Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (February 2019)
28 slides from Processa Pharmaceuticals's investor presentation, Feb 25, 2019
Slide 1: Processa Pharmaceuticals
cZ Processa Pharmaceuticals Developing Products to Improve the Survival and/or Quality of Life for Patients Who Have a High Unmet Medical Need David Young, Pharm.D., Ph.D. CEO February 23, 2019
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: Investors: Risk vs Return
Investors LOW RETU RN HIGH HIGH NO MAYBE?? RISK PROBABLY LOW cz) Processa Pharmaceuticals
Slide 4: Biotech Companies: Risk vs Return
Biotech Companies Low RETURN HIGH Companies in Discovery, with Platforms or Therapeutic|Specialty Focus HIGH RISK Generics, POC Clinical Evidence POC Clinical Evidence (Processa) LOW cz) Processa Pharmaceuticals
Slide 5: Why Aren't More Biotech Companies in the High Return-Low Risk Quadrant?
Why Aren’t More Biotech Companies in the High Return-Low Risk Quadrant? 1. Vested in their Platform or Therapeutic Specialty 2. Stage of Development, Drug, Indication, Patient Population 3. Lack the Correct Team (Science, Development, Management) 4. Lack Experience Developing Drugs for Approval & Co
Slide 6: Processa Pharmaceuticals
Processa Pharmaceuticals (OTCQB:PCSA) * Clinical stage biotech drug development company ¢ Drugs/indications with potentially high return on investment to achieve the Processa vision of becoming a multi-billion dollar company — Developing drugs to treat patients with high unmet medical need condition
Slide 7: How is Processa Decreasing the Risk of Failure?
How is Processa Decreasing the Risk of Failure? 1. Vested in their platform or therapeutic specialty Regulatory Science Approach to Drug Development, Not Drug Discovery or Specific Therapeutic Area 2. Stage of development, drug, indication, patient population Select Drugs that Have Some Evidence of
Slide 8: How is Processa Decreasing the Risk of Failure?
How is Processa Decreasing the Risk of Failure? 3&4. Lack the correct team - developing drugs for approval & commercialization Our Established Team Over Last 30 Years Taught FDA Reviewers, Assisted in Preparing FDA Guidances, Member of an FDA Advisory Committee, Involved with > 30 FDA Approvals & >
Slide 9: Processa Pharmaceuticals Financial Overview
Processa Pharmaceuticals Financial Overview OTCQB (2/8/19) PCSA - $3.00 per share Market Cap (2/8/19) $116M Shares Outstanding ~38.8M Shares Cash or Cash ~$1.5M (+ $1.8M Investment Paid Directly to Equivalent (2/8/19) CRO - 100% Phase 2a Trial) Insider Ownership % > 70% Headquarters Hanover, MD cz)
Slide 10: PCS-499: Deuterated Analog of a Major Active Metabolite of Pentoxifylline (PTX)
PCS-499: Deuterated Analog of a Major Active Metabolite of Pentoxifylline (PTX) PCS-499 metabolizes to same active pose metabolites as PTX but metabolite profile is inno different after PCS-499 administration than PTX (% exposure to various metabolites and administered drug) Anti- Fibrotic Effect Ph
Slide 11: Evidence PCS-499 Better and Different than PTX
Evidence PCS-499 Better and Different than PTX PTX widely used off-label with mixed results often because of dose limiting side effects In Phase 1 studies the exposure to key active moieties after PCS-499 administration was 2x greater than PTX at the same dose administered In Phase 1 studies dose li
Slide 12: Match a Good Drug with One or More Diseases
Match a Good Drug with One or More Diseases
Slide 13: 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 standard of care or FDA approved treatment, no know
Slide 14: Necrobiosis Lipoidica (NL) Pentoxifylline (PTX) Clinical Evidence
Necrobiosis Lipoidica (NL) Pentoxifylline (PTX) Clinical Evidence « Dermatologists mainly use topical steroids and other drugs with poor response and undesired toxicity profiles « PTX is used OFF-LABEL; response can start after 1 month with significant improvement 3-12 months (published case studies
