Core Insights - Valneva SE has entered into an exclusive agreement with CSL Seqirus for the marketing and distribution of its three proprietary vaccines in Germany [1][2] - The agreement includes the commercialization of Valneva's chikungunya vaccine IXCHIQ® starting July 2025, and its Japanese Encephalitis vaccine IXIARO® and cholera/ETEC vaccine DUKORAL® from January 2026 [2] - This new agreement replaces a previous partnership with Bavarian Nordic, which is set to conclude at the end of December 2025 [2][3] Company Performance - Valneva's product sales reached €48.6 million in Q1 2025, with €42.8 million coming from proprietary vaccines [4] - The company anticipates product sales to grow to €170-180 million in 2025, contributing to positive cash flows for its commercial business [4] Strategic Focus - The partnership with CSL Seqirus is expected to enhance Valneva's commercial sales in Germany, leveraging CSL's strong presence in the travel vaccine market [4] - Valneva specializes in developing vaccines for infectious diseases, focusing on unmet medical needs and applying expertise across multiple vaccine modalities [5][6] Pipeline Development - Revenues from the commercial business support the advancement of Valneva's vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7]

Core Points - Valneva SE, a specialty vaccine company, announced that all resolutions recommended by the Board of Directors were approved by shareholders at the Annual General Meeting held in Lyon, France [1] - The approved resolutions included the financial statements for 2024, capital increase delegations, and the appointment of Dr. Gerd Zettlmeissl to the Board for a three-year term [2] - Valneva's management confirmed the Company's full-year 2025 financial guidance during the meeting [4] Company Overview - Valneva SE develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, focusing on unmet medical needs [5] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's commercial business revenues support the advancement of its vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development partnered with Pfizer, and other candidates against Shigella, Zika virus, and other public health threats [7] Board and Auditor Information - Dr. Gerd Zettlmeissl, a vaccine expert with over 30 years of experience, was appointed to the Board, while Mr. James Sulat was reappointed for a one-year term [2][3] - The term of Deloitte & Associés as Statutory Auditor was renewed for six years [3]

IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV)Antibody levels remained high after six months in both dose groups, although more robust with the full doseSix-month data confirm full dose selection for pivotal Phase 3 trial Saint-Herblain (France), June 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 cli ...

Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva’s commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world’s leading Lyme disease vaccine candidate. VLA15 is partnered with Pfize ...

Core Viewpoint - Valneva SE's chikungunya vaccine IXCHIQ has been recommended for a pause in use for individuals aged 65 and over by the FDA and CDC due to ongoing investigations into serious adverse events [1][3]. Company Summary - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [8]. - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [9]. - Valneva is committed to maintaining high safety standards and has proactively engaged with health authorities regarding reported serious adverse events related to IXCHIQ [2][4]. Vaccine and Safety Information - The FDA and CDC have recommended the use of IXCHIQ for individuals aged 18 to 60 years, while the EMA recommends it for individuals aged 12 to 64 years [5]. - Over 40,000 doses of IXCHIQ have been administered worldwide, with most serious adverse events reported in elderly individuals with significant underlying medical conditions [3][5]. - Valneva continues to monitor adverse events, particularly from the chikungunya vaccination campaign in La Réunion, where no further serious adverse events have been reported outside this public vaccination effort [4]. Chikungunya Overview - Chikungunya is a mosquito-borne viral disease that has caused significant outbreaks globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [6][7]. - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [7].

Core Points - The European Medicines Agency (EMA) has initiated a review of Valneva's chikungunya vaccine IXCHIQ due to reports of serious adverse events (SAEs) in elderly individuals, leading to a temporary suspension of its use for those over 65 years old [1][2] - A total of 17 SAEs, including two deaths, have been reported globally among elderly individuals with significant underlying medical conditions [2] - The exact cause of these SAEs and their relationship to the vaccine remain undetermined, and healthcare professionals are reminded not to administer IXCHIQ to individuals with weakened immune systems [3] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [9] - The company has a strong track record of advancing multiple vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [10] - Valneva is also developing vaccine candidates for Lyme disease, Zika virus, and other global public health threats [10] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant economic and medical burdens expected to grow due to climate change [8] - Between 2013 and 2023, more than 3.7 million chikungunya cases were reported in the Americas, highlighting the disease as a major public health concern [8]

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...

Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]

Core Points - The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) updated its recommendation for Valneva's chikungunya vaccine IXCHIQ®, maintaining its use for travelers aged ≥18 to chikungunya outbreak areas and considering it for those in elevated risk areas for extended stays [1][2] - ACIP recommended a precaution for IXCHIQ® use in individuals aged ≥65 due to ongoing investigations of serious adverse events (SAEs) reported in older vaccinated individuals [2][3] - Valneva has supplied approximately 80,000 doses of IXCHIQ® across the U.S., Canada, and Europe, with no new SAEs reported since January 2025, and ongoing safety monitoring has not identified any safety signal concerns inconsistent with the U.S. product label [5] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, including the world's first chikungunya vaccine [9][10] - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [10][11] - Revenues from Valneva's commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [11] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing significant health issues, with over 3.7 million cases reported in the Americas between 2013 and 2023 [7][8] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, with the disease's economic impact expected to grow due to climate change [8]

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]