Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Day (November 2016)
89 slides from Novavax's investor day presentation, Nov 14, 2016
Slide 1: Novavax Investor and Analyst Presentation November 9, 2016
` 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
3 Agenda Novavax Opportunities, Technology & Pipeline Stanley C. Erck , President and CEO Emerging Viruses: Zika E Vaccine Colonel (R) James Cummings, M.D., Senior Director, Clinical Development Resolve™ Phase 3 Older Adults Trial Results and Next Steps Louis Fries , M.D., SVP, Chief Medical Officer
Slide 4: Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines
x Proprietary vaccine technology platform for efficient production of a new class of highly immunogenic nanoparticles x Pipeline includes late stage product with first - to - market potential addressing urgent unmet, medical needs of large segments of the population x Novavax RSV F Vaccine is a mult
Slide 5: RSV F Maternal Vaccine Candidate has first to market potential
GSK RSV F + adjuvant (Maternal) Phase 1 Phase 3 Live - attenuated Particle - based Subunit Phase 2 Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential 5 Gene - based vectors NIH, MedImmune Multiple candidates (Pediatrics) Novavax RSV F Vaccine (Pediatrics) Novavax RSV F Va
Slide 6: Novavax clinical and preclinical pipeline
6 Novavax clinical and preclinical pipeline Ebola + Matrix - M TM Older Adults (60+ ) Pediatrics (6 mos – 5 yrs) Infants (Maternal Immunization) Preclinical Phase 1 Phase 2 Phase 3 RSV Influenza Nanoparticle Emerging Viruses Clinical Preclinical Zika Combination Respiratory
Slide 7: RSV annual U.S. cost burden exceeds $30B across targeted populations
RSV annual U.S. cost burden exceeds $30B across Novavax targeted populations Annual US Infections Annual US Cost Burden Targeted US Population >2.5 million* Older Adults All adults 60 years of age and older >$28 billion* ~65 million Pediatrics Children >6 months - 5 years ~9.8 million ~$2.3 billion
Slide 8: Novavax corporate strategy
Novavax corporate strategy Focus near term on development of RSV F Vaccine for Infants via Maternal Immunization Support robust pipeline of new disease candidates using validated platform Continue to broaden portfolio of nanoparticle vaccines x Execute restructuring plan designed to meet following o
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 10 • Disease background • Novavax Zika vaccine and study strategy • Rationale for our vaccine candidate: a look at key external data • Concluding Remarks
Slide 11: 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 Zika overview 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.
• Locally acquired mosquito - borne cases reported: 139 • Travel - associated cases reported: 3,988 • Laboratory acquired cases reported: 1 • Total: 4,128* • Sexually transmitted: 32 • Guillain - Barré syndrome: 13 • Cases in Pregnancy: 1005 § • Live born infants with birth defects: 25 • Pregnancy l
Slide 14: Projected impact of Zika in Puerto Rico and lifetime care cost
PLOS NTD DOI:10.1371/journal.pntd.0004877 August 25, 2016 WHO estimates $10 million lifetime care cost per U.S. incidence of microencephaly Lifetime care of 7,500 children with microcephaly would cost $75 Billion 36,000 Births/year 25,000 Pregnancies/year Infected with Zika Virus 7,500 Births/year w
Slide 15: Novavax Zika Vaccine Formulation and partner development program
` Novavax Zika Vaccine Formulation and partner development program
Slide 16: Zika virus structure
16 Zika virus structure Envelope protein ( EnvD ) M protein Genomic RNA Capsid protein Lipid membrane
Slide 17: Pathway to a Zika Virus Vaccine
17 • 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 down selected in a number of wa
Slide 18: Novavax ZIKV nanoparticle vaccine: EnvD with Matrix-M
• Recombinant nanoparticle ZIKV env elope d imers ( 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 Novavax ZIKV nanoparticle vaccine: EnvD with Matr
Slide 19: SPR Biacore analysis shows ZIKV EnvD binds 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 Human Zika receptor: DC - SIGN KD =6.7 nM KD =9.3 nM
Slide 20: Potent Zika-Dengue antibody cross-neutralization using envelope dimer
20 Potent Zika - Dengue antibody cross - neutralization found utilizing envelope dimer ( EnvD ) structure
Slide 21: ZIKV EnvD Vaccine: EDE1 Quaternary Epitope neutralizes Zika and Dengue
