Good. Thank you, everyone. Thank you, everyone. I'm Andrew Fein. I'm one of the Biotechnology Analysts at H.C. Wainwright. It's my pleasure to next have a company we've followed for a very, very long time now, DBV Technologies. Presenting for the company, or speaking for the company, are Daniel Tassé, its CEO, and Pharis Mohideen, its Chief Medical Officer. Thank you both very much. Thanks for having us. So maybe, you know, the best place to start is just the latest update. You know, you reported not too long ago. So maybe just get everyone up to speed with where things stand- Yeah ... and what the path forward seems to be- Yeah - at least at this point. So let me set the stage, and maybe Pharis can chime in with the more specific data. So as you know, we are developing a cutaneous patch worn on the back of the children to tap into the powerful immune properties of the human skin, recruiting the antigen, presenting them to the lymphatic system, and through that, building over time a desensitization. So it's a desensitization model, with an expectation, obviously, there's will be long-term benefit, to probably be registered on one year data via VIASKIN Peanut. VIASKIN is our platform, VIASKIN Peanut is our lead product, and right now, we're pursuing two BLAs in parallel: one in children one to three, with what we call the original patch. I suspect we'll be coming back to, well, we have two patches in time, and the other one in the children four to seven, with what is a modified patch. Both patches are identical when it comes to the mode of action. As you know, we put microgram amounts of peanut protein on the skin of the child, asked to recruit this immune response. So the mode of action is the same. The inner workings of the patch that delivers the allergen are the same, but there is a larger, rounder patch for the older kids. And both BLAs being in parallel, there's obviously an element here of constructive independence between the two. When program goes faster than the other one, great, but the BLA, supplemental BLA, the value of the supplemental BLA is entirely embedded into the BLA. We don't have the situations here. Those are essentially our two programs. I hope that sort of answers your question. Yeah, very good. Very good. Yeah. And so where do things stand? Where, what's the, what's the latest? Pharis, you know the whole work. So as Daniel said, we have two separate BLA programs. We have the one to three year-old indication with the original square patch. That data has been presented. It's in the New England Journal of Medicine. We had a pre-BLA meeting with the FDA last year, and basically, they saw the efficacy data. They did not ask us to conduct any more efficacy data for one to three year-olds. They did ask for a supplemental safety study, basically just to get our exposures on active close to the 600 per ICH guidelines. They were not looking for any specific safety signal. So that program is laid out, an efficacy study and a supplemental safety study. The four to seven year-old indication with the modified circular patch is basically a mirror image program. We have the VITESSE study, which we started last year for four to seven year-olds. That's a 12-month efficacy and safety study. Very similarly, the FDA asked for a supplemental safety study, the same logic. They're not looking for any safety signal. They just want us to get close to the 600 exposed for the ICH guidelines. So as I said, excuse me, the VITESSE study started last year. We surpassed our 50% recruitment mark in the first quarter of this year. We're on schedule for the last patient of first visit in the third quarter of this year, and then run it for one year, and then the data readout will come at that point. Okay. So data from both programs next year? Yeah, we should have data to inform both BLAs in 2025. On one side, obviously, is a study that we're running, VITESSE is running nicely. The other one is finishing the dialogue with the agency, so that what we generate in those safety studies is exactly what they want, so that essentially the review, the issues are kept to a minimum. How do you kind of foresee the turnaround time between data and filing? Weeks. That's what I told the team. My expectation would be weeks b ut not to be dismissive, it's a lot of work to put a BLA together. For a drug device combination, when the drug happens to be biological, it's a massive amount of work. That being said, that work is progressing nicely in parallel. The dialogue with the agency on all the elements of CMC is progressing quite nicely, so we don't believe it's going to be rate limiting to essentially turning the clinical data into the clinical section of the FDA. So we expect the BLA would be filed within, at most, a small handful of months after the data readout. Okay. That's, that's very helpful. Yeah. In the context of the current commercial opportunity, you know, obviously, over the years, we've seen, you know, things kind of wax and wane, right? Or at least, you know, optically, from, you know, a tremendous amount of interest, as evidenced by the Aimmune Adcom to, you know, COVID, where everyone was staying at home. Yeah A nd not being exposed to anything, to now, post-COVID, where presumably people are being exposed, kids are being exposed to all sorts of things back at school once more. Yeah. If you were to kind of plot it. Has interest reached the levels that it seemingly were at pre-COVID? And if not, kind of where do things stand and how people—it just, I mean, you might wanna remind people- Yeah. you know, where things, you know, give a little bit of history about, you know, Nestlé's lack of involvement. Yeah in the immune asset now. So what are families doing? You know, how are they dealing with things? Well, yeah, so I- Go ahead and take up sort of the medical side of that. Yeah, sure. I'll come to the commercial side. There's still huge, huge interest. Yeah. With Palforzia and or immunotherapy, that has been around literally for hundreds of years, right? So patients who wanted it could find practitioners who offered