Slide 15: Market Opportunity for PCS-499 in NL
Market Opportunity for PCS-499 in NL Maximum Gross Annual Sales Worldwide $1.2B - $2.7B 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 in US * 200,000 - 500,000 Patients Worldwide ZZ, i ‘Source: Muller SA, et al
Slide 16: Necrobiosis Lipoidica (NL)
Necrobiosis Lipoidica (NL) « Multi-faceted Disorder Affecting the Skin and the Tissue under the Skin NL Gollazen Decrease in Decrease in Increase in lacrencon Inflammation Ben Blood Flow- Fat Deposition Platelet Cytokines (eg, ss x Degeneration i . Fibrosis Oxygenation Survival TNFa) &B Processa Pha
Slide 17: PCS-499 Pharmacology
PCS-499 Pharmacology Broad PDE Inhibitor Anti- Fibrotic Effect Pharmacology of PCS-499 & 1 | Metabolites Inhibits Cytokines (eg, TNFa) Decrease Blood Viscosity Inhibits Platelet Aggreg. BB Processa Pharmaceuticals
Slide 18: Diverse PCS-499 Pharmacology Matches NL Pathophysiology
Diverse PCS-499 Pharmacology Matches NL Pathophysiology Increase in Cytokines (eg, TNFa) Decrease in Platelet Survival Decrease in Blood Flow- Oxygenation Increase in Fibrosis Collagen Inflammation Degeneration Fat Deposition Broad PDE Inhibitor Inhibits Platelet Aggregation Decrease Blood Viscosity
Slide 19: Status of PCS-499 NL Program
Status of PCS-499 NL Program Pre-IND collaborative meeting with FDA defining program (Oct 2017); In-licensed PCS- 499 (March 2018); Orphan Designation for PCS-499 in NL (June 2018) PCS-499 NL IND cleared by FDA (Oct 2018) - investigating safety and tolerance of PCS- 499 in NL patients with an evalua
Slide 20: 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 21: 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 22: Our Leadership
OUR LEADERSHIP Sian Bigora, Pharm.D., Chief Development Officer o Former VP, Regulatory Affairs at Mallinckrodt, Questcor Pharmaceuticals, AG] Therapeutics, GloboMax o Former Instructor of FDA Reviewers James Stanker, CPA, Chief Financial Officer o 25 years of Financial and Executive Leadership Expe
Slide 23: Additional Efforts
Additional Efforts Increase Probability of Company Success Decrease Company Risk Increase Shareholder Value
Slide 24: Additional Efforts
Additional Efforts Evaluating PCS-499 in Other Indications Where Preliminary Clinical Evidence Exists for PTX Efficacy and PTX Dose Limiting Adverse Events Evaluating and Negotiating Acquisition of Drugs with Existing Evidence of Clinical Efficacy (e.g., Women’s Health, Oncology, CNS) Income Generat
Slide 25: Achievements Over Last Months and Key Future Milestones
¥ Achievements Over Last 15 Months * Key Future Milestones Milestone Achievement Obtain Listing on |v Listing on OTCQB - Dec 2018 Public Market ¢ Listing on Nasdaq or NYSE — Working Toward This**** Raise Funds v¥ $6.88M Private Placement — June 2018 ¢ Raise Additional Funds — Working Toward This****
Slide 26: Achievements Over Last Months and Key Future Milestones
¥Y Achievements Over Last 15 Months ¢ Key Future Milestones Milestone Achievement PCS-499 v Pre-IND FDA Meeting on the Development Program — Oct 2017 Development in v In-licensed PCS-499 -— March 2018 Necrobiosis v Orphan Designation — June 2018 Lipoidica (NL); Multi- | ~ FDA IND Clearance — October
Slide 27: Plan and Timeline
Plan and Timeline PCS-499 *Complete Enrollment of Phase 2a »*Complete 6 Month 1° *SPA Submission NL Dose Tolerance Trial Endpoint of Trial for All | *Phase 2b/3 Initiated and +Partial Readout on Dose Patients Completed Tolerance for Patients +Request Meeting with Complete FDA Required FDA on Phase 2
Slide 28: Summary
Summary Developing Drugs to Treat Patients with High Unmet Medical Need Conditions that Could Provide a ROI to Achieve the Processa Vision of Becoming a Multi-Billion Dollar Company Experienced Team to Navigate: 1) Drug Development & FDA Using PCSA Regulatory Science Approach & 2) SEC/Financial Req.
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