Processa Pharmaceuticals, Inc. · NASDAQ:PCSA

Processa Pharmaceuticals — Corporate Update (March 2022)

27 slides from Processa Pharmaceuticals's corporate update, Mar 17, 2022

  1. Slide 1: Clinical Pipeline Update

    G Processa Pharmaceuticals Clinical Pipeline Update March 2022

  2. 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

  3. Slide 3: Processa Highlights

    Processa Highlights > Development Company Focused on Improving the QOL or Survival of Patients with an Unmet Medical Need + Present programs represent 5 different U.S. markets with potential sales of $500 M to $1.5 B for each drug + Each drug has the potential to expand into additional markets > Man

  4. 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 e eo DEVELOP NOT DISCOVER — REGULATORY SCIENCE PLATFORM eo * Clear and obvious © Evidence of clinical * Improve Benefit/Risk ° Leverage

  5. Slide 5: Processa Pipeline - Five Drugs Each with $1B Market Opportunity

    Processa Pipeline - Five Drugs Each with $1B Market Opportunity Multiple High Value Milestones in 2022 Drug Disease Target | Nonclin | Phase | Phase | Phase Status 2022 Milestones 1 2 3 Pcs499 Ulcerative 3 Patients Dosed; 1H'22 — Complete Interim Group Phase 2B Necrobiosis 3 Patient in Pre-Screening

  6. Slide 6: Next Generation Capecitabine - Capecitabine Combined with PCS6422

    Next Generation Capecitabine - Capecitabine Combined with PCS6422 > Modified Phase 1B protocol to evaluate timeline of DPD enzyme inhibition - de novo formation + 75 mg b.i.d. of capecitabine after a single dose of 6422 in Cohort 2 was safe but did not alter the effect of DPD throughout the 7 days o

  7. Slide 7: PCS499 - Ulcerative Necrobiosis Lipoidica (uNL)

    PCS499 - Ulcerative Necrobiosis Lipoidica (uNL) > 3 patients enrolled; preliminary results show ulcers may have closed in some patients > 3 patients in pre-screen (identified through pictures to have an ulcer(s), expressed interest in being screened) > COVID-19 has affected enrollment (patients in p

  8. Slide 8: PCS12852 and PCS3117

    PCS12852 and PCS3117 > PCS12852 (Gastroparesis) * Sites being initiated; the 1st two patients are in screening; expected FPI 1H’22 * Complete enrollment in 40’22 with preliminary topline efficacy results in Dec 2022 - Jan 2023 > PCS3117 (Metastatic Pancreatic and Other Cancers) * Developing biomarke

  9. Slide 9: Processa Pipeline - Five Drugs Each with $1B Market Opportunity

    Processa Pipeline - Five Drugs Each with $1B Market Opportunity Multiple High Value Milestones in 2022 Drug Disease Target Status 2022 Milestones PCS499 Ulcerative 3 Patients Dosed; 1H’22 - Complete Interim Group Enrollment Phase 2B Necrobiosis 3 Patient in Pre-Screening; 2 - Interim Analysis, Compl

  10. Slide 10: Our People Lead to Success

    Our People Lead to Success Management Team David Young, PharmD. PhD Chief Executive Officer, Chairman of the Sian Bigora, Fharmp: Michael Floyd . Board Chief Development Officer Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business — Strategy Officer Chief Financial Officer

  11. Slide 11: Pipeline Backup Slides

    @ Processa Pharmaceuticals Pipeline Backup Slides

  12. Slide 12: Next Generation Capecitabine

    G Processa Pharmaceuticals Next Generation Capecitabine (Combination of Capecitabine with PCS6422) Metastatic Colorectal Cancer

  13. Slide 13: Next Generation Capecitabine: Interim Results in GI Cancer

    Next Generation Capecitabine (Combination of PCS6422 and Capecitabine): Interim Results in GI Cancer (> $1B Market) When PCS6422 Irreversibly Inhibits DPD, Next Generation Capecitabine Should be More Potent Than FDA Approved Capecitabine Capecitabine (Xeloda®) ~ 20% of FU GZ GY Process Pharmaceutica

