Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Rare & Orphan Disease Summit 2021
16 slides from Processa Pharmaceuticals's conference presentation, May 21, 2021
Slide 1: Necrobiosis Lipoidica: A Rare Disease Affecting Many
Rare & Orphan Disease Summit May 21, 2021 Necrobiosis Lipoidica A Rare Disease Affecting Many David Young, PharmD, PhD Chairman and CEO
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements The following summary is provided for informational Forward‐looking statements, by their very nature, are purposes only and does not constitute an offer or subject to uncertainties and contingencies and assume solicitation to acquire interests in the investment
Slide 3: Processa's Differentiated Approach
Processa’s Differentiated Approach Experience in Adding Value to Companies with Over 30 FDA Approvals Unmet Medical Need + Efficacy Evidence + Regulatory Science + Capital Efficiency + Potentially High ROI • Clear and obvious • Evidence of • Improve Benefit/Risk • Leverage • Intelligently patient ne
Slide 4: Processa Pipeline – Multiple Opportunities For Success
Processa Pipeline – M ultiple Opportunities For Success Pipeline of Drugs to Treat Patients who Need Better Treatment Options Drug Disease Target Preclinical Phase 1 Phase 2 Phase 3 Market Size PCS499 Ulcerative Necrobiosis > $1 B Lipoidica PCS6422 Metastatic Colorectal, Breast > $1 B Cancer PCS1285
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 PDE the amount of key active moieties after 1.2 gm of 499 or PTX Inhibitor is admi
Slide 6: What is Necrobiosis Lipoidica (NL)?
W hat is Necrobiosis Lipoidica (NL)? Skin and tissue below the skin becomes necrotic, can last from months to years with complications such as infections, amputation, and squamous cell Severe NL Mild NL cancer 70% of the patients are women between 20 – 60 years old; 60% of NL patients are diabet
Slide 7: Is NL or Ulcerative NL Rare or Ultra Rare?
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 70% No Ulcer Often misdiagnosed for diabetic ulcer unless a biopsy is obtained
Slide 8: What Treatment Options Exist for Ulcerative NL or NL?
W hat 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 t
Slide 9: Why PCS499 for the Treatment of uNL?
W hy 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 targe
Slide 10: PCS499 Target Profile for Ulcerative Necrobiosis Lipoidica (uNL)
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 to
Slide 11: PCS499 FDA Designated Orphan Drug - Efficacy
PCS499 FDA Designated Orphan Drug - Ulcerative Necrobiosis Lipoidica (uNL) Differentiation of PCS499 from Existing Therapy Present Off-label therapy including PTX Efficacy • No approved NL or uNL treatment in U.S. or worldwide; Off-label drugs are prescribed to treat NL with mixed Adverse results
Slide 12: Phase 2A Trial of 1.8 gm/d of PCS499 in NL Patients
Phase 2A Trial of 1.8 gm/ d of PCS4999 in NL Patients 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 t
Slide 13: Phase 2B Trial Design for PCS499 in 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 determi
Slide 14: PCS499 uNL Potential Gross Sales of $600M - $1.4B
PCS499 uNL Potential Gross Sales of $600M - $1.4 B 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 ~$1.0B effective/safe in pat
Slide 15: Processa Corporate and Regulatory Science Approach
Processa Corporate and Regulatory Science Approach Benefit Pipeline Criteria Risk Unmet Medical Need Efficacy Evidence Regulatory Science Risk Capital Efficiency Potentially High ROI Benefit Earnings Update | May 2021 15
Slide 16: Processa Capital Structure and Share Information
Processa Capital Structure and Share Information M ay 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: $21,40
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