Excellent. Can you hear me okay? Welcome back everyone to H.C. Wainwright's 28th Annual Global Investment Conference. My name is Matthew Caufield. I am a Senior Biotech Analyst here at H.C. Wainwright, and we are pleased to welcome DBV Technologies. We are joined by Daniel Tassé, CEO at DBV. Thank you very much for joining us.
Thanks for having me. Thanks, everyone.
Excellent. Maybe to start things off, from a catalyst standpoint, the most important upcoming updates are the VIASKIN Peanut BLA submissions in children ages four to seven. That's expected in 3Q. Then there's also a BLA submission under Accelerated Approval, potentially for toddlers, and that's the age group one to three. We're looking at that one for year-end 2026. Can you walk us through the progress that you've made into getting these submissions to this stage, t o be submitted to the agency?
Q3 means 30 - 15. Obviously, we maintain our planning to file this by the end of the quarter. We've had some good discussions with the agency, as you know. VIASKIN Peanut is a very novel technology. Even the approach, which is exploiting the immune properties of the skin as to desensitize children, has no analog to start off with. Plus the fact that it's a drug-device combination regulated as a drug, reviewed by the biological division. There's some regulatory complexity here. The exchanges with the agency to make sure that what matters to them was properly structured and easy for them to find was obviously very much welcome, which is why, again, we'll be filing in four to seven by the end of this quarter.
Our plan is to file in one to three by the end of the year also, with a discussion on the form of that filing, everything else that take place with the agency as part of the usual pre-BLA discussions, which will take place after the first BLA goes in.
Excellent. The team had previously mentioned the process of reformatting the BLA for the agency. Has that process remained largely administrative in nature? Is there any important additional color there for investors heading towards the planned submissions?
Your question is very important. If I may, I would call it formatting rather than reformatting.
Got you.
It's not like they actually seen something and says, we don't like it. Redo it. The discussion were around how you organize the data for the CMC data, which as you know, is a massive file for any product, particularly for ours, given the nature of the product. As well as how do we organize the data for data tabulation and for analysis biostats here. So those discussions entirely about making sure the data was not only complete, but organized in a way that made it easy for the agency to review it. As I said, those discussions have been very fruitful, and I'm thankful to the agency for the level of engagement, and very grateful for where all this landed.
Excellent. Then maybe just taking a step back, for those that may be newer to the VIASKIN Peanut patch story, what defines the greatest unmet needs presently in peanut allergy? What more can you share about the prospective market opportunity that's out there?
Your question is fundamental here. It's a symptomatic disease, if you look at what the psychology of the family is living with. A child with a peanut allergy changes family dynamic for everything. The restaurants you go to, how you think about summer camp, how you think about play dates, whether your child gets to sit with his friends or her friends, or at the peanut-free table at school. All of that is part of what we're trying to address here. What our product is meant to do is to improve the quality of life of the whole family by making the child and the family feel safe. That if they were accidentally to consume peanut, the consequence would be very little as opposed to serious. That's essentially what our approach to desensitization is supposed to do.
That's the value proposition. As we talk to families, as we talk to physicians, as we talk to caregivers, it resonates loud and clear. By wearing this patch, by putting it on my kids back every day at the same time, I'm providing this. The image has been used by some parents as an airbag that will deploy if my child accidentally eats peanut. The consequence will be very little, as opposed to very serious.
Very helpful.
Does that answer your question?
Absolutely. With the potential comprehensive therapeutic coverage across toddlers and children, when are patients typically diagnosed, and when do they typically begin any sort of oral immunotherapy presently, for example?
That is the dimension about peanut allergy that has changed the most over the last few years. The age of diagnosis a few years ago was between the age of three and five. Now, it is closer to three, in fact, as early as 18 months of age. The reason for that is that many families choose to introduce peanuts to the child's diet sooner. With the expectation or the hope that it is going to prevent developing a peanut allergy. That is unfortunately borne out by facts. What it does do though, which is really important and beneficial to the family, is if the child does have a peanut allergy, is diagnosed sooner.
Since all forms of immunotherapy, the best candidates are the youngest candidates because their immune system is most plastic, most likely to respond to the therapy. This reduction in the average age of diagnosis has turned out to be something that is certainly attractive for kids to go on VIASKIN Peanut, given the fact that we expect to have that indication, which nobody else has. Most importantly, we are offering a product that is easy to use and safe, which is what you want first and foremost in what will be a multi-year therapy in a pediatric population. The age of diagnosis is slipping to younger kids or evolving to younger kids, which we think is very much pro-outcome in a toddler population.
Then kind of along those lines, VIASKIN has been supported by the positive test top line, the earlier EPITOPE data, and now there is a phase II THRIVE study looking at the youngest infant population, the age of 6 months- 12 months. What do you hope to determine from that trial? Is that kind of with sights on a label extension opportunity or what is kind of the mindset there?
