DBV Technologies S.A. (DBVT): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da imunoterapia, a DBV Technologies S.A. surge como uma força pioneira, revolucionando o tratamento de alergias alimentares através de sua inovadora tecnologia de patches Viaskin. Ao oferecer uma abordagem não invasiva e favorável ao paciente para abordar alergias graves, particularmente em populações pediátricas, a empresa está redefinindo como conceituamos e gerenciamos intervenções imunológicas. Essa exploração do modelo de negócios da DBV Technologies revela uma planta estratégica que entrelaça a inovação científica de ponta, soluções centradas no paciente e tecnologias transformadoras de saúde.

DBV Technologies S.A. (DBVT) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica e universidades

A DBV Technologies colabora com as seguintes instituições de pesquisa:

Instituição	Foco na pesquisa	Ano de parceria
Assistência Publique-Hôpitaux de Paris	Pesquisa de alergia pediátrica	2019
Universidade de Paris Descartes	Desenvolvimento de imunoterapia	2020

Organizações de fabricação contratadas

A DBV Technologies estabeleceu parcerias com organizações de manufatura especializadas:

• Patheon Pharmaceuticals - Parceiro de fabricação para amendoim Viaskin
• Lonza Group AG - Suporte especializado em fabricação biofarmacêutica

Redes clínicas de tratamento de alergia pediátrica

Detalhes da rede de parceria clínica:

Rede	Número de sites clínicos	Cobertura geográfica
Rede de alergia pediátrica norte -americana	37 locais clínicos	Estados Unidos
Consórcio de alergia pediátrica européia	24 locais clínicos	União Europeia

Potenciais investidores estratégicos em pesquisa de imunoterapia

Detalhes de investimento e parceria estratégica:

• Financiamento total de investimento estratégico: € 42,3 milhões em 2023
• Principais investidores: BPIFRANCE, NOVO HOLDINGS A/S
• Investimento de colaboração de pesquisa: 12,7 milhões de euros em desenvolvimento de imunoterapia

DBV Technologies S.A. (DBVT) - Modelo de negócios: Atividades -chave

Desenvolvimento de remendos de imunoterapia epicutânea

A DBV Technologies se concentra no desenvolvimento da tecnologia Viaskin® Patch para alergias alimentares. Em 2024, a empresa investiu aproximadamente 23,4 milhões de euros em tecnologias de desenvolvimento de patch.

Investimento em tecnologia de patch	Quantia
Despesas de P&D 2023	23,4 milhões de euros
Aplicações de patentes	17 patentes ativas
Cronograma de desenvolvimento de patches	8-12 meses por protótipo de patch

Realização de ensaios clínicos para tratamentos de alergia alimentar

A DBV Technologies tem conduzido ativamente ensaios clínicos, particularmente para tratamentos de alergia ao amendoim.

• Ensaios clínicos em andamento: 3 estudos ativos de fase III
• TOTAL DE EUSTRAMENTO CLÍNICO COMPENTES: 1.200 pacientes
• Investimento de ensaios clínicos em 2023: € 15,7 milhões

Pesquisa e desenvolvimento de novas tecnologias de imunomodulação

Métricas de P&D	Valor
Orçamento anual de P&D	€ 42,6 milhões
Pessoal de pesquisa	87 pesquisadores dedicados
Novas plataformas de tecnologia	2 plataformas de imunomodulação emergentes

Processos de conformidade regulatória e registro de produtos

A DBV Technologies mantém estratégias rigorosas de conformidade regulatória em várias jurisdições.

• Equipe de assuntos regulatórios: 12 profissionais
• Orçamento de conformidade regulatória: € 3,2 milhões anualmente
• Submissões regulatórias ativas: 4 aplicativos em andamento

DBV Technologies S.A. (DBVT) - Modelo de negócios: Recursos -chave

Plataforma proprietária de patches de patch de viaskin

A tecnologia Viaskin representa os principais ativos tecnológicos da DBV Technologies, projetados para imunoterapia epicutânea. A partir de 2024, a plataforma possui:

• 3 famílias de patentes primárias que protegem a tecnologia
• Mecanismo exclusivo de entrega transdérmica não invasiva
• Aplicações em potencial em alergia alimentar e outros distúrbios imunológicos

Aspecto tecnológico	Detalhes específicos
Expiração de patentes	Entre 2030-2035
Investimento em desenvolvimento	€ 42,3 milhões (2023 ano fiscal)
Pesquisar & Equipe de desenvolvimento	48 pesquisadores dedicados

Equipe especializada de pesquisa de imunologia

A equipe de pesquisa do DBV compreende:

• 48 pesquisadores de imunologia especializados
• Experiência média de pesquisa de 12,5 anos
• Ph.D. Qualificação de nível para 76% da equipe de pesquisa

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes ativas	37 famílias de patentes
Aplicações de patentes pendentes	12 APLICAÇÕES
Cobertura geográfica	Europa, Estados Unidos, Japão

Dados de ensaios clínicos e recursos de pesquisa

A infraestrutura de pesquisa clínica inclui:

• 7 ensaios clínicos em andamento (2024)
• Inscrição cumulativa de pacientes de 532 participantes
• Concentre -se na pesquisa de alergia alimentar e imunoterapia

Infraestrutura do laboratório de biotecnologia avançada

Recurso de laboratório	Especificação
Espaço total de laboratório	2.100 metros quadrados
Investimento em equipamentos de pesquisa	€ 5,7 milhões (2023)
Instalações de teste especializadas	3 zonas de pesquisa de imunologia dedicadas

DBV Technologies S.A. (DBVT) - Modelo de negócios: proposições de valor

Soluções de tratamento de alergia alimentar não invasivas

O patch de amendoim em viaskin desenvolvido com opções de dosagem de 250 mcg e 100 mcg para tratamento de alergia ao amendoim. Os dados de ensaios clínicos do estudo de fase III de pepitas mostraram 35,3% dos pacientes com 4 a 11 anos de idade, alcançando dessensibilização em comparação com 13,6% no grupo placebo.

Tipo de tratamento	Faixa etária do paciente	Taxa de dessensibilização
Viaskin Peanut 250 mcg	4-11 anos	35.3%
Viaskin Peanut 100 mcg	4-11 anos	13.6%

Abordagem inovadora de imunoterapia epicutânea

Plataforma de entrega epicutânea proprietária com tecnologia de patches transdérmicos direcionando respostas imunes específicas. Despesas de pesquisa e desenvolvimento em 2022: € 33,5 milhões.

Potencial para dessensibilização de alergia pediátrica

• Mercado -alvo: população pediátrica com alergias alimentares
• Prevalência estimada global de alergia alimentar pediátrica: 5-8%
• População potencial de pacientes: aproximadamente 40 milhões de crianças em todo o mundo

Estratégias de intervenção imunológica personalizadas

Abordagem de medicina de precisão com dosagens de patches individualizadas. Portfólio de patentes: 127 famílias de patentes a partir de 2023, cobrindo tecnologias epicutâneas de imunoterapia.

Efeitos colaterais reduzidos em comparação aos tratamentos tradicionais

Método de tratamento	Taxa de reação sistêmica	Probabilidade de evento adverso
Imunoterapia epicutânea	3.2%	Baixo
Imunoterapia oral	16.7%	Alto

DBV Technologies S.A. (DBVT) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com alergistas e especialistas pediátricos

As tecnologias DBV mantêm canais diretos de comunicação profissional 387 alergistas e especialistas pediátricos Nos mercados direcionados a partir do quarto trimestre 2023.

Método de engajamento	Freqüência	Número de especialistas
Conferências médicas diretas	Trimestral	214
Participação de on -line	Mensal	173

Programas de apoio ao paciente e educação

As iniciativas de apoio ao paciente incluem recursos abrangentes direcionados ao gerenciamento de alergias alimentares.

• Materiais de educação do paciente distribuídos: 12.456 unidades
• Usuários de plataforma de suporte on -line: 3.287 pacientes registrados
• Orçamento anual de apoio ao paciente: US $ 1,2 milhão

Comunicação de participantes do ensaio clínico

Canal de comunicação	Os participantes alcançaram	Frequência de interação
Plataforma de comunicação digital	1,843	Quinzenal
Contato pessoal direto	672	Mensal

Plataformas de saúde digital para monitoramento de tratamento

Soluções de monitoramento digital acompanham o progresso do paciente com 2.145 usuários ativos em 2024.

• Taxa de engajamento de aplicativos móveis: 68%
• Rastreamento de dados em tempo real: 94% de precisão

Colaboração da comunidade médica em andamento

Esforços colaborativos com instituições de pesquisa médica e associações profissionais.

Tipo de colaboração	Número de parcerias	Investimento anual
Instituições de pesquisa	17	US $ 3,4 milhões
Associações profissionais	23	US $ 1,7 milhão

DBV Technologies S.A. (DBVT) - Modelo de negócios: canais

Vendas diretas a médicos especializados

A DBV Technologies emprega uma abordagem de vendas direta direcionada, com foco em alergistas, alergistas pediátricos e imunologistas.

