Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Q1 2021 Earnings Presentation
20 slides from Processa Pharmaceuticals's earnings presentation, May 13, 2021
Slide 1: 1Q 2021 Earnings Call
@ Processa Pharmaceuticals 1Q 2021 Earnings Call | May 13, 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: Summary Timeline for Clinical Trials
Summary Timeline for Clinical Trials 1Q 2Q 3Q 4Q 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 Analysis First 2 Cohorts 2H’21, Phase 2 or 3 Final Analysis 2H’22 Initiate 2023 Interim Analysis 1Q’22, Phase 3 Final Analysis 2H’22 I ite 2023 Initiate Sites, Begin Patient Dosing Phase 2B Pre-IND Meeting
Slide 4: Highlights of 1Q2021
Highlights of 1Q2021 Continued Development of Drug Pipeline Each Having Potential Sales of $1 B or More vPcCs499 + Selected clinical sites for Phase 28 trial in patients with ulcerative necrobiosis lipoidica (uNL) + Have begun screening patients for uNL trial + Adding sites vPCS6422 + Selected sites
Slide 5: Processa's Differentiated Approach
Processa’s Differentiated Approach Repeatable, Capital-efficient Blueprint Platform with Potential to Generate Significant ROI fj oo ee DEVELOP NOT DISCOVER = REGULATORY SCIENCE PLATFORM e Ls ——, Unmet Medical Need + Efficacy Evidence + RegulatoryScience + Capital Efficiency + |e)Ciiei\Viallelnae)!
Slide 6: Processa Pipeline - Multiple Opportunities For Success
Processa Pipeline- Multiple Opportunities For Success Processa Pipeline — Multiple Opportunities For Success Drug Disease Target PCS6422 Metastatic Colorectal, Breast Cancer Preclinical Phase 1 Phase 2 Phase 3 Market Size >$1B PCS499 Ulcerative Necrobiosis Lipoidica >$1B PCS12852 Gastroparesis, Func
Slide 7: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) ( Capecitabine » oe loda®} / > Target Indication: X< (Xel ) y —~ a * Treatment of metastatic colorectal cancer when combined with capecitabine > Target Claims: * 6422+capecitabine combination provides patients with a better benefit-
Slide 8: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) >» Safety Differentiation of 6422+Capecitabine vs Existing Cancer Chemotherapy + 50-70% of capecitabine patients have adverse events from FBAL resulting in a decrease in capecitabine dose or stopping capecitabine chemotherapy * 6422
Slide 9: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) >» Economic Value: Initial Markets * 6422 + Capecitabine combination potential 1% line therapy for a number of cancers (e.g., metastatic colorectal and breast cancer) v Response Rate * Colorectal cancer; > 145,000 new patients/yr U.
Slide 10: PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®)
PCS6422 Chemotherapy Modifier of Cancer Drug Capecitabine (Xeloda®) > Present Phase 1B Trial to Determine Appropriate Dosing of 6422 and Capecitabine + 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
Slide 11: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL) Provides Efficacious/Safe Treatment for Patients with No Treatment Options > Target Indication: * Treatment of ulcerative necrobiosis lipoidica ("UNL") > Target Claims: + Completely closes open necrobiosis lipoidica ulcers; i
Slide 12: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL) > Differentiation of PCS499 from Existing Therapy No approved NL or uNL treatment in U.S. or worldwide Off-label drugs are prescribed to treat NL with mixed results, many have side effects limiting their use (e.g., pentoxifyl
Slide 13: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
ER PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL) Ulcerative Necrobiosis Lipoidica (UNL) >» Economic Value: Initial Markets * 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
Slide 14: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
PCS499 FDA Designated Orphan Drug- Ulcerative Necrobiosis Lipoidica (UNL) » Phase 2B to Better Define Variables for Phase 3: 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 co
Slide 15: PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis
PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis > Target Indication: + Treatment of moderate to sever gastroparesis > Target Claims: + Improves gastric emptying rate and the symptoms associated with moderate to severe gastroparesis (e.g., bloating, pain, nausea, vomiting) - Pro
Slide 16: PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis
PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis > Differentiation of 12852 from Existing therapy Other 5HT4 Drug Dopamine D2 + Present use of approved drugs and off- 12852 (e.g., Cisapride, Antagonist labelled drugs in gastroparesis is limited by side effects of these drugs Pru
Slide 17: PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis
PCS12852 Potent-Selective 5HT4 Agonist for Treatment of Gastroparesis > 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 18: Summary Timeline for Clinical Trials
Summary Timeline for Clinical Trials 1Q 2Q 3Q 4Q 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 Analysis First 2 Cohorts 2H’21, Phase 2 or 3 Final Analysis 2H’22 Initiate 2023 Interim Analysis 1Q’22, Phase 3 Final Analysis 2H’22 I ite 2023 Initiate Sites, Begin Patient Dosing Phase 2B Pre-IND Meeting
Slide 19: Key Clinical Catalysts
Key Clinical Catalysts 10 20 30 40 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 ie | —e—_— > — > PeSoa22 FPI Eonort 1 12 Cohort 3 & 4 Final Phase 2 or 3 Phase 1B Analyses Analyses Analysis pcs499 —_—, ————*+ TT —— Phi 3 Phase 2B EP Analysis Analysis ase PCS12852 hb _—_ en Phase 2A he Ed Interim Fin
Slide 20: What's Coming Over the Next Months?
What’s Coming Over the Next 6 Months? > First Patient Dosed in PCS499 Phase 2B Ulcerative NL Trial > First Patient Dosed in PCS6422 Phase 1B GI Cancer Trial and Analysis of Cohort 1 & 2 Data > IND Clearance for PCS12852 in Gastroparesis > Invited Presentation at the Oppenheimer Rare & Orphan Disease
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