Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Day (November 2016)
89 slides from Novavax's investor day presentation, Nov 9, 2016
Slide 1: Novavax Investor and Analyst Presentation
` Novavax Investor and Analyst Presentation November 9, 2016
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: Agenda
Agenda Novavax Opportunities, Technology Stanley C. Erck, President and CEO & Pipeline Emerging Viruses: Zika E Vaccine Colonel (R) James Cummings, M.D., Senior Director, Clinical Development Resolve™ Phase 3 Older Adults Trial Louis Fries, M.D., SVP, Chief Medical Officer Results and Next Steps Pre
Slide 4: Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines
Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines Proprietary vaccine technology platform for efficient production of a new class of highly immunogenic nanoparticles Pipeline includes late stage product with first-to-market potential addressing urgent unmet
Slide 5: Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential
Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential Phase 1 Phase 2 Phase 3 NIH, MedImmune Live-attenuated Multiple candidates (Pediatrics) Novavax RSV F Novavax Particle-based Vaccine RSV F Vaccine (Pediatrics) (Older Adults) Novavax RSV F Vaccine (Maternal) Subunit GSK G
Slide 6: Novavax clinical and preclinical pipeline
Novavax clinical and preclinical pipeline Clinical Preclinical Phase 1 Phase 2 Phase 3 RSV Infants (Maternal Immunization) Older Adults (60+) Pediatrics (6 mos – 5 yrs) Emerging Viruses Ebola + Matrix-MTM Preclinical Zika Influenza Nanoparticle Combination Respiratory 6
Slide 7: RSV annual U.S. cost burden exceeds $30B across Novavax targeted populations
RSV annual U.S. cost burden exceeds $30B across Novavax targeted populations Novavax RSV Older Adult & Maternal vaccines have first-to-market potential Infants via Maternal Older Adults Pediatrics Immunization All adults 60 years of age Children Infants, birth – 6 months and older >6 months - 5 year
Slide 8: Novavax corporate strategy
Novavax corporate strategy Focus near term on development of RSV F Execute restructuring plan designed to meet Vaccine for Infants via following objectives Maternal Prioritize development activities to achieve Immunization valuation events within 2017 Reduce cash burn, extend financial horizon
Slide 9: ZIKA
` ZIKA James F Cummings COL (R) MD FACP FIDSA FASTMH Senior Director of Clinical Development
Slide 10: Novavax Zika vaccine
Novavax Zika vaccine • Disease background • Novavax Zika vaccine and study strategy • Rationale for our vaccine candidate: a look at key external data • Concluding Remarks 10
Slide 11: Zika overview
Zika overview • Flavivirus • Transmitted by Mosquitoes • Sexually spread • 80% asymptomatic • Common Clinical Symptoms • Fever, Rash, Joint pain, Conjunctivitis • Microcephaly • Guillain-Barré • April 19, 2016: Zika added to FDA’s Priority Review Voucher Program Act 11
Slide 12: Global areas of active Zika transmission
Global areas of active Zika transmission http://www.cdc.gov/zika/geo/active-countries.html as of 2 NOV 2016 12
Slide 13: Zika case counts in the U.S.
