Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Jefferies Healthcare Conference 2019
28 slides from Processa Pharmaceuticals's conference presentation, Jun 7, 2019
Slide 1: Processa Pharmaceuticals - Jefferies Healthcare Conference
@ Processa Pharmaceuticals David Young, Pharm.D., Ph.D. CEO Jefferies Healthcare Conference June 4-7, 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: Biotech Approach vs Processa Approach
Biotech Approach vs Processa Approach Biotech Industry: New Molecular Entity (NME) Drug Development is Very Risky with a High Likelihood of Failure Processa Business Model: Develop Drugs with Lower Risk of Failure and Potentially High ROI GB Processa Pharmaceuticals
Slide 4: Decrease Drug Development Risk & Increase Potential Return
Decrease Drug Development Risk & Increase Potential Return People Processes Increase ==> Shareholder Value GB Processa Pharmaceuticals
Slide 5: Return and Risk Depend on People, Processes, Products
Return and Risk Depend on People, Processes, Products People: Requires a drug development & corporate team with the expertise and experience to obtain FDA approval with an acceptable ROI v Over the last 25+ years Processa team has > 30 FDA approvals, > 100 FDA meetings, trained FDA reviewers, & work
Slide 6: Our People
@ Processa Pharmaceuticals Our People
Slide 7: 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 8: 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 FDAAdvisory Committee Member
Slide 9: 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 10: Board of Directors
Board of Directors David Young, Chairman of the Board and Patrick Lin, Director Virgil Thompson, JD, Independent Director * Chairman of the Board of Spinnaker Biosciences, Inc.; Former CEO & Director Spinnaker Chairman of the Board of Aradigm Corporation; Director of Genz Corporation ¢ Former Chairm
Slide 11: Our Drug Development Process
@ Processa Pharmaceuticals Our Drug Development Process
Slide 12: Processa Regulatory Science Approach to Approval
Processa Regulatory Science Approach to Approval Over the Last 25+ Years, Our Team Has Formulated 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 experienc
Slide 13: Our Product
@ Processa Pharmaceuticals Our Product
Slide 14: Higher ROI by selecting drugs and indications
Higher return on investment (ROI) by selecting drugs and indications with higher potential gross sales, faster time to market, & differentiated from existing treatments Decrease risk of failure by selecting drugs with some clinical evidence of efficacy/safety, pharmacology-tox understood, & value ad
Slide 15: PCS-499: Deuterated Analog of a Major Active Metabolite of PTX
PCS-499: Deuterated Analog of a Major Active Metabolite of FDA Approved Pentoxifylline (PTX) Broad PCS-499 metabolizes to same active PDE Inhibitor moieties as PTX (including reversibly metabolized to PTX itself) but the nae metabolite profile is different after PCS- ribrole 499 administration than
Slide 16: High Return: PCS-499 Different than PTX
High Return: PCS-499 Different than PTX In pre-clinical toxicology studies, the maximum tolerated dose (MTD) for PCS-499 was greater than for PTX In Phase 1 studies, dose limiting side effects (e.g., nausea, vomiting, headaches) for PCS-499 administered orally occurred at a dose approx. 50% greater
Slide 17: Key Active Moieties after PCS-499 vs PTX
Key Active Moieties after 1.8 gm of PCS-499 > 3x the Amount after 1.2 gm of PTX PK Parameters (Geometric Mean) for Active Moieties (Day 4) PCS-499 900 mg BID PCS-499 600 mg TID PTX 400 mg TID (n=5) (n=5) (n=6) Cmax/Dose (ng/mL/mg) 2.11 AUC(0-24)/Dose 19:3) 16.2 1.32 (ng.h/mL/mg) a ——————— 2.6x highe
Slide 18: Higher Return: Indication Dependent
Higher Return: Indication Dependent Necrobiosis Lipoidica (NL) PTX used off-label Occurs in women/men 20 — 60 y/o Skin becomes necrotic; 30% of patients have painful ulcerations; complications - infections, amputation, squamous cell cancer No standard of care or FDA approved treatment; Dermatologist
Slide 19: Potential High Return: NL Market Opportunity
Potential High Return: NL Market Opportunity Max Annual Gross Sales Worldwide $1.2B - $2.7B Necrobiosis Lipoidica (NL) Max Gross Sales ~ $700M ($400M - $1B) we Max Gross Sales US Max Gross Sales SDI Other than US ~$1.2B ($700M - $1.7B) + 74,000— 185,000 Patients in US + 200,000— 500,000 Patients in
Slide 20: NL Pathophysiology
NL Pathophysiology Decrease in Decrease in Increase in 4 Inflammation Recleasn Blood Flow- Fat Deposition Platelet Cytokines (eg, Incieese 9 Oxygenation Survival TNFa) GB Processa Pharmaceuticals
Slide 21: PCS-499 Diverse Pharmacology Beneficial for Treatment of Indications
PCS-499 Diverse Pharmacology Beneficial for The Treatment of a Number of Indications Broad PDE Decrease Blood Inhibits Platelet Viscosity Aggregation Inhibits Cytokines Anti-Inflammatory Anti-Fibrotic Effect Inhibitor (eg, TNFa) ] l I ! PCS-499 PCOL GB Processa Pharmaceuticals
Slide 22: Diverse PCS-499 Pharmacology Matches NL Pathophysiology
Diverse PCS-499 Pharmacology Matches NL Pathophysiology Decrease in Decrease in Increase in 4 Inflammation Recleasn Blood Flow- Fat Deposition Platelet Cytokines (eg, Incieese 9 Oxygenation Survival TNFa) Broad PDE Inhibitor Decrease Blood Inhibits Platelet Inhibits Cytokines Anti-Fibrotic Effect An
Slide 23: Lower Risk: Clinical Efficacy Evidence already Exists
Lower Risk: Clinical Efficacy Evidence already 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 perc
Slide 24: Status of PCS-499 NL Program
Status of PCS-499 NL Program Defined development program in pre-IND collaborative meeting with FDA (Oct 2017); FDAstated that 1 pivotal study may be acceptable for NL Received Orphan Designation providing 7 years of Market Exclusivity (June 2018) PCS-499 IND cleared by FDA (Sept 2018) for PCS-499 sa
Slide 25: 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 but where PCS-499 can be differentiated from PTX and other treatments « Negotiating acquisitions of new molecular entities and re-purposed drugs with some evi
Slide 26: Processa Financial Overview
Processa Financial Overview OTCQB (6/4/19) PCSA - $2.50/share Market Cap (6/4/19) $96.7M Shares Outstanding ~38.7M Shares Cash or Cash Equivalent (6/4/19) ~$1.0M (Plus an Additional $1.3M from Investor who Directly Pays CRO for Phase 2 Trial Costs) Total 2019 Remaining Expenses Other ~ $1.4M (2019 A
Slide 27: Summary
Summary The potential future valuation of Processa is significantly greater than the present market cap-stock price Processa has an experienced team to navigate 1) the FDA drug development and approval process using their Regulatory Science approach and 2) the SEC/Financial requirements of a public
Slide 28: Summary
Summary Clinical evidence of PCS-499 efficacy in NL patients already exists through PTX off-label use Phase 2 trial is confirming that NL patients can tolerate a significantly higher dose of PCS- 499 than a PTX dose with key results available 2H2019 2019 end of year FDA meeting planned to define NL
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