Stablecoin Development Corporation · AMEX:SDEV
Stablecoin Development — NovaBay Pharmaceuticals — BIO CEO Conference 2013
44 slides from Stablecoin Development's conference presentation, Feb 11, 2013
Slide 1: Corporate Presentation - BIO CEO Conference
Corporate Presentation BEYOND ANTIBIOTICS! NYSE MKT: NBY BIO CEO Conference New York City February 11, 2013
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, within the meaning of applicable U.S. securities laws, which statements can, in some cases, be identified with terms such as “project” "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "
Slide 3: Antibiotic Drug Development Megatrend
Antibiotic Drug Development Post-Antibiotic Era - Confirmed by WHO Antibiotic Era - Widespread Resistance - 1930 - 2010 - “Super Bugs”/ MRSA - Penicillin - Flesh Eating - 150 Antibiotics - LE ? - Wonder Drugs - Save Millions of Lives Pre-Antibiotic Era - LE 85 Bacteria containing NDM-1 enzyme - Pre-
Slide 4: White Blood Cell in Action
White Blood Cell in Action Invading Microbe White Blood Cell Red Blood Cells Hypochlorous Acid (HOCl) N-Chlorotaurine (NCT) Natural compound Natural compound NVC-101 – Stable Formulation Rapid acting Rapid acting Effective BUT unstable 3 3
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Slide 6: NVC-422: First Ever Stable Form of N,N-Dichlorotaurine
NVC-422: First Ever Stable Form of N,N-Dichlorotaurine N,N-Dichlorotaurine (NNDCT) Natural Compounds Rapid Acting Effective NVC-422 NVC-422 5
Slide 7: Our Solution: Compounds that Mimic Nature
Our Solution: Compounds that Mimic Nature NVC-422 (N,N-dichloro-2,2-dimethyltaurine) effective and stable, broad patent protection • Good safety profile • Fast • Broad spectrum of activity • Effective against multi-drug resistant bacteria • Effective against biofilm 6
Slide 8: Four Distinct Business Units Pursuing Independent Opportunities
FOUR DISTINCT BUSINESS UNITS PURSUING INDEPENDENT OPPORTUNITIES $2 Bil (WW) $400-600 Mil (WW) $100-200 Mil (US) 7
Slide 9: Company History / Major Milestones
Company History / Major Milestones 2000 1998-2003 2007 2007 2009 2012 Aganocide Patent Initial Public Offering Partnership in 2009 Partnership in 2012 NVC-101 Founded 1998 - 2003 2007 October, 2007 in $20,000,000 Dec. 2000 Discovery and development of NovaBay licenses the Strategic marketing U.S. Pa
Slide 10: Pipeline Continues to Advance
Pipeline Continues to Advance Therapeutic Pre- Approved/ Form Phase I Phase II Phase III Area clinical cleared Eye Ophthalmology Drops Enrolling Global Phase 2b* Aganocides® Dermatology Topical Enrolling Global Phase 2b* (NVC-422) Gel Irrigation Enrolling Ph 2, Part 2 Urology Solution NeutroPhase® A
Slide 11: EyeBay
EyeBay NVC-422 Eye Drops for the Treatment of Viral Conjunctivitis (Pink Eye) Un-Partnered Program
Slide 12: Adenoviral Conjunctivitis
Adenoviral Conjunctivitis • Number 1 unmet medical need in ocular infections • Epidemic Keratoconjunctivitis (EKC) most severe •Can be sight threatening •Highly contagious •Causes large epidemic outbreaks 11
Slide 13: Worldwide Conjunctivitis Market
Worldwide Conjunctivitis Market Bacterial and Viral WW = $2 billion Viral Viral (Ex-US) (US) $400 (1) $300 (1) Bacterial Bacterial (Ex-US) (US) $768 $457 (1) Extrapolated from Japanese incidence data of 1 million cases of adenoviral conjunctivitis per year. Other published estimates of incidence sup
Slide 14: Mechanism of Action
Mechanism of Action (1) NVC-422 rapidly oxidizes Cys and Met residues on viral proteins NVC-422 (2) This results in structural changes and disintegration of the capsid protein assembly, leading to viral Untreated Ad5 inactivation Cavity Formation Deformation Dissociation/Aggregation TEM (UC Berkeley
