beyond antibiotics
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Beyond Antibiotics. Corporate Presentation February 10, 2014. NYSE-MKT: NBY. Forward-Looking Statements. - PowerPoint PPT PresentationTRANSCRIPT
Beyond Antibiotics
Corporate Presentation
February 10, 2014
NYSE-MKT: NBY
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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", "expect“, “targets”, “potential”, and other similar expressions. These forward-looking statements reflect NovaBay’s current expectation and assumptions, such as expected efficacy of compounds, timing of clinical trials, future results of clinical trials, other expected or targeted events and potential market sizes and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These risks and uncertainties include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed in the Company's filings with the SEC which filings can be found at www.sec.gov. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable U.S. securities laws.
Forward-Looking Statements
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Antibiotic Resistance Crisis
Pre-Antibiotic Era- Pre-1930s- Minor injury = Death- Life Expectancy (LE) ~55
Alexander Fleming Bread Mold Observation
Antibiotic Era- 1930 – 2010- Penicillin- 150 Antibiotics- Wonder Drugs- Save Millions of Lives- LE ~80
Megatrend
Bacteria containing NDM-1 enzyme
Post-Antibiotic Era- Confirmed by WHO- Widespread Resistance- “Super Bugs”/ MRSA - Flesh Eating- Will this effect LE?
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White Blood Cell in Action
N-Chlorotaurine (NCT)Natural Compound
Rapid ActingEffective
BUT Unstable
Hypochlorous Acid (HOCl)Natural Compound
24 months Stable FormulationRapid Acting
Being Commercialized in 2014
White Blood Cell
Red Blood Cells
Invading Microbe
5
Auriclosene (NVC-422) First Ever Stable Form of N,N-Dichlorotaurine
N,N-Dichlorotaurine (NNDCT)
Natural CompoundsRapid Acting
Effective
Limited Shelf
Life
auriclosene 0 100 200 300 400 500 6000
20
40
60
80
100
120
Time (days)
% o
f Ini
tial C
once
ntra
tion
NNDCT
auriclosene
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• Good safety profile• Fast• Broad spectrum of activity• Effective against multi-drug
resistant bacteria• Effective against biofilm
New Chemical EntityCompounds that Mimic Nature
(N,N-dichloro-2,2-dimethyltaurine) Effective and Stable, Broad Patent Protection
auriclosene
7L. D’Lima, L. Friedman, L. Wang, P. Xu, M. Anderson and D. Debabov. No Decrease in Susceptibility to NVC-422 in Multiple Passage Studies against MRSA, S. aureus, P. aeruginosa and E. coli. Prepared for submission to AAC.
Auriclosene (NVC-422) Serial Passage Against MRSA (MIC)
Fold
chan
ge in
MIC
Time in Days
= Fusidic acid
Mupirocin
NVC-422NO RESISTANCE
detected
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6 Million U.S. Patients
Two Distinct Anti-Infective Product Groups
WW: $600M
US: $100M-$200M
WW: $700M
Aganocides®Lead: Auriclosene
(NVC-422)
Wound Care Chronic
Non-healing Wounds
Dermatology Impetigo
Ophthalmology Pink Eye
Urology UCBE
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EyeBayOphthalmology Viral Conjunctivitis
(Aganocide®) DermaBay
DermatologyImpetigo
(Aganocide®)
UroBayUrology
UCBE(Aganocide®) MediBay
Advanced Wound Care
Chronic wounds(NeutroPhase
®)Business
Units$700M (WW) $600 Mil (WW)
$100-200 Mil (US)
Four Distinct Business UnitsPursuing Independent Opportunities
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Company History / Major MilestonesCorporate Partners Have Contributed ~$60 million
Founded
Novato, CA
NVC-101
Discovery and development of
NeutroPhase for wound care
Partnership
Licenses right to develop Aganocide compounds for ophthalmology uses
Initial Public OfferingOctober
Listing on NYSE-AmexNBY
$20,000,000
NovaBay licenses the right to Aganocide for impetigo
and Acne
Partnership
Strategic marketing agreement with Pioneer
Pharma for China, SE Asia
Largest Trial For viral conjunctivitis ever
launched
Launch Global Phase 2b Clinical Trial
Impetigo represents“gateway” indication
Launch Global Phase 2b Clinical Trial
Granted in multiple Ex-US countries
Aganocides Issued Additional Composition of
Matter Patents
2000
2012
2007 20091998-2003 2006 2012
20132012 2012 2012
Partnership Distribution Agreement
Shin-Poong Pharma- South Korea
Equity Investment
Licenses right to Aganocidefor Animal Health
2012- 2013
Partnership
$8.2 million to date
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Pipeline Continues to Advance
* FDA has agreed that conjunctivitis Phase 2b trial could be considered pivotal
Therapeutic Area Delivery Scope
(Patients)
2013 2014
Q1 Q2 Q3 Q4 Q1 Q2
Aganocides®
(auriclosene)
Urology(UCBE)
Irrigation Solution
US (38)
Dermatology(Impetigo)
Topical Gel
Global (300+)
Ophthalmology(Viral Conjunctivitis)
Eye drops Global (500+)
