Novavax, Inc. · NASDAQ:NVAX

Novavax — Technical Presentation (March 2020)

11 slides from Novavax's technical presentation, Mar 24, 2020

  1. Slide 1: NanoFlu Phase 3 Topline Data

    NANOFLU PHASE 3 TOPLINE DATA Nasdaq: NVAX | March 24, 2020

  2. Slide 2: 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

  3. Slide 3: 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

  4. Slide 4: 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

  5. Slide 5: 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,

  6. Slide 6: 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

  7. Slide 7: 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

  8. Slide 8: Immunogenicity: Seroconversion

    Immunogenicity: Seroconversion Egg- or wild-type VLP- based Day 28 HAI 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 ( 1.9, 8.1)

  9. Slide 9: 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 - Assay Strain SCR SCR Fluzone Quad 95% CI HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/128

  10. Slide 10: 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.

  11. Slide 11: 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

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