DBVT

Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation there will be an opportunity to ask questions. [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. This afternoon, DBV Technologies issued a press release that outlines our financial results for the three and six months ended June 30, 2024. 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 Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV’s Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer. I will now pass the call over to Daniel. Daniel?

Thank you Katie, and thank you everyone for joining our call this evening to review DBV's second quarter and first half 2024 financial results. For those of you who may be less familiar with our business, DBV is developing Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy, including food allergy. Viaskin is based on epicutaneous immunotherapy, we refer to it as EPIT, and it is our method of delivering biologically active compounds to the immune system through intact skin to progressively induce immune tolerance. Our most advanced candidate is Viaskin Peanut, which we are developing for peanut allergic children, ages one through seven, where there exists a significant unmet medical need in the U.S. and around the world, and critically, is an age group where the immune system is particularly malleable. It is also where there is the most risk to these children from accidental exposure to peanut. Moreover, 75% to 80% of children with a peanut allergy will not outgrow their peanut allergy over their lifetime. And today we are pleased to provide updates on our two Viaskin Peanut development program – programs sorry, one in children aged four to seven years of age using the modified larger circular patch, and one in toddlers age one to three using the original square patch. As you know, we plan on filing two separate biological license applications or BLAs, one for each age group. There are three key highlights we wish to share with you today. Beginning with the program in children four to seven years old, let's remember that we are running the VITESSE Phase 3 pivotal trial of the modified Viaskin Peanut patch in that population. Results from this trial, together with the COMFORT Children supplemental safety study, will form the basis of a BLA for this age group. Since the middle of last year, we have seen very good momentum enrolling the VITESSE trial patients and we are unchanged in our expectation that the final subject will be screened by the end of the third quarter of this year. Turning to our other program in toddlers one to three years of age, let's recall that we announced successful results from the Phase 3 efficacy study, or pivotal study known as EPITOPE, which clearly met its primary endpoint and was published in the New England Journal of Medicine last year. Also recall that the FDA requested that we conduct a supplemental safety study, which we'd call COMFORT, COMFORT Toddlers, to increase the number of subjects on treatment in the one- to three-year-old safety database in support of that BLA. We submitted the COMFORT Toddlers protocol to the FDA in November of last year, and the agency responded in March. Since then, we have been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study, and the dialogue has mainly focused on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. I will let Pharis, our Chief Medical Officer, get into the details in a bit more of a moment here, but let me state, firstly, that we recognize the importance of that question, and we believe the right answer to that question resides in the result of our existing trial, EPITOPE. And in an effort to seek alignment with FDA, we have recently submitted to the agency a draft labeling proposal, with comprehensive supportive data and analyses that were informed by the EPITOPE pivotal data, focused on the user experience during the first 90 days of treatment, so the first three months of treatment, to address agency's queries about patch wear time. The agency asked us for more details and analysis about that proposal, which we provided to FDA on June 28th. And while we are awaiting a response from FDA on this labeling proposal, we continue to advance study preparation activities to be able to initiate the study once we have protocol alignment. Finally, the third update is the result of continued cost-saving measures. Through that, we have extended our cash runway into Q1 of 2025, and I will let Virginie, our CFO, give more details on that shortly. At this point, I would like to turn the call over to our Chief Medical Officer, Dr. Pharis Mohideen, for a more detailed update on our clinical programs. Pharis?

Thank you, Daniel. First, let's start with the tests. If you recall, this is a 600-patient study in 4 to 7 year olds with peanut allergy using the modified Viaskin Peanut patch. We have 86 sites across the U.S., Canada, Europe, UK, and Australia. The study is assessing the efficacy and safety of Viaskin Peanut over the course of 12 months of treatment. I'm really pleased with the progress that we have made. The test has been a company-wide priority, and it's taken a coordinated effort within DBV to get to this point. For example, our medical affairs team is small in numbers, but they are incredibly diligent and never fail to engage our multiple stakeholders at medical conferences. And of course, our investigators and their staff did a fantastic job. And we really appreciate the support that we have received from the patient advocacy groups and the academic societies. I must also thank our study participants, the parents, caregivers and subjects for their tremendous contributions. As we said in the press release, we anticipate to close recruitment by the end of the third quarter of this year. We estimate that top line results would follow approximately 12 months after the last patient is screened. We will certainly provide more detailed updates along the way. Let’s move now to the status of the COMFORT Toddlers supplemental safety study protocol. The FDA asked us to do a supplemental safety study in the one to three-year old patient population to add to the EPITOPE safety database in this age group. Following a Type C protocol meeting, we submitted the Toddlers safety protocol to the FDA in November of 2023. The agency responded with comments in March of this year. Since then, DBV and FDA have been engaged in ongoing dialogue. These exchanges largely focused on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. On June 28, DBV submitted a proposed draft labeling approach with comprehensive supportive data and analyses intended to address the agency’s concerns related to patch wear time experience. We are now waiting for the FDA’s feedback on this labeling proposal. Let me explain the labeling proposal that we submitted to the FDA. The agency’s questions we believe are best answered with the data from our pivotal trial EPITOPE. We are still in discussion with the agency and awaiting feedback, but I can give you an overview of the concept. Based on our analysis of the EPITOPE data, we have identified two groups within the Viaskin Peanut treatment arm. We call the two groups the label in and label out subjects. The baseline immunological characteristics of the label in and label out subjects such as peanut-specific IgE, Skin Prick Test and eliciting dose are similar. So there is clearly a difference in the sensitivity to the locally applied peanut allergen that drive differences in patch wear time experience. This is what we refer to as differences in immune physiology in the press release. Within the first 90 days on treatment, it is possible to identify and separate subjects into those that are very likely to have a robust efficacy response relative to those who are less likely to have a robust efficacy response. All of this can be done with just the patch wear time experience during the first 90 days on treatment. Subjects that are very likely to have a robust efficacy response are called label in. The proposed prescribing information, the label would recommend that these subjects continue Viaskin Peanut treatment. Alternatively, subjects that are less likely to have a robust efficacy response are called label out and the proposed prescribing information would recommend a shared decision making process between the healthcare provider and the parent or caregiver to determine if treatment should be discontinued. In other words, for subjects identified as label out, the proposed label indicates that clinical efficacy is less likely and discontinuation of treatment should be discussed. If Viaskin Peanut is approved, we believe this labeling proposal would give prescribers a pragmatic, data driven way to discuss and provide guidance on patch wear time experience to parents and caregivers. At this point, I'd like to invite Virginie to cover financial highlights.

