Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (June 2020)
33 slides from Novavax's investor presentation, June 2020
Slide 1: Creating Tomorrow's Vaccines Today
NOVAVAX Creating Tomorrow’ s Vaccines Today - e ¥ > Nasdaq: NVAX | June 2020
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: Significant opportunities for value creation
Significant opportunities for value creation NanoFlu™ Phase 3 clinical trial achieves all primary endpoints • US BLA to be submitted under FDA’s accelerated approval pathway Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May • Preliminary results expected in July Recombinant prot
Slide 4: Novavax vaccine pipeline
4 Novavax vaccine pipeline PROGRAM DESCRIPTION PRECLINICAL CLINICAL PHASE 1 PHASE 2 PHASE 3 Matrix-M NanoFlu™ – Nanoparticle Seasonal Influenza Vaccine - Older Adults (65+ yrs) Matrix-M NVX-CoV2373 – Coronavirus vaccine candidate ResVax™ - RSV F Vaccine - Infants via Maternal Immunization* Matrix-M
Slide 5: NVX-CoV2373 program update
NVX-CoV2373 w w w . w e b s i t e . c o m program update novavax.com 5
Slide 6: Coronavirus disease 2019
Coronavirus disease 2019 COVID 19 Pandemic - A global public health threat • Global protection for 2nd and 3rd waves may be required • Demand of 6-8 billion doses globally– estimated by BMGF, CEPI, WHO and BARDA • Potential need for a seasonal vaccine, similar to influenza *Coronavirus image CDC Lib
Slide 7: Accelerating NVX-CoV2373 advances worldwide efforts to address COVID pandemic
Accelerating NVX-CoV2373 advances worldwide efforts to address COVID pandemic • In preclinical studies, NVX-CoV2373 demonstrated high immunogenicity and stimulated high levels of neutralizing antibodies • Initiated first-in-human trial in May; preliminary results are expected in July 2020 • GMP clin
Slide 8: Novavax proven expertise in developing emerging infectious disease vaccines
Novavax proven expertise in developing emerging infectious disease vaccines Novavax’ prior experience with emerging Safe and effective recombinant infectious disease vaccines positions us expression system and Matrix-M well for current COVID-19 crisis vaccine adjuvant • Developed 2 prior coronavirus
Slide 9: NVX-CoV2373 candidate entering Phase 1 clinical trial
NVX-CoV2373 candidate entering Phase 1 clinical trial Preclinical results • Created several candidates; evaluated in animal models with collaborators (University of Maryland) • Identified NVX-CoV2373, SARS-CoV-2 candidate, for Phase 1 clinical trials • NVX-CoV2373 demonstrated high immunogenicity an
Slide 10: NVX-CoV2373 generated a strong immune response and stimulated high levels of neutralizing antibodies
CONFIDENTIAL 10 NVX-CoV2373 generated a strong immune response and stimulated high levels of neutralizing antibodies Anti-SARS-CoV-2 rS IgG vs receptor inhibition antibodies (A) very immunogenic; (B) antibodies block spike protein binding A A n ti-S A R S -C o V -2 rS Ig G T ite r: + M a trix M 1 G
Slide 11: NVX-CoV2373: Neutralizing antibodies
NVX-CoV2373: Neutralizing antibodies NVX-CoV2373 induced antibodies neutralize wild-type SARs-CoV-2 virus after 1st dose; 8-fold increase after 2nd dose SARs-CoV-2 virus Neutralization Titers Key early development milestones: RBD D13 BV2373 • stable and immunogenic RBD D28 • key role of Matrix-M con
Slide 12: Novavax at the forefront of fighting a COVID pandemic
Novavax at the forefront of fighting a COVID pandemic Novavax has a viable immunogenic vaccine candidate (NVX-CoV2373) against SARS-CoV-2 Novavax is experienced at rapid vaccine development under pandemic circumstances NVX-CoV2373 leverages the same technology platform and uses the same adjuvant as
Slide 13: NanoFlu program update
NanoFlu w w w . w e b s i t e . c o m program update novavax.com 13
Slide 14: Influenza older adult U.S. market >$2B
Influenza older adult U.S. market >$2B Total U.S. and U.S. Market 5 EU Major Markets Population >65 Medicare Reimbursement Vaccination Rate ~62M $55 estimated Medicare 60-90% $2B >$4B # of U.S. older adults vaccination assumes 60% vaccination in 2023 allowable pricing for rate current & CDC goal rat
Slide 15: 2019 Presidential Executive Order encourages influenza vaccine innovation
2019 Presidential Executive Order encourages influenza vaccine innovation Critical policy objectives include: • Reducing the reliance on egg-based influenza vaccine production • Expanding alternative methods • Advancing the development of new, broadly protective vaccine candidates Recombinant influe
Slide 16: Flu is not just another cold
Flu is not just another cold Number of deaths 40,231 Motor vehicle accidents 2017 47,600 Opioid overdose 2017 79,400 Influenza 2017-2018 season 0 10K 20K 30K 40K 50K 60K 70K 80K 90K Based on data from the Centers for Disease Control and Prevention (2018a), National Safety Council (2018), and Scholl,
Slide 17: 2018-2019 U.S. flu season demonstrates need for improved vaccine effectiveness in older adults
2018-2019 U.S. flu season demonstrates need for improved vaccine effectiveness in older adults Vaccine effectiveness by strain in older adults Circulating Virus 40% % of vaccine effectiveness (VE) 35% 34% 30% 25% 20% 15% 16% 13% 10% 12% 5% A/H3N2 A/H1N1 B/Yamagata B/Victoria Lineage not subtyped 0%
Slide 18: Two issues contribute to poor flu vaccine effectiveness
Two issues contribute to poor flu vaccine effectiveness1 Antigenic Egg adaptation evolution and drift Viruses are modified to grow better in chicken eggs Vaccines are derived from recommended strains, but when Over multiple egg-growth viruses “drift” – natural genetic passages, these changes can evo
Slide 19: NanoFlu: A novel flu vaccine
NanoFlu: A novel flu vaccine • Recombinant nanoparticle • Non-egg based • Adjuvanted with Matrix-M • Exact genetic match to recommended vaccine strains PROVIDES GREATER ~87% of flu Novavax is advancing NanoFlu is AND BROADER vaccine doses are an improved flu vaccine differentiated… IMMUNE RESPONSES
Slide 20: NanoFlu program: Rapid evolution and diversity of H3N2 requires a better vaccine
NanoFlu program: Rapid evolution and diversity of H3N2 requires a better vaccine Phylogeny Epitope mutations ^ A/Cardiff/508/19 A/CA/94/19 A/Singapore/2016 A/Tokyo/EH1801/18 A/Swiz/8060/17 A/Neth/1268/19 A/HK/4801/14 A/Kansas/14/17 x A/ID/13/18 2013 2014 2015 2016 2017 2018 2019 novavax.com 20
Slide 21: NanoFlu Phase 3 results
NanoFlu w w w . w e b s i t e . c o m Phase 3 results novavax.com 21
Slide 22: NanoFlu Phase 3 clinical trial goals and design
NanoFlu Phase 3 clinical trial goals and design • To demonstrate the non-inferior immunogenicity of NanoFlu, relative to Fluzone® Quadrivalent, in terms of hemagglutination Primary inhibition (HAI) antibody responses to all vaccine homologous influenza strains at Day 28. objectives • To describe the
Slide 23: NanoFlu Phase 3 clinical trial conclusions
NanoFlu Phase 3 clinical trial conclusions Primary endpoint met: demonstrated immunologic non-inferiority to Fluzone in terms of hemagglutination inhibition (HAI) antibody responses (assayed with egg-derived virus reagents) against all four vaccine homologous strains (per CBER criteria). Statistical
Slide 24: Immunogenicity: Primary endpoint GMT
Immunogenicity: Primary endpoint GMT Egg - based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad D28 GMT Ratio Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15) Success: All 95% CI A/Kans
Slide 25: Immunogenicity: Primary and secondary GMT endpoints
Immunogenicity: Primary and secondary GMT endpoints Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad D28 GMT Ratio Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03,
Slide 26: Immunogenicity: Effect on drifted strains (GMT)
Immunogenicity: Effect on drifted strains (GMT) Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad D28 GMT Ratio Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15
Slide 27: Immunogenicity: Primary endpoint seroconversion
Immunogenicity: Primary endpoint seroconversion Egg- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad Absolute SCR Difference NanoFlu - Assay Strain SCR SCR Fluzone Quad 95% CI HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1
Slide 28: Immunogenicity: Seroconversion
Immunogenicity: Seroconversion Egg- or wild-type VLP- based Day 28 HAI GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad Absolute SCR Difference NanoFlu - Fluzone Assay Strain SCR SCR Quad 95% CI HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)
Slide 29: Immunogenicity: Seroconversion including drifted strains
Immunogenicity: Seroconversion including drifted strains Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone) NanoFlu Fluzone Quad Absolute SCR Difference NanoFlu - Fluzone Assay Strain SCR SCR Quad 95% CI HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/128
Slide 30: Topline safety
Topline safety Safety events (through Day 28) NanoFlu Fluzone Quad (SD) N 1333 1319 Counts (%) of Subjects with Events Any treatment emergent adverse event 659 (49.4) 551 (41.8) (TEAE) Any Solicited TEAE 551 (41.3) 420 (31.8) Local solicited 372 (27.9) 243 (18.4) Severe local solicited 8 (0.6) 2 (0.
Slide 31: NanoFlu Phase 3 clinical trial conclusions
NanoFlu Phase 3 clinical trial conclusions Primary endpoint met: demonstrated immunologic non-inferiority to Fluzone in terms of hemagglutination inhibition (HAI) antibody responses (assayed with egg-derived virus reagents) against all four vaccine homologous strains (per CBER criteria). Statistical
Slide 32: Significant opportunities for value creation
Significant opportunities for value creation NanoFlu™ Phase 3 clinical trial achieves all primary endpoints • US BLA to be submitted under FDA’s accelerated approval pathway Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May • Preliminary results expected in July Recombinant prot
Slide 33: Creating Tomorrow's Vaccines Today
NOVAVAX Creating Tomorrow’s Vaccines Today