Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (May 2020)
34 slides from Processa Pharmaceuticals's investor presentation, May 28, 2020
Slide 1: Processa Pharmaceuticals Corporate Presentation May 2020
G Processa Pharmaceuticals Corporate Presentation May 2020
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 Overview
Processa Pharmaceuticals Overview Corporate Facts (OTCQB: PCSA) Pipeline Focus * 2017 reverse merger to form Processa * $11.8 M total cash raised as private & public company * > $40M invested in drugs prior to Processa in-licensing * 2019 overhead (including salaries) < $2.5 M * 5.5 million shares o
Slide 4: Our People Are a Competitive Advantage
Our People Are a Competitive Advantage @ Processa Pharmaceuticals
Slide 5: Our People Lead to Success
Our People Lead to Success « Established and proven Executive Team with 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 a proven record of success and
Slide 6: Our Leadership
Our Leadership David Young, Pharm.D., Ph.D., CEO, Chairman of the Board * 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
Slide 7: Our Leadership
Our Leadership Patrick Lin, Chief Business and Strategy Officer and Director, Board of Directors « 20 Years Financing and Investing Experience in Biopharma Sector; * 25 years on Wall Street involved with over 500 IPOs and follow on offerings * — Principal/Founder Primarius Capital, Small Cap Focus,
Slide 8: Our Strategy and Competitive Advantage
Our Strategy and Competitive Advantage @ Processa Pharmaceuticals
Slide 9: Our Strategy: Obtain Drugs with High Potential Value
Our Strategy: Obtain Drugs with High Potential Value, Lower Risk of Failure during Development Increase return on investment (ROI) by selecting drugs and indications with higher potential gross sales, faster time to market, & differentiation from existing treatments Sales (Gross & Treatment Net) Dif
Slide 10: Our Strategy: Lower Risk of Failure during Development
Our Strategy: Obtain Drugs with High Potential Value, Lower Risk of Failure during Development fc of \\ Efficacy | Already} |. Completed y)
Slide 11: Competitive Advantage: Processa Approach to Obtaining Drug Approval
Competitive Advantage: Processa Approach to Obtaining Drug Approval Over the Last 30+ Years, Our Team Has Refined a Regulatory Science Platform or Approach for the Development of Drugs for FDA Approval *« The Regulatory Science Platform is based on our experience teaching FDA reviewers, conducting r
Slide 12: Processa Unmet Medical Need Pipeline
Processa Unmet Medical Need Pipeline @ Processa Pharmaceuticals
Slide 13: Processa Pipeline May 2020
Processa Pipeline May 2020 PCS499: Ulcerative (Phase 2803. Necrobiosis Lipoidica PCS11T: Small Cell Lung, Metastatic Colorectal, GLPTOX Pancreatic, or Ovarian Cancer PCS100: Fibrotic Disease ———————— Potential In-Licensed Drug Cancer or GI rz) Processa Pharmaceuticals
Slide 14: PCS499: Deuterated Analog of a Major Active Metabolite of Pentoxifylline
PCS499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX) PCS499 metabolizes to same active moieties as PTX (including reversibly metabolized to PTX itself) but the metabolite profile is different after PCS499 administration than PTX (i.e., the % exposure to various
Slide 15: Patient Need: No Approved Treatment for Necrobiosis Lipoidica
Patient Need: No Approved Treatment for Necrobiosis Lipoidica (NL) * Occurs in women/men 20 — 60 y/o and NL can last for months to years * Skin becomes necrotic with complications such as infections, amputation, squamous cell cancer * 30% of NL patients have painful ulcers with ulcer closure occurri
Slide 16: High Value: Ulcerative NL Market Opportunity
High Value: Ulcerative NL Market Opportunity Max Annual Gross Sales > $1.0 B (@$30,000/Patient/Year) Ulcerative Necrobiosis Lipoidica (NL) Max Gross Sales ~$1.6B ($986M - $2.4B) Max Gross Sales US Max Gross Sales SDI Other than US * 22,200 — 55,500 Patients in US * 60,000 — 150,000 Patients in High
Slide 17: High Value: Faster Time to Market
High Value: Faster Time to Market Development of PCS499 can be expedited given many of the NDA required chemistry, manufacturing, toxicology and Phase 1 studies have already been conducted by Concert Pharmaceuticals prior to Processa acquiring the drug. In a March 2020 meeting, FDA stated that, give
Slide 18: High Value: Differentiation from other Treatments
High Value: Differentiation from other Treatments * Since there is no standard of care for NL because appears to work, a new efficacious-safe drug would easily differentiate itself from the unsuccessful treatments used today « After PCS499 administration, the same active moieties exist systemically
Slide 19: Lower Risk: Clinical Evidence Supporting Use of PTX and PCS499 in NL
Lower Risk: Clinical Evidence Exists Supporting the Use of PTX and PCS499 in NL PTX is used OFF-LABEL and response can start after 1 month with significant improvement within 1-9 months (published case studies and clinical experience) PTX does not have widespread use; a small percentage of patients
