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Beyond Antibiotics. Corporate Presentation February 10, 2014. NYSE-MKT: NBY. Forward-Looking Statements.
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Beyond Antibiotics Corporate Presentation February 10, 2014 NYSE-MKT: NBY
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", "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.
Antibiotic Resistance Crisis • Post-Antibiotic Era • Confirmed by WHO • Widespread Resistance • “Super Bugs”/ MRSA • Flesh Eating • Will this effect LE? • Antibiotic Era • 1930 – 2010 • Penicillin • 150 Antibiotics • Wonder Drugs • Save Millions of Lives • LE ~80 • Pre-Antibiotic Era Bacteria containing NDM-1 enzyme • Pre-1930s • Minor injury = Death • Life Expectancy (LE) ~55 Megatrend Alexander Fleming Bread Mold Observation
White Blood Cell in Action Invading Microbe White Blood Cell Red Blood Cells N-Chlorotaurine (NCT) Natural Compound Rapid Acting Effective BUTUnstable Hypochlorous Acid (HOCl) Natural Compound 24 months Stable Formulation Rapid Acting Being Commercialized in 2014
Auriclosene(NVC-422) First Ever Stable Form of N,N-Dichlorotaurine N,N-Dichlorotaurine (NNDCT) Natural Compounds Rapid Acting Effective auriclosene Limited Shelf Life auriclosene
New Chemical EntityCompounds that Mimic Nature auriclosene (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
Auriclosene(NVC-422) Serial Passage Against MRSA (MIC) = Fusidicacid Fold change in MIC NVC-422 NO RESISTANCE detected Time in Days Mupirocin L. 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.
Two Distinct Anti-Infective Product Groups Aganocides® Lead: Auriclosene (NVC-422) Wound Care Chronic Non-healing Wounds Ophthalmology Pink Eye Dermatology Impetigo 6 Million U.S. Patients WW: $700M WW: $600M Urology UCBE US: $100M-$200M
Four Distinct Business UnitsPursuing Independent Opportunities $700M (WW) $600 Mil (WW) $100-200 Mil (US)
Company History / Major MilestonesCorporate Partners Have Contributed ~$60 million 2009 2007 2012 2006 1998-2003 2000 Partnership Initial Public Offering October Partnership NVC-101 Partnership Founded Novato, CA $20,000,000 Discovery and development of NeutroPhase for wound care NovaBay licenses the right to Aganocide for impetigo and Acne Strategic marketing agreement with Pioneer Pharma for China, SE Asia Licenses right to develop Aganocide compounds for ophthalmology uses Listing on NYSE-Amex NBY 2012 2012 2012 2012- 2013 2012 2013 Aganocides Issued Additional Composition of Matter Patents Distribution Agreement Launch Global Phase 2b Clinical Trial Launch Global Phase 2b Clinical Trial Equity Investment Partnership Largest Trial For viral conjunctivitis ever launched Impetigo represents “gateway” indication $8.2 million to date Granted in multiple Ex-US countries Shin-Poong Pharma- South Korea Licenses right to Aganocide for Animal Health
Pipeline Continues to Advance Phase 2, Part 2 Data Enrolling Global Phase 2b Data Enrolling Global Phase 2b* Data NeutroPhase® Commercial Launch Underway Partnered in U.S., China, SE Asia and S. Korea ; Seeking Partners WW * FDA has agreed that conjunctivitis Phase 2b trial could be considered pivotal
Un-Partnered Program UroBay Urinary Catheter Blockage and Encrustation (UCBE) Unmet Medical Need U.S. Orphan Drug and Fast Track Applications Filed
Urinary Catheter Blockage and Encrustation (UCBE) • ~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
Device-Related Infections More Common in patients with UCBE Urine flow
UroBay UCBE (Urinary Catheter Blockage and Encrustation) Phase 2 Trial Results
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 15
Per Subject Catheter Encrustation2 treatments per week for 4 weeks; per protocol N = 14(p value = <0.001)
Auriclosene Reduces Catheter Blockages & Complete Encrustation * Using McNemar exact test; N = 14 17
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 18
Estimated Cost of Managing UCBE PatientsImpact 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 • Prophylactic Antibiotic Therapy $ 72 • Treatment of UTI (Bacteremia) $ 24 Total $1,456 + Lost Productivity +$,$$$ Cost of Prophylactic Auriclosene Therapy $ 160
MediBay NeutroPhase® for the Treatment of Chronic Non-healing Wounds FDA (510)k Cleared Commercial Launch Underway
NeutroPhase Value Proposition • 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 for Wound CareNBY Business Strategy • Partner in the US and around the world • Export NeutroPhase from the US 01/12: Established commercialization deal with Pioneer Pharma for marketing rights in China (including $1.3M payments to NBY) 04/13: Exclusive Distribution with Shin Poong Pharma in South Korea 11/13 and 09/12 : Expansion of marketing partnership with PioneerPharma to include S.E. Asia (included $8.2 M equity investments in NBY)
Pioneer PharmaMajor Marketing Presence in China Covered every province in China 510Regional Distributors Covering 7000Hospitals Covering over 49,572 Drugstores
EyeBay Auriclosene Eye Drops for the Treatment of Viral Conjunctivitis (Pink Eye) Unmet Medical Need
Worldwide Conjunctivitis MarketBacterial and Viral (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.
Adenoviral ConjunctivitisUnmet Medical Need • Number 1 unmet medical need in ocular infections • Epidemic Keratoconjunctivitis (EKC) • Can be sight threatening • Highly contagious • Causes large epidemic outbreaks
Viral Conjunctivitis Phase IIa (Proof-of-Concept) Trial Results
Clinical SuccessClearing of Redness 69% on Day 18 in EKC Adenoviral Patients 15% Separation from Vehicle % of Patients (n = 29) Phase IIa 15% • Sustained clinical cure: the sum of bulbar conjunctival injection and foreign body sensation is zero and remains zero for all subsequent visits
Clinical SuccessBlurred Vision Clearing 92% on Day 18 in EKC Adenoviral Patients42% Separation from Vehicle % of Patients (n = 21) Phase 2a 42% • Sustained clearing of blurred vision is obtained if symptom is zero and remains zero for all subsequent visits
Summary: Proof-of-Concept Phase 2a StudyPatients with EKC Serotypes Sustained Microbiological Success Sustained Clinical Cure Sustained Clearing of Blurred Vision Resolution of SEIs Safe and Well Tolerated
Adenoviral Conjunctivitis Timeline Phase 1 – Escalating Exposure Study COMPLETED Phase 2a – Proof-of-Concept Study COMPLETED • Phase 2b – BAYnovation: Global Safety/Efficacy StudyONGOING • 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
2014 Anticipated Milestones* *Expected as of February 2014
NBY Management Team Keith Bley, Ph.D. SVP, Product Development (NeurogesX, Roche, Syntex) Ron Najafi, Ph.D. Chief Executive Officer (Aldrich, Rhone Poulenc Rorer, Applied Biosystems) Tom Paulson Chief Financial Officer (Abbott, Quidel,. Ciba-Corning, Neurogen, Avigen) Roy Wu SVP, Business Development (Genelabs, Kissei, Syntex) Russell Hoon SVP, Advance Wound Care (Xylos, Tutogen, Integra) David Stroman, Ph.D. SVP, Ophthalmology (Alcon, Upjohn) Kenneth Krantz, MD, Ph.D. Vice President, Medical Affairs (Searle, Schering-Plough, Ayerst, J&J)
Beyond Antibiotics Corporate Presentation February 10, 2014 NYSE-MKT: NBY