DBV Technologies S.A.

Apologies for the late start of our conference. Welcome to the DBV full year 2023 financial results and business update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. And again, our sincere apologies for the delay in starting today. This afternoon, BBV Technologies issued a press release that outlines our financial results for the 12 months ended December the 31st, 2023. This press release is available in the Press Releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our clinical and regulatory development plans. The design of our anticipated clinical trials the timing and results of interactions with regulatory agencies, our forecast of our cash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassay, Chief Executive Officer of DBV, Dr. Forrest Mohreddin, DBV's Chief Medical Officer, and Virginie Boussina, our Chief Financial Officer. Before handing the call over to Daniel, for those of you who may be new to DBV, we are developing ViaSkin, an investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies and other immunological disorders, with ViaSkin Peanut as our lead candidate. I will now pass the call over to Daniel. Daniel?

Eddie, thank you, and thank you, everyone. Again, I need to add my apologies. We were waiting for confirmation that the K had been uploaded. It usually takes a minute. It took much longer today. We will obviously dig into this and make sure it doesn't happen again. So my apologies for having you on hold for 30 minutes. Today, we'll obviously give you an update on our progress when it comes to Vicent Pina programs and regulatory pathway, and then Virginie will share with us a financial update. But before we do that, I'd like to share with you a few perspectives about viaskin peanuts and the peanut allergy market, things that we have not discussed in a while. Starting last week, DBV attended the American Academy of Allergy, Asthma, and Immunology Annual Scientific Meeting, which was held in Washington, D.C. The meeting, which is known as Quad AI, is regarded as the premier event in the allergy immunology community. And every year, we have a lot of boots on the ground at Quad AI to listen, engage with all of our key stakeholders, allergists, and patient advocacy groups at the top of that list. One of the highlights of Quad AI this year was the fact that the product here, if you've been to Quad AI, the product theaters are a big deal and attract a lot of traffic. The one we hosted was called Importance of Early Intervention for Peanut Allergy. And I'm very proud of the fact that it had an unprecedented attendance. In fact, we're told that we broke the record for Quad AI event and the best attended product theater ever. The room held 125 people, 230 allergists or more showed up, the point here being that intervening early in peanut allergy is important. Our technology is important, creating much interest. And obviously, that's the most validating feedback that there is, all the hard work that's been going in. Which I'd like to use to just, again, reinforce our commitment to the space and to the importance and the benefit of generating plenty of data and plenty of long-term data. We understand and we understand the huge responsibility we have of establishing the long-term safety and clinical benefits of via skin peanut because treating children is an important responsibility. Our open label extension commitment to patients, while it takes time and effort and financial resources, ensures a rich population of subjects on via skin peanuts to guide treatments, inform options, and optimize outcomes for patients. And we do have extensive follow-up of our subjects. You may recall we recently reported back in November our interim year two data from our open label extension study in toddlers. And obviously we cannot wait to see what the year three data will look like when we share it later on this year. In 2024, we will continue to work towards creating a robust data package in toddlers and children. We have a lot of work cut for us, but we're enthusiastic about it. Over the next year, we expect to have approximately 1,400 children, age 1 to 7, enrolled globally in our Phase II trials. All our Phase II studies have an open-label extension, which, as I mentioned just now, is key understanding long-term treatment and the benefits of our therapy. And it goes without saying, we will have the largest cumulative exposure to an investigational product ever in pediatric food allergies. It's going to be a massive safety database. For our one to seven-year-olds, we will have, in fact, close to 1,700 subjects on active treatment. And if we combine that with the data from our prior phase three trials, To break this down, we'll have approximately 600 toddler patients, 600 toddlers aged one to three, and about 1,100 patients aged four to seven will have been on immunotherapy for up to three years. And let's not forget all the work we've done in four to 11 before that, where some of those children were treated with myosin for up to five years. In fact, some of that data was shared at Quad AI last weekend. To sum it all up and put this in perspective, Over 1 million biotin patches have been applied to children age 1 through 11 in our clinical development program. That's obviously more than 1 million days of therapy that makes up the safety database of this product, safety and efficacy database of this product. It is, as I said, the most comprehensive research in children with peanut allergy. We have a well-studied product with demonstrated efficacy and consistently favorable safety profile. We're proud of that, and we keep on building that database. The second point I wish to touch on today is the disease-modifying potential advice in PNAP. I'd like to share with you data that's been discussed in the past but put together, I think, as an important perspective here. Let's start with our recent and striking observation in toddlers. from year two of our ongoing open label extension study. The data showed that approximately three out of five toddlers could consume almost 3.5 grams of peanut protein without triggering stopping symptoms during the food challenge. That is the equivalent of 12 to 14 peanuts. Way beyond what would be anticipated during accidental exposure and a massive jump from what was a median eliciting dose at baseline of 100 milligrams. These data suggest the virus in peanut is potentially rewiring immune systems, and we suspect that is due to a plasticity immune system in this age group. We also have two other data sets from prior studies showing that virus in peanut can induce what is known as sustained unresponsiveness to the allergen in older children who, After two to three years of treatment, 80% of participants maintained desensitization of 1,000 milligrams or more two months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests that virus can induce sustained unresponsiveness to the allergen by modulating the epigenetic signature of specific T cell compartments. Remember, vascular peanut has a unique mode of action that leverages skin properties and tolerance, and there's no other product out there that shares that mode of action. With all this in mind, while this is not the indication we'll be pursuing at approval, we fully intend post-approval, and as part of our long-term commitment to these children, To explore a vascular peanut is fundamentally disease-modifying after a few years of treatment. With that as background on our commitment to science and to our patients, I'll turn the call over to Farris, our chief medical officer, for a detailed update on our two vascular peanut programs.