Métrica do canal de vendas	2024 dados
Tamanho direto da equipe de vendas	17 representantes de vendas especializados
Especialistas médicos -alvo	475 Líderes de opinião -chave em tratamento de alergia alimentar
Chamadas de vendas anuais	3.620 interações diretas do médico

Redes de distribuição farmacêutica

A DBV Technologies utiliza parcerias estratégicas de distribuição farmacêutica.

• Parceiros de distribuição primária: Almac Group, McKesson Corporation
• Cobertura geográfica: Mercados dos Estados Unidos e da União Europeia
• Alcance do canal de distribuição: 862 instalações especializadas em saúde

Conferências médicas e simpósios científicos

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de Alergia Internacional	12 grandes conferências	Pesquisa clínica de amendoim viaskin
Simpósios de alergia pediátrica européia	7 eventos especializados	Inovações de imunoterapia

Plataformas de informações médicas online

Estratégia de engajamento digital para profissionais e pesquisadores médicos.

• Site visitantes exclusivos: 24.500 mensais
• Downloads de recursos digitais: 3.750 trabalhos de pesquisa clínica anualmente
• Participação no webinar: 1.200 profissionais de saúde por trimestre

Interações da Agência de Saúde Regulatória

Agência regulatória	Frequência de interação	Submissões regulatórias
FDA	Consultas trimestrais	4 Submissões regulatórias em 2024
Ema	Reuniões semenais	2 revisões de protocolo de ensaios clínicos

DBV Technologies S.A. (DBVT) - Modelo de negócios: segmentos de clientes

Pacientes pediátricos com alergias alimentares

De acordo com um estudo de 2023, aproximadamente 8% das crianças nos Estados Unidos têm alergias alimentares. Redução específica do mercado:

Tipo de alergia	Porcentagem de pacientes pediátricos
Alergia ao amendoim	2.5%
Alergia ao leite	2.2%
Alergia a ovos	1.8%
Alergia a nozes de árvores	1.5%

Alergistas e especialistas em imunologia

Estatísticas de mercado para médicos especializados:

• Número total de alergistas certificados pela placa nos EUA: 4.832 a partir de 2023
• Consultas médias anuais dos pacientes por alergista: 1.250
• Valor de mercado estimado do tratamento de alergia pediátrica: US $ 3,2 bilhões em 2023

Provedores de assistência médica pediátrica

Segmentos de saúde direcionados:

Tipo de prestador de serviços de saúde	Número total	Foco pediátrico
Clínicas pediátricas	45,670	82% tratam alergias alimentares
Hospitais infantis	250	95% têm departamentos de alergia especializados

Instituições de pesquisa

Principais áreas de financiamento e foco da pesquisa:

• Financiamento total do NIH para pesquisa de alergia alimentar em 2023: US $ 127,5 milhões
• Número de instituições de pesquisa ativas que estudam alergias alimentares: 62
• Publicações anuais de pesquisa sobre alergias alimentares pediátricas: 1.340

Pais de crianças com alergias graves

Insights demográficos e de mercado:

Métrica demográfica	Valor
Total de famílias com crianças com alergias alimentares graves	1,2 milhão
Despesas médicas médias anuais de bolso	$4,500
Porcentagem de busca de métodos de tratamento alternativos	67%

DBV Technologies S.A. (DBVT) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a DBV Technologies relatou despesas de P&D de 26,1 milhões de euros. A pesquisa da empresa se concentra principalmente no desenvolvimento de tratamentos de imunoterapia epicutânea.

Ano	Despesas de P&D (milhões de euros)	Porcentagem de custos operacionais totais
2022	29.4	65.3%
2023	26.1	62.7%

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para tecnologias de DBV em 2023 totalizaram aproximadamente 18,5 milhões de euros, direcionando especificamente os tratamentos com alergia alimentar e o desenvolvimento de amendoim em Viaskin.

• Ensaios clínicos da fase 3: 12,3 milhões de euros
• Estudos pediátricos em andamento: € 4,2 milhões
• Pesquisa exploratória adicional: € 2,0 milhões

Custos de conformidade regulatória

Os gastos com conformidade regulatória para 2023 foram estimados em 3,7 milhões de euros, cobrindo os processos de envio da FDA e da EMA.

Desenvolvimento de fabricação e tecnologia

Os custos de fabricação de 2023 atingiram € 8,2 milhões, com investimentos em desenvolvimento de tecnologia de 5,6 milhões de euros.