Well, the most important thing is the claim that we want to obviously demonstrate here. If you allow me to get a bit of a biotech soapbox, if I may.
Please.
We all get into this business because once in a while, you come across science that could really change the world and change outcomes for patients. What we're trying to show is that introducing peanuts to the skin in a way that is easy and non-invasive for a child that's just been diagnosed with a peanut allergy at the age of 6 months and 12 months, three years or four years of treatment can bring a lifetime benefit. And the lifetime benefit that we're trying to show is defined as ad libitum consumption.
The word cure does not exist in language of allergists, and understandably so, because cure means different thing to different people. But what we're trying to achieve is after three years or four years of treatment, the child goes off therapy, and in that 12 months post-therapy, they live with peanuts the same way as a child who was not diagnosed with a peanut allergy. That includes some quality of life measurements here, and that's what we're trying to show here. So success there would show that it's possible if you're diagnosed early on and you add the patch, which is we believe an easy routine for family if they get in.
You would have the disease modification benefit that I think we're all aspiring for. Once we've shown that claim, working with the agencies around the world to add that to the label comes next, but first the claim.
Understood. When we look to the peanut allergy landscape, it's notable to also mention Palforzia in the treatment of peanut allergy. It went from development by Aimmune to two different sales, only to then be discontinued this year. What were the greatest limitations there, and what can be learned to hopefully help a successful VIASKIN launch if approved?
Let me start with the learnings. There's two things about Palforzia sort of adventure that are lost and I think are important to remind people of. One, it was quasi universally recommended by allergists to families whose child was just diagnosed with peanut allergy. The willingness to prescribe by allergists was very high.
Which I think is a good marker for our product, any other product in this space. Secondly, at the other end of sort of the value proposition scale, they did a pretty good job on market access, reimbursement, closed pharmacy distribution, reasonable co-pays. They did a fine job on that front. You have a product here that doctors are willing to prescribe, payers are willing to reimburse. It did not succeed because the product turned out to be very cumbersome for families to use. Now, the label to best manage the risk of anaphylaxis on treatment, which is a significant risk if you give oral immunotherapy, you give peanuts to kids allergic to peanut every day, require the children to be at rest for three hours a day per the dose. If you have kids between the age of, pick the number, that is very difficult to do here.
The product was not successful for that reason. We are the antithesis of Palforzia. Put the patch on. It takes 10 seconds or 12 seconds. It is a loving gesture. The parent or the caregiver puts the patch on the child's back. It is a loving gesture to rub it to make sure that it sticks appropriately. Bedtime, bath time, in the morning the child gets up. And there was absolutely no limitation to daily living. Go chase the dog. Go to your basketball practice. We believe that we're offering a value proposition that is very much aligned to the needs of a long-term therapy in a chronic population, ease of use, and safety, because without that, you don't get an outcome. Our product provides that.
That's very helpful. With peanut allergy awareness and obviously the unmet need, what are your thoughts on why this has not been necessarily a more competitive commercial landscape over the years?
That's a really important question. Obviously I'm not running the R&D department of other big pharma, big biotech companies, but I think there's something really important that you touch on with your questions, if I may, and again people may not agree with me here. There's two schools of thought on how to treat food allergies. Desensitization, re-educate the immune system of the patient as the immune system will not recognize the allergen to be dangerous. Or the other one, block the response to the allergen.
IgE blockade is done systemically, and these are two fundamentally different treatment strategies. IgE blockade in older patients makes best sense, however, their immune system is not plastic enough to be re-educated in the first place. Not surprisingly, XOLAIR and other products in that space are doing very well in adolescents and adults. The product, to use XOLAIR as an example, is not used very much in children under the age of 10. In peanut- allergic children, with just peanut or peanut as part of a multi-allergen condition, the penetration of XOLAIR is about 1% in that population here, because allergists would rather go with the other treatment strategy, desensitization through immunotherapy in younger kids, because they have the immune system to respond to it. If disease modifying, as many believe, then the benefit essentially is the one we'll be extracting out of the THRIVE study, for example.
What I'm surprised is that so much energy has gone to IgE blockade. But arguably, it's a bigger market. That's for anybody that passes the age of 10 is a candidate for IgE blockade. The younger kids, where immunotherapy makes better sense, unfortunately, we're pretty much the only one in that space. I'm fine with it as a business person, but as a parent with children with food allergy, it's a bit thinner than we want it to be.
Sure. No doubt.
That make sense?
Yeah.
Again, to be clear, I am just offering an opinion here.
During the quarterly update, the team discussed commercial planning, testing a broad pricing range, payer discussions, patient segmentation. How are those initiatives advancing, and what further thoughts can you share about those priorities?
