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Valneva Reports H1 2022
Results and Provides Corporate Updates
progress on late-stage clinical programs
Disease Vaccine Candidate VLA15
Chikungunya Vaccine Candidate VLA1553
marketing authorizations granted for inactivated COVID-19 vaccine
FY 2022 Financial Guidance
Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate - Valneva
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya
Vaccine Candidate - Valneva
Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot
Chikungunya Vaccine Candidate - Valneva
Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001
Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine -
Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001 -
Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine
Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration
Agreement for Lyme Disease Vaccine Candidate VLA15
Financial Information
(unaudited results, consolidated
| in million | 6 months ending June 30 | |
| 2022 | 2021 | |
| Total revenues | 93.2 | 47.5 |
| Product sales | 33.3 | 31.8 |
| Net loss | ( 171.5 ) | (86.4) |
| Adjusted EBITDA loss | (136.0) | (80.1) |
| Cash (at end of period) | 336.2 | 346.7 |
(France), August 11, 2022 - Valneva SE (Nasdaq:
VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first half of the
year, ended June 30, 2022. The half year financial report, including the condensed consolidated interim financial report and the
half year management report, is available on the Company's website (Financial Reports
provide a live webcast of its half year financial results conference call beginning at
3 p.m. CEST or 9 a.m. EDT today. This webcast will also be available on the Company's website.
Please refer to this link: https://edge.media-server.com/mmc/p/gpxqaier
Thomas Lingelbach, Valneva's
Chief Executive Officer, commented, "Valneva continued to achieve significant R&D milestones in the first half
of the year. Our updated Lyme disease collaboration agreement with Pfizer included a substantial equity investment which we see
as a strong sign of confidence and recognition of our vaccine expertise, and the recent Phase 3 initiation brings us a step closer
to a potential vaccine solution against Lyme disease. Our chikungunya vaccine program successfully met all Phase 3 clinical endpoints,
readying us for BLA submission. Our COVID-19 vaccine became the first to receive full marketing authorization in Europe, and we
look forward to delivering the first doses in Europe in the coming weeks. However, given the revised volume of orders from the
EU Member States, we are evaluating how to re-shape our operations. Looking at our other commercial products, we are seeing a faster
recovery than expected in the travel vaccine market and demand may even exceed our current supply capacity in the later part of
the year. I would like to take this opportunity to thank our shareholders, partners and employees for their ongoing support and
Clinical Stage Vaccine
LYME DISEASE VACCINE
Phase 3 study initiated
Valneva and Pfizer 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 August 2022, Valneva
and Pfizer announced the initiation of a Phase 3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists (VALOR)"
(NCT NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15 in approximately 6,000 participants five years
of age and older in highly endemic regions in the United States and Europe. As per the terms of the collaboration agreement between
the two companies, Valneva will receive a $25 million milestone payment from Pfizer within 60 days following initiation of the
Pending successful Phase
3 completion, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)
and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2025.
Valneva and Pfizer entered
into a collaboration agreement in April 2020 to co-develop VLA1510. In June 2022,
the terms of this collaboration were updated, and Pfizer invested 90.5 ($95) million in Valneva as part of an Equity Subscription
Agreement11. If approved, Pfizer will commercialize VLA15 and Valneva will be
eligible to receive substantial milestone and royalty payments.
Initiation of BLA rolling
submission with U.S. FDA imminent
VLA1553 is a live-attenuated,
single-dose vaccine candidate against the chikungunya virus, a mosquito-borne virus that has spread to more than 100 countries
with the potential to rapidly expand further. There are currently no preventive vaccines or effective treatments for the chikungunya
virus available and VLA1553 is currently the only chikungunya vaccine candidate that successfully completed primary analysis in
a pivotal Phase 3 study.
reported final pivotal Phase 3 data in March 202212 and final lot-to-lot consistency
results in May 202213, enabling BLA submission with the FDA. Valneva
expects initiation of the rolling submission for approval of VLA1553 in persons aged 18 years and above imminently. This rolling
BLA submission will be part of the accelerated approval pathway agreed upon with the FDA in 202014.
Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15
and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine
Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate - Valneva
Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate - Valneva
Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage for Phase 3 Study
Valneva is currently targeting
the end of 2022 for completion of the BLA submission. Once all portions of the application have been submitted and if the FDA has
accepted the filing, the FDA will determine priority review eligibility and the action date upon which the FDA will complete its
evaluation. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was
also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva currently plans
to make regulatory submissions for VLA1553 in Europe in the first half of 2023.
A clinical trial of VLA1553
in adolescents is currently ongoing in Brazil15, which may support future regulatory
submissions and label extensions following a potential initial regulatory approval in adults in the US. Conducted by Instituto
Butantan and 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.
Pre-Clinical Vaccine
The Company plans to advance
research and development activities relating to two of its pre-clinical assets, VLA1554 and VLA2112. VLA1554 is a vaccine candidate
targeting the human metapneumovirus (hMPV), which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory
tract infection in children and is also a common cause of morbidity and mortality in immunocompromised patients and older adults.
VLA1554 is currently in pre-clinical proof of concept studies. VLA2112 is a vaccine candidate targeting the Epstein-Barr virus,
which is one of the most common human viruses and can cause infectious mononucleosis and other illnesses. VLA2112 is currently
in a late-stage evaluation phase.
JAPANESE ENCEPHALITIS
VACCINE (IXIARO /JESPECT )
is the only Japanese encephalitis vaccine licensed and available in the U.S., Canada and Europe.
In the first half of 2022,