Zika case counts in the U.S. U.S. States U.S. Territories • Locally acquired mosquito-borne cases • Locally acquired cases reported: 30,074 reported: 139 • Travel-associated cases reported: 104 • Travel-associated cases reported: 3,988 • Total: 30,178* • Laboratory acquired cases reported: 1 • Guill
Slide 14: WHO estimates $10 million lifetime care cost per U.S. incidence of microencephaly
WHO estimates $10 million lifetime care cost per U.S. incidence of microencephaly Puerto Rico: Projected teratogenic impact of maternal ZIKV infection on 2017-2018 birth cohort 36,000 Births/year 25,000 Pregnancies/year 7,500 Births/year with Infected with Zika Virus Zika Virus Birth Defects 9.7 Bir
Slide 15: Novavax Zika Vaccine
Formulation and partner Novavax Zika Vaccine ` development program
Slide 16: Zika virus structure
Zika virus structure Envelope protein (EnvD) M protein Capsid protein Genomic RNA Lipid membrane 16
Slide 17: Pathway to a Zika Virus Vaccine
Pathway to a Zika Virus Vaccine • Flaviviruses have been difficult targets for vaccine production for many years. • Novavax’ Sf9 platform technology is a responsive, agile system for developing vaccines based upon the genomic sequence of the emerging infectious disease • These constructs are then do
Slide 18: Novavax ZIKV nanoparticle vaccine: EnvD with Matrix-M
Novavax ZIKV nanoparticle vaccine: EnvD with Matrix-M™ • Recombinant nanoparticle ZIKV envelope dimers (EnvD) • Purified EnvD forms 5 – 10nm nanoparticles • ZIKV EnvD vaccine with Matrix-M™ adjuvant is highly immunogenic and induces protective levels of neutralizing antibodies in preclinical models
Slide 19: SPR Biacore analysis demonstrates ZIKV EnvD binds to human Zika receptors
SPR Biacore analysis demonstrates ZIKV EnvD binds to human Zika receptors AXL and DC-SIGN ZIKV EnvD (homodimers) ZIKV E80i (refolded) Human Zika receptor: AXL KD =6.7 nM Human Zika receptor: DC-SIGN KD =9.3 nM
Slide 20: Potent Zika-Dengue antibody cross-neutralization found utilizing envelope dimer structure
Potent Zika-Dengue antibody cross-neutralization found utilizing envelope dimer (EnvD) structure 20
Slide 21: EDE mAb 1 ZIKV EnvD vaccine target
ZIKV EnvD Vaccine: EDE1 Quaternary Epitope neutralizes Zika and Dengue viruses EDE mAb1 Envelope Dimer Epitope (EDE): Known Zika-Dengue antibody cross neutralization binding site ZIKV EnvD vaccine target 1Barba-Spaeth, et al. Structural basis of potent Zika-Dengue virus antibody cross-neutralization
Slide 22: Binding assay demonstrates Dengue EDE antibodies bind to ZIKV EnvD vaccine
Binding (KD) assay demonstrates Dengue EDE antibodies bind to ZIKV EnvD vaccine but not ZIKV E80 Antibodies (mAbs): EDE1 EDE1 KD=6.9 nM KD=175 nM EnvD No binding No binding E80 (refolded) 1EDE1 C8 binding to Zika sE dimers K =9 nM; neutralized all four dengue serotypes and Zika [Barba-Spaeth et al.
Slide 23: EnvD with Matrix M induces Zika neutralizing antibody titers at protective levels
EnvD structure with Matrix M shown to induce Zika neutralizing antibody titers at levels expected to be protective (post boost) Study 702-067 (n=10) Protective1 HA1-E80 ZIKV EnvD ZIKV E80i (fusion) (dimer) (refolded) 1Larocca, et al. 2016 Jun 28. doi: 10.1038/nature18952 (Dan Barouch) 23
Slide 24: Novavax pre-clinical development program underway
Novavax pre-clinical development program underway • Nanoparticle vaccine candidate: • ZIKV EnvD homodimers that form 5 – 10 nm particles selected as lead product • Non-human primate (NHP) testing performed at Harvard, (Dan H. Barouch, M.D., Ph.D., Professor of Medicine, Harvard Medical School; Direc
Slide 25: Concluding Remarks
NOVAVAX Creating Tomorrow's Vac Concluding Remarks
Slide 26: Development pathways for ZIKV vaccine
Development pathways for ZIKV vaccine 26
Slide 27: Zika vaccine landscape (October 19, 2016)