NeutroPhase® Commercial Launch Underway NeutroPhase®
(NVC-101) Wound CarePureHOCl
SolutionPartnered in U.S., China, SE Asia and S. Korea ; Seeking Partners WW
Phase 2, Part 2 Data
Enrolling Global Phase 2b Data
Enrolling Global Phase 2b* Data
Un-Partnered Program
Urinary Catheter Blockage and Encrustation (UCBE)
Unmet Medical Need
U.S. Orphan Drug and Fast Track Applications Filed
UroBay
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• ~74,000 patients in the US (mostly Spinal Cord injury, MS, Stroke) suffer from frequent blockage and encrustation
• Blockage and encrustation is often due to urease forming bacteria and bladder stone is the resulting product
• NVC-422 is capable of eradicating this bacteria without giving rise to resistance
• NVC-422 will prevent and treat patients prone to blockage and encrustation
Urinary Catheter Blockage and Encrustation (UCBE)
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Device-Related Infections More Common in patients with UCBE
Urine flow
UroBay
UCBE (Urinary Catheter Blockage and Encrustation)
Phase 2 Trial Results
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UCBE Clinical Trial Design (CL1001)
• Double-blind, crossover design, multi-center study
• Total of 67 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
• Each subject received both treatment regimens – one each of study drug and saline control
– Parts 1 & 2: Treatment regimen consisted of 7 treatments over 2-weeks (3 times/week)
– Part 3: Treatment regimen consisted of 8 treatments over 4- weeks (2 times/week)
• A single treatment consisted of 2 sequential catheter irrigations; each irrigation was 25 mL of study solution retained in the catheter for 15 minutes and then drained
16
17
Per Subject Catheter Encrustation2 treatments per week for 4 weeks; per protocol N = 14
(p value = <0.001)
1000
31100
453
100100100100100100
10087
Saline
00
400
6075
00
829
0
731
NVC-422
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Auriclosene Reduces Catheter Blockages & Complete Encrustation
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N = 14
Auriclosene Saline P-Value
Percent of catheters removed for clinical blockage
14.3% 64.3% 0.016*
Percent of removed catheters that have 100% encrustation
0.0% 64.3% 0.003*
* Using McNemar exact test; N = 14
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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 of safety and efficacy in this indication in order to allow registration in the US and EU
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$ Million
• Scheduled Frequent Catheter Changes $ 520
• Lithotripsy and Cystoscopy $ 300
• ICU Hospitalizations $ 300
• Emergency Catheter Removal (ER) $ 160
• Unscheduled Catheter Changes $ 80
• Prophylactic Antibiotic Therapy $ 72
• Treatment of UTI (Bacteremia) $ 24Total $1,456
+ Lost Productivity +$,$$$
Estimated Cost of Managing UCBE PatientsImpact of 100,000 Patients on the U.S. Health Care System
Cost of Prophylactic Auriclosene Therapy $ 160
MediBay
NeutroPhase® for the Treatment of Chronic Non-healing Wounds • FDA (510)k Cleared• Commercial Launch Underway
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• Significant Markets– Over 6 million patients in US (Diabetic, Venous, Pressure Ulcers)
• Proprietary Technology– Patented formulation – 0.01% Pure hypochlorous acid – No resistance expected based on novel mechanism of action
• Extensive Clinical Experience– Seton Medical Center human clinical trial– Published posters, peer-reviewed publication in medical journal
WOUNDS– Current clinical use with KOLs
• Risk Mitigation – Multiple Business Opportunities– Launching into multiple markets worldwide
NeutroPhase Value Proposition
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• Partner in the US and around the world • Export NeutroPhase from the US
NeutroPhase for Wound CareNBY Business Strategy
01/12: Established commercialization deal with Pioneer Pharma for marketing rights in China (including $1.3M payments to NBY)
11/13 and 09/12 : Expansion of marketing partnership with PioneerPharma to include S.E. Asia (included $8.2 M equity investments in NBY)
04/13: Exclusive Distribution with Shin Poong Pharma in South Korea
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Pioneer PharmaMajor Marketing Presence in China
Covered every province in China
510 Regional Distributors
Covering 7000 Hospitals
Covering over 49,572 Drugstores
EyeBay
Auriclosene Eye Drops for the Treatment of Viral Conjunctivitis (Pink Eye)
Unmet Medical Need
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Bac-terial
(US) $457
Bac-terial
(Ex-US) $768
Viral (US)
$300 (1)
Viral (Ex-US) $400 (1)
WW = $2 billion
(1) Extrapolated from Japanese incidence data of 1 million cases of adenoviral conjunctivitis per year. Other published estimates of incidence support greater frequencies in US and other countries.
