Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Q2 2021 Earnings Presentation
14 slides from Processa Pharmaceuticals's earnings presentation, Aug 12, 2021
Slide 1: 2Q 2021 Earnings Call
2Q 2021 Earnings Call | August 12, 2021
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements The following summary is provided for informational Forward-looking statements, by their very nature, are purposes only and does not constitute an offer or subject to uncertainties and contingencies and assume solicitation to acquire interests in the investment
Slide 3: Processa's Differentiated Approach
Processa’s Differentiated Approach Repeatable, Capital-efficient Blueprint Platform with Potential to Generate Significant ROI Potentially High Unmet Medical Need + Efficacy Evidence + Regulatory Science + Capital Efficiency + ROI • Clear and obvious • Evidence of clinical • Improve Benefit/Risk • L
Slide 4: Processa Pipeline – Multiple Opportunities For Success
Processa Pipeline – Multiple Opportunities For Success Drug Disease Target Preclin Phase Phase Phase Status Milestones 1 2 3 PCS499 Ulcerative 2 Patients Enrolled; 1 Patient in Interim Analysis 1H’22; Phase 2B Necrobiosis Screening; 10 Patients Pre-Screen Final Analysis 2H’22; * Lipoidica Failures;
Slide 5: PCS499 to Be First to Market for Ulcerative Necrobiosis Lipoidica (uNL)
PCS499 to Be First to Market for the Treatment of Ulcerative Necrobiosis Lipoidica (uNL) Severe NL Mild NL Ø Skin, tissue below the skin becomes necrotic, last from months to years with complications such as infections, amputation; Histopathology ≠ diabetic ulcers Ø 30% of NL patients have painful u
Slide 6: Unmet Medical Need, Evidence of Clinical Efficacy, PCS499 Improves Benefit-Risk
Unmet Medical Need, Evidence of Clinical Efficacy, PCS499 Improves Benefit-Risk Ø PCS499 is the deuterated analog of a major metabolite of PTX; has identical metabolites and pharmacological targets but PK of 499 + metabolites is different than PTX + metabolites resulting in a better 499 safety profi
Slide 7: PCS12852 Potent-Selective 5HT4 Agonist: Gastroparesis
PCS12852 Potent-Selective 5HT4 Agonist: Gastroparesis ($1 B Market) Submit IND for Phase 2A Trial in 3Q’21, FPI in 1Q’22 Normal Gastric Emptying Gastroparesis Other 5HT4 Drug Dopamine D2 12852 (e.g., Cisapride, Antagonist Prucalopride, (.e.g,, Mosapride) Metoclopramide) Binding • Very specific • Les
Slide 8: PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis
PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis Ø Economic Value: Initial Markets • Prevalence of moderate to severe gastroparesis in U.S. reported to be over 200,000 to > 1,500,000 patients depending on formal diagnosis vs symptom presentation • Present use of approved drugs a
Slide 9: In Licensed PCS3117 for Gemcitabine Resistant Pancreatic and Lung Cancer Patients
In Licensed PCS3117 for Gemcitabine Resistant Pancreatic and Lung Cancer Patients Ø PCS3117 has similar structure to gemcitabine but is activated through a different pathway and causes cancer cell apoptosis in more ways than gemcitabine Ø PCS3117 has been shown in gemcitabine resistant cancer patien
Slide 10: Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine
Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine Ø Biomarker assays are being developed and evaluated to potentially define a targeted, personalized medicine UCK2 Expression dCK Expression approach to identifying patients who will respond to 3117 better than gemcitab
Slide 11: PCS6422 Combined with Capecitabine To Provide Better Safety/Efficacy Profile
PCS6422 Combined with Capecitabine To Provide Better Safety/Efficacy Profile PCS6422 Irreversibly Inhibits Dihydropyrimidine Dehydrogenase (DPD) Enzyme Capecitabine (Xeloda®) 6422 Inhibits DPD Allowing Two Ways to Win Ø Lower Side Effects by Lowering 5-FU Metabolite FBAL– Potentially Improve QOL & R
Slide 12: Unmet Medical Need and Evidence of Clinical Benefit
Unmet Medical Need and Evidence of Clinical Benefit Ø Safety Differentiation of 6422+Capecitabine vs Existing Chemotherapy Decrease Incidence of HFS (Grade 3&4) FBAL Side Effects • 50-70% of capecitabine patients have adverse events from FBAL resulting in decreasing capecitabine dose or stopping the
Slide 13: Summary Timeline of Pipeline and Key Clinical Milestones
Summary Timeline of Pipeline and Key Clinical Milestones 1H 2H 1H 2H 2023-2025 2021 2021 2022 2022 PCS499 • Initiate Sites • Interim • Final Analysis • Phase 3 Trial Phase 2B • FPI Analysis • NDA Submission PCS12852 • Pre-IND Meeting • IND Submission • FPI • Final Analysis • Final Analysis Phase 2A
Slide 14: What's Expected Over the Next 6 Months?
What’s Expected Over the Next 6 Months? Ø Complete enrollment of patients for the interim analysis of PCS499 Ø IND Clearance for PCS12852 in Gastroparesis Ø Analysis of Cohort 1 & 2 in the 6422 Phase 1B Dose Escalation Study Ø Development of PCS3117 Biomarker Assays and Initiation of Assay Validatio
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