Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (August 2015)
34 slides from Novavax's investor presentation, August 2015
Slide 1: Creating Tomorrow
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Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain information contained herein, particularly information relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical development, product sales, operating expenses, our
Slide 3: Investment Highlights
Investment Highlights Data from 4 clinical trials expected in the 3rd quarter 2015 • Seasonal quadrivalent flu • RSV older adults • RSV maternal (protection of infants) • Ebola Novavax Vaccine Platform • Recombinant nanoparticles that induce robust and functional immunity • Matrix-M adjuvant that in
Slide 4: Product Pipeline
Product Pipeline Funding Program Preclinical Phase 1 Phase 2 Phase 3 Support RSV Older Adults * Infants (Maternal Immunization) Pediatrics (6 mos – 6 yrs) Influenza Quadrivalent Seasonal Combination Respiratory New Vaccines Pandemic (H7N9 + Matrix-M) Ebola + Matrix-M 4 *Our funding and development a
Slide 5: Novavax Platform Technology
Novavax Platform Technology Unique capabilities • Select and engineer genetic sequences encoding vaccine antigens • Sf9 cellular machinery produces correctly modified and folded proteins • Full-length antigens expressed in native conformation assemble into highly immunogenic nanoparticle • Safety da
Slide 6: Novavax Nanoparticle Technology
Novavax Nanoparticle Technology Recombinant Nanoparticles: Virus-Like Particles (VLP) RSV & Ebola Seasonal & Pandemic Influenza Hydrophilic head HA and NA of protein Protein particle Empty - No genetic material Hydrophobic tail of protein particle M1 Matrix Protein Protein particles form micelles fo
Slide 7: RSV F Vaccine
RSV F Vaccine Older Adults Infants via Maternal Immunization Pediatrics 7
Slide 8: RSV Vaccine: Multi Billion Dollar Market Opportunity
RSV Vaccine: Multi Billion Dollar Market Opportunity RSV Franchise, US and EU31: • 23M annual RSV infections • 5M are medically attended • $28B direct & indirect economic burden in US Most frequent cause of infant hospitalization in the U.S. Severe disease often leads to ongoing wheezing • Associate
Slide 9: RSV Vaccine Franchise
RSV Vaccine Franchise Young Infants Via Maternal Older Adults Pediatrics Immunization To protect infants Healthy individuals ≥ 60, Children 2-6 yrs, <6 months prevent hospitalization decrease respiratory and death disease burden, prevent medical care, wheezing 9
Slide 10: Site II on F Protein Provides an Unchanging Target
While the Changing Virus Presents a Challenge, Site II on F Protein Provides an Unchanging Target RSV Surface Proteins • Attachment Protein (G) • Fusion Protein (F) Strain changes are largely due to variation of the G protein Frequency of changes across the RSV genome The Fusion (F) protein changes
Slide 11: Novavax RSV-F Protein Vaccine Induces Antibodies that Mimic Palivizumab
Novavax RSV-F Protein Vaccine Induces Antibodies that Mimic Palivizumab RSV F Protein 1 • Site II, the antibody binding site is displayed on the vaccine • Site II on the F protein is targeted by palivizumab (Synagis®) and motavizumab (Numax®) • These mAbs have been shown to prevent RSV disease in in