ZIKV EnvD Vaccine: EDE1 Quaternary Epitope neutralizes Zika and Dengue viruses 21 EDE mAb 1 Envelope Dimer Epitope (EDE): Known Zika - Dengue antibody cross neutralization binding site ZIKV EnvD vaccine target 1 Barba - Spaeth, et al. Structural basis of potent Zika - Dengue virus antibody cross - n
Slide 22: Binding assay shows Dengue EDE antibodies bind ZIKV EnvD vaccine
Binding (K D ) assay demonstrates Dengue EDE antibodies bind to ZIKV EnvD vaccine but not ZIKV E80 E80 (refolded) EnvD EDE1 EDE1 K D =175 nM K D =6.9 nM No binding No binding 1 EDE1 C8 binding to Zika sE dimers K D =9 nM ; neutralized all four dengue serotypes and Zika [Barba - Spaeth et al. Nature
Slide 23: EnvD with Matrix M induces protective-level Zika neutralizing antibody titers
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) Protective 1 1 Larocca, et al. 2016 Jun 28. doi : 10.1038/nature18952 (Dan Barouch ) HA1 - E80 ZIKV EnvD ZIKV E80i (fusion) (dimer) (refolded) 23
Slide 24: Novavax pre-clinical development program underway
24 • Nanoparticle vaccine candidate: • ZIKV EnvD homodimers that form 5 – 10 nm particles selected as lead product • N on - human primate (NHP) testing performed at Harvard, (Dan H. Barouch , M.D., Ph.D., Professor of Medicine, Harvard Medical School; Director, Center for Virology and Vaccine Resear
Slide 25: Concluding Remarks
` Concluding Remarks
Slide 26: Development pathways for ZIKV vaccine
26 Development pathways for ZIKV vaccine
Slide 27: Zika vaccine landscape
Zika vaccine landscape ( October 19, 2016) RECOMBINANT OR SUBUNIT LIVE ATTENUATED WHOLE INACTIVATED NUCLEIC ACID OTHER VIRAL VECTOR DISCOVERY AND IN VITRO CLINICAL PRE - CLINICAL TECHNNOLOGY/ PLATFORM 27 Novavax INSTITUTO BUTANTAN VBI VACCINES INSTITUTO BUTANTAN SINGERGIUM BIOTECH PROTEIN SCIENCES C
Slide 28: Novavax ZIKV EnvD vaccine summary
28 • 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 women of child - bearing age an
Slide 29: Thank you
NOVAES Thank you
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: RSV F Vaccine background
31 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 descri
Slide 32: E-201: Phase 2 Trial of RSV F Vaccine in Older Adults
RT - PCR confirmed RSV Events Product - Limit Survival Estimate Log - Rank test: p=0.039 E - 201: Phase 2 Trial of RSV F Vaccine in Older Adults Early and durable protection from RSV infection Proportion of Group With No RSV Infection Time to RSV Onset 0.90 0.92 0.94 0.96 0.98 1.00 Day 0 Day 50 Day
Slide 33: Phase 3 RSV-E-301
` Phase 3 – RSV - E - 301
Slide 34: E-301: Design
34 • Target population: older adults ≥ 60 years old • Randomized, observer blind, placebo controlled trial, in 60 US sites • Subjects who had not had 2015 - 16 IIV (~45%) were offered co - administration on Day 0 and approximately ¾ accepted. • Stratification variables: prior IIV, CHF/COPD, residenc
Slide 35: E-301: Demographic characteristics of the study population
35 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% 8
Slide 36: E-301: Topline safety
36 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 solici
Slide 37: E-301: Efficacy - Primary Endpoint RSV-msLRTD
37 E - 301: Efficacy - Primary Endpoint: RSV Moderate - Severe Lower Respiratory Tract Disease (RSV - msLRTD) Placebo RSV F Vaccine Efficacy % (95% CI) P - value 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 (0.5
Slide 38: E-301: Efficacy - Secondary Endpoint RSV-ARD
38 E - 301: Efficacy - Secondary Endpoint RSV Acute Respiratory Disease (RSV - ARD) Placebo RSV F Vaccine Efficacy % (95% CI) P - value 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%
Slide 39: E-301: RSV-ARD medically attended respiratory illness events
39 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% Urge
Slide 40: E-301: Incidence and efficacy hospitalization
40 E - 301: Summary of incidence and efficacy hospitalization Placebo Group RSV F Vaccine Efficacy 4 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
Slide 41: E-301: Immunogenicity (Representative Subset)
41 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
Slide 42: E-301: Immunogenicity
42 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
Slide 43: E-301: Summary
43 • 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 on: • S
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
Vaccine Vaccine Placebo Placebo Vaccine Placebo 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
Slide 46: E-202: Summary
46 • 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 (ITT
Slide 47: Discussion
NOVAVAX, Discussion
