Slide 1: Corporate Presentation
Y nde —” NasVaxin. Corporate Presentation Vaccines improve life We improve vaccines
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains "forward-looking statements". These statements include words like "may," "expects," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause
Slide 3: Agenda
Agenda Vaccine Market NasVax Overview Status of Programs Roadmap & Summary
Slide 4: Vaccine Market
Vaccine Market CAGR: 11%-14% 2007: $16B 2012: $25B-$30B Product age group — Adults & r Breakdown adolescents Players 35% Pediatric 65% Wyeth 14% GSK 22% Novartis 7% North America 48% a Others Sanofi- 13% Pasteur 23% * NasVaxu
Slide 5: Vaccine Market
Vaccine Market Unmet needs include increased efficacy, alternative delivery Favorable risk–reward profile vs. most small-molecule drugs Generally shorter timelines Usually less expensive Higher probability of success High margins Similar to other small molecules and biologics Future long-term growth
Slide 6: M&A Activity
M&A Activity Novartis – Chiron MedImmune – Aviron (phase 3) $5.1B, value $8.8B (2006) $1.5B (2001) GSK - ID Biomedical Sanofi-Pasteur – Acambis $1.4B (2005) $550M (2008) Chiron – Powderject Pfizer – PowderMed $880M (2003) ~$380M (2006) Crucell – Berna GSK – Corixa $480M (2006) $300M (2005) Novartis
Slide 7: Agenda
Agenda Vaccine Market NasVax Overview Status of Programs Roadmap & Summary
Slide 8: NasVax – Overview
NasVax – Overview Founded in 2004 13 employees Traded on TASE (NSVX), December 2005 Major shareholders: Public (44%), Meytav (28%), Prof. Barenholz (9%), Pontifax (8%) Core technology platform: VaxiSome Adjuvant-Delivery Current portfolio Phase 1/2a: Influenza Preclinical: Hepatitis B, Avian Flu, An
Slide 9: Vision and Strategy
Vision and Strategy Improve global health through enhanced potency Vision vaccines & immunotherapeutics and alternative routes of delivery. “NASVAX INSIDE”: platform technology is Strategy embedded in various products via internal development programs, and out-license technology for indications not
Slide 10: Management & BoD
Management & BoD Zvika Rubinstein, Chairman Einat Zisman, PhD, Director CEO Meytav Incubator, Former Managing Director Chief Business Officer, Yeda Eureka Technologies Ltd Safi Landskroner, Director V.P. of Generic Business Development and Regulatory Yechezkel Barenholz, PhD, Founder Affairs, Dexxon
Slide 11: Technology
Technology Adjuvant An agent that enhances the immune response to a vaccine or immunotherapeutic, thus making it more effective Core technology (CCS/C based) Adjuvant-Delivery system VaxiSome is the formulation of CCS/C and a given vaccine Benefits comparing to existing vaccines Adjuvant component:
Slide 12: Dual Value Proposition
Dual Value Proposition Adjuvant Nasal delivery Increased efficacy: Flu (elderly) Local IgA: Flu, S. pneumoniae Dose-sparing: Flu, Avian Flu Ease & Self-administration Decrease # doses: Hep-B, Anthrax Bioterrorism attack (fast deployment) Enable future products: HCV Developing countries (needle reuse
Slide 13: Advantages Over Marketed/P3 Competition
Advantages Over Marketed/P3 Competition VaxiSome Alum MPL (AS) MF59 Virosome CpG (Phase 1/2a) In market In market In market In market Phase 3 Th1 / Th2 9 - 9 9 9 9 Nasal Delivery 9 - - - - - Synthetic Chemical 9 9 - 9 9 9 Biocompatible Biodegradable 9 Predicted - - 9 9 9 Partnering 9 9 No patent - -
Slide 14: Advantages Over Phase 1/2 Competition
Advantages Over Phase 1/2 Competition for prophylactic vaccines VaxiSome Proteosome IC31 ISCOM Flagellin Inulin (Phase 1/2a) (Phase 2) Phase 2 Phase 2 Phase 1 Phase 1 Th1 / Th2 9 9 9 9 9 ? Nasal Delivery 9 only - - ? - Synthetic Chemical 9 - 9 - - - Biocompatible Biodegradable 9 Predicted - 9 ? 9 9
Slide 15: Potential Product Opportunities
Potential Product Opportunities Current Partnerships Influenza Pneumococcal Hepatitis B Respiratory Syncytial Virus Avian Flu HCV Anthrax Malaria Future New Fields Clostridium difficile Cancer Japanese Encephalitis Alzheimer's Disease Group A Strep Immunotherapeutics West Nile Virus
Slide 16: Business Model
Business Model Internal Product Development Technology Out-Licensing 2 -3 internal programs Multiple programs Requires IP & target access Partner’s IP & target Relatively low initial investment Partner investment in programs Develop to end-Phase 2 / market Leverage PoC to license platform Risk – Nas
