Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Medinvest Oncology Investor Conference 2023
29 slides from Processa Pharmaceuticals's conference presentation, Jun 21, 2023
Slide 1: Next Generation Chemotherapy: Improved Treatment for More Patients
6/16/2023 @ Processa Pharmaceuticals Next Generation Chemotherapy: Improved Treatment for More Patients David Young, Pharm.D., Ph.D. President and CEO Processa Pharmaceuticals, Inc NASDAQ: PCSA Medinvest Oncology Investor Conference June 21, 2023
Slide 2: Forward Looking Statement and Disclosures
6/16/2023 Forward Looking Statement and Disclosures vrocesa 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
Slide 3: Present Chemotherapy vs. Expectations of Next Generation Chemotherapy
6/16/2023 Present Chemotherapy vs. GQ Prvces Marcia Expectations of Next Generation Chemotherapy Present Chemotherapy Patients Presenting with Cancer Initially Treated with Chemo. Patients Experiencing Side Effects That Require Dose Reduction or Discontinuation Patients Receiving Full Course Prescri
Slide 4: Present Chemotherapy vs. Expectations of Next Generation Chemotherapy
6/16/2023 Present Chemotherapy vs. Expectations of Next Generation Chemotherapy Present Chemotherapy GQ Prvces Marcia Next Generation Chemotherapy Patients Presenting with Cancer Initially Treated with Chemo. Patients Experiencing Side Effects That Require Dose Reduction or Discontinuation Patients
Slide 5: Next Generation Chemotherapy Overview
6/16/2023 Next Generation Chemotherapy Overview @ wrovesa Pharmaceuticals Processa Solution Develop Next Generation Chemotherapy (NGC) Drugs — Improving Cancer Exposure to Widely Used FDA Approved Cancer Killing Molecules with a Proven History of Therapeutic Success Use Processa Regulatory Science A
Slide 6: Investor Highlights
6/16/2023 Investor Highlights @ Provessa Pharmaceuticals * Clinical stage drug development company with 3 Processa P| maceuticals Next Generation Chemotherapy (NGC) drugs with a (NASDAQ: PCSA) greater likelihood of FDA approval in a more efficient development program Stock Price (as of 6/12/23) $0.7
Slide 7: Processa's NGCs Enhance Potential to Kill Cancer Cells
6/16/2023 Processa’s NGCs Enhance Potential to Kill @ Provessa Pharmaceuticals Cancer Cells 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 Cancer Improved Maintained A
Slide 8: Optimizing Cancer Treatment
6/16/2023 Optimizing Cancer Treatment @ Process Pharmaceuticals Processa Develops NGCs Using its Regulatory Science Approach andFDA’s Project Optimus Oncology Initiative * Optimal Dosage Regimen (ODR) creates a better balance between side FY fom effects and patient response with potentially a a — Fe
Slide 9: Regulatory Science Approach
6/16/2023 Regulatory Science Approach U: Response Relationship Between Drug and Patient * 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 MID Toxicity
Slide 10: Case Study: NGC-Irin Dose-Response for Safety and Efficacy Differs from Irinotecan
6/16/2023 Case Study: NGC-Irin Dose-Response for Safety and @ wrovesa Pharmaceuticals Efficacy Differs from Irinotecan in Animal Cancer Models Irinotecan NGC-Irin Lower — Lower fae > Toxety Bosethan MIP / toxicty F frcaey é Efficacy q | Dose or Drug Exposure of Irinotecan Dose or Drug Exposure NGC-I
Slide 11: Processa's Pipeline of Drugs
6/16/2023 Processa’s Pipeline of Drugs @ ree Pharmacia Next Generati eee ies Improving Safety and Efficacy Development Stage Next Generation Capecitabine (Pcs6422) Next Generation Gemcitabine (Pcs3117) Next Generation Irinotecan (Pcsi1T) PCs12852 Pcs499 NASDAQ: PESA Hepatocellular, Pancreatic, Color
Slide 12: Processa's Pipeline of Drugs
6/16/2023 Processa’s Pipeline of Drugs GP Procesa Pharmaceuticals Next Generation Chemotherapies Improving Safety and Efficacy a [l Colorecal ard breast cancer Proof of Concept ils with ower dosing of PCS6422 NesGerentn corel epoch Parco tas, i nse eNO oe Ges Nees mes Se eam ase 2 Interim analysis (
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6/16/2023
Slide 14: Capecitabine and 5-FU Are Most Widely Used Cancer Chemotherapy Agents
6/16/2023 Capecitabine (Oral Pro-Drug of 5-FU) and 5-FU Are Most @ Process Pharmaceuticals Widely Used Cancer Chemotherapy Agents Capecitabine (Xeloda®) NGC-Cap + Therapeutic dose determined by side effects from ] + Metabolism of 5-FU to Catabolites no longer ‘Anti Tumor Response Catabolites (non-ca
Slide 15: Highlights of NGC-Cap
6/16/2023 Highlights of NGC-Cap @ Provessa Pharmaceutical * More likely to be FDA approved + More efficient development program than new type of oncology drugs Development * Develop using Project Optimus & Processa’s Regulatory Science Approach Commercial + > 200,000 newly diagnosed patients per yea
