Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Oppenheimer 33rd Annual Healthcare Conference (March 2023)
23 slides from Processa Pharmaceuticals's conference presentation, Mar 14, 2023
Slide 1: Development of Next Generation Chemotherapy Using Regulatory Science and Project Optimus
@ Processa Pharmaceuticals Development of Next Generation Chemotherapy Using Regulatory Science and Project Optimus David Young, PharmD, PhD President and CEO Oppenheimer 33rd Annual Healthcare Conference March 14, 2023
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: Developing Cancer Drugs in 2023 and Beyond
Ce Developing Cancer Drugs in 2023 and Beyond Goal: Treat Each Cancer Patient with the “Right” Drug at the “Right” Dose >» FDA goal is to ensure that the benefit of the therapy outweighs the risks associated with therapy and the cancer itself. > To achieve their goal, FDA has a new oncology initiati
Slide 4: Advantages of Processa's Regulatory Science Approach & Next Generation Chemotherapies
Advantages of Processa’s Regulatory Science Approach & Next Generation Chemotherapies (NGCs) Why is Processa Different than Other Oncology Biotech Companies? oa W_ Nccs= Processa FDA-Approved C( Regulatory / DrugsModified Science | to Alter (FDA Project \ Metabolism Optimus) x and/or Y Distributior,
Slide 5: Next Generation Chemotherapies Act on Established Targets
Next Generation Chemotherapies Act on Established Targets Most Oncology Companies Specialize in Drug Delivery or New Targets (eg, Immuno-Oncology, Gene Tx) Different Processa A\ ch oo Alter Metabolism and/or Distribution Drug Gets into the Body and of FDA-Approved Drugs or Their Active Metabolites W
Slide 6: Processa's Regulatory Science Approach Improves Development and Product Differentiation
Processa’s Regulatory Science Approach Improves Development and Product Differentiation > PCSA Regulatory Science approach: * was conceived from 2 FDA contracts in the 1990s. + evaluates the factors influencing FDA’s Risk-Benefit analyses. + has resulted in > 30 FDA approvals for indications across
Slide 7: Prior to FDA Project Optimus Initiative
Prior TO FDA Project Optimus Initiative Previous 30 Years of Oncology Clinical Drug Development What Happens to Oncology Drugs in Patients? Previous Maximum Tolerated Dose (MTD) Approach Inherent Assumption: Decreasing dose or drug exposure decreases not only the toxicity (adverse events) but also d
Slide 8: FDA Project Optimus
FDA Project Optimus: Clinical Effect/Response May Not Follow the Same Pattern for All Oncology Drugs > Prior assumption that decreasing dose or drug exposure decreases not only the toxicity (adverse events) but also decreases efficacy in a similar manner may not be correct for all drugs (See Left vs
Slide 9: reast, Gastric, Pancreat
1H 2023 2025 reast, Gastric, Pancreat & Other Cancers nei Non-Small Cell Lung, reast & Other Cancers Ovarian, Cervical, & Other Cancers PCS12852 Moderate/Severe Gastroparesis & Other GI Motility Conditions Pcs499 H Out-Licensing, Partnering, Spin-Off Ulcerative iosis Lipoidic: Discontinue uNL Ph 2B,
Slide 10: Approvals for Indications in Almost Every FDA Division
Approvals for Indications in Almost Every FDA Division Two FDA Contracts Where Regulatory Science Was Conceived Management Team Involved With Billion-Dollar Exits (Questcor - $5.7 B & Gentium - $1.0 B) A Michael Floyd Chief Operating Officer of David Young, PharmD, PhD. Sian Bigora, Pharm. President
Slide 11: Financial Highlights and Capital Structure
Financial Highlights and Capital Structure > Cash on September 30, 2022 was $9.1 million. > On February 9, 2023 we closed an offering for net proceeds of $5.7 million from the sale of 7.8 million shares. > Our current cash balance, include offering proceeds in 2023 provides a cash runway into the th
Slide 12: Next Generation Chemotherapy Capecitabine (NGC-Cap)
GB Processa Pharmaceuticals Next Generation Chemotherapy Capecitabine (NGC-Cap) (Combination Regimens of PCS6422 and Capecitabine) Colorectal Cancer, Gastric, Breast Cancer, Pancreatic Cancer, and Other Cancers
Slide 13: 5-FU & Capecitabine - Most Widely Used Cancer Chemotherapy Agents
5-FU & Capecitabine - Most Widely Used Cancer Chemotherapy Agents Capecitabine + The Maximum ToleratedDose (MTD) for Capis determinedfrom « AEs associated with Catabolites and Anabolites + 50% - 70% of patients on capecitabine have dose-limiting side effects requiring a change in therapy + Approxima
Slide 14: Next Generation Chemotherapy-Capecitabine (NGC-Cap)
Next Generation Chemotherapy-Capecitabine (NGC-Cap) Absorption, Metabolism, No change in absorption of NGC-CAP compared to Cap Distribution + Less metabolism of NGC-Cap to catabolites + More metabolism of NGC-Cap to anabolites + More distribution of NGC-Cap to cancer cells Side Effects + NGC-Cap AEs
Slide 15: NGC-Cap Project Optimus: Evaluating Safety as a Function of Drug Exposure
NGC-Cap Project Optimus: Evaluating Safety as a Function of Drug Exposure and 6422 Regimens in Phase 1B Trial Evaluate Safety vs Exposure As Project Optimus Requires Efficacy Toiity 3 Toxicity - on on 3 (NGC Regimen A) 3 5-FU Exposure Level B 06 06 2 4 efcacy (NGC Regimen B) 2 - TBD TBD = (NGC Regim
Slide 16: Next Milestones of NGC-Cap in 2023-2024
Next Milestones of NGC-Cap in 2023-2024 > NGC-Cap Cohort 3 (300 mg Cap per day x 7 days) is enrolling for evaluation of Adverse Event-Exposure relationship; no DLTs with one dose of 6422 and 150 mg Cap per day x 7 days. > Potential 5-FU exposures and NGC regimens have been identified for a Phase 2B
Slide 17: Next Generation Chemotherapy Gemcitabine (PCS3117)
@ Processa Pharmaceuticals Next Generation Chemotherapy Gemcitabine (PCS3117) Pancreatic Cancer - Recurrent Pancreatic Cancer after Surgery and Adjuvant Therapy, Biliary Cancer, Non-Small Cell Lung, and Other Cancers
Slide 18: PCS3117: Next Generation Chemotherapy - Gemcitabine (NGC-Gem)
PCS3117: Next Generation Chemotherapy — Gemcitabine (NGC-Gem) Ct > Gemcitabine is the most widely used chemotherapy agent used to treat pancreatic, non- l WN small cell lung, biliary cancer. Ho, > U.S. pancreatic cancer Gemcitabine sales are ~ $1 B; U.S. market for all cancer/indications ry is >$1.5
Slide 19: NGC-Gem Milestones in 2023-2024
NGC-Gem Milestones in 2023-2024 > PCSA will complete the assay for possible biomarkers in pancreatic cancer patients (potential biomarkers to identify potential non-responders to Gemcitabine and responders to NGC-Gem). > PCSA will meet with FDA to discuss pancreatic cancer development program and Ph
Slide 20: Next Generation Chemotherapy Irinotecan (PCS11T)
Zz Processa Pharmaceuticals Next Generation Chemotherapy Irinotecan (PCS11T) Colorectal, Lung, Pancreatic, Cervical and Other Cancers
Slide 21: Next Generation Chemotherapy-Irinotecan (PCS11T)
Next Generation Chemotherapy-Irinotecan (PCS11T): Lipophilic Prodrug of SN-38 (Irinotecan Active Metabolite) > 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 t
Slide 22: NGC-Irin Clinical Effect/Response Do Not Follow the Same Pattern in Animal Cancer Model
NGC-Irin Clinical Effect/Response Do Not Follow the Same Pattern In Animal Cancer Model > Efficacy is maintained at lower doses of NGC-Irin compared to Irinotecan in colorectal cancer xenograft model > SN38 had 200-times greater uptake in cancer cells vs muscle after NGC-Irin compared to only 15-tim
Slide 23: NGC-Irin Milestones in 2023-2024
Ce NGC-Irin Milestones in 2023-2024 > Drug Substance manufacturing site has been selected and Drug Product manufacturing sites are being evaluated. Drug development “roadmaps” are being developed for lung, pancreatic, colorectal, and other potential cancers. Vv > PCSAwill complete manufacturing of D
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