All right. Good afternoon, everyone. Welcome to Guggenheim Healthcare Innovation Conference. My name is Yatin Suneja, one of the biotech analysts here at Guggenheim. It is my pleasure to welcome our next presenting company, DBV. From the company, we have a few executives here. We have the Chief Executive Officer, Daniel Tassé. We have Chief Medical Officer, Pharis Mohideen. And then we have the Chief Commercialization Officer, Kevin Trapp, who just joined the company about 10 days ago. So we're happy to have you all here. Daniel, I'm going to hand it over to you to make some opening comments. In your opening comments, touch a little bit on, in general, what is there seem to be a lot of interest in the food allergy space. So touch on that. What is driving that interest?
Maybe give a little bit of an overview of the DBV story, where you are, what are some of the milestones, and then we'll go into the Q&A.
Thanks for the question. Thanks, everyone, for joining today. There's interest, I think, for the right reasons that there should be interest in biotech. One, it's a large unmet need. We estimate that 17-33 million Americans suffer from a food allergy. In the space of peanut allergy in children, that alone is 700,000 kids, 670,000. Large unmet need when it comes to the medical reality and epidemiology. The other good half of all of this is there's an interesting development, promising science. We like to think we're part of that ourselves. We'll come to it in a second here. This intersection of what you want in this space, you did such a nice job overviewing all of this recently. There's promising development, but I think has brought interest and capital to the space.
What we do at DBV, the founders figured out that the human skin is a very powerful immune organ. Tapped into the right way, it can be used to desensitize against allergens. They were smart enough to focus on food allergy, with the lead product being peanut allergy for that technology here. We have a very novel patch technology. There is no analog for it. Epicutaneous immunotherapy, EPIT, the platform we call VIASKIN. Via the skin, we can desensitize children. We are focusing entirely on children, young children, highest unmet need, very plastic immune systems to respond to it also. That is what we do. I'll stop there for now.
Got it. Very helpful. I think that context was helpful. With regard to your program, you have two approaches, right? You're going after ages four to seven, and then you're also going after a younger kid. Can you just help me understand what we have seen? I'm going to go grab some water.
No problem at all. Thank you. See, we have two programs in parallel. We have two patches that are very similar. The engine of the patch, the uniform ring, the allergen, the dose, the mode of administration is exactly the same. The patch in children one to four is smaller and square. The patch for children four to seven is larger and round. The only difference is the Band-Aid-like material that surrounds that inner core here. We have two BLAs in parallel, not the traditional BLA supplemental BLA structure for historical reasons. That has been good for us as a management team. I think it is good also for investors. The two programs are not being tethered to each other. Whichever one gets to market fastest can help those patients sooner. Helps, obviously, in being good stewards of your capital.
Right now, the plan is to file in four to seven, the first half of next year. We can talk about the program in a second here. And to file in children one to three with a distinct BLA in the latter half of 2024.
Yeah. In the four to seven , what have you generated so far? I think you were running a news, there is another study that you're running, which is going to read out relatively soon. Just put in context what you have generated and what gives you confidence that you can replicate successfully results in the phase III that you're running.
Correct. I'll have Pharis answer that since it's been hard work.
The study you're referring to is the VITESSE trial. It's the four to seven-year-olds with the circular patch that Daniel described. It's the largest study of its kind that's been conducted in this age range, 654 randomized subjects. We went from the four to eleven-year-old original study that was done four or five years ago. Like other forms of allergen immunotherapy, younger patients just have more responsive, more plastic immune systems. To answer your question, the study is in four to seven-year-olds. It's a large study. It's a 12-month efficacy endpoint study. This is what we're going to need to support the BLA moving forward. It's a little bit different from the four to eleven in the sense that it's younger. We're also going after a more sensitive patient population. We've capped the inclusion at 100 mg at entry as opposed to 300 in the past.
In broad strokes, it's a younger, more sensitive patient population.
What is the endpoint? Exactly what would you have to show for it to be successful?
Great. There is a statistical endpoint that we need to show. The FDA has that as the lower bound of the 95% confidence interval difference between active and placebo needs to be about 15%, 1.5. The way we get there is we look at the percent of responders. We have two responder criteria. Those that enter the study at 30 mg at day one need to get to 300 in their food challenge eliciting dose one year later. That is one group. Those who enter a little bit higher at the 100 mg at day one as their eliciting dose need to get to 600 mg. You look at the percentage of responders active versus placebo, and then overarching with that 15% lower bound.
