Valneva(VALN) - 2023 Q4 - Annual Report

Valneva's Participation at 24th World Vaccine Congress Valneva will actively participate in the 24th World Vaccine Congress, presenting on its chikungunya vaccine IXCHIQ®, moderating discussions, and receiving award nominations Overview of Congress Participation Valneva SE announced its active participation in the 24th World Vaccine Congress in Washington D.C., from April 1-4, 2024, where it will present on its chikungunya vaccine IXCHIQ®, moderate a roundtable, and join a panel discussion - Valneva SE will participate in the 24th World Vaccine Congress in Washington D.C. from April 1-4, 2024[1] - The company will present on its single-shot chikungunya vaccine, IXCHIQ®, moderate a roundtable, and participate in a panel discussion[1] - Valneva will have a display at booth 433 in the exhibit area[1] Key Presentations and Discussions Valneva executives and partners will lead and participate in several key sessions, including a roundtable on Zika and chikungunya, presentations on IXCHIQ® antibody persistence, and a panel discussion on chikungunya eradication efforts, alongside a presentation on the Lyme disease vaccine candidate VLA15 - Valneva's Head of Global Market Access & Value Evidence, Gerard Vondeling, and Market Access Manager, Adrianne de Roo, will moderate the 'Public Health Priorities: The Emerging Threats of Zika and Chikungunya' interactive roundtable on April 2[2] - Valneva's VP of Clinical Development, Susanne Eder-Lingelbach, will present on 'Antibody persistence of a single-dose live-attenuated chikungunya virus vaccine (VLA1553) in adults' on April 3[4] - Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in the 'Vaccine Development and Efforts towards Eradicating Chikungunya' panel discussion on April 3[4] - Eduardo Forleo-Neto from Pfizer will present '6-Valent, OspA-based Lyme Disease Vaccine (VLA15) - Clinical Development Overview' on April 3, discussing the Pfizer and Valneva partnered vaccine candidate[5] Awards and Recognition Valneva's chikungunya vaccine, IXCHIQ®, has been nominated as a finalist for the 'Best Prophylactic Vaccine' award, and Valneva's CEO will present another industry award - Valneva is a finalist for the 'Best Prophylactic Vaccine' award for IXCHIQ® at the Vaccine Industry Excellence Awards ceremony on April 2[3] - Valneva CEO Thomas Lingelbach will present the 'Best Production / Process Development award' at the event[3] Key Vaccine Candidates This section details Valneva's leading vaccine candidates, including the approved chikungunya vaccine IXCHIQ® and the Phase 3 Lyme disease vaccine VLA15 IXCHIQ® (Chikungunya Vaccine) IXCHIQ® is Valneva's single-shot, live-attenuated chikungunya vaccine, approved in the U.S. and recommended by the CDC for individuals 18 years and older at increased risk of exposure, with continued approval contingent on confirmatory studies - IXCHIQ® is the world's first and only chikungunya vaccine to address this unmet medical need[3] - It is approved in the U.S. and recently recommended by the U.S. Advisory Committee on Immunization Practices (ACIP), with these recommendations adopted by the Centers for Disease Control and Prevention (CDC)[3] - IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV[6] - Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies, as it was approved under FDA's accelerated approval pathway[6] VLA15 (Lyme Disease Vaccine) VLA15 is the most advanced Lyme disease vaccine candidate, currently in Phase 3 clinical development in partnership with Pfizer, targeting six common OspA serotypes and demonstrating a strong immune response and satisfactory safety profile - VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with two Phase 3 trials in progress (VALOR - NCT05477524 and NCT05634811)[7] - It is partnered with Pfizer for this study and global commercialization, with recruitment completion for the study announced in December 2023[5] - This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, covering the six most common OspA serotypes prevalent in North America and Europe[7] - VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical trials so far[7] About Valneva SE Valneva SE is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for unmet medical needs, supported by a robust pipeline and commercial business Company Profile and Strategy Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, aiming to provide first-, best-, or only-in-class solutions for unmet medical needs - Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs[8] - The company takes a highly specialized and targeted approach, applying deep expertise across multiple vaccine modalities[8] - Valneva focuses on providing either first-, best- or only-in-class vaccine solutions[8] Pipeline and Commercial Business Valneva has a strong track record of advancing vaccines from R&D to approval, currently marketing three proprietary travel vaccines and leveraging its commercial infrastructure for third-party vaccines, with revenues supporting its pipeline, including the Lyme disease and Zika virus vaccine candidates - Valneva has a strong track record, having advanced multiple vaccines from early R&D to approvals[9] - The company currently markets three proprietary travel vaccines as well as certain third-party vaccines leveraging its established commercial infrastructure[9] - Revenues from its growing commercial business help fuel the continued advancement of its vaccine pipeline[10] - The pipeline includes the only Lyme disease vaccine candidate in advanced clinical development (partnered with Pfizer), as well as vaccine candidates against the Zika virus and other global public health threats[10]