Slide 12: RSV Vaccine Franchise: Target Populations
RSV Vaccine Franchise: Target Populations Young Infants Via Maternal Older Adults Pediatric Immunization To protect infants Healthy individuals ≥ 60, Children 2-6 yrs, <6 months prevent hospitalization decrease respiratory and death disease burden, prevent medical care, wheezing 12
Slide 13: RSV is the Leading Cause of Hospitalizations of Full-term Infants
RSV is the Leading Cause of Hospitalizations of Full-term Infants and Peaks in First 6 Months of Life • RSV is largely a disease of healthy, full-term infants o The smaller airways and Up to 80% of immature immune systems of infants makes them more hospitalizations susceptible to severe disease occu
Slide 14: Placental Transfer of Antibodies to Protect Young Infants
Placental Transfer of Antibodies to Protect Young Infants via Maternal Immunization • Protection via transplacental transport of mother’s antibodies into baby’s blood is effective against flu, whooping cough: At full term, baby has >100% of mother’s antibody levels CDC recommends Tdap vaccine in
Slide 15: 90% of all Births Occur at the Time of Peak Transplacental Antibody Transfer
90% of all Births Occur at the Time of Peak Transplacental Antibody Transfer Over 90% of Births Occur Between 37 and 43 Weeks 1,600 1,400 1,200 U.S. Births (in thousands) 1,000 800 600 400 > 90% of Births 200 0 35 36 37 38 39 40 41 42 43 Weeks All Births 15
Slide 16: 90% of all Births Occur at the Time of Peak Transplacental Antibody Transfer
90% of all Births Occur at the Time of Peak Transplacental Antibody Transfer Time of Peak Transplacental Antibody Transfer Overlaps with >90% of Births 1,600 1,400 1,200 U.S. Births (in thousands) 1,000 800 600 Peak Transplacental Antibody Transfer 400 > 90% of Births 200 0 35 36 37 38 39 40 41 42 4
Slide 17: Phase 1 Study in Women Elicited Protective Antibody Levels
Vaccine in Phase 2 Study in Women of Child- Bearing Age Elicited Protective Antibody Levels RSV F Protein Vaccine induces Palivizumab-Competing Antibodies (PCA) Throughout Full-Term Birth Timeframe 1,600 450 1,400 400 350 1,200 U.S. Births (in thousands) 300 1,000 PCA* µg/ml 250 800 200 600 Peak Tra
Slide 18: Maternal Immunization: Current Clinical Trial in Pregnant Women
Maternal Immunization: Current Clinical Trial in Pregnant Women M203 Phase 2 RSV F Vaccine in Pregnant Women, 3rd Trimester, enrolled, ongoing • Randomized, observer-blinded, placebo-controlled in 50 subjects • Immunization in third trimester women • Primary endpoint: safety and immunogenicity in mo
Slide 19: RSV Vaccine Franchise: Target Populations
RSV Vaccine Franchise: Target Populations Young Infants Via Maternal Older Adults Pediatric Immunization To protect infants Healthy individuals ≥ 60, Children 2-6 yrs, <6 months prevent hospitalization decrease respiratory and death disease burden, prevent medical care, wheezing 19
Slide 20: RSV Disease Burden in the Older Adults – U.S.
RSV Disease Burden in the Older Adults (≥ 65 yrs) – U.S. Deaths 14,000 ˜852,680 Medical ER (151,801) + Hospital Interventions Admissions (203,612) (35.5% of = ˜355,400 (14.8% of RSV RSV infections) infections) Physician Office Visits ~497,280 (17% of RSV infections – healthy) (29% of RSV infections
Slide 21: Annual Vaccine for Older Adults: 47 Million Seniors in U.S.
