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

Pfizer Inc. PFE, +1.70% said Tuesday that an experimental Lyme disease vaccine it's developing with Valneva SE VALN, -13.23% will move into a Phase 3 clinical trial that includes children who are at least 5 years old, based on "positive" results among pediatric participants from the Phase 2 study. The Phase 3 trial is expected to begin in the third quarter.

Pfizer, Valneva plan to move Lyme disease vaccine candidate into Phase 3 trial

SAINT-HERBLAIN, France & NEW YORK--(BUSINESS WIRE)--Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be

Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate

Saint - Herblain (France), April 2 6 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $60 million debt financing agreement with funds managed by leading US-based healthcare investment firms Deerfield Management Company and OrbiMed. This extension will provide Valneva immediate access to $20 million, with an additional $20 million available upon potential conditional approval of its inactivated COVID-19 vaccine candidate, VLA2001, by the European Medicines Agency. The increased funding will be used to further invest in R&D, including market access preparations for Valneva's chikungunya vaccine candidate, VLA1553.

Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed

Saint Herblain (France), April 25 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the rolling review process of its inactivated, COVID-19 vaccine candidate, VLA2001, with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”).

Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate

The Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE's (NASDAQ: VALN)COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age. MHRA found that VLA2001 meets safety,.

Valneva Shares Jump As Its COVID-19 Vaccine Receives Conditional Approved In UK

Saint Herblain (France), April 14 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age.

Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine

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Saint - Herblain ( France), March 24 , 20 22 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing of its 2021 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) on March 23, 2022 under the filing number D.22-0140 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC) on March 24, 2022.

Valneva Announces Filing of 2021 Universal Registration Document and US Form 20-F

Valneva Reports Full Year 2021 Results and Provides Corporate Updates

Saint- Herblain (France), March 16 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, announces today that its Supervisory Board has renewed the term of office of the Company's Management Board members for an additional three years starting at the end of the Company's June 2022 Annual General Meeting (AGM).

Valneva Announces Renewal of the Term of Office of its Management Board Members

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Saint Herblain (France), March 1 1 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the regulatory review of its inactivated, COVID-19 vaccine candidate, VLA2001, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Valneva Provides Regulatory Update on its COVID-19 Vaccine Candidate

Valneva's (VALN) phase III study evaluating its chikungunya vaccine achieves all primary and secondary endpoints. The stock rises 9.2% following the announcement.

Valneva (VALN) Completes Phase III Chikungunya Vaccine Study

Valneva SE (NASDAQ: VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year.

Read Why Valneva's Stock Gained 7% Today

Saint Herblain ( France), March 8 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021. Valneva now expects to commence the pre-submission process with the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

VALNEVA Declaration of shares and voting rights - February 28, 2022

Saint Herblain (France), March 1 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valneva's inactivated, adjuvanted COVID-19 vaccine, VLA2001. This authorization follows a rolling review process with the Bahraini NHRA and reflects the NHRA's initiative to support the authorization of COVID-19 vaccines.

Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001

Saint Herblain (France), February 25, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided an initial assessment of Valneva's inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva has received a list of questions from the CHMP and is confident that it will be able to respond to these in the coming days. Following the Company's response, the EMA will provide a timetable towards anticipated conditional approval.

Valneva Receives Initial CHMP Assessment of its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

Saint Herblain ( France), February 21 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its subsidiary Valneva Scotland has been awarded research and development funding of up to £20 million by Scottish Enterprise.

Valneva Awarded Up to £20 Million by Scottish Enterprise to Advance Vaccine Development

Valneva SE VALN and Pfizer Inc PFE have reported further Phase 2 data for their Lyme disease vaccine candidate, VLA15.  Get the Inside Access Traders Are Using to Profit More and Win Bigger.

Valneva - Pfizer Choose Three-Dose Schedule For Lyme Vaccine Candidate Moving Forward

Saint-Herblain (France) and New York, February 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in 2022, subject to regulatory approval.

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

Total revenues of €348.1 million in 2021 compared to €110.3 million in 2020 – an increase of 216%

Valneva Reports Full Year 2021 Revenue and Cash; Provides First 2022 Guidance

CEPI-funded trial intended to support potential label expansion in this age group

Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate

Valneva SE (NASDAQ: VALN) has started booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare.  This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results.

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