Slide 15: Viral Conjunctivitis Phase IIa Trial Results
Viral Conjunctivitis Phase IIa (Proof-of-Concept) Trial Results
Slide 16: Clinical Success: 69% on Day 18 in EKC Adenoviral Patients
Clinical Success: 69% on Day 18 in EKC Adenoviral Patients 15% Separation from Vehicle 80 % of Patients (n = 29) 69 70 Phase IIa 60 15% 54 50 NVC-422 Vehicle 40 38 31 30 19 20 13 13 10 6 8 0 0 0 0 Day 3 Day 5 Day 7 Day 9 Day 11 Day 18 Sustained clinical cure: the sum of bulbar conjunctival injection
Slide 17: Blurred Vision Clearing 92% on Day 18
Blurred Vision Clearing 92% on Day 18 in EKC Adenoviral Patients 42% Separation from Vehicle 100 92 % of Patients (n = 21) 90 85 Phase IIa 80 NVC-422 Vehicle 69 42% 70 62 60 50 50 46 40 38 31 30 25 20 13 13 10 - - Day 3 Day 5 Day 7 Day 9 Day 11 Day 18 Sustained clearing of blurred vision is obtained
Slide 18: Positive Effects on Sub-Epithelial Infiltrates (SEIs)
NVC-422 Demonstrates Positive Effects on Sub-Epithelial Infiltrates (SEIs) 70.0% 62.5% 60.0% 56.3% 50.0% 42.1% 40.0% 33.3% 30.0% 20.0% 10.0% 0.0% NVC-422 Vehicle NVC-422 Vehicle % Patients (n=30) that developed SEIs % Patients (n=16) with SEIs resolved 17
Slide 19: Summary of Proof-of-Concept Phase IIa Study
Summary of Proof-of-Concept Phase IIa Study Patients with EKC Serotypes Sustained Microbiological success Sustained Clinical cure Sustained Clearing of blurred vision Resolution of SEIs Prevention of infection to the other eye Safe and well tolerated 18
Slide 20: Adenoviral Conjunctivitis -- Timeline
Adenoviral Conjunctivitis -- Timeline Phase I – Escalating Exposure Study (C 08-01) – Completed Phase IIa – Proof-of-Concept Study (C 07-53) – Completed • Phase IIb – BAYnovation – Global Safety/Efficacy Study - Ongoing – Enrollment began May 4, 2012 – Completion and results expected in mid-2013
Slide 21: BAYnovation Investigators in the US
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Slide 22: BAYnovation Investigators in India
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Slide 23: DermaBay
DermaBay NVC-422 Dermal Gel for the Treatment of Impetigo Partnered Program
Slide 24: Dermatology Partnered with Galderma
Dermatology Partnered with Galderma Indication Impetigo: Highly Contagious Skin infection • MRSA infection on the rise Impetigo • Among most common skin diseases in children • ~1.3 mil prescriptions (USA), 13 mil (US, Europe, Japan and Brazil) • Current products give rise to resistance NVC-422 • Act
Slide 25: Patient 167/GMC (0.5%)
167/GMC (0.5%, 21 doses) S. aureus Visit 1 Visit 3 SIRS = 10 SIRS = 0 Day 8 - (“Skin Infection Rating Score”) Success 24
Slide 26: Patient 111/KVI (0.5%)
111/KVI (0.5%, 21 doses) S. aureus Visit 1 Visit 3 Day 8 - SIRS = 8 SIRS = 0 Success 25
Slide 27: Patient 280/RRS (1.5%)
280/RRS (1.5%, 20 doses) S. aureus Visit 1 Visit 3 Day 8 - SIRS = 11 SIRS = 0 Success 26
Slide 28: Phase IIa Results Clinical and Bacteriological Response
Phase IIa Results Clinical and Bacteriological Response – Follow up (Day 8 and 15) • Clinical Response = Clinical Success • Bacteriological Response = Bacteriological Success • There were no recurrences of infection at target lesion in any treatment group Clinical Bacteriological 100% 95% 95% 92% 90
Slide 29: Leading Brands All Develop Resistance
Leading Brands All Develop Resistance Mupirocin, Retapamulin and Fusidic acid $400 Mil / Yr Combined Sales WW 28
Slide 30: NVC-422: Serial Passage Against MRSA