Zika vaccine landscape (October 19, 2016) TECHNNOLOGY/ PLATFORM DISCOVERY AND IN VITRO PRE-CLINICAL CLINICAL RECOMBINANT OR INSTITUTO PROTEIN SCIENCES MUNDO SANO INSTITUT BHARAT BUTANTAN PASTEUR BIOTECH SUBUNIT CORPORATION ZFSW VBI VACCINES SINGERGIUM UMN PHARMA HAWAII BIOTECH BIOTECH INC. Novavax N
Slide 28: Novavax ZIKV EnvD vaccine summary
Novavax ZIKV EnvD vaccine summary • Novavax Zika vaccine addresses a significant market opportunity • Sexual transmission of Zika distinguishes it from other recent pandemic threats like Dengue and Chikugunya and indicates it cannot be managed by containment alone • Case for vaccinating all men and
Slide 29: Thank you
Creating Tomorrow’s Vaccines Today “
Slide 30: RSV F Vaccine in Older Adults: Results of Phase 3 (E301) and Rollover Phase 2 (E202)
RSV F Vaccine in Older Adults: Results of Phase 3 (E301) and Rollover Phase 2 (E202) trials ` Path Forward Louis Fries, M.D. SVP, Chief Medical Officer
Slide 31: Background
Background RSV F Vaccine • Baculovirus-Sf9 insect cell-derived recombinant nanoparticle vaccine • Induction of broadly neutralizing antibodies to Site I, II and IV • Protection from challenge in animal models (cotton rat and baboons) • Phase 2 older adults: efficacy against clinical RSV endpoints de
Slide 32: E-201: Phase 2 Trial of RSV F Vaccine in Older Adults
E-201: Phase 2 Trial of RSV F Vaccine in Older Adults Early and durable protection from RSV infection RT-PCR confirmed RSV Events Product-Limit Survival Estimate Log-Rank test: p=0.039 1.00 Proportion of Group With No RSV Infection 0.98 135 ug RSV F Vaccine 0.96 Placebo 0.94 0.92 p=0.039 October 31,
Slide 33: Phase 3 – RSV-E-301
NOVAVAX Creating Tomorrow's Vaccines Today Phase 3 — RSV-E-301
Slide 34: E-301: Design
E-301: Design • Target population: older adults ≥ 60 years old • Randomized, observer blind, placebo controlled trial, in 60 US sites Group Treatment Dose Subjects Randomization Active 135µg RSV F w/o Al 0.5mL IM 5921 1:1 Placebo Formulation buffer 0.5mL IM 5935 • Subjects who had not had 2015-16 II
Slide 35: E-301: Demographic characteristics of the study population
E-301: Demographic characteristics of the study population Placebo RSV F Vaccine Safety Population N 5935 5921 Age, mean (SD) 69.8 (7.0) 69.9 (7.1) 60 to 75 years (%) 76.4% 76.5% > 75 years (%) 23.5% 23.5% > 85 years (%) 1.7% 2.1% Male/female (%) 42 / 58 43 / 57 Race/ethnicity (%) White 88.9% 87.6%
Slide 36: E-301: Topline safety
E-301: Topline safety Placebo Group RSV F Vaccine Safety population N 5935 5921 Subjects with: Any TEAE n (%) 3367 (56.7%) 3467 (58.6%) Solicited TEAE n (%) 1304 (22.0%) 1458 (24.6%) Severe solicited TEAE n (%) 76 (1.3%) 95 (1.6%) Local solicited TEAE n (%) 349 (5.9%) 522 (8.8%) Systemic solicited T
Slide 37: E-301: Efficacy - Primary Endpoint RSV-msLRTD
E-301: Efficacy - Primary Endpoint: RSV Moderate- Severe Lower Respiratory Tract Disease (RSV-msLRTD) Efficacy % Placebo RSV F Vaccine P-value (95% CI) Per-protocol-efficacy N 5917 5892 RSV msLRTD n (%) 26/5905 (0.44%) 28/5885 (0.48%) -7.9% (-84, 37) 0.779 60-75 years 23/4517 (0.51%) 25/4519 (0.55%)
Slide 38: E-301: Efficacy - Secondary Endpoint RSV-ARD
E-301: Efficacy - Secondary Endpoint RSV Acute Respiratory Disease (RSV-ARD) Efficacy % Placebo RSV F Vaccine P-value (95% CI) Per-protocol-efficacy N 5917 5892 ` RSV-ARD n (%) 117/5905 (1.98%) 102/5885 (1.73%) 12.6% (-14, 33) 0.314 60-75 years 94/4517 (2.08%) 88/4519 (2.0%) 6.4% NS >75 years 23/139
Slide 39: E-301: Incidence and Efficacy – medically attended respiratory illness events
E-301: Summary of Incidence and Efficacy – RSV-ARD medically attended respiratory illness events Placebo Group RSV F Vaccine Efficacy* 5910 5898 Any Medical Attendance 44 (0.74%) 37 (0.63%) 15.7% Physician Call 7 (0.12%) 5 (0.08%) 28.4% Physician Office Visit 32 (0.54%) 27 (0.46%) 15.5% Urgent Care
