Stablecoin Development Corporation · AMEX:SDEV
Stablecoin Development — NovaBay Pharmaceuticals — Investor Day (September 2013)
30 slides from Stablecoin Development's investor day presentation, Sep 17, 2013
Slide 1: Beyond Antibiotics
Beyond Antibiotics Ron Najafi, Ph.D. Chief Executive Officer Thomas J. Paulson NYSE-MKT: NBY Chief Financial Officer Keith Bley, Ph.D. Senior VP, Drug Development UCBE Analyst & Investor Event September 17, 2013
Slide 2: Forward-Looking Statements
Forward-Looking Statements • This presentation contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the potential for auriclosene to dramati
Slide 3: Megatrend - Antibiotic Resistance Crisis
Megatrend - Antibiotic Resistance Crisis Post-Antibiotic Era - Confirmed by WHO - Widespread Resistance - “Super Bugs”/ MRSA - Flesh Eating Antibiotic Era - Will this effect LE? - 1930 – 2010 - Penicillin - 150 Antibiotics - Wonder Drugs - Save Millions of Lives Pre-Antibiotic Era - LE ~80 Bacteria
Slide 4: Two Distinct Anti-Infective Product Groups
Two Distinct Anti-Infective Product Groups Aganocides® NeutroPhase® Lead: Auriclosene Chronic Non- Healing Wounds (NVC-422) Dermatology Ophthalmology ~6 Million U.S. Patients Impetigo Pink Eye WW: ~$700M WW: ~$400M Urology UCBE US: ~$100M 3
Slide 5: Pipeline Continues to Advance
Pipeline Continues to Advance Results From Three Advanced Clinical Trials Expected in the Next 3 to 9 Months 2013 2014 Therapeutic Scope Delivery Area (Patients) Q1 Q2 Q3 Q4 Q1 Urology Irrigation US Phase 2, Part 2 Data (UCBE) Solution (38) Aganocides® Dermatology Topical Global (Impetigo) Enrolling
Slide 6: Anticipated Upcoming Milestones
Anticipated Upcoming Milestones* Year Date Event H1 NeutroPhase Partnerships USA / ROW 2013 H2 Data - Part 2 of Phase 2a Urology (UCBE) H2 Data - Phase 2b Impetigo Global study H1 Data - Phase 2b BAYnovation Global Study H1 Sign Conjunctivitis Partner 2014 H1 Initiate Impetigo Phase 3 Global Studies
Slide 7: Financial Overview
Financial Overview Key Statistics Million Market Cap $64 (9/16/13) 6/30/13 Cash and Equivalents $11.4 (Plus an additional ~$1M of Acc/Rec from Partners) Debt $0 Shares Outstanding 37 (only common outstanding) 6
Slide 8: Estimated Cost of Managing UCBE Patients
Estimated Cost of Managing UCBE Patients Impact of 100,000 Patients on the U.S. Health Care System $ Million • Scheduled Frequent Catheter Changes $ 520 • Lithotripsy and Cystoscopy $ 300 • ICU Hospitalizations $ 300 • Emergency Catheter Removal (ER) $ 160 • Unscheduled Catheter Changes $ 80 • Proph
Slide 9: Auriclosene For Prevention of Urinary Catheter Blockage & Encrustation: Results From Clinical Study CL1001
Auriclosene For Prevention of Urinary Catheter Blockage & Encrustation: Results From Clinical Study CL1001 Keith Bley, PhD Senior Vice President of Product Development NovaBay Pharmaceuticals
Slide 10: Auriclosene (NVC-422)
Auriclosene (NVC-422) H3 C CH3 SO3Na Cl2N • N,N-dichloro-2,2-dimethyltaurine is a stable analog of endogenous compounds produced by neutrophils to destroy bacteria • Fast-acting, broad spectrum antimicrobial • Three active INDs: conjunctivitis, skin infections, and urology • > 1300 subjects exposed
Slide 11: Clinical Studies With Auriclosene Irrigation Solution in Urology
Clinical Studies With Auriclosene Irrigation Solution in Urology • Phase 1 – Safety study in 29 healthy volunteers (CL0703) – 100 mL of 0.01 to 0.1% auriclosene instilled into bladder for 15 minutes – Dosed once daily for up to 7 days • Phase 2 1. Effects on bacteriuria in 20 chronically catheterize
Slide 12: CL1001 Synopsis
CL1001 Synopsis • Objective: Assess the ability of Auriclosene Irrigation Solution to prevent or reduce the blockage and encrustation of indwelling urinary catheters • Population: Patients with indwelling transurethral or suprapubic urinary catheters who have a recent history of urinary catheter enc
Slide 13: CL1001 Design
CL1001 Design • Double-blind, crossover design, multi-center study • Subjects randomized to receive one study solution (0.2% auriclosene or saline) for the first treatment regimen and, after a washout period (7 to 21 days), crossed over to receive the other solution for the second treatment regimen
Slide 14: Can Catheter Irrigation Solution Prevent Blockage and Encrustation?
Can Catheter Irrigation Solution Prevent Blockage and Encrustation? Irrigate catheter with 25 mL of Auriclosene Irrigation Solution or saline for 15 minutes, then repeat Perform irrigation procedure twice per week 1
Slide 15: Key Inclusion Criteria
Key Inclusion Criteria • Patient (age > 18 years) requiring an indwelling transurethral or suprapubic catheter who has a history over the past year of two or more episodes of catheter blockage and/or encrustation • Urine pH of ≥ 6.9 or a urine pH ≥ 6.5 and presence of at least one urease-producing b
Slide 16: Key Exclusion Criteria
Key Exclusion Criteria • Subject with T6 lesion or above and recent history of significant autonomic dysreflexia (requiring intervention or treatment) or found to have significant autonomic dysreflexia with a screening irrigation test procedure • Significant bladder stone formation present prior to
Slide 17: Subject Demographics
Subject Demographics Part 1 Part 2 Part 3 Total N = 20 N = 28 N = 19 N = 67 Mean 46.0 46.2 48.0 46.6 Age (years) Range 23-75 21-76 22-81 21-81 Gender Male 17 (85%) 19 (68%) 14 (74%) 50 (75%) Spinal cord Diagnosis 20 (100%) 26 (93%) 17 (89%) 63 (94%) injury Transurethral 15 (75%) 13 (46%) 6 (32%) 34
Slide 18: Measurement of Catheter Encrustation
Measurement of Catheter Encrustation • After removal, catheter shipped on ice to central laboratory • Catheters sectioned at EH, CS1, CS2, and others as needed • All sections were imaged using StereoZoom – Luminal area highlighted red (encrusted) or blue (not encrusted) in Photoshop – Analyzed on UN
Slide 19: Example of Encrustation Measurement
Example of Encrustation Measurement Calculated percentage area of encrustation = 31.4% • Maximal encrustation at any point used as primary measurement, as best reflects loss of catheter patency • Calculated with UN-SCAN-IT 18
Slide 20: Results From Clinical Study CL1001
Results From Clinical Study CL1001 19
Slide 21: Difference in Encrustation Per Subject in Part 1
Difference in Encrustation Per Subject in Part 1 (Preliminary formulation; 3X per week for 2 weeks) Benefit Saline Auriclosene Subject N = 14 100 Percentage encrustation saline minus % encrustation auriclosene 20
Slide 22: Effects of Auriclosene Irrigation Solution on Catheter Encrustation in Part 2
Effects of Auriclosene Irrigation Solution on Catheter Encrustation in Part 2 (3X per week for 2 weeks) Benefit Saline Auriclosene N = 20 Subject 100 Percentage encrustation saline minus % encrustation auriclosene 21
Slide 23: Auriclosene Irrigation Solution Decreased Catheter Encrustation in Part 3
Auriclosene Irrigation Solution Decreased Catheter Encrustation in Part 3 (2X per week for 4 weeks) Benefit Saline Auriclosene N = 14 Wilcoxon signed-rank test p<0.001 100 Percentage encrustation saline minus % encrustation auriclosene 22
Slide 24: Auriclosene Irrigation Solution Reduces Maximum Percent Area of Encrustation
Auriclosene Irrigation Solution Reduces Maximum Percent Area of Encrustation N = 14 Auriclosene Saline Mean percentage 21.7 76.9 encrustation 95% CI (2.1, 41.2) (54.9, 98.8) 23
Slide 25: Auriclosene Reduces Catheter Blockages & Complete Encrustation
Auriclosene Reduces Catheter Blockages & Complete Encrustation N = 14 Auriclosene Saline P-Value Percent of catheters removed for clinical 14.3% 64.3% 0.016* blockage Percent of removed catheters that have 0.0% 64.3% 0.003* 100% encrustation * Using McNemar exact test; N = 14 24
Slide 26: Safety & Adverse Events
Safety & Adverse Events • There were no SAEs • More bladder AEs were observed following treatment with auriclosene than with saline • All treatment-related AEs (including any symptoms of irrigation-induced autonomic dysreflexia with saline or auriclosene) were mild or moderate in severity, transient
Slide 27: Bacteria Give Rise to Crystalline Biofilm
Bacteria Give Rise to Crystalline Biofilm Urease Urea Struvite Hydroxyapatite crystals crystals Crystalline biofilm Catheter encrustation Sediment Bladder stones 26
Slide 28: Auriclosene Kills Bacteria and Reduces Crystalline Biofilm Accumulation
Auriclosene Kills Bacteria and Reduces Crystalline Biofilm Accumulation Urease Urea Auriclosene Struvite Hydroxyapatite crystals crystals Crystalline biofilm Catheter encrustation Sediment Bladder stones 27
Slide 29: Summary and Conclusions
Summary and Conclusions • Auriclosene Irrigation Solution used twice per week significantly reduces encrustation and blockage in indwelling urinary catheters • No significant safety or tolerability issues have been identified • Future pivotal clinical studies will seek to provide additional evidence
Slide 30: Beyond Antibiotics
Beyond Antibiotics Ron Najafi, Ph.D. Chief Executive Officer Thomas J. Paulson NYSE-MKT: NBY Chief Financial Officer Keith Bley, Ph.D. Senior VP, Drug Development UCBE Analyst & Investor Event September 17, 2013
NovaBay Pharmaceuticals — Investor Day (September 2013) on 6ix