NVC-422: Serial Passage Against MRSA (MIC) 600 80.0 70.0 60.0 Fusidic acid 50.0 40.0 NVC-422: 30.0 20.0 NO RESISTANCE 10.0 detected 0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Fusidic acid Fusidic acid 15 Fusidic acid Fusidic acid 16 Fusidic acid Fusidic acid 17 Fusidic acid 18 Mupirocin Mupirocin 19 Mupi
Slide 31: MediBay: NeutroPhase Commercial Launch Pending
MediBay NeutroPhase® for the treatment of Chronic Non-healing Wounds (FDA: 510k Cleared) Commercial Launch Pending
Slide 32: NeutroPhase Value Proposition
NeutroPhase Value Proposition • Significant Markets Over 6 million patients in US annually Rest of World Market considered larger than US • Proprietary Technology Patented Formulation – Pure Hypochlorous Acid No resistance expected based on novel mechanism of action • Extensive Clinical Expe
Slide 33: NeutroPhase Marketing Strategy
NeutroPhase Marketing Strategy We intend to establish commercialization partnerships with pharmaceutical, biotechnology or other leading organizations with the experience and resources to bring our products to market. • Current Partnerships: China and Asia distributor: Pioneer Pharma, Shanghai-Chin
Slide 34: NeutroPhase for Wound Care
NeutroPhase for Wound Care NBY Business Strategy • Partner in US and around the world • Export NeutroPhase from the USA Jan, 2012 – Established commercialization deal with Pioneer Pharma for marketing rights in China (including $1.3M payments to NBY) Sept, 2012 – Expansion of marketing partnersh
Slide 35: Intellectual Property
Intellectual — Property —=—s—s
Slide 36: Intellectual Property Portfolio
Intellectual Property Portfolio* • Aganocide® compounds (NVC-422 and others) – 4 Issued US patents – 14 Issued foreign patents – 61 other patent applications pending in 15 patent families – Composition-of-matter patent protection through at least 2024 • NeutroPhase® (NVC-101) – 3 – 510(k)’s cleared
Slide 37: Financial Overview
Financial Overview 13
Slide 38: Financial Overview Key Statistics
Financial Overview Key Statistics Million Market Cap (Jan. 8) $42 Sept 30 Cash and Equivalents + (Cap. $17 Raise net $5 Mil) Debt $0 Shares Outstanding (common) 37 37
Slide 39: Anticipated Upcoming Milestones
Anticipated Upcoming Milestones* Date Event 2012 Q4 / \ Start Conjunctivitis Phase 2b in India & Brazil 2013 H1 NeutroPhase Potential Partnerships USA / ROW H1 Data - Part 2 of Phase 2a Urology (UCBE) H2 Urology Potential Partnership in Europe and Asia Mid Data - Phase 2b Impetigo Global study H2 Da
Slide 40: NBY Management Team
NBY Management Team David Stroman, Ph.D. Ron Najafi, Ph.D. Senior Vice President Chief Executive Officer Ophthalmology Behzad Khosrovi, M.A., Ph.D. Tom Paulson Chief Alliance Officer; S.V.P., Chief Financial Officer Product Development Kenneth Krantz, MD, Ph.D. Roy Wu Vice President, Medical S.V.P.,
Slide 41: Experienced Leadership Board of Directors
Experienced Leadership Board of Directors Paul Freiman Alex McPherson, MD, Ph.D. – Former CEO, NTII; Former Chairman & CEO, Syntex (Lead Independent Director, Chair-N&GC) – Former President & CEO, Biomira Inc. Charles Cashion – Past President CMA, Deputy Minister Health (Chair- Audit Committee) – SV
Slide 42: Investment Highlights
Investment Highlights • Lead Aganocide® program (NVC-422) is currently in three Phase II trials targeting significant unmet medical needs with data from all trials currently expected in 2013 • Validating partnership with Galderma for NVC-422 in Impetigo • Targeting considerable market opportunities:
Slide 43: NovaBay App Now Available
NovaBay App Now Available For iPhone, iPad and Android 42
Slide 44: Corporate Presentation
Corporate Presentation BEYOND ANTIBIOTICS! NYSE MKT: NBY