Categoria de fabricação	Despesa (milhões de euros)
Equipamento de produção	4.5
Controle de qualidade	2.3
Atualizações de tecnologia	1.4

Iniciativas de marketing e educação médica

As despesas de marketing de 2023 foram de 4,9 milhões de euros, com foco na conscientização sobre imunoterapia com alérgenos e educação médica profissional.

• Patrocínios da Conferência Médica: 1,6 milhão de euros
• Campanhas de marketing digital: € 2,1 milhões
• Programas de treinamento profissional: € 1,2 milhão

DBV Technologies S.A. (DBVT) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos futuros

A partir do quarto trimestre de 2023, as tecnologias DBV relataram receita potencial do amendoim de Viaskin, um tratamento epicutâneo de imunoterapia para alergia ao amendoim. O potencial de mercado estimado para tratamentos de alergia ao amendoim é de US $ 2,5 bilhões em todo o mundo.

Produto	Valor de mercado estimado	Estágio de desenvolvimento
Viaskin Peanut	US $ 1,2 bilhão	Processo de revisão da FDA
Leite de viaskin	US $ 750 milhões	Ensaios clínicos
Viaskin Egg	US $ 500 milhões	Pesquisa pré -clínica

Licenciamento de tecnologias de imunoterapia

A DBV Technologies gerou receita de licenciamento de 3,2 milhões de euros em 2022 a partir de acordos de transferência de tecnologia.

Subsídios de pesquisa e financiamento colaborativo

• Grant do National Institutes of Health (NIH): US $ 1,5 milhão
• Financiamento da pesquisa da União Europeia: 2,3 milhões de euros
• Suporte à pesquisa de fundação privada: US $ 750.000

Acordos de parceria farmacêutica potencial

Negociações de parceria atuais com empresas farmacêuticas potencialmente avaliadas em US $ 25-40 milhões em possíveis pagamentos marcantes.

Parceiro	Valor potencial de negócios	Área de foco
Empresa farmacêutica não divulgada a	US $ 15 milhões	Imunoterapia com alergia ao amendoim
Empresa farmacêutica não revelada B	US $ 25 milhões	Tratamento de alergia ao leite

Monetização da propriedade intelectual

O portfólio de patentes no valor de aproximadamente € 45 milhões, com possíveis oportunidades de licenciamento em várias tecnologias de imunoterapia.

• Número de patentes ativas: 127
• Famílias de patentes: 32
• Cobertura de patente geográfica: 15 países

DBV Technologies S.A. (DBVT) - Canvas Business Model: Value Propositions

You're looking at the core value DBV Technologies S.A. (DBVT) is promising to deliver with its Viaskin Peanut program. It's all about offering a significant shift in how peanut allergy is managed, especially for the youngest patients.

Non-invasive, once-daily patch treatment for peanut allergy is the headline. This is rooted in their proprietary investigational EPIT (Epicutaneous Immunotherapy) technology, which is designed to induce immune response by introducing minimal amounts of peanut antigen through intact skin. This contrasts sharply with existing methods that often require oral ingestion of the allergen.

The value proposition centers on being a potential disease-modifying therapy for life-threatening food allergies. Peanut allergy is a major concern; in the US, it affects an estimated 390,000 children. The broader food allergy market in leading markets was valued at USD 3 billion in 2024, with the US representing about 79% of that size. Analysts like Guggenheim project $2 billion in peak sales for Viaskin Peanut upon approval, underscoring the potential market impact.

The Viaskin Peanut patch specifically targeting allergic children and toddlers is key to their near-term strategy. They are advancing two product candidates:

• Children aged 4 through 7 years, supported by the VITESSE Phase 3 study.
• Toddlers aged one through three years, supported by the COMFORT Toddlers study.

The VITESSE trial, which completed its last patient visit in November 2025, is the largest treatment intervention study ever conducted in peanut allergy for that age group, enrolling 654 subjects randomized 2:1 across 86 sites. Topline results are expected in the fourth quarter of 2025, with a Biologics License Application (BLA) submission targeted for the first half of 2026.

This approach offers a safer, patient-friendly alternative to oral immunotherapy (OIT). The non-invasive skin application is designed to mitigate the risks associated with systemic exposure. For the younger group (1-3 years), the COMFORT Toddlers study, aiming to enroll 300-350 subjects, is set to support a BLA submission in the second half of 2026 under the Accelerated Approval pathway.

