Good afternoon, everyone. Thanks for joining us today. I'm Daniel Tassé, the CEO of DBV. We are a company focusing in a specific pocket of immunology, which is food allergy, food allergy in children, specifically. Our lead product is to treat peanut allergies by name of Viaskin Peanut. We are looking at filing two BLAs this year, one in children four to seven. That's called the Viaskin Peanut Children Program, and we should file a BLA by the middle of 2026. By the end of 2026, we'll be filing the sister BLA in children one to three. That's what we refer to as being our toddler program. So that's sort of the year we have in front of us here. We have breakthrough designation from the FDA, and obviously, we'll be asking for priority review with our first filing. Got it. Very good. So maybe let's start on high level- Sure ... on food allergy first, right? I mean, I mean, everybody's following the launch of Xolair, which has been pretty phenomenal. So the question for you is that, what is driving recent interest in this space? Like, what is the market opportunity, at least for the two patient population that you are going after? Yeah, I think it's two things. I think the success of Xolair and the noise around that, plus, our clinical success also- Yeah ... and our little contribution to that noise reinforces something that as citizens, parents, neighbors, we know. Food allergies are a real thing- Yeah ... they're prevalent, and the impact on health and on quality of life of families is significant. So that there's now mobilization of science and capital to help these patients, I think is sort of a validation of it. The other part is that there's been a lot of activities, basic research in immunology for the last 20 years. The first wave of application has been immuno-oncology, now, more broadly in I&I. It's been an expectation of experts in the field, an expectation of the patient, advocacy groups, that eventually that knowledge will be directed to the immunology of food allergy, and we're starting to see that also. Got it. So I think broadly speaking, there are two approaches, right? You either have an immunotherapy or the not a novel approach, but it's basically IgE, anti-IgE. Can you just walk us through the pros and cons of each, modalities as it relates to the food allergies? Yeah, and you think you're right to sort of look at it that way, and not as necessarily competitive- Yeah ... propositions, but two ways to approach it. One is, can you help desensitize the patient to what makes them sick? The idea here is to go, obviously, from desensitization eventually to tolerance and to what we call sustained unresponsiveness, which is the way we call cure in food allergy. The other approach is to block IgE response, so that if you are exposed to whatever makes you sick, you blunt the immune response here. So those are sort of two approaches. We are on the desensitization side- Yeah ... so longer therapy, but it is disease-modifying, or at least very much believe it's disease-modifying, and thus, could bring with three or four years of treatment, a long-term benefit. While obviously, IgE blockade works as long as you block IgE. Once you come off therapy, obviously, you're still, allergic here. But both are important, and if you talk to, again, loved ones who have, a food allergy, patients are crying for options, and it's good that there's these two range of options. Got it. So now, let's dive deeper into why, what is VIASKIN? Like, what is the technology behind it? Yeah. What exactly it is doing? Yeah ... in patients? It's the platform is called Viaskin, so it tells you something. So obviously, it's a patch being worn on the skin. Via the skin, we are exploiting what are the very powerful, and for a long time, not really fully appreciated in medicine, immune properties of the skin. The human skin is a very powerful immune organ. We can think of sensitization, a poison ivy, but it's just as powerful at desensitizing also, if exploited in the right condition. What we do is we provide minuscule amounts, microgram amounts of the allergen to the skin of the patient, in our case, children, age one to seven. And through the exposure of the skin to these small dose of allergen, there's a recruitment of the allergen by Langerhans cells in the skin, antigen-presenting cells, that then mobilize a T reg response distally, which desensitizes the patient against the reaction to accidental consumption of that allergen here. So it's T reg mobilization through the skin, through Langerhans cells. Got it. So you have two approaches or two, sort of commercial strategy or development strategy, right? Let's start with four to seven first. Yeah. You recently announced VITESSE data. Could you put that data in context? Like, what exactly did you see? What are the next steps? I think you're gonna file a BLA. What is left from a BLA filing perspective? So VITESSE was the, or is the largest, trial performed in peanut allergy. It was 654 patients, randomized 2-to-1 active to placebo. It's a registration trial for the FDA. It's been discussed, to a great extent with the agency. The FDA, wants for desensitization products, for food allergy, 600 patients or so on treatment for at least six months with a safety database. VITESSE was important because we very carefully crossed over the placebo