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]

Shares of Valneva (VALN) rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.The safety of the vaccine wil ...

Core Insights - Valneva SE and LimmaTech Biologics AG have initiated a Phase 2 infant safety and immunogenicity study for Shigella4V2 (S4V2), a tetravalent bioconjugate vaccine candidate against shigellosis, marking a significant step in vaccine development [1][3][4] Industry Overview - Shigellosis is the second leading cause of fatal diarrheal disease globally, with an estimated 165 million infections annually, of which 62.3 million occur in children under five years [2][6] - The disease results in approximately 600,000 deaths each year, highlighting the urgent need for an effective vaccine [6] Study Details - The Phase 2 study (Identifier: NCT06523231) will involve around 110 nine-month-old infants to determine the optimal vaccine dosage for future Phase 3 trials [3] - The study is randomized, controlled, and blinded, taking place at a single site in Kenya, with results expected in the second half of 2025 [3] Company Statements - Dr. Juan Carlos, Chief Medical Officer of Valneva, emphasized the unacceptable mortality rates from shigellosis and the company's commitment to developing vaccines for unmet medical needs [4] - Dr. Patricia Martin, COO of LimmaTech, highlighted the trial's initiation as a significant milestone in their collaboration with Valneva to address this global health threat [4] Regulatory Status - The U.S. FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious health condition and fill an unmet medical need [5]

LOS ANGELES, April 7, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Valneva SE ("Valneva" or "the Company") (NASDAQ: VALN) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Valneva is the subject of a CDC notice posted on February 25, 2025. According to the go ...

Saint Herblain (France), April 1, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 12 years of age and older. This label extension complements the adult marketing authorization in Europe Valneva received in July 20241. With this approval, IXCHIQ® becomes avail ...

With this extension, IXCHIQ®, the first vaccine against the chikungunya virus (CHIKV), is now available for administration for individuals 12 years of age and older in the European Union (EU). Saint Herblain (France), April 1, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individ ...

Core Viewpoint - Valneva SE has filed a prospectus supplement to renew its registration statement for an At-the-Market (ATM) offering program, allowing it to sell up to $75 million of American Depositary Shares (ADS) [1][2]. Group 1: ATM Program Details - The ATM Program allows Valneva to offer and sell ADSs representing two ordinary shares, with a total gross amount of up to $75 million [2]. - The program was originally established in August 2022 but has not been utilized to date [1]. - The Sales Agreement with Jefferies LLC will remain in effect until the maximum amount is reached or terminated early [2]. Group 2: Use of Proceeds - Valneva intends to use the net proceeds from the ATM Program to fund manufacturing, commercialization, research and development of its products, working capital, and other general corporate purposes [5]. Group 3: Regulatory and Market Information - The ADSs are listed on the Nasdaq Global Market under the symbol "VALN," while the ordinary shares are listed on Euronext Paris under the symbol "VLA" [4]. - The ADSs will be issued under a shelf registration statement on Form F-3, which is pending effectiveness by the SEC [3][12]. Group 4: Share Capital Increase - The issuance of ADSs may occur through share capital increases without preferential subscription rights, with a maximum of 7,666,666 ordinary shares available for issuance [7]. - This represents a potential dilution of approximately 4.5% based on the existing share capital [7]. Group 5: Investor Eligibility - The ATM Program is available only to qualified investors, including individuals and entities involved in the pharmaceutical and biotechnology sectors [9][10].

Core Points - Valneva SE, a specialty vaccine company, filed its 2024 Universal Registration Document with the French Financial Markets Authority and its Form 20-F with the U.S. Securities and Exchange Commission on March 24, 2025 [1] - The 2024 Universal Registration Document includes the Company's Annual Financial Report, Annual Management Report, Corporate Governance Report, and Sustainability Statement [2] - These documents are accessible on Valneva's website and will also be available on the AMF and SEC websites [3] Company Overview - Valneva SE focuses on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [4] - The company has successfully advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines, including the world's first chikungunya vaccine [5] - Revenues from the commercial business support the advancement of the vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development partnered with Pfizer and the most clinically advanced Shigella vaccine candidate [6]