Got it. Then.
Through this 30 mg or less as it is.
Correct. That's right.
Correct. For this specific threshold, what have you shown in the Papeete study?
Right. Great question. We have the ability to look at the Papeete study that he's referring to is the four to 11-year-old study that we've conducted in the past. Out of that data set, we have 190 subjects who are four to seven. We can look at the response rate of, as Daniel said, those who entered below 30 mg, 1, 3, 10, 30, getting to the VITESSE endpoint. We can also look at the group that entered at 100 mg, getting to the Papeete endpoint of 1,000. We did not have 600 in the VITESSE study. We have extremely robust modeling around the VITESSE study to have a very good reassurance of the endpoint. I'll remind you that based on that data cut, we have about five times more patients in VITESSE. As we mentioned, it's a 654-patient study.
You want to touch on the numbers, maybe?
Yeah, just touch on the numbers a little bit.
In terms of?
The delta to 19 placebo, the 35%.
Yeah. When we looked at the four to seven-year-old looking at the Papeete response criteria, we have about a 34%-35% delta with that cohort. We were very conservative in terms of our statistical planning for the VITESSE study. We gave ourselves a haircut down to a 28% delta between the two. We decreased the active arm response rate, and we increased the placebo to also give us a lot of conservative statistical planning around that endpoint.
What is the powering assumption in general, like from a.
Oh. We targeted 600 patients that would give us at least 90% power. When I gave kind of the two-minute warning, the study's shutting down, we had a deluge of patients that came in. We ended up randomizing 654 subjects, 9% more. Now we're at greater than 90% power for that endpoint.
Got it. So just to summarize, so in Papeete, I think in that four to subgroup, you already saw a pretty high, let's say, response rate, close to 35%. And you have sort of really overpowered this VITESSE study to above 90% with a 28%.
That's spot on.
OK. Any other unique feature of VITESSE that we need to sort of focus on or keep in mind? Because these data are sort of going to come very soon. What else do we need to focus on here?
Assessing the safety profile?
Yeah.
Or verifying it. Treating children one to seven, obviously, the parents are interested in safety very much, as much as efficacy and ease of use. We will be tracking that. As you know, all our previous studies done with the technology on all age groups have shown that the safety profile was actually rather remarkable.
Got it. Pharis, you mentioned that the younger the patient, the more sort of flexible the immune system is. Is there a particular percentage of younger kids, whether it's four, five, six, or seven, that you are targeting? Just curious on the age of these patients.
Yeah. There was no pre-specified number that we had to meet. As it turned out, we have more four and five-year-olds. 57% of the study population are constituted by four to five-year-olds. We know they tend to respond a little bit better than the older patients, so.
Got it. If this study is successful, and you just need to hit that confidence interval of 15, what will be the next step when you will be able to find? Is there anything else on the safety side that you need to do?
No, nothing else on the safety side. This study will be sufficient to support efficacy and safety, given the placebo patients moving over to crossing over to active. That is more than sufficient to satisfy the agency for safety. Thus, we will be filing a BLA, with VITESSE being the key element of it in the first half of 2026.
Got it. I want to touch on commercials. I'll go to Kevin. Kevin, maybe perhaps you could introduce yourself since you are new to the company. What led you to join the company? I have a few questions about specifically four to seven age group. How are you thinking?
Sure. Sure. Yeah, it's great to be here. I'm new to the company, but not so new. I was the Chief Commercial Officer back in 2018 to 2020 at DBV before the setback with the Papeete study. It's great to be back. It's an area that I'm passionate about. I really want to get this to families. We can speak about the unmet needs and what we're here on this profile. Prior to that, I was at Bristol Myers for 27 years. In between there, I was in a biotech consulting firm, Biotech Value Advisors.
Very good. Thank you. Now, let's stick to four to seven, because that sort of is the first BLA. Put in perspective the commercial market there. What infrastructure you need, where you are on the manufacturing, and all of that.
