Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (November 2017)
20 slides from Novavax's investor presentation, November 2017
Slide 1: November 2017 Investor Presentation
` November 2017 Investor Presentation
Slide 2: Safe harbor statement
Safe harbor statement Certain information, particularly information relating to future performance and other business matters, including expectations regarding clinical development, market opportunities and anticipated milestones constitute forward-looking statements within the meaning of the Privat
Slide 3: Novavax Targets: Influenza and RSV, the leading causes of respiratory tract infection
Novavax Targets: Influenza and RSV, the leading causes of respiratory tract infection Influenza (Flu) Efficacy of seasonal flu vaccines is inconsistent and rarely better than 50%1 Annual flu vaccination is universally recommended due to large burden of disease Flu vaccine market was approximat
Slide 4: RSV F Vaccine Phase 3 Trial: Infants via Maternal Immunization
` RSV F Vaccine Phase 3 Trial: Infants via Maternal Immunization
Slide 5: Phase 3 RSV F Vaccine for infants addresses significant unmet medical need
Novavax Phase 3 RSV F Vaccine for infants via maternal immunization addresses significant unmet medical need • RSV is the most common cause of lower respiratory tract • RSV is largely a disease of healthy, infections among young children full-term infants • RSV is the leading cause of hospitalizatio
Slide 6: Phase 3 RSV F Vaccine maternal immunization trial: Goals and design
Phase 3 RSV F Vaccine for infants via maternal immunization trial: Goals and design Primary Determine the efficacy of maternal immunization with the RSV F Objective Vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with objective measures of medical significance of LRTI throug
Slide 7: The Phase 3 Prepare trial has entered its third year
The Phase 3 Prepare™ trial has entered its third year Global infrastructure has been established to drive enrollment and surveillance Recruitment and surveillance are going well and indicate trial feasibility Global Season 1: 16 sites in 5 countries Global Season 2: 46 sites in 7 countries Global Se
Slide 8: Nanoparticle influenza vaccine with Matrix-M (NanoFlu)
` Nanoparticle influenza vaccine with Matrix-M™ (NanoFlu)
Slide 9: Novavax' nanoparticle influenza vaccine candidate (NanoFlu)
Novavax’ nanoparticle influenza vaccine candidate (NanoFlu) • Novavax’ history of seasonal influenza vaccine development has led to a recent breakthrough, our NanoFlu vaccine • Flu has established preclinical models and correlate immunogenicity markers that are likely to predict clinical benefit • N
Slide 10: A significant percentage of older adults get vaccinated for influenza
A significant percentage of older adults get vaccinated for influenza • Current older adult influenza immunization rates in North America: Vaccination rate Year USA (U.S. CDC) 66.7% 2014/15 Canada (Statistics Canada)1 64.1% 2014 Total (pop. wt. avg.) 66.4% • CDC aims to have at least 90% of adults a
Slide 11: Influenza virus - Primary vaccine target: Hemagglutinin
Influenza virus - Primary vaccine target: Hemagglutinin • Receptor binding region is the target for antibodies HA Protein Structure that prevent virus binding to cells. These antibodies are highly strain-specific and dominate the immune response. • Antibodies to receptor binding site can be detected
Slide 12: Flu program data published in Vaccine
Flu program data published in Vaccine Full publication is available on Novavax website or at: http://www.sciencedirect.com/science/article/pii/S0264410X17310885 12
Slide 13: Ferret immunogenicity & challenge study
Ferret immunogenicity & challenge study NanoFlu™ is Novavax’ HA nanoparticle influenza vaccine candidate combined with its proprietary Matrix-M™ adjuvant Novavax Fluzone HD Fluzone Quadrivalent NanoFlu A/Michigan (H1N1) A/California (H1N1) A/HongKong (H3N2) B/Brisbane B/Phuket 13
Slide 14: Immunogenicity: NanoFlu induced superior HAI Day 42 antibody responses
Immunogenicity: NanoFlu induced superior Hemagglutination Inhibition (HAI) Day 42 antibody responses A/Michigan (H1N1) A /M ic h ig a n /4 5 /2 0 1 5 A/California (H1N1) A /C a lifo r n ia /0 7 /2 0 0 9 512 2048 1024 256 512 128 256 H A I T ite r H A I T ite r 64 128 32 64 32 16 16 8 LO D 8 LO D 4 4
Slide 15: Immunogenicity: NanoFlu induced superior Microneutralizing Day 42 antibody responses
Immunogenicity: NanoFlu induced superior Microneutralizing (MN) Day 42 antibody responses A/Michigan (H1N1) A/California (H1N1) 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu + Matrix M Matrix M A/Hong Kong (H3N2) B/Brisbane 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + Matrix M N
Slide 16: NanoFlu induced broadly neutralizing antibodies against drifted A(H3N2) viruses
Immunogenicity: NanoFlu vaccine induced broadly neutralizing antibodies against drifted A(H3N2) influenza viruses 4096 N IV + M NanoFlu + aMatrix t r i x MM Fluzone F l u z o nHD e H D M N T ite r s (L o g 2 ) 1024 Fluzone F lu z o n e Q IV 256 64 16 50% 4 5 4 1 7 3 9 4 /0 2 /0 9 2 /1 /0 /1 /9 /1 /0
Slide 17: NanoFlu superior in protecting ferrets challenged with matched and drifted H3N2
NanoFlu vaccine was superior in protecting ferrets challenged with matched and 10-year drifted H3N2 (unmatched) strain A/Hong Kong/4801/2014 (H3N2)–like A /H o n g K o n g /4 8 0 1 /2 0 1 4 ( H 3 N 2 ) A/Brisbane/10/2007 (H3N2)-like A /B r is b a n e /1 0 /2 0 0 7 ) H 3 N 2 ) - lik e A/Alaska/140/20
Slide 18: Phase 1/2 trial of NanoFlu vaccine initiated in older adults
Phase 1/2 trial of NanoFlu vaccine initiated in older adults • Primary objective: assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD) • 330 healthy older adults; 110 per group • Evaluate immu
Slide 19: NanoFlu product development strategy
NanoFlu product development strategy Seasonal, older adult vaccine candidate in head-to-head trial • Late 2017: Data from Phase 1/2 trial designed to show product differences from current market leader • 1Q 2018: FDA meeting expected, potential for accelerated approval • Late 2018: Pivotal Phase 3 i
Slide 20: Upcoming NanoFlu and RSV F Vaccine milestones
Upcoming NanoFlu and RSV F Vaccine milestones Novavax is the leader in RSV vaccine development • Phase 3 program for RSV maternal immunization supported by Bill & Melinda Gates Foundation grant of $89 million • Interim data analysis in 2018 Differentiated NanoFlu program • Data from Phase 1/2 trial