DBV Technologies S.A. (DBV) Earnings Call Transcript & Summary

Hello, everybody. Our presentation will be starting shortly. We are just waiting for the 10-K to be filed, and we apologize for the delay. Apologies for the late start of our conference. Welcome to the DBV Full Year 2023 Financial Results and Business Update Conference Call. [Operator Instructions] 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, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 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 Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV's Chief Medical Officer; and Virginie Boucinha, 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?

Thank you, and thank you, everyone. Again, I need to add my apologies. We were waiting for the 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 our Viaskin Peanut programs and regulatory pathway, and then Virginie will share with us the financial update. But before we do that, I'd like to share with you a few perspectives about Viaskin Peanut and the peanut allergy market, things that we have not discussed in a while. Starting the fact that last week, DBV attended the American Academy of Allergy, Asthma & 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 and immunology community. And every year, we have a lot of boots on the ground at Quad AI to listen and engage with all of our key stakeholders, allergists and patient advocacy groups at the very top of that list. One of the highlights of Quad AI this year was the fact that the product theaters -- 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 had an unprecedented attendance. In fact, were told that we broke the record for Quad AI events and the best-attended product theater ever. The room held 125 people, 330 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 on 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 chemical benefits of Viaskin Peanut because treating children is an important responsibility. Our open-label extension amendment to patients, while it takes time and effort and financial resources, ensures a rich population of subjects on Viaskin Peanut 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 2 data from our open-label extension study in toddlers. And obviously, we cannot wait to see what the year 3 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 aged 1 to 7 enrolled globally in our Phase III trials. All our Phase IIb studies have an open-label extension, which, as I mentioned just now, is key to understanding long-term treatments and the benefits of our therapy. And it goes without saying, we will have the largest cumulative exposure to investigational product ever in pediatric food allergies. It's going to be a massive safety database for our 1- to 7-year-old. We'll have, in fact, close to 1,700 subjects on active treatment. And we combine that with the data from our prior Phase III trials. We -- to break this down, we have approximately 600 toddler patients -- 600 toddlers aged 1 to 3 and about 1,100 patients aged 4 to 7 will have been on immunotherapy for up to 3 years. And let's not forget all the work we've done in 4 to 11 before that, where some of those children were treated with Viaskin Peanut for up to 5 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 Viaskin Peanut patches have been applied to children aged 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. And it is, as I said, the most comprehensive research in children with peanut allergy. We have a well-studied product that demonstrate efficacy and consistently favorable safety profile. We're proud of that, and we keep on doing that database. The second point I wish to touch on today is the disease-modifying potential of Viaskin Peanut. 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 2, our ongoing open-label study extension study. Data has showed that approximately 3 out of 5 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 will be anticipated during accidental exposure, and a massive jump from what was a median eliciting dose at baseline of 100 milligrams. This data suggests Viaskin Peanut is potentially rewiring immune systems, and we suspect that is due to a plasticity of immune system in this age group. We also have 2 other data sets from prior studies showing that Viaskin Peanut can induce what is known as sustained unresponsiveness of the allergen in older children who, after 2 to 3 years of treatment, 80% of participants maintained desensitization of 1,000 milligrams or more 2 months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests that Viaskin Peanut induce sustained unresponsiveness to the allergen by modulating the epigenetic signature of specific T cell compartments. Remember, Viaskin Peanut has a unique mode of action that leverages skin properties and destolerance, 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 2 -- to explore that Viaskin 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 Pharis, our Chief Medical Officer, for a detailed update on our 2 Viaskin Peanut programs.