Slide 17: Agenda
Agenda Vaccine Market NasVax Overview Status of Programs Roadmap & Summary
Slide 18: Influenza VaxiSome vs. Fluad in Rats
Influenza VaxiSome vs. Fluad® in Rats VaxiSome-Influenza vaccine: more immunogenic than a commercial adjuvanted flu vaccine when tested head-to-head
Slide 19: Influenza VaxiSome vs. Inflexal in Rats
Influenza VaxiSome vs. Inflexal® in Rats VaxiSome-Influenza vaccine: more immunogenic than a second commercial adjuvanted flu vaccine
Slide 20: Hepatitis B – Results in Mice
Hepatitis B – Results in Mice VaxiSome-HepB vaccine is more immunogenic than a commercial HepB vaccine (on alum) 30,000 F-Ag 25,000 Alum-Ag 20,000 Titer (m IU/m l) CCS/C-Ag * 15,000 10,000 5,000 0 0 5 10 15 20 25 Time (weeks) * P<0.05
Slide 21: Avian Flu: H5N1 Virus in Mice
Avian Flu: H5N1 Virus in Mice VaxiSome-Avian Flu vaccine is more immunogenic than Alum-Avian Flu vaccine Time (weeks)
Slide 22: Anthrax – Results in Guinea Pigs
Anthrax – Results in Guinea Pigs VaxiSome-Anthrax enhances immunogenicity of Protective Antigen and more immunogenic than a licensed veterinary vaccine
Slide 23: Summary of preclinical studies
Summary of preclinical studies VaxiSome significantly enhances the level of specific antibodies for a range of vaccine antigens Influenza split-virion and whole-virion, rHA, HBsAg, anthrax PA Enhancement observed in 4 species (1-3 species tested per antigen) Higher levels of protective immunity to i
Slide 24: Current Pipeline
Current Pipeline Pre-clinical Phase 1/2a Phase 2 Phase 3 Influenza Intramuscular Influenza Intranasal Hep B (SciGen) Avian Flu Anthrax
Slide 25: Influenza IM Clinical Trial – Summary
Influenza IM Clinical Trial – Summary Phase 1/2a Design: dose-escalating double-blind Primary goal: safety Secondary goal: immunogenicity Compare VaxiSome-Influenza Vaccine vs. commercial Influenza Vaccine Stages June 2007 – Vaccinate 97 Adults November 2007 - Vaccinate 60 Elderly (key target group
Slide 26: Meta-analysis of GMT ratios – adjuvanted vs. non-adjuvanted vaccine
Meta-analysis of GMT ratios – adjuvanted (FluAd ®) vs. non-adjuvanted vaccine •Banzhoff et al. (2003) conducted a meta-analysis of all available data from Fluad® clinical trials in elderly subjects (3,600 from 13 trials) to determine immunogenicity and safety in subjects with underlying chronic dise
Slide 27: Influenza IM Clinical Trial – Summary
Influenza IM Clinical Trial – Summary Observations on Immunogenicity (HI) Judged by fold ↑ in HI from pre- to post-vaccination and by persistence post- vaccination Elderly receiving VaxiSome-Influenza show higher fold ↑ HI titers at 1, 3 & 6 months compared to those receiving Influenza Vaccine Elder
Slide 28: Strategy – Present to Future
Strategy – Present to Future Present: adjuvant – delivery system is being leveraged to Create patent-protected superior vaccines using off-patent antigens Enhance partners’ proprietary products Future: acquire novel antigens → become an innovative vaccine franchise Protea as the first such opportuni
Slide 29: Protea – Improved pneumococcal vaccine
Protea – Improved pneumococcal vaccine Streptococcus pneumoniae one of the world’s deadliest bacteria Causes meningitis and acute otitis media in infants and young children Causes pneumonia in young children and elderly Kills >1 million people per year Economic burden in US >$4B / year Current marke
Slide 30: Agenda
Agenda Vaccine Market NasVax Overview Status of Programs Roadmap & Summary
Slide 31: Objectives for 2009
Objectives for 2009 Clinical trials influenza Complete Phase 1/2a dose-optimization study in Elderly (started Oct 2008) Complete Phase 1/2a two-dose intranasal (started Oct 2008) Conduct Phase 2 study in Europe HepB (jointly with SciGen) Complete preclinical and initiate IM Phase 1/2a clinical studi
Slide 32: Summary
Summary Vaccines are a lucrative, fast-growing market with long-term growth opportunities Generally shorter, lower-cost development cycles relative to small-molecule drugs Proprietary VaxiSome technology platform with proven applicability across multiple vaccines Comprehensive efficacy and initial s