Slide 1: The Processa Regulatory Science Approach
@ Processa Pharmaceuticals The Processa Regulatory Science Approach David Young, PharmD, PhD President and CEO Processa Pharmaceuticals, Inc (NASDAQ: PCSA)
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 intende
Slide 3: Our People Lead to Success
Our People Lead to Success Management Team David Young, PharmD. PhD Sian Bigora, PharmD. Michael Floyd President and Chief Executive Officer Chief Development Officer Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business - Strategy Officer Chief Financial Officer Chief Admi
Slide 4: Processa Approach to Building a High ROI Pipeline of Drugs
Processa Approach to Building a High ROI Pipeline of Drugs Track Record of 30 FDA Approvals Across Almost Every Division of FDA = o% = DEVELOP NOT DISCOVER —— REGULATORY SCIENCE PLATFORM Lp f—. Unmet Medical Need + Efficacy Evidence + Regulatory Science Capital Efficiency + Potentially High RO! * Cl
Slide 5: Processa Pharmaceuticals, Inc Highlights
Processa Pharmaceuticals, Inc (NASDAQ: PCSA) Highlights > The creation of the Processa Regulatory Science Approach to drug development began 30 years ago from 2 FDA contracts that addressed multiple regulatory FDA questions and has been refined with approvals in almost every division of FDA > The Ma
Slide 6: In Drug Development - How do you Approach Development?
In Drug Development - How do you Approach Development? Science vs Regulatory vs Regulatory Science Regulatory FDA Decisions Based on Regulatory Science September 2022
Slide 7: Benefit-Risk Assessment: Foundation for FDA's Regulatory Review/Approval
Benefit-Risk Assessment: Foundation for FDA’s Regulatory Review/Approval EDA States: “Simply put, for a drug to be approved for marketing, FDA must determine that the drug is effective and that its expected benefits outweigh its potential risks to patients. This assessment is informed by an extensiv
Slide 8: Benefit-Risk Integrated Assessment
rr Benefit-Risk Integrated Assessment Dimension ase and Drug Analysis of Condition + Identify patients and the seriousness of their condition while recognizing and measuring what matters most to patients re ions + Define standard of care and therapeutic treatment options + Benefit-risk of present op
Slide 9: Examples of our Regulatory Science Approach in Drug Development
Examples of our Regulatory Science Approach in Drug Development » Evaluate and Minimize Risk (Approach Used by Processa Team at Questcor) + Acthar FDA approval: Risk is more than the safety of the drug (Processa Team when at Questcor obtained sNDA approval in 2010 for Infantile Spasms and 18 other i
Slide 10: Case Study 1: Risk is More than Safety of a Drug
Case Study 1: Risk is More than Safety of a Drug in a Serious Life-Threatening Condition such as Infantile Spasms >» Typically occurs in children less than 2 years old; occurs in 2,000 — 2,500 children per year » Premature death rate of 5-31% and > 60% of untreated/inadequately treated patients have
Slide 11: Case Study 1: Acthar Gel Used Off-Label for IS
Case Study 1: Acthar Gel Used Off-Label for IS Acthar is a purified preparation of adrenocorticotropic hormone in a gel that was used off-label for the treatment of IS for over 30 years with a wide range of dosage regimens IS sales in 2006-2007 represented almost 100% of sales for Questcor Acthar wa
Slide 12: Case Study 1: Benefit Outweighed Safety Risk & Risks Associated with Off-Label Use
rr Case Study 1: Benefit Outweighed Safety Risk & Risks Associated with Off-Label Use > Negotiated with FDA what was to be included in the sNDA given conducting a trial when patients are treated off-label for IS was not ethical > BENEFIT + Emphasized that approval would provide consistent guidance o
Slide 13: Case Study 1: Benefit-Risk Integrated Assessment
Case Study 1: Benefit-Risk Integrated Assessment Analysis of Condition + Identify patients and the seriousness of their condition while recognizing and measuring what matters most to patients IS - Very Serious Orphan Condition Current Treatment Options + Define standard of care and therapeutic treat
Slide 14: Case Study 2: Select Clinically Meaningful Primary Endpoint in Targeted Population
Case Study 2: Select Clinically Meaningful Primary Endpoint in Targeted Population > In NL patients the skin and tissue below the skin becomes necrotic and can last from months to years with complications such as infections, amputation, and cancer; improvement of NL has not been quantified > 70% of
Slide 15: Case Study 2: Why PCS499 for the Treatment of uNL?