Thank you, Daniel. As a reminder, we intend to submit 2 separate BLAs for the treatment of peanut allergy. In the 1 to 3 year olds, we are using the original Square patch. The 12-month efficacy study, EPITOPE, is completed, and the results were published in the New England Journal of Medicine. In the pre-BLA meeting held in April of 2023, the FDA did not request any additional efficacy data, but did request a supplemental safety study to increase exposure on active product to close to 600 subjects per ICH guidelines. To be clear, the FDA was not looking for a specific safety signal or a specific safety concern. We call this 6-month safety study, COMFORT Toddlers. In parallel, we are running the 4- to 7-year-old indication with the modified circular patch. We started this program last year with the 12-month VITESSE study. Recruitment is ongoing at this time. This indication will also have a 6-month supplemental safety study, which we call COMFORT Children. The 2 studies combined will have 600 subjects on active treatment to meet the ICH guidelines. So our attention this year will be focused on completing recruitment for VITESSE and starting our 2 supplemental safety studies. As Daniel mentioned, DBV has always been committed to generating the most robust data set possible in our clinical trials. The test is no exception. We recently submitted an amendment to extend the open-label phase so that every subject enrolled in the trial has the opportunity to receive Viaskin Peanut for up to 3 years. And remember, we also have our Expanded Access Program for subjects that have completed a treatment in a DBV clinical trial and want to continue to receive Viaskin Peanut. So the test is set up to provide another large, robust data set, unmatched by any other peanut allergy study in this age group. Recall that the population in the test is considered to be more sensitive than subjects in our previous studies, with the inclusion-eliciting dose set at 100 milligrams. This is aligned with a younger 4- to 7-year-old age group, where we believe Viaskin Peanut can provide great clinical benefit. In VITESSE, we have 86 clinical centers spread across the U.S., Canada, Australia and Europe. Sites in every country are open and actively recruiting subjects. Like other sponsors, we were set back by the new European Clinical Trials directive, which significantly delayed our opening of our European sites. However, that's behind us now, and we expect to build momentum and complete screening by Q3 this year. That brings me to the COMFORT Children supplemental safety study in 4- to 7-year olds. This will have a 6-month core period, followed by an open-label extension. We'll provide an additional 6 months of treatment for subjects randomized to active products and 12 months of treatment for subjects randomized to placebo. Every subject will have the opportunity to receive Viaskin Peanut for a full year. This will be a 270-subject study, randomized 3:1 active to placebo. The main inclusion criteria will be based on skin prick test and peanut-specific IgE levels. These criteria are sufficient to ensure a similar patient population relative to VITESSE. Thus, there is no need for a food challenge as part of the inclusion criteria. One of the differences in COMFORT Children relative to VITESSE is the use of a simplified instructions for use. The safety study IFU states, each DBV712 250-microgram epicutaneous system is intended to be warm for a full day, 24 hours. This is a shift away from the 24, plus minus 4, hours per day and the minimum wear time used in previous studies. This new IFU more accurately reflects allergen immunotherapy and how we expect our product to be labeled, if approved. Based on a past similar safety study we conducted in 4- to 11-year olds, we believe COMFORT Children would be an attractive study with potential subject and at research centers. This showed that study start-up activities with our CRO have already begun so that we will be in a good position to initiate the study at an optimal time. Okay, let's move to the toddler program. The results from the first 12 months of the EPITOPE study were published last year in the New England Journal of Medicine. The open-label extension to EPITOPE is ongoing. Recall that all subjects have the option to receive Viaskin Peanut for up to 3 years. For subjects originally randomized to active treatment, we have data for 2 years on treatment. And