Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (July 2021)
24 slides from Processa Pharmaceuticals's investor presentation, Jul 15, 2021
Slide 1: Processa Pharmaceuticals: Access to Giving
@ Processa Pharmaceuticals Access to Giving July 15, 2021 David Young, PharmD, PhD Chairman and CEO
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: Processa Highlights
Processa Highlights Increase Prob. of Approval - Experienced Exec. Team & Staff - Drug Development Regulatory Science Platform - Pipeline Drugs Selected to Increase Prob of Success & Mitigate Risk Drug Development Platform - 30 FDA Approvals, 100 FDA Meetings, 2 FDA Regulatory Science Contracts Capi
Slide 4: Processa's Risk Abated Approach and Criteria for Drug Selection
Processa’s Risk Abated Approach and Criteria for Drug Selection Experience in Adding Value to Companies: > 30 FDA Approvals & Regulatory Science Contracts from FDA eo e DEVELOP NOT DISCOVER = REGULATORY SCIENCE PLATFORM e A Capital Efficiency + * Clear and obvious * Evidence of * Improve Benefit/Ris
Slide 5: Processa Capital Structure and Share Information
Processa Capital Structure and Share Information on March 31, 2021 > Stock Listing: PCSA- NASDAQ > 52 Week Low-High: $3.95 - $13.15 > Price (July 9, 2021): $8.14 > Market Cap (July 9, 2021): $126,345,954 > Shares Outstanding: 15,521,616 > Fully Diluted Shares: 16,511,147 > Cash, Cash Equivalents: $2
Slide 6: Processa Pipeline: Multiple Opportunities For Success
Processa Pipeline— Multiple Opportunities For Success Pipeline of Drugs with Funding to Obtain Results for Key Milestones Drug Disease Target Preclinical Phase 1 Phase 2 Phase 3 Key Milestones PCS499 Ulcerative Phase 2B Necrobiosis * Lipoidica : FPI Phase 3 SPA 2023 PCS12852 Gastroparesis, Phase 2A
Slide 7: First to Market for the Treatment of Ulcerative Necrobiosis Lipoidica (UNL)
First to Market for the Treatment of Ulcerative Necrobiosis Lipoidica (UNL) > Skin, tissue below the skin becomes necrotic, can last from months to years with complications such asinfections, amputation, and cancer Severe NL Mild NL > 70% of the patients are women between 20 - 60 years old; 60% of N
Slide 8: Unmet Medical Need, Evidence of Clinical Efficacy, PCS499 Improves Benefit-Risk
a Unmet Medical Need, Evidence of Clinical Efficacy, PCS499 Improves Benefit-Risk > No FDA approved treatment for uNL or NL, no standard of care, all treatments are inadequate > Drugs have been used off-label with mixed success (e.g., pentoxifylline (PTX)) - side effect profile, limited efficacy > P
Slide 9: Phase 2A PCS499 Improves Benefit-Risk Profile
Phase 2A PCS499 Improves BenefitRisk Profile > 1.8 gm/d of 499 has better safety profile than 1.2 gm of PTX in animal tox studies and Phase 1 healthy human volunteer studies > In the Phase 2A study of 10 NL and 2 ulcerative NL patients, all ulcers closed in the 2 ulcerative NL patients, including ne
Slide 10: Ulcerative NL (uNL) Target Population
Ulcerative NL (uNL) Target Population Ulcerative Necrobiosis Lipoidica (uNL) > Economic Value: Initial Markets Max Gross Sales * 75,000 - 185,000 NL patients in U.S. * 22,000 —- 55,000 uNL patients in U.S. + Presently no approved treatment and off-labeled ~$1.0B drugs have mixed efficacy/safety resu
Slide 11: PCS499 FDA Designated Orphan Drug: Phase 2B Design
i eee 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 deter
Slide 12: PCS6422 Chemotherapy Modifier of Capecitabine (Xeloda)
PCS6422 Chemotherapy Modifier of Capecitabine (Xeloda®) PCS6422 Irreversibly Inhibits Dihydropyrimidine Dehydrogenase (DPD) Enzyme Capecitabine Converts to 5-FU in the body Capecitabine (Xeloda®) + ~20% of 5-FU Metabolizes to Molecules with Anti- . Tumor Activity and side effects such as neutropenia
Slide 13: Unmet Medical Need and Evidence of Clinical Benefit
Unmet Medical Need and Evidence of Clinical Benefit > Safety Differentiation of 6422+Capecitabine vs Existing Cancer Chemotherapy 50-70% of capecitabine patients have adverse events from FBAL resulting in decreasing capecitabine dose or stopping chemotherapy Decrease Incidence of HFS (Grade 3&4) FBA
