SEC Form 6-K filed by Valneva SE
Valneva SE (Registrant) | ||||||||||||||||||||
Date: January 7, 2025 | /s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President |
Valneva SE (Registrant) | ||||||||||||||||||||
Date: January 7, 2025 | /s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President |
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Date | Price Target | Rating | Analyst |
---|---|---|---|
8/3/2022 | $34.00 | Buy | H.C. Wainwright |
SC 13D/A - Valneva SE (0001836564) (Subject)
SC 13G/A - Valneva SE (0001836564) (Subject)
SC 13D/A - Valneva SE (0001836564) (Subject)
H.C. Wainwright initiated coverage of Valneva SE with a rating of Buy and set a new price target of $34.00
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
6-K - Valneva SE (0001836564) (Filer)
Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet 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 placement2Lower 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 guidan
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 phasingNet 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 contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarterSignificantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial
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 agreement2Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected tot
Saint Herblain (France), January 30, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.Under this new one-year contract, the DoD will buy a minimum of $32.8 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO® doses have continued in 2024 under the supply contract signed in September 20231. The new contract will commence immediately. Dipal Patel, Chief Commercial Officer of Valneva commented, "We are
Saint-Herblain (France), January 22, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA) today announced positive results for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group. Trial VLA1553-221 met its primary endpoint, demonstrating that the vaccine was well tolerated b
Saint-Herblain (France), January 20, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.1, Europe, and Canada2. Data from this trial are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations. The o
Saint-Herblain (France), June 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business
Saint-Herblain (France), May 21, 2024 – Valneva SE (NASDAQ:VALN, 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 pre-clinical and translational R&D activities in support of the Company's strategic ambition to provide first-, best- or only-in-class vaccine solutions. Dr. Schuitemaker brings more than two decades of experience in vacc
Saint-Herblain (France), June 21, 2023 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2022 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, as well as the appointment of a new Supervisory Board member and the reappointment of two of them. Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva's Supervisory