Valneva SE

Valneva SE is a specialty vaccine company. The firm focuses on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. It takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. It operates through the following segments: Commercialized products, COVID, Vaccine candidates and Technologies and services. The Commercialized products segment markets vaccines, currently IXIARO and DUKORAL vaccines, as well as third-party products. The COVID segment engages in the development, manufacturing and distribution related to COVID-19 vaccine candidate, VLA2001. The Vaccine candidates segment engages in proprietary research and development programs aiming to generate new approvable products in order to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies, excluding COVID-19 vaccine candidate, VLA2001. The Technologies and services segment provides services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q4 2021

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Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. It currently provides three proprietary travel vaccines: IXIARO, DUKORAL, and IXCHIQ. The IXIARO is an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis in adults, adolescents, children, and infants aged two months and older. The DUKORAL is a drinkable vaccine that helps prevent diarrhea caused by heat-labile toxin-producing ETEC, as well as cholera. The IXCHIQ is a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus. The company also offers additional vaccines, including VLA1553, VLA15, VLA160, VLA200, VLA1601 and others. Valneva was founded on May 28, 2013 and is headquartered in Saint-Herblain, France.

Pfizer

Saint-Herblain (France) & New York , September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. These results from the VLA15-221 Phase 2 study showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19).

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Saint- Herb lain (France ) , August 31 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023.

Valneva to Participate in Investor Conferences in the United States and Europe in September 2023

Saint - Herblain ( France), August 29 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has completed screening validation of the Company's regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canada's performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Health Canada Accepts Valneva's Chikungunya Vaccine License Application for Review

Saint- Herb lain (France ) , August 28 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. Immunogenicity data for the trial are expected in November 2023.

Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

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MATFORS, Sweden, Aug. 23, 2023 (GLOBE NEWSWIRE) -- NorthX Biologics AB, (‘NorthX'), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, today announces that it has appointed Dr Janet Hoogstraate as its new Chief Executive Officer with immediate effect. This move follows the company's strategic merger with Valneva Sweden's Clinical Trial Manufacturing Unit announced July 3, 2023

NorthX Biologics Welcomes Dr Janet Hoogstraate as New CEO Following Merger with Valneva Clinical Trials Manufacturing Unit

Up to an additional $100 million made available in two tranches Saint - Herblain ( France ), August 1 7 , 202 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed. The add-on loan facility provides Valneva with immediate access to $50 million, with an additional $50 million available at the Company's discretion until December 31, 2023.

Valneva Announces Extension of Existing Loan Agreement

Saint - Herblain ( France), August 14 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, Valneva's chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November.

Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate

Positive Phase 3 data from Bavarian Nordic's chikungunya virus (CHIKV) vaccine candidate, PXVX0317, reinforces bullish view on Valneva's VLA1553 due to its superior clinical profile. Valneva's VLA1553 demonstrated impressive seroresponse rates and durability, with future data releases from Bavarian Nordic's additional Phase 3 trial expected to provide a comprehensive comparison between the two vaccines. Valneva has submitted a regulatory application to Health Canada for VLA1553 approval and received Fast Track.

Valneva: VLA1553 Takes The Lead In The Chikungunya Vaccine Race

Saint - Herblain ( France), June 2 2 , 202 3 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its Supervisory Board has recommended a change of governance model.

Valneva Supervisory Board Recommends Transition from a Two-Tier Governance Model to a Board of Directors

Saint - Herblain ( France), June 2 1 , 202 3 – Valneva S E (Nasdaq: VALN; Euronext 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.

Valneva Announces Successful Outcome of its AGM and the Appointment of Pfizer's Former Vaccine R&D Head to its Supervisory Board

Valneva SE Sponsored ADR (VALN) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Strength Seen in Valneva SE Sponsored ADR (VALN): Can Its 15.8% Jump Turn into More Strength?

Saint- Herb lain (France ) , June 13 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company's pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world's leading peer-reviewed medical journal.

Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet

Saint-Herb lain (France ) , May 3 1 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Combined General Meeting to be held on June 21, 2023 at 2 p.m. CEST, at the hotel InterContinental Lyon – Hotel Dieu, 20 Quai Jules Courmont, 69002 Lyon (France).

Valneva Announces the Availability of Documentation for its Shareholder Meeting

The European Commission's revised advance purchase agreement jeopardizes Valneva's (VALN) COVID-19 vaccine program.

Valneva (VALN) Stock Down 53% in the Past Year: Here's Why

Saint- Herb lain (France ) , May 30 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company's single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above. If accepted, Health Canada will provide additional information on the potential approval timeline.

Valneva Files for Chikungunya Vaccine Authorization with Health Canada

Valneva SE (NASDAQ:VALN ) Q1 2023 Earnings Conference Call May 4, 2023 9:00 AM ET Company Participants Joshua Drumm - VP, IR Thomas Lingelbach - Chairman, President & CEO Peter Buhler - CFO Conference Call Participants Kevin Strang - Jefferies Edward White - H.C. Wainwright & Co Boran Wang - Guggenheim Securities Simon Scholes - First Berlin Rajan Sharma - Goldman Sachs Group Samir Devani - Rx Securities Limited Max Herrmann - Stifel, Nicolaus & Company Operator Good day and thank you for standing by.

Valneva SE (VALN) Q1 2023 Earnings Call Transcript

Product sales increased 98.6% to €3 2 . 1 million in the first quarter of 202 3 compared to € 16 . 2 million in the first quarter of 2022

Valneva Reports First Quarter 2023 Financial Results and Provides Corporate Updates

Saint - Herblain ( France), March 31 , 20 2 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 30 2023, of its 2022 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.23-0199 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).

Valneva Announces Filing of 2022 Universal Registration Document and US Form 20-F

Saint Herblain (France), March 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23rd World Vaccine Congress in Washington, D.C.

Valneva to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C.

Valneva's pipeline and high-stakes clinical catalysts warrant a buy rating, despite the setback in its Lyme disease Phase 3 trial. The CHIKV vaccine candidate is on track for PDUFA in August 2023, and the company plans to launch one or two programs in clinical trials by the close of 2023.

Valneva Q4: Resilient Pipeline And Partnership With Pfizer, Reinforcing A Promising Future

Valneva SE (NASDAQ:VALN ) Q4 2022 Earnings Conference Call March 23, 2023 10:00 AM ET Company Participants Joshua Drumm - Vice President of Investor Relations Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Evan Wang - Guggenheim Securities Max Herrmann - Stifel Nicolaus Rajan Sharma - Goldman Sachs Samir Devani - Rx Securities Operator 0Good day, and thank you for standing by. Welcome to the Valneva Full-Year 2022 Financial Results Conference Call.

Valneva SE (VALN) Q4 2022 Earnings Call Transcript

Total revenue s of €3 6 1 . 3 million in 202 2 compared to €348 . 1 million in 2021

Valneva Reports Full Year 2022 Results and Provides Corporate Updates

Dynavax Technologies

Saint - Herblain ( France), March 2 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001. As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a new partnership1. It is, however, completing remaining clinical studies and submissions as agreed with regulators.

Valneva Provides Clinical and Regulatory Updates for its COVID-19 Vaccine VLA2001

Saint- Herb lain (France) , March 1 , 2 02 3 – 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 the Cowen 43rd Annual Healthcare Conference, to take place in-person March 6 - 8, 2023 in Boston, Massachusetts.

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