Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Rare & Orphan Disease Summit (May 2021)
16 slides from Processa Pharmaceuticals's conference presentation, May 20, 2021
Slide 1: Rare & Orphan Disease Summit
Rare & Orphan Disease Summit May 21, 2021 Necrobiosis Lipoidica A Rare Disease Affecting Many David Young, PharmD, PhD Chairman and CEO (_)PPENHEIMER @ Processa Pharmaceuticals
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's Differentiated Approach
Processa’s Differentiated Approach Experience in Adding Value to Companies with Over 30 FDA Approvals on e— DEVELOP NOT DISCOVER — REGULATORY SCIENCE PLATFORM e, — Unmet Medical Need + Efficacy Evidence + Regulatory Science + Capital Efficiency + [Zecintrli\ allel ae)| * Clear and obvious * Evidence
Slide 4: Processa Pipeline — Multiple Opportunities For Success
Processa Pipeline — Multiple Opportunities For Success Pipeline of Drugs to Treat Patients who Need Better Treatment Options Preclinical Market Size Disease Target PCS499 Ulcerative Necrobiosis Lipoidica PCS6422 Metastatic Colorectal, Breast >$1B Cancer PCS12852 Gastroparesis, Functional >$1B Consti
Slide 5: PCS499: Diverse Pharmacological Properties
PCS499: Diverse Pharmacological Properties Deuterated analog of the major metabolite of Pentoxifylline (PTX) (PTX FDA approved for claudication in the 80s) Metabolizes qualitatively to the same PTX metabolites but the amount of key active moieties after 1.2 gm of 499 or PTX is administered, is more
Slide 6: What is Necrobiosis Lipoidica (NL)?
What is Necrobiosis Lipoidica (NL)? > Skin and tissue below the skin becomes necrotic, can last from months to years with complications such asinfections, amputation, and squamous cell Severe N Mild NL ~ Fy cancer > 70% of the patients are women between 20 - 60 years old; 60% of NL patients are diab
Slide 7: Is Necrobiosis Lipoidica (NL) or Ulcerative NL (uNL) Rare or Ultra Rare?
a Is Necrobiosis Lipoidica (NL) or Ulcerative NL (uNL) Rare or Ultra Rare? 75,000 — 185,000 NL Patients in the US 30% >» Patients seen by numerous physicians including primary Ulcerated care, endocrinologist, dermatologist > Often misdiagnosed for diabetic ulcer unless a biopsy is obtained > Diagnos
Slide 8: What Treatment Options Exist for Ulcerative NL or NL?
What Treatment Options Exist for Ulcerative NL or NL? > There is no FDA approved treatment for NL or UNL and there is no standard of care; all are inadequate > Drugs have been used off-label with mixed success (for example; pentoxifyline (PTX), immunomodulating drugs) but all are inadequate given th
Slide 9: Why PCS499 for the Treatment of UNL?
Why PCS499 for the Treatment of UNL? PTX is not approved for NL, but it is used off-label and, in a small percentage of patients, PTX treatment will completely close ulcers for patients who can tolerate the highest labelled dose, supporting the hypothesis that PTX and its metabolites may be targetin
Slide 10: PCS499 Target Profile for Ulcerative Necrobiosis Lipoidica (uNL)
a PCS499 Target Profile for Ulcerative Necrobiosis Lipoidica (uNL) > Target Indication: + Treatment of ulcerative necrobiosis lipoidica (“UNL”) + PCS499 has FDA orphan designation for NL > Target Claims: * Completely closes open necrobiosis lipoidica ulcers; improves non-ulcerated NL lesions + Well
Slide 11: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL) > Differentiation of PCS499 from Existing Therapy Present Off-label therapy + No approved NL or uNL treatment in U.S. or worldwide; including PTX | Efficacy | Off-label drugs are prescribed to treat NL with mixed results >» W
Slide 12: Less Than 5% of uNL Patients Have Ulcers Naturally Heal During First 1-2 Years
Less Than 5% of uNL Patients Have Ulcers Naturally Heal During First 1-2 Years After Occurrence > PCS499 was well tolerated at 1.8 gm/d > In the only two NL patients with open ulcers, all ulcers completely closed » Ulcers occurring from contact trauma to the NL lesion during the study also completel
Slide 13: PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL)
PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (UNL) > Phase 2B to Better Define Variables for Phase 3: General Design: Randomized, double-blind placebo-controlled trial of 1.8 gm/d of 499 in 20 uNL patients with primary efficacy evaluation at 6 months + Objective: To determine
Slide 14: PCS499 uNL Potential Gross Sales of $600M - $1.4B
PCS499 uNL Potential Gross Sales of $600M - $1.4B Ulcerative Necrobiosis Lipoidica (uNL) > Economic Value: Initial Markets Max Gross Sales * 22,000 —- 55,000 patients in U.S. have uNL + Presently no approved treatment and off- labeled drugs not proven to be significantly effective/safe in patients w
Slide 15: Processa Corporate and Regulatory Science Approach
Processa Corporate and Regulatory Science Approach Pipeline Criteria cca ia Unmet Medical Need Efficacy Evidence 4 " "4 Capital Efficiency Potentially High ROI Update | May 2021
Slide 16: Processa Capital Structure and Share Information
Processa Capital Structure and Share Information May 14, 2021 > Stock Listing: PCSA- NASDAQ > 52 Week Low-High: $3.95 - $13.15 > Price (May 14, 2021): $6.15 >» Market Cap (May 14, 2021): $95,457,938 > Shares Outstanding: 15,521,616 > Fully Diluted Shares: 16,511,147 > Cash, Cash Equivalents: $21,404
Processa Pharmaceuticals — Rare & Orphan Disease Summit (May 2021) on 6ix