Thank you very much, Pharis. So we'll now briefly review financial highlights for the first semester of 2024. And there are two highlights I would like to elaborate on, our cash run rate and our P&L, in particular operating expenses. So number one, we close H1 with €66.2 million of cash on hand and our cash runway now takes us into first quarter of 2025, which is an extension from prior communication where our cash runway was sufficient to fund operations until 2024 year-end. This extension is due to cost saving measures we have implemented and that we will continue to drive. There's another point I would like to highlight as we consider cash consumption in H1 of 2024. In the first semester, cash used in operations totaled $70 million, largely for ongoing clinical trials and for CMC and regulatory activities. It is important to note that H1 cash consumption includes $24 million of non-recurring costs such as comfort study, startup costs, move projects, supply chain activities. I will now elaborate briefly on our financials in terms of P&L. Our operating income amounts to $2.6 million for the semester and it is now exclusively composed of the research tax credit, the CIF French scheme following the termination of the collaboration agreement with Nestle Health Sciences. Operating expenses total $65 million that's plus 28% on last year, but it is driven by what really matters. That's Viaskin Peanut clinical and CMC activities, and again a third of it are non-recurring expenses. So for the semester we book a net loss of $60.5 million. So I'd like to reiterate that we continue to maximize the efficiency of our spend and remain highly disciplined in our cash management. That concludes the financial overview, and I'll turn the call back to Daniel for closing remarks. Danielle?

Merci, Virginie. Before bringing the call for your questions, I would like to take a moment to recap. Our anticipated milestones the remainder of 2024, which is a critical year for DBV. So first, by the end of the third quarter, reiterating that we anticipate completing enrollment in our ongoing VITESSE Phase 3 efficacy trial in children age four to seven years of age, and obviously that's something that we will communicate once that's done. Secondly, we believe that DBV's proposed labeling approach is a pragmatic solution backed with robust analyses and data from EPITOPE. Importantly, and I wish to add that on April 29, the Office of Vaccine Research and Review, which is known as OVRR, which is the regulatory division within FDA that has responsibility for Viaskin Peanut, stated that non-COVID related backlogs, the products such as ours were behind them now, and that the agency would have more bandwidth for interaction with sponsors. And we are seeing that firsthand in our interactions with the agency in the last few months for both CMC questions as well as clinical related questions. And it's obviously we're encouraged by that. And later this year, we anticipate having the year three results from our ongoing open-label extension EPITOPE, our successful Phase 3 trial in toddlers. Recall that we had saw further statistical, further and significant improvements across all efficacy parameters in desensitization year two. We look forward to sharing with you later this year, the year three results, as well as the publication of the year two results of the open label extension in a medical journal. With that, I want to thank everyone on the phone and webcast for joining us today. I will now ask Pharis and Virginie to join me for the Q&A.

At this time, we will conduct the question-and-answer session. [Operator Instructions] And our first question will come from Jon Wolleben with Citizens JMP.

Hey, good afternoon. Thanks for the update and taking the questions. Maybe just one quick clarification on the label-in, label-out, and then I have some follow-ups on that. When you say patch wear time experience, do you mean how long the kids are wearing the patch or the experience they have while wearing the patch or an interplay between those two concepts?

Yes, important question Jonathan, thanks for asking. No it’s the former. It’s the fact that some kids wear the patch easily 24 hours a day. Other kids it varies more from one day to the other. So that patch wear time experience measured in hours of wear varies in some patients, and that’s the data that is rich to identify patients will be best responders in a nutshell. Pharis, is that a good way to put it?

Yes, that’s a good way, Daniel. The other way I like to think about it, Jonathan, is it’s kind of like a holistic experience, right? So not just is the patch there or not like an adhesion type of assessment, but it’s the day-to-day variability in the wear time. It’s the individual sensitivity, tolerability, itching, what kind of experience did they have? Was it difficult to wear it all day long or was it easy? There may be some lifestyle components in that that’s a little harder to tease out, but it’s not just one element. And as Daniel said, you can look at average daily wear time, but that doesn’t always tell you the story in terms of day-to-day variability. So I like to think of it as more of a holistic experience with the product. Does that help to kind of fill in some of the gaps there?

Yes. Well, does that make it harder to quantify them, though, than a simple number of hours worn?

No, not necessarily. We have – we just – it’s kind of the opposite. We have a lot of data, and we can look at a lot of different parameters. And with all of that data, you can get a pretty good sense of the type of experience the patient’s having. Obviously, we can’t talk to the patients, right. But there's so much data that we collect in our trials, that you can get a pretty good characteristic of these patients, and there's really quite a clear differentiation between those who are labeled and labeled out based on this whole accumulated data set that we have on them.

Got it. Okay. And then you guys said there's an association between a robust clinical efficacy response. I'm wondering if you could put some parameters around what you define as a robust response, and then what percentage of the EPITOPE patients were label and label out based on this criteria?

Does you want to take it or want me to take it.

Yes. I can, no, I can take it. Yes. So, at this point, because we're still in dialogue with the FDA, we are. It's probably not the best idea to throw out specific numbers and details, but we know this data set really, really well, and those numbers are robust in terms of what you've seen in the past from the EPITOPE results. And it is a pretty good separation between the two in terms of the size of those who are labeled in versus labeled out. I know that's kind of vague, but at this point, until we have final agreement with the FDA and have wrestled this down, it's probably nothing the right time to discuss it. But obviously, as we move forward, we'll present all of this in a public fashion.

