Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — LD Micro Invitational June 2021
21 slides from Processa Pharmaceuticals's conference presentation, Jun 9, 2021
Slide 1: LD Micro Invitational
@ Processa Pharmaceuticals LD Micro Invitational June 9, 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
Slide 4: 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 (June 7, 2021): $6.51 > Market Cap (June 7, 2021): $101,045,720 > Shares Outstanding: 15,521,616 > Fully Diluted Shares: 16,511,147 > Cash, Cash Equivalents: $2
Slide 5: Processa Pipeline - Multiple Opportunities For Success
Processa Pipeline - Multiple Opportunities For Success PCS499 Pipeline of Drugs to Treat Patients who Need Better Treatment Options Disease Target Ulcerative Necrobiosis Lipoidica Preclinical Phase 2B FPI May Market Size PCS6422 Metastatic Colorectal, Breast Cancer Phase 1B FPI June >$1B PCS12852 Ga
Slide 6: 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 DEVELOP NOT DISCOVER * Clear and obvious patient need * Favorable competitive dynamics @ Process Pharmaceuticals Unmet Medical Need + eo
Slide 7: Regulatory Science Approach
Regulatory Science Approach Regulatory Science Approach >» Program Designed to Improve Benefit-Risk Profile to Meet FDA Requirements and Patient/Physician Requirements > Program and Clinical Trials Anticipate FDA Requirements for Approval > Interact Collaboratively with FDA While Negotiating Program
Slide 8: Example 1: Ulcerative Necrobiosis Lipoidica (UNL)
Example 1: Ulcerative Necrobiosis Lipoidica (UNL) > Skin, tissue below the skin becomes necrotic, can last from months to years with complications such as infections, amputation, and cancer Severe N Mild NL 7 > 710% of the patients are women between 20 - 60 years old; 60% of NL patients are diabetic
Slide 9: Unmet Medical Need, Evidence of Clinical Efficacy, PCS499 Improves Benefit-Risk
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 > PCS
Slide 10: Phase 2A PCS499 Improves Benefit-Risk Profile
Phase 2A PCS499 Improves Benefit-Risk Profile > In a study of 10 NL and 2 ulcerative NL patients, all ulcers closed in the 2 ulcerative NL patients, including new contact trauma ulcers > Non-ulcerated patients reported improvement in NL but clinical significance could not be determined > 1.8 gm/d of
Slide 11: 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 drugs have not been proven to be significantl
Slide 12: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica
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
Slide 13: Example 2: PCS6422 Chemotherapy Modifier of Capecitabine (Xeloda)
Example 2: 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
Slide 14: 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)
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% pena meee eT enor nor ; Lower Dose of 6422 Administered Hours Before 5-FU/
Slide 16: PCS6422 - Capecitabine Combination Different than Capecitabine
PCS6422 - Capecitabine Combination Different than Capecitabine » 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 walsunvival line + Colorectal cancer; > 145,000 new pat
Slide 17: PCS6422 Chemotherapy Modifier of Capecitabine (Xeloda)
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 18: PCS12852 Potent-Selective 5HT4 Agonist: Gastroparesis ($1 B Market)
PCS12852 Potent-Selective 5HT4 Agonist: Gastroparesis ($1 B Market) Gastric Emptying Rate (%) using 13C-Spirulina Submit IND for Phase 2A Trial in 3Q’21, FPI in 1Q’22 Normal Gastric Emptying Gastroparesis Other 5HT4 Drug Dopamine D2 7 i E (e.g., Cisapride, Antagonist Prucalopride, (e.g, Mosapride) M
Slide 19: Regulatory Science Approach Helps to Select Drugs for Pipeline
Regulatory Science Approach Helps to Select Drugs for Pipeline Successful Treatment of Cancer Depends on Many Factors Including a Patients Genetic Make-up and the Biological Differences Between the Tumor and Normal Tissue > Potential Phase 2B/3 Acquisition (Drug X): + Prior trials showed Drug X was
Slide 20: Summary Timeline of Pipeline and Key Clinical Catalysts
Summary Timeline of Pipeline and Key Clinical Catalysts 2H 1H 2H 2021 2022 2022 PCS499 + Initiate Sites ¢ Interim Analysis + Final Analysis + Phase 3 Trial Phase 2B ° FPI (May) + NDA Submission PCS6422 + Initiate Sites + Interim Analysis ¢ Final Analysis + Initiate Dose ¢ Final Analysis Stage 2 Phas
Slide 21: Our People Lead to Success
Our People Lead to Success Management Team David Young, PharmD. PhD Sian Bigora, PharmD. Michael Floyd Chief Executive Officer, Chairman of the Board Chief Development Officer Chief Operating Officer Patrick Lin James Stanker, CPA Wendy Guy Chief Business — Strategy Officer Chief Financial Officer C
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