Novavax, Inc. · NASDAQ:NVAX
Novavax — Corporate Update (July 2018)
39 slides from Novavax's corporate update, July 2018
Slide 1: Corporate Update
Corporate Update July 2018 © 2018 Novavax, Inc. All rights reserved. NASDAQ:NVAX
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, our planned use of the proceeds from the offering, market opportunities and anticipated milestones constitute forward-
Slide 3: Agenda
Agenda Company overview ResVaxTM program update The flu problem and NanoFluTM program update Questions 3
Slide 4: Pipeline
Pipeline PROGRAM DESCRIPTION PRECLINICAL CLINICAL Phase 1 Phase 2 Phase 3 ResVax - RSV F Vaccine - Infants via Maternal Immunization* RSV F Vaccine - Older Adults (60+ yrs) RSV F Vaccine - Pediatrics (6 mos – 5 yrs) NanoFlu – Nanoparticle Seasonal Influenza Vaccine - Older Adults (65+ yrs) Combinati
Slide 5: Novavax priority targets: ResVax and NanoFlu
Novavax priority targets: ResVax and NanoFlu ResVax - RSV F Vaccine for Infants Via Maternal Immunization (IVM) ✓ RSV remains a major unmet medical need for newborns in their first 6 months of life ✓ Novavax has the only RSV vaccine in a Phase 3 clinical trial ✓ Informational analysis of Phase 3 tri
Slide 6: ResVax program update
ResVax program update NOVAVAX Creating Tomorrow’s Vaccines Today
Slide 7: Rationale for selection of fusion protein as vaccine
Rationale for selection of fusion protein as vaccine F Protein Frequency of Amino Acid Changes 1 • Surface glycoprotein key to infectivity F Protein • Generally conserved • Several broadly neutralizing Site sites, some highly II conserved • Site II and Site IV highly conserved and associated with cl
Slide 8: RSV Hospitalizations
Over 75% of hospitalizations occur within the first 6 months of life1 Average Age-Specific Rate and Number of RSV Hospitalizations Among Children in First Year of Life, 2000-20052 1 Rate per 1,000 Children 35 10,000 RSV Hospitalizations 9,000 30 8,000 25 7,000 20 6,000 5,000 15 4,000 10 3,000 2,000
Slide 9: Phase 3 ResVax trial goals and design
Phase 3 ResVax trial goals and design Primary Determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory Objective tract infection (LRTI) with objective measures of medical significance of LRTI from 90-180 days of life in infants Design Randomize
Slide 10: Primary and secondary endpoints
Primary and secondary endpoints Primary Endpoint: medically-significant RSV LRTI • Presence of RSV detected by RT-PCR during a continuous illness episode, AND • At least one manifestation of LRTI (cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheez
Slide 11: Informational analysis
Informational analysis Novavax performed an informational analysis in 4Q 2017 • Novavax wanted to ensure that the ongoing investment in this multi-year Phase 3 trial was justified based on a high probability of a commercially-viable determination of efficacy • After discussion with FDA, the analysis
Slide 12: Phase 3 outcome de-risked by successful informational analysis
Phase 3 outcome de-risked by successful informational analysis 100% Data from the informational analysis Against Primary Endpoint allowed Novavax to Vaccine Efficacy (VE) 60% calculate an observed vaccine efficacy point estimate in the range of 45-100% at that time 40% 0% Above result based on 1,307
Slide 13: Prepare enrollment milestone
PrepareTM enrollment milestone Press Release Novavax Reaches Significant Enrollment Milestone in the Prepare(™) Phase 3 Trial of its RSV F Vaccine • Prepare trial is assessing the efficacy of Novavax’ RSV F Vaccine for infants via maternal immunization • Enrollment of ~4,600 participants enables ini
Slide 14: ResVax: pathway to license
ResVax: pathway to license BLA filing By 4Q 2019/1Q 2020 Interim analysis completed by 1Q 2019 (conducted by independent statistician) 3,000+ infants born to mothers receiving RSV F vaccine ~4,600 mothers enrolled by 2Q 2018 14
Slide 15: ResVax market opportunities
ResVax market opportunities 15