that. So that wasn't the problem or the challenge. It's the product itself is very difficult to use, right? As people, initial enthusiasm was so huge, and then as you go through the REMS and 11 visits, and I have to do this and this, and my child has to sit still for three hours. Yeah. But for example, omalizumab was just approved, right? The IgE blocker. There's tremendous interest there. Obviously, for us, more products only help us to build that dialogue between the general pediatrician, who basically used to say, "Avoid an epi, go away." Now they can refer them to the allergist, and hopefully, with our product being approved at some time in the future, other products coming our way, I think it's all good. In terms of the enthusiasm, you know, it's still huge. We just came back from Quad AI, and we broke the product theater record with standing room only. I'm not sure if you were there, but, I was not. It was, it was amazing, and the topic was early intervention for peanut allergy. So there's still huge, huge interest. I'll add to that. So this is what Pharis and his team are observing in dialogue with the medical community through the more formalized market research to sort of anchor that with data. What is quite clear is despite the fact that Palforzia was not a commercial success, it's not because the two things that matter to any competitive product including VIASKIN Peanut did not play out. The first thing is the product was universally recommended by immunologists to families with a recent diagnosis of peanut allergy. The willingness to prescribe was there, so it was not a treating is not worthwhile. It is worthwhile, and that sentiment is clearly expressed by treating physicians. The other side, which is you have access, is it reimbursed in a way that's acceptable to the families and obviously sufficiently rich for the sponsor? The answer was clearly yes. I mean, the managed care access for Palforzia was good, reasonable copays, reasonable buydown programs for the copays, and good distribution through closed pharmacies. So it's prescribed, and it's paid for. The product did not succeed, as Pharis said, because it's a very cumbersome product. What we're offering is the antithesis of that. Product's easy to use. You put the patch on your child's back every day. That routine is easy to build. There's no restrictions of daily living, so put the patch on, you go on with your life. And moreover, as we've shared with i n a number of forums, the, there's an element of validation to the parents that is very powerful. That routine, that ritual is very important because every night, the parent, by putting the patch on the child's back, essentially reinforces, "I'm doing everything I can. Mm. I read labels. I talk to the babysitter. I talk to the baker to make sure I know what's in those cookies. We carry an EpiPen just in case, but now I'm doing the one thing that provides that supplemental coverage, or protection." And the psychology of that, Andrew, is usually important because there's sort of two tracks to the unmet need. One is avoiding anaphylaxis and the serious consequences of accidental peanut consumption when it happens. The other big need is every day parents live with that fear. Today is the day the phone's gonna ring, and our life has been changed, and by wearing the patch, you make the risk of that consequence to be less, and with that, the family anxiety to be less. That's a big part of the value capture- Mm. of our model here. Does that make sense? Yeah. Yeah. Do you agree with that? Yeah. It's very helpful. You know, maybe just in the context of the BLAs, you can speak about the commercial opportunity- Mm-hmm. each represents and how people ought to think. So the epidemiology is about 600. Actually, the exact numbers are 290,000 kids between the ages of one and three in the U.S. have a peanut allergy, and then about 380,000 children between the age of 4 and 7. The birth cohort is roughly 100,000 kids are born every year with a food allergy, and 80% of them will not outgrow it. One of the, When I said peanut allergy, no, food allergy. 100,000 kids born with peanut allergy, 80% of children will not outgrow it, and the not outgrowing it plays out by the time they go to school. So if they have not outgrown by the time they're six or seven years old, they have it for the rest of their lives. So both markets are sizable, and the psychology of the unmet need, though, is important behind that. The age of diagnosis of all food allergies, including peanut, is typically one to five. As children explore new foods as part of the growing, obviously, this is when you may discover that they are allergic to one of them, making the surprise element and willingness to treat in the younger children to be higher. On the other hand, when it comes to ability to turn the epidemiological market into a business, a transactional market, the one or two year-old may not have an allergist yet, as Pharis was touching on, while the older children might, because besides their food allergy, they might have atopic conditions, they might have asthma, they're likely to be in the allergist care. So those are the two elements that drive essentially commercial potential. Opportunity to treat a one to three year-old is highest. Maturity of the transactional market is higher in the older kids, but we see this as a significant market opportunity in both age groups. Does that make sense? Yeah. Yeah. Very helpful. I guess, you know, you alluded to it a little bit earlier, but obviously there's been a recent approval in this space. You know, as you've been meeting with investors post that event, I'm sure the questions come up, kind of, can you speak to that? Yeah. You know, speak about, you know, where it fits in, how it's likely or not likely to change things. Yeah. What's the feedback been from physicians as well? Absolutely. I'll give you the macro picture, and I'll have Pharis walk you through the details of it. If you talk to parents of children with food allergies or peanut allergies, they're crying for treatment