Yeah. Children four to seven, largely as standard of care today, have avoidance and epinephrine as their choice. There are other therapies available. In our analysis of that, there's not a lot of usage of the anti-IGs or OIT. They try them, but there's still an unmet need there. That's 400,000 patients. What we hear is that the ability to talk to parents, these are largely millennial parents. We talk to them extensively on the profile of the product. To me, the big challenge here is how do we move the market from what is largely management of the disease, with that being avoidance, to treatment. This age range is very unique. We've talked about the plasticity of the immune system to really change the course of the disease and potentially to tolerance. I think that's something that's very exciting.
Parents are willing to use this progressive efficacy over a few years with the patch to build towards that. From my lens, we've got to build out the team this year. We've done a lot of data and analytics working with the DBV team already. Really understanding what are the drivers of those parents in that age group. There are 4,500 allergists that we'll focus on at launch. That's pretty relevant. Small sales force, probably around 70 sales representatives. Obviously, starting to initiate discussions with payers on that front. Manufacturing, and I'll let Daniel speak a little bit more to that. I think that's ramping up nicely. We're looking at what's the total demand here, both in four to seven and then in life cycle in 2027 with one to three.
One to three.
Manufacturing a little bit.
Sure.
Yeah. So the product is manufactured through CDMO, the name of Fareva in France, very well-established contract manufacturing organization. Have seen the FDA often. To simplify, American peanuts from Virginia, sent to the south of France, will be turned into the API at a Santa Fe facility, and then sent up to Fareva to make the final product. We're in a good spot. We've worked hard at it. The product is unique, being a drug-device combination and its complexity. We've been all over that. Good dialogue with the agency also to make sure that what they want to see, we will have when it comes time to pre-approval inspection.
Got it. Going back to Kevin on the market, how should we think about price? I know it's not even approved yet, but just conceptually, what are sort of the brackets? How should we think about it? If you are, maybe one more question I'll ask. If you are a parent and if your kid has a peanut allergy, why would you not use it? Just put it on the skin, delivers it. Is there a patient population that you can sort of get faster than you need more convinced?
Yeah, I think that's work we'll continue to do. I think on price, I mean, you've got the analog in the market with Palforzia. That's probably in the $10,000 net range just as kind of a ballpark. We'll have the discussions with payers. We obviously need to see the data that comes out of the test to go and talk to them. In terms of patients and uptake, we've seen in all of our market research a significant interest in a product that can be non-invasive. This is on the back each day that has the safety profile we've seen come out of this. That's really, it's using the body's natural abilities, right? It's helping to retrain the immune system at this age to build up that tolerance and, as I said, potentially be disease modifying, which is obviously exciting.
I think we have to really understand all of that as we think about the price decision. But there are clearly parents that we've talked to now over five, six years that we just saw, many of our advocates and patients at the recent college meeting that are expressing tremendous interest in the profile and really want us to get it there as fast as possible.
Got it. Daniel, I think you and I have discussed this. Can you maybe, I don't know how much you can share, but talk about where this administration and the FDA is in terms of bringing these types of therapies to the medicine, because the alignment that you are able to reach with the FDA was pretty, I would say, pretty good and very efficient.
Thank you. You're kind to say so. There's no doubt that food allergy seems to be of importance to this administration. Talking about the FDA specifically, many people know that Dr. Makari, the commissioner, wrote a book about many of the things in American medicine that could be done better, including how we go about addressing food allergy. That provided a dialogue between us and the administration and the FDA that I think has been rich and fruitful. We like where you are on that front. I also want to make it a shout-out to the agency. The division directorship that has been in place now for a couple of years in the Office of Vaccine Research and Review to the people who review us have been engaged, objective, responsive. They hit their deadlines. We can talk science about them.
A big part of the progress we've made on the regulatory front, the administration has been a part of it. Also, the people in the agency doing the hard work have been what we want regulators to be.
Helpful.
Does that answer your question?
Yeah, it's helpful. In the other group, subgroup, one to three years, I mean, there you don't even need an efficacy study. Just help us understand what the dynamic there are, what you're doing, what exactly are the next steps there.
Yeah. We've completed the one to three-year-old 12-month efficacy study a few years ago. We called that one EPITOPE. The FDA has seen that. They have not asked for additional efficacy data for us to submit the BLA. They did ask us to conduct a supplemental safety study to meet the ICH guidelines that say you should get between 300-600 subjects for at least six months of exposure. We're conducting that study as we speak. That one is called COMFORT Toddlers. It's a six-month safety study. There's no efficacy associated with that. Once that study is completed, we'll get our exposure numbers close to the 600 that the FDA has asked. They've been very consistent with that measure throughout our development program.