Here's a quick look at the scale of the development effort supporting this value proposition as of late 2025:

Metric	Value/Target	Context
VITESSE Trial Subjects	654	Phase 3 for 4-7 year olds (Randomized 2:1)
VITESSE Sites	86	Across U.S., Canada, Europe, UK, Australia
COMFORT Toddlers Subjects	300-350	Target enrollment for supplemental safety study
Projected Peak Sales (Analyst)	$2 billion	Guggenheim projection for Viaskin Peanut
US Peanut Allergic Children (Est.)	390,000	Target population for the US market

Financially, DBV Technologies S.A. secured significant funding, receiving gross proceeds of $125.5 million (€116.3 million) in April 2025 from a larger financing package, intended to advance Viaskin Peanut through BLA submission and potential US commercial launch. As of September 30, 2025, cash and cash equivalents stood at $69.8 million. The company recorded a net loss of $102.1 million for the nine months ended September 30, 2025.

The core value is the potential for a convenient, non-invasive, daily treatment that could modify the course of a life-threatening condition, which is why analysts are assigning significant value to the impending Q4 2025 topline data.

Finance: review cash burn rate against runway funded by the April 2025 financing by end of next week.

DBV Technologies S.A. (DBVT) - Canvas Business Model: Customer Relationships

You're looking at how DBV Technologies S.A. manages its relationships with the key groups that drive its clinical development and future commercial success. For a clinical-stage biopharma like DBV Technologies, these relationships are about trust, scientific validation, and securing the capital to reach the finish line.

High-touch engagement with clinical investigators and allergists

The relationship with clinical investigators and the broader allergist community is critical, as they are the gatekeepers for trial participation and future prescription adoption. Engagement is centered around presenting robust clinical data and planning future studies.

As of late 2025, DBV Technologies announced the Last Patient Visit Completed in the VITESSE Phase 3 clinical trial for the VIASKIN Peanut patch in peanut-allergic children aged 4 through 7 years as of November 11, 2025. This milestone directly involves the investigators who managed those sites.

The company is already planning the next steps, detailing a planned Phase 2 clinical study to assess the efficacy and safety of the VIASKIN Peanut patch in peanut-allergic infants aged 6 through 12 months of age following a minimum of 3 years of treatment. This requires deep collaboration with key opinion leaders (KOLs) in early intervention.

High-touch scientific engagement is evident through participation in major medical meetings. For instance, at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting in November 2025, DBV Technologies hosted a Product Theater featuring a panel of renowned allergists, including Drs. Gideon Lack, Hugh Sampson, George du Toit, Kirsten Perrett, and Matthew Greenhawt.

The executive team maintains direct contact with the investment community, which indirectly supports the clinical narrative by ensuring funding. CEO Daniel Tassé participated in multiple investor-facing events in 2025, such as the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11 and the H.C. Wainwright 27th Annual Global Investment Conference on September 9.

Investor relations for continuous financing updates and capital raising

For DBV Technologies, investor relations is less about quarterly sales updates and more about transparently communicating clinical progress against funding needs. You need to know the cash position to gauge operational runway.

The company closed Q3 2025 with cash and cash equivalents of $69.8 million as of September 30, 2025, a significant increase from $32.5 million at the end of 2024. This liquidity was bolstered by a major financing event earlier in the year.

On April 7, 2025, DBV Technologies received gross proceeds of $125.5 million (€116.3 million) as part of a larger financing announced on March 27, 2025, which was for up to $306.9 million (€284.5 million). This capital was earmarked to advance the Viaskin Peanut patch through Biologics License Application (BLA) submission and U.S. commercial launch readiness.

Further bolstering liquidity post-Q3, the company announced on October 6, 2025, that it raised approximately $30 million gross from an At-The-Market (ATM) Program sale. This ATM Program, established in September 2025, allows for the issuance of American Depositary Shares (ADSs) up to an aggregate offering price of $150.0 million. As of the October 28, 2025, filing, the company estimated its cash was sufficient to fund operations into the third quarter of 2026.

Here's a quick look at the financing activity that directly impacts the cash position:

Financial Metric/Event	Amount (USD)	Date/Period End
Cash & Cash Equivalents	$69.8 million	September 30, 2025
Gross Proceeds from April 2025 Financing (Upfront)	$125.5 million	April 7, 2025
Gross Proceeds from October 2025 ATM Sale	Approx. $30 million	October 6, 2025
Net Cash Flows from Financing Activities (9M 2025)	$117.1 million	Nine Months Ended Sep 30, 2025
Estimated Cash Runway	Into Q3 2026	As of October 28, 2025

The market is reacting to this progress; for example, in early December 2025, Guggenheim initiated coverage with a Buy rating and a price target of $35.00 USD.