options, and Pharis touched on it. There's a dialogue between the parents and the doctor. It has to do with the fact that, is the child active? What kind of school do they go to? Does the family go camping? It might be away from an emergency room. So all of this is part of dialogue that needs to take place. Having more options is important. Xolair's approval is an option I think is attractive on the margin, but is important to have, and maybe Pharis can tell you more about that. Yeah. Obviously, we have great relationships with our investigators, and we've asked them this question quite a lot. So what we hear back from them is there are certain special cases where they would use omalizumab, and it's usually for that patient who is kinda two standard deviations- Mm-hmm ... out in terms of sensitivity. Maybe they have three, four, or five food allergies, and they have documented anaphylactic life-threatening reactions to minuscule, minuscule amounts of exposure. For those patients, they may prescribe that. Remember, it's a one or two injections per month therapy for younger patients, and that doesn't play well usually. There could be unusual circumstances where the patient may be in an environment that represents a higher risk situation than they normally would be in, so that would be another situation. But for the typical patient that we see in our clinical trials, there's a high reluctance to prescribe it for multiple reasons. It's an injection, and then two, there's really no clear understanding of what an IgE blocker does in a developing immune system. So that's the other thing we hear. Chronically. Yeah. I'm not sure I want to do that in my patient yet. I have to see a little more data in what this means longer term. Yeah. Does that help? Yeah, no, that's very helpful. It'll be used in older children and those, as Pharis says, that are really rather acute and complex conditions. Okay. I guess in the context of VIASKIN being a platform. Yeah A s well as an individual product, you know, is from an investor perspective- I s there appetite to see? I guess, how are you thinking about asset allocation, resource allocation in the context of things beyond the peanut program? That's an important question. So yes, there's a platform. We already go to two phase IIb programs with our milk program. Pharis can describe them in a second here. Behind that, other tree nuts is a huge unmet need. Celiac, another huge unmet need where we're working on. So, if we had significant amounts of capital, we'd be accelerating these programs. We also want to be and it's not because of a lack of appetite by investors, we need to be good stewards of the capital we have right now in a market that's been obviously a little bit chaotic, so that we marshal all of our resources. More than 90% of our spend is going right now to getting VIASKIN Peanut to approval, and that's gonna do two things. It's a validation of the platform at that point in time that I think makes essentially the attractiveness of the other assets to be even higher. It'll also reduce our cost of capital, so all these other programs that experts are interested in, parents are interested in, investors I know are interested in, to be funded at that point in time. But once we pass those milestones, making the capital allocation to be a better stewardship of our capital. Does that make sense? Yeah- Yeah N o, very, very much so. I mean, I think, you know, another area that's worth asking about is, you know, the company's been around for a while. You know, as you've done these investor meetings, there's the question of, you know, meeting with people who've probably met with the company over... Mm-hmm ... a number of years. Do you get a sense that they're waiting for a particular event to occur, before they, you know, kind of pull the trigger on an investment? Because, you know, there's belief, obviously, in the commercial opportunity. I I think there's belief in the approach. Yeah. I think there's, you know, some question about the company's historical ability to execute. Mm-hmm. I guess, what are they waiting to see? Yeah ... before they- Mm-hmm ... you know, all the pieces kind of come together for them in, in your eyes? It's clearly lifting what is a regulatory overhang. So the ability to execute, again, I need to defend my team here. When it comes to running trials, we do it very well. When it comes to putting together a coherent story about patch adhesion expectations back in 2018, 2019, that was not done well, but we're under new management for that reason. So I think the team's ability to execute is very strong, but it's been a long regulatory road that's been complicated by one thing, lack of clarity on the part of DBV's part of what is it that the patch experience should be? We fixed that. And the other part, obviously, has been that of the last four years, two or 2.5 were lost, and understandably so to the pandemic. We are reviewed by the vaccine division at the FDA. It's only a month ago that Dr. Kaslow announced that they finally caught up to all of the backlog of work from the pandemic. So what have been slow processes now are behind us, but essentially, the last four years could have played out in two years for us, but we all understand why that is, quite simply. So regulatory overhang is what we have to to address, which is why, again, we're not going to move forward any more programs until literally every element that matters in dialogue between us and the agency has been agreed to, so that what we bring the market is a BLA that has very low review risk around it because everything will have been agreed beforehand, and that's terribly important, so. It sounds like a lot of that occurs in 2025. A lot of it, the dialogue occurs as we speak. Right. And then this guy's going to execute the studies machine-like. That's actually the least of my concerns. Yeah. Great. I'll look forward to a very exciting next 12 months or so. We have perfectly reached the time limit. Thank you. Perfectly. Andrew, thank you. Great dialogue, as always. Thanks, everyone, for attending.