Fair enough.

There's a reference point, I would add here, Jonathan, if I may. We have 67% overall response rate, so, obviously, the label lens would have a better response rate than that. By definition, it's a traditional enrichment strategy here, so. But the quantification will come down to the agreement we come to with the agency. If we can come to that agreement, the details will be shared at that point in time.

Got it. And one last one for me. Update on COMFORT Children, you guys don't have any expectations for feedback timing there it doesn't seem. Wondering, do you think that any progress with COMFORT Toddlers would help with COMFORT Children, or are there different issues and feedback from FDA there.

Yes, I'll take that one, Ferris. The two were intertwined. The ability to get to the right protocol design for COMFORT Toddlers was an element, obviously of COMFORT Children. So we wanted to solve for toddlers first, children will come next year as the next step in our discussions with the agency. But job one is to get to agreement in one year to three year olds.

Got it. Okay. Thanks again for taking the questions.

Please. Thank you.

[Operator Instructions] And it appears there are no further questions. Mr. Tassé, I'll turn the conference back to you.

I’m sure I'm not on mute, I'm not. Well, that concludes our call for this afternoon. Again, thank you. We are pleased with our progress the first half of the year. We look forward to achievement of the additional value creating milestones that I described this year and next. As always, we will keep you posted on our progress and I wish you all a very good evening.

This concludes today's conference call. Thank you for attending.

Apologies for the late start of our conference. Welcome to the DBV Full Year 2023 Financial Results and Business Update Conference Call. All participants will be in listen-only mode. [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 31st, 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 Dr. 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?

Katie, thank you and thank you everyone. Again I need to add my apologies, we were in fixed 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 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 data, 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 AAAAI is regard as the premier events in the allergy immunology community and every year we have a lot of boots on the ground at AAAAI to listen, engage with our key stakeholders, allergists, and patient advocacy groups at very top of that list. One of the highlights of AAAAI this year was the fact that the product theater who's been to AAAAI, 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 to say that had an unprecedented attendance. In fact, we're told that we broke the record for AAAAI events and the best attended product theater ever. There held 125 people, 223 allergists or more showed up. The point here being that intervening early in peanut allergy is important, our technology's important, creating much interest, and obviously that's the most validating feedback there is on the hardware that's been going in, which I'd like to use to just again reinforce our commitment to this space and to the importance and the benefit of generating plenty of the data and plenty of long-term data. We understand and we understand the huge responsibility we have of establishing the long-term safety and clinical benefits of Viaskin Peanut because treating children is an important responsibility. Our open-label extension commitment 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 two data from our open-label extension study in toddlers. And obviously, we cannot wait to see what the year three data will look like when we share it later on this year. In 2024, we will continue to work towards stream a robust data package in toddlers and children. We have a lot of work cut for us, but we're enthusiastic about next year, we expect to have approximately 1,400 children, aged one to seven, enrolled globally in our Phase three trials. All our Phase IIb studies have an open label extension, which as I mentioned just now is key 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 allergy is going to be a massive safety database for our one to seven year olds who have in fact close to 1,700 subjects on active treatment. And we combine that with the data from our prior Phase two trials. We break this down with approximately 600 toddler patients, 600 toddlers age one to three and about 1,100 patients age four to seven. We'll have been on immunotherapy for up to three years. And let's not forget all the work we've done in four to 11 before that, where some of those children were treated with Viaskin Peanut for up to five years. And that's and that data was shared at quite a high last weekend. To sum it all up and put this in perspective, over one million Viaskin patches have been applied to children age one through 11 in our clinical development program. That's obviously more than one million days of therapy that makes up the safety database of this product's, safety and efficacy database as described. And it is as I said the most comprehensive research in children with peanut allergy. We have a well-studied product, with demonstrated efficacy and consistently favorable safety profile. We're proud of that and we keep on building 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 two of our ongoing open-label study extension study. Data showed that approximately three out of five 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, what we anticipated during accidental exposure and a massive jump from what was a median eliciting dose at baseline of 100 milligrams. These data suggest that Viaskin Peanut is potentially rewiring immune systems and we suspect that is due to a plasticity immune system in this age group. We also have two other data sets from prior studies, showing that Viaskin Peanut can induce, what is known as sustained unresponsiveness to the allergen in older children, who after two to three years of treatment, 8% of participants maintained desensitization of Amylin 1000 milligrams or more at two months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests the Viaskin Peanut induces sustained unresponsiveness of the Allergan by modulating the epigenetic signature a specific T-cell compartments. Remember Viaskin Peanut has a unique mode of action that leverages skin's in properties induce tolerance and there's no other product. I would add there that shows that mode of action. With all this in mind while this is not been the case we'll be pursuing at approvals, we fully intend post-approval. And as part of our long-term commitment to these sooner exploring 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 two best Internet programs.

