Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (January 2021)
23 slides from Processa Pharmaceuticals's investor presentation, Jan 11, 2021
Slide 1: Processa Pharmaceuticals Corporate Presentation January 2021
@ Processa Pharmaceuticals CORPORATE PRESENTATION JANUARY 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: Processa Pharmaceuticals (NASDAQ: PCSA)
Processa Pharmaceuticals (NASDAQ: PCSA) Differentiated Business Model Applying the Processa Requlatory Regulatory Science Platform Science Platform to Drug Development ie Processa Team Taught FDA Reviewers Capital Efficient - Very Low Overhead, Disciplined Licensing, Y Received FDA Contracts to Inte
Slide 4: Processa's Differentiated Development Approach
Processa’s Differentiated Development Approach Repeatable, Capital-efficient Blueprint Platform with Potential to Generate Significant ROI DEVELOP NOT DISCOVER ©) REGULATORY SCIENCE PLATFORM ES High Unmet + Efficacy + Regulatory + Capital Potentially Medical Need Evidence Science Efficiency High ROI
Slide 5: Processa Pipeline — Multiple Opportunities For Success
Processa Pipeline — Multiple Opportunities For Success Use Studies of Prior Companies and Hundreds of Millions of Dollars Invested Ulcerated Necrobi Unmet Medical Need "4 GI Motility ————————————— Disorders PCS499 GI, Breast Cancer Efficacy Evidence "4 Phase 2A a4 Phase 1B Value [eer Ewin_¥ —— Regul
Slide 6: PCS6422 Irreversibly Inhibits Dihydropyrimidine Dehydrogenase (DPD) Enzyme
PCS6422 Irreversibly Inhibits Dihydropyrimidine Dehydrogenase (DPD) Enzyme Xeloda ” Xeloda® (Capecitabine) Converts to 5- FU in the body: * ~ 20% of 5-FU Metabolizes to Molecules with Anti-Tumor Activity * ~80% of 5-FU Metabolizes to Molecules that Cause Dose Limiting Side Effects Side Effects Anti-
Slide 7: PCS6422-Xeloda Combination Target Population: Cancer Patients
PCS6422 -— Xeloda Combination Target Population: Cancer Patients Who Need a Better & Safer Cancer Treatment Option - Multiple $1B Xeloda® (Capecitabine) and 5-FU Xeloda and 5-FU are the cornerstones of cancer chemotherapy with millions of patients treated annually Widely used as 1° line therapy in +
Slide 8: PCS6422 Significantly Reduces HFS
PCS6422 Significantly Reduces HFS Patients Receiving 6422 and Oral 5-FU Had Lower Incidence of HFS (Particularly Grade 3/4) Compared to Xeloda or i.v. 5-FU Because of Significantly Less Toxic 5-FU Metabolites (F-BAL) Incidence of HFS (Grade 3/4) 20 Hand-foot syndrome (HFS) is the most common adverse
Slide 9: PCS6422 Effect on 5-FU Efficacy Depends on Dose Amount and Time of Dosing
PCS6422 Effect on 5-FU Efficacy Depends on Dose Amount and Time of Dosing Relative to 5-FU Administration Improve Efficacy with 6422: Lower Dose of 6422 Administered Hours Before 5-FU/LV in Xeloda Resistant Patients 6422/5-FU/LV (Median PFS - 140d) PRS (t) 300 350 5-FU = 5-Fluoruracil; LV = Leucovor
Slide 10: Positive 6422-Xeloda Phase 1B Trial Increases Probability of FDA Approval
Positive 6422-Xeloda Phase 1B Trial Increases Probability of FDA Approval by Providing Information to Help Design Pivotal Trial Completed Pharmacology, Toxicology, CMC ¥ 6422 + 5-FU Phase 3 Clinical Trials — Efficacy of 6422 + 5-FU not Demonstrated Due to Sub-Optimal Scheduling and Dosing v¥ Phase 2
Slide 11: PCS499: Diverse Pharmacological Properties
PCS499: Diverse Pharmacological Properties Deuterated Analog of Major Active Metabolite of Pentoxifylline (PTX), FDA Approved for Claudication 1 499 metabolizes qualitatively to same active moieties as PTX but quantitatively has different amounts of these metabolites PTX has dose limiting side effec
Slide 12: PCS499: Necrobiosis Lipoidica (NL) Diverse Pathophysiology
