DBV Technologies S.A. (DBVT): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje de inmunoterapia en rápida evolución, DBV Technologies S.A. surge como una fuerza pionera, revolucionando el tratamiento con alergia alimentaria a través de su innovadora tecnología Viaskin Patch. Al ofrecer un enfoque no invasivo y amigable para el paciente para abordar las alergias graves, particularmente en las poblaciones pediátricas, la compañía está redefiniendo cómo conceptualizamos y gestionamos las intervenciones inmunológicas. Esta exploración del lienzo de modelo de negocio de DBV Technologies revela un plan estratégico que entrelaza la innovación científica de vanguardia, las soluciones centradas en el paciente y las tecnologías de atención médica transformadora.

DBV Technologies S.A. (DBVT) - Modelo de negocio: asociaciones clave

Instituciones y universidades de investigación farmacéutica

DBV Technologies colabora con las siguientes instituciones de investigación:

Institución	Enfoque de investigación	Año de asociación
Asistencