Slide 1: NanoFlu Phase 3 clinical trial goals and design
1 novavax.com NanoFlu Phase 3 clinical trial goals and design Primary objectives • To demonstrate the non - inferior immunogenicity of NanoFlu, relative to Fluzone® Quadrivalent, in terms of hemagglutination inhibition (HAI) antibody responses to all vaccine homologous influenza strains at Day 28. •
Slide 2: NanoFlu Phase 3 clinical trial conclusions
2 novavax.com 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 cri
Slide 3: Immunogenicity: Egg-based Day 28 HAI GMTs and GMT ratios
3 novavax.com 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) A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27) B/Maryland/15/2016 (Vic) (Homologous) 110.7
Slide 4: Immunogenicity: Egg- and VLP-based Day 28 HAI GMTs and GMT ratios
4 novavax.com 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) A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27) B/Maryland/15/2016 (Vic) (Homologous) 110.7
Slide 5: Immunogenicity: GMTs and ratios including drifted H3N2 strains
5 novavax.com 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) A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27) B/Maryland/15/2016 (Homologous) 110.7 106.3
Slide 6: Immunogenicity: Egg-based SCR and SCR difference
6 novavax.com NanoFlu Fluzone Quad Absolute SCR Difference Assay Strain SCR SCR NanoFlu - Fluzone 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) A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1)
Slide 7: Immunogenicity: Egg- and VLP-based SCR and SCR difference
7 novavax.com NanoFlu Fluzone Quad Absolute SCR Difference Assay Strain SCR SCR NanoFlu - Fluzone 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) A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1)
Slide 8: Immunogenicity: SCR including drifted H3N2 strains
8 novavax.com NanoFlu Fluzone Quad Absolute SCR Difference Assay Strain SCR SCR NanoFlu - Fluzone 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) A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1)
Slide 9: Topline safety events through Day 28
9 novavax.com Topline safety N 1333 1319 Counts (%) of Subjects with Events Any treatment emergent adverse event ( TEAE) 659 (49.4) 551 (41.8) Any Solicited TEAE 551 (41.3) 420 (31.8) Local solicited 372 (27.9) 243 (18.4) Severe local solicited 8 (0.6) 2 (0.2) Systemic Solicited 369 (27.7) 292 (22.1
Slide 10: NanoFlu Phase 3 clinical trial conclusions
10 novavax.com 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 cr