Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Cowen & Co. 39th Annual Health Care Conference 2019
26 slides from Processa Pharmaceuticals's conference presentation, Mar 13, 2019
Slide 1: Processa Pharmaceuticals
@ Processa Pharmaceuticals Developing Products to Improve Survival and/or Quality of Life for Patients Who Have a High Unmet Medical Need David Young, Pharm.D., Ph.D. CEO Cowen & Co. 39th Annual Health Care Conference 2019 March 18, 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: Increase Shareholder Value by Achieving High Returns While Minimizing Risk
Increase Shareholder Value by ___ Achieving High Returns While Minimizing Risk High Returns While Minimizing Risk oS Increase oS People Processes Shareholder (=) Value GB Processa Pharmaceuticals
Slide 4: Return and Risk Depend on People, Processes, Products
Return and Risk Depend on People, Processes, Products People Requires a Drug Development and Corporate Team with the expertise and experience to obtain FDA approval with an acceptable ROI Processes Requires processes to obtain FDA approvals and management processes to meet corporate and growth devel
Slide 5: Built on High Return — Low Risk Model
Processa Pharmaceuticals (OTCQB:PCSA) Built on High Return — Low Risk Model Clinical stage biotech company developing drugs with a higher potential return and lower risk of failure Products: Developing drugs to treat patients with high unmet medical need conditions People: Team of staff with a prove
Slide 6: Processa Pharmaceuticals Financial Overview
Processa Pharmaceuticals Financial Overview OTCQB (3/8/19) PCSA - $2.36/share Market Cap (3/8/19) $91.3M Shares Outstanding ~38.8M Shares Cash or Cash Equivalent | ~$1.45M (+ $1.8M Investment Paid Directly to (3/8/19) CRO for 100% of Phase 2a Trial) Total 2019 Expenses ~ $2.5M Other than Phase 2a Tr
Slide 7: Our People
@ Processa Pharmaceuticals Our People
Slide 8: Our People Lead to Success
Our People Lead to Success 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 a Proven Record of Success an
Slide 9: 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 10: 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 samice Stanker, CPA, Chief Financial Officer 25 years of Financial and Executive Leadership Exper
Slide 11: Our Drug Development Process
@ Processa Pharmaceuticals Our Drug Development Process
Slide 12: Processa Technology Platform or Processes
Processa Technology Platform or Processes Over the Last 25+ Years Our Team Has Developed a Regulatory Science Approach to Developing Drugs for FDA Approval — R&D studies performed to provide the scientific foundation upon which FDA will make regulatory decisions — Processa has the experience to anti
Slide 13: Our Product
@ Processa Pharmaceuticals Our Product
Slide 14: Clinical Evidence and Development Milestones
/ Clinical Evidence Sales (Gross & Net) Already Already y Develop. Milestones 2-4 Years
Slide 15: PCS-499: Deuterated Analog of a Major Active Metabolite of Pentoxifylline
PCS-499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX) Broad PCS-499 metabolizes to same active PDE moieties as PTX (including reversibly aaa metabolized to PTX itself) but the Anti- metabolite profile is different after gee PCS-499 administration than PTX (i th
Slide 16: Evidence PCS-499 Different than PTX
Evidence PCS-499 Different than PTX * PCS-499 pharmacology, key GLP tox, key Phase 1 trials completed * In pre-clinical toxicology studies the maximum tolerated dose for PCS-499 was greater than for PTX « In Phase 1 studies dose limiting side effects (e.g., nausea, vomiting, headaches) for PCS-499 a
Slide 17: Key Active Moieties from PCS-499 > 2x PTX per mg Dose Administered
Key Active Moieties from PCS-499 > 2x PTX per mg Dose Administered 400 mg TID 1.02 AUC(0-24)/Dose (ng-h/ml/mg) 19.3 16.2 7.32 — ~ PK Parameters (Geometric Mean) for Active Moieties (Day 4) PCS-499 900 mg BID PCS-499 600 mg TID (n=5) (n=5) 248 Cmax/Dose (ng/mL/mg) a:oxhigber 2.2x higher 1800 mg daily
Slide 18: Necrobiosis Lipoidica (NL) - No Approved Treatment
Necrobiosis Lipoidica (NL) - No Approved Treatment 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 treatment;
Slide 19: NL Market Opportunity
NL Market Opportunity Max Annual Gross Sales Worldwide $1.2B - $2.7B Necrobiosis Lipoidica (NL) Max Gross Sales ~$1.2B | ig ($700M - $1.7B) [Max Gross Sales US Max Gross Sales SDI Other than US + 200,000 - 500,000 Patients in High Sociodemographic Index (SDI) Countries G&A Processa Pharmaceuticals 1
Slide 20: Clinical Evidence of NL Efficacy for Pentoxifylline (PTX) and PCS-499
Clinical Evidence of NL Efficacy for Pentoxifylline (PTX) and PCS-499 Dermatologists mainly use topical steroids and other drugs with poor response PTX is used OFF-LABEL and response can start after 1 month with significant improvement within 3-12 months (published case studies and clinical experien
Slide 21: Clinical Evidence of NL Efficacy for Pentoxifylline (PTX) and PCS-499
Clinical Evidence of NL Efficacy for Pentoxifylline (PTX) and PCS-499 + After PCS-499 administration the same active moieties exist systemically as in PTX but the amounts of some active moieties are greater after PCS-499 administration. * PSC-499 tolerated oral dose in NL patients (PCSA Phase 2 Tria
Slide 22: Diverse PCS-499 Pharmacology Matches NL Pathophysiology
Diverse PCS-499 Pharmacology Matches NL Pathophysiology Decrease in Decrease in Increase in : Inflammation Roce Blood Flow. Fat Deposition Platelet Cytokines (eg, Increase eg Oxygenation Survival TNFa) Broad PDE Inhibitor Inhibits Platelet Aggregation Decrease Blood Viscosity Inhibits Cytokines (eg,
Slide 23: Status of PCS-499 NL Program
Status of PCS-499 NL Program * Defined development program in pre-IND collaborative meeting with FDA (Oct 2017); Orphan Designation for PCS-499 in NL (June 2018); PCS-499 NL IND cleared by FDA (Sept 2018) — PCS-499 safety/tolerance trial in NL patients * First patient dosed January 2019 in Phase 2 t
Slide 24: Additional Efforts To Increase Shareholder Value
Additional Efforts To Increase Shareholder Value Evaluating PCS-499 in other indications where preliminary clinical evidence exists for PTX or PCS-499 efficacy Evaluating and negotiating acquisition of other drugs with existing evidence of clinical efficacy (e.g., CNS, Oncology, Women’s Health, orph
Slide 25: Summary
Summary Significant present and future value to be added Processa offers a higher return and lower risk investment for shareholders as well as a potential future valuation of billions of dollars Processa has an experienced team to navigate 1) the FDA drug development and approval process using their
Slide 26: Summary
Summary Clinical evidence of PCS-499 efficacy in NL patients already exists Phase 2 trial is confirming that PCS-499 is better tolerated than PTX in NL patients with key results available 2"! and 3' quarter 2019 (PCS-499 rNPV > $200 M) 2019 end of year meeting with FDA defining next key study (Phase
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