  14. Slide 14: Next Generation Capecitabine: Next Steps and "Audible" Call by Processa

    a Next Generation Capecitabine: Next Steps and “Audible” Call by Processa v v v_ Response Rate v Survival Time HFS Rate &/or Severity % Treatment Resist. Pts >» Since 6422 irreversibly inhibits DPD, metabolism to FBAL after 6422 administration occurs from some DPD not being inhibited and/or the form

  15. Slide 15: 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 combination p

  16. Slide 16: PCS499 Ulcerative Necrobiosis Lipoidica

    @ Processa Pharmaceuticals PCS499 Ulcerative Necrobiosis Lipoidica

  17. Slide 17: PCS499: First Drug to Treat Ulcerative Necrobiosis Lipoidica (uNL)

    PCS499: First Drug to Treat Ulcerative Necrobiosis Lipoidica (uNL) Severe NL Mild NL Skin and tissue below the skin becomes necrotic; can last from months to years with complications such as infections, amputation, and cancer Vv > Literature reports approximately 22,000 — 55,000 uNL patients in U.S.

  18. Slide 18: Unmet Medical Need, Evidence of Clinical Efficacy

    Unmet Medical Need, Evidence of Clinical Efficacy > 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)); provide poor safety profile given their limited efficacy > PCS499 is the d

  19. Slide 19: Phase 2A PCS499 Improves Benefit-Risk Profile

    Phase 2A PCS499 Improves Benefit-Risk Profile > 1.8 gm/d of 499 has a 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

  20. Slide 20: PCS12852 Gastroparesis

    @ Processa Pharmaceuticals PCS12852 Gastroparesis

  21. Slide 21: 2H'22 - PCS12852 Trial Conduct Completed

    Ie 2H’22 - PCS12852 Trial Conduct Completed PCS12852 Potent and Selective 5HT4 Agonist for Treatment of Gastroparesis > Target Indication: 100 © * Treatment of moderate to sever = gastroparesis e so P e) 0.1 mg 12852* > Target Claims: ae ; i 2 : * Improves gastric emptying rate on ® $ t i . —s > 2 a

  22. Slide 22: PCS12852: Potent & Selective 5HT4 Agonist for Treatment of Gastroparesis

    PCS12852: Potent & Selective 5HT4 Agonist for Treatment of Gastroparesis ($1B Market) Bindin Efficac PCS12852 Specific & potent 5HT4 receptor binding No serious side effects in clinical studies to date Increase gastric emptying rate in patients with constipation @ Processa Pharmaceuticals Other 5HT4

  23. Slide 23: PCS3117 Metastatic Pancreatic Cancer

    @ Processa Pharmaceuticals PCS3117 Metastatic Pancreatic Cancer

  24. Slide 24: 1H'22 - PCS3117 Biomarker Assay Development Completed

    1H’22 - PCS3117 Biomarker Assay Development Completed NH2 NH2 NH2 Sn Sn | A | A | Sy N ‘O N (e) HO. as F HO. oN O HO. ° F OH OH OH F RX-3117 Gemcitabine (dFdC) onl OH Oral Administration IV Administration Cytidine (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) (Cytosine + Ribose Ring) > Gem

  25. Slide 25: Gemcitabine Resistant Patients

    Gemcitabine Resistant Patients > 55% - 85% of patients are inherently resistant to gemcitabine or acquire resistance Gemcitabine’s overall response or disease control rate is 15% to 45% depending on the type of cancer and trial « Inherent or acquired resistance caused by v Increase in CDA activity Y

  26. Slide 26: Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine

    Ie Target Population: More Likely to Respond to or Activate PCS3117 than Gemcitabine Vv 3117 is metabolized to its active metabolite through a different route than gemcitabine; has a different MOA than gemcitabine Treat patients more likely to respond to 3117 than gemcitabine Biomarker assays are be

  27. Slide 27: PCS3117 Prior Evidence of Clinical Efficacy and Safety in Cancer Patients

    Ie PCS3117 Prior 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

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