Q2 2026 DBV Technologies SA Earnings Call

July 16, 2026

Operator: Welcome to the DBV Q2 2026 results and business update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Jonathan Neely, investor relations. Please go ahead, sir.

Speaker #1: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad.

Speaker #1: To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jonathan Neely, Investor Relations.

Operator: To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Jonathan Neely, investor relations. Please go ahead, sir.

Speaker #1: Please go ahead, sir.

Speaker #2: Thank you. Good afternoon. DBV Technologies reported financial results for the second quarter and half year of 2026. This update is available in the press releases section of the DBV Technologies website.

Jonathan Neely: Thank you. This afternoon, DBV Technologies reported financial results for Q2 and H1 of 2026. This update 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 forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, the timing and the results of interactions with regulatory agencies, 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.

Speaker #2: 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 forecast of estimated cash runway; clinical and regulatory development plans; the design and conduct of our clinical trials; the timing and results of interactions with regulatory agencies; and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies.

Speaker #2: 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.

Jonathan Neely: 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.

Speaker #2: 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.

Jonathan Neely: 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, our chief executive officer, as well as Pharis Mohideen, our chief medical officer, and Kevin Trapp, our chief commercial officer. I will now pass the call over to Daniel. Daniel.

Speaker #2: 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.

Speaker #2: Joining me on the call today are Daniel Tassé, our Chief Executive Officer, as well as Faris Mohadeen, our Chief Medical Officer, and Kevin Trapp, our Chief Commercial Officer.

Jonathan Neely: Joining me on the call today are Daniel Tassé, our chief executive officer, as well as Pharis Mohideen, our chief medical officer, and Kevin Trapp, our chief commercial officer. I will now pass the call over to Daniel. Daniel.

Speaker #2: I will now pass the call over to Daniel. Daniel?

Speaker #3: Thank you, Jonathan, and thank you all for joining us today. 2026 is, and will continue to be, a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the Viaskin Peanut patch for children aged 4 through 7 by the FDA.

Daniel Tassé: Thank you, Jonathan, and thank you all for joining us today. 2026 is and will continue to be a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the Viaskin Peanut patch for children aged four through seven by the FDA. It's certainly a tremendous amount of work to move from the clinical to commercial stage. Today, we'd like to walk you through a summary what we've accomplished toward that goal in H1 of the year. Pharis and Kevin have joined me today to help describe how we have advanced our lead program toward BLA submission, continued constructive engagement with FDA, expanded the Viaskin Peanut clinical program, and strengthened the foundation required to become a commercial stage company. I'll start with the status of the BLA.

Speaker #3: It's certainly a tremendous amount of work to move from the clinical to commercial stage, so today we'd like to walk you through a summary of what we've accomplished toward that goal in the first half of the year.

Speaker #3: Faris and Kevin have joined me today to help describe how we have advanced our lead program toward DLA submission, continued constructive engagement with the FDA, expanded the Viaskin Peanut clinical program, and strengthened the foundation required to become a commercial-stage company.

Speaker #3: I'll start with the status of the DLA. As we shared two weeks ago, we have continued to optimize our BLA submission for the Viaskin Peanut Patch in children ages 4 through 7 through our engagement with the FDA, which has been constructive and collaborative.

Daniel Tassé: As we shared 2 weeks ago, we continue to optimize our BLA submission for the Viaskin Peanut patch in children aged four through seven through our engagement with the FDA, which has been constructive and collaborative. These discussions have been particularly valuable for a novel, first of its kind product like the Viaskin Peanut patch. Let me reiterate, the FDA has not requested additional data. The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now, since our objective is a timely and efficient review of the BLA for VP in four to seven, and we plan to submit an optimized BLA in Q3 of 2026 to support an efficient FDA review.

Speaker #3: These discussions have been particularly valuable for a novel, first-of-its-kind product like the Viaskin Peanut patch, and let me reiterate, the FDA has not requested additional data.

Speaker #3: The work underway is focused on incorporating FDA feedback related to the organization, mapping, and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now, since our objective is a timely and efficient review of the BLA for VP in Q4 to Q7, and we plan to submit an optimized BLA in the third quarter of 2026 to support an efficient FDA review.

Daniel Tassé: In addition to these conversations, our progress in H1 2026 include important developments in our clinical program. Let me invite Pharis Mohideen, our Chief Medical Officer, to tell you a little bit more about that.

Speaker #3: In addition to these conversations, our progress in the first half of 2026 includes important developments in our clinical program, and let me invite Faris Mohadeen, our Chief Medical Officer, to tell you a little bit more about that.