for those randomized to placebo, we have the 1-year crossover data from placebo to active. These data were presented as the very first-ever late breaker as the American College of Allergy, Asthma & Immunology Annual Meeting last November. In the interim data from the open-label extension to EPITOPE, we observed continued improvement in treatment response following the second year of treatment, which is consistent with our previous open-label extension data in 4- to 11-year olds. Using the responder criteria in EPITOPE, the response rate increased from 67% to almost 84%. And 4 out of 5 subjects, 81%, consumed an eliciting dose of greater than or equal to 1,000 milligrams. To put this into perspective, the median eliciting dose at baseline was 100 milligrams. That's a tenfold increase. Finally, participants consumed -- sorry, 56% of participants consumed the entire food challenge of nearly 3.5 grams or about 14 peanut kernels without meeting the food challenge stopping criteria. We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical data set. During the second year of treatment, the safety results in toddlers were entirely consistent with trials in older children which demonstrated a well-tolerated, predictable safety profile. Local application site reactions were the most commonly reported adverse events, though, notably, the frequency of such reactions decreased in the second year of treatment with Viaskin Peanut. No subjects had treatment-related serious treatment-emergent adverse events during the second year of treatment with Viaskin Peanut and no treatment-related permanent study discontinuations occurred. Furthermore, there were no treatment-related anaphylactic events during the second year of treatment with Viaskin Peanut. And remember, our studies use a very broad definition of anaphylaxis, purposefully designed to set a very low bar in reporting anaphylactic events. Overall, we were extremely pleased with the results of the secondary treatment from an efficacy point as well as from a safety point. We did not present the placebo crossover data in the slides today, but it was discussed at the college meeting in November. And the placebo crossover efficacy and safety appear to be virtually identical to the first 12-month data set in EPITOPE that was published in the New England Journal. This confirms what was observed previously and also provides reassurance that slightly older subjects, the 3-year olds in EPITOPE that crossed over as 4-year-olds in an open-label extension, had a robust treatment effect. This bodes well for the VITESSE study. Let me wrap up with the toddler -- COMFORT Toddler study. This is a 6-month study that will include 400 subjects randomized 3:1 active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to 1 year. COMFORT Toddlers will use the same IFU as COMFORT Children. So there will be consistency between the 2 studies. This study will use the same square patch as the EPITOPE study. One of the differences between COMFORT Toddlers and COMFORT Children, other than the obvious difference in age range and patch, is that the toddler study will use a double-blind, placebo-controlled food challenge as part of the inclusion criteria. We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that as EPITOPE as possible. We believe the food challenge was the best way to ensure that outcome, unit-specific IgE, is more reliable as a biomarker of peanut allergy in older children, but is less reliable in toddlers. Our EPITOPE data shows that half of our subjects had peanut-specific IgE levels at or below 14, but still tested positive for peanut allergy by food challenge. That is they had low IgG levels, but we're still allergic whereas the older subjects in the middle and far-right figures on the slide has much fewer subjects with low IgE that were peanut-allergic. We appreciate that this adds a bit of complexity to the study, and they have a small impact on, but we believe this will allow us to best replicate the EPITOPE study population for a BLA submission in the future. As we have stated previously, we will initiate COMFORT Toddlers after we receive FDA feedback on the protocol, which was submitted in November last year. The DBV clinical team has been gearing up with our CRO for study initiation. We believe we are in a position to initiate the study in a short period of time, pending FDA feedback on the protocol. With that, back to you, Daniel.

