Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — LD Micro Invitational June 2018
19 slides from Processa Pharmaceuticals's conference presentation, Jun 4, 2018
Slide 1: Processa Pharmaceuticals
@ Processa Pharmaceuticals Developing Products to Improve the Survival and/or Quality of Life for Patients Who Have a High Unmet Medical Need Patrick Lin Chief Business and Strategy Officer LDidicro & aM INVITATIONAL David Young, Pharm.D., Ph.D. JUNE 4 - 6%, 2018 | BEL AIR, CA CEO June 2018
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. Any such offer or solicitation may be made only by means of a confide
Slide 3: Processa Pharmaceuticals (OTC:PCSA) Background
Processa Pharmaceuticals (OTC:PCSA) Background Clinical Stage Drug Development Private Company (Promet Therapeutics, LLC) Formed in Dec 2015; Reverse Merger with a Dormant Non-Biotech OTC Company in Oct 2017 Mission is to Develop Drugs to Treat Patients with High Unmet Medical Need Conditions Decrea
Slide 4: Key Milestones and Achievements
Key Milestones and Achievements Reverse Merged into Dormant Public OTC Company in Oct 2017 followed by 1:7 Reverse Split Raised $4.27M as Promet in 2015 & $6.88M in Private Placements, Including an Ongoing PIPE Met with the FDA on the Development of PCS499 for Necrobiosis Lipoidica (Billion Dollar M
Slide 5: Processa Pharmaceuticals Financial Overview
Processa Pharmaceuticals Financial Overview Symbol-Share Price (5/30/18) | PCSA - $3.25 Market Cap (5/30/18) $115M Shares Outstanding 35.3M Prior to Private Placements & ~38.8M Post Private Placements Private Placements $6.88M (Last Closing on June 29, 2018) Cash (5/30/18) $5.4M (Includes $6.88M fro
Slide 6: Successful Drug Development
Successful Drug Development COMMERCIALIZATION CAPITAL PEOPLE BB Processa Pharmaceuticals
Slide 7: Our People Lead to Success
Our People Lead to Success We Know The Way To The FDA Established and Proven Executive Team with Over 20+ Years of Biotech Management Experience Most Recently Helped Transform Questcor Pharmaceuticals from $15M Market Cap in 2007 to $5.6B in 2014 when acquired by Mallinckrodt Development Team has Wo
Slide 8: Our Leadership
OUR LEADERSHIP David Young, Pharm.D., Ph.D., CEO + Former Board Member, CSO of Questcor Pharmaceuticals ~$15M Market Cap to $5.6B in 7 years + Former President, AGI Therapeutics; Founder & CEO, GloboMax + Former Instructor of FDA Reviewers; Former FDA Advisory Committee Member Patrick Lin, Chief Bus
Slide 9: Our Leadership
OUR LEADERSHIP Sian Bigora, Pharm.D., Chief Development Officer + Former VP, Regulatory Affairs at Mallinckrodt, Questcor Pharmaceuticals, AGI Therapeutics, GloboMax + Former Instructor of FDA Reviewers Wendy Guy, Chief Administrative Officer + Former Senior Manager in Business Operations at Questco
Slide 10: Necrobiosis Lipoidica (NL)
Necrobiosis Lipoidica (NL) 74,000-185,000 in US & 200,000 — 500,000 Worldwide (Includes Non-Diabetic Patients & 0.3% of All Diabetic Patients) = = aq — & Processa Pharmaceuticals 10
Slide 11: Necrobiosis Lipoidica (NL)
Necrobiosis Lipoidica (NL) * Multi-faceted Disorder Affecting the Skin and the Tissue under the Skin Decrease in Decrease in Increase in Blood Flow- Fat Deposition Platelet Cytokines Oxygenation survival (eg, TNFa) Increase in Fibrosis Collagen Degeneration Inflammation BB Processa Pharmaceuticals
Slide 12: Necrobiosis Lipoidica (NL) - No Approved Treatment
Necrobiosis Lipoidica (NL) - No Approved Treatment Occurs in Women/Men 20 — 60 y/o; Potential to Last for Month or Years; Skin Becomes Necrotic; 30% of Patients Have Painful Ulcerations; Complications - Infections, Amputation, Squamous Cell Cancer No Current FDA Approved Treatment, No Known Biotech
Slide 13: PCS499 Diverse Pharmacology Useful for Multiple Indications
PCS499 Diverse Pharmacology Useful for Multiple Indications PCS499 is the Deuterated Form of the Major Metabolite of Pentoxifylline (PTX) - Pharmacology Slightly Different from PTX - Greater Exposure to PCS499 after PCS499 Administered than the Non-Deuterated Form of PCS499 after PTX Administered Pr
Slide 14: PCS499 Diverse Pharmacology Useful for Multiple Indications
PCS499 Diverse Pharmacology Useful for Multiple Indications Evidence of PCS499 Efficacy in Patients with Necrobiosis Lip -— PTX Case Studies and Experience of NL KOLs -— PCS499 Exposure After PCS499 Administration Significantly Different than Non-Deuterated Metabolite Exposure after PTX Administrati
Slide 15: PCS499 Pharmacology Matches NL Pathophysiology
NL Decrease in Increase in Decrease in Blood Flow- Fat Deposition Platelet Cytokines (ea, Survival TNFa) Eaptosis Collagen Increase in Degeneration Inflammation Oxygenation Broad PDE Inhibitor Decrease Blood Inhibits Platelet Inhibits Cytokines Anti-inflammatory (eg, TNFa) Anti-Fibrotic Effect Visco
Slide 16: Market Opportunity
Market Opportunity Maximum Gross Annual Sales Worldwide $1.2B - $2.7B Necrobiosis Lipoidica (NL) Max Gross Sales * 200,000 — 500,000 Patients Worldwide * 74,000-185,000 in US + Max Gross Annual Sales Based on Prevalence Range: © $1.1B - $2.7B Worldwide o $400M - $1.0B in US [Max Gross Sales US = Max
Slide 17: Negotiations Underway for Additional Assets
Negotiations Underway for Additional Assets + Presently Negotiating with 3 Companies to License/Develop Drugs in the Oncology, Cardiovascular and CNS Space + Two Types of Agreements Being Negotiated — Option to Purchase or In-License Drug — Development Team Collaboration (DTC) Partnership where the
Slide 18: Plan and Timeline
Plan and Timeline Pcs499_— «Submit IND *Readout on Max Dose *Begin Phase 2b/3 Pivotal *Phase 2b/3 Readout; if FDA NL “Begin Phase 2Max Dose Acceptable to Patients, FDA —_* Begin Last Phase 1 & Tox Acceptable, Single Pivotal Study Safety Study, Prelim Eff Studies * NDA Submission in NL Portfolio + Fi
Slide 19: Summary
Summary The Challenge: To Maximize ROI by Efficiently Developing Drugs in High Unmet Medical Need Conditions The Solution: Assemble a Team Experienced in Navigating Through Development and FDA Approval Follow Processa Pipeline Selection Criteria (e.g., Clinical Evidence of Efficacy Exists, Minimal R
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