Annual Vaccine for Older Adults: 47 Million Seniors in U.S. • 14,000 older and high risk adults die of RSV infection or complications per year in the U.S.1 • As many as 180,000 older adults are hospitalized for serious respiratory symptoms each year1 • Significant opportunity for an annual seasonal
Slide 22: RSV Vaccine for Older Adults: Phase 1 Immunogenicity Results
RSV Vaccine for Older Adults: Phase 1 Immunogenicity Results • 220 Older adults, >60 yrs, single dose RSV F Nanoparticle Vaccine administered w/Flu vaccine. • Vaccine was well-tolerated and palivizumab-competing antibody (PCA) response was robust and durable • Unadjuvanted vaccine could be used as a
Slide 23: RSV Vaccine for Older Adults: Clinical Development Plans
RSV Vaccine for Older Adults: Clinical Development Plans E201 Phase 2 RSV Vaccine in Older Adults: enrolled, ongoing • Randomized, observer-blinded, placebo-controlled 1:1 in 1,600 subjects • Primary endpoint: incidence of RSV+ illness • Exploratory endpoint: vaccine effect on a RSV+ illness • This
Slide 24: Summary: RSV Clinical Studies in All Target Populations
Summary: RSV Clinical Studies in All 3 Target Populations Maternal Phase 2: Safety and immunogenicity in 3rd trimester women and their infants • Active immunization of mothers, safety, transplacental antibody transfer and half-life • Enrolled, ongoing Older Adults Phase 2: Safety, epidemiology and e
Slide 25: Influenza VLP Program
Influenza VLP Program Quadrivalent Seasonal Combination Respiratory 25
Slide 26: Immunologic Targets of the Novavax Influenza Vaccines
Immunologic Targets of the Novavax Influenza Vaccines: Three Shots on Goal Hemagglutinin HA1 ‘Head’ Receptor binding domain (RBD) RBD Viral entry (stem) HA2 ‘Stem’ Fusion • NVAX VLP vaccine induces antibodies to Subunit both1 Neuraminidase Release of virus from infected cells • H7N9 and H5N1 vaccine
Slide 27: Seasonal Influenza: Clinical Development Plans
Seasonal Influenza: Clinical Development Plans Phase 2 Dose Confirmation Trial in Healthy Adults • Randomized, observer-blinded, dose-ranging trial in 400 healthy adults • Data for end-of-phase 2 meeting with FDA • FSI November 2014 • Funded under BARDA contract • Combination of HA and NA antibody r
Slide 28: Combination Respiratory Vaccine: RSV F + Seasonal Influenza
Combination Respiratory Vaccine: RSV F + Seasonal Influenza Combination Vaccine Could Replace Seasonal Flu Vaccines Flu RSV Flu + RSV 28
Slide 29: Emerging Viruses
Emerging Viruses Pandemic Influenza (H7N9) Ebola Zaire (Makona) 29
Slide 30: Novavax Avian Flu Vaccine: More Immunogenic Than Any Similar Vaccines
Novavax Avian Flu Vaccine: More Immunogenic Than Any Similar Vaccines Published To Date H7N9 VLP alone or with Saponin Adjuvant (2013) • 225 subjects vaccinated 91 days post publication of gene sequence • Achieved dose-sparing goals with 5 μg dose • Seroconversion and seroprotection rates: 81% HAI,
Slide 31: Rapid Response to an Emerging Threat
Rapid Response to an Emerging Threat • Makona Ebola genetic sequence published1 • Manufactured Glycoprotein (GP) nanoparticle vaccine Nov ‘14 Immunogenicity • 100x antibody levels compared to published data2,3 GP Nanoparticle Two Lethal Challenge Studies: • Macaques were immunized with 5 ug GP nanop
Slide 32: Financial and Corporate Highlights
Financial and Corporate Highlights Novavax by the Numbers*: Cash and Investments: $327.7 M Debt: None BARDA contract for seasonal and pandemic flu: $179 M Shares Outstanding: 267.9 M Employees: 350 * Novavax, Inc. March 31, 2015 10Q 32
Slide 33: Upcoming Development Milestones
Upcoming Development Milestones Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 Ongoing Trials RSV Maternal Ph 2 RSV Older Adults Ph 2 RSV Pediatric Ph 1 Seasonal Flu Ph 2 Ebola Ph 1 Planned Trials RSV/Flu Combo Ph 1 H7N9 + Matrix Ph 2 Trial Initiated 33
Slide 34: Investment Highlights
Investment Highlights Data from 4 clinical trials expected in the 3rd quarter 2015 • Seasonal quadrivalent flu • RSV older adults • RSV maternal (protection of infants) • Ebola Novavax Vaccine Platform • Recombinant nanoparticles that induce robust and functional immunity • Matrix-M adjuvant that in