Financial Performance - The company reported net losses of €12.2 million, €101.4 million, and €143.3 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated net loss of €563.9 million as of December 31, 2024[31]. - The company may require additional funding to finance operations and achieve strategic ambitions, with potential delays or reductions in planned investments if capital is not raised[37]. - Rising inflation and interest rates may increase operating costs and reduce profitability, posing challenges to financial performance[142][144]. - The company’s cash and cash equivalents are held in third-party financial institutions, which may exceed insurance limits, posing a risk if these institutions face adverse conditions[147]. Regulatory and Approval Challenges - The company anticipates that if the Phase 3 trial of its Lyme disease vaccine candidate is successful, Pfizer will apply for regulatory approval in the United States and European Union in 2026[32]. - Regulatory uncertainties and changes, including the recent U.S. Supreme Court decision, could adversely impact the company’s ability to obtain approvals for future product candidates[49]. - The company has experienced delays in regulatory approvals, such as the Phase 2 pediatric study for S4V2, shifting the target for submission of a BLA for the Lyme disease vaccine candidate from 2025 to 2026[65]. - Regulatory authorities may impose additional testing or monitoring requirements for the company's product candidates, which could significantly impact business operations[82]. - The company is subject to ongoing regulatory oversight for its current and future products, which may include costly post-marketing testing[80]. - Manufacturing facilities and clinical trial sites are subject to significant government regulations, and failure to comply could lead to fines, suspensions of clinical trials, or delays in product approvals[171]. Market and Competitive Landscape - The company is focusing on the commercialization of approved products for chikungunya, Japanese encephalitis, and cholera, but market opportunities may differ significantly from estimates[54]. - The company faces intense competition from major pharmaceutical companies and specialized biotechnology firms, which may have greater resources and experience[104]. - The company may not be successful in gaining significant market share for approved product candidates due to competition from similar products[108]. - The company is exposed to various risks when penetrating multiple markets, including foreign currency fluctuations and complex regulatory requirements[95]. Clinical Trials and Development Risks - Enrollment and retention of subjects in clinical trials are critical and may be hindered by various factors, including public perception and competing vaccines[73]. - Clinical trials are expensive and time-consuming, with potential delays negatively impacting the commercialization of product candidates[62]. - The company may face increased development costs if clinical trials experience delays, particularly for the Lyme disease vaccine candidate currently in Phase 3 trials[67]. - Negative results in clinical trials could hinder recruitment for future studies, leading to increased costs and program delays[74]. - The company relies on third-party organizations for clinical trials, which may affect the timely conduct and adherence to regulations, impacting development programs[74]. Supply Chain and Manufacturing - The company relies on single-source suppliers for critical materials, such as fetal bovine serum, which could impact production if supply is disrupted[112]. - The manufacturing facility in Livingston, Scotland is the sole source of commercial quantities of drug substance for IXIARO and IXCHIQ, while the facility in Solna, Sweden is the sole source for DUKORAL, making them critical to supply[164]. - The company may be required to increase manufacturing capacity to meet demand for approved products, which could be complex and affected by external factors[165]. - The company has outsourced important manufacturing steps, which could lead to delays or inconsistencies in production[168]. Intellectual Property and Legal Risks - The company’s ability to obtain and maintain patent protection is critical, as failure to do so could allow competitors to commercialize similar products, adversely affecting market position[178]. - Patent prosecution is complex and costly, and the company may not be able to maintain all necessary patent rights, which could limit competitive advantages[182]. - The company faces risks of legal proceedings alleging infringement of third-party intellectual property rights, which could negatively impact its business success[194]. - If found to infringe third-party patents, the company may be required to obtain licenses, potentially incurring significant fees and royalties, which could impair commercialization efforts[196]. - The company may be involved in lawsuits to protect its patents, which could be expensive and time-consuming, potentially distracting management from core business activities[203]. Cybersecurity and Operational Risks - Cybersecurity threats are increasing in frequency and sophistication, posing risks to the company's IT systems and confidential information[152]. - The company has experienced past cyberattacks and anticipates continued threats, which could disrupt operations and impact financial condition[150]. - Any significant system failure or security breach could have a material adverse effect on the company's business and financial condition[153]. - The company relies on several third-party contract manufacturing organizations (CMOs) for the manufacture and supply of components, with some materials sourced from a single or limited number of suppliers, posing a risk to production continuity[170]. Strategic Collaborations and Partnerships - Strategic collaborations, such as the one with Pfizer for the Lyme disease vaccine, may require relinquishing control over development and commercialization, impacting financial conditions post-2025[68]. - The company relies on collaborations with biopharmaceutical companies for marketing and distribution, which may be impacted by the termination of existing agreements[115]. - The company has drawn down $200 million (€192.5 million) under a Financing Agreement, with loans bearing interest at 9.95%[41]. - The Financing Agreement includes covenants for minimum revenue and liquidity set at €115 million and €35 million, respectively, which the company has amended several times since 2020 due to revenue recognition delays[42].