patients to active. We always have open label extension on our studies. I'll come back to that in a second, and thus, with the placebo crossovers, we have over 600 patients that's satisfying the agency, for the ISS. We certainly had more than enough power for, for efficacy. What we've shown is a placebo-adjusted delta of 32 points of active to placebo. That's important to the FDA for approval. It's also important to patients and to parents, and to allergists, but in the context of the fact that every patient who starts immunotherapy for any form of allergy, whether it's cat dander or pollen or food allergy, they're told by the allergist, "You're gonna be on treatment for three to five years. That's how we desensitize you. Yeah. So thus, the result at one year are important to get approval from the FDA, but we have religiously, and I think very well executed, open label extension in all of our studies, as to show the benefit at year two and year three, which has shown, again, improvement efficacy and a side effect profile, if anything, actually improves slightly over time. So the VITESSE results are important 'cause at one year, we surpass the statistical endpoint that the agency has for us. We've shown a very, very nice and as expected, safety profile, and thus, we believe the product is gonna be very much acceptable to the agency when it comes to approval. And the bulk of those 654 patients are on open label extension right now to see the benefits- Got it. -growing at year two and three. So that's four to seven? That's four to seven, yeah. Yeah, four to seven. How, what about one to three? Right there, can you just compare and contrast the data and the consistency of data? Yeah. With that cohort? And also tell us how many patients are four to seven and one to three. So the market for four to seven and one to three, or the studies? Market. The market, okay. So it's about 100,000 kids per age of birth cohort, so there are 380,000 kids... 390,000 kids, aged four to seven in the U.S., with a peanut allergy today. There are gonna be 280,000 kids, one to three, so it's 670,000 children with a diagnosed peanut allergy, as of today. And again, that birth cohort is about 100,000 kids a year. The results we showed in one to three-year-old, to be specific with numbers, maybe that would be helpful, 67% was the response rate on active, 33.5% on placebo, 22.4% delta to the lower bound of the confidence interval. The agency wants us to beat 15, so clearly, met the primary endpoint statistically, and showed about a 33.5-point delta active to placebo. In the older kids, the placebo response rate was expected to be less. It was 15%, we showed 47% on active, again, a 32-point delta. And as we've seen in one to three, 67% efficacy at year one, that became 86% at year three against the primary endpoint. The most important data point from that study, and the one that speaks to the disease modification potential of the product, was that kids on treatment for three years, 68% of them in the one to three population, could consume the whole food challenge, which was 12-14 peanuts worth of peanut protein, without having an anaphylactic reaction. So they moved from being responsive at 100 milligrams, at entry, to more than five grams- Wow! upon exit, which is a rather remarkable clinical response. Got it. So the efficacy remains very consistent, irrespective of the age, is sort of the message. Correct. -right? Yeah. Okay, so let's just go through four to seven real quickly. Yeah. The next step is the BLA filing. What is the alignment you have with the FDA? Do we need to meet with the FDA before you submit it, and when are you gonna submit it? We'll submit by the middle of the year, by June 30th. Working hard, obviously, to make it as soon as possible. We have had a lot of discussion with the agency on this protocol, as well as the CMC file, being a drug device combination that the FDA has never seen before. We invest a lot in CMC communication. I'm very confident that we have had the right rich- Mm-hmm ... dialogue and thus alignment with the agency. So, there's no need to talk to the agency anymore. We have everything we need to know, both for the clinical file and the CMC file. Got it. You will seek for Priority Review. This is a BLA? This is a BLA, yeah. Okay. It's a biological product- Biological So we have. Okay ... 12 years of data exclusivity also. Then on one to three, it's, you know, basically 300,000 kids. There, you just need to complete the safety, and then you're gonna file by the end of this year? That's it. Yep. That's it. Okay, so let's talk a little bit about the commercial, because I think you could be in the market, like depending on whether you get priority review or not, sometime in 2027, in the first half. Yeah. Talk about the commercial strategy, how big of a build-out will be required? How should we think about pricing? What payer work you've done? Yes, all obviously critical questions here. The prescribing audience, and thus the physician we'll be targeting with our sales force, is 4,500 allergists, immunologists in the country. The great majority of which see adults and pediatric patients. So our one-to-seven-year-old, peanut allergic children will be seen by allergists. Obviously, these patients, and obviously the families, have pediatricians as