Thank you, Pharis. Before turning the call over to Virginie to review the financials, let me cover a corporate update. During the fourth quarter, we further strengthened our leadership team in advance of our 2 BLA submissions and anticipated commercialization so that we are best positioned for long-term success. On top of our new CFO, Virginie, who joined us in November, we appointed Dr. Kevin Malobisky, PhD, as our new Chief Operations Officer. Kevin has an extensive track record of more than 35 years in biopharmaceuticals, strategic and operational leadership roles, including roles that span both research as well as drug development and drug approval. Kevin will be instrumental to a successful BLA submission, and I couldn't be more thrilled that he has joined our leadership team. I would like to take the opportunity to formally welcome Kevin to our team, and he's already making a very positive impact. So really delighted to have both Virginie and Kevin joining us. Without further ado, we'll invite Virginie to cover briefly our financial highlights.

Thank you very much, Daniel. And I will now provide a brief overview of our financials for the year 2023, which I invite you to further review in our press release and filings. There are 3 highlights I would like to point out for year 2023. Number one, we closed the year with $141 million in cash. Number two, we dedicated over 90% of the cash we used in operations to progressing Viaskin Peanut's clinical development and preparing for BLA filing. Number three, our 2023 P&L includes the favorable impact of the termination of our collaboration with Nestlé. As you may be aware, in quarter 4 of last year, 2023, we terminated a collaboration agreement with Nestlé, which was meant to develop and commercialize a diagnostic market for cars milk allergy. This contract was draining resources and attention away from our priority Viaskin Peanut with neither tangible nor medium-term income. Terminating the contract with a financially sound decision with material positive impact on our '23 financial expenses and net loss. One more word on our financials and resources allocation. If you consider our financial statements without the impact of the Nestlé collaboration agreement, our operating expenses increased by 25% in 2023 to support Viaskin Peanut clinical study CMC preparation, regulatory activities and getting ready from the manufacturing side, in view of all of this for the approval and launch of Viaskin. Back over to you, Dan.

Thanks, Virginie. Now before communicate DBV's upcoming milestones, I would be remiss if I did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and how we believe Viaskin Peanut will serve that community. There's nothing we hear more clearly from the food allergy community that this therapeutic area desperately needs treatment alternatives. The recent FDA approval of omalizumab, which goes by the brand name Xolair, the treatment of food allergy in children and adult, is a welcome addition. We see treatment for food allergy requiring a range of options, just like other immunological conditions, such as asthma, atopic dermatitis or inhalant allergies. And I'm asking you here to imagine the position of a parent with a young child just diagnosed with peanut allergy at a pediatrician's office or the allergist's office until they recently stopped there. The only option available to concerned parents and caregivers was avoidance and diligent readiness with an epinephrine auto-injector. Today is a different story, and over time, will keep on getting different better. Children are now channeled to the allergist's office, where they and their families can have real conversations, as illustrated here, about all the conditions and all the circumstances that surround the life of that child in that family. And that was another topic that we picked up in talking with KOLs and experts at Quad AI. Having a range of treatment options available only fuels a conversation, and for the 670,000 children in the U.S., ages 1 through 7, currently living with the daily burn of a peanut allergy, every patient's story and situation is unique, requires a bespoke solution, and that's what's needed here. Simply put, 1 client will not fit all. In an ever-evolving market, and we want to be very much part of that evolution, Viaskin Peanut will always be a very important product. In fact, it will be, as the opinion of most, a foundational product, as was evidenced after speaking with hundreds of allergists attending the Quad AI conference. Before I open up the call for questions, I would like to take a moment to share our anticipated milestones through 2024, and this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT Toddlers trial, the 6-month supplemental safety trial in support of the BLA. We also anticipate completing enrollment of our ongoing VITESSE Phase III efficacy trial in children aged 4 through 7 years of age. And once VITESSE enrollment is close to completion, we'll initiate recruitment for our 6-month COMFORT Children trial in support of that BLA. Recruitment, as Pharis touched on, will be carefully timed so as not to compete for the same study subjects across 2 different clinical trials. During the second quarter, we also plan to host an Investor Day, and we will share those details as soon as possible. We hope many of you will be able to join us. We also plan to announce the 3-year results from our ongoing Phase III open-label extension of the EPITOPE trial earlier on this year. And finally, the publication in Science and Medical Affairs [indiscernible] at DBV continues to be operating very actively, anticipate publication of additional manuscripts, which includes publications of the results of the year 2 open-label extension of EPITOPE, which Pharis shared a few minutes ago. And additional invite to review with a peer-reviewed scientific journal as well as submitting extracts of new results presentation and upcoming conferences. So we'll keep on publishing a lot of data on our technology and its benefits. With that, we'll now ask Pharis and Virginie to join me for the Q&A. And operator, if you could open up the line for questions, that would be great.

[Operator Instructions] Our first question comes from Jon Wolleben with Citizens JMP.