Slide 16: What parents are not expecting
What parents are not expecting ~70% of all babies will be infected with RSV before 1 year of age1 Signs of RSV: Facts of RSV: • Symptoms may be cough, runny or stuffy nose, • The highest rates of RSV infection in babies occur in trouble breathing or sometimes, fever 6 weeks to 6 months of age2 • Fre
Slide 17: While RSV can impact all infants, babies 6 wks-6 mos have the highest rates
While RSV can impact all infants, babies 6 wks-6 mos have the highest rates of hospitalization1 … disguised as a familiar illness but, in reality, a harmful virus that can result in hospitalization or even death… I had no idea what respiratory syncytial virus, or RSV, was, but it was about to rock o
Slide 18: Among U.S. infants, RSV is the #1 cause of hospitalization
Among U.S. infants, RSV is the #1 cause of hospitalization1 A significant burden to families and the healthcare system, especially in infants <6 months ~33,400 – 76,1554,5 Hospital Admissions • 77% of all first year RSV infections occur before six ~109,0004 ER Visits months ~2.1 M 2,3 • 400k medical
Slide 19: ~$6.2 B: Total Cost Burden
Population of 8.6M, in 9 major markets, to be addressed with ResVax ~$6.2 B: Total Cost Burden** U.S. EU5 ASIA (UK, Italy, France, Spain, Germany) (Japan, South Korea, Taiwan) 3.9 M 3.1 M 1.6 M Births Annually Births Annually Births Annually ~2.1 M ~1.2 M ~.5 M Infections/Year Infections/ Year Infec
Slide 20: Major Markets peak revenue opportunity >$1.5 B
Major Markets peak revenue opportunity >$1.5 B Births Annually Births Post Immunization U.S. Market Vaccination Rate 3.9M births 95% infants born after 80-90% immunization > $750 M net revenue mother vaccinated rate after ACIP for U.S. market in U.S. annually (28-36 wks g.a.) recommendation Other Ma
Slide 21: Maternal vaccination becoming a priority for healthcare providers and policy makers
Maternal vaccination becoming a priority for healthcare providers and policy makers Current vaccines recommended via maternal immunization include: ✓ Neonatal Tetanus ✓ Whooping cough (Pertussis)2 ✓ Influenza2 Initiatives underway to increase vaccination rates of pregnant mothers • National Vaccine
Slide 22: The flu problem and NanoFlu program update
The flu problem and NanoFlu program update 22
Slide 23: The current flu vaccine problem: A(H3N2) viruses
The current flu vaccine problem: A(H3N2) viruses During the 2017/18 U.S. flu season: • Vaccine effectiveness against H3N2 for older adults in the U.S. was estimated at 17%1,2 • Roughly 61% of flu-related hospitalizations were associated with A(H3N2) viruses3 1. Interim Estimates of 2017–18 Seasonal
Slide 24: H3N2 in the 2017/18 flu season highlights need for better vaccine
H3N2 in the 2017/18 flu season highlights need for better vaccine Two issues contributing to MISMATCH and poor flu vaccine effectiveness Antigenic evolution Egg adaptation A/Sing and drift Viruses are modified to grow better in chicken eggs Vaccines are derived from recommended strains, but when Ove
Slide 25: Antigenic drift issue
Antigenic drift issue • All flu viruses are constantly changing An example: and evolving • This results in antigenically drifted A/Hong Kong (H3N2) recommended for 2017 flu vaccines in S. Hemisphere viruses A/Hong Kong drifted and new antigenic • Current vaccines may not be able to strain A/Singapor
Slide 26: Rapid evolution and diversity of H3N2
Rapid evolution and diversity of H3N2 Most common in Australia summer ’17 A/Singapore Most common in U.S. 17/18 season Epitope Changes Circulating H3N2 A/Hong Kong viruses present in 1 15 2017-18 season Number of significant changes to important regions of the hemagglutinin gene = Vaccine Viruses A/
Slide 27: Egg adaptation issue
Egg adaptation issue . . . Egg propagated vaccine viruses acquired changes in Egg-based flu vaccines are predominant the HA that • ~87% of commercial flu vaccines in U.S. manufactured in subsequently altered eggs2 antigenicity against • Same manufacturing technology used for over 50 years circulatin