Thank you, Daniel. As a reminder, we intend to submit two separate BLAs for the treatment of peanut allergy. In the one to three 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. 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 six month safety study COMFORT Toddlers. In parallel, we are running the four to seven year old indication with the modified circular patch. We started this program last year with a 12 month PEPITES study. Recruitment is ongoing at this time. This indication will also have a six month supplemental safety study, which we call COMFORT Children. The two studies combined will have 600 subjects on active treatment to meet the ICH guideline. So our attention this year will be focused on completing recruitment for the test and starting our two supplemental safety studies.\\ As Daniel mentioned, DBV T 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 three years. And remember, we also have our expanded access program for subjects that have completed in treatment in a DBV clinical trial. And once you continue to receive Viaskin Peanut. So that test is set up to provide another large robust dataset 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 four to seven year old age group, where we believe Viaskin Peanut can provide great clinical benefit. In the test we have 86 clinical centers spread across the US, 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 four to seven year olds. This will have a six month core period followed by an open-label extension that will provide an additional six months of treatment for subjects randomized to active product and 12 months of treatment for subjects randomized to placebo. Every subjects will have the opportunity to receive Viaskin Peanut for a full year. This will be a 270 subjects study randomized three to one 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 the tests. Thus, there is no need for a food challenge, as part of the inclusion criteria. One of the differences in COMFORT Children relative to the tests, is the use of a simplified instructions for use. The safety study IFU states each DBV’s 712 -microgram epi-cutaneous system is intended to be worn for a full day 24 hours. This is a shift away from the 24 plus minus four 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 enabled, if approved. Based on a past similar safety study, we conducted in four to 11 year olds, we believe COMFORT Children would be on attractive study, with potential subjects and at research centers. Be assured 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 top of the 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 three years. For subjects or originally randomized to active treatment, we have data for two years on treatment and for those randomized to placebo, we have the one-year crossover data from placebo to active. These data were presented as the very first ever, late-breaker at the American College of Allergy, Asthma and Immunology annual meeting last November. In the interim data, from the Open-Label Extension to EPITOPE, we observed continued improvement and treatment response following the 2nd year of treatments, which is consistent with our previous Open-Label Extension data in four to 11 years olds. Using the Responder criteria and EPITOPE, the response rate increased from 67% to almost 84% and four out of five subjects, 81% consumed an eliciting dose of greater than or equal to 1000 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 dataset. During the 2nd 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 2nd year of treatment with Viaskin Peanut. No subjects had treatment-related serious, treatment-emergent adverse events during the 2nd year of treatment, with Viaskin Peanut and no treatment related permanent study discontinuations occurred. Furthermore, there were no treatment related anaphylactic events, during the 2nd year of treatment with Viaskin Peanut. Remember, our studies used a very broad definition of anaphylaxis, principally designed to set a very low bar in reporting anaphylactic events. Overall, we were extremely pleased, with the results of the 2nd year of treatment from an efficacy point as well as from a safety point. We didn't 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 appeared 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 of three year olds and EPITOPE that crossed over as four year olds in the Open-Label extension some 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 six month study that will include 400 subjects randomized three to one active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to one year. COMFORT Toddlers will use the same IFU as COMFORT Children. So, there will be consistency between the two 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 recruitment. 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 two 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 three 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 four of last year 2023, we terminated a collaboration agreement with Nestlé, which was meant to develop and commercialize a diagnostic market for cow's 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 was a financially sound decision with material positive impact on 23 financials expenses and net loss. One more word on our financials and resources allocation. If you consider our financial statements without the impact of the Nestle collaboration agreement our operating expenses increased by 25% in 2023 to support VP clinical Viaskin Peanut clinical studies, CMC preparation regulatory activities and getting ready from the manufacturing site in view of all of this for the approval and launch [indiscernible] Back over to you Daniel.

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 we believe Viaskin Peanut will serve that community. There's nothing. We see more clearly from the food allergy community that this therapeutic area desperately need treatment alternatives. The recent FDA approval of Ameluz omalizumab, which was the brand name is all there for the treatment of food allergy and adult is a welcome addition. We see treatment for food allergy requiring a range of options just like others immunological conditions such as asthma, atopic dermatitis or inhaled allergies. And I'm asking you here to imagine the position of a parent with a young child was diagnosed with peanut allergy either pediatricians office or the allergists office [ph] until very recently stopped there. The only option available to concerned parents and caregivers was avoidance and diligent readiness with epinephrine auto-injector. Today is a different story. And over time we keep on getting different better. Children are now channeled to the allergist office where they and their families can have real conversations as illustrated here about all the conditions there and all the circumstances that surround and the life of that shop in that family. And that was another topic that we picked up in talking with KOLs and experts at quantity. I having a range of treatment options available only fuels that conversation and for the 670,000 children in the US ages one through seven currently living with a daily burn of a peanut allergy. Every patient story in situation is unique, requires a bespoke solution and that's what's needed here. Simply put one size 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 the opinion of most a foundational product as was evident after speaking with hundreds of outages attending [indiscernible] conference. Before I open up the call for questions I would like to take a moment to share our anticipated milestones for 2024 and this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT-II trial the six month supplemental safety trial in support of the BLA. We also anticipate completing enrollment of our ongoing Vitesse Phase 3 efficacy trial in children aged four to seven years of age. And once the test enrollment is close to completion. We'll initiate recruitment for our six month comfort children trial in support of that PLA. Recruitment as far as touched on will be carefully time so as not to compete for the same study subjects across two 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 three-year results from our ongoing Phase 3 open-label extension of the October trial earlier on this year. And finally the publication in Science and Medical Affairs [indiscernible] DBV continues to be operating very actively, anticipate publication of additional manuscripts which includes publications of the results of the year to open label extension of EPITOPE, which Pharis showed a few minutes ago and additional invite review with a peer-reviewed scientific journal as well as submitting abstracts of new results for presentation in upcoming conferences and 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 lines for questions, that'd be great.

We will now begin the question-and-answer session. [Operator Instructions] Jon Wolleben with Citizens JMP. Please go ahead.

Hey, good afternoon and thanks for taking the questions. 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.

Yeah, Jon, it’s Pharis. So this EU 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 one country. So in the past you could go one off to Germany, Italy, Spain, whichever countries you want to, 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 one country protests and has an issue all of the countries are stuck, they can't participate and you can't pull out and won off, bill 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 2 protocols that went through. And so the system wasn't quite worked out, and I think there was a 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 on how many of the expected 600 patients have been enrolled so far?

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 sales were up and running, we've been up and running there as expected. What I can share is we expect that 60 to 90 days would be sufficient to get through the new directive process. It took us closer to -- actually took exactly nine months to go through it. And that explains why we are out of abundance of prudence pushing the expectation of last patient screen from a 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 one coming before the other?

Yeah. So I'll have Pharis answer the first question on COMFORT Toddlers, and I'll talk about the benefits of having the two programs being parallel with.

Yeah. Jon as we've always said, we will start our Phase 3 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 [indiscernible] being ready to go once we get that feedback. So we believe it will be a short period turnaround from a financial standpoint. So again and it's the right thing to do for Phase 3 trials get FDA feedback in alignment before we start to run.

And we're in communication with them and they may reinforce to us. And we believe from the pace of no response e-mails everything else that they are -- this is 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?

Yeah to come back to the benefits of the two doses in parallel, is that your other question?

Yes, yes please.

Look, both markets are use. So I think it was essentially coming down to a rate to commercial potential, rate them even, quite simply. Obviously the program in toddlers is more straightforward is only one study to run. What we have to run with in four to seven year olds. But that was why we were very happy when the agency agreed, that these would be two separate BLAs. Making not one to be junior to the other by being the BLA and the supplemental BLA and thus, whichever one can file first. We will file first and making us as a Commercial matter in different two which one is ready first.

Okay. And then, just to …

That makes sense?

Yeah. Last -- last one for me Daniel. I know you touched on this, but product approval. Can you discuss how allergist you speak to or thinking about Viaskin Peanut to use versus older used EPITOPE. 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 the product profile? And I'll jump back in the queue. Thanks.

Yeah. I'll have Pharis to give you more detail, because the stuff, we've also talked a bunch about or just acquired. I know there's very little overlap between the two markets which is why, as all their approval is important here by offering options. And the populations are pretty significantly different. So Pharis will share the, which is done from it.

Sure. So we spent quite a bit of time quite talking to our different sites. And the take-home message we're getting from them is that, lower had been approved a long time and it has been used off-label with OIT in certain situations. And there hasn't been huge, huge off-label use for Peanut Allergy, as a standalone indication or even multiple food allergies. And the reason you know for our one to seven year olds the way we've been told is, especially in the toddlers one to three, 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 a immune system that is still evolving very immature. And of course, it's an injectable. In the older patients' maybe six or seven, what we've heard was there could be extreme, extreme cases of patients that are ultra-ultra sensitive. So the anecdote that was told to me was practitioner has a patient who could go to Chuck E. Cheese: and especially so allergic to mount that any of the residual Pizza Cheese Greece that's on there. And if they have touch them after their eyes they would go into an anaphylactic reaction. And this is just almost straight verbatim 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 it's consistent with what we're hearing as well.

Yeah.

So good to hear and thank you for the feedback and color guys.

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

[Operator Instructions]

Next question operator.

[Operator Instructions ]Our next question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.

Yes. Thank you for taking my question. Could you just walk us through the steps ahead to get to the BLA filing for the Toddlers? And the second question does your cash runway until the end of Phase 4 includes the start of both safety studies? Thank you.

Good question. So the answer is the same for 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 two studies, a continuation of the test, a lot of work we do and also when it comes to regulatory dossiers, CSA, 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 toddler dossier, sign-off from the FDA on the protocol and then initiation of the trial. As Pharis said 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 this study will enroll. We know there's a lot of enthusiasm for that study. We know that food challenges, especially, one that 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. And but we have no analogs 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 BLA filing. We expect also that once we have the clinical data to move to filing a BLA, we'll move rather quickly. The CMC work will be done by then and it's not a complex dose here by the way right here. So, it's pretty straightforward. It comes to the clinical data that we have to fully analyze. Answering your questions, Sushila?

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.

Covered a lot today and thanks for those questions. So, to recap we're continuing to advance VITESSE, our Phase 3 study in peanut allergy children four to seven. In parallel the successful completion of the supplemental COMFORT safety studies are important. And as I shared with our colleagues asking questions here, we have two BLAs are distinct in parallel and thus one is not relating to the other one at the moment we have sign 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 quite a AAAAI, we will pick-up when it comes to talking to investigators, we will pick-up in our market research, families want treatment options -- the more treatment options are available, the more dynamic of 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 to 2023 and 2024. We're laser-focused on execution. And lastly, I want to apologize again profusely for a call that started later than expected. I thank you all. Wish you a good evening.

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

Welcome to the DBV's Third Quarter Financial Results and Business and Regulatory 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. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 9 months ended September 30, 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 Tasse, Chief Executive Officer of DBV and Dr. Pharis Mohideen, DBV's Chief Medical Officer. I will now pass the call over to Daniel. Daniel?

Katie, thank you and thank you all for joining us on this call today. The purpose of today's call is to first provide a business update on our 2 Viaskin Peanut program, including the receipt of DBV's requested feedback from the FDA regarding remaining protocol design elements for our 2 pending supplemental safety studies which, as you know, are named COMFORT Toddlers and COMFORT Children and secondly, to review with you DBV's financial results for the third quarter of 2023. Let me start by summarizing what has already been established regarding our 2 Viaskin Peanut programs in development before turning over to Pharis for an update on requested feedback we have received from the FDA and thus, the next steps in our clinical and regulatory work. As you may recall, DBV is advancing in parallel, 2 clinical programs for Viaskin Peanut. Viaskin Peanut in toddlers, children aged 1 to 3 and Viaskin Peanut in children aged 4 to 7. And it's important to recognize that Viaskin Peanut in 1 to 3 year olds and Viaskin Peanut in 4 to 7-year-olds are separate product candidates with independent clinical and regulatory path that we believe will ultimately support 2 distinct BLAs. Now let me pass it over to Pharis to share with you more details.

Thank you, Daniel. Let's start with a brief recap of Viaskin Peanut program in toddlers ages 1 to 3 which you will recall, uses the original square Viaskin Peanut patch. We already completed our pre-BLA meeting for toddlers in April of this year. As we previously announced, the agency confirmed that our Phase III EPITOPE study met the prespecified criteria for success for the primary endpoint and therefore, did not request an additional efficacy study. The FDA did ask for a supplemental safety study with the original square patch to increase the total number of subjects on active treatment to approximately 600 per regulatory guidelines. The FDA did not raise any specific safety concerns associated with this request. The 4-year to 7-year-old indication will also have a supplemental safety study to increase the number of subjects on treatment with the modified circular patch to approximately 600 subjects, when combined with the active subjects in the test, the ongoing Phase III efficacy and safety study. So we believe there is nice symmetry to the 2 BLA programs. The 1-year to 3-year-old indication has a completed efficacy and safety study in EPITOPE and a planned supplemental safety study in COMFORT Toddlers. We believe that this will constitute the pivotal studies needed for a BLA submission. Similarly, the 4-year to 7-year-old indication will have the test for efficacy and safety in COMFORT Children for supplemental safety. We've discussed the key design elements of both supplemental safety studies in the past. But just to remind you, both studies will be 6 months in duration, double-blind, placebo-controlled, 3:1 randomization active to placebo and both will generate adhesion data. COMFORT Toddlers will include 400 subjects and COMFORT Children will be 270 subjects in total. These numbers have not changed. Okay. So that brings us to today. After receiving the Type C meeting feedback on the safety studies in July, we requested clarification from the FDA. There were a few remaining protocol design elements relevant to both safety studies as well as 1 of the inclusion criterion just for COMFORT Toddler that we felt needed additional clarity. I'm pleased to report that we have received written feedback from the FDA, clarifying those remaining protocol design elements. The protocols for both supplemental safety studies will have the same language guiding how the product should be used such as, each DBV712 250-microgram epi-cutaneous system is intended to be worn for a full day 24 hours. We believe that this language is more concise and simpler and harmonizing the language in both safety studies makes a lot of sense. Further to this approach, both supplemental safety studies will seek to enroll subjects that are as closely aligned with their respective Phase III efficacy studies as is feasible. For COMFORT Toddlers, this means using the same eligibility criteria as in the EPITOPE study. In EPITOPE, the main inclusion criteria centered around a documented history of peanut allergy, confirmed by immunologic markers, IgE and skin prick testing and a double-blind placebo-controlled food challenge. We previously believed that no food challenge would be required for COMFORT Toddlers but in exchanges with the FDA, we chose these inclusion criteria options as the best way to ensure that we could recruit a study population that would be as similar to EPITOPE as possible. While there is a significant body of immunological literature in older peanut-allergic children, the same is just not true in the toddler range. Because of this, we felt that reliance on immunological parameters alone for the main inclusion criteria did not provide the same level of assurance as the EPITOPE eligibility criteria. However, for COMFORT Children, we will use a history of peanut allergy and immunologic parameters for the inclusion criteria. The medical literature supports this approach, as does our experience in the completed 4 to 11-year-old safety study REALISE which served as a supplemental safety study for PEPITES. With this approach, we are confident that we can enroll a study population that will be similar to that of the test. There will not be a need for a confirmatory double-blind, placebo-controlled food challenge for COMFORT Children. Since EPITOPE was a successful study, meeting the prespecified criteria for success for the primary endpoint and we have received regulatory guidance from FDA, COMFORT Toddlers is our highest priority to get started as quickly as possible. Now that we have received clarification, we can submit the safety protocol to the FDA expeditiously and anticipate enrollment to begin in the first quarter of 2024. In parallel, the COMFORT Children protocol will be finalized and submitted to the FDA. Since it is a smaller study relative to COMFORT Toddlers and we don't wish to compete with the test recruitment at this time, we plan to initiate enrollment in COMFORT Children after COMFORT Toddlers. We are continuing to work diligently on appropriate study start-up activities for both COMFORT studies, while in parallel, continuing to advance the test, our Phase III study in 4-year to 7-year olds. To summarize, we are very pleased with the engagement and clarity of the feedback received from the FDA. We feel that harmonizing the approach to how the product should be used is even simpler and more concise than what previously existed. We are confident we can enroll subjects in our supplemental safety studies that will align nicely with the respected efficacy studies and we remain confident that this work will support BLAs in both age groups and potentially bring a new treatment option to clinicians and families. At this point, I'll turn the call back over to Daniel to review the financial results. Daniel?

Thank you, Pharis. And now let's briefly review the financial highlights for Q3 2023. Our cash and cash equivalents as of September 30 are $149.1 million compared to -- sorry, $209.2 million as of December 31, 2022, a net decrease of $60.1 million, mainly due to the following: $66 million of cash was used in operating activities, mainly driven by clinical work and initiation of the VITESSE trial where the first patient was screened in March of this year. And then $7 million of net proceeds on the issuance and sale of new ordinary shares in the form of ADS' which took place on June 16, 2023, pursuant to the company's at-the-market program which was established in May of 2022. You can see we continue to maximize the efficiency of our spend. We remain highly committed and disciplined in our cash management. We have a lot of clinical work to do by next year. We anticipate we'll have about 1,400 patients or subjects enrolled in Viaskin Peanut Phase III studies. So we've covered a lot today and if you allow me to recap. Pharis' team is working diligently to implement the feedback we requested from the FDA into the COMFORT safety study protocols for submission to the agency. We expect to submit the finalized COMFORT Toddlers protocol in the next few weeks, anticipate initiating the COMFORT Toddlers study in the first quarter of 2024. We believe that the successful completion of the supplemental COMFORT Toddlers safety study would be an important step towards filing a BLA seeking marketing approval in the U.S. of this potential novel therapy for peanut allergenic toddlers and their families. As Pharis mentioned, initiation of COMFORT Children is expected after the start of COMFORT Toddlers and in close alignment with VITESSE recruitment. And we are continuing to advance VITESSE, successful completion of which will be an important step towards filing a separate BLA seeking marketing approval in the U.S. for this potential novel therapy in peanut allergic children aged 4 to 7. I want to thank everyone on the phone and on the webcast for joining us today. And I will now ask Pharis to join me for Q&A. Operator, if you can open the line, please?

[Operator Instructions] Our first question will come from Rajan Sharma with Goldman Sachs.