PCS499: Necrobiosis Lipoidica (NL) Diverse Pathophysiology Requires Diverse Pharmacology PTX Successfully Treats Some NL Patients who can Tolerate the Drug Decrease in Decrease in Increase in e Inflammation pcolageny Blood Flow- De can Platelet Cytokines Increase in 9 Oxygenation PI Survival (eg, TN
Slide 13: PCS499 Target Population: Ulcerative Necrobiosis Lipoidica (uNL)
PCS499 Target Population: Ulcerative Necrobiosis Lipoidica (uNL) Patients Have No Treatment Options - $1B Market PCS499 has 7-year exclusivity with Orphan Designation for NL Ulcerative NL Ulcerative Necrobiosis Lipoidica (uNL) Max Gross Sales ~640M ($360M - $920M) ~1.6B ($986M - $2.48) «Clinical Pre
Slide 14: PCS499 Well Tolerated and Completely Closes Ulcers in a NL Patient Study
PCS499 Well Tolerated and Completely Closes Ulcers ina mules NL Patient Study Evidence of PTX Efficacy in Ulcerated NL Patients: Number of case reports that PTX can close ulcers in NL patients if they can tolerate the highest dose of PTX, KOLs would like a more potent PTX = Tolerance of PCS499 Bette
Slide 15: Positive PCS499 Phase 2B Placebo Controlled Increases Probability of FDA Approval
Positive PCS499 Phase 2B Placebo Controlled Increases Probability of FDA Approval by Providing Data to Help Design Phase 3 Trial Chemistry, Manufacturing, Control (CMC), Pcol, Most Tox Phase 1 Human Volunteer Studies (SD, MD, Food Effect) Phase 2A, 2B Trials in DN Phase 2A Demonstrated Safety, Poten
Slide 16: 5HT4 Receptor Agonist, PCS12852, More Potent and Selective to 5HT4
5HT4 Receptor Agonist, PCS12852, More Potent and Selective to 5HT4 than Other 5HT4 Drugs & Lower Cardiovascular Toxicity Risk 12852 Binds Better to 5HT4 Receptors Than Other Drugs Approved or Being Developed Other 5-HT receptor 5-HT4q receptor Selectivity for 5-HT4 vs. the respective 5-HT subtype (-
Slide 17: PCS12852 Target Population: Present Therapeutic Options for Patients with Gastroparesis
PCS12852 Target Population: Present Therapeutic Options for Patients with Gastroparesis Have Serious Side Effects - $1B Market Normal gastric emptying Gastroparesis (prevalence > 4M patients in U.S.) is characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach
Slide 18: PCS12852: Enhanced Gastric Emptying Rate in Patients with Decreased GI Motility
PCS12852: Enhanced Gastric Emptying Rate in Patients with Decreased GI Motility Compared to Baseline 100 « 80 Change from baseline in 7 0.1 mg 12852 gastric emptying rate ia $ I increased in 0.1 mg and 3 6 ae ae 0.05 mg PC$12852 groups: eR e $ Gastric Emptying Breath 3.2 ee Test (GEBT) showed a =e”
Slide 19: Positive PCS12852 Phase 2A Trial Increases the Probability of FDA Approval
Positive PCS12852 Phase 2A Trial Increases the Probability of FDA Approval by Providing Data to Help Design Phase 2/3 Trial v Pharmacology v Toxicology, v Chemistry, Manufacturing, Control (CMC) QO New Manufacturing Site Change (Final Product) Q Pre-IND Meeting, IND Submission | PCS12852 Unmet Medic
Slide 20: Summary: How Do We Increase the Value of Processa?
Summary: How Do We Increase the Value of Processa? Increase Probability of FDA Approval with Key Interim Results in 2021, Completion of our 3 Clinical Trials, Obtain Information to Design Larger FDA Registration Trials 1Q 2Q 3Q 4Q 1H 2H 2023-2026 2021 2021 2021 2021 2022 2022 PCS6422 Phase 1B PCS499
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
Slide 22: Processa Capital Structure and Share Information
Processa Capital Structure and Share Information > Stock Listing: PCSA— NASDAQ > 52 Week Low-High: $3.95 - $18.00 > Price: January 4, 2021 $6.60 > Shares Outstanding: 14,187,977 > Fully Diluted Shares: 14,874,743 > Cash, Cash Equivalents: $15,400,000 > 2020 Overhead Cash Burn: $2,100,000 >» Debt: No
Slide 23: Processa Pharmaceuticals
“ Processa Pharmaceuticals Thank you for your kind attention Any questions or to schedule a meeting mfloyd@processapharma.com
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