Slide 20: Status of Safety/Tolerability PCS499 NL Study
Status of Safety/Tolerability PCS499 NL Study * PCS499 well tolerated at 1.8 gm/d and efficacy seen in the two NL patients with open ulcers; the ulcers in these severe NL patients completely closed « Ulcers occurring from physical contact during the study were also completely closed Baseline Month 5
Slide 21: PCS499 Pharmacology Affects the Many Pathophysiological Changes in NL
PCS499 Pharmacology Affects the Many Pathophysiological Changes Occurring in NL NL Decrease in Fat Decrease in Increase in Increaseinl - Collagen ie Inflammation 4 Blood Flow- Be Platelet Cytokines (eg, : 2 Degeneration Oxygenation Deposition Survival TNFa) Fibrosis Inhibits Cytokines (eg, TNFa) Inh
Slide 22: PCS499 Catalysts
PCS499 Catalysts Complete CMC, Non-Clinical, Phase 1 NDA Requirements | Other NDA Requirements _ * FDA agreed next study a Phase 2B or 3 study with only difference being the number of patients + Preparing Phase 2B/3 protocol for U.S./E.U. and recruiting lead investigators ¢ Planning to conduct a Pha
Slide 23: PCS11T: Next Generation Irinotecan Cancer Drug
PCS11T: Next Generation lIrinotecan Cancer Drug A pro-drug of SN-38, the active molecule formed from Irinotecan -— SN-38 is connected to a molecule that interacts with the cell membrane; SN-38 preferentially accumulates in the membrane of tumor cells and the tumor core more than normal cells PCS11T
Slide 24: Efficacy Maintained at Lower Doses of PCS11T Compared to Irinotecan
Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model MTD % MTD % MTD 1200 1200 —O— Grpi#t: Control =e Gip#t: Control 4000 | ***#ee: Grp#5: CPT-11 Some/kg, ip eo arpx0: aT-117 75mgkg, ip 4000 || ~S=Stp#B:CPT-11 25me/ke, ip Oe GipA9: ATT-1
Slide 25: Efficacy Studies in Tumor-Bearing Mice
Efficacy Studies in Tumor-Bearing Mice Tumor Compound Treatment Number —Anti-tumor Effect of Mice (%TGlvs. Control} Hoa ATT-1T 80mg/kg, q2wx2 9 93 At equimolar doses, PCS11T (formerly ATT- mall Cel Lung ; ‘ Carcinoma ——_—‘Winotecan Tamas, aeW2 2 Sh 11T) demonstrated superior efficacy across a swez0:
Slide 26: PCS11T Catalysts
PCS11T Catalysts IND Enabling Studies (GMP CMC, GLP Tox) va SEE ts IND Submission LIND. an: * FDA Pre-IND meeting completed with agreement on IND requirements + Phase 1B IND to be submitted December 2021 «If other clinical ready drugs are not in-licensed, initiate Phase 1B study in 1H 2022 rz) Proce
Slide 27: PCS100 Anti-fibrotic and Anti-inflammatory Drug
PCS100 Anti-fibrotic and Anti-inflammatory Drug Affects collagen expression and TGF-8 pathway History — Incomplete tox package but FDA cleared IND for Duchenne Muscular Dystrophy (DMD) - Efficacy observed in pediatric DMD patients; previous company mismanaged DMD study resulting in a Serious Adverse
Slide 28: Catalysts for PCS100 and Potential In-Licensed Drug
Catalysts for PCS100 and Potential In-Licensed Drug PCS100 Fibrotic Conditions, jo GLP Tox, IND, Phase 1. GLP Tox Needed for IND Potential In-Licensed Drug Cancer or GI Lass 1B.0f nse 28 Stuy rz) Processa Pharmaceuticals
Slide 29: Financial Metrics and Catalysts Over the Next Months
Financial Metrics & Catalysts Over the Next 24 Months @ Processa Pharmaceuticals
Slide 30: Processa Financial Overview
Processa Financial Overview OTCQB (5/22/20) PCSA - $6.90/share Market Cap (5/22/20) $38M Shares Outstanding 5.5 M Shares Prior Cash Investment in Processa $9.8 M as OTCQB Processa ($11.8 M total as Processa + Predecessor Company Promet) Present Cash Balance (5/22/20) $369K Convertible Line-of-Credit
Slide 31: Value-Added Catalysts by Drug
Value-Added Catalysts Occurring Over the Next 24 Months By Drug * Obtain Nasdaq listing, raise funds to support the catalysts (3Q2020) * PCS499 - Initiate Phase 2B study (1Q2021); Complete study within 18 months (4Q2022) - Out-license PCS499 for development and commercialization outside the U.S. * P
Slide 32: Value-Added Catalysts by Date
Value-Added Catalysts Occurring Over the Next 24 Months by Date 2020 - Obtain Nasdaq listing, raise funds to support the catalysts (3Q2020) 2021 - PCS499: initiate Phase 2B or Phase 3 study (1Q2021) - Potential In-Licensed Drugs: Initiate Phase 1B or Phase 2A (1Q2021) — PCS11T: Obtain IND (4Q2021) 2
Slide 33: 2020 — 2022 Use of Proceeds ($20M Net)
2020 — 2022 Use of Proceeds ($20M Net) ¢« No Additional Drugs In-Licensed - $5MSG8&A -— $5MPCS499 Phase 2B study (completed n 2022) - $3MPCS11T (IND enabling studies) - **$7MPCS11T (Phase 1B study initiated in 2022, completed in 2023-2024) - Shifting $1M of proceeds to PCS100 dependent on FDA pre-IN
Slide 34: Summary
Summary Focused on Acquiring and Developing Drug Products for Patients Needing Treatments to Extend Survival and/or Significantly Improve Quality of Life Building a pipeline of high value drugs for patients with unmet medical need conditions Experienced management, development team with a track reco
Processa Pharmaceuticals — Investor Presentation (May 2020) on 6ix