Slide 48: E-301: Investigating the results
48 • 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? E - 301: Investigating the results
Slide 49: E-301: Trial conduct and Product
49 E - 301: Trial conduct and P roduct • 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 laborator
Slide 50: E-301: Potential influence of low attack rate
50 E - 301: Potential influence of low attack r ate Sources: 1 Struchiner and Halloran Epidemiol Infect 2007; 135:181 - 94] 2 Arnold S. Monto, MD, The Clinical Presentation and Outcomes of Influenza and RSV Infection in Older Adults , presented at OPTIONS Aug2016 • Modulation of detectable efficacy
Slide 51: Synthesis of E-201, E-301 and E-202 results
51 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 - ho c. • Conditioning circumstances: • RSV attac
Slide 52: Going forward
52 • 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/or efficac
Slide 53: Going forward: Phase 2 Older Adults Clinical Trial goals and design
Going forward: E - 205 Phase 2 Older Adults Clinical Trial goals and design 53 When ▪ Trial initiation in 1Q 2017 ▪ Topline data in 3Q 2017 Where ▪ Southern hemisphere Objectives: ▪ To ascertain whether adjuvantation or a two - dose primary regimen can alter the quantity and quality of the immune re
Slide 54: Thank you
` Thank you
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 56 • 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: Lesson
Slide 57: RSV F Maternal Vaccine Candidate has first to market potential
GSK RSV F + adjuvant (Maternal) Phase 1 Phase 3 Live - attenuated Particle - based Subunit Phase 2 Novavax Phase 3 RSV F Maternal Vaccine Candidate has first to market potential 57 Gene - based vectors NIH, MedImmune Multiple candidates (Pediatrics) Novavax RSV F Vaccine (Pediatrics) Novavax RSV F V
Slide 58: Protection of cotton rats via active and passive immunization
58 Protection of cotton rats via active and passive immunization RSV neutralizing antibodies in cotton rats, and protects against RSV challenge Raghunandan et al. 2014 Vaccine 32 (2014) 6485 – 6492 See also: PLoS One . 2012;7(11):e50852. A B C Sterilizing Immunity
Slide 59: Positive correlation between PCA and RSV microneutralizing antibodies
59 There is a positive correlation between PCA and RSV microneutralizing antibodies Data derived from Guinea pig antibody transfer study: Vaccine( 47):6488 - 92, 2015.
Slide 60: Infant Baboons Born to Immunized Mothers
60 Infant Baboons Born to Immunized Mothers: Evidence of reduced clinical disease after RSV challenge Palivizumab - treated Infants Infants of Vaccinated Mothers p = 0.0008 p = 0.0028 Relative to controls, treated infants had: x Decreased peak viral load in BAL x 2 - 4 - fold decreased leukocyte cou
Slide 61: Rationale for Selection of Dose Formulation and Regimen
Rationale for Selection of Dose Formulation and Regimen: Women of child - bearing age 61 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 wo
Slide 62: RSV F Vaccine: Phase 2 Study in Third Trimester Maternal Immunization
` RSV F Vaccine: Phase 2 Study Evaluated the Safety and Immunogenicity of RSV F Vaccine for Third Trimester 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
Slide 64: Safety summary
Safety summary 64 Maternal Safety x 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 x There were no SAEs attributed as causally related Labor & Delivery Events x Events
Slide 65: Vaccine-induced maternal antibodies transfer transplacentally
65 Phase 2 RSV F Vaccine Trial in Pregnant Women: Vaccine - induced maternal antibodies transfer transplacentally Antibody Source Delivered <30 days post vaccination (N = 7*) Delivered >30 days post vaccination (N = 14*) All (N = 21*) Estimated T 1/2 in Infants Anti - F IgG Cord Mothers Ratio 7,227
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 Trial in Pregnant Women: Summary
Phase 2 RSV F Vaccine Trial in Pregnant Women: Summary x Vaccine was well - tolerated x Response to RSV F vaccine in pregnant women replicated immune response in non - pregnant women x Maternal antibody peaks 14 days post vaccination x Anti - F, PCA, and neutralizing transplacental antibody transfer
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 69 Primary Objective D etermine the efficacy of maternal immunization with the RSV F Vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia in infants through a minimum of the first 90 days of life. Design Randomized, Observer - Blind,
