Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — World Orphan Drug Congress USA 2023
17 slides from Processa Pharmaceuticals's conference presentation, May 24, 2023
Slide 1: Applying FDA's Project Optimus to the Development of Next Generation Chemotherapy
@ Processa Pharmaceuticals Applying FDA’s Project Optimus to the Development of Next Generation Chemotherapy Treatment of Rare Cancers David Young, PharmD, PhD President and CEO Processa Pharmaceuticals, Inc World Orphan Drug Congress USA 2023
Slide 2: Forward Looking Statement and Disclosures
Forward Looking Statement and Disclosures @ Provessa Pharmaceuticals This presentation includes forward-looking statements based upon our current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predi
Slide 3: Company Overview
@ Processa Pharmaceuticals Company Overview NASDAQ: PCSA Stakeholders’ Goals * Safer & More Effective Treatment + Improve Likelihood of Success in a Short Time * Significant Investment Upside with Low Risk Processa Solution * Develop Next Generation Chemotherapy (NGC) Drugs - Modifications of Widely
Slide 4: Investor Highlights
Processa Pharmaceuticals Investor Highlights * Clinical stage drug development company with 3 Next Generation Chemotherapy (NGC) drugs potentially improving the side effect profile while enhancing the effectiveness * Greater likelihood of FDA approval given increased exposure of Processa Pharmaceuti
Slide 5: Processa's Differentiated NGCs Increase Cancer Cell Exposure to Proven Cancer-Killing Molecules
rocessa Pharmaceuticals Processa’s Differentiated NGCs Increase Cancer Cell Exposure to Proven Cancer-Killing Molecules Unique Next Generation Oncology Drugs Alter Metabolism and/or Distribution of FDA-Approved Cancer Drugs or Their Active Metabolites While Maintaining Existing Mechanism of Killing
Slide 6: Ultimate Goal of Cancer Drug Development: Right Drug at the Right Dose
Ultimate Goal of Cancer Drug Development — Treat Each == @ Procesi Pharmaceuticals Patient with the Right Drug at the Right Dose Processa Develops NGCs Using Company’s Regulatory Science Approach and FDA's Project Optimus Oncology Initiative ¢ Optimal Dosage Regimen (ODR) to be determined as require
Slide 7: Project Optimus & Our Regulatory Science Approach Recognize the Need to Evaluate Exposure-Response
Project Optimus & Our Regulatory Science Approach Recognize the @ Processa Pharmaceuticals Need to Evaluate the Exposure-Response Relationships * Assumption Using Prior Maximum Tolerated Dose Approach to Define the Optimal Dosage Regimen (ODR) (Left Figure): Dose- or exposure-response relationships
Slide 8: NGC-IRIN Dose-Response for Safety and Efficacy Follow Different Patterns
NGC-IRIN Dose-Response for Safety and Efficacy Follow Different — Z Processa Pharmaceutical Patterns in Animal Cancer Models, Irinotecan Follows Same Pattern lrinotecan Lower bo NGC-IRIN Lower Dose Lower Dose sowermose MTD MID / Toxicity than MTD | Toxicity than MTD ty FH FH 2 Efficacy g 2 al Fl 3 é
Slide 9: Processa's Pipeline of Drugs
4 Provessa Pharmaceuticals Processa’s Pipeline of Drugs Next Generation Chemotherapies Improving Safety and Efficacy Development Stage Next Generation | enatocellular, Pancreatic, Colorectal, Breast, icapectabing Gastric, & Other Solid Tumor Cancers (Pcs6422) ie Next Generation pancreatic, Gall Blad
Slide 10: Processa's Pipeline of Drugs
& Processa Pharmaceuticals Processa’s Pipeline of Drugs Next Generation Chemotherapies Improving Safety and Efficacy SY A [Colorectal and breast cancer Proof of Concept trials with lower dosing of PCS6422 Next Generation Ed FDA discussion Project Optimus & Phase 2 design Hepatocellular, Pancreatic,
Slide 11: NGC-CAP
NE (NGC-CAP) f PCS6422 and Capecitabine) atic, Colorectal Cancer, , and Other Cancers
Slide 12: Capecitabine (Oral Pro-Drug of 5-FU) and 5-FU are Most Widely Used Cancer Chemotherapy Agents
Capecitabine (Oral Pro-Drug of 5-FU) and 5-FU are @ Provessa Pharmaceuticals Most Widely Used Cancer Chemotherapy Agents Capecitabine <=> + Maximum Tolerated Dose (MTD) for Capecitabine is [~~ 10% - 20% of 5-FU MeteLalins by been - 7 7 Metabolizes (Anabolites) poe rrbri-silet nied determined from AE
Slide 13: Highlights of Next Generation Chemotherapy-Capecitabine (NGC-Cap)
Highlights of Next Generation Chemotherapy- @ Processa Pharmaceuticals Capecitabine (NGC-Cap) * NGC-Cap has fewer Catabolites formed and is safer than Capecitabine based on previous clinical trials and the ongoing Phase 1b trial where 0% of the patients have Catabolite related side effects (Capecita
Slide 14: Next Milestones of NGC-Cap in 2023
Next Milestones of NGC-Cap in 2023 Begin Phase 2 Trial Preparation (e.g., Writing 202023 Protocol, CRO Selection, Site Interviews, Drug Manufacturing) Complete Enrollment of Phase 1b MTD Trial 2H2023 Submit Phase 2 Protocol to IND, Begin 4Q2023 Initiating Sites, Begin Screening Patients Evaluate Oth
Slide 15: Corporate Summary
Corporate Summary GP Processa Pharmaceuticals * Clinical stage drug development company with a robust pipeline of Phase 2-ready Next Generation Chemotherapy (NGC) drug candidates with the potential to significantly reduce the number and severity of many side effects compared to existing chemotherapy
Slide 16: Processa Senior Management
Processa Senior Management Approvals for Indications in Almost Every FDA Division & Processa Pharmaceuticals Two FDA Contracts Where Regulatory Science Was Conceived Management Team Involved With Billion-Dollar Exits (Questcor - $5.7 B & Gentium - $1.0 B) David Young, Pharm.D, Ph.D. President & CEO
Slide 17: Investor & Media Relations
Investor & Media Relations: ng § =) =) oO 13) Ss | F Ay 3 a oO 2 Ay Yj
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