But first, I was hoping you can give a little bit more color on this EU directive. And then also, can you comment how many of the 600 expected patients in VITESSE you've already enrolled to date?

I'll have Pharis answer the question on the directive and then...

Jon, this is Pharis. So this new directive is a little bit different from how things were done in the past. So you have to submit your dossier, your protocol, and the countries that you've selected in Europe all are banded together essentially as 1 country. So in the past, you could go 1 after Germany, Italy, Spain, whichever countries you wanted. In this case, they're all bundled into one. So if any country has any objection, it has to go all the way to be resolved and that process can continue almost indefinitely. And the big difference here is if 1 country protests and has an issue, all of the countries are stuck. They can't participate. And you can't pull out and one-off go separately to all the different countries. So it is a bit different. And I think the challenge here was we were one of the first Phase III protocols that went through. And so the system wasn't quite worked out. And I think there was just a glitch here and there. And as these new things come through, they're not always well oiled. So that's the nature of the difference in the directive now versus how it was in the past.

Got it. And can you comment how many -- yes. Can you comment on how many of the expected 600 patients have been enrolled so far?

Yes. We don't provide that clarity of guidance for competitive reasons here. The study is progressing well against the forecast we had in place, assuming that the sites were up and running. They've been up and running later than expected, but I can share is we expect that 60 to 90 days will be sufficient to get through the new director process. It took us closer to -- actually took exactly 9 months to go through it. And that explains why we are out of abundance of prudence, pushing the expectation of last patient screen from first half of -- Q2 of 2024 to Q3 of 2024.

Got it. Okay. And any timing guidance on when COMFORT Toddlers will be starting? And then how do you think about the parallel programs? Do you want them to be exactly parallel with BLA submissions in the same time period? Does that make it easier for you or potentially the review division? Or could there be staggering and 1 coming before the other?

Yes. So I'll have Pharis answer the first question on COMFORT Toddlers, and I'll talk about the benefits of having the 2 programs in parallel here.

Yes. Jon, as we've always said, we will start our Phase III programs when we have FDA feedback. So we're waiting for the FDA feedback. We've done all the preparations we can in terms of the team and the [indiscernible] Will be ready to roll once we get that feedback. So we believe it will be a short period turnaround from a clin ops standpoint. So again, I think it's the right thing to do for Phase III trials, get FDA feedback in alignment before we start to run.

And we're in communication with them, and they reinforced to us, and we believe from the pace of response e-mails, everything else that they are -- they say it's a top priority. We very much see that, but we're just waiting for that final sign off before starting the study out of, again, common sense prudence.

And then the other question? Yes, to come back to the benefits of the 2 doses in parallel, is that your other question?

Yes. Yes, please.

Look, both markets are huge. So it was essentially coming down to a race to commercial potential, rate them even quite simply. Obviously, the program in toddlers is more straightforward. There's only 1 study to run. While we have 2 to run with -- in 4- to 7-year-olds. But that was why we were very happy when the agency agreed that these would be 2 separate BLAs, making not 1 to be junior to the other by being the BLA and the supplemental BLA, and thus, whichever 1 we can file first, we will file first and making us as a commercial matter indifferent to which 1 is ready first. Does that make sense?

And then -- yes. Last 1 for me, Daniel. You touched on this, the Xolair approval. Can you discuss how allergists you speak to are thinking about Viaskin Peanut use versus Xolair use? Do you think there's an overlap between the patients that may like both? Or do you think these are going to be separate addressable markets based on product profiles? And I'll jump back in the queue.

Yes. I'll have Pharis give you more detail because we've also talked to a bunch of allergists at Quad AI. But no, there's very little overlap between the 2 markets, which is why Xolair's approval is important here by offering options. The populations are pretty significantly different. So Pharis do you want to share the -- what you've learned from a...

