Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (March 2021)
15 slides from Processa Pharmaceuticals's investor presentation, March 2021
Slide 1: Clinical Pipeline Update March 2021
CLINICAL PIPELINE UPDATE MARCH 2021
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: Highlights of 2020
Highlights of 2020 Expanded Drug Portfolio to 4 Drugs with Each Having Potential Max Sales of $1 B or More Completed PCS499 Phase 2A trial in patients with Expanded Financial and Human Capital necrobiosis lipoidica, demonstrating 499 was safe and efficacious in patients with ulcers Up-listed to Na
Slide 4: Processa's Differentiated Development Approach
Processa’s Differentiated Development Approach Repeatable, Capital-efficient Blueprint Platform with Potential to Generate Significant ROI DEVELOP NOT DISCOVER REGULATORY SCIENCE PLATFORM High Unmet Efficacy Regulatory Capital Potentially Medical Need Evidence Science Efficiency High ROI Clear and
Slide 5: Processa Pipeline – Multiple Opportunities For Success
Processa Pipeline – Multiple Opportunities For Success Use Studies of Prior Companies and Hundreds of Millions of Dollars Invested Ulcerated Necrobiosis Lipoidica Phase 2B Pipeline Unmet Medical Need Metastatic Gastroparesis PCS499 Colorectal Cancer Phase 2A Phase 1B Efficacy Evidence PCS12852 PCS64
Slide 6: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) • Target Indication: • Treatment of metastatic colorectal cancer when combined with capecitabine • Target Claims: • 6422+capecitabine a better benefit-risk profile (less adverse events and/or better efficacy) than capecitabine • Tar
Slide 7: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) • Economic Value: • > 145k new patients with colorectal cancer/yr in us and > 1.8 M patients worldwide • 45% of the new patients with colorectal cancer presently receive capecitabine • Potential for 6422+capecitabine combo to replac
Slide 8: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) • Next Trial - Phase 1B: • General Design: 3+3 cohort capecitabine MTD trial after a single safe dose of 6422; 1 dose 6422, 7d of capecitabine, 7d of no capecitabine; up to 6 cohorts of capecitabine b.i.d. at 75mg/d to 600 mg/d • Ob
Slide 9: PCS499 Treatment of Ulcerative Necrobiosis Lipoidica
PCS499 Treatment of Ulcerative Necrobiosis • Indication: Lipoidica • Treatment of ulcerative necrobiosis lipoidica (“uNL”) • Claims: • Completely closes open necrobiosis lipoidica ulcers; improves non-ulcerated NL lesions • Differentiation of 499 vs Other Drugs Used in Ulcerative Necrobiosis Lipoidi
Slide 10: PCS499 Treatment of Ulcerative Necrobiosis Lipoidica
PCS499 Treatment of Ulcerative Necrobiosis Lipoidica • Economic Value: • 22,000 – 55,000 patients in U.S. have uNL • Presently no approved treatment and off-labeled drugs not proven to be significantly effective/safe in patients with NL or uNL • 499 would be the first approved drug to treat patients
Slide 11: PCS499 Treatment of Ulcerative Necrobiosis Lipoidica
PCS499 Treatment of Ulcerative Necrobiosis Lipoidica • Next Trial - Phase 2B: • General Design: Randomized, double-blind placebo-controlled trial of 1.8 gm/d of 499 in 20 uNL patients with primary efficacy evaluation at 6 months • Objective: To determine complete closure response rate of ulcers in p
Slide 12: PCS12852 Treatment of Gastroparesis
PCS12852 Treatment of Gastroparesis • Indication: • Treatment of moderate to severe gastroparesis • Claims: • Improves the symptoms associated with moderate to severe gastroparesis • Differentiation of 12852 vs Other Drugs Used in Gastroparesis • 12852 - Highly specific, potent 5HT4 agonist (more sp
Slide 13: PCS12852 Treatment of Gastroparesis
PCS12852 Treatment of Gastroparesis • Economic Value: • 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 and off-labelled drugs in gastroparesis is limited
Slide 14: Summary: Timeline for Trials
Summary: Timeline for Trials Obtain Key Interim Results in 2021/2022, Complete 3 Clinical Trials, Obtain Information to Design FDA Registration Trials & Increase Probability of FDA Approval 1Q 2Q 3Q 4Q 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 PCS6422 Initiate Sites, Analysis First 2 Cohorts 2H’
Slide 15: Summary: Key Clinical Catalysts
Summary: Key Clinical Catalysts 1Q 2Q 3Q 4Q 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 PCS6422 FPI Cohort 1, 2 Cohort 3 & 4 Final Phase 2 or 3 Phase 1B Analyses Analyses Analysis PCS499 FPI Interim Final Phase 3 Phase 2B Analysis Analysis PCS12852 IND FPI Interim Final Phase Phase 2A Analysis Ana
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