Slide 40: E-301: Summary of incidence and efficacy hospitalization
E-301: Summary of incidence and efficacy hospitalization Placebo Group RSV F Vaccine Efficacy4 5910 5898 RSV-associated hosp.1 2 (0.03) 0 (0.00) NE Any respiratory hosp.2 53 (0.90) 41 (0.70) 22.5% Any cardio-respiratory hosp.2 91 (1.54) 81 (1.37) 10.8% Any hospitalization (Regardless of diagnosis wi
Slide 41: E-301: Immunogenicity (Representative Subset)
E-301: Immunogenicity (Representative Subset) Placebo RSV F Vaccine Anti-F IgG EU* Day 0 GMEU (95% CI) 896 (794, 1011) 981 (866, 1110) Day 28 GMEU (95% CI) 977 (865, 1104) 6694 (5929, 7558) Geo mean fold rise (95% CI) 1.06 (0.99, 1.13) 6.10 (5.37, 6.94) Sero-response rate (95% CI) 4.7% (2.4, 8.3) 89
Slide 42: E-301: Immunogenicity
E-301: Immunogenicity Placebo RSV F Vaccine RSV/A Microneutralization* titers Day 0 GMT (95% CI) 287 (280, 294) 296 (289, 303) Day 28 GMT (95% CI) 280 (273, 286) 502 (490, 514) Geo mean fold rise (95% CI) 0.98 (0.97, 0.99) 1.69 (1.67, 1.72) % Two-fold rise (95% CI) 6.5% (5.8, 7.1) 45.3% (44.0, 46.6)
Slide 43: E-301: Summary
E-301: Summary • Safety profile consistent with Phase 2 results • RSV-ARD and RSV-msLRTD attack rates markedly lower than expected • Efficacy • Failed to show efficacy against RSV msLRTD • Trend suggesting efficacy against RSV ARD, but not significant • Impact of similar amplitude to RSV ARD effect
Slide 44: Phase 2 Rollover Trial RSV-E-202
` Phase 2 Rollover Trial RSV-E-202
Slide 45: E-202: Design of Phase 2 Rollover Trial
E-202: Design of Phase 2 Rollover Trial Designed to examine the necessity and potential benefit of an annual re-immunization • Enrolled older adult subjects from RSV-E-201; provided a unique opportunity to evaluate: • Ability to enhance vaccine immune response 1 year after initial dose • Duration of
Slide 46: E-202: Summary
E-202: Summary • Safety demonstrates ~5-6% increase in mild injection site pain in the group receiving a second active dose; otherwise no obvious differences • Surveillance data demonstrate RSV-ARD (2.4% in placebo) and RSV-msLRTD (0.3% in placebo) attack rates were low, confirming E-301 • Efficacy
Slide 47: Discussion
NOVAVAX Creating Tomorrow's Vaccines Today Discussion
Slide 48: E-301: Investigating the results
E-301: Investigating the results • NO obvious trial design differences to explain divergence of E-201 and E-301 efficacy results • Hypotheses: • Flawed conduct of E-301? • Differences between test articles used in E-301 vs. E-201? • Occurrence and impact of unusually low attack rate? 48
Slide 49: E-301: Trial conduct and Product
E-301: Trial conduct and Product • Site performance • Within industry standards of recent large influenza trials • 83% of illnesses swabbed, >98% of swabs within 5 days of onset. • 50 newly trained sites overall performed nearly as well overall as the 10 experienced sites • RT-PCR laboratory perform
Slide 50: E-301: Potential influence of low attack rate
E-301: Potential influence of low attack rate • Modulation of detectable efficacy by attack rate is well recognized in influenza trials • Studies with the same investigators, vaccine products, trial methods, and study populations can show 40-50% decrements in observed efficacy in sequential years wh
Slide 51: E-201, E-301 and E-202: A unifying view
E-201, E-301 and E-202: A unifying view Phase 2 trial in Older Adults (E-201) • A significant 41% efficacy against RSV ARD was seen, but with wide confidence intervals (trial not actually powered for that level of efficacy). A significant 64% efficacy against RSV msLRTD was noted post-hoc. • Conditi
Slide 52: Going forward
Going forward • Novavax will continue the development of the RSV F Vaccine candidate • Immunogenicity is notably more vigorous in younger adult subjects (including pregnant women) and especially children (and young adults with low baseline MN titers) • Several avenues for enhanced immunogenicity and
