Slide 1: VLA2001 Cov-Compare Topline Results
VLA2001 Cov-Compare Topline Results October 18, 2021
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information d
Slide 3: Agenda
Agenda 1 Introduction 2 Cov-Compare Trial and Topline Results 3 VLA2001 Route to Licensure and Development Plan 4 Closing Remarks Valneva - VLA2001 Cov-Compare Results October 18, 2021 3
Slide 4: Introduction
INTRODUCTION Valneva - VLA2001 Cov-Compare Results October 18, 2021 4
Slide 5: Valneva's Response to the Global COVID-19 Crisis
Valneva’s Response to the Global COVID-19 Crisis Well-Known Inactivated Approach Based on Proven Technology VLA2001: • Inactivated, adjuvanted SARS-Cov 2 whole virus vaccine • Intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during t
Slide 6: VLA2001 – The Only Inactivated Vaccine Against COVID-19 in Clinical Development in Europe
VLA2001 – The Only Inactivated Vaccine Against COVID-19 in Clinical Development in Europe Program acceleration enabled through use of Valneva’s FDA-registered facility in 1 Scotland, where commercial manufacturing commenced January 20211 Valneva’s proven expertise with inactivated vaccines and Dynav
Slide 7: Cov-Compare Trial and Topline Results
COV-COMPARE TRIAL AND TOPLINE RESULTS Valneva - VLA2001 Cov-Compare Results October 18, 2021 7
Slide 8: About Phase 3 Cov-Compare Trial (VLA2001-301)
About Phase 3 Cov-Compare Trial (VLA2001-301) Randomized, observer-blind, controlled, immunogenicity trial comparing VLA2001 to AstraZeneca’s conditionally approved vaccine, AZD1222 (ChAdOx1-S) 2,972 participants 30 years of age and older randomized (2:1) received two doses of either VLA2001 (n=
Slide 9: Safety and Tolerability Results - VLA2001 was Well Tolerated
Safety and Tolerability Results - VLA2001 was Well Tolerated Primary Endpoint: Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination Overall, 92.0% of participants reported any AE (92.6%, 88.7% and 98.1% in the VLA2001 Under 30 years, VLA2001 30 years and above, and AZD1222
Slide 10: VLA2001-301 – Preliminary Safety Conclusions
VLA2001-301 – Preliminary Safety Conclusions VLA2001 was well tolerated across all tested age groups Participants in the younger age group vaccinated with VLA2001 showed an overall safety profile comparable to the older age group VLA2001’s tolerability profile was more favorable compared to the comp
Slide 11: SARS-CoV-2 Neutralizing Antibody Levels (ND50) - VLA2001 Higher Than AZD1222 at Day 43
SARS-CoV-2 Neutralizing Antibody Levels (ND50)- IMM – VLA2001 Higher Than AZD1222 at Day 43 IMM includes all randomized and vaccinated participants of the IMM subset for the primary endpoint evaluation, who were SARS-CoV-2 seronegative and have at least one evaluable post-baseline antibody titer mea
Slide 12: Immunogenicity Results – Primary Endpoint Met
Immunogenicity Results – Primary Endpoint Met SARS-CoV-2 Neutralizing Antibodies (ND50)- IMM – VLA2001 1.39 x AZD1222 Co-Primary Endpoint: Ratio of geometric mean titer (IMM population) of SARS-CoV-2-specific neutralizing antibodies, at two weeks after the second vaccination (i.e. Day 43) in adults
Slide 13: High Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies
High Proportion of Participants With Seroconversion in Terms of Neutralizing Antibodies – PP Co-primary Endpoint: Seroconversion (PP population) (defined as 4-fold increase from baseline) of SARS-CoV- 2-specific neutralizing antibodies, at two weeks after the second vaccination (i.e. Day 43) in adul
Slide 14: VLA2001-301 Immunogenicity Conclusions – Endpoints Met
VLA2001-301 Immunogenicity Conclusions – Endpoints Met The trial met its co-primary immunogenicity endpoints at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and above › VLA2001 demonstrated superiority against AZD1222 (ChAdOx1-S) in terms of geometric mean titer for
Slide 15: Overall Clinical Data Conclusions
Overall Clinical Data Conclusions All Endpoints Achieved The trial met its co-primary endpoints. VLA2001 demonstrated: › superiority against AZD1222 (ChAdOx1-S), in terms of geometric mean titer for neutralization antibodies, as well as › non-inferiority in terms of seroconversion rates at two wee
Slide 16: VLA2001 Route to Licensure & Development Plan
VLA2001 ROUTE TO LICENSURE & DEVELOPMENT PLAN Valneva - VLA2001 Cov-Compare Results October 18, 2021 16
Slide 17: VLA2001 – SARS-CoV-2 Clinical Development Plan
VLA2001 – SARS-CoV-2 Clinical Development Plan Ongoing Planned 2022 Ph1/2 VLA2001-201 Ph3 VLA2001-301 • Extension for booster • Primary Adults • N= 77 N=4012* • Age 18-55 • Extension for • 6 Months follow-up booster n=400 • Age 18-55+ Ph3 VLA2001- 301a Ph3 VLA2001-321 • Adolescence • Pediatric • Pri
Slide 18: VLA2001: Route to Licensure
VLA2001: Route to Licensure Valneva to submit Cov-Compare data to UK Medicines and Healthcare products Regulatory Agency (MHRA) › Rolling submission with MHRA commenced in August 20211 › Final submission to MHRA anticipated for November › Potential initial approval expected by year-end Valneva p
Slide 19: Closing Remarks
CLOSING REMARKS Valneva - VLA2001 Cov-Compare Results October 18, 2021 19
Slide 20: Thank you
Thank you Merci Danke Tack WAvalneva