Slide 1: Next Generation Chemotherapy: Improved Treatment for More Patients
@ Processa Pharmaceuticals Next Generation Chemotherapy: Improved Treatment for More Patients David Young, Pharm.D., Ph.D. President, Research and Development Processa Pharmaceuticals, Inc NASDAQ: PCSA
Slide 2: Forward Looking Statement and Disclosures
Forward Looking Statement and Disclosures @ Process Pharmaceutical 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, predict
Slide 3: Present Chemotherapy Profile vs Desired Chemotherapy Profile
Present Chemotherapy Profile vs Desired Chemotherapy Profile Patients Presenting with Cancer Initially Treated with Chemo Patients Responding to Oncology Chemotherapy Patients Not Responding to Oncology Chemotherapy Patients Experiencing Side Effects That Require Dose Reduction or Discontinuation Pa
Slide 4: How Can Processa Provide the Desired Chemotherapy?
Processa Pharmaceuticals How Can Processa Provide the Desired Chemotherapy? Processa Two-Part Solution Use Processa’s Regulatory Science Approach & FDA’s Project Optimus Oncology Initiative to Increase the Probability of Approval and Define an Optimal Dosage Regimen Develop Next Generation Chemother
Slide 5: Processa Senior Management
Processa Senior Management George Ng Chief Executive Officer Joined Processa 2023 Former Roles: + 00 & Director, Calidi Biotherapeuties ‘+ Partner, PENG Life Science Ventures + Founder and President, Silex Pharmaceuticals + JD, University of Notre Dame; BASc, University of California, Davis Patrick
Slide 6: Investor Highlights
Investor Highlights @ Processa Pharmaceuticals * Management with significant drug development experience Processa Pharmaceuticals that is aligned with FDA’s Project Optimus Oncology Initiative (NASDAQ; PCSA) to define the Optimal Dosage Regimens for each cancer drug * Management Team involved with B
Slide 7: How Can Processa Provide the Desired Chemotherapy?
Processa Pharmaceuticals How Can Processa Provide the Desired Chemotherapy? Processa Two-Part Solution Use Processa’s Requlatory Science Approach & FDA’s Project Optimus Oncology Initiative to Increase the Probability of Approval and Define an Optimal Dosage Regimen Develop Next Generation Chemother
Slide 8: Role of Regulatory Science and Project Optimus
Role of Regulatory Science and Project Optimus (Determining the @ Processa Pharmaceuticals, Optimal Dosage Regimen) Processa Develops NGCs Using its Regulatory Science Approach and FDA’s Project Optimus Oncology Initiative * Processa Regulatory Science Approach defines the “best” FDA acceptable way
Slide 9: NGCs Enhance the Potential to Kill Cancer Cells by Altering Metabolism and/or Distribution
NGCs Enhance the Potential to Kill Cancer Cells by Altering the @ Process Pharmaceutical Metabolism of the Drug and/or the Distribution to Cancer Cells * NGCs use different scientific approaches to Alter Metabolism and/or Distribution of FDA-Approved cancer drugs or their active metabolites while ma
Slide 10: Processa's Pipeline of Drugs
Processa’s Pipeline of Drugs @ Processa Pharmaceuticals Development Stage Sa oe SS Hepatocellular, Pancreatic, Colorectal, Breast, Complete Gees Gastric, & Other Solid Tumor Cancers Enea Next Generation Gemcitabine Pancreatic, Gall Bladder, Non-Small Cell Lung, fest & Other Solid Tumor Cancers Next
Slide 11: Highlights of all NGCs
Highlights of all NGCs @ Process Pharmaceusieal More likely to obtain FDA approval given cancer-killing molecules are in existing chemotherapy & implementation of Regulatory Science Approach Development, More efficient development program expected than new types of oncology drugs Commercial > 200,00