Slide 53: Going forward: E-205 Phase 2 Older Adults Clinical Trial goals and design
Going forward: E-205 Phase 2 Older Adults Clinical Trial goals and design Trial initiation in 1Q 2017 When Topline data in 3Q 2017 Where Southern hemisphere To ascertain whether adjuvantation or a two-dose primary regimen can alter the quantity and quality of the immune response to RSV F vac
Slide 54: Thank you
NOVAVAX Creating Tomorrow's Vaccines Today
Slide 55: Protecting Infants via Maternal Immunization: Progress Towards an RSV Vaccine
Protecting Infants via Maternal Immunization: ` Progress Towards an RSV Vaccine Greg Glenn, M.D. President, Research and Development
Slide 56: Novavax' RSV F Vaccine: Infants via Maternal Immunization
Novavax’ RSV F Vaccine: Infants via Maternal Immunization • Review of the competitive landscape • Key preclinical data • Phase 2: key safety & immunogenicity results • Phase 3: • Study Design • Endpoints • Optimal Vaccination Window • Safety • Support for continuance of the maternal trial: Lessons l
Slide 57: Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential
Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential Phase 1 Phase 2 Phase 3 NIH, MedImmune Live-attenuated Multiple candidates (Pediatrics) Novavax RSV F Novavax Particle-based Vaccine RSV F Vaccine (Pediatrics) (Older Adults) Novavax RSV F Vaccine (Maternal) Subunit GSK G
Slide 58: Protection of cotton rats via active and passive immunization
Protection of cotton rats via active and passive immunization RSV neutralizing antibodies in cotton rats, and protects against RSV challenge A B C Sterilizing Immunity Raghunandan et al. 2014 Vaccine 32 (2014) 6485–6492 58 See also: PLoS One. 2012;7(11):e50852.
Slide 59: Positive correlation between PCA and RSV microneutralizing antibodies
There is a positive correlation between PCA and RSV microneutralizing antibodies Data derived from Guinea pig antibody transfer study: Vaccine(47):6488-92, 2015. 59
Slide 60: Infant Baboons Born to Immunized Mothers: reduced clinical disease after RSV challenge
Infant Baboons Born to Immunized Mothers: Evidence of reduced clinical disease after RSV challenge Infants of pregnant baboons immunized with RSV F are protected from RSV challenge in a manner similar to infants treated with palivizumab Palivizumab-treated Infants Infants of Vaccinated Mothers Place
Slide 61: Rationale for Selection of Dose Formulation and Regimen: Women of child-bearing age
Rationale for Selection of Dose Formulation and Regimen: Women of child-bearing age Two-Dose Regimens Single-Dose Regimens Aluminum-adjuvanted formulations provide: 1. Enhanced neutralizing antibody responses in young women with the lowest pre- immunization titers (i.e., whose infants would be at hi
Slide 62: RSV F Vaccine: Phase 2 Study
Evaluated the Safety and RSV F Vaccine: ` Immunogenicity of RSV F Vaccine for Third Trimester Phase 2 Study Maternal Immunization
Slide 63: Phase 2 RSV F Vaccine Trial in Pregnant Women: Overview
Phase 2 RSV F Vaccine Trial in Pregnant Women: Overview • In September 2014, we initiated a Phase 2 clinical trial in healthy pregnant women, 18-40 years of age, with singleton pregnancy • The trial was a randomized, observer-blinded, placebo-controlled study of 50 pregnant women at 8 sites in the U
Slide 64: Safety summary
Safety summary Maternal Safety The only imbalance of AEs were solicited and local: • Predominantly mild-moderate and transient injection site pain, consistent with prior trial in women of child-bearing age There were no SAEs attributed as causally related Infant Safety There were no imbalances
Slide 65: Vaccine-induced maternal antibodies transfer transplacentally