Speaker #4: Thank you, Daniel. While much of our team is laser-focused on BLA preparation and submission, we are also working hard to continue building our scientific platform.

Pharis Mohideen: Thank you, Daniel. While much of our team is laser focused on BLA preparation and submission, we are also working hard to continue to build our scientific platform. Today I will share an update on four main topics. The COMFORT Toddlers study, VITESSE, THRIVE, and whether or not the prevalence of peanut allergy has changed over the last 10 years. First, let me start with COMFORT Toddlers. I'm pleased to say that in Q2, we closed recruitment for COMFORT Toddlers, a supplemental safety study evaluating the Viaskin Peanut patch in toddlers aged 1 to 3 years. This is an important milestone as we look to progress this program. About VITESSE, we presented new data from our phase III study in 4 to 7-year-olds at the American Academy of Allergy, Asthma & Immunology Annual Meeting earlier this year.

Speaker #4: So today I will share an update on four main topics: the COMFORT Toddlers study, the TEST, THRIVE, and whether or not the prevalence of peanut allergy has changed over the last 10 years.

Speaker #4: First, let me start with COMFORT Toddlers. I'm pleased to say that in the second quarter, we closed the recruitment for COMFORT Toddlers, a supplemental safety study evaluating the Viaskin Peanut patch in toddlers aged 1 to 3 years.

Speaker #4: This is an important milestone as we look to progress this program. About the test, we presented new data from our Phase 3 study in 4- to 7-year-olds at the American Academy of Allergy, Asthma, and Immunology annual meeting earlier this year.

Speaker #4: This data included additional efficacy assessments demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. And last month, at the European Academy of Allergy and Clinical Immunology Congress, we presented the test data showing that subjects with asthma, eczema, and/or other food allergies—common comorbid conditions for our study population—had no difference in the Viaskin treatment effect.

Pharis Mohideen: This data included additional efficacy assessments demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. Last month at the European Academy of Allergy and Clinical Immunology Congress, we presented VITESSE data showing that subjects with asthma, eczema, and or other food allergies, common comorbid conditions for our study population had no difference in the Viaskin treatment effect. This is an important dimension of the treatment of food allergies and peanut allergies, since they are often accompanied by other atopic conditions. A population of children we recruited in VITESSE is very typical of the overall peanut allergy population seen in allergists' offices.

Speaker #4: This is an important dimension of the treatment of food allergies and peanut allergies, since they are often accompanied by other atopic conditions. The population of children we recruited in the test is very typical of the overall peanut allergy population seen in allergists' offices.

Speaker #4: This data reinforces our confidence in the potential role that the Viaskin Peanut Patch may play, both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives.

Pharis Mohideen: This data reinforces our confidence in the potential role that the Viaskin Peanut patch may play, both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives. Also at EAACI, the design elements for THRIVE were presented by Doctor Kirsten Perrett, who is the co-lead investigator, along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the Viaskin Peanut patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged 6 through 12 months following 3 to 4 years of treatment with the Viaskin Peanut patch. We are pleased to have shared the first subject was enrolled in this first of its kind study last month at Doctor Doug Mack's site in Canada.

Speaker #4: Also at EYAKI, the design elements for THRIVE were presented by Dr. Kirsten Peret, who is the co-lead investigator along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the Viaskin Peanut Patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged 6 to 12 months, following three to four years of treatment with the Viaskin Peanut Patch.

Speaker #4: We are pleased to have shared that the first subject was enrolled in this first-of-its-kind study last month at Dr. Doug Mack's site in Canada. We believe this study is nicely aligned with the earlier introduction of allergens into the diet, and consequently, more patients are being identified with a food allergy at an earlier age.

Pharis Mohideen: We believe this study is nicely aligned with earlier introduction of allergens into the diet and consequently more patients being identified with a food allergy at an earlier age. Given the positive results of the phase III EPITOPE study in 1 to 3-year-olds, which was published in The New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study. A question that we frequently get is whether the prevalence of peanut allergy has changed. I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults.

Speaker #4: Given the positive results of the Phase 3 EPITOPE study in 1- to 3-year-olds, which was published in the New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study.

Speaker #4: We pay very close attention to the ever-evolving food allergy treatment landscape, and a question that we frequently get is whether the prevalence of peanut allergy has changed.

Speaker #4: I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults.

