Chikungunya Fever

Integral Molecular, a company that develops vaccines and therapeutics, announced a five-year $8 million contract from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). The funding will be used to support the company's continuing research into emerging viruses recognized as potential pandemic threats. This marks the fourth similar contract awarded to the company in 15 years. Prior contracts allowed responses to virus outbreaks such as SARS-CoV-2, Zika, Ebola, dengue and chikungunya. Integral Molecular will utilize its mapping platform to pinpoint antibody binding sites (epitopes) on viruses, characterizing immune responses to viral threats. According to the company, this type of information can help scientists design effective vaccines. Additionally, Integral Molecular's Reporter Virus Particles (RVPs) is expected to play a vital role in the research. In a statement, the company said the non-replicative virus particles allow safe and high-throughput neutralization studies of highly pathogenic viruses with the use of standard laboratory facilities, and RVPs empower researchers to quickly develop vaccines and therapeutics. The NIAID contract will allow Integral Molecular to expand its research on potential pandemic threats, including Rift Valley Fever, Crimean-Congo Hemorrhagic Fever and Enterovirus D68 viruses. "We are grateful to NIAID for their continued support and trust in our capabilities," Benjamin Doranz, CEO of Integral Molecular, said in a statement. "Viral threats can emerge quickly and with little warning. This contract enables us to contribute to pandemic preparedness by focusing on understudied viruses identified as potential threats, using our technologies to make virology research more accessible to laboratories around the world." THE LARGER TREND In June, Integral Molecular, received ISO 9001 certification for the quality systems and processes used in their virology offerings. In April, Integral Molecular launched its Virus Neutralization Assay Services, which permitted researchers to rapidly obtain high-quality data to advance their vaccines and therapeutic antibodies. Neutralization Assay Services allow diverse applications including neutralization profiling for antibodies targeting viral proteins. That same month, researchers at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), developed an artificial intelligence tool that predicts whether a patient will respond to cancer-treatment drugs using individual tumor cells, according to a study published in Nature Cancer. Conventional approaches to drug-patient matching center on bulk sequencing of tumor DNA and RNA. The new AI approach, PERCEPTION, takes advantage of single-cell RNA sequencing, which provides better-resolution data to fine-tune predicted drug responses. In 2022, Ro, a direct-to-patient care company, secured an agreement with the National Institute on Aging (NIA) to develop the Registry for Equal Access to Clinical Trials in Alzheimer's Disease (REACT-AD). Ro will employ its telehealth platform to screen and recruit patients who are at a heightened risk for developing Alzheimer's disease or other related dementia to join REACT-AD for potential participation in NIA-conducted and funded clinical trials. The NIA, part of the NIH, was charged with analyzing the data received and supervising the publication of research findings that emanate from REACT-AD.

Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s first and only approved chikungunya vaccine, IXCHIQ ® , at several leading scientific conferences during the fourth quarter of 2024. At the International Society of Vaccines Annual Congress taking place in Seoul, South Korea, Valneva will present on the two-year antibody persistence and safety data of its single-dose chikungunya vaccine in adults aged 18 years and above today at 5:00 pm Korea Standard Time (KST). The Company will also display a poster at the event complementing the presentation. At the American Society of Tropical Medicine and Hygiene (ASTMH) 2024 Annual Meeting in New Orleans, Louisiana, Valneva will hold a presentation on the pivotal Phase 3 six-month safety and immunogenicity data of its single-dose chikungunya vaccine in adolescents in Brazil on November 16, 2024, at 11:15 am Central Daylight Time (CDT). The Company will also display four posters: “Chikungunya: Ongoing Dose-Response, Safety, and Immunogenicity Phase 2 Trial of Single-dose Live-attenuated Vaccine (VLA1553) in Children aged 1 to 11 years”, “Modelling of 5 Year Antibody Persistence after Vaccination with Live Attenuated Chikungunya Vaccine VLA1553 (IXCHIQ ® )”, “The Global Health Burden of Chikungunya from 2011 to 2020: A Model-Driven Analysis on the Impact of an Emerging Vector-Borne Disease” and “Predicting Chikungunya in Miami: Outbreak Impact and Effectiveness of Vaccine Intervention with IXCHIQ ® ”. Finally, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European Congress taking place November 17 - 20, 2024 in Barcelona, Spain, Valneva will present a poster on the cost-effectiveness of IXCHIQ ® vaccination in Puerto Rico. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years. 1 In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas. 2 Between 2013 and 2023, more than 3.7 million cases were reported in the Americas 3 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem. 4 About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at . Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 2 3 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). . Last accessed 01 Aug 2023. 4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2024_10_21_Chik_Q4_2024_Conference_Presentations_PR_EN_Final

October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech. Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who need them earlier1. Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO). Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.” Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, stated, “We are highly encouraged by the FDA’s Fast Track designation, which reinforces our efforts and underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat.” It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year, particularly among children in Low- and Middle-Income Countries (LMICs). Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions. In August 2024, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech2 for the development, manufacturing and commercialization of S4V. Following positive Phase 1/2 results3 earlier this year, LimmaTech will conduct a Phase 2 Controlled Human Infection Model study (CHIM) in the U.S. and a Phase 2 pediatric study in LMICs, both expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved. The anticipated regulatory pathway for S4V will leverage a combination of CHIM studies to support potential initial approval in adults followed by field efficacy studies to potentially expand the indication to children. Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections4 are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths5. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available. We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. 1 Fast Track | FDA 2 2024_08_01_VLA_LMTB_S4V_PR_EN_Final.pdf (lmtbio.com) 3 20240221_LimmaTech_Shigella-Interim-Data-PR_Final.pdf (lmtbio.com) 4Shigellosis | CDC Yellow Book 2024 5 Shigellosis | CDC Yellow Book 2024 The content above comes from the network. if any infringement, please contact us to modify.