Phase 2 RSV F Vaccine Trial in Pregnant Women: Vaccine-induced maternal antibodies transfer transplacentally Delivered <30 days Delivered >30 days Antibody Source All Estimated T1/2 in post vaccination post vaccination (N = 21*) Infants (N = 7*) (N = 14*) Cord 7,227 8,659 8,153 Anti-F IgG Mothers 12
Slide 66: Competitive ELISA RSV F Epitope Site I, II, and IV
Phase 2 RSV F Vaccine Trial in Pregnant Women: Competitive ELISA RSV F Epitope Site I, II, and IV Little or no serum antibody at Day 0 competitive with mAbs specific to known neutralizing sites after years of exposure to RSV 66
Slide 67: Phase 2 RSV F Vaccine Trial in Pregnant Women: Summary
Phase 2 RSV F Vaccine Trial in Pregnant Women: Summary Vaccine was well-tolerated Response to RSV F vaccine in pregnant women replicated immune response in non-pregnant women Maternal antibody peaks 14 days post vaccination Anti-F, PCA, and neutralizing transplacental antibody transfer confi
Slide 68: Phase 3 Study: Infants via Maternal Immunization
` Phase 3 Study: Infants via Maternal Immunization
Slide 69: Phase 3 Study: Goals and design
Phase 3 Study: Goals and design Determine the efficacy of maternal immunization with the RSV F Vaccine against Primary symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia in infants through Objective a minimum of the first 90 days of life. Design Randomized, Observer-Blind, Place
Slide 70: Key Secondary Objectives for the Phase 3 Prepare Trial
Key Secondary Objectives for the Phase 3 Prepare™ Trial Determine the efficacy of maternal immunization with the RSV F Vaccine in reducing the incidence of: • RSV LRTI with severe hypoxemia (SpO2 <92% at sea level or <87% at altitudes >1800 meters) or the need for high flow nasal cannula or mechanic
Slide 71: Data Safety Monitoring Board (DSMB)
Data Safety Monitoring Board (DSMB) Primary Mandate of the DSMB is Safety Data Review • Evolving aggregate safety data are reviewed in a completely unblinded fashion and on a monthly basis during enrollment • The DSMB is composed of both pediatric and obstetrical experts • The DSMB is supported by a
Slide 72: Supportive Data for the RSV F Vaccine for infants via maternal immunization
Supportive Data for the RSV F Vaccine for infants via maternal immunization • Protection demonstrated in relevant animal models (cotton rats and baboons) • Induction of broadly neutralizing antibodies to Site I, II and IV • Site II-specific antibodies, palivizumab and motavizumab, have demonstrated
Slide 73: Recent lessons learned
Recent lessons learned • Can we refine our immune measures? • In general, high affinity antibodies targeting broadly neutralizing epitopes are considered most desirable for protection • mAbs Palivizumab and Motavizumab characterized by high affinity binding of Site II on the F protein • Clinical eff
Slide 74: Background: B cells produce antibodies in a variety of ways
Background: B cells produce antibodies in a variety of ways RSV Vaccine Somatic hypermutation RSV Vaccine +Adjuvant? Affinity maturation Clonal selection Activated IgG Memory IgG Naïve BActivated cells GC GC Memory GCGC BMemory cells B cells BActivated cells B cells B cells B cells B cells B cells P
Slide 75: Older Adults: B cells depleted as we age
Older Adults: B cells depleted as we age RSV Vaccine Somatic hypermutation RSV + Memory B cells w/o Adjuvant? Class-switching depleted Affinity maturation Clonal selection Activated RSV+ IgG Memory IgG Naïve BActivated cells GC GC Memory GCGC BMemory cells B cells BActivated cells B cells B cells B
Slide 76: Vaccine Induced Site II Antibodies, Measuring Affinity: Women of Childbearing Age
Vaccine Induced Site II Antibodies, Measuring Affinity: Women of Childbearing Age Palivizumab Individual subject sera from women of child-bearing age Phase 2 trial probed by Surface Plasmon Resonance with Site II Peptide: 254-277 NSELLSLINDMPITNDQKKLMSNN 76
