Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (December 2017)
20 slides from Processa Pharmaceuticals's investor presentation, Dec 6, 2017
Slide 1: Processa Pharmaceuticals
&A Processa Pharmaceuticals (Formerly Promet Therapeutics, LLC) 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 LDidlicRo & po ALM ATH EVENT David Young, Pharm.D., Ph.D. : CEO and Inter
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 Highlights
Processa Pharmaceuticals Highlights Clinical Stage Drug Development Company — Our focus is Phase 2 on Treat High Unmet Medical Need — Existing POC Clinical Data for Structural Analog Experienced Team of Drug Developers, Pharma Executives, Biotech Investors Collaborate and Negotiate with FDA Using a
Slide 4: Processa Pharmaceuticals Financial Overview
Processa Pharmaceuticals Financial Overview Symbol-Share PCSA - $3.64* Summary of Salient Points Pric » October 4, 2017: Promet Therapeutics, LLC signs Option & Headquarters Hanover, MD License Agreement with CONCERT Pharmaceuticals (CNCE: $22.93) Market Cap $128.4M > October 4, 2017: Asset purchase
Slide 5: Summary of PIPE Offering
Summary of PIPE Offering Financing: | PIPE Reg D, 506c Security: | Common Stock and Warrants 1) $4M (+$3.0M Existing Cash) Covers One (1) Max. Tolerated Dose Phase 2 Trial, Some Tox for Second Asset 2) $8M (+$3.0M Existing Cash) Covers Two (2) Max Tolerated Dose Phase 2 Trials, Some Tox for Second A
Slide 6: We Know How to Succeed in Drug Development
We Know How to Succeed in Drug Development a ~| COMMERCIALIZATION CAPITAL PRODUCTS = 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 in 2007 to $5.6B Market Cap in 2014 in Mallinckrodt acquisition (370x increase in 7 years
Slide 8: Our Leadership
OUR LEADERSHIP David Young, Pharm.D., Ph.D., CEO and Interim CFO . Former Board Member, CSO of Questcor Pharmaceuticals ~$15M Market Cap to $5.6B in 7 Yearss . Former President, AGI Therapeutics; Founder & CEO, GloboMax . Former Instructor of FDA Reviewers and FDA Advisory Committee Member Patrick L
Slide 9: Major Criteria for Selecting Pipeline Products for Development
Major Criteria for Selecting Pipeline Products for Development Tens of Thousands of Drugs Evaluated Preclinically by Pharma and Biotech Thousands of Drugs Evaluated Clinically (6,550 Industry Sponsored Studies in 2014) Few Drugs FDA Approved (30 NME & 56 505(b)(2) Approvals in 2014) Processa Pipelin
Slide 10: PCS499 Diverse Pharmacology Useful for Two Indications
PCS499 Diverse Pharmacology Useful for Two Indications PCS499 has Multiple Pharmacological Targets and is the Analog of a Major Metabolite of an Approved Drug — Modulates Immune Cells (e.g., Neutrophils) and Cytokines (e.g., TNF a) — Effects on Blood Viscosity & Oxygenation, Platelet Aggregation — A
Slide 11: PCS499 For Treatment of Necrobiosis Lipoidica (NL) - No Approved Treatment
PCS499 For Treatment of Necrobiosis Lipoidica (NL) - No Approved Treatment Inflammatory Site Disorder With Pathophysiology Involving the Immune System and Blood Flow Skin Becomes Necrotic; 30% of Patients Have Painful Ulcerations Potential to Last for Month or Years Complications: Infections, Amputa
Slide 12: PCS499 For Treatment of Necrobiosis Lipoidica (NL) - No Approved Treatment
PCS499 For Treatment of Necrobiosis Lipoidica (NL) - No Approved Treatment *« Evidence of PCS499 Efficacy in Patients with NL — Diverse Pharmacology Targets Mixed Pathophysiological Changes Associated with NL — Some Dermatologists Use a Drug with Similar Pharmacology but Have Mixed Results (Dose Pro
Slide 13: Market Opportunity Based on Average Prevalence
Market Opportunity Based on Average Prevalence Necrobiosis Lipoidica (NL) $1.9B Max Gross Sales Based on Average Prevalence in All SDI Countries Max Gross Sales US_ Max Gross Sales SDI Otherthan US Target Population 200,000 ~ 500,000 Patients in High Sociodemographic Index (SDI) Countries (74,000-18
Slide 14: PCS499 To Treat Radiation Therapy Adverse Effects in Head/Neck Cancer
PCS499 To Treat Radiation Therapy Adverse Effects (RTAE) in Head/Neck Cancer — No Approved Treatment radiation —> normal tissue «Patients with Head/Neck Cancer Receiving Radiation i} Therapy (RT) Often Have Progressive Fibrotic Tissue myofibroblast & macrophage/monocyte Sclerosis and/or Xerostomia f
Slide 15: PCS499 To Treat Radiation Therapy Adverse Effects in Head/Neck Cancer
PCS499 To Treat Radiation Therapy Adverse Effects (RTAE) in Head/Neck Cancer — No Approved Treatment Evidence of PCS499 Efficacy In Patients with RTAE — Diverse Pharmacology Targets Mixed Pathophysiological Changes radiation —4 normal tissue Associated with RTAE ll fibroblast & hi rt — Some Radiatio
Slide 16: Market Opportunity Based on Average Prevalence
Market Opportunity Based on Average Prevalence Radiation Related Adverse Effects in Head/Neck Cancer $686M Max Gross Sales Based on Average Prevalence in All SDI Countries «Max Gross SalesUS ‘ll Max Gross Sales SDI Other than US Target Population 76,000 ~ 184,000 Patients in High Sociodemographic In
Slide 17: Portfolio and Anticipated Pipeline Timeline with Key Milestones
Portfolio and Anticipated Pipeline Timeline with Key Milestones = FDA Pre-IND : Pcsa99 Meeting in Oct. Jf Max Tolerated Cc Phase 2b Dose in Pivotal Study E NDA, EMEA Necrobiosis Lipoidica = Phase 2 Study Ranging Study Submission PCs499 FDA Meeti = ‘an, eee Max Tolerated Phase 2b Dose Pivotal Study N
Slide 18: Processa rNPV for Only NL and RTAE by Clinical Milestone
Processa rNPV for Only NL and RTAE by Clinical Milestone Valuation Based on: *Team Experience and Past Successes *PCS499 in Clinical Stage of Development for 2 Indications *Risk Adjusted Net Present Value (rNPV) of PCS499 in High SDI Countries (See Below, See Appendix)" 2018-2019 eae eran me rNPV: P
Slide 19: Summary of PIPE Offering
Summary of PIPE Offering Financing: | PIPE Exemption: | Reg D, 506c Security: | Common Stock and Warrants Amount: | 1) $4M (+$3.0M Existing Cash) Covers One (1) Max. Tolerated Dose Phase 2 Trial, Some Tox for Second Asset 2) $8M (+$3.0M Existing Cash) Covers Two (2) Max Tolerated Dose Phase 2 Trials
Slide 20: 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 or Pre-Clinical POC Data Exists, Minim
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