Slide 70: Key Secondary Objectives for the Phase 3 Prepare Trial
Key Secondary Objectives for the Phase 3 Prepare™ Trial D etermine the efficacy of maternal immunization with the RSV F Vaccine in reducing the incidence of: • RSV LRTI with severe hypoxemia (SpO 2 <92% at sea level or <87% at altitudes >1800 meters) or the need for high flow nasal cannula or mechan
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
Slide 72: Supportive Data for the RSV F Vaccine for infants via maternal immunization
72 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 demonst
Slide 73: Recent lessons learned
73 • 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 efficacy demonstrated,
Slide 74: Background: B cells produce antibodies in a variety of ways
Naïve B cells Activated B cells Activated B cells Activated B cells GC GC B cells GC GC B cells Memory B cells IgG Memory B cells RSV Vaccine RSV Vaccine + Adjuvant? Background: B cells produce antibodies in a variety of ways Somatic hypermutation Affinity maturation Clonal selection Abs Plasma cell
Slide 75: Older Adults: B cells depleted as we age
Naïve B cells Activated B cells Activated B cells Activated B cells GC GC B cells GC GC B cells Memory B cells IgG Memory B cells RSV + Memory B cells depleted RSV Vaccine w/o Adjuvant? Older Adults: B cells depleted as we age Abs Plasma cells IgM IgG IgG IgG Plasma cells IgG IgG IgG Plasma B cells
Slide 76: Vaccine Induced Site II Antibodies: Women of Childbearing Age
Vaccine Induced Site II Antibodies, Measuring Affinity: Women of Childbearing Age 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 Palivizumab
Slide 77: Vaccine Induced Site II Antibodies: 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 Placebo 78 WOMEN OF CHILDBEARING AGE OLDER ADULT PCA - , No measurable Site II binding PCA+, No measurable Site II binding PCA+, High Affinity RSV F Vaccine RSV F Vaccine w/Alum Adjuvants and/or multiple dose strategy 2 7 % 100% 0% 2 0 % 6.6% 20% 53% 47% 53%
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 a ffinity > palivizumab • Aluminum increases both the affinity and the amount of high affinity antibody • Phase 3 Prepare™ trial formu
Slide 80: Thank you
NOVAVAX Creating Tomorrow's Vaccines Today Thank you
Slide 81: Financial and Operational Update
` Financial and Operational Update Buck Phillips SVP, Chief Financial Officer
Slide 82: 2016 Operational Priorities - By Program
82 2016 Operational Priorities - By Program Activities YTD Status RSV F Vaccine Execute Ongoing Clinical Trials • Phase 3 Older Adults (Resolve™) • Phase 3 Infants via Maternal (Prepare™) • Phase 2 Older Adults Rollover Older Adult BLA Filing in 2017 Conduct pre - commercialization activities Scale
Slide 83: YTD Quarterly Financial Comparison - Q3 2016
83 YTD Quarterly Financial Comparison - Q3 2016 Decline in Operating Expenses and Cash B urn in Q3 Q3 relative to Q1 and Q2 a) R&D expense decline due to wind - down of both the Phase 3 RSV Older Adults trial and the Phase 2 RSV Older Adults rollover trial. b) G&A expense decline due to a reduction
Slide 84: YTD Quarterly Financial Comparison - Q3 2016
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 expenses 79,480 79,003 66,539 Loss from operations (75,262) (76,498) (63,308) Interest income (expense), net (1,95
Slide 85: 2017 Operational Priorities - By Program
85 2017 Operational Priorities - By Program Activities Current Status RSV F Vaccine Prepare Trial ( Phase 3 Infants via Maternal Immunization) Phase 2 Older Adults regimen and adjuvant trial Ongoing Planned Zika Vaccine Phase 1 enabling work, including NHP challenge studies Phase 1 safety and immuno
Slide 86: 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: • 30% reduction in full
Slide 87: 2016 Q4 and 2017 Financial Guidance - Summary Discussion
87 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 exp
Slide 88: Novavax aims to discover, develop and commercialize groundbreaking nanoparticle vaccines
x 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 x High Value Product Portfolio • RSV F Vaccine Phase 3 Prepare t rial addressing #1 cause of infant hospitalizati
Slide 89: Milestone timeline: trial initiations
Milestone timeline: trial initiations RSVF Vaccine Older Adults Dose/formulation finding trial RSVF Vaccine Infants via Maternal Immunization Zika Phase 1 P otential to initiate trial (pending pre - clinical outcome) 2016 Q3 Q4 Q1 2017 Q2 Q3 Q4 Pre - clinical Initiated non - human primate challenge