Slide 77: Vaccine Induced Site II Antibodies, Measuring Affinity: Older Adults
Vaccine Induced Site II Antibodies, Measuring Affinity: Older Adults Individual subject sera from older adults Phase 1 trial probed by Surface Plasmon Resonance with Site II Peptide: 254-277 NSELLSLINDMPITNDQKKLMSNN 77
Slide 78: Pathways to Higher Quality Antibodies
Pathways to Higher Quality Antibodies WOMEN OF CHILDBEARING AGE OLDER ADULT PCA-, No measurable Site II binding 6.6% PCA+, No measurable Site II binding 20% PCA+, High Affinity Placebo 0% 20% 27% RSV F Vaccine 53% Adjuvants and/or RSV F Vaccine multiple dose 47% 53% 100% w/Alum strategy 78
Slide 79: Implications
Implications • WOCBA have intact RSV+ immune memory to Site II • Single dose adjuvanted vaccine results in very high affinity antibodies • Vaccine-induced antibody affinity > palivizumab • Aluminum increases both the affinity and the amount of high affinity antibody • Phase 3 Prepare™ trial formulat
Slide 80: Thank you
NOVAVAX Creating Tomorrow's Vaccines Today
Slide 81: Financial and Operational Update
` Financial and Operational Update Buck Phillips SVP, Chief Financial Officer
Slide 82: 2016 Operational Priorities
2016 Operational Priorities - By Program Activities YTD Status RSV F Vaccine Execute Ongoing Clinical Trials • Phase 3 Older Adults (Resolve™) Data Announced • Phase 3 Infants via Maternal (Prepare™) Ongoing • Phase 2 Older Adults Rollover Data Announced Older Adult BLA Filing in 2017 Discontinued C
Slide 83: YTD Quarterly Financial Comparison
YTD Quarterly Financial Comparison - Q3 2016 Decline in Operating Expenses and Cash Burn in Q3 Quarter Ended March 31, 2016 June 30, 2016 Sept 30, 2016 Revenue $ 4,218 $ 2,505 $ 3,231 Expenses: Research and development 68,952 64,904 52,983 a General and administrative 10,528 14,099 13,556 b Total ex
Slide 84: YTD Quarterly Financial Comparison
YTD Quarterly Financial Comparison - Q3 2016 Decline in Operating Expenses and Cash Burn in Q3 Quarter Ended March 31, 2016 June 30, 2016 Sept 30, 2016 Revenue $ 4,218 $ 2,505 $ 3,231 Expenses: Research and development 68,952 64,904 52,983 a General and administrative [ 10,528 14,099 13,556 b Total
Slide 85: 2017 Operational Priorities
2017 Operational Priorities - By Program Activities Current Status RSV F Vaccine Prepare Trial (Phase 3 Infants via Maternal Immunization) Ongoing Phase 2 Older Adults regimen and adjuvant trial Planned Zika Vaccine Phase 1 enabling work, including NHP challenge studies Ongoing Phase 1 safety and im
Slide 86: Corporate Restructuring
Corporate Restructuring • Restructuring plan objectives: • Prioritize development activities to achieve clinical data events in 2017 • Reduce cash burn, extend financial horizon and minimize near-term dilution • Maintain operational core competencies to execute development plans • Key Components: •
Slide 87: 2016 Q4 and 2017 Financial Guidance
2016 Q4 and 2017 Financial Guidance - Summary Discussion 2016 Q4 relative to 2016 Q1-Q3: • Increased revenue under the BMGF grant resulting from increased enrollment in the Prepare trial • Consistent R&D expenses due to final visit for all participants in the Resolve trial • Decrease in G&A expenses
Slide 88: Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines
Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines Resources to execute the development plan discussed today • $300 million in cash and investments as of September 30, 2016 • $89 million BMGF grant supporting RSV Phase 3 Prepare™ trial High Value Product Por
Slide 89: Milestone timeline: trial initiations
Milestone timeline: trial initiations 2016 2017 Q3 Q4 Q1 Q2 Q3 Q4 Phase 3 RSVF Vaccine Global Infants via enrollment Maternal ongoing Immunization Phase 2 RSVF Vaccine Initiation of Older Adults multi-arm trial Dose/formulation finding trial Pre-clinical Phase 1 Initiated non- Potential to initiate