Slide 16: Next Milestones of NGC-Cap in 2023
6/16/2023 Next Milestones of NGC-Cap in 2023 iets coe Begin Phase 2 Trial Preparation (e.g., Writing Protocol, CRO Selection, Site Interviews, Drug 2Q2023 Manufacturing) Complete Enrollment of Phase 1b MTD Trial euEe Submit Phase 2 Protocol to IND, Begin Initiating Sites ozo) Evaluate Other Regulato
Slide 17: Next Generation Chemotherapy Gemcitabine (NGC-Gem)
6/16/2023 @ Processa Pharmaceuticals NEXT GENERATION CHEMOTHERAPY GEMCITABINE (NGC-GEM) (Chemical Modification of Gemcitabine) Pancreatic, Biliary, Ovarian, Non-Small Cell Lung, and Other Cancers wv
Slide 18: Next Generation Chemotherapy Gemcitabine (NGC-Gem) and Gemcitabine
6/16/2023 Next Generation Chemotherapy Gemcitabine (NGC-Gem — @ Prcesa pharmaceuticals or PCS3117) and Gemcitabine Active Cancer dK ho Killing Molecules —_—____ * a In Some Cancers Gemcitabine (dFdC) sore i i IV Administration Oral 5 UCK2 Expression >> dCK Expression . jn Administration: = Be 8 £2 P
Slide 19: Highlights of NGC-Gem
6/16/2023 Highlights of NGC-Gem @ wrovesa Pharmaceuticals * Oral administration rather the intravenous as with Gem + More likely to be FDA approved Development + More efficient development program than new type of oncology drugs Commercial + Developed using Project Optimus & Processa’s Regulatory Sc
Slide 20: Next Milestones of NGC-Gem in 2023
6/16/2023 Next Milestones of NGC-Gem in 2023. Milestone Approx. Date Evaluate Assay Procedure to Measure 2 Potential Biomarkers (Ongoing) UMterehre) Re-analyze Clinical Cancer Data Using Project Optimus Approach (Ongoing) OES Meet with FDA to Discuss. Phase 2 Trial caine Submit Phase 2 Protocol to I
Slide 21: Next Generation Chemotherapy Irinotecan (NGC-Irin)
@ Processa Pharmaceuticals NEXT GENERATION CHEMOTHERAPY IRINOTECAN (NGC-IRIN) (Chemical Modification of Active Molecule in Irinotecan) Lung, Pancreatic, Cervical and Other Cancers 21 6/16/2023
Slide 22: Next Generation Chemotherapy-Irinotecan (NGC-Irin): Pro-Drug of SN-38
6/16/2023 Next Generation Chemotherapy-Irinotecan (NGC-Irin): Pro- GZ Process Prarmacewicals Drug of SN-38 (Active Metabolite of Irinotecan) * Cancer killing metabolite of Irinotecan is SN-38 + Irinotecan sales prior to generics > $1B * In NGC-Irin, SN-38 linked to Nano-Motor Transporting molecule a
Slide 23: Case Study: NGC-Irin Dose-Response for Safety and Efficacy Differs from Irinotecan
6/16/2023 Case Study: NGC-Irin Dose-Response for Safety and @ wrovesa Pharmaceuticals Efficacy Differs from Irinotecan in Animal Cancer Models NGC-Irin Irinotecan Lower Dose Toxicity g : fticacy 3 EB g 3 3 q £ | ‘Dose or Drug Exposure of lrnotacan ose or Drus Exposure NGCAtin Decreasing the dose of
Slide 24: Highlights of NGC-Irin
6/16/2023 Highlights of NGC-Irin @ Process Pharmaceuticals * More likely to be FDA approved * More efficient development program than new type of oncology drugs * Developed using Project Optimus & Processa’s Regulatory Science Approach * > 200,000 newly diagnosed patients per year in U.S. with cance
Slide 25: Next Milestones of NGC-Irin in 2023
6/16/2023 Next Milestones of NGC-Irin in 2023 pprox. Date Select Drug Substance and Drug Product Mid-2023 manufacturing site Drug development “roadmaps” being developed for lung, pancreatic, colorectal, Mid-2023 and other potential cancers Complete manufacturing of Drug Substance and Drug Product fo
Slide 26: Summary of Potential Milestones in 2023
6/16/2023 Summary of Potential Milestones in 2023 @ wrovesa Pharmaceuticals Begin Phase 2 Trial Preparation (e.g., Writing Protocol, CRO Selection, Site Interviews, Drug Manufacturing) 202023 Complete Enrollment of Phase 1b MTD Trial 2H2023, Submit Phase 2 Protocol to IND, Begin Initiating Sites, 40
Slide 27: Processa Senior Management
27 6/16/2023 Processa Senior Management David Young, Pharm.D, Ph.D. President & CEO ‘oined Processa 2018 Former Roles: + C80 & Independent Director, Questeor + USS. President, AGI Therapeutics + CEO, GloboMax + Assodate Professor, University of Maryland + Pharm.D, PhD, University ofS. California Pat
Slide 28: Investor Summary
6/16/2023 Investor Summary * Clinical stage drug development company with a robust pipeline of 3 Next Generation Chemotherapy (NGC) drug candidates with the potential to improve the treatment of patients with multiple types of cancers | * Number of Key Milestones achievable over the next 12 months +
Slide 29: Investor & Media Relations
6/16/2023 Investor & Media Relations: CORE IR IR@processapharma.com
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