their primary care physician. It's been well established within the pediatric community that when they see a child with a peanut allergy, they do three things within the AAP guidelines. One is prescribe an epinephrine auto-injector or delivery mechanism. Two, recommend avoiding the food, and three, refer them an allergist. The allergists do the full diagnosis, initiation of treatment in this population here. So the 4,500 allergists are our target audience. We estimate right now that about three out of five children with a peanut allergy are currently seen by an allergist, either for their peanut allergy or comorbidities. The allergic march brings many of these- Yeah -kids to have asthma, atopic dermatitis, another food allergy. So they're, at this point in time, 60% of them, we estimate, are currently already seen by an allergist. We need to mobilize the other 40% from the allergist to... From the pediatrician allergist office. So that density of prescribing, of prescribers, means we can probably reach them with between 50-70 sales reps. We're finalizing that assessment. A big part of the commercialization here should include a rich communication dialogue with the families. Again, if you know anybody with a food allergy, the parents tend to be very engaged. The patient advocacy groups are well organized. There are chat groups online. It's a very communicative and engaged community, so our ability to engage dialogue with them would be important. So this would be a big part of the marketing mix, obviously. And to price, which I think was another of your question, Yatin, we obviously have not decided yet what the price is going to be. A helpful analog, but not the definitive analog, I would suggest, is the fact that, Palforzia, the one approved product for desensitization, which is oral immunotherapy by Aimmune, sold to Nestlé and then sold on to Stallergenes, is getting a net price of about $1,000 a month. So that's a reasonable reference point. We're not suggesting that's gonna be our price. It's just a reasonable reference point when it comes to at least modeling. We've had qualitative discussions with investors, with payers already, and that's a price that they see as being a reasonable reference point with the possibility of a premium, 'cause we believe we have a much superior product to what Palforzia is, but we have not done the quant research to finalize that yet. Got it. So I'll come back to Palforzia in a sec. The question is, for these patients, these, you know, 700,000 patients that you have identified from one to seven- Yeah. How many have peanut allergies, specifically? And then the second question is, for when you talk to either physicians or their caregiver, what do they want to address if they don't... If peanut allergy-- If they have multiple food allergies? Yeah. That's a really important question. So between 60%-70% of kids with a peanut allergy, 50 and 70% also have another food allergy. So that's the. So 30%-50% are peanut alone. The other ones have another food allergy. Also, about 50% of these kids have either atopic dermatitis or asthma, or/and asthma. So these are atopic children who are already in the allergist's office. It has been quasi-universal in all of our market research with parents and with allergists, that they see peanut allergy as the highest order stressor and concern for reasons that we can all relate to, I think. Peanuts are ubiquitous. They're not expensive, so you find them everywhere. There are traces of peanuts in food. There are not traces of eggs in food. Right. Also, there's either eggs in a cake or there's no eggs. That the reaction are unpredictable. Your last reaction to a peanut is not predictive of the severity of your next one, and obviously, the consequence of peanut allergies could be quite serious. So to parents, if they can take peanut off the table, and I'm sorry for the, the pun in saying that here, that is really important to them. Because kids, most kids will outgrow their peanut, their milk allergy, and it's easier to avoid the sesames and, and shellfishes, essentially So peanut is the higher order priority for parents. You said 30%-35% are pure peanut? Yeah, 30%-40% are peanut. 30%-40% are peanut. Okay, about the 60. Okay, helpful. Now, the other question related to this is that what is the... In your view, what is the relative use of IgE in the patient population that you are going after? Like, how much of a competition that is for you? When it comes to competition at the patient level, it's not a large phenomenon for two reasons. Reason number one is, IgE blockade, systemically and chronically, in a developing immune system, is not something the allergists wish to do unless the child has six or seven allergies, plus atopic dermatitis, then it might make sense to use- Got it ... Xolair or IgE blockade. But the majority of kids, even if they're multi-allergic, allergists don't wish to do that. And again, the absence of safety on long-term IgE blockade in kids is one question. The other one is, it's a needle, it hurts. So for many kids or for many parents, it's just not an attractive approach, but that's a practical consideration that's secondary to the desirability of IgE blockade in a young child. ... Got it. Okay, then I'm gonna go back now to Palforzia. So you mentioned that you have a