Sure. So we spent quite a bit of time at Quad AI talking to our different sites. And the take-home message we're getting from them is that Xolair has been approved a long time, and it had been used off-label with OIT in certain situations. And there hasn't been huge, huge off-label use for peanut allergy as a stand-alone indication or even multiple food allergies. And the reason for our 1 to 7 year olds, the way we've been told is, especially in the toddlers 1 to 3, none of the investigators we spoke to would use it as sort of monotherapy for multiple food allergies or single food allergies because it's a toddler population, it's unknown what it would do for an immune system that is still evolving, very immature. And of course, it's an injectable. In the older patients, maybe 6 or 7, what we've heard was there could be extreme, extreme cases of patients that are ultra-ultrasensitive. So the anecdote that was told to me was a practitioner has a patient who could go to Chuck E. Cheese, and especially so allergic to melt that any of the residual pizza cheese grease that's on there. And if they had touched them out or their eyes, they would go into an anaphylactic reaction. And this is just almost straight to bet on what this investigator told me. And for a case like that, where it's well documented that the sensitivity is just extreme, and they've tried to avoid and done everything they can, that patient might be a candidate for omalizumab. But again, it's a pretty extreme case, and they don't tend to overlap with our patients very much at all. I don't know if that helps, Jonathan, but that's just what we've gathered as anecdotes talking to as many of the investigators as we can to get an understanding of how the product may be used.

No, that's consistent with what we're hearing as well. So good to hear, and thanks for the feedback and color guys.

Yes. The formal market research also, besides data with KOLs, shows, yes, that to be used in older kids and adolescents or young adults who are multi-allergic at times in their life, where you want to make sure that their behavior, whatever they're experiencing, is covered. It's not the population that we wish to help with our product.

[Operator Instructions] Our next question comes from Sushila Hernandez with Kempen.

Could you just walk us through the steps ahead to get to the BLA filing for the bottlers? And the second question, does your cash runway until the end of '24 include the start of both safety studies?

Good question. So the answer to the second part of your question is yes. Our forecasts have always been, as you know, rather smart and conservative. So this assumes the -- not only the initiation of those 2 studies, the continuation of VITESSE. A lot of work we're doing also when it comes to regulatory CMC and building up inventory also. So there's a lot of our expenses this year are going to that. As far as next steps for the toddler dossier, sign-off from the FDA on the protocol and then initiation of the trial. As Pharis says, we've been in dialogue with many of the investigator sites, we can turn that around pretty quickly. What we don't know is how quickly the study will enroll. We know there's a lot of enthusiasm for that study. We know that food challenges, especially only 1 at entry in toddlers is easier to do, much easier to do than food challenges in older children. So we're confident this study will enroll at a good pace. But we have no analogues here. And for that reason, we're going to leave that as an open question until we have more data to guide more precisely to study completion in BLA file. We expect also that once we have the clinical data, to move to filing a BLA would move rather quickly. The CMC work will be done by then. And it's not a complex dossier by the way, right? So it's pretty straightforward. It comes to the clinical data that we have to pull and analyze. Is that ample answering your question, Sushila, yes?

Yes, thank you.

This concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.

I covered a lot today, and thanks for those questions. So to recap, we're continuing to advance VITESSE, our Phase III study in peanut-allergic children 4 to 7. In parallel, the successful completion of the supplemental COMFORT Safety studies are important. And as I just shared with the new colleagues asking questions here, we have 2 BLAs that are distinct and in parallel, and thus, 1 is not relating to the other one. And the moment we have signed off on the protocol in toddlers, we will initiate that study as well, lined up. We are very confident or remain very confident this work will support BLAs in both age groups. And as we've picked up from dialogues with allergists at Quad AI, what we pick up when it comes to talking to investigators, what we pick up in our market research, families want treatment options. The most human options are available, the more dynamic the market will be, and we all benefit from that. And this concludes the call for today. Again, we hope that we will keep on conveying the success of our programs through 2023 to 2024 with laser focus on execution. And lastly, I want to apologize again profusely for a call that started later than expected. I thank you all. I wish you a good evening.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.