New debt facility extends repayment from Q1 2026 to Q4 2030, lowers interest rate and provides access to additional capital for future business developmentCompany adjusts 2025 financial guidance and provides key business updates Saint-Herblain (France), October 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a debt facility for up to $500 million in non-dilutive financing with funds managed by Pharmakon Advisors, LP. An initial ...

Long-lasting antibody persistence was comparable in older (65+) and younger adultsLong-term antibody persistence is a key competitive advantage for a vaccine targeting unpredictable outbreak diseases like chikungunya Saint-Herblain (France), September 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data four years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s ...

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Valneva SE regarding possible violations of federal securities laws and unlawful business practices following adverse events related to its chikungunya virus vaccine, IXCHIQ [2][3][4] Group 1: Legal Investigation - The law firm is encouraging Valneva stockholders who have suffered losses to contact them for discussions about their legal rights [1][5] - The investigation is focused on whether Valneva has engaged in unlawful business practices that may have affected stockholder interests [2] Group 2: Recent Events Impacting Valneva - On February 25, 2025, the CDC announced an investigation into five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ, leading to a 13.57% drop in Valneva's ADR price, closing at $6.75 on February 28, 2025 [3] - On August 22, 2025, the FDA suspended the marketing application for IXCHIQ due to safety concerns, resulting in an 18.99% decline in Valneva's ADR price, closing at $9.43 on August 25, 2025 [4]

Core Insights - Valneva SE announced positive immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, showing strong immune response and favorable safety profile after a third booster dose [1][3][4] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [12] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [13] Vaccine Development - VLA15 is the only Lyme disease vaccine candidate in advanced clinical development, with two Phase 3 trials nearing completion [2][6] - The vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease, and aims to inhibit the bacterium's ability to infect humans [6][8] Clinical Study Results - The Phase 2 study (VLA15-221) involved 560 healthy participants aged 5 to 65, demonstrating a 100% seroconversion rate across all age groups after the third booster dose [3][9] - The safety profile after the third booster was consistent with previous doses, with no safety concerns reported by the independent Data Monitoring Committee [4][7] Market Need - There are currently no approved human vaccines for Lyme disease, with approximately 476,000 cases diagnosed annually in the U.S. and 132,000 in Europe, highlighting a significant unmet medical need [2][11] - The geographic expansion of Lyme disease increases the urgency for vaccination solutions [3][11] Collaboration - Valneva has a collaboration agreement with Pfizer for the development and commercialization of VLA15, initiated in April 2020 [4]

Group 1 - U.S. stocks experienced mixed performance, with the Dow Jones index declining over 200 points on Monday [1] - Keurig Dr Pepper Inc. shares fell sharply by 7.8% to $32.38 following the announcement of its acquisition of JDE Peet's [1] - Valneva SE shares dropped 21% to $9.19 after the FDA suspended the license for IXCHIQ [3] Group 2 - DeFi Development Corp. saw its shares dip 18% to $16.51 after announcing a $125 million offering of 4.2 million shares at $12.50 per share [3] - Venu Holding Corporation's shares fell 13.3% to $15.56 after announcing an offering of 1.7 million shares [3] - Axogen, Inc. shares declined 10.2% to $14.60 due to an FDA Major Amendment designation delaying the Avance Nerve Graft decision to December 5, 2025 [3]

Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Valneva SE regarding possible violations of federal securities laws due to alleged misrepresentations and omissions by the company and its executives [1] Company Developments - On August 25, 2025, Valneva acknowledged that the FDA suspended the license for its chikungunya vaccine Ixchiq, following four reports of serious adverse events, mandating the cessation of all shipping and sale of the vaccine within the United States [3] Legal Context - Investors who purchased Valneva securities and incurred significant losses may be eligible to participate in a potential class action or seek recovery of their losses [2]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ® due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs primarily among elderly individuals with multiple underlying health conditions [2] Financial Impact - Sales of IXCHIQ® contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] - Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ® license in the United States but has not modified its revenue guidance at this time [4] Commitment to Safety and Access - Valneva is committed to upholding high safety standards and will continue to engage proactively with health authorities in all territories where IXCHIQ® is licensed [3] - The CEO emphasized the company's commitment to maintaining access to IXCHIQ® as a global health tool for addressing chikungunya outbreaks, particularly in low-and-middle-income countries [4] Chikungunya Overview - Chikungunya virus (CHIKV) 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 [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, with the medical and economic burden expected to grow due to climate change [6]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs [2] Financial Impact - IXCHIQ sales contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] 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 [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Viewpoint - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ®, for individuals aged 12 years and older, marking a significant milestone in addressing the chikungunya virus [1][3]. Company Developments - IXCHIQ® is now authorized for adults in Canada and has received an adolescent label extension in Europe [1]. - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, with similar durability across age groups [2]. - Valneva's Chief Medical Officer emphasized the importance of making the vaccine accessible to all age groups, especially in endemic regions [3]. - IXCHIQ® was the first chikungunya vaccine approved in an endemic country, receiving authorization from Brazil earlier this year [3][4]. Industry Context - Chikungunya is increasingly recognized as a public health issue, with recent outbreaks reported in Brazil, India, and China [3][5]. - The World Health Organization has identified chikungunya as a major public health problem, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5]. - Valneva's partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) aims to enhance access to IXCHIQ® in low- and middle-income countries [3][4][6].

Core Insights - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ, for individuals aged 12 years and older, complementing previous authorizations in Canada and Europe [1][3][10] - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, indicating its long-term efficacy [2][5] - The approval is significant as chikungunya outbreaks are increasing globally, particularly in endemic regions, highlighting the need for accessible vaccination [3][4][5] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing vaccines from R&D to market [7] - The company currently markets three proprietary travel vaccines and is advancing multiple vaccine candidates, including those for Lyme disease and Zika virus [7] Industry Context - Chikungunya virus is a mosquito-borne disease causing severe joint pain and other debilitating symptoms, with over 3.7 million cases reported in the Americas from 2013 to 2023 [6] - The World Health Organization has identified chikungunya as a major public health issue, exacerbated by climate change and the geographical spread of mosquito vectors [6] - Valneva's partnership with CEPI aims to enhance access to IXCHIQ in low- and middle-income countries, addressing the growing public health threat posed by chikungunya [4][5]