Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (May 2020)
34 slides from Processa Pharmaceuticals's investor presentation, May 2020
Slide 1: Corporate Presentation May 2020
Corporate Presentation May 2020 1
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 • Acquiring & developing drugs for patients needing treatments • $11.8 M total cash raised as private & public company to extend survival or improve quality of life • > $40M invested
Slide 4: Our People Are a Competitive Advantage
Our People Are a Competitive Advantage 4
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 a
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, Nu
Slide 8: Our Strategy and Competitive Advantage
Our Strategy and Competitive Advantage 8
Slide 9: Our Strategy: Obtain Drugs with High Potential Value, Lower Risk of Failure during Development
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 Time to Market Sales Treatment (G
Slide 10: Our Strategy: Obtain Drugs with High Potential Value, Lower Risk of Failure during Development
Our Strategy: Obtain Drugs with High Potential Value, Lower Risk of Failure during Development Decrease risk of failure by selecting drugs with some clinical evidence of efficacy/safety, pharmacology-tox understood, & value-added catalysts in 1-4 years Clinical Evidence of Efficacy Some Tox. Already
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 re
Slide 12: Processa Unmet Medical Need Pipeline
Processa Unmet Medical Need Pipeline 12
Slide 13: Processa Pipeline May 2020
Processa Pipeline May 2020 Pre-IND Phase 1 Phase 2 Phase 3 PCS499: Ulcerative Phase 2B/3 Necrobiosis Lipoidica PCS11T: Small Cell Lung, Metastatic Colorectal, GLP Tox Pancreatic, or Ovarian Cancer PCS100: Fibrotic Disease GLP Tox Potential In-Licensed Drug Phase 1B or Phase 2A Cancer or GI 13
Slide 14: PCS499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX)
PCS499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX) • PCS499 metabolizes to same active moieties as PTX (including reversibly Broad PDE metabolized to PTX itself) but the Inhibitor metabolite profile is different after PCS499 administration than PTX (i.e., Ant
Slide 15: Patient Need: No Approved Treatment for Necrobiosis Lipoidica (NL)
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 Max Annual Gross Sales > $1.0 B
High Value: Ulcerative NL Market Opportunity Max Annual Gross Sales > $1.0 B (@$30,000/Patient/Year) Ulcerative Necrobiosis Lipoidica (NL) Max Gross Sales ~ $640M ($360M - $920M) ~$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 – 1
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,
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 Exists Supporting the 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 patie
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 Occurring in NL
PCS499 Pharmacology Affects the Many Pathophysiological Changes Occurring in NL NL Decrease in Decrease in Increase in Collagen Fat Increase in Inflammation Blood Flow- Platelet Cytokines (eg, Degeneration Deposition Fibrosis Oxygenation Survival TNFα) Decrease Inhibits Inhibits Broad PDE Anti- Anti
Slide 22: PCS499 Catalysts
PCS499 Catalysts 2020 2021 2022 2023 - 2026 Phase 2B/3 Study Phase 2B/3 2024-2025 NDA 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
Slide 23: PCS11T: Next Generation Irinotecan Cancer Drug
PCS11T: Next Generation Irinotecan 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 • PCS11
Slide 24: Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model
Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model At MTD At ½ MTD At ¼ MTD Tumor Growth Inhibition Tumor Growth Inhibition Tumor Growth Inhibition 100% ATT11-T 100% ATT11-T 100% ATT11-T 100% CPT-11 64% CPT-11 53% CPT-11
Slide 25: Efficacy Studies in Tumor-Bearing Mice
Efficacy Studies in Tumor-Bearing Mice At equimolar doses, PCS11T (formerly ATT- 11T) demonstrated superior efficacy across a variety of cancers
Slide 26: PCS11T Catalysts
PCS11T Catalysts 2020 2021 2022 2023 - 2026 IND Enabling Studies IND Enabling Studies (GMP CMC, GLP Tox) IND Submission IND Phase 1B Study Phase 1B Study • FDA Pre-IND meeting completed with agreement on IND requirements • Phase 1B IND to be submitted December 2021 • If other clinical ready drugs ar
Slide 27: PCS100 Anti-fibrotic and Anti-inflammatory Drug
PCS100 Anti-fibrotic and Anti-inflammatory Drug • Affects collagen expression and TGF-β 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 Adv
Slide 28: Catalysts for PCS100 and Potential In-Licensed Drug
Catalysts for PCS100 and Potential In-Licensed Drug 2020 2021 2022 2023 - 2026 PCS100 Fibrotic Conditions, GLP Tox, IND, Phase 1 GLP Tox Needed for IND Potential In-Licensed Drug Phase 1B or Phase 2A Study Cancer or GI 28
Slide 29: Financial Metrics & Catalysts Over the Next 24 Months
Financial Metrics & Catalysts Over the Next 24 Months 29
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 Occurring Over the Next 24 Months 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 Occurring Over the Next 24 Months 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 (4Q202
Slide 33: 2020 – 2022 Use of Proceeds ($20M Net)
2020 – 2022 Use of Proceeds ($20M Net) • No Additional Drugs In-Licensed – $5 M SG&A – $5 M PCS499 Phase 2B study (completed n 2022) – $3 M PCS11T (IND enabling studies) – **$7 M PCS11T (Phase 1B study initiated in 2022, completed in 2023-2024) – Shifting $1M of proceeds to PCS100 dependent on FDA p
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
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