Valneva Reports Full Year 2021 Results and Provides Corporate Updates

Valneva Reports Full Year 2021 Results and Provides Corporate Updates

Excellent progress on clinical programs

Lyme Disease Vaccine Candidate VLA15

Further positive Phase 2 results, including booster response

Phase 3 expected to commence in the third quarter of 2022

Inactivated COVID-19 Vaccine Candidate VLA2001

Positive pivotal Phase 3 results

Purchase Agreements approved by European Commission (EC) and Kingdom of Bahrain for up to 60 million doses

and one million doses, respectively, in 2022 and 2023

Positive homologous booster results between seven to eight months after primary vaccination

Confirmed neutralization of ancestral virus, Delta and Omicron variants in laboratory studies

Emergency Use Authorization granted in Bahrain; reviews ongoing with the European Medicines Agency (EMA)

and the UK Medicines and Healthcare products Regulatory Agency (MHRA)

Single-Shot Chikungunya Vaccine Candidate VLA1553

Final positive pivotal Phase 3 results

Pre-submission process expected to commence in the second quarter of 2022

Strong full-year 2021 revenues and cash position

Total revenues of 348.1 million in

2021 compared to 110.3 million in 2020 - an increase

Includes 94.8 million of product and other revenues (excluding COVID), at the higher end of the

Company's previously communicated guidance of 85 to 100 million, and

253.3 million of COVID-related revenues under the terminated UK agreement

Cash position of 346.7

million at December 31, 2021

Reflects $209.6 million of combined gross proceeds from Nasdaq initial public offering (IPO) and European

placement in May 2021, plus November 2021 follow-on offering, and

Pre-payments under the EC COVID-19 vaccine supply agreement

2022 financial guidance

Total revenues between 430 to 590 million expected, including:

350 to 500 million of COVID-19 vaccine sales subject to regulatory approvals and deliveries

60 to 70 million of other vaccine sales

Approximately 20 million of Other Revenues (revenues from collaborations, licensing and services)

R&D expenses expected between 160 million to 200 million

Financial Information

(2021 audited results, consolidated per IFRS)

Saint-Herblain (France), March

24, 2022 - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today

reported its audited consolidated financial results for the year ending December 31, 2021 and provided corporate updates. The 2021 audited

consolidated financial statements are available on the Company's website (Financial Reports - Valneva).

Valneva will provide a live webcast of its full-year 2021 results conference call beginning at 3 p.m. CET today. This webcast will

also be available on the Company's website. Please refer to this link: https://edge.media-server.com/mmc/p/qieuu6at

Peter B hler, Valneva's Chief Financial Officer, commented,

"2021 was an exceptional year for Valneva, marked by unprecedented R&D progress and our successful Nasdaq listing. We reported

positive Phase 3 results for two vaccine candidates (COVID-19 and chikungunya) and we expect both vaccines, if approved, to make a positive

change to people's lives. With close to 350 million in cash, we entered 2022 in a strong position and will continue to focus

on gaining regulatory approvals and preparing market entry for our key late-stage programs."

Clinical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE - VLA15

Phase 2 results reported

Valneva and Pfizer2 are developing VLA15, a Lyme disease vaccine candidate that targets the outer surface

protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. The vaccine candidate covers the six OspA serotypes expressed

by Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe.

In February 2022, Valneva and Pfizer reported further positive Phase 2 data for VLA153 confirming the robust

immunogenicity profile observed for adults (18-65 years) in previous Phase 2 studies. The companies are also evaluating VLA15 in pediatric

participants aged 5 to 17 years, with first data expected in the second quarter of 2022. Based on the latest Phase 2 results, Valneva

and Pfizer plan to proceed with a three-dose primary series vaccination schedule for adults (18-65 years) in a planned Phase 3 clinical

trial, which they expect to initiate in the third quarter of 2022, subject to regulatory approval.

SARS-CoV-2 VACCINE CANDIDATE - VLA2001

First Emergency Use Authorization

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19

in Europe. It is produced using Valneva's established Vero-cell platform, leveraging the manufacturing technology for the Company's

commercial Japanese encephalitis vaccine, IXIARO .

Valneva remains focused on achieving regulatory approvals of VLA2001. In March 2022, VLA2001 was granted emergency

use authorization from the Kingdom of Bahrain4. Valneva now expects to deliver the first VLA2001 shipments to Bahrain at the

end of March 2022 as per the purchase agreement signed in December 20215.

VLA2001 is in advanced review processes with the EMA and UK MHRA, as recently communicated6. Subject to

acceptance of Valneva's responses by the EMA's Committee for Medicinal Products for Human Use (CHMP), Valneva anticipates

receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age

in April 2022. Following such conditional approval, the Company would expect to start delivering planned doses of VLA2001 to European

countries in the second quarter of 2022. Valneva signed an agreement with the European Commission (EC) in November 2021 to supply up to

60 million doses of VLA2001 over two years, including 24.3 million doses in 20227 and the remainder via options in 2023.

In order to gradually expand the label and indications of VLA2001 to further age groups, Valneva is currently conducting

additional clinical studies, including for potential use as a homologous and heterologous booster vaccine in the course of 2022.

CHIKUNGUNYA VACCINE CANDIDATE - VLA1553

Final Positive Phase 3

Valneva is developing a single-dose vaccine candidate against the chikungunya virus, a mosquito-borne virus that has

spread to over 120 countries.

In March 2022, Valneva announced successful completion of the Phase 3 pivotal trial of VLA15538. The final

six-month analysis confirmed the very high level of seroprotection reported in August 2021. Six months after receiving a single vaccination,

96.3% of participants showed protective CHIKV neutralizing antibody titers. VLA1553's good safety and tolerability profile was also

consistent with topline Phase 3 data. Valneva now expects to commence the pre-submission process with the U.S. Food and Drug Administration

(FDA) in the second quarter of 2022.

The Company also previously reported positive topline lot-to-lot manufacturing consistency results for VLA15539.

This is one of the standard requirements for vaccine licensure, and final lot-to-lot results are expected in the second quarter of 2022.

Valneva also initiated a Phase 3 trial in adolescents in January 2022. The trial, conducted in Brazil by Instituto

Butantan, is designed to support label extension to this age group following a potential initial regulatory approval in adults in the

U.S10. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the trial is also expected to support licensure

of the vaccine in Brazil, which would be the first potential approval for use in an endemic region.

JAPANESE ENCEPHALITIS VACCINE (IXIARO /JESPECT )

IXIARO is the only Japanese encephalitis vaccine licensed and available in the U.S., Canada and Europe.

Sales of IXIARO were 45.1 million in 2021 compared to 48.5 million in 2020. While the

COVID-19 pandemic continued to adversely impact the travel industry and vaccine sales to the private market, the impact on IXIARO

sales was mitigated by the Company's contract with the U.S. Government's Department of Defense (DoD).

CHOLERA / ETEC11-DIARRHEA VACCINE (DUKORAL )

DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae

and/or heat-labile toxin producing ETEC, the leading cause of travelers' diarrhea. DUKORAL is

authorized for use in the European Union and Australia to protect against cholera and in Canada, Switzerland, New Zealand and Thailand

to protect against cholera and ETEC.

DUKORAL recorded sales of 2.4 million in 2021 compared to 13.3 million