much more superior product than Palforzia. Could you explain why? Did I say that? So, Why do you, why do you believe that? Yeah. Just walk us through the- Yeah ... the difference, the label, because you know, I do understand it's a pretty complex label. Yeah, it is. So Palforzia's approval was a big deal 'cause it was the first product approved to desensitize children with a food allergy. Allergists wanted to prescribe it, and parents were okay with trying it. Moreover, they did a pretty good job of getting managed care coverage. What turned out to be the difficulty with OIT and PALFORZIA is the fact that you are giving escalating doses of peanut protein to a child who's allergic to peanut proteins every day. The dose escalation requires a visit to the physician's office every two weeks, and there's 11-16 such visits over six to nine months, so it's very taxing on the families to manage the updosing. And then, the rate of anaphylaxis on treatment was 18%. Wow! On dose escalation, 15% on dose maintenance, and the best way to minimize the risk of anaphylaxis on treatment was to make sure the child did not have elevation of body temperature or heart rate. Thus, the REMS that came with PALFORZIA required the child to be quiescent, at rest for three hours a day as they took the dose. It's not possible. It's difficult to do, to say the least. That being said, for many families, not the majority, they're willing to make that commitment. Yeah. Again, that's fantastic, and thus, Palforzia was an important addition. Homebrew OIT is offered by some allergists, so the fact that the option is there. Okay. Now, you don't expect any of that, or like- We do not. How clean of a label it'll be? Just give the patch every day, at one time, a similar time. Yeah, that's what we've. Assuming that we showed in clinical studies reflected in the label, which is- Yeah ... obviously, the discussion that needs to take place with the FDA. Only the first patch of years of treatment was administered in the doctor's office- Sure ... with a one-year observation period. That hour was used. I said one year, I meant one hour. One hour, one hour. Oh, you said one year, yeah. Observation period, which was used by the physician or the nurse to instruct the family how to apply the product and put it on. We've seen no adverse events in that hour, and we've seen also, since there was no limitation to daily living in our studies, kids could run around, chase the dog, take a bath, go to basketball practice. And we have not seen any case of severe anaphylaxis in any of our clinical studies, so we like to think we will not have a REMS 'cause there's nothing to- Correct. There's no mitigation strategy to a risk that was identified through our studies. Then, everybody gets an anaphylaxis if you have one. If you are diagnosed with peanut allergy, you do get a... Not anaphylaxis, you do get EpiPen. That's exactly it. Correct. We'll still recommend carrying an EpiPen out of prudence. Moreover, these kids may be allergic to something else than just peanuts. Okay. Okay, I think that part I'm good at. Now, the other question is, you know, as you... So as you think about, let's say, the, the pipeline, obviously there is a lot to do on the commercials, Yeah ... but there is a potential to go after other allergies. Where is that on the priority list? How are you thinking about other indication with this technology? It's obviously a priority, or we're Phase IIb ready for cow's milk allergy. It's gonna be our second product. We have an interesting, still pre-IND program in celiac. But right now, we wanna make sure that we get VIASKIN Peanut approved. With that, we do two things: We validate the platform, reduce our cost of capital, make our ability to be quite bold in pursuing other indications, to be then our strategy. Got it. In terms of the manufacturing and your ability to supply, given how many patches you would need, where are you with the manufacturing? We're in good shape for manufacturing. The product is manufactured with a CMO in France. We can supply the launch in the first few years of launch, but obviously, to support the outer years of the launch, as well as ex-US expansion, we'd be looking at probably tripling our manufacturing capacity over the next few years. That takes about three years, as you know, to build a plant and qualify it, so- Got it ... we'd rather start sooner than later. Would you be able to launch, like, immediately upon approval, or, like, how much time you would need post-approval from a launch perspective? We'll need a handful of weeks. Oh, that's it. The patches will be manufactured. We just need to package it with the right, brand name, and, NDC code, and all of that. Okay. All right, I think that's all I had. How's the cash and the burn rate? Pro forma Q3, we have $320 million. If you look at the warrant exercise of January as well as the ATM, placements, we're gonna have our year-end results, sometime later on in March. Mm-hmm. We are sufficiently funded to take the company through launch in 2027, and by that I mean the bold investments we need to make to build what we think is gonna be a very significant brand, including inventory build-up. Got it. Got it. Daniel, I think that's all I had for you. Thank you so much. Thank you so much. Thank you, and thanks, everyone, for-