So firstly, just on timelines and I was just wondering what impact do the need for food challenging COMFORT Toddlers have on your anticipated timeline? So I'm going to say you mentioned that the duration of the trial itself is not changing but just wondering if you expect the need for food challenge to impact enrollment timelines or kind of these which you could enroll that trial? And then I just have a follow-up as well, please.

Sure. Pharis, do you want to take that one?

Sure. So as I said, Rajan, we anticipate first patient to be enrolled in the first quarter of 2024. We expect that the food challenge could add some time through recruitment period. But we know our sites well and they know how to do food challenges well. And we believe that there's more understanding of our product and this probably is generated from the New England Journal of Medicine publication. So it's a really good time. And so once the study is initiated, we'll have a better understanding of the timeline and we'll come back with more details. But right now, we're not going to talk about the back end until we get the study up and running and go in and see how things are going. But we're confident that we can get this done.

Okay, perfect. And then, the follow-up was just around costs and just wondering if the food challenge requirement impacts the potential cost of the trial and whether you're comfortable that you kind of have sufficient run rate to fund through to completion of all of the required trial?

So the addition of the food challenge will not add significantly to the cost of the trial. So that's not a factor here. And as we've guided, Rajan, we have sufficient cash to go into 2025. That is not enough, we need to complete all of those trials but we'll be looking at raising capital at 1 point in time but no rush to do so and as Pharis said job 1 for us right now is to get those studies up and running which we can do rather expeditiously. So this is what we say when it comes to the financial position. We're in a good position to be able to we think it is right by the business and look at access to capital in due time but we're in no rush to do so.

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

I just want to thank everybody again for joining us today, important development for us. And as always, we're always available for continued conversations. Thank you. And I wish also all those of you with little ones, happy [indiscernible]. Have a nice evening.

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

Good afternoon, and welcome to the DBV Technologies Second Quarter Financial Results Conference Call. My name is Vaishnavi, and I am the operator for this call. At this time all participants are in a listen-only mode. [Operator Instructions] Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company’s request. And now, I’d now like to turn it over to Katie Matthews, Head of Investor Relations. Katie, please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the three and six months ended June 30, 2023. This press release is available in the Press Release 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 our product candidates is 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 occur after this call. Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, Chief Medical Officer; and Sébastien Robitaille, Chief Financial Officer. I will now pass the call over to Daniel. Daniel?

Katie, thank you, and thank you all for joining us on this call today. The purpose of this call today is twofold. One, to provide a business update on our two Viaskin Peanut programs, including feedback we received recently from the FDA through a Type C Meeting on our two pending supplemental safety studies, one in toddlers, one in children, and secondly, to review DBV financial highlights for the first half of 2023. Now, let me summarize what I think has been well established regarding our two Viaskin Peanut development programs before turning the call over to, Pharis, for an update on the recent FDA exchanges and next steps in our clinical and regulatory work. As you know, DBV is advancing in parallel to clinical programs for Viaskin Peanut, Viaskin Peanut in toddlers, age one to three, and Viaskin Peanut in children, age four to seven. It's important to recognize that Viaskin Peanut in one to three year olds, and Viaskin Peanut in four to seven year olds are separate product candidates with independent clinical and regulatory path that we believe will ultimately support two distinct BLAs. With that being said as a reminder, let me pass the call on to Pharis, who will share with you more details. Pharis.

Thanks, Daniel. Let's start on slide number three, with the pathway for toddlers. Just to remind you, the Viaskin Peanut program in toddlers ages one to three uses the original square Viaskin Peanut patch. Efficacy in this age group was fully supported by our Phase 3 study known as EPITOPE, which was completed in June 2022. Recapping those results, Viaskin Peanut demonstrated a statistically significant treatment effect with a p-value of less than 0.001 with a 67% of subjects in Viaskin Peanut arm meeting the treatment responder criteria after 12 months, that's double compared to 33.5% of subjects in the placebo arm. The predefined endpoint was achieved with the lower bound of the 95% confidence interval in 22.4%, which was well above the pre-specified 15% mark. We were, of course, delighted that the results from EPITOPE were published in the New England Journal of Medicine in May. The publication also featured an accompanying editorial entitled good news for toddlers with food allergies. This past April, we received pre-BLA written responses from the FDA regarding the next steps for the Viaskin Peanut Toddler program. As we have previously announced, the agency confirmed that our Phase 3 EPITOPE study met the pre specified criteria for success for the primary endpoint and therefore did not request an additional efficacy study. But FDA did ask that we conduct a supplemental safety study using the original square Viaskin Peanut patch to support and complement the efficacy and safety results collected from EPITOPE. This study is intended to bring the safety database in this age group to approximately 600 total subjects on active treatment, which is consistent with FDA's position in support of the company's dossier in four to seven year olds, as previously announced in December 2022. Let me add a little more detail around that. The FDA has not raised any specific safety concerns with respect to the Viaskin Peanut development program, which includes toddlers and children. Thus, we are not looking for or being asked to assess any specific safety signal in particular. The FDA has been consistent in their communications with us, dating back to the original BLA in 2019, in wanting exposure numbers on active treatment to be approximately 600 subjects in total. Let's move now to slide number four, and the four to seven year old indication in children, which is evaluating Viaskin Peanut using the modified circular patch. Efficacy will be supported by our pivotal Phase 3 study, VITESSE, which was modeled on EPIT, our Phase 3 study in four to eleven year olds. We initiated enrollment in VITESSE in March, and we are making good progress. As with toddlers, we also plan to initiate a supplemental safety study in approximately 270 additional peanut allergic children ages four to seven years. When added to the safety data generated by VITESSE, the supplemental safety study in children will bring our safety database to approximately 600 children on active therapy in this age group. Recall that in December of last year, the FDA agreed that the supplemental study in four to seven year olds would be six months of treatment duration. Now let's discuss the progress that we have made with our Viaskin Peanut supplemental safety study following receipt of Type C Meeting Written Responses from the FDA. The meeting had two main objectives. One, to discuss key study design elements, and two, to agree that a six month study would be adequate in toddlers. Let me summarize where we are, both safety studies, toddlers and children, will be six months in duration. They will be double-blind, placebo-controlled studies. No food challenges will be required for participation for either study. As I just mentioned, with the four to seven year old children safety study will include about 270 subjects. The Toddler safety study will include about 400 subjects in total. Both studies will have 3:1 randomization of active:placebo. Both supplemental safety studies will also generate patch adhesion data in the same manner previously agreed to with the FDA for the VITESSE Phase 3 study. Now that we have received this feedback, we will finalize the protocols and submit them to the FDA for their formal 90 day review. Viaskin Peanut is a novel complex product for which there is no analog, and we believe that taking a best practice approach with the formal FDA review process serves us and the FDA very well. As they said, a picture is worth a thousand words. So, here's a picture of the two patches. Both have the same foam ring and 250 microgram dose of peanut protein. The only difference is the shape and the size of the overlay. The safety studies will be named COMFORT Toddlers in one to three year olds, and COMFORT Children in four to seven year olds. COMFORT stands for characterization of the optimal management of food allergy, relief, and treatment. At this point, I'll turn the call back over to Daniel, to review the financial results. Daniel?

