Financial Officer C
Slide 21: Pipeline Background Slides
@ Processa Pharmaceuticals Pipeline Background Slides
Slide 22: Next Generation Capecitabine
@ Processa Pharmaceuticals Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Metastatic Colorectal Cancer, Breast Cancer, Pancreatic Cancer, Other Cancers
Slide 23: 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 24: Unmet Medical Need and Evidence of Clinical Benefit
Unmet Medical Need and Evidence of Clinical Benefit > Safety Differentiation of 6422 + Capecitabine vs Existing Chemotherapy + 50-70% of capecitabine patients have adverse events from FBAL resulting in decreasing capecitabine dose or stopping therapy + Clinical trial of the 6422 + capecitabine provi
Slide 25: Next Generation Capecitabine Phase 1B Interim Results
cc Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) g 2 vy Response Rate v Survival Time HFS Rate &/or Severity % Treatment Resist. Pts Phase 1B Next Generation Capecitabine Cohort 1 and 2 Interim Results No DLTs, no drug-related adverse events greater than Grade 1, and no hand
Slide 26: PCS499
@ Processa Pharmaceuticals PCS499 Ulcerative Necrobiosis Lipoidica (uNL)
Slide 27: PCS499: Would be the First Drug Approved
cc PCS499: Would be the First Drug Approved T Ul wa N Hiosis Lipaidics (UNL oranyE ¢ NI >» Skin and tissue below the skin become necrotic forming open ulcers; can last from months to years with complications such asinfections, amputation, and cancer Severe NL allan > Literature reports approximately
Slide 28: Unmet Medical Need, Evidence of Clinical Efficacy
cc 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 >» PCS499 is
Slide 29: 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 Pha
Slide 30: PCS12852
@ Processa Pharmaceuticals PCS12852 Gastroparesis
Slide 31: Gastroparesis
Gastroparesis PCS12852 is a More Potent and More Selective 5HT4 Agonist than Previous 5HT4 Agonists > Target Indication: %0 + Treatment of moderate to severe gastroparesis jrulina GEBT at Baseline vs > Target Claims: " + Improves gastric emptying rate and the symptoms associated with moderate to sev
Slide 32: 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 33: PCS3117
@ Processa Pharmaceuticals PCS3117 Metastatic Pancreatic Cancer, Biliary Cancer, Other Cancers
Slide 34: 1H'22 - PCS3117 Biomarker Assay Development Completed
1H’22 - PCS3117 Biomarker Assay Development Completed NH, Nip NH Sn SN Lk LAN (4 N ‘O N ‘0 HO. AY F HO. N ie} HO. °. 0. : OH OH OH OF RX-3117 Gemcitabine (dFdC) oH (OH Oral Administration IV Administration Cytidine (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) (Cytosine + Ribose Ring) » Ge
Slide 35: PCS3117 for Cancer Patients Resistant to Gemcitabine
cc 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 mod
Slide 36: 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 37: PCS11T
@ Processa Pharmaceuticals PCS11T Small Cell Lung, Pancreatic, Colorectal, Other Cancers
Slide 38: PCS11T: Lipophilic Prodrug of SN-38
PCS11T: Lipophilic Prodrug of SN-38 (Irinotecan Active Metabolite) v 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 39: 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 TH oo oe Muscle oe Muscle oe Plasma 100 ePlasma Tumor me Tumor Tumor/muscle = 15 Tumor/muscle = 200 SN-38, ng/g
Slide 40: Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan
Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model Tumor volume, mm3 MTD % MTD % MTD 1000 eo Gopi: Control eo Grpi2: cPT-11 100me/ke ip ses@ves Grpt3: ATT-11T 150me/kg, jp a Gopi: Control se@ees Grp5: CPT-11 Some/ke ip eo Sip6: ATT-IT