Pharis Mohideen: Doctor Alessandro Fiocchi, a leading allergist, and colleagues conducted a standardized survey-based study of peanut allergy prevalence in children using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength. In the United States, the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior US literature, including the approximate 2.2% prevalence rate previously reported by Doctor Ruchi Gupta and colleagues in 2018. Importantly, the Gupta data were collected in 2015 and 2016 while the Fiocchi data were collected in 2022 and 2023. These two independent data sets collected approximately 7 years apart, both point to a US pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion.

Speaker #4: Dr. Alessandro Fiocci, a leading allergist, and colleagues conducted a standardized survey-based study of peanut allergy prevalence in children, using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength.

Speaker #4: In the United States, the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior U.S. literature, including the approximate 2.2% prevalence rate previously reported by Dr. Ruchi Gupta and colleagues in 2018.

Speaker #4: Importantly, the Gupta data were collected in 2015 and 2016, while the Fiocci data were collected in 2022 and 2023. These two independent data sets, collected approximately seven years apart, both point to a U.S. pediatric peanut allergy prevalence of approximately 2%.

Speaker #4: The confidence intervals further support that conclusion. Gupta reported a 95% confidence interval of 2% to 2.5%, which overlaps with the estimates across each pediatric age group in the Fiocci paper.

Pharis Mohideen: Gupta reported a 95% confidence interval of 2% to 2.5%, which overlap with the estimates across each pediatric age group in the Fiocchi paper. I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?

Speaker #4: I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?

Speaker #5: Thank you, Faris. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the U.S. has not changed.

Kevin Trapp: Thank you, Firas. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the US has not changed. This is an important point. The Fiocchi data reinforces that peanut allergy remains a persistent population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent. Peanut allergy also remains one of the most common food allergies in children, and it still creates a daily burden for patients, families, and healthcare systems. That is why our work matters and why, as we move toward BLA submission, we're planning now for what it takes to bring Viaskin Peanut patch to the market at scale if approved. For commercial, that means focusing on building the infrastructure a successful US launch requires. We are investing across market access, patient services, brand readiness, field force planning, and launch operations.

Speaker #5: This is an important point. The Fiocci data reinforces that peanut allergy remains a persistent, population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent.

Speaker #5: Peanut allergy also remains one of the most common food allergies in children, and it still creates a daily burden for patients, families, and healthcare systems.

Speaker #5: That is why our work matters, and why, as we move toward BLA submission, we're planning now for what it takes to bring Viaskin Peanut Patch to the market at scale, if approved.

Speaker #5: For commercial, that means focusing on building the infrastructure a successful U.S. launch requires. We are investing across market access, patient services, brand readiness, field force planning, and launch operations.

Speaker #5: We have built the launch model around cross-functional execution. Commercial is working closely with Medical Affairs, our Regulatory team, Pharmacovigilance, Quality, Supply, and Manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply, and the regulatory timeline.

Kevin Trapp: We have built the launch model around cross-functional execution. Commercial is working closely with medical affairs, our regulatory team, pharmacovigilance, quality, supply, and manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply, and the regulatory timeline. Our goal in the end is to ensure a prescriber and patient experience that supports their needs and fits into their daily routines. It looks simple on the front end but is so complex on the back end. We're also spending real time with the food allergy community, including caregivers, advocates, physicians, and payers, to understand where the greatest barriers exist and how DBV can support adoption of the peanut patch. In short, we're doing the work now to drive both a successful launch and the long-term growth of Viaskin Peanut patch.

Speaker #5: Our goal in the end is to ensure a prescriber and patient experience that supports their needs and fits into their daily routines. It looks simple on the front end, but is so complex on the back end.

Speaker #5: We're also spending real time with the food allergy community, including caregivers, advocates, physicians, and payers, to understand where the greatest barriers exist and how DBV can support adoption of the peanut patch.

Speaker #5: In short, we're doing the work now to drive both a successful launch and the long-term growth of Viaskin Peanut Patch. As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the Viaskin Peanut Patch, if approved.

Kevin Trapp: As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the Viaskin Peanut patch if approved. We're reviewing what the future would look like for our manufacturing capacity, supply chain readiness, and related capital requirements. We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need. Our planning must reflect that potential. Daniel, I'll pass it back to you.

Speaker #5: So we're reviewing what the future would look like for our manufacturing capacity, supply chain readiness, and related capital requirements. We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need.

Speaker #5: Our planning must reflect that potential. Daniel, I'll pass it back to you.

Speaker #1: Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of the Viaskin Peanut Patch.

