Valneva IPO Presentation Deck
VLA1553: Development Outlook
Pivotal Phase 3 Trial - Topline Read-out Expected Mid-2021
■ Phase 3 Clinical Development Program underway
Pivotal Phase 3 safety and immunogenicity trial in 4,131 healthy volunteers fully
enrolled¹
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Topline read-out on Day 29 (based on surrogate of protection) mid-2021
Lot-to-Lot consistency trial initiated (VLA1553-302) in ~400 volunteers²
Antibody persistence follow-up trial initiated (VLA1553-303) - up to 375 volunteers
from VLA1553-301 will be followed up annually for five years after a single
immunization¹
Adolescents' clinical trial in 750 volunteers in Brazil planned to commence in 2021³
Accelerated approval pathway agreed with FDA4
■ VLA1553 may be eligible for Priority Review Voucher upon FDA approval5
¹ Vaineva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial 2 Valneva Initiates Phase 3 Clinical Lot
Consistency Study for its Single-Shot Chikungunya Vaccine Candidate. In collaboration with development partner Instituto Butantan, under CEPI funding. Valneva Announces
Publication of 2020 Universal Registration Document and Provides Business Updates https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-
review-voucher-program
Valneva - Roadshow Presentation
April 2021
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