Valneva SE

Good day and thank you for standing by. Welcome to the Valneva's first quarter 2025 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Joshua Drum, Vice President, Global Investor Relations. Please go ahead.

Thank you. Hello, and thank you for joining us to discuss Velneva's first quarter 2025 results and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the three months ended March 31st, 2025, which were published earlier today, available within the financial reports section of our investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach, and CFO, Peter Buehler, who will provide an overview and update on our business, as well as our key financial results for Q1 2025. There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward-looking statements, which are subject to certain risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, May 7, 2025, and Valneva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.

Thank you, Josh, and good day to all of you. Pleasure to provide the update during today's earnings call. Yeah, the first quarter 2025 was a solid quarter with strong overall financial performance. Total revenues reached almost 50 million euros The reduction in operating cash burn is reflecting our continuous focus on cash and cash management. And this is also shown in a cash position north of 150 million euros, excluding the recent proceeds from our April ATM transaction. And in quarter one, we also made progress on the regulatory front, predominantly around Ixchic label extensions and further approvals. When we look a little bit more into the details of the first quarter 2025, we got a new Ixchic contract awarded by the US Department of Defense. We responded to the French government's call for Ixchic to combat the chikungunya outbreaks in La Réunion and Mayotte. And we responded to the cholera outbreak in Mayotte by supplying doses of Ducoral. So all in line with our mission to address unmet medical needs. With regards to the key regulatory achievements that I mentioned earlier, We got the marketing authorization for ixtric in the UK in individuals 18 years of age and older. And we also submitted the respective adolescent label extension application. We got the ixtric label extension in Europe for individuals 12 years of age and older by the European Medicines Agency. And the ixtric marketing authorization in Brazil represents the first approval of a chikungunya vaccine in an endemic country. On clinical data and pipeline progress, we reported high sustained immune response in adolescents one year after ixtric vaccination with a single dose as part of our phase three. We reported positive phase two pediatric results for ixtric, and as such could decide the dose for the planned phase three study in the pediatric population. And we initiated the first vaccination in the phase two infant study in Africa of our tetravalent Shigella vaccine candidate, S4V2. Turning our attention a little bit to Lyme, You all are very aware of the Lyme program and the medical needs that Lyme disease represents globally. There is no vaccine available to prevent Lyme disease in humans, and we see a growing annual burden of disease with almost half a million cases reported, and these are confirmed cases reported in the United States, more than 100,000 cases reported in Europe, and those numbers are heavily impacted by under-reporting or not even existing reporting systems in some of the countries. When we look at the clinical manifestations, two to 30% develop really severe clinical manifestations, including caditis, neuropoliosis, or arthritis, and five to 10% have persistent symptoms, even following treatment. Therefore, we see a huge unmet medical need for a preventative solution and hence commercial opportunity for Valneva, especially given that we are talking about almost 90 million people in the US and more than 200 million people in Europe who live in endemic regions where Lyme represents a major risk. You all know that we are in year three or in the third tick season. of the ongoing phase three study Valor. And we are expecting first data at the end of this year. This is a study that includes more than 9,000 participants, five years of age and above, who are at high risk of Lyme disease. We are measuring here against the placebo control setting, randomized one-to-one, against placebo 2 to 1 North America, Europe. And the primary endpoint is the rate of confirmed Lyme disease cases. So prevention of the disease after the second consecutive tick season. And right now we have the second cohort undergoing the booster vaccination. And then we have quite significant number of secondary endpoints including The rate of confirmed Lyme disease cases after the first season after the primary series so very exciting year and and we hope to see the first data is set by the end of the year, which will be followed by a significant number of secondary endpoints and other data associated with the study and provided positive data and we expect filing with the regulatory authorities next year. With that, let me turn over to Ikschik. You know that our Chikungunya vaccine is a highly differentiated vaccine, and we are glad that we have been able to report strong clinical data thus far across all the studies and across all the target populations. that we have been evaluating and got licensed by now. At the same time, we have experienced recent changes to ICSIC recommendations in response to reports of serious adverse events in frail elderly individuals. As such, ACIP recommended precaution for use in 65+, EMA cautioned against use, in frail older adults, especially those with comorbidities. And in France, a Spanish recommendation for use in 65 plus. All of that, you know, pending ongoing investigations. As we stated in our different publications and communications, we are highly committed to standards of safety and appreciate, therefore, these precautionary decisions. All investigations into SAEs remain ongoing, and it's worth noting that causality has not been definitely established at this point in time. We will, of course, continue to closely monitor all reported adverse events and cooperate fully with health authorities while working proactively on a potential update of the product indication. We have now a bit more than 40,000 doses administered, so doses of ixtric that landed in people's arms. And we continue to see a positive risk benefit in the vast majority of people with potential exposure to the disease. And we would like to remind one more time that ixtric must not be given to people who are immunodeficient or immunosuppressed due to disease or treatment. When we look at the further development of ixchic that we are currently conducting, we are preparing for the post-proceding effectiveness phase four program. This is a program to confirm the effectiveness following licensure based on an immunological surrogate of protection, the so-called accelerated tubal pathway. and to further help optimizing the description of the safety profile. We are planning an observational effectiveness study in Brazil, pragmatic randomized control effectiveness and safety study in endemic countries, and prospective safety core study and pregnancy surveillance in Brazil. We have ongoing label extensions to expand access to the vaccine for all age groups, and the We reported already the phase three data in adolescents, which landed in some countries and some regulatory jurisdictions already in a label extension. Others are still under review. And we plan to start a phase three study in children aged one to 11 years of age. On the product profile, all of that, and across all programs, we would like to confirm the long-term durability of the immune response to further differentiate our vaccine. Turning to Shigella, which is really the most advanced program right now in the tetravenous bioconjugate vaccine space, targeting Shigellosis infections. It's a program that we have partnered with Lima Tech. It includes the four most common pathogenic Shigella bacteria serotypes. Lima Tech in the past reported positive phase one, two clinical data, and the program got awarded FDA prospect designation. We expect a huge unmet medical need, of course, primarily in children living in low-medium income countries, but also a substantial added value for travelers and military personnel. And the Shigella disease and the work around Shigella vaccines has been identified as a priority by the World Health Organization. As mentioned at the beginning, we launched a phase two infant study this year, and we expect data already for the latter part of this year. We have an ongoing phase two B, so-called controlled human infection models. This is a study that goes in two steps. The first step is to optimize dose and schedule second is to challenge and get with the challenge a first idea around pilot efficacy we announced that we have slightly extended the immunogenicity phase so the so-called step one and as such we are not expecting the pilot efficacy data as previously announced in the second half of this year, but in the first half of next year. And of course, we will work continuously on this exciting program and make sure that we progress towards the next development phases. Turning to Zika, we expect phase one results later this year on our second generation optimized vaccine candidate against the Zika virus. It's an inactivated whole virus vaccine based vaccine that leverages our technology that we developed and further optimized as part of our COVID work and our COVID vaccine during the pandemic VLA 2001. And of course, we hope to see positive data that would enable further development against the disease that can have quite devastating effects. And please be reminded that there is currently absolutely no vaccine or specific treatment available. And as such, we hope also for support of public institutions, for example, to help advance a potential vaccine against Zika virus. With that, I would like to hand over to Peter to provide us with the financial report.