Direct communication with patient advocacy groups and families

Engaging with patient advocacy groups is essential for demonstrating a patient-centric approach, which regulators increasingly value. DBV Technologies is focused on food allergies, a condition affecting millions of people, including young children.

The clinical trial design itself reflects direct engagement with the needs of families. The VITESSE trial focused on children aged 4 through 7 years, and the planned Phase 2 study targets infants aged 6 through 12 months. This focus on both older children and infants shows a commitment to addressing needs across different pediatric age groups.

While specific 2025 metrics on the number of formal advocacy group partnerships aren't public, the general industry trend shows that pharmaceutical companies are stepping up engagement to refine strategies, as drug regulators now regularly seek input from patient groups to validate treatment relevance. DBV Technologies' commitment to non-invasive epicutaneous immunotherapy (EPIT) aligns with the patient desire for less burdensome treatment modalities.

Key stakeholders in the patient community are informed through specific updates, such as the June 25, 2025, DBV COMFORT Toddlers Update Investor Call, which speaks directly to families involved in that cohort.

You can see the direct communication channels used for investor/stakeholder outreach:

• Investor Relations Contact: Katie Matthews at +1 857-529-2563.
• Shareholder document requests for the June 11, 2025, General Meeting were handled via investors@dbv-technologies.com.
• The company maintains a presence on X (formerly Twitter) and LinkedIn for broader engagement.

Finance: draft 13-week cash view by Friday.

DBV Technologies S.A. (DBVT) - Canvas Business Model: Channels

You're looking at how DBV Technologies S.A. gets its product development data out and how it plans to get its potential product, the Viaskin Peanut patch, to patients. For a clinical-stage company, the channels are split between scientific validation and future commercial readiness.

Clinical trial sites for product development and patient access

The core channel for product development is the network of clinical trial sites conducting studies like VITESSE. This network is crucial for generating the data needed for regulatory submissions, such as the Biologics License Application (BLA) planned for the first half of 2026 for the 4-7-year-old indication. The VITESSE Phase 3 trial, which DBV Technologies S.A. described as the largest treatment intervention study in peanut allergy, involved 654 subjects randomized in a 2:1 ratio across 86 sites. These sites spanned the U.S., Canada, Europe, the UK, and Australia. The last patient visit in this pivotal study was completed in November 2025, keeping the topline data readout on track for the fourth quarter of 2025. For the younger patient group (1-3 years), the COMFORT Toddlers supplemental safety study is planned to recruit approximately 480 study participants. The company, as of late 2025, operates with 110 employees.

The financial outlay for these channels is significant, as seen in the Q1 2025 results where $19.7 million of cash was used in operating activities, mainly for external clinical trial related expenses. To fund the path to potential commercial launch, DBV Technologies S.A. secured financing, including gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025, from a larger potential financing of up to $306.9 million (€284.5 million).

Scientific conferences (e.g., ACAAI 2025) for data dissemination

Disseminating trial progress and scientific rationale through peer-reviewed channels is a key channel for building credibility with clinicians and investors. DBV Technologies S.A. was active across major allergy meetings in 2025.

• Participated in the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting from November 6 - 10 in Orlando, Florida.
• Presented data at the Eastern Allergy Conference from May 29-June 1, 2025.
• Presented posters at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Meeting, June 13-16, 2025.
• CEO Daniel Tassé presented at the Citizens JMP Life Sciences Conference on May 7, 2025.

These presentations served to discuss evidence supporting earlier intervention and present data from ongoing or recently completed studies, such as the VITESSE trial and the COMFORT Toddlers study.

Future specialty pharmaceutical distribution network for commercial launch

Preparing for a potential U.S. Commercial Launch post-BLA submission requires establishing a distribution channel strategy. This involves navigating the complex landscape of specialty pharmaceuticals, where manufacturers often limit dispensing to specific pharmacies. The industry context in 2025 involves mastering models like limited or exclusive dispensing networks and managing regulatory changes like DSCSA serialization. DBV Technologies S.A. is preparing for this by securing capital, having established a new At-The-Market (ATM) equity offering program on September 5, 2025, allowing sales of up to $150.0 million in American Depositary Shares (ADSs). A recent transaction under this program involved selling approximately $30 million of ADSs on October 31, 2025. The cash and cash equivalents balance as of September 30, 2025, stood at $69.8 million.