Slide 12: Summary of Milestones in 2023
Summary of Milestones in 2023 **Complete Phase 1B MTD Trial Enrollment, Analyze Data to Assist in Phase 2 Design **Define Reg. Paths to Approval & ODR Phase 2 Design with FDA Begin ODR Phase 2 Trial Prep. (e.g., Writing Protocol, CRO Selection, Site Interviews) ‘Submit ODR Phase 2 Protocol to IND, B
Slide 13: Investor Summary
Investor Summary D bocese Phssmaccuicale * Management with significant drug development experience that is aligned with FDA’s Project Optimus Oncology Initiative to define the Optimal Dosage Regimens for each cancer drug * Management Team involved with Billion-Dollar exits * 3 Next Generation Chemot
Slide 14: Investor & Media Relations
Z Processa Pharmaceuticals Investor & Media Relations: CORE IR IR@processapharma.com
Slide 15: Appendix
Slide 16: Processa's Pipeline of Drugs
Processa’s Pipeline of Drugs GP Processa Pharmaceutical Next Generation Chemotherapies Improving Safety and Efficacy pated Timeline) ‘Complete enrollment (End of 2028) Cancer animal study determining dose-response relationship Re-analysis of animal dose-response results using Project Optimus (Mid 20
Slide 17: Develop NGCs Using Processa's Regulatory Science Approach and FDA's Project Optimus
9 @ Processa Pharmaceuticals Develop NGCs Using Processa’s Requlatory Science Approach and FDA's Project Optimus
Slide 18: Regulatory Science Approach Utilizes Evaluation of the Exposure-Response Relationship
* Maximum Tolerated Dose (MTD) approach assumes the Optimal Dosage Regimen (ODR) is the MTD and the dose- or exposure-response relationships for toxicity and efficacy follow a similar pattern 50% MTD MTD Toxicit Efficacy or Effect or Response Dose or Drug Exposure NasbAg: PesA Regulatory Science App
Slide 19: Case Study: NGC-Irin Dose-Response for Safety and Efficacy Differs from Irinotecan
Case Study: NGC-Irin Dose-Response for Safety and Efficacy Differs @ Processa Pharmaceuticals from Irinotecan in Animal Cancer Models Irinotecan NGC-lIrin Lower Lower Dose MID sscity Dosethan MID / Toxicity 3 ffcacy 3 re Efficacy 3 5 ai Dose or Drug Exposure of Irinotecan_ Dose or Drug Exposure NGC-
Slide 20: Next Generation Chemotherapy Drugs (NGCs)
9 @ Processa Pharmaceuticals Next Generation Chemotherapy Drugs (NGCs) Alter Metabolism and/or Distribution of FDA- . f Approved Drugs or their Cancer-Killing Molecules xn :
Slide 21: NGC-Cap: Decrease Metabolism of Capecitabine
NGC-Cap: Decrease Metabolism of Capecitabine* (Oral Pro-Drug of 5-FU) to Metabolites Only Causing Side Effects and Increase Distribution of Cancer-Killing Molecules to Cancer Cells Capecitabine (Xeloda®) i, Set Metabolizes (Catabolites) ues |=> =. oe ~ 2% - 10% of 5-FU Renally Excreted No Anti-Tumor
Slide 22: NGC-Gem (Oral): Increase Metabolism to Cancer-Killing Molecules
NGC-Gem (Oral): Increase Metabolism to Cancer-Killing @ Process Pharmaceuticals Molecules Given Different Metabolizing Enzyme than Gemcitabine (IV) Active Cancer Active Cancer Ho. Killing Molecules Killing Molecules Xue ¥ ~y) HF Gemcitabine (dFdC) IV Administration NGC-Gem Oral Administration In Som
Slide 23: NGC-Irin: Increase Distribution of Cancer-Killing Molecule to Cancer Cells
NGC-Irin: Increase Distribution of Cancer-Killing Molecule to @ Process Pharmaceuticals Cancer Cells + Cancer-killing metabolite of Irinotecan is SN-38 * In NGC-Irin, SN-38 linked to Nano-Motor Transporting molecule allowing for more SN-38 to accumulate in the membranes of cancer cells than in norma