Slide 28: Not all influenza vaccines are the same
Not all influenza vaccines are the same ✓ Recombinant nanoparticle ~87% of flu Novavax is vaccine doses advancing an NanoFlu is ✓ Non-egg based different are egg- improved flu ✓ Adjuvanted with Matrix-M based1 vaccine Exact genetic match to recommended vaccine strains Broader immune response address
Slide 29: The nanoparticle influenza vaccine and Matrix-M adjuvant
The nanoparticle influenza vaccine and Matrix-M adjuvant Recombinant hemagglutinin (HA) nanoparticle vaccine • Baculovirus/Sf9 insect cell system • Express recombinant, full-length, wild-type HA that assembles into HA homotrimers • Purified HA homotrimers form higher order nanoparticle structures of
Slide 30: NanoFlu demonstrates improved immune responses compared to egg-based high-dose flu vaccine
NanoFlu demonstrates improved immune responses compared to egg-based high-dose flu vaccine
Slide 31: NanoFlu Phase 1/2 clinical trial goals and design
NanoFlu Phase 1/2 clinical trial goals and design Primary Determine the safety and immunogenicity of NanoFlu vaccine Objective Randomized 1:1:1, stratified by age Design Number of Participants • 330 clinically-stable adults ages >60 years U.S. Study Length of Study Participation • 1 year • NanoFlu:
Slide 32: Phase 1/2 clinical trial results
Phase 1/2 clinical trial results Homologous HAI results Significantly higher hemagglutination inhibition (HAI) antibody responses against H3N2 strain, higher against H1N1strain, and comparable against B/Brisbane strain. Addresses egg-adaptation mismatch. Antigenic drift HAI results Significantly hig
Slide 33: HAI antibody response against wild-type vaccine-homologous strains (2017-18)
HAI antibody response (GMFRs) against wild-type vaccine-homologous strains (2017-18) Ratio of Day 21 GMTs 47% ↑ p=0.0056 4 Geometric Mean Fold Titer Rise (95% CI) 3.2 3 2.7 2.6 2.1 2.0 2.1 1.9 1.9 2 1.5 1 0 45µg NanoFlu 180µg IIV3-HD 45µg NanoFlu 180µg IIV3-HD 45µg NanoFlu 180µg IIV3-HD NanoFlu Nano
Slide 34: HAI antibody responses against generations of drifted wild-type A(H3N2) strains
HAI antibody responses (GMFRs) against 5 generations of drifted wild-type A(H3N2) strains Ratio of 5 Ratio of Ratio of Day 21 GMTs Ratio of Ratio of Geometric Mean Fold Titer Rise (95% CI) Day 21 GMTs Day 21 GMTs Day 21 GMTs Day 21 GMTs 54% ↑ 38% ↑ p=0.0058 28% ↑ p=0.036 47% ↑ p=0.0056 64% ↑ p=0.000
Slide 35: Comparison of HAI responses against H3N2 strains
Comparison of HAI responses against H3N2 strains In our trial, statistically significant increase in the ratio of day 21 geometric mean titers (GMTs) between NanoFlu vaccine and IIV3-HD against three H3N2 strains: • 47% higher NanoFlu response against homologous strain (A/Hong Kong) • 64% higher Nan
Slide 36: Rapid evolution and diversity of H3N2 requires a better vaccine
Rapid evolution and diversity of H3N2 requires a better vaccine Most common in Australia summer ‘17 A/Singapore NanoFlu vaccine has potential Most common in to provide broader protection U.S. this season against antigenic drift Epitope Changes Circulating H3N2 A/Hong Kong viruses present in 1 15 201
Slide 37: NEJM published NanoFlu clinical trial data
NEJM published NanoFlu clinical trial data NanoFluTM Phase 1/2 trial data published in a peer-reviewed letter to the editor in The New England Journal of Medicine NanoFlu demonstrates significantly improved immune responses against a panel of homologous and drifted A(H3N2) influenza viruses compared
Slide 38: NanoFlu completed and next steps
NanoFlu completed and next steps PUBLISH / PRESENT DISCUSS INITIATE CONDUCT INITIATE Phase 1/2 Data and Phase 2 End of Potential to clinical data Phase 2 study Phase 2 initiate Phase 3 results study design meeting with with FDA FDA Completed Completed Projected for Projected for Projected for Fall 2
Slide 39: Thank you
NOVAVAX Thank you