Valneva SE (VALN) Stock

The FDA application complements recent label extension submissions to the EMA and Health Canada, highlighting Valneva's strategic push to enhance IXCHIQ's global reach.

To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ®.

Saint Herblain (France) and Schlieren (Zurich) , November 13, 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 first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech1.

Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 million Net Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2 Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidance between €160 million to €170 million and currently anticipated total revenues between €170 million and €180 million Expected R&D investments between €65 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Launch of the world's first chikungunya vaccine in Canada and Europe underway; Further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025); Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution         Secured exclusive worldwide license for S4V2 Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline3 - recently granted FDA Fast Track4 Submitted key label extension(s) for IXCHIQ® in Europe and Canada5 Published IXCHIQ® two-year antibody persistence and safety data in the Lancet Infectious Diseases6 further demonstrating the vaccine's highly differentiated immunological profile Awarded new $41.3 million CEPI grant7 to contribute significantly to IXCHIQ® Phase 4 costs and other studies supporting broader access to the vaccine Pfizer completed primary vaccination (three doses) in Phase 3 VALOR Lyme disease trial8 Advancing Phase 1 clinical trial for second-generation Zika vaccine candidate toward expected data readout and further decision on potential development path in 20259 Financial Information (Unaudited results, consolidated per IFRS) € in million Nine months ended September 30,   2024 2023 Total Revenues 116.6 111.8 Product Sales 112.5 106.1 Net profit/(loss) 24.7 -69.3 Adjusted EBITDA10 48.6 -46.0 Cash 156.3 171.3 Saint-Herblain (France), November 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2024. The condensed consolidated interim financial results are available on the Company's website ( Financial Reports – Valneva ).

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.

Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The meeting will be conducted in a hybrid way – in person and webcast. To register, click here.

To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing.

Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000.

Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22.6 million new ordinary shares (the “Offer Shares”) at a price of €2.66 per Offer Share to certain categories of investors via a private placement through an accelerated bookbuilding process starting immediately.