Slide 14: Unmet Medical Need, Evidence of Clinical Benefit, Regulatory Science Platform
Unmet Medical Need, Evidence of Clinical Benefit, Regulatory Science Platform > Efficacy Differentiation of 6422+Capecitabine vs Existing Cancer Chemotherapy + ~30% of patients do not respond at all to capecitabine and ~30% are partial responders * Clinical trial of the 6422 + capecitabine combinati
Slide 15: PCS6422-Capecitabine Combination Different than Capecitabine
PCS6422- Capecitabine Combination Different than Capecitabine > Economic Value: Initial Markets * 6422 + Capecitabine combination potential 15 line therapy for a number of cancers (e.g., metastatic colorectal and breast cancer) v Response Rate ¥ ‘Survival Time * Colorectal cancer; > 145,000 new pati
Slide 16: PCS6422 Chemotherapy Modifier of Capecitabine: Phase 1B Trial
PCS6422 Chemotherapy Modifier of Capecitabine (Xeloda®) > Present Phase 1B Trial to Determine Appropriate Dosing of 6422 and Capecitabine + General Design: MTD Stage 1 will be a 3+3 cohort capecitabine trial after a single safe dose of 6422; 1 dose 6422, 7d of capecitabine, 7d of no capecitabine; up
Slide 17: PCS3117 vs Gemcitabine vs Cytidine
PCS3117 vs Gemcitabine vs Cytidine NH, NH, NH2 “SN SSN | pe | A | Sy N ‘0 A F ae N HO. N {e) HO ° 0. IH IH H OH OH RX-3117 Gemcitabine (dFdC) i Oral Administration IV Administration Cytidine (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) (Cytosine + Ribose Ring) > Gemcitabine Market + First
Slide 18: Differences Between Gemcitabine vs PCS3117
Differences Between Gemcitabine vs PCS3117 Activation to Cancer Killing Metabolites and Mechanism of Cancer Cell Death Gemcitabine Brac Fe racnel 224] dFdcDP COA | cro [woe | ibition of DNA synthesis dFdu dFdU —— dFauMP dFACTP + 202032 — Apoptosis RRM! “sto CDP ———- dcDP —— dCTP —<ts- — Proliferatio
Slide 19: Evidence of Clinical Efficacy and Safety in Cancer Patients
a Evidence of Clinical Efficacy and Safety in Cancer Patients » PCS3117 monotherapy Phase 2A trial as second or third-line therapy in patients with progressive metastatic pancreatic cancer after 1-5 previous therapies of chemotherapy (93% (40/43) refractory to gemcitabine) * 31% (14 patients) had pr
Slide 20: Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine
Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine > Biomarker_assays are being developed and evaluated to potentially define a targeted, personalized medicine approach to identifying patients who will respond to 3117 UCK2 Expression dCK Expression better than gemcitab
Slide 21: PCS3117 Treatment Resistant Gemcitabine Patients
PCS3117 Treatment Resistant Gemcitabine Patients > 55% - 85% of patients are inherently resistant to gemcitabine or GewicitabiedT rested Patents acquire resistance $815 M USS. - $1.7 B Worldwide Max Gross Sales * Gemcitabine overall response or disease control rate is 15% to 45% depending on type of
Slide 22: PCS3117 6-18 Month Development Plan in Pancreatic Cancer
PCS3117 6-18 Month Development Plan in Pancreatic Cancer > Refine and evaluate biomarker assays for 3117 over the next 6-9 months: + Anumber of assays presently exist that could potentially be used + Assays need to be evaluated and refined for more routine use as required in a Phase 3 pivotal trial
Slide 23: Summary Timeline of Pipeline and Key Clinical Catalysts
Summary Timeline of Pipeline and Key Clinical Catalysts 1H 2H 1H 2H 2023-2025 2021 2021 2022 2022 PCS499 + Initiated Sites + Interim + Final Analysis + Phase 3 Trial Phase 2B + FPI (May) Analysis + NDA Submission PCS12852 + Pre-IND * IND Submitted and ° FPI(1H’22) + Final Analysis + Phase 2B Trial P
Slide 24: Our People Lead to Success
Our People Lead to Success Management Team David Young, PharmD. PhD Sian Bigora, PharmD. Chief Executive Officer, Chairman of the Board Chief Development Officer Michael Floyd Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business — Strategy Officer Chief Financial Officer C
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