Valneva SE · EURONEXT:VLA
Valneva — Corporate Update (November 2023)
19 slides from Valneva's corporate update, Nov 13, 2023
Slide 1: Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ
Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® November 13, 2023
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: IXCHIQ: The world's first licensed chikungunya vaccine
IXCHIQ® The world’s first licensed chikungunya vaccine1 1 Please refer to the full Prescribing Information: https://www.fda.gov/media/173758/download 3
Slide 4: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-transmitted disease with potentially debilitating consequences ▪ Transmitted by Aedes mosquitoes1 ▪ Often causes large, explosive outbreaks, affecting one-third to three- quarters of the population1; difficult to predict next outbreaks2 ▪ Outbreaks
Slide 5: Over 3/4 of the world's population lives in areas at risk of CHIKV
Over 3/4 of the world’s population lives in areas at risk of Chikungunya Virus (CHIKV) ▪ The areas of greatest risk for travelers are thought to be the Americas, parts of Africa, and Southeast Asia1,2 ▪ Returning infected travelers can trigger local outbreaks (e.g. Southern U.S./Europe)2 1. Puntasec
Slide 6: High Disease Burden & Health-Economic Impact
High Disease Burden & Health-Economic Impact of CHIKV patients 43% suffer from chronic chikungunya ▪ Potentially debilitating effects may last from months to years ▪ Many who experience severe infection never fully recover1,2 1. Puntasecca CJ, King CH, LaBeaud AD. Measuring the global burden of chik
Slide 7: CHIKV infections carry an economic burden
CHIKV infections carry an economic burden Combination of hospital-related costs and loss of productivity $18,646,900 ▪ Includes direct and indirect costs: ▪ Direct: outpatient visits, testing, and medications ▪ Indirect: loss of productivity due to absenteeism, and years lived with disability $11,08
Slide 8: CHIKV Associated With Significant Psychosocial and Quality of Life Burden
CHIKV Associated With Significant Psychosocial and Quality of Life (QoL) Burden Chikungunya Depression Pain The post-CHIKV vicious circle1-5 Limitation Handicap of Social Life in Daily Life QoL Self Stopping Physical Deprecation Activities Weight Deconditioning Gain Stiffening 1. Simon F. CISTM16. 2
Slide 9: IXCHIQ: The 3rd Vaccine Valneva has brought from early R&D to approval
IXCHIQ®: The 3rd Vaccine Valneva has brought from early R&D to approval1 Meticulous Development Leveraging our Strengths in Development and Manufacturing In-licensing/ Rolling Initial U.S. pre-clinical Phase 1 Phase 3 BLA4 NHP Study Approval R&D 2018 – 2019 2020 – 2021 submission 2015-2017 Nov 9, 20
Slide 10: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2,5 Live-attenuated CHIKV vaccine demonstrates rapid and long-lasting immunity with a single shot Immunogenicity Data Safety Data ▪ 99% Seroresponse3 Rate (SRR) after a single ▪ VLA1553 was generally well tolerated among the >3,600 vaccination adults and 754 adoles
Slide 11: VLA1553 Induces Early and Sustained Response Regardless Of Age
VLA1553 Induces Early and Sustained Response Regardless Of Age High seroresponse rates across studies Seroresponse sustained at highest levels up to Month 12 Comparable titers in younger and older adults Geometric Mean Titer (GMT) - CHIKV Neutralizing Antibodies ** * 10000 100 3 507 90 1 056 1 031 8
Slide 12: VLA1553: Fast and Robust Induction of Neutralizing CHIKV Antibodies
VLA1553: Fast and Robust Induction of Neutralizing CHIKV Antibodies High neutralizing antibody titers at Day 15 in Phase 1; by Day 29 for pivotal trial endpoint 10000 Geometric Mean Titer (GMT) 1000 Adults Phase 3 Pivotal Study1, N = 266 Adults Phase 1 Study2, Low Dose, 100 Seroresponse Threshold *
Slide 13: IXCHIQ is approved under the accelerated licensure pathway
IXCHIQ® is approved under the accelerated licensure pathway1 Phase 4 aims to verify the clinical benefit in two2 key post-marketing effectiveness studies VLA1553-402 VLA1553-404 Observational effectiveness study in population > 12 years Pragmatic randomized controlled effectiveness and safety of age
Slide 14: Chikungunya Global Market Segments
Chikungunya Global Market Segments Global market for chikungunya vaccines estimated to exceed $500 million per year by 20321 Segments Targeted Directly by Valneva Segments Targeted via Partnership Travelers from Non-Endemic Regions Endemic Region Use Travel vaccine for individuals travelling to area
Slide 15: IXCHIQ Fits Perfectly Within our Existing Commercial Infrastructure
IXCHIQ® Fits Perfectly Within our Existing Commercial Infrastructure High-caliber team with significant experience in the vaccine space Commercial Footprint Highly experienced teams with deep expertise in vaccine market segments Commercial infrastructure in most key markets; footprint extended throu
Slide 16: IXCHIQ Key Features and Differentiators
IXCHIQ® Key Features and Differentiators ▪ We expect to benefit by being first to market with a potentially best-in-class vaccine ▪ We believe we have a differentiated and competitive product characterized by a strong and durable immunological response from a single injection ▪ No overall difference
Slide 17: Preparing for Global Market Launches
Preparing for Global Market Launches Planned Additional and Future Regulatory Processes1 IXCHIQ® : Valneva Instituto Butantan Additional Additional Markets LATAM/other Europe/UK Brazil LMICs9 Countries with Canada established travelers' Prioritization in 2024: First submission in 2024 Filed marketin
Slide 18: Thank you
Thank you WAvalneva
Slide 19: Q&A
Q&A