Worldwide Conjunctivitis MarketBacterial and Viral
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• Number 1 unmet medical need in ocular infections• Epidemic Keratoconjunctivitis (EKC)
– Can be sight threatening– Highly contagious – Causes large epidemic outbreaks
Adenoviral ConjunctivitisUnmet Medical Need
Viral Conjunctivitis
Phase IIa(Proof-of-Concept)Trial Results
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Clinical SuccessClearing of Redness
Sustained clinical cure: the sum of bulbar conjunctival injection and foreign body sensation is zero and remains zero for all subsequent visits
Day 3 Day 5 Day 7 Day 9 Day 11 Day 18 -
10
20
30
40
50
60
70
80
6 13 13
19
38
69
- - -
8
31
54
NVC-422 Vehicle
% of Patients (n = 29) Phase IIa
15%
69% on Day 18 in EKC Adenoviral Patients15% Separation from Vehicle
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Clinical SuccessBlurred Vision Clearing
Sustained clearing of blurred vision is obtained if symptom is zero and remains zero for all subsequent visits
Day 3 Day 5 Day 7 Day 9 Day 11 Day 18 -
10 20 30 40
50 60 70 80 90
100
31
46
62 69
85 92
-
13 13
25
38
50
NVC-422 Vehicle
% of Patients (n = 21) Phase 2a
42%
92% on Day 18 in EKC Adenoviral Patients42% Separation from Vehicle
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Sustained Microbiological Success
Sustained Clinical Cure
Sustained Clearing of Blurred Vision
Resolution of SEIs
Safe and Well Tolerated
Summary: Proof-of-Concept Phase 2a StudyPatients with EKC Serotypes
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Phase 1 – Escalating Exposure Study COMPLETED
Phase 2a – Proof-of-Concept Study COMPLETED
• Phase 2b – BAYnovation: Global Safety/Efficacy Study ONGOING– US Enrollment began May, 2012– India Enrollment began December, 2012– Brazil enrollment began April, 2013– Sri Lanka enrollment to began September, 2013– Completion and results expected in the first half of 2014
• Phase 3 study: BAYnovation II, Second Global Safety/Efficacy Study• Anticipated NDA filing ~ 2017• Anticipated Product Launch ~ 2018
Adenoviral Conjunctivitis Timeline
Financial Overview
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Financial OverviewKey Statistics
Million
Market Cap (2/7/14)
$45
Cash and Equivalents(Estimated 12/31/13)
$13
Debt $0
Shares Outstanding - Common(Plus: 4.7M Warrants + 7.2M stock options) 45
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2014 Anticipated Milestones*
*Expected as of February 2014
Business Unit Date Event
Urology H1 Initiate a second phase 2b study in UCBE
Wound CareH1 Additional NeutroPhase partnerships
H1 Additional NeutroPhase country registrations
Ophthalmology
H1 Phase 2b conjunctivitis global study
H2 Announce new consumer lens care product (market through major distributors)
H2 Launch of i-Lid Cleanser (targeting ophthalmologists/optometrists)
Dermatology
H2 Initiate phase 2b study in impetigo
H2 FDA discussion of clinical development of NVC-422 in Necrotizing Fasciitis
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NBY Management Team
Roy WuSVP, Business Development(Genelabs, Kissei, Syntex)
Ron Najafi, Ph.D.Chief Executive Officer
(Aldrich, Rhone Poulenc Rorer, Applied Biosystems)
Tom PaulsonChief Financial Officer
(Abbott, Quidel,. Ciba-Corning, Neurogen, Avigen)
Kenneth Krantz, MD, Ph.D.Vice President, Medical Affairs
(Searle, Schering-Plough, Ayerst, J&J)
David Stroman, Ph.D.SVP, Ophthalmology
(Alcon, Upjohn)
Russell HoonSVP, Advance Wound Care(Xylos, Tutogen, Integra)
Keith Bley, Ph.D.SVP, Product Development(NeurogesX, Roche, Syntex)
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Experienced LeadershipBoard of Directors
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Paul Freiman Former CEO, NTII; Former Chairman & CEO, Syntex
Alex McPherson, MD, Ph.D.Lead Independent Director, Chair-N&GC
Former President & CEO, Biomira Inc.Past President CMA, Deputy Minister Health
Gail MaderisPresident and CEO, BayBioFormer CEO of Five Prime Therapeutics Former president of Genzyme Oncology
Charles CashionChair- Audit Committee
SVP, CFO at Conatus PharmaFormer CFO at IDUN Pharmaceuticals, Inc.
Tony WicksChair-Compensation Committee
Former CEO of several mining companies
Mark SieczkarekFormer Chairman & CEO, Solta MedicalFormer CEO, ConceptusFormer SVP, The Americas Region, Bausch & Lomb
Massimo Radaelli, Ph.D. Chairman & CEO, Noventia PharmaChairman, Bioakos Pharma
Ron Najafi, Ph.D. Chairman & CEO, NovaBay
Beyond Antibiotics
Corporate Presentation
February 10, 2014
NYSE-MKT: NBY