Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ , to UK MHRA ® Saint Herblain (France), March 31, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ , currently approved in adults , to adolescents aged 12 to 17 ...

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].

Core Viewpoint - Valneva SE is responding to a chikungunya outbreak in La Réunion by providing 40,000 doses of its vaccine IXCHIQ, with a focus on vaccinating vulnerable populations, particularly adults aged 65 and over with co-morbidities [1][2][4]. Group 1: Company Actions and Vaccine Details - Valneva will supply 40,000 doses of IXCHIQ starting in early April, with the option to provide more doses as needed [1]. - IXCHIQ is the world's first licensed chikungunya vaccine, approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5]. - The company is focused on expanding access to IXCHIQ, including a partnership with CEPI that received a $41.3 million grant to enhance vaccine access in Low- and Middle-Income Countries (LMICs) [5][6]. Group 2: Public Health Context and Response - Chikungunya cases in La Réunion have surged, with 8,600 cases reported and nearly 3,000 new cases in the week of March 3 to 9, 2025, prompting local authorities to implement a Level 4 emergency crisis management plan [2]. - The Haute Autorité de Santé recommended prioritizing vaccination for adults aged 65 and over, especially those with co-morbidities, followed by adults aged 18 and over with co-morbidities [4]. - The CDC has issued a travel alert due to the outbreak, highlighting the potential for transmission to mainland France and other territories [2]. Group 3: Broader Implications and Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ in Asia, ensuring affordable access to public health markets in LMICs [6][7]. - The company previously established a partnership with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for Latin American countries [7]. - The World Health Organization has identified chikungunya as a significant public health issue, with the disease affecting over 110 countries and the economic impact expected to grow due to climate change [9].

Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France’s Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the I ...

Company Overview - Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, addressing unmet medical needs [10][11] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines, including the world's first and only chikungunya vaccine, IXCHIQ® [11][12] Chikungunya Vaccine Response - Valneva is responding to a chikungunya outbreak in France's Island of La Réunion by providing 40,000 doses of its vaccine IXCHIQ® starting in early April 2025, with the option to supply more [1] - The vaccine supply is supported by the local public health agency and is prioritized for adults aged 65 and over with co-morbidities, as recommended by France's national public health agency [1][4] Outbreak Context - Chikungunya cases in La Réunion have surged, with 8,600 cases recorded and almost 3,000 new cases reported during the week of March 3 to 9, 2025 [2] - Local authorities have implemented a Level 4 emergency crisis management plan to contain the outbreak, and the CDC has issued a travel alert due to the risk of transmission to mainland France [2] Vaccine Approval and Expansion - IXCHIQ® is the first licensed chikungunya vaccine approved in the U.S., Europe, Canada, and the UK for individuals aged 18 and older, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5] - Valneva is focused on expanding the vaccine's label and access, including a partnership with CEPI supported by a $41.3 million grant to enhance access in Low- and Middle-Income Countries (LMICs) [5][6] International Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply the chikungunya vaccine in Asia at affordable prices for public health markets in LMICs [6][7] - This agreement complements a previous license signed with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for distribution in Latin America and selected LMICs [7]

Joshua Drumm Thank you. Hello, and thank you for joining us to discuss Valneva’s Full Year 2024 Results and Corporate Update. It’s my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the 12 months ended December 31, 2024, which were published earlier today available within the Financial Reports section on our Investor website. I’m joined today by Valneva’s CEO, Thomas Lingelbach; and CFO, Peter Bühler, who will prov ...

Core Insights - Valneva SE reported consolidated financial results for the year ended December 31, 2024, highlighting double-digit sales growth and significant clinical and regulatory progress, setting the stage for future advancements in 2025 [1][3][5]. Financial Performance - Product sales increased by 13% to €163.3 million in 2024 from €144.6 million in 2023, while total revenues rose by 10% to €169.6 million from €153.7 million [6][35]. - The net loss for 2024 was €12.2 million, a significant improvement from a net loss of €101.4 million in 2023, largely due to the sale of a Priority Review Voucher [6][46][47]. - Operating cash burn was reduced by 67% to €67.2 million in 2024 compared to €202.7 million in 2023, with cash and cash equivalents at €168.3 million at year-end [5][49][51]. R&D and Regulatory Highlights - Valneva made substantial clinical and regulatory progress, including the completion of primary vaccinations in the Phase 3 study for its Lyme disease vaccine candidate, VLA15, and securing additional regulatory approvals for its chikungunya vaccine, IXCHIQ® [7][24][30]. - The company anticipates further data readouts and product approvals in 2025, with a focus on advancing its science-driven pipeline [5][6]. Product Portfolio - Valneva's commercial portfolio includes three vaccines: IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®, with IXIARO® sales increasing by 28% to €94.1 million in 2024 [10][11][36]. - DUKORAL® sales grew by 8% to €32.3 million, driven by increased demand in Canada [13][37]. - Initial sales of IXCHIQ® amounted to €3.7 million in 2024 following its launch in multiple markets [38]. Future Outlook - The company expects product sales to grow to €170-180 million and total revenues to reach €180-190 million in 2025, with R&D investments projected between €90-100 million [6][5]. - Valneva aims to maintain a strong cash position to support strategic investments while targeting a more than 50% reduction in operating cash burn in 2025 [5][6].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Valneva SE and its officers or directors following adverse events reported after vaccination with its chikungunya virus vaccine [1][2]. Group 1: Investigation Details - The investigation is initiated on behalf of investors of Valneva SE, focusing on possible securities fraud or other unlawful business practices [1]. - The U.S. Centers for Disease Control and Prevention (CDC) is investigating five hospitalizations for cardiac or neurologic events in individuals aged 65 and older after receiving Valneva's chikungunya virus vaccine [2]. Group 2: Market Impact - Following the CDC's announcement, Valneva's American Depositary Receipt (ADR) price dropped by $1.06, or 13.57%, closing at $6.75 per ADR on February 28, 2025 [2]. Group 3: Firm Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [2].