Daniel Tassé: Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of the Viaskin Peanut patch. At the same time, we always approach these investment decisions thoughtfully in alignment with regulatory progress, commercial readiness, and disciplined capital allocation. In closing, H1 2026 reinforced our conviction in DBV's future. We are advancing our lead program in four to seven-year-olds towards BLA submission. We have closed recruitment for COMFORT Toddlers supplemental safety study in one to three-year-olds. We are expanding our Viaskin Peanut clinical program with the very important THRIVE study. We are funded into Q3 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the long-term success of the Viaskin Peanut patch.

Speaker #1: At the same time, we always approach these investment decisions thoughtfully, in alignment with regulatory progress, commercial readiness, and disciplined capital allocation. So, in closing, the first half of 2026 reinforced our conviction in DBV's future.

Speaker #1: We are advancing our lead program in four- to seven-year-olds towards BLA submission. We have closed recruitment for the COMFORT toddler supplemental safety study in one- to three-year-olds.

Speaker #1: We are expanding our Viaskin Peanut clinical program with a very important DRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the long-term success of the Viaskin Peanut Patch.

Speaker #1: Now, we're doing all of this with a clear purpose: to help children and families living with the daily burden of peanut allergy. I will now pass it over to the operator for questions.

Daniel Tassé: Now, we're doing all of this with a clear purpose, to help children and families living with the daily burden of peanut allergy. I will now pass it over to the operator for questions.

Speaker #2: If you would like to ask a question, please press star one on your telephone keypad now. You'll be placed into the queue in the order received.

Operator: If you would like to ask a question, please press star one on your telephone keypad now. You will be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. Our first question comes from Yatin Suneja at Guggenheim.

Speaker #2: Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now.

Speaker #2: And our first question comes from Yatin Sunesha at Guggenheim.

Speaker #4: Hey guys, thank you for taking my question, and thank you for all the details—very helpful. So, just two quick questions from me.

Yatin Suneja: Hey, guys. Thank you for taking my question, and thank you for all the details. Very helpful. Just two quick questions from me.

Daniel Tassé: Yeah.

Speaker #1: Yeah.

Yatin Suneja: First is with regard to the filing and the acceptance and the timelines around it. What are your working assumptions? How should we think about the acceptance timelines? Will this be a standard review or a priority review? With regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback, any changes in manufacturing dossier or anything you sort of have to do from a launch perspective?

Speaker #4: First is with regard to the filing and the acceptance and the timelines around it. So what are you working assumption? Like how should we think about the acceptance timelines?

Speaker #4: Will this be a standard review or a priority review? And then, with regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback—any changes in the manufacturing dossier, or anything you have to do from a launch perspective?

Daniel Tassé: No, thanks for those questions, Yatin. Let me start with the first one. The regulatory timelines are we will be asking for priority review given the fact that Viaskin Peanut, the platform, has a breakthrough designation, thus making us eligible for priority review. As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA. That was the purpose of the update a few weeks ago here. After we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review. Right now, we're assuming 60 days. Could it be shorter? There's a possibility, given how closely we're working with the agency, but the formal timelines are 60 days.

Speaker #1: No, thanks for those questions, Yatin. Let me start with the first one. So, the regulatory timelines are: we will be asking for priority review given the fact that Viaskin Peanut, the platform, has a breakthrough designation, thus making us eligible for priority review.

Speaker #1: As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA—that was the purpose of the update a few weeks ago here.

Speaker #1: So, after we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review.

Speaker #1: Right now, we're assuming 60 days. Could it be shorter? There's a possibility, given how closely we're working with the agency, but the formal timelines are 60 days.

Speaker #1: We'll ask for priority review, which would be a six-month review at that point in time. I hope that answers the first half of your question.

Daniel Tassé: We'll ask for priority review, which would be a six-month review at that point in time. I hope that answers the first half of your question. On CMC, no, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here. There's nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product and the way we will describe that in the Module 3, the CMC section of the BLA.

Speaker #1: On CMC—no, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here, so there's nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product and the way we will describe that in Module Three, the CMC section of the BLA.

Yatin Suneja: Got it. One more question, if I may.

Speaker #4: Got it. One more question, if I may.

Daniel Tassé: Please.

Speaker #1: Please.

Speaker #4: Now, like what is now the gating factor or what are some of the things that you need to sort of get either an alignment or you have to complete it on your end?

Yatin Suneja: What is now the gating factor? What are some of the things that you need to get either an alignment or you have to complete it on your end? Could you just tell us before you can submit the BLA? Thank you.

Speaker #4: Could you just tell us, before you can submit the BLA? Thank you.

Speaker #1: Yeah, there are discussions ongoing, Yatin, as you know, on CMC, and also on formatting and tabulation of the biostats table. So, that discussion is also going on in parallel.

Daniel Tassé: Yeah. There are discussions ongoing, Yatin, as you know, on CMC and also on formatting tabulation of the biostats table. That discussion is also going on in parallel. Completing the discussions with the FDA on CMC and the same completion on biostats are the two gating items right now progressing in parallel.

Speaker #1: So, completing the discussions with the FDA on CMC, and the same completion on biostats, are the two gating items right now, progressing in parallel.

Speaker #4: Thank you very much.

Yatin Suneja: Thank you very much.

Speaker #1: Thank you.

Daniel Tassé: Thank you.

Speaker #2: And our next question comes from Sushila Hernandez, VLK.

Operator: Our next question comes from Sushila Hernandez of VLK.

Speaker #5: Yes, thank you for taking my questions. I also have two. So, do I understand correctly that you have engaged with the FDA since the last conference call that you organized?

Operator: Yes, thank you for taking my questions. I also have two. Do I understand correctly that you have engaged with the FDA since the last conference call that you organized? If so, have they provided with additional suggestions on the structuring, mapping of the BLA package or on any other fronts?

Sushila Hernandez: Yes, thank you for taking my questions. I also have two. Do I understand correctly that you have engaged with the FDA since the last conference call that you organized? If so, have they provided with additional suggestions on the structuring, mapping of the BLA package or on any other fronts?

Speaker #5: And if so, have they provided you with additional suggestions on the structuring or mapping of the BLA package, or on any other fronts?

Speaker #1: Yep. Okay, so those are your two questions, Sushila? Sorry about that. Yes, the short answer is yes. The dialogue with the agency is ongoing.

Daniel Tassé: Yeah. Okay. Those are your two questions, Sushila? Sorry about that. Yes. The short answer is yes, the dialogue with the agency is ongoing, when dialogue is both talking as well as exchanging emails. Yes, there's been further discussion of what they want, all of which are things that we're accommodating within, again, nothing that is being discussed right now requires incremental data or we see as being fundamentally problematic in any way. I trust that answers the two halves of your question.

Speaker #1: When dialogue is both talking as well as exchanging emails. And yes, it's been further discussion of what they want, all of which are things that we're accommodating within. Again, nothing that is being discussed right now requires incremental data, or we see as being fundamentally problematic in any way.

Speaker #1: I trust that means you have three questions.

Speaker #5: Yes, thank you. And then just one more question. So, with the recruitment completed for the safety study in toddlers, could you just remind us how long you will follow these toddlers before the study is completed?

Daniel Tassé: Yes. Thank you. Just one more. With the recruitment-

Sushila Hernandez: Yes. Thank you. Just one more. With the recruitment-

Daniel Tassé: Please

Daniel Tassé: completed of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Daniel Tassé: Please

Sushila Hernandez: completed of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Daniel Tassé: Saras, you want to take that one? It's your baby.

Speaker #1: Sarah's going to take that one. It's your baby.

Speaker #5: So, with the—yeah, with the recruitment completed—oh, sorry. Yeah, go ahead.

Pharis Mohideen: Yeah.

Pharis Mohideen: With the recruitment completed. Oh, sorry. Yeah, go ahead.

Sushila Hernandez: With the recruitment completed. Oh, sorry. Yeah, go ahead.

Speaker #3: No, it's a six-month safety study. Again, there's no efficacy component to it. We did the food challenge up front to have inclusion and exclusion criteria, but it's a six-month treatment period.

Pharis Mohideen: No, it's a 6-month safety study. Again, there's no efficacy component to it. We did the food challenge up front to have inclusion/exclusion, but it's a 6-month treatment period.

Speaker #5: Okay, that's clear. Thank you.

Pharis Mohideen: Okay. That's clear. Thank you.

Sushila Hernandez: Okay. That's clear. Thank you.

Speaker #2: And our next question comes from Kristen Kluska of Cantor Fitzgerald.

Operator: Our next question comes from Kristen Kluska of Cantor Fitzgerald.

Kristen Kluska: Thanks so much for the updates. Couple questions from me. First, I think most of us on the line probably have never submitted an application before. Can you help us just to try to imagine what it's like to reformat things? Why isn't it as simple as just copy and pasting in other areas? Sorry for the basic question, I think it will help since we don't have this experience.

Speaker #6: Thank you so much for the updates. I have a couple of questions. First, I think most of us on the line probably have never submitted an application before.

Speaker #6: So, can you help us try to imagine what it's like to reformat things? Why isn't it as simple as just copying and pasting it in other areas?

Speaker #6: Sorry for the basic question, but I think it will help since we don't have this experience.

Daniel Tassé: I appreciate that question, Kristen, because it really is critical. There's nothing you do in an office that looks like filing a BLA. This is not a zip file you attach to an email. This is not a link to some data site when it comes to doing due diligence. It's a massive document that includes literally hundreds of thousands of pages and tests and validations and protocols, all organized in a way that's obviously delineated under the regulations of the CFRs. All of this includes a lot of hyperlinking so that the FDA can easily, or as easily as possible, navigate from one element to the other one.

Speaker #1: I appreciate that question, Kristen, because it really is critical. Yeah, there's nothing you do in an office that looks like filing a BLA. This is not a zip file you attach to an email.

Speaker #1: This is not a link to some data site when it comes to doing due diligence. It's a massive, massive document that includes literally hundreds of thousands of pages, tests, validations, and protocols.

Speaker #1: All organized in a way that's obviously delineated under the regulations that the CFRs specify. And then, all of this includes a lot of hyperlinking so that the FDA can easily, or as easily as possible, navigate from one element to the other.

Speaker #1: And all of that rigor and structure needs to be done in a way that is formatted to FDA standards—one, for their ease of review, and two, to make sure that, given the size of that file, there are no issues through the FDA's IT firewalls.

Daniel Tassé: All of that rigor and structure needs to be done in a way that is formatted to FDA standards, one, for their ease of review, and two, to make sure that given the size of that file, there's no issues through the FDA IT firewalls. To add to that, the sense of the massiveness of the undertaking, since there's a lot of linkage of something that's in one part of the BLA to another one, a big part of what sponsors do is to verify that all of those linkages work, and that as you change something, you don't change something in a domino document later on. It sounds like a lot of small things, and that's exactly what it is. It's a lot of small things. I don't know if that answers your question here, but it's a massive undertaking. It's all about details.

Speaker #1: And to add to that, the sense of the massiveness of the undertaking, since there's a lot of linkage of something that's in one part of the BLA to another one, is a big part of what sponsors do.

Speaker #1: So, verify that all of those linkages work, and that as you change something, you don't change something in a domino document later on. It sounds like a lot of small things, and that's exactly what it is.

Speaker #1: It's a lot of small things. I don't know if that answers your question here, but it's a massive undertaking that's all about details.

Speaker #6: Yeah, thank you so much for that additional color. And then on COMFORT Toddlers, just—are you still planning to file that later this year, or how should we be thinking about that based on the time to collect the safety data?

Kristen Kluska: Thank you so much for that additional color.

Daniel Tassé: Yeah.

Kristen Kluska: On COMFORT Toddlers.

Daniel Tassé: Yes

Kristen Kluska: Are you still planning to file that later this year, or how should we be thinking about that based on the time to collect the safety data?

Speaker #1: Yeah, we are still planning to file by the end of the year. For example, COMFORT is a supplemental safety study. The pivotal trial is EPITOPE.

Daniel Tassé: Yeah, we are still planning to file by the end of the year. COMFORT is a supplemental safety study.

Kristen Kluska: Yes.

Daniel Tassé: The pivotal trial is EPITOPE. Let's not forget that's already completed here. That shows efficacy. We talked about the amount of commonality and overlap in content of the BLI 1 to 3, 4 to 7. That's obviously part of things we're learning as we work closely with FDA in 4 to 7. We maintain our objective of filing by the end of the year, as we work through that logistic. Obviously, that will be in dialogue with the FDA, obviously.

Speaker #1: Let's not forget that that's already completed here. That shows efficacy. We talked about the amount of commonality and overlap in content of the BLA in 1 to 3, 4 to 7.

Speaker #1: That's obviously part of things we're learning as we work closely with the FDA in Q4 to Q7. So we maintain our objective of filing by the end of the year.

Speaker #1: As we work through that logistic, and obviously, that will be in dialogue with the FDA, obviously.

Speaker #6: Okay. Thank you so much. I appreciate it. You did. Thank you.

Kristen Kluska: Okay. Thank you so much. Appreciate it.

Daniel Tassé: I don't know if that answered your question. Yeah.

Kristen Kluska: It did. Thank you.

Speaker #1: Thank you.