The team has done a very nice job of doing all that work. As you know, launching a big brand in this industry requires work for a long, long time prior to launch. A lot of work to be done to understand the psychology of prescribers, of families. How do they get information? Where do they get information? How can we help essentially direct them to the information that is most relevant to them? As well as talking to payers to talk not only about price, but price as connected to the prior authorization process.
What will be the prioritization process? What does it look like? Is it cumbersome? What can we do to help it make it easier for the clinic and the practice? All of that work has evolved very much. I am very happy with the progress we have here. What we do know, and I am happy to reiterate, allergists are the ones who treat food allergies. Parents expect allergists to be the ones taking care of treatment. It lines up nicely with the American Academy of Pediatrics guideline on management of food allergy, which asks of pediatricians to do three things, recommend avoiding the food, prescribe an EPIPEN delivery device, and go see the allergist.
Allergist is supposed to treat these patients. We've observed that about 60% of kids one to seven, put our two indications together, with a peanut allergy are already in the allergist's office. It might be for their peanut allergy, it might be for their asthma, it might be for their shellfish allergy. They're already there, making us focusing on allergists to be by far the preferable strategy.
Very helpful. Turning back to successful VIASKIN development for both toddlers and children, what do you view as the most important VIASKIN differentiators for its clinical profile in terms of getting peanut allergy patients potentially onto therapy and receptive to therapy?
It's the intersection efficacy, safety, and obviously ease of use. Not to discount efficacy, but efficacy is meaningless unless you have treatment compliance, w hich our product offers brilliantly, given the fact that the adverse event profile shows very few patients discontinuing. Our most common adverse event is redness of the skin where the patch is. It is very rarely treatment limiting.
Very rarely. So we have a pretty strong safety profile. The ease of use, we've talked about, it's so easy for families to fit into their routine here, making the ability to deliver the outcome that allergists want after three, four, or five years of treatment to be something that is much more straightforward here. So we like to think that it's the ability to stick, no pun intended, or maybe pun was intended, with therapy for three to five years is key here for a product to succeed.
Absolutely.
Make sense?
Yeah. Based on your interactions with KOLs and allergists, what is your sense of physician preference for proactive immunotherapy versus avoidance and potential infrequent epinephrine use in an emergency, for example?
That's another question that is fascinating, and the marketer in me is going to kick in here. In focus group, as you talk to families and parents, and get a sense of what is it we're solving for here, as I said, although anaphylaxis because of accidental peanut consumption happens hopefully only every few years, wh at we are hearing from physicians and from parents is the whole strategy of read the label, talk to the babysitter, talk to the waiter, and avoid the food, while carrying an EPIPEN, is really saying, we're planning for failure.
It's a strategy that only makes sense because you accept there will be accidental peanut consumption, and you're trying to push it back or push it out as far as possible. What we hear from families, no, that's not a satisfactory strategy because it reinforces the need to be anxious every day. The risk is real. What our patch is meant to do is mitigate that sense of risk by the fact that by desensitizing the child, if he or she does accidentally consume peanuts, the consequence would be much less than it would be if it wasn't for VIASKIN therapy. In doing so, you're addressing the ultimate symptom, which is family quality of life.
Understood. I know we only have another minute or two left here, but I just wanted to get your views on the available therapy XOLAIR, indicated for lower reaction risks from accidental exposure to peanuts and other foods, patients ages one year and older. It's a subcutaneous injection. Obviously, that's going to have its own limitations compared to a topical adhering therapy. Maybe just some high-level thoughts there on differentiation.
As I shared, XOLAIR is not used very much at all in children one to seven with a peanut allergy. Because again, it's not the treatment strategy allergists want. They would prefer to desensitize. If you stop using XOLAIR, obviously, your risk is the same here. We welcome XOLAIR because offering treatment options to parents, plural, is important. Even if it's not the right option for most kids, it's a point that's available and contributes hopefully to this rising tides floats all boats here. Immunotherapy is the approach of choice in younger children.
Excellent. Then maybe just our last question, based on timing, where do things presently stand on your cash runway as you approach BLA submissions? Can you speak further to your anticipated plans for internal versus partnered launch, pending FDA acceptance and approval?
Correct. Let me start with the latter one. We are launching it ourselves. We have not looked at partnering it. Nobody out there is an obvious partner that brings muscle and scale to this space here. We would rather be the ones who provide that and the expertise. Our cash runway is sufficient to take us into Q3 of next year, which means we have enough money to fund all the investments necessary to launch the product, including hiring a sales force.
Obviously, incremental capital would be welcome because we do not want to launch . Right now, we have the financial means to make all the investments necessary to make this product a significant success.
Excellent. Well, very excited to see those submissions. Daniel and DBV, thank you very much for your time.
Thanks so much.
Appreciate it. Thanks everyone for attending.