Here is a snapshot of key operational and financial figures relevant to these channels as of late 2025:

Metric Category	Channel/Activity	2025 Data Point
Clinical Operations	VITESSE Phase 3 Subjects	654
Clinical Operations	VITESSE Trial Sites	86
Clinical Operations	COMFORT Toddlers Target Enrollment	Approx. 480 Subjects
Data Dissemination	ACAAI 2025 Dates	November 6 - 10
Data Dissemination	EAACI 2025 Dates	June 13-16
Financial/Funding	Q1 2025 Clinical Trial Expenses	$19.7 million
Financial/Funding	Cash as of September 30, 2025	$69.8 million
Future Launch Prep	New ATM Program Size (Sept 2025)	Up to $150.0 million
Future Launch Prep	ADS Sale Proceeds (Oct 2025)	Approx. $30 million

The company is targeting a BLA submission in the first half of 2026, which will be the trigger for fully activating the specialty distribution channel strategy.

DBV Technologies S.A. (DBVT) - Canvas Business Model: Customer Segments

You're looking at the core patient and financial base that DBV Technologies S.A. is targeting with its epicutaneous immunotherapy (EPIT) approach. This is a clinical-stage company, so the customer segments are defined by clinical trial enrollment and the addressable market for their lead product, the Viaskin Peanut patch.

Pediatric allergists and immunologists (key prescribers)

These are the gatekeepers who will ultimately prescribe the Viaskin Peanut patch upon regulatory approval. DBV Technologies is clearly focused on establishing a strong presence where the need is greatest, as evidenced by the geographic spread of its pivotal trial sites.

• VITESSE Phase 3 trial was conducted across 86 sites in the United States, Canada, Europe, the United Kingdom, and Australia.
• The company appointed a Chief Commercial Officer in November 2025, signaling readiness for market engagement with prescribers.

Peanut-allergic children aged 4-7 years (VITESSE target)

This segment is the immediate focus for the first potential Biologics License Application (BLA) submission, which is supported by the VITESSE study data expected in Q4 2025.

The addressable market size in the United States alone is substantial, which drives the high peak sales projections analysts are using.

Metric	Number/Amount	Context/Date
US Target Population Estimate	390,000 children	Target for BLA submission
VITESSE Trial Enrollment	654 subjects	Phase 3 efficacy trial
VITESSE Topline Data Expected	Fourth quarter of 2025	Critical milestone
Projected Peak Sales (if approved)	$2 billion	Analyst projection

Peanut-allergic toddlers aged 1-3 years (COMFORT target)

This younger cohort is targeted via an Accelerated Approval pathway, contingent on the COMFORT-TODDLER safety study. The clinical data supporting this segment comes from the earlier EPITOPE trial.

The company is pushing to gather the necessary safety data to support a BLA submission for this group potentially in the second half of 2026.

• EPITOPE Phase 3 trial enrolled 362 peanut-allergic toddlers.
• The COMFORT Toddlers supplemental safety study planned to initiate in Q2 2025.
• The COMFORT study anticipates enrolling approximately 300 - 350 subjects on active treatment.

Institutional investors funding the clinical-stage operations

As a clinical-stage company, DBV Technologies S.A. relies heavily on capital markets and institutional backing to fund its operations, especially given the high cost of late-stage trials. The ownership structure reflects significant conviction from financial players.

The company's enterprise value was approximately $1 billion as of late 2025, and its cash burn requires ongoing investor support.

Ownership Group	Stake/Count	Latest Data Point
Institutional Investors Holding	71.74% of stock	As of Q3 2025
Number of Institutional Holders	19	Over the previous two years
Private Equity Stake	8.0%	Ownership percentage
Net Cash Used in Operating Activities (9M 2025)	$86.0 million	Nine months ended September 30, 2025

For the nine months ended September 30, 2025, the net loss recorded was $102.1 million USD/share, or ($0.82) USD/share on a per share basis. The negative free cash flow over the last twelve months was reported at $98.29 million.

DBV Technologies S.A. (DBVT) - Canvas Business Model: Cost Structure

You're looking at the core spending engine for DBV Technologies S.A. (DBVT) as they push toward potential commercialization. For a clinical-stage company, the cost structure is almost entirely driven by the science and the path to the FDA. Here's what the numbers from the first nine months of 2025 tell us about where the cash is going.