Daniel Tassé: Thank you.

Speaker #2: And our next question comes from John Willoughbin of Citizens Capital.

Operator: Our next question comes from Jon Wolleben of Citizens Capital.

Jon Wolleben: Hey, thanks for taking the question. A couple on commercial from me. Do you guys have any sense of the average price of XOLAIR in one to seven-year-olds and what pricing band you guys have been testing with payers?

Speaker #7: Hey, thanks for taking the question. A couple on commercial for me. Do you guys have any sense of the average price of Zoller in one- to seven-year-olds, and what pricing band you guys have been testing with payers?

Speaker #1: Do you have anything to say on that?

Daniel Tassé: Kevin, you take that one?

Speaker #3: Yeah, John, it's Kevin. Yeah, sure. As you know, I mean, Zolair is IG- and weight-based, so it'll vary across that age range. We've seen prices from around $10,000 into the $30,000s, right, depending on that.

Kevin Trapp: Yeah, John, it's Kevin. You want me to take? Yeah, sure. Yeah. As you know, XOLAIR is IgE and weight-based, it'll vary across that age range. We've seen prices from around $10,000 into the $30,000s, right, depending on that. We've tested a range of prices. We're not going to finalize anything yet. We've got payer discussions that'll be upcoming here in the next month, advisory boards. The research is being done and as we get tighter on this, we get closer to launch, we can give you some more ranges.

Speaker #3: We've tested a range of prices. I mean, we're not going to finalize anything yet. We've got payer discussions that will be upcoming here in the next month, as well as advisory boards.

Speaker #3: But the research is being done, and as we get tighter on this and get closer to launch, we can give you some more ranges.

Speaker #7: Okay. And then when we think about commercial, do you have a sense, in your research, what proportion of one- to seven-year-olds with peanut allergy would seek some form of therapy? And then, digging into that, who would be a likely candidate for bias against peanut versus who would not be?

Jon Wolleben: Okay. When we think about commercial, do you have a sense in your research what proportion of 1 to 7-year-olds with peanut allergy would seek some form of therapy? Digging into that, who would be a likely candidate for Viaskin Peanut versus who would not be?

Speaker #3: Yeah, we're working through the segment. Yeah, sure. Yeah, I mean, look, we've done a lot of both parent research and allergist research, and I would say that we always see very significant demand as we talk to parents.

Kevin Trapp: Yeah.

Jon Wolleben: Can you comment through that?

Jon Wolleben: We're working through the segment. Yeah, sure. Yeah, look, we've done a lot of both parent research and allergist research. I would say that we always see very significant demand as we talk to parents. We know it's not one market. As we continue to look through segmentation and who will activate first, we think there's a number of things in our framework from those that have just been diagnosed or just had a reaction, those that have already sought out immunotherapy but perhaps didn't continue with it for either the burden of frequency of visits or the tolerability. There's a group that maybe get farther out in their avoidance at epi. They may need more education. They'll be later down the path. We've got our framework, Jon. We're doing a lot of work on segmentation and prioritization.

Speaker #3: And we know it's not one market. So, as we continue to look through segmentation and who will activate first, we think there's a number of things in our framework: from those that have just been diagnosed or just had a reaction, to those that have already sought out immunotherapy but perhaps didn't continue with it, either due to the burden of frequency of visits or tolerability.

Speaker #3: And then there's a group that maybe gets farther out in their avoidance and EPI, and they may need more education, and they'll be later down the path.

Speaker #3: So, we've got our framework done. We're doing a lot of work on segmentation and prioritization, and again, I think we'll have more to say on that in the second half of the year.

Kevin Trapp: Again, I think we'll have more to say to that in H2 if we're talking about a commercial day at some point. Is that helpful?

Speaker #3: We think we're talking about a commercial day at some point, so—is that helpful?

Jon Wolleben: Okay. It'll be more helpful around the commercial day, but I appreciate you guys taking the question.

Speaker #7: Okay. It will be more helpful around the commercial day, but I appreciate you guys taking the question.

Daniel Tassé: Candor is wonderful. Thanks, Jon.

Speaker #1: Candor is wonderful. Thanks, John.

Speaker #2: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Sam Slitzky of LifeSci Capital.

Operator: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Sam Slutsky of LifeSci Capital.

Sam Slutsky: Hey, good evening. Appreciate the question. Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is in terms of, are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general? Just what's the end goal of that study, hopefully?

Speaker #8: Hey, good evening. Appreciate the question. Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is? In terms of, are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general?

