Valneva Reports Strong 2018 Results, Expects Further Growth and Major Pipeline Progression in 2019

Major R&D milestones achieved in 2018, double-digit product sales revenue growth delivered; Lyme and chikungunya programs expected to advance further in 2019

Valneva SE, a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, reported today its full year unaudited consolidated financial results for the year ending December 31, 2018.

A webcast for the financial community and media will be held today at 3:00 pm. (CET). A replay will be available on the Company’s website. Please refer to this link: https://edge.mediaserver.com/m6/p/dk7vyzzx

Commercial Vaccines

JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®)

In 2018, revenues from IXIARO®/JESPECT® product sales reached €69.6 million, representing year-on-year growth of 19% (CER). The increase was largely driven by demand in the U.S., including in the private market where Valneva has taken direct control of sales and marketing.

There was also a strong increase in IXIARO® sales in Canada in 2018 compared to 2017. Last month, Valneva announced the signing of a new $59 million contract with the U.S. government DoD. Under the terms of the agreement, Valneva will supply IXIARO® doses to the Defense Logistics Agency of the DoD, in 2019 and 2020, with $59 million in guaranteed revenues and potentially worth up to $70 million.

Following this contract award, subject to detailed supply planning to the U.S. DoD, Valneva projects that revenues from IXIARO®/JESPECT® sales will grow at a minimum of 15% in 2019. Further penetration of the U.S. private market will continue to be a key growth driver in 2019, in addition to the DoD supply. Noting that detailed logistical planning for supply to the DoD is ongoing, the Company will provide mid-term guidance during 2019 regarding the IXIARO® sales outlook for 2019 and 2020.

CHOLERA / ETEC7-DIARRHEA VACCINE (DUKORAL®)

In 2018, despite supply constraints in the first half of the year, revenues from DUKORAL® sales increased to €30.4 million, largely driven by strong sales performance in Canada. This was somewhat offset by a combination of adverse exchange rate movements (mainly between the Canadian dollar and the Euro).

Valneva expects DUKORAL® revenues to grow by up to 5% in 2019, through continued market penetration in key markets such as Canada and the UK.

Clinical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE – VLA15: Phase 2 development underway; Positive initial booster data and final Phase 1 data reported

Valneva’s vaccine candidate VLA15 is currently in Phase 2 clinical development. The overall objective of Phase 2 is to determine the final dose and schedule for use in Phase 3 pivotal field efficacy studies.

Given the range of immune response and the variability across the different serotypes observed in Phase 1, the ongoing Phase 2 study (VLA15-201) includes two higher doses (135 μg and 180μg, both adjuvanted with alum). An additional study evaluating an alternative vaccination schedule (VLA15-202) is scheduled to commence mid-2019. The Company expects initial Phase 2 data (on the primary endpoint) mid-2020.

Valneva also recently reported positive initial booster data and final Phase 1 data. The final Phase 1 data confirmed the safety and tolerability profile observed at all time-points, as reported in the interim analysis. VLA15 demonstrated a favorable safety profile and had no associated safety concerns. In addition, the final Phase 1 immunogenicity results indicated that the alumadjuvanted formulations elicit higher immune responses at all time-points, confirming the interim data findings. As expected, based on the interim Phase 1 data, antibody titres declined post-Day
84 across all groups, trending towards baseline at approximately one-year post initial vaccination.

The single booster re-vaccination in the period 12 to 15 months after the initial dose in the primary immunization resulted in a significant immune response, yielding OspA antibody titres at levels 2.7-fold (ST3 ) to 5.8-fold (ST1) over the initial titres observed at Day 84 (geometric mean fold rise (GMFR)).

Lyme disease is the most common vector-borne illness in the northern hemisphere for which there is no other clinical vaccine candidate in development worldwide. According to the US Centers for Disease Control and Prevention (CDC), approximately 300,00010 Americans are infected with Lyme disease annually with at least a further 200,000 cases in Europe.

VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia and is intended to protect against the majority of human pathogenic Borrelia species. VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. VLA15 has been awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA).

CHIKUNGUNYA VACCINE CANDIDATE – VLA1553: Positive initial Phase 1 results reported

Valneva recently reported positive Phase 1 interim results for its chikungunya vaccine candidate. The interim results showed an excellent immunogenicity profile after a single vaccination with a 100% seroconversion rate14 achieved at Day 28 in a pooled analysis15 of all vaccinated groups. Results also showed that 96.5% of subjects achieved at least a 16-fold increase in antibody titres and a high geometric mean titre, fully supporting VLA1553’s differentiated target product profile.

The pooled safety profile of all groups was considered acceptable, supporting further development. No serious adverse events nor adverse events of special interest were reported up to Day 28 and the local tolerability was considered excellent. Valneva is committed to advance its chikungunya vaccine candidate as quickly as possible into pivotal trials, after dialogue and alignment with the authorities. The Company expects unblinded safety and immunogenicity data at dose group level by mid-2019 including additional information on whether subjects are protected from chikungunya viremia. This may allow Valneva to determine a future development pathway to licensure.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. As of 2017, there have been more than one million reported cases in the Americas16 and the economic impact is considered significant (e.g. Colombia outbreak 2014: $73.6 million). The medical burden is expected to grow as the distribution of the CHIKV primary mosquito vectors continues to spread further geographically. There are no preventive vaccines or effective treatments available and as such, chikungunya can be considered a major public health threat.

VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate aiming for protection against various chikungunya virus outbreak phylogroups and strains designed for long-lasting protection conferred by neutralizing antibodies in adults and children18. The target populations for vaccines against chikungunya are travelers, military personnel or individuals at risk who live in endemic regions.

VLA1553 has been awarded Fast Track Designation by the FDA.

ZIKA VACCINE CANDIDATE – VLA1601: Positive interim Phase 1 results reported

At the end of 2018, Valneva and its partner, Emergent BioSolutions, reported positive Phase 1 results for their vaccine candidate against the Zika virus20 in a randomized, observer-blinded, placebo-controlled, single center study. VLA1601 met the study’s primary endpoint showing a favorable safety profile in all doses and schedules tested. The vaccine candidate was also immunogenic in all treatment groups and induced both dose- and schedule-dependent neutralizing antibodies against the Zika virus with the kinetics expected for an inactivated, alum-adjuvanted whole-virus vaccine. Seroconversion Rates (SCR) reached up to 85.7% on Day 35 (interim analysis of data up to Day 56).

The final analysis at day 208 after first vaccination, which is expected in the first half of 2019, will include additional immunogenicity data such as Geometric Mean Titres (GMTs), rate of subjects with seroconversion and fold-increase of Zika virus-specific neutralizing antibody titres as compared to baseline, measured by plaque reduction neutralization tests (PRNT).

Zika virus infection is a mosquito-borne viral disease caused by the Zika virus (ZIKV), a flavivirus transmitted by Aedes mosquitoes21. Disease outbreaks have been reported in tropical Africa, South-East Asia, the Pacific Islands, and, since 2015, in the Americas. According to the World Health Organization (WHO), there is scientific consensus that the ZIKV is a cause of microcephaly and Guillain-Barré syndrome. Between 2015 and early January 2018, over 500,000 cases of suspected Zika infection and many cases of the congenital syndrome associated with the ZIKV were reported by countries and territories in the Americas, according to the WHO. There is currently no specific treatment available.

VLA1601 is a highly purified inactivated whole virus vaccine candidate developed using Valneva’s proven and licensed inactivated Japanese encephalitis (JE) vaccine platform.

About Valneva SE

Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with approximately 480 employees. More information is available at www.valneva.com.