Case Study 2: Why PCS499 for the Treatment of UNL? > Drugs used off-label with mixed success given their side effect profile and/or limited efficacy (for example; pentoxifylline (PTX), immunomodulating agents) > PCS499 is the deuterated analog of a major metabolite of PTX; has identical metabolites
Slide 16: Case Study 2: PCS499 Safe and Efficacious in NL and uNL Patients
Case Study 2: PCS499 Safe and Efficacious in NL and uNL Patients > In open-label trial of 10 NL and 2 uNL patients, all ulcers closed in the 2 uNL patients, including new contact trauma ulcers & non-ulcerated patients reported an improvement > 1.8 gm/d of PCS499 was well tolerated in the 12 patients
Slide 17: Case Study 2: Benefit-Risk Integrated Assessment
Case Study 2: Benefit-Risk Integrated Assessment Analysis of Condition + Identify patients and the seriousness of their condition while recognizing and measuring what matters most to patients Serious condition - affects QOL & may lead to other medical issues Current Treatment Options + Define standa
Slide 18: Pipeline of Five Drugs Each with $1B Market Opportunity
ie a Pipeline of Five Drugs Each with $1B Market Opportunity > 4 Drugs in the clinical stage of development and 1 in Pre-IND = 3 Drugs targeting the treatment of cancer (Phase 1B, Phase 2B, Pre-IND Stage) (Blue Box, Blue Arrows) = 1 Drug in Phase 2B targeting an orphan condition with no approved tre
Slide 19: Pipeline Milestones 2022 and 2023
Pipeline Milestones 2022 and 2023 Drug Disease Target Status and Milestones Next Metastatic Colorectal Cancer Cohorts 1, 2A, and 2B Completed Generation U.S. Incidence: > 60K Pts Capecitabine U.S. Max Ann. Sales: 2H2022: Complete Enrollment of Cohort 2B, 2C and Conduct Interim Analysis of Cohort Pha
Slide 20: Pipeline Milestones 2022 and 2023
Pipeline Milestones 2022 and 2023 Drug Disease Target Status and Milestones Next Generation Capecitabine Phase 1B (PCS6422) Metastatic Colorectal Cancer U.S. Incidence: > 60K Pts U.S. Max Ann. Sales: $500 M-$1.0B Global Max Ann. Sales: >$1.0B Cohorts 1, 2A, and 2B Completed 2H2022: Complete Enrollme
Slide 21: Pipeline Milestones 2022 and 2023
Pipeline Milestones 2022 and 2023 Drug Disease Target Status and Milestones
Slide 22: Pipeline Milestones 2022 and 2023
Pipeline Milestones 2022 and 2023 Drug Disease Target Status and Milestones PCS499 Ulcerative Necrobiosis + 3 Pts Completed Trial, 1 Pt in Trial, Supplemental Patient Enrollment Phase 2B Lipoidica Programs Improving Recruitment U.S. Prevalence: 10K - 50K Pts + 2H2022: Complete Interim Cohort Enrollm
Slide 23: Pipeline Milestones 2022 and 2023
Pipeline Milestones 2022 and 2023 Drug Disease Target Status and Milestones September2022 3
Slide 24: Processa Pharmaceuticals, Inc in 2022
rr Processa Pharmaceuticals, Inc (NASDAQ: PCSA) in 2022 Multiple High-Value Milestones to Be Achieved during the Next 4 Months for the 3 Drugs in Clinical Trials >» APCS6422 dosage regimen in Next Generation Capecitabine (combination of PCS6422 and Capecitabine) will be determined that will alter DP