Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (January 2020)
28 slides from Processa Pharmaceuticals's investor presentation, Jan 14, 2020
Slide 1: Corporate Presentation January 2020
G Processa Pharmaceuticals Corporate Presentation January 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: PCSAD) * Formed as private company in 2016 and became public as Processa in 2017 » Raised total cash of $11.8 M since 2016 * Over $40M invested in drugs prior to Processa in- licensing them * 2019 overhead and internal R&D costs, including sa
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 Sian Bigora, Pharm.D., Chief Development Officer * Former VP, Regulatory Affairs at Mallinckrodt, Questcor Pharmaceuticals, AGI Therapeutics, GloboMax « Former Instructor of FDA Reviewers James Stanker, CPA, Chief Financial Officer ¢ 30 years of Financial and Executive Leadership Expe
Slide 8: Our Strategy and Competitive Advantage
Our Strategy and Competitive Advantage @ Processa Pharmaceuticals
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 Decrease risk of failure by selecting drugs with some indications with higher potential gross sales, faster time to clinical evidence of efficacy/
Slide 10: Competitive Advantage: Processa Approach to Obtaining Drug Approval
Competitive Advantage: Processa Approach to Obtaining Drug Approval Over the Last 25+ 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 11: Processa Present Portfolio: PCS-499 & PCS-100
Processa Present Portfolio: PCS-499 & PCS-100 @ Processa Pharmaceuticals
Slide 12: PCS-499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline
PCS-499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX) PCS-499 metabolizes to same active moieties as PTX (including reversibly Broad metabolized to PTX itself) but the Inhibitor metabolite profile is different after PCS-499 administration than PTX (i.e., the %
Slide 13: 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 Potential to last for months or years Skin becomes necrotic; 30% of patients have painful ulcerations; complications - infections, amputation, squamous cell cancer No standard of care or FDA approved t
Slide 14: High Value: NL Market Opportunity
High Value: NL Market Opportunity Max Annual Gross Sales > $1.0 B Necrobiosis Lipoidica (NL) Max Gross Sales ~$1.2B ($700M - $1.7B) Max Gross Sales US Max Gross Sales SDI Other than US 74,000 — 185,000 Patients in US 200,000 — 500,000 Patients in High Sociodemographic Index (SDI) Countries & Process
Slide 15: High Value: Faster Time to Market
High Value: Faster Time to Market Development of PCS-499 can be expedited given many of the NDA required chemistry, manufacturing, pre-clinical and Phase 1 studies have already been conducted by Concert Pharmaceuticals. In our NL pre-IND (Investigation New Drug) meeting with the FDA, FDA agreed to t
Slide 16: High Value: Differentiation from other Treatments
High Value: Differentiation from other Treatments Since there is no standard of care for NL and the treatment options presently used result in minimal efficacy (even off-label use of PTX, the non-deuterated parent drug of PCS-499), a new efficacious-safe drug would have the opportunity to differenti
Slide 17: Lower Risk: PCS-499 Pharmacology, Toxicology, PK Already Evaluated
Lower Risk: PCS-499 Pharmacology, Toxicology, PK Already Evaluated Pharmacology of PCS-499 and PTX has been evaluated The toxicology in animals and safety in humans for PCS-499 and PTX has been evaluated The CMC for PCS-499 has been defined and already being refined for NDA submission The single and
Slide 18: Lower Risk: PCS-499 Only Drug Other than PTX to Target NL Pathophysiological Changes
Lower Risk: PCS-499 is the Only Drug Other than PTX to Target the Many NL Pathophysiological Changes | | Decrease in | Decrease in Increase in 5 4 Collagen Fat Increase in Inflammation “ Blood Flow- Be Platelet Cytokines (eg, ts i Degeneration Oxygenation Deposition Sneeal TNFa) Fibrosis Broad POE A
Slide 19: Lower Risk: Clinical Evidence Supporting Use of PTX and PCS-499 in NL
Lower Risk: Clinical Evidence Exists Supporting the Use of PTX and PCS-499 in NL PTX is used OFF-LABEL and response can start after 1 month with significant improvement within 3-12 months (published case studies and clinical experience) PTX does not have widespread use; a small percentage of patient
Slide 20: Status of PCS-499 NL Program
Status of PCS-499 NL Program Defined development program in pre-IND collaborative meeting with FDA; FDA stated that 1 pivotal study may be acceptable for NL Received Orphan Designation (7 years of Market Exclusivity upon approval) PCS-499 IND cleared by FDA for PCS-499 Phase 2a safety/tolerability t
Slide 21: Status of Safety/Tolerability PCS-499 NL Trial
Status of Safety/Tolerability PCS-499 NL Trial *« PCS-499 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 Mont
Slide 22: PCS-100 Anti-fibrotic and Anti-inflammatory Drug
PCS-100 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 trial resulting in a Serious Adver
Slide 23: Financial Metrics & 12-18 Month Catalysts
Financial Metrics & 12 - 18 Month Catalysts @ Processa Pharmaceuticals
Slide 24: Processa Financial Overview
Processa Financial Overview OTCQB (1/09/20) PCSAD - $18.00/share Market Cap (1/09/20) $99 M Shares Outstanding 5.5 M Shares Prior Cash Investment in Processa $11.8M Present Cash Balance (1/09/20) $770 K Convertible Line-of-Credit $1.4 M (full $1.4 M still available) Remaining Phase 2 Trial Expenses
Slide 25: Catalysts Over the Next 12-18 Months
Catalysts Over the Next 12 — 18 Months Obtain Nasdaq listing, raise funds to support the catalysts briefly described below Development of PCS-499 — Complete Phase 2 trial (safety, tolerability, efficacy trial) in NL patients (1H2020) - Meet with FDA to discuss remaining requirements for NDA submissi
Slide 26: Use of $12 M++ Proceeds
Use of $12 M++ Proceeds Raise Funds or Out-License Salaries, General, Administration PCS-499: FDA Meeting, SPA Submission, NDA Submission PCS-499: Complete CMC, Non-Clinical, Phase 1 (eg, Drug Interaction, Special Pop) PCS-499: Small Phase 2b/3 Trial P tl s R i ’ PCS-100 or 3 Portfolio Drug: FDA Mee
Slide 27: Use of $17 M++ — $31 M** Proceeds
Use of $17 M ++ — $31 M** Proceeds Out-License or Raise Funds Salaries, General, Administration PCS-499: FDA Meeting, SPA Submission, NDA Submission PCS-499: Complete CMC, Non-Clinical, Phase 1 (eg, Drug Interaction, Special Pop) PCS-499: Larger Phase 2b/3 Adaptive Pivotal Trial with Interim Analysi
Slide 28: 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 portfolio of high value drugs for patients with unmet medical need conditions Experienced management, development team with a track rec
Processa Pharmaceuticals — Investor Presentation (January 2020) on 6ix