Once that's completed, we can combine those two together to form the BLA along with the more than 1,000 patients that we have historically from our other studies.
That will be an sBLA, most likely.
No, that would be a standalone BLA. We have two completely independent programs. As Daniel said, it's great for us because one is not tied to the other. Somewhat paradoxically, the study that's been completed is the EPITOPE study and one to three is coming a little bit later because we have to do that safety study relative to the four to sevens.
I see. I think the patch is a little bit different. Right? One has a square. One's just round. That's the only difference.
That's exactly it. The square patch was the original patch used in children one to three. The FDA wanted a different patch at the time of the Papeete's readout, which we modified, just the larger patch. As I said, the engine is the same. One has a bit more suspension.
OK. The timeline for the BLA is second half of next year?
Yeah, first half four to seven, the first half of next year, one to three in the second half of next year.
So basically about six-ish months behind. OK. How is the market opportunity here relative to four to seven?
Yeah, I mean, we talked about the size of it. I think you guys put out a really nice report on the market. Thank you for that. Again, I think it's the ability to mobilize parents in a relatively small segment of allergists. I think broadly, we know where the competition is. There are two approved products, Xolair and Palforzia. At least our analysis of the one to seven age bracket is there's relatively limited usage. Options are good. I mean, every decision is between a family and their allergist or physician. We certainly want to see options out there. We think this is a very unique age range where safety is paramount. We think the patch really can deliver on that.
Like you said, it's a small gesture of love every day and kind of putting the patch on the child's back and being able to desensitize them over a three to five year period.
I may add a quick comment, if I may. The age of diagnosis of all food allergies is one to five, typically. As our kids try new foods, we find out they might be allergic to one of them. The one to three population is particularly important when it comes to parents' psyche and willingness to do something. One of the reasons why we looked at a six to 12 month study, we discussed at the college this weekend to look at whether or not three years of treatment in six to 12 month olds would have the lifelong benefit of ad lib consumption. That study will be starting roll sometime next year.
Got it. What are the safety considerations? What have you produced or shown any safety liability with the patch? Like what happens, a little bit of itchiness? How is the compliance for these patches?
Yeah.
With our data set of more than a million patch days across our development program, we have characterized safety for this product very, very well. We have very high compliance rates in our clinical trials, north of 98%. We do open label extensions. We have very high retention rates in those studies. The most common side effect that we see are local application site reactions. You're putting an irritant allergen on the skin of a highly atopic patient. In some ways, it's a good marker that something is happening. The frequency of those events decreases over time, as does the severity. Most importantly, almost nobody discontinues the study because of that side effect.
Where do you put the patch? In the back?
Between the back, between the scapula. It is changed out once a day, as Daniel said. It literally takes about 15 seconds to put it on. As opposed to sort of other modes of therapy, whether it is an injection or force-feeding peanut, it is kind of a loving gesture. The parent can feel like, OK, I am protecting my child today in a simple way. One other thing we did not mention is the product goes on and the child is a child. They can go and do absolutely anything they want. We have patients that swim in our trials, soccer, whatever they want to do. It really is a very lifestyle-friendly product.
These kids still carry an EpiPen.
Absolutely.
OK. I think that's all I had for you. How are the financials looking? How much cash, the bond rate, obviously.
Thank you. We have cash till the end of 2026 at this point in time. Importantly, the VITESSE data readout hitting the primary endpoint will bring the acceleration of warrants that will bring in $181 million if all of them are exercised. The trigger is 15% delta to lower bound confidence interval in the VITESSE trial. Assuming we're successful and those warrants are exercised, we will have more sufficient capital to take us through launch in four to seven. We call investments are necessary to build a great brand. So we like our financial position.
Got it. And then the official guidance for VITESSE is around this year, like December, January?
Before the end of this year.
Before the end of this year.
Before.
Before.
In the next few weeks.
In the next few weeks. Awesome. Thank you so much. That's all we had for you. Thank you.
Thanks, everyone, for attending.
Thank you.