Thank you, Pharis. Now, let's briefly review financial highlights of the first half 2023. Move to slide number eight. Cash, cash equivalents were $174 million as of June 30th compared to a position of $209.2 million as of December 31, which is a net decrease of $35.2 million. $46.4 million of cash were used in operating activities, which the biotech company was mostly driven by clinical R&D, the initiation of VITESSE Phase 3 trial being the biggest component here. Cash used for operation in the six months ended on June 30, 2023, increased by 34.7 million compared to the six months ended June 30, 2022. Now in 2022, the company received 24.8 million euros during the six months ending June 30 2022 for reimbursement of 2019, 2020, and 2021, French research tax credits. We’ve raised $7.8 million proceeds from the issuance and sale of new ordinary shares in form of American Depositary Shares, ADSs, which took place on June 16, 2023, pursuant to our At-The-Market, ATM program which was established in May 2022. In closing, we continue to maximize the efficiency of our spend to make sure we are highly disciplined in our cash management. We have a lot of clinical work to do by next year. We anticipate to have about 1,400 subjects enrolled in Viaskin Peanut Phase 3 studies, which is the bulk of our focus in our broadcast sheets. So let me summarize the fact we've covered quite a bit of information today. So let me recap. Our four to seven year old efficacy study, VITESSE, opened with first subject screened in March of this year, and we are pleased with the ongoing progress of that trial. We are also actively finalizing the two supplement COMFORT safety study protocols in toddlers and children. We expect to initiate these studies once we have final FDA review of the protocols in parallel, we are diligently working on appropriate study start up activities for both supplement safety studies, and the things such as site feasibility, site selection contract with many sites that can be done very effectively in parallel. We believe that the successful completion of the supplemental COMFORT Toddlers safety study would be an important step towards filing a BLA, seeking marketing approval of this potential novel breakthrough technology for peanut allergic toddlers and their families. I want to thank everyone on the phone and webcast for joining us today. I'll ask Pharis and our Chief Financial Officer at Sébastien, to join me for a Q&A. Operator, let's open the line for questions, please.

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Jon Wolleben with JMP Securities. Please go ahead.

Hi, good afternoon, and thanks for taking the questions.

Hi, Jon. Good to hear from you.

Good talking to you, Daniel. Couple of questions on the update today. Just wondering what other protocol details are you trying to get alignment with FDA? And when do you think that that could happen to start the COMFORT programs?

It's three on one front. I'll let Pharis, answer that question, since he's doing all the hard work. Pharis?

Yeah. Hi, Jon. How are you doing? So, for protocol details, it's just the usual sort of last bit of details you want to get alignment on something inclusion, exclusion type things. The main things that we mentioned that we were really happy about were the six month duration. Remember, we weren't sure if that could have been a 12 month and then the size of the trial. So, hopefully, that answers the first part. When would we get back to the FDA again? We're working to finalize that protocol, as Daniel said, and then we'll submit it back to them. Not sure if that really answers your question, but as I said, we're working hard to finalize it, and then we'll get it out the door.

Okay. And can you give an update on the VITESSE enrollment? You guys have previously said you expect the screen the last patient first half of next year. Just wondering about the early traction you're getting. And then I believe you also previously said you might wait to start I get COMFORT Children now until VITESSE is done screening, is that still the expectation for kind of staggering those studies?

Yes. It is. Let me take that one. Yes. VITESSE is enrolling as expected, we are not changing what was the guidance we've given, that we would have last patient in first half of next year top line results, first half 2025. That's unchanged. Things are progressing as planned. As you know, safety trials are easier to recruit and efficacy trials in this space, being a six month trial, our plan is still to initiate COMFORT in children towards the end of enrollment of the VITESSE trial as to not compete ourselves, they’ll be able to give us also the same sites, which, you know, many investigators know as well and know the product well. And so that remains very much the plan here. I hope it answers your question.

Yes. And then one last from me, if I may. Given the agreement on the high level details from FDA, does this make any changes to your cash runway guidance to with regards to COMFORT Toddlers?

An important question, it does not. We expect the study would be six or 12 months and duration turns out to be six consistent with realized which was a safety trial company for eleven year olds, back in 2019, and the six month COMFORT children trial. So, that was very much part of our financial projections here. So, we certainly have more in the financial needs initiated, all these trials in parallel and drive them to execution, and the feedback we have from the FDA changes nothing to what was our clinical trial planning.

Great. Thanks again for taking the questions and congrats.

Yes. Thank you.

[Operator Instructions] Daniel, looks like there are no more questions. Do you have any closing remarks?

Nothing, but a big thank you to you, Vaishnavi, and to everybody joining the call today. As you know, I was available for follow-up discussions if you wish. So, thank you so much. Have a great day.

The conference has now concluded. Thank you for joining today.