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...
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...
Saint-Herblain (France), November 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at upcoming investor conferences in the United States and Europe. Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host moderated “fireside chat” presentations to discuss the Company’s key value drivers and...
Live event and webcast TODAY at 10 AM ET Saint Herblain (France), October 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an investor day today in New York City to discuss the Company’s key value drivers over the next 12-18 months and beyond. Valneva’s Chief Executive Officer Thomas Lingelbach, Chief Financial Officer Peter Bühler, and other members of the Company’s senior leadership team will highlight the Company’s substantial...
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...
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. Context of the Offering The...
VALNEVA Declaration of shares and voting rights August 31, 2024 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B Declaration date: September 4, 2024 Number of shares composing the share capital of Valneva Total number of voting rights including suspended voting rights* Description of the change Date on which this...
VLA15-221 Phase 2 study: strong immune response shown one month after a second booster dose (month 31) in pediatric and adult populations Significant anamnestic antibody response observed across all six serotypes, consistent with previous results Favorable safety profile of VLA15 observed in all age groups and for all vaccinations Saint-Herblain (France) and New York, NY, September 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive...
First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasing Net Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost...
VALNEVA Declaration of shares and voting rights July 31, 2024 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B Declaration date: August 6, 2024 Number of shares composing the share capital of Valneva Total number of voting rights including suspended voting rights* Description of the change Date on which this...
VALNEVA Declaration of shares and voting rights May 31, 2024 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B Declaration date: June 4, 2024 Number of shares composing the share capital of Valneva Total number of voting rights including suspended voting rights* Description of the change Date on which this change...
Saint-Herblain (France), June 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024. Valneva will present and meet with global institutional investors to discuss VLA15, the world’s leading Lyme Disease vaccine candidate, in Phase 3 development and partnered with Pfizer; the Company’s growing commercial business,...
Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024. Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio. Specifically, Dr. Schuitemaker will focus on accelerating Valneva’s...
Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV) 1 . Significantly extended cash runway with recent update of debt financing agreement 2 Substantially lower cash burn expected in 2024 as Valneva expects to complete its...
VALNEVA Declaration of shares and voting rights March 31, 2024 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B Declaration date: April 4, 2024 Number of shares composing the share capital of Valneva Total number of voting rights including suspended voting rights* Description of the change Date on which this...
Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). There are currently no preventive vaccines or effective treatments available against ZIKV. As such, this mosquito-borne disease remains a public health threat and is...
Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC). Valneva’s 2023 Universal Registration Document – available in its entirety in French – includes the Company’s 2023...
Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV) 1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway 2 Operational...
Reimbursements deferred by 18 months to start in January 2026 instead of July 2024 Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed to extend the interest-only period of its existing loan by eighteen months. Reimbursements of the first $100 million tranche will now start in January 2026 instead...
Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA. Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen...