Slide 1: Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) November 8, 2022 302022 PZ) Processa Pharmaceuticals
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements @ Processa Pharma 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
Slide 3: 3Q2022 Highlights of Positive NGC and PCS12852 Trials
3Q2022 Highlights of Positive Next Generation Capecitabine (NGC) and PCS12852 Trials > In the ongoing NGC Phase 1B trial, Processa has successfully identified NGC dosage regimens and 5-Fluorouracil (5-FU) exposures that were well tolerated as well as NGC regimens and 5-FU exposures that had dose-lim
Slide 4: Next Generation Capecitabine (NGC)
G Processa Pharmaceuticals Next Generation Capecitabine (NGC) (Combination Regimens of PCS6422 and Capecitabine) Metastatic Colorectal Cancer, Breast Cancer, Pancreatic Cancer, Other Cancers
Slide 5: 5-Fluorouracil Approved by FDA in 1962 & Capecitabine Approved in 1998
5-Fluorourcail Approved by FDA in 1962 & Capecitabine (Oral Form of 5-Fluorouracil) Approved by FDA in 1998 Capecitabine (Xeloda®) — ~ 10% - 20% FU Metabolizes ~ 70% - 80% of 5- FU Metabolizes Anti-Tumor FBAL Response Side Effects DPD (eg, HFS) (Dihydropyrimidine Dehydrogenase Enzyme) Side Effects (
Slide 6: Next Generation Capecitabine (NGC): Improved Efficacy & Side Effect Profile
Next Generation Capecitabine (NGC): Improved Efficacy & Side Effect Profile PCS6422 Irreversibly Inhibits DPD (Dihydropyrimidine Dehydrogenase Enzyme) > By combining a regimen of PCS6422 Capecitabine with a capecitabine regimen, the 5-FU (Xeloda®) formed from capecitabine is only metabolized to anab
Slide 7: Moving Closer to NDA: Phase 1B Trial to Evaluate Safety
Moving Closer to NDA: Phase 1B Trial to Evaluate Safety Vv Vv Each Next Generation Capecitabine (NGC) dosage regimen is a combination of a PCS6422 regimen and a separate capecitabine regimen; Example of a single treatment cycle: —- Cap Cap Cap Cap Cap Cap Cap — From the different NGC regimens evalua
Slide 8: FDA Wants Sponsors to Develop Oncology Drugs Using Principles of Project Optimus
FDA Wants Sponsors to Develop Oncology Drugs Using Principles of Project Optimus EffectfResponse 100+ 0 Dose Selection for Oncology Dose Optimization Rather Than MTD Toxicity / / Efficacy EffecUResponse 100" o- Toxicity Efficacy 50 100 200 400-800 0 50 100 200 400 800 Dose/Drug Exposure enl0S¢/Drug
Slide 9: PCS12852
G Processa Pharmaceuticals PCS12852 GI Motility Conditions (eg, Gastroparesis)
Slide 10: Gastroparesis
Gastroparesis Normal Gastric Emptying Gastroparesis Gastroparesis is a condition that affects the normal spontaneous movement of the muscles (motility) in your stomach. The typical symptoms are: > Feeling full soon after starting a meal > Feeling full long after eating a meal > Nausea, Vomiting > To
Slide 11: 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 > Allthese drugs have a poor side effect profile limiting their use > Present market size for gastroparesis is estimated to be over $
Slide 12: PCS12852: 5-HT4 Receptor Agonist - Wide Range of GI Motility Disorders
PCS12852: 5-HT4 Receptor Agonist - Wide Range of GI Motility Disorders Clinically Proven Mechanism of Action > Enhancement of both GI motility & secretion via increased Ach, 5-HT, Cl-and mucus release > Neural anti-inflammatory effects on post-operative ileus by inhibiting macrophage and neutrophil
Slide 13: PCS12852 Effect on Gastric Emptying: South Korean and US Trials
PCS12852 Effect on Gastric Emptying: South Korean and US Trials Gastric Emptying Rate (%) using 13C-Spirulina GEBT at Baseline PCS12852 is a More Potent and More Selective 5HT4 Agonist than Previous 5HT4 Agonists South Korean Trial 7-8 patients per group Healthy Volunteers (<3 Bowel Movements perWk)
Slide 14: Moving Closer to NDA for Drugs, Each with the Potential of $1B Sales
Moving Closer to NDA for 3 Drugs, Each with the Potential of $1B Sales * 2022 Milestones in Dark Red Text * 2023 Study Start-Up in Dark Blue Text 2022: 6422 Phase 1B Effect on Potency/Safety 7 Commercialization Phase 3 Pivotal Registration Trials Phase 2 Proof-of-Concept and y Preliminary Efficacy-
Slide 15: Corporate Overview
G Processa Pharmaceuticals Corporate Overview
Slide 16: Our People Lead to Success
Our People Lead to Success > 30 years ago members of the Processa Development Team were involved with 2 FDA contracts where the concept of Regulatory Science was conceived > Development Team members further developed the Processa Regulatory Science Approach while obtaining > 30 FDA approvals for ind
Slide 17: Approach to Building the Processa Drug Pipeline
Approach to Building the Processa 5 Drug Pipeline Drug Development Company Not a Discovery Company Potential De-Risk Devel. with Regulatory Evidence of Clinical Advantages in Efficacy & Prior Development Supporting Data Greater Probability of Unmet Medical Need + Efficacy Evidence + RegulatoryScienc
Slide 18: Differentiated Business Model
I eee Processa Pharmaceuticals, Inc (NASDAQ: PCSA) Differentiated Business Model > Processa has a capital-efficient approach based on very low overhead, disciplined licensing, and intelligent/efficient development, all leading to a potentially high ROI (6 C-suite to receive < $600,000 total cash sal
Slide 19: Pipeline of Five Drugs Each with $1B Market Opportunity
Pipeline of Five Drugs Each with $1B Market Opportunity Drug Disease Target Market Next Generation Metastatic Colorectal Cancer U.S. Incidence of Metastatic Colorectal Cancer : > 60K Pts Capecitabine and Other Types of Cancer U.S. Max Ann. Sales mCRC: $500 M - $1.0 B (PCS6422) Global Max Ann. Sales
Slide 20: Moving Closer to NDA for Drugs, Each with the Potential of $1B Sales
Moving Closer to NDA for 3 Drugs, Each with the Potential of $1B Sales * 2022 Milestones in Dark Red Text * 2023 Study Start-Up in Dark Blue Text 2022: 6422 2023: 6422 Phase 1B Effect on Phase 1B MTD, Potency/Safety Phase 2B y Commercialization Phase 3 Pivotal Registration Trials Phase 2 Proof-of-Co