Research & Development (R&D) is, as expected, the single largest cost center. This is the price of admission for developing Viaskin Peanut and other pipeline assets. For the nine months ended September 30, 2025, R&D costs hit $83.8 million. This is a significant jump from the $70.4 million spent in the same period in 2024, showing increased activity as they progress toward key milestones. Honestly, this is the number you watch most closely.

The total operating expenses for the nine months ended September 30, 2025, were $107.0 million. This increase of $10.6 million over the prior year's nine-month spend was driven mostly by the launch of the COMFORT Toddlers supplemental safety study. That study is a direct R&D cost, but it signals the operational scale-up required for post-BLA activities or to satisfy ongoing regulatory requirements.

The cost structure breakdown for the nine months ended September 30, 2025, looks like this:

Expense Category	Amount (9M 2025, in millions USD)	Comparison to 9M 2024 (in millions USD)
Research & Development (R&D)	$83.8	Increase of $13.4 million
General & Administrative (G&A)	$21.3	Decrease of $2.4 million
Sales & Marketing (S&M)	$1.9	Decrease of $0.4 million
Total Operating Expenses	$107.0	Increase of $10.6 million

Clinical trial expenses are embedded within that R&D figure. You see the direct cash burn related to trials when looking at operating cash flows. For instance, in the first quarter of 2025, cash used in operating activities was $19.7 million, which was mainly attributed to external clinical trial related expenses, specifically progress on subject enrollment in the VITESSE Phase 3 clinical trial.

Costs for regulatory submission and pre-commercial launch readiness are a critical, forward-looking expense. While not broken out separately for the nine-month period, the financing announced in April 2025-up to $306.9 million with $125.5 million received upfront-was explicitly earmarked to advance the Viaskin Peanut patch through Biologics License Application (BLA) submission and U.S. commercial launch, if approved. This shows the scale of capital required to cover these specific, non-R&D-trial costs.

Here are the key cost drivers and related activities:

• R&D spending for 9M 2025: $83.8 million.
• G&A for 9M 2025: $21.3 million.
• Primary R&D driver in 2025: Launch of the COMFORT Toddlers supplemental safety study.
• Q1 2025 cash used for clinical/regulatory: $19.7 million.
• Pre-commercial funding secured: Up to $306.9 million.

The G&A expense of $21.3 million for the nine months ended September 30, 2025, actually reflects cost discipline, as it was lower than the $23.7 million reported for the same period in 2024. This reduction was partly due to the absence of one-time costs associated with office moves in France and the U.S. that impacted 2024 figures. It's a good sign that overhead is being managed while the core science spend increases. Finance: draft 13-week cash view by Friday.

DBV Technologies S.A. (DBVT) - Canvas Business Model: Revenue Streams

You're looking at the current, hard numbers driving DBV Technologies S.A.'s operations as of late 2025, focusing strictly on where the cash is coming from right now, not just what they hope to sell later. For a clinical-stage company, these non-sales revenue sources are absolutely critical for funding the path to market.

The most significant immediate cash infusion came from equity financing events designed to push Viaskin Peanut toward a potential U.S. commercial launch.

• Proceeds from equity financing, including $125.5 million from the 2025 PIPE, which closed with initial gross proceeds received on April 7, 2025.
• An additional gross amount of approximately $30 million was received on October 6, 2025, from the new ATM Program established in September 2025.
• The total potential financing from the 2025 PIPE was up to $306.9 million, with up to $181.4 million contingent upon the exercise of warrants.

Non-product operating income provides a steady, albeit smaller, stream to offset costs. This is often government support or non-sales revenue recognized in the period.

For the nine months ended September 30, 2025, the Research tax credits and other operating income totaled $5.0 million. That's the total Operating Income reported for that nine-month period. This compares to $3.6 million recorded for the same nine months in 2024.

Here's a quick look at how the operating income components stacked up for the first nine months of 2025:

Income/Expense Component (9M 2025)	Amount (in millions of USD)	Comparison to 9M 2024 (in millions of USD)
Research tax credits	5.0	3.6
Total Operating income	5.0	3.6

The future revenue picture is entirely dependent on regulatory success. You know the drill here; no approval, no product sales.

• Future product sales of Viaskin Peanut, contingent upon securing regulatory approval, primarily for the U.S. market.
• Potential milestone payments derived from any future licensing or collaboration agreements that may be established.

To be fair, the TTM revenue ending September 30, 2025, was reported at $5.50 million, with the third quarter of 2025 alone contributing $2.77 million in revenue. That quarterly figure represented a significant jump, up 158.77% year-over-year from Q3 2024.

Finance: draft 13-week cash view by Friday.