Speaker #8: Just kind of, what's the end goal of that study, hopefully?

Daniel Tassé: Pharis? Mr. Arnould, I can add to it.

Speaker #1: Paris? At the start, I can answer it.

Pharis Mohideen: Yeah. This is a phase II study. It's really almost more of a proof of concept study, Sam. The objective, and this is sort of trampolining off of the 1 to 3-year-old success that we saw in EPITOPE at that age group. We're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. The ultimate goal is to see if these patients can get to the point where they can consume peanut ad lib. We have a very broad definition because one size doesn't fit all in this patient population. At this point, we're running the study. It's not really intended to be a registration study. It's a single-arm study. We've not talked to agencies about what this data set could do. We just started recruitment, as I mentioned. It's in its early stages.

Speaker #3: Yeah, so this is a Phase 2 study. It's really almost more of a proof-of-concept study, Sam. So the objective—and this is sort of trampolining off of the 1- to 3-year-old success that we saw in EPITOPE as that age group.

Speaker #3: So we're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. And the ultimate goal is to see if these patients can get to the point where they can consume peanut ad libitum.

Speaker #3: And we have a very broad definition, because one size doesn't fit all in this patient population. At this point, we're running the study—it's not really intended to be a registration study.

Speaker #3: It's a single-arm study. We've not talked to agencies about what this data set could do. We just started recruitment, as I mentioned; it's in its early stages.

Speaker #3: But for us, conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness. And with the introduction of food allergens earlier, this population absolutely does exist, right?

Pharis Mohideen: For us, conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness. With the introduction of food allergens earlier, this population absolutely does exist, right? It's early stages, Sam. Again, right now, we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations. For now, it's open sites recruit and see what the study shows.

Speaker #3: So it's early stages, Sam. Again, right now we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations.

Speaker #3: But for now, it's an open-site recruit and see what the study shows.

Speaker #1: I'll add one thing, Faris, if I may. What's not changing here is the duration of treatment, right? We expect kids will be on therapy for three, four, or five years.

Daniel Tassé: I'll add one thing, Pharis, if I may. What's not changing here is the duration of treatment, right? We expect kids will be on therapy for three, four, five years. We're trying to do the same thing here in six to 12-month-olds. We could have decided to do this study as part of a phase IV study post-approval. I think the question is too important and too pressing to wait that long. Moreover, we're running this study with obviously some degree of confidence given what we know about our product, that it's going to show some benefits here. That's why we're calling it phase II study. It's a question that deserves to be answered, and it does not change the treatment paradigm of using Viaskin Peanut in toddlers with peanut allergic.

Speaker #1: We're trying to do the same thing here in 6- to 12-month-olds. So we could have decided to do this study as part of a Phase 4 study post-approval.

Speaker #1: I think the question is too important and too pressing to wait that long. Moreover, I mean, we're running the study with obviously some degree of confidence, given what we know about our product, that it is going to show some benefits here.

Speaker #1: That's why we're calling it a phase two study. But it's a question that deserves to be answered. And it does not change the treatment paradigm of using Viaskin Peanut.

Speaker #1: In toddlers who are peanut allergic. Is that helpful, Sam? Yeah? Thank you.

Sam Slutsky: Okay, thanks.

Daniel Tassé: Is that helpful, Sam? Yeah.

Sam Slutsky: Yep.

Daniel Tassé: Thank you.

Speaker #2: And this concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tesley for any closing remarks.

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

Speaker #1: Well, that’s—oh, there we go. Okay. Well, thank you. That concludes our call for this afternoon. Again, we are very pleased with our progress towards commercialization.

Daniel Tassé: Well, next. Oh, there we go. Okay. Well, thank you. That concludes our call for this afternoon. Again, we are very pleased with our progress towards commercialization, remain committed, as we're answering your questions, at transforming the lives of children and families living the daily burden of food allergy. It is a burden. We think we have a technology that can make a big difference there. We're proud of the work that we're doing and the science that we're pursuing to try to change the life of families. Thank you. Good evening. We'll talk to you soon.

Speaker #1: Remain committed as we're answering your questions. It's transforming the lives of children and families living with the daily burden of food allergy. It is a burden.

Speaker #1: We think we have a technology that can make a big difference there, and we're proud of the work that we're doing and the science that we're pursuing.

Speaker #1: To try to change the lives of families. So thank you. Good evening, and we'll talk to you soon.

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

Speaker #2: This concludes today's conference call. Thank you for attending.

Operator: The host has ended this call. Goodbye

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