Q2 2024 DBV Technologies SA Earnings Call

and some of the other people in this country. Thank you. for being here. Thank you. Thank you for having me. Thank you. Thank you. Thank you for having me.

Operator: 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.

Operator: Business Update Conference Call. All participants will be in a listen-only mode.

Speaker Change: Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode.

Operator: 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 1 on your telephone keypad. To withdraw your question, please press the pound key, then 1. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Speaker Change: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: 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 the pound key, then one. Please note this event is being recorded.

Speaker Change: After today's presentation, there will be an opportunity to ask questions.

Speaker Change: To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press the pound key, then 1.

Katie Matthews: I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Speaker Change: Please note, this event is being recorded.

Speaker Change: I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Daniel TASS: Thank you. This afternoon, DBV Technologies issued a press release for outlines our financial results for the three and six months and the June 30th, 2024. This press release is available in the press release section of the DBV Technologies website.

Katie Matthews: 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. 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 plan. The design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our crash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies.

Katie Matthews: 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.

Daniel TASS: 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 trial, 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 through-dology. 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 the statement. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements.

Katie Matthews: 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 statement to account for or reflect events or circumstances that occur after this call.

Speaker Change: 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.

Speaker Change: The design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our crash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies.

Speaker Change: These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause a company's actual results to differ significantly from those suggested by these statements.

Speaker Change: Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.

Daniel TASS: Please refer to the company's filings with the SEC and the French AMF 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.

Speaker Change: Please refer to the company's filings of the SEC in the French AMF information concerning risk factors that could cause the company's actual results

Speaker Change: to differ materially from expectations.

Daniel TASS: Except as required by law, the company disclaimed any obligation to publicly update or revise any forward-looking statement to account for or reflect events or circumstances that occur after this call.

Speaker Change: 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 statement to account for or reflect events or circumstances that occur after this call

Daniel TASS: Joining me on the call today are Daniel Tasse, Chief Executive Officer of DBV, Dr. Faris Mohateen, DBV's Chief Medical Officer, and Virginia Brutina, our Chief Financial Officer.

Katie Matthews: Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV, Dr. Pharis Mohideen, DBV's Chief Medical Officer, and Virginie Boucinha, our Chief Financial Officer. I will now pass the call over to Daniel.

Speaker Change: Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV, Dr. Pharis Mohideen, DBV's Chief Medical Officer, and Virginie Boucinha, our Chief Financial Officer. I will now pass the call over to Daniel. Daniel? Dr. Pharis Mohideen, Chief Executive Officer of DBV, Dr. Pharis Mohideen, Dr. Pharis Mohideen, Dr. Pharis Mohideen, Dr. Pharis Mohideen…

Daniel TASS: I will now pass the call over to Daniel. Daniel?

Daniel TASS: Thank you, Cagody, 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 ethycutaneous 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 1 through 7, where there exists a significant unmet medical need in the US and around the world, and critically, is an age group where the immune system is particularly malleable.

Daniel Tassé: 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. Blyskin 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.

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.

Speaker Change: 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.

Speaker Change: Blyskin 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.

Daniel Tassé: Our most advanced candidate is Viaskin Peanut, which we are developing for peanut allergic children ages 1 through 7, 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 for these children from accidental exposure to peanuts. Moreover, 75-80% of children with a peanut allergy will not outgrow their peanut allergy over their lifetime.

Speaker Change: Our most advanced candidate is Viacin Peanut, which we are developing for peanut-allergic children ages 1 through 7, where there exists a significant unmet medical need in the U.S. and around the world.

Speaker Change: critically, is an age group where the immune system is particularly malleable.

Daniel TASS: 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 programs, one in children age seven years of age using the modified larger sexual repatch, 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.

Speaker Change: It is also where there is the most risk.

Speaker Change: to these children from accidental exposure to peanut.

Speaker Change: Moreover...

Speaker Change: 75 to 80 percent of children with a peanut allergy will not outgrow their peanut allergy.

Daniel Tassé: And today, we are pleased to provide updates on our two Vyaskin peanut development programs, one in children aged 4 to 7 years of age using the modified larger circular patch, and one in toddlers aged 1 to 3, using the original square patch. As you know, we plan on filing two separate Biological License Applications, or BLAs, one for each agency.

Speaker Change: over their lifetime.

Speaker Change: And today, we are pleased to provide updates on our two Viaskin peanut development programs.

Speaker Change: Program, sorry, one in children aged four to seven years of age using the modified larger six-year patch, and one in toddlers aged one to three using the original square patch.

Speaker Change: As you know, we plan on filing two separate Biological License Applications, or BLAs, one for each age group.

Daniel TASS: 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 VTES Phase Three pivotal trial of the modified by a skin peanut patch in that population. Results from this trial, together with the Comfort Children's Supplemental Safety Study, will form the basis of the DLA for this age group. Since the middle of last year, we have seen very good momentum in rolling the VTES 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.

Daniel Tassé: There are three key highlights we wish to share with you. Beginning with the program in children four to seven years old, let's remember that we are running the VITESP Phase III Pivotal Trial of the Modified Bias Skin Peanut Patch in that population. Results from this trial, together with the Comfort Children's 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 Z-Test 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 for toddlers 1 to 3 years of age.

Speaker Change: There are three key highlights we wish to share with you today.

Speaker Change: Beginning with the program in children 4 to 7 years old, let's remember that we are running the VITESS phase 3 pivotal trial of the modified bias skin peanut patch in that population.

Speaker Change: Results from this trial, together with the Comfort Children's Supplemental Safety Study, will form the basis of a BLA for this age group.

Speaker Change: Since the middle of last year, we have seen very good momentum in rolling the Z-Test trial patients.

Speaker Change: And we are unchanged in our expectation that the final subject will be screened by the end of the third quarter of this year.

Daniel TASS: Turning to our other program in toddlers one to three years of age, let's recall that we announced successful results from the phase three FSC 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 call Comfort Toddlers, to increase the number of subjects on treatments in the one to three year old safety database in support of that DLA. We submitted the Comfort Toddlers protocol to the FDA in November of last year, and the agency responded in March.

Speaker Change: Turning to our other program in toddlers 1 to 3 years of age.

Daniel Tassé: Let's recall that we announced successful results from the phase 3 FQC 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've called Comfort Comfort Toddlers, to increase the number of subjects on treatment in the one to three-year-old safety database in support of that BLM.

Speaker Change: Let's recall that we announced successful results from the phase 3 FQC 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.

Speaker Change: Also recall that the FDA requested that we conduct a supplemental safety study, which we've called Comfort Comfort Toddlers, to increase the number of subjects on treatment in the one to three-year-old safety database in support of the DLA.

Daniel Tassé: We submitted the Comfort Toddlers Protocol to the FDA in November of last year, and the agency responded in March. Consent, We have been engaged in ongoing dialogue with the FDA regarding the Comfort Toddlers Supplemental Safety Study, and the dialogue has mainly focused on patchware time experience, including How prescribers would advise parents and caregivers to manage day-to-day variability in patchware. 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 results of our existing trial, Epita.

Speaker Change: We submitted the Comfort Toddlers Protocol to the FDA in November of last year.

Daniel TASS: 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 patchware time experience, including how prescribed rules would advise parents and caregivers to manage day-to-day variability in patchware time. I will at Ferris or 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 the FDA, we have recently submitted to the agency a draft labeling proposal.

Speaker Change: And the agency responded in March.

Sam: and Sam.

Sam: We have been engaged in ongoing dialogue with the FDA regarding the Comfort Toddlers Supplemental Safety Study.

Sam: And the dialogue has mainly focused on patch wear time experience, including how prescribers would advise parents and caregivers.

Sam: to manage day-to-day variability in patch wear time.

Speaker Change: 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.

Pharis Mohideen: And we believe the right answer to that question resides in the results of our existing trial, Epidope.

Daniel Tassé: And in an effort to seek alignment with FDA, we have recently submitted a Draft Labeling Proposal but 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 the agency's queries about patch wear. The agency asked us for more details and analysis about that proposal, which we provided to FDA on June 28.

Speaker Change: And in an effort to seek alignment with SBA, we have recently submitted to the agency

Daniel TASS: With comprehensive supporting, supportive data and analyses that were informed by the epitope pivotal data. Focus on the user experience during the first 90 days of treatment, the first three months of treatment, to address the 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 the FDA on this labeling proposal, we continue to advance study preparation activities to be able to initiate the study once we have protocol alignment.

Speaker Change: A Draft Labeling Proposal

Speaker Change: with comprehensive supportive data and analyses that were informed by the Epitope Pivotal Data.

Speaker Change: focused on the user experience during the first 90 days of treatment, so the first three months of treatment, to address the agency's queries about patch wear time.

Speaker Change: The agency asked us for more details and analysis about that proposal, which we provided to FDA on June 28.

Daniel Tassé: And while we are awaiting a response from SBA 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. 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?

Speaker Change: 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.

Daniel TASS: 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 would like to give more details on that shortly.

Speaker Change: 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.

Pharis Mohideen: At this point, I would like to turn the call over to our Chief Medical Officer, Dr. Pharis Mohideen, for more detailed updates on our clinical programs. Pass. Thank you, Daniel. First, let's start with the test. If you recall, this is a 600-patient study in 47-year-olds with peanut allergy using the modified Bioskin peanut patch. We have 86 sites across the US, Canada, Europe, the UK, and Australia. The study is assessing the efficacy and safety of Bioskin 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 BBV to get to this point.

Speaker Change: 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 program.

Pharis Mohideen: First, let's start with Vitesse. If you recall, this is a 600-patient study in 4- to 7-year-olds with peanut allergies using the modified Bioskin peanut pack. We have 86 sites across the U.S., Canada, Europe, the U.K., and Australia. The study is assessing the efficacy and safety of vascaine 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 number, but they are incredibly diligent and never fail to engage our multiple stakeholders at medical conferences.

Speaker Change: [inaudible]

Pharis Mohideen: Thank you, Danielle.

Speaker Change: First, let's start with Vitesse.

Speaker Change: If you recall, this is a 600-patient study in 4- to 7-year-olds with peanut allergy using the modified Bioskin peanut patch.

Speaker Change: We have 86 sites across the U.S., Canada, Europe , U.K., and Australia.

Speaker Change: The study is assessing the efficacy and safety of Bioskin peanut over the course of 12 months of treatment.

Speaker Change: I'm really pleased with the progress that we have made.

Speaker Change: The test has been a company-wide priority and it's taken a coordinated effort within DBV to get to this point.

Pharis Mohideen: 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 do 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.

Speaker Change: 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.

Pharis Mohideen: And, of course, our investigators and their staff do a fantastic job, and we really appreciate the support that we have received from patient advocacy groups and the academic society. I must also thank our study participants, the parents, caregivers, and patients, for their tremendous contribution. As we said in the press release, we anticipate to close recruitment by the end of the third quarter of this year.

Speaker Change: And, of course, our investigators and their staff do a fantastic job.

Speaker Change: And we really appreciate the support that we have received from the patient advocacy groups and the academic societies.

Speaker Change: I must also thank our study participants.

Speaker Change: the parents, caregivers, and subjects for their tremendous contributions.

Speaker Change: As we said in the press release, we anticipate to close recruitment by the end of the third quarter of this year.

Pharis Mohideen: We estimate that top-line results will 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 toddler safety protocol to the FDA in November of 2023. The agency responded with comments in March of this year.

Speaker Change: We estimate that top-line results would follow approximately 12 months after the last patient is screened.

Pharis Mohideen: We will certainly provide more detailed updates along the way.

Speaker Change: We will certainly provide more detailed updates along the way.

Pharis Mohideen: 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 toddler 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 patchware time experience, including help prescribers would advise parents and caregivers to manage day-to-day variability in patchware time.

Speaker Change: Let's move now to the status of the Comfort Toddlers Supplemental Safety Study Protocol.

Speaker Change: The FDA asked us to do a supplemental safety study in the 1- to 3-year-old patient population to add to the epitope safety database in this age group.

Speaker Change: Following a type C protocol meeting, we submitted the toddler safety protocol to the FDA in November of 2023.

Pharis Mohideen: Since then, DBV and FDA have been engaged in ongoing dialogue. These exchanges largely focused on patched wartime experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patched wartime. 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 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.

Speaker Change: The agency responded with comments in March of this year.

Speaker Change: Since then, DBV and FDA have been engaged in ongoing dialogue.

Speaker Change: These exchanges largely focused on patched wartime experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patched wartime.

Pharis Mohideen: On June 28, DBV submitted a proposed draft labeling approach with comprehensive supportive data and analysis intended to address the agency's concerns related to patchware time experience. We are now waiting for the FDA's feedback on this labeling proposal.

Speaker Change: 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.

Speaker Change: We are now waiting for the FDA's feedback on this labeling proposal.

Pharis Mohideen: 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 Pena treatment arm. We call the two groups the Label Inn and Label Out subjects. The baseline immunological characteristics of the Label Inn and Label Out subjects, such as peanut-specific IgE, skin-prick test, and eliciting dose, are similar.

Speaker Change: Let me explain the labeling proposal that we submitted to the FDA.

Speaker Change: The agency's questions, we believe, are best answered with the data from our pivotal trial epitope.

Speaker Change: We are still in discussion with the agency and awaiting feedback, but I can give you an overview of the concept.

Pharis Mohideen: Based on our analysis of the epitope data, we have identified two groups within the Viaskin peanut treatment arm. We call these 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 per test, and eliciting dose are similar. Thus, there is clearly a difference in the sensitivity to the locally applied peanut allergen that drives differences in patch wear time experience.

Speaker Change: Based on our analysis of the epitope data, we have identified two groups within the Bioskin peanut treatment arm.

Speaker Change: We call the two groups the Label In and Label Out subjects.

Speaker Change: The baseline immunological characteristics of the label-in and label-out subjects

Speaker Change: such as peanut-specific IgE, skin perk test, and eliciting dose are similar.

Pharis Mohideen: So there is clearly a difference in the sensitivity to the locally applied peanut allergy and that drive differences in patchware 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 patchware time experience during the first 90 days on treatment. Subjects that are very likely to have a robust efficacy response are called Label Inn.

Speaker Change: So there is clearly a difference in the sensitivity to the locally applied peanut allergen that drive differences in patch wear time experience.

Pharis Mohideen: 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 subgroups of 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 wartime experience during the first 90 days on treatment.

Speaker Change: This is what we refer to as differences in immune physiology in the press release.

Speaker Change: Within the first 90 days on treatment, it is possible to identify and separate subjects.

Speaker Change: and to those that are very likely to have a robust efficacy response.

Speaker Change: relative to those who are less likely to have a robust efficacy response.

Speaker Change: All of this can be done with just a patch wartime experience during the first 90 days on treatment.

Pharis Mohideen: 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 Bioskin peanut treatment. Alternative, Subjects that are less likely to have a robust efficacy response are called labeled out, and the proposed prescribing information would recommend a shared decision-making process between the health care provider and the parent or caregiver to determine if treatment should be discontinued. In other words, for subjects identified as Label L, the proposed label indicates that clinical efficacy is less likely, and discontinuation of treatment should be discussed.

Speaker Change: Subjects that are very likely to have a robust efficacy response are called label-in.

Pharis Mohideen: The proposed prescribing information, the label, would recommend that these subjects continue via skin 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 a skin peanut is approved, we believe this labeling proposal would give prescribers a pragmatic, data-driven way to discuss and provide guidance on patchware time experience.

Speaker Change: The proposed prescribing information, the label, would recommend that these subjects continue Bioskin peanut treatment.

Speaker Change: Alternatively,

Speaker Change: Subjects that are less likely to have a robust efficacy response are called labeled out.

Speaker Change: and the proposed prescribing information would recommend a shared decision-making process between the health care provider and the parent or caregiver to determine if treatment should be discontinued.

Speaker Change: 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.

Pharis Mohideen: If Pfizer's campaign is approved, we believe this labeling proposal would give prescribers a pragmatic, data-driven way to discuss and provide guidance on patch wartime experience for parents and caregivers. At this point, I'd like to invite Virginie to cover financial highlights.

Speaker Change: If Fireskin 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 and patient care. For more information, visit www.farskinpeanut.com.

Pharis Mohideen: to parents and caregivers.

Rajanie: At this point, I'd like to invite Rajanie to cover financial highlights. Thank you very much, Pharis. We'll now briefly review financial highlights for the first semester of 2024. There are two highlights I would like to elaborate on. I'll cash from the way and I'll pee now in particular operating expense. For number one, we close H1 with 66.2 million of cash on hand. And our cash run will now take us into the first quarter of 2025, which is an extension from prior communication where our cash run will be sufficient to fund operations until 2024. This extension is due to cost saving measures we have implemented and that we will continue to drive.

Virginie Simone Jeanine Boucinha: Thank you very much, Pharis. So we'll now briefly review the financial highlights for the first semester of 2024. And I have two highlights I would like to elaborate on, our cash runaway and our P&L, in particular our operating expenses. So number one, we closed H1 with $66.2 million of cash on hand. And our cash runway now takes us into the first quarter of 2025, which is an extension from prior communication where our cash runway was sufficient to fund operations until 2024. This extension is due to cost-saving measures we have implemented and that we will continue to drive.

Speaker Change: to parents and caregivers.

Speaker Change: At this point, I'd like to invite Virginie to cover financial highlights.

Virginie Simone Jeanine Boucinha: Thank you very much Pharis. So we'll now briefly review financial highlights for the first semester of 2024. And I have two highlights I would like to elaborate on.

Virginie Simone Jeanine Boucinha: Our cash runaway, and our P&L, in particular, our operating expense.

Virginie Simone Jeanine Boucinha: So, number one.

Virginie Simone Jeanine Boucinha: We closed H1 with $66.2 million of cash on hand. And our cash runway now takes us into the first quarter of 2025, which is an extension from prior communication, where our cash runway was sufficient to fund operations until 2024.

Virginie Simone Jeanine Boucinha: This extension is due to cost-saving measures we have implemented and that we will continue to drive.

Rajanie: There's another point I would like to highlight as we consider cash consumption in H1 of 2024. In the first semester, cash choosing operations total 70 million dollars, largely for ongoing clinical trials and for CMC and regulatory activities. It is important to note that H1 cash consumption includes 24 million dollars of non-recurring costs, such as comfort studies per their cost, move projects, supply chain activities.

Virginie Simone Jeanine Boucinha: There's another point I would like to highlight as we consider cash consumption in H1 of 2020. In the first semester, cash-through-the-in operations total $17 million, largely for ongoing clinical trials and for CMC and regulatory activities. But it's important to note that H1 cash consumption includes $24 million of non-recurring costs, such as comfort study startup costs, move projects, and supply chain activities. I will now elaborate briefly on our financials in terms of Q&A.

Virginie Simone Jeanine Boucinha: There's another point I would like to highlight as we consider cash consumption in H1 of 2024.

Virginie Simone Jeanine Boucinha: In the first semester, cash choose-in operations total $70 million, largely for ongoing clinical trials and for CMC and regulatory activities.

Virginie Simone Jeanine Boucinha: It is important to note that H1 Cash Consumption includes $24 million of non-recurring costs such as comfort studies, startup costs, moves, projects, supply chain activities.

Rajanie: I will now elaborate briefly on our financials in terms of K&R. Our operating income amounts to 2.6 million dollars. Further, semester, it is now exclusively composed of the research tax credit, the CIF French. Following the termination of the collaboration agreements with Nestlé Health Sciences. Operating expenses total 65 million dollars; that's close 28% on last year, but it is driven by what really matters. That's why it's keeping a clinical and CMC activities. And again, a third of it are known recurring expenses. So for this semester, we will connect a loss of 60.59 million dollars. So I'd like to reiterate that we continue to maximize the efficiency of our spend and remain highly disciplined in our cash management.

Speaker Change: I will now elaborate briefly on our financials in terms of P&L.

Virginie Simone Jeanine Boucinha: 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 Science. Operating expenses total $65 million. That's plus 28 percent on last year, but it is driven by what really matters. That's via skin peanut clinical and CMC activity.

Speaker Change: 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.

Speaker Change: Operating expenses total $65 million. That's plus 28% on last year, but it is driven by what really matters. That's Viacom Clinical and CMC activities.

Virginie Simone Jeanine Boucinha: And again, a third of it is non-recurring use cases. So for this semester, we'll have 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.

Speaker Change: And again, a third of it are non-recurring expenses.

Speaker Change: So for this semester, we book a net loss of $60.5 million.

Speaker Change: So I'd like to reiterate that we continue to maximize the efficiency of our spend and remain highly disciplined in our cash management.

Daniel TASS: That concludes the financial overview, and I'll turn the call back to Daniel for closing remarks. Daniel.

Speaker Change: That concludes the financial overview, and I'll turn the call back to Daniel for closing remarks. Daniel?

Daniel TASS: Thank you, Daniel.

Daniel TASS: Mr. Virginia, before we need to call for your questions, I would like to take a moment to recap our anticipated milestones are made of 2024, which is a critical year for DBV. So first, by the end of the third quarter, we're reiterating that we anticipate completing enrollment in our ongoing CIFS, CIFC trial in children age 4 to 7 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 analysis.

Daniel Tassé: Before we need a call for your questions, I would like to take a moment to recap. Our anticipated milestones are 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 Phase III FQC 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 ethics.

Daniel Tassé: Merci Virginie.

Daniel Tassé: Before we need a call for your questions, I would like to take a moment to recap.

Speaker Change: Our anticipated milestones for the remainder of 2024, which is a critical year for DBV.

Speaker Change: So first, by the end of the third quarter, reiterating that we anticipate completing enrollment in our ongoing FITESC Phase III FQC trial in children aged four to seven years of age. And obviously, that's something that we will communicate once that's done.

Speaker Change: Secondly,

Speaker Change: We believe that DBV's proposed labeling approach

Daniel TASS: And data from epitope importantly, now wish to add that on April 29th, the Office of Vaccine Research and Review, which is known as OVR, which is the regulatory division within FDA that has the responsibility for bias and peanuts stated. that non-COVID-related backlogs, so 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 as I was so encouraged by that.

Speaker Change: is a pragmatic solution backed with robust analyses and data from Epidope.

Daniel Tassé: Importantly, and I wish to add, that on April 29th, the Office of Vaccine Research and Review, which is known as OVRR, which is the regulatory division within the FDA that has responsibility for via skin peanut, stated that non-COVID-related backlogs, so 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 research.

Speaker Change: Importantly, and I wish to add...

Speaker Change: that on April 29th, the Office of Vaccine Research and Review, which is known as OVRR, which is the regulatory division within the FDA that has responsibility for Viascaine peanut, stated

Speaker Change: that non-COVID-related backlogs of products such as ours were behind them now and that the agency would have more bandwidth for interaction with sponsors.

Speaker Change: And we are seeing that firsthand in our interactions with the agency in the last few months for both C&C questions as well as clinical-related questions, and it's always super encouraged by that.

Daniel Tassé: So it's always super encouraging, and later this year, we anticipate having the Year 3 results from our ongoing open label extension epitope, our successful phase 3 trial in toddlers. Recall that we saw further and significant improvements across all FQC parameters in desensitization in Year 2. We look forward to sharing with you later this year the Year 3 results, as well as the publication of the Year 2 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.

Daniel TASS: And later this year, we anticipate having the year three results from our ongoing open label extension episode, our successful phase suite trial and toddlers. Recall that we had so further statistical, further and significant improvements across all FSC 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.

Speaker Change: And later this year, we anticipate having the Year 3 results from our ongoing Open Label Extension epitope.

Speaker Change: Our successful phase 3 trial in toddlers. Recall that we had saw further statistical

Speaker Change: further and significant improvements across all FQC parameters in desensitization year 2. We look forward to sharing with you later this year the year 3 results.

Speaker Change: as well as the publication of the Year 2 results of the Open Label Extension in a medical journal.

Daniel TASS: With that, I want to thank everyone on the phone and webcasts for joining us today.

Operator: I will now ask Pharis Mohideen if there is any need to join me for the Q&A. At this time, we will conduct the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad now. You will be placed in the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, please press star one on your phone now.

Speaker Change: 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.

Operator: At this time, we will conduct the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad now. You'll be placed in the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, please press star 1 on your phone now. And our first question will come from John Wolleben with Citizens JMP.

Speaker Change: At this time, we will conduct the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad now. You'll be placed into the queue in the order received.

Speaker Change: Please be prepared to ask your question when prompted.

Speaker Change: Once again, if you have a question, please press star 1 on your phone now.

John Wallaban: And our first question will come from John Wallaban with Citizens JMP. Hey, good afternoon. Thanks for the update and taking the question. Maybe just one quick clarification on the label and label out, and then I follow up on that. When you say patch, where 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?

Speaker Change: And our first question will come from John Wolleben with Citizens JMP.

Jonathan Wolleben: Hey, good afternoon. Thanks for the update and taking the question. 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?

Jonathan Wolleben: Hey, good afternoon. Thanks for the update and taking the questions.

Jonathan Wolleben: 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?

Daniel Tassé: Important question, Jonathan. Thanks for asking. 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 next. 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 who will be best responders, in a nutshell. Pharis, is that a good

Pharis Mohideen: And important question, John, thanks for asking. 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, where time experience measured in hours of wear, varies in some patients. And that's the data that is rich; identify patients will be best responders in a nutshell. Pharis is a good way to put it. Yeah, that's a good way, Danielle. The other way I like to think about it, Jonathan, is it 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.

Speaker Change: 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.

Speaker Change: Whether 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.

Speaker Change: And that's the data that is rich to identify patients who will be best responders, in a nutshell.

Pharis Mohideen: Yeah, 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, you know, tolerability, itching, what kind of experience did they have? Was it difficult to wear it all day long, or was it easy?

Speaker Change: Pharis, is that a good way to put it?

Pharis Mohideen: Yeah, that's a good way, Daniel. The other way I like to think about it, Jonathan, is it's kind of like...

Jonathan Wolleben: holistic experience right so not just

Speaker Change: 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, you know, tolerability, itching, what kind of experience did they have? Was it difficult to

Pharis Mohideen: It's the individual sensitivity, you know, tolerability itching. What kind of experience did they have? Was it difficult to wear it all day long, or was it easy? You know, 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 Danielle 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?

Speaker Change: There were all day long or was it easy, you know, 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

Pharis Mohideen: You know, 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?

Daniel Tassé: You can look at average daily work 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?

Pharis Mohideen: Yeah, well, does that make it harder to quantify them, though, than a simple number? No, not necessarily. It's kind of the opposite.

Pharis Mohideen: Yeah, well, does that make it hard to quantify them, though? No, no, 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, with all of that data, you can get a pretty good sense of the type of experience the patients have in. 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 sets that we have on them.

Speaker Change: Yeah, well, does that make it harder to quantify them, though, than a simple number? 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.

Pharis Mohideen: 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 is 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 idea of these patients. And there's really quite a clear differentiation between those who are labeled in and labeled out based on this whole accumulated data set that we have on them.

Speaker Change: And with all of that data, you can get a pretty good sense of.

Speaker Change: 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...

Speaker Change: Quite a clear differentiation between those who are labeled in and labeled out based on this whole accumulated data set that we have on them.

Pharis Mohideen: Got it. Okay. And then you guys said there's an association between a robust clinical efficacy response. I'm wondering if you could, you know, put some parameters around what you define as a robust response.

Pharis Mohideen: 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 labeled "label-in" or "label-out" based on this criteria.

Speaker Change: 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-in, label-out based on this criteria?

Pharis Mohideen: And then what percentage of the epitope patients were labeled and labeled out based on this criteria?

Pharis Mohideen: Does anyone want to take it, or do you want me to take it?

Pharis Mohideen: Yeah, I can, I can take it.

Pharis Mohideen: Yeah, I can. No, I can't take it.

Pharis Mohideen: Yeah, so at this point, because we're still in dialogue with the FDA, we're, 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.

Speaker Change: Do you guys want to take it or do you want me to take it? Yeah, I can take it. Yeah, so at this point, because we're still in dialogue with the FDA, we're...

Pharis Mohideen: Yeah, so at this point, because we're still in dialogue with the FDA, 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 there is a pretty good separation between the two in terms of the size of those who are labeled in versus those who are labeled out.

Speaker Change: 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.

Speaker Change: and it is a

Speaker Change: 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

Pharis Mohideen: I know that's kind of vague, but at this point, until we have a final agreement with the FDA and have wrestled this down, it is.

Pharis Mohideen: But at this point, until we have final, you know, agreement with the FDA and have wrestled this down, it's probably not the right time to discuss it. But obviously, as we move forward, we'll present all of this in a public fashion. Fair enough.

Speaker Change: But at this point, until we have final, you know, agreement with the FDA and have wrestled this down, it's probably not the right time to discuss it. But obviously, as we move forward, we'll present all of this in a public fashion.

Pharis Mohideen: It's not the right time to discuss it, but obviously, as we move forward, we'll present all of this in a public fashion. There's a reference point I would add here, Jonathan, if I could.

Pharis Mohideen: There's a reference point I would add here, Jonathan, if I may. We have 67% overall response rates. Obviously, the label ends would have a better response rate than that by definitions. 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.

Daniel Tassé: We have a 67% overall response rate, so obviously, the label-ins would have a better response rate than that by definition. It's a traditional enrichment strategy here, 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.

Speaker Change: There's a reference point I would add here, Jonathan, if I may. We have 67% overall response rate, so obviously the label ends would have a better response rate than that.

Speaker Change: By definition, it's a traditional enrichment strategy here, 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.

Jonathan Wolleben: Got it. And one last one for me. Update on comfort children. You guys don't seem to have any expectations for feedback timing there, it doesn't seem. Wondering, you know, do you think that any progress with comfort toddlers would help with comfort children, or are there different issues and feedback from FDA there?

Pharis Mohideen: And one last one from me: update on comfort children. You guys don't have any expectations for feedback timing there. It doesn't seem wondering, you know, do you think that any progress with comfort toddlers would help with comfort children or their different issues and feedback from FDA there?

Jonathan Wolleben: Got it. And one last one from me, update on Comfort Children, you guys.

Speaker Change: Don't have any expectations for feedback timing there, it doesn't seem. Wondering, you know, do you think that any progress with comfort toddlers would help with comfort children, or are there different issues and feedback from FDA there?

Pharis Mohideen: Yeah, I'll take that one, Faris. Okay. The two, the two were intertwined. The ability to get to the right protocol designed for comfort and 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 to three years. Got it. Okay. Thanks again for taking the questions. Please. Thank you. And once again, if you would like to ask a question, please press star one on your phone now.

Pharis Mohideen: I'll take that one, Pharis. The two are intertwined. The ability to get to the right protocol design for comfort in toddlers was an element, obviously, of comfort in 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 to three-year-olds. Okay.

Speaker Change: I'll take that one, Pharis. The two are intertwined. The ability to get to the right

Jonathan Wolleben: Got it. Okay. Thanks again for taking the question. Please. Thank you. And once again, if you would like to ask...

Speaker Change: Protocol Designed for

Pharis Mohideen: Comfort in 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 to three year olds.

Pharis Mohideen: Got it. Okay. Thanks again for taking the questions.

Operator: And once again, if you would like to ask a question, please press star 1 on your phone now. And it appears there are no further questions. Mr. Tassi, I'll turn the conference back to you.

Daniel Tassé: I'm not on mute. I'm not.

Speaker Change: Please. Thank you.

Speaker Change: And once again, if you would like to ask a question, please press star 1 on your phone now.

Operator: And it appears there are no further questions.

Daniel TASS: Mr. Tassie, I'll turn the conference back to you. I'm not on mute; I'm not.

Speaker Change: And it appears there are no further questions. Mr. Tassi, I'll turn the conference back to you.

Daniel Tassé: Well, that concludes our call for this afternoon. Again, thank you. I look forward to the 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.

Daniel TASS: But that concludes our call for this afternoon. Again, thank you. We are pleased with our progress for the first half of the year. We're forward to achievement of the additional value creating milestones that I describe this year and next. As always, we will keep you posted on progress.

Tassi: 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.

Speaker Change: I 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.

Operator: Now, I wish you all a very good evening.

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

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

Speaker Change: And this concludes today's conference call. Thank you for attending.

Operator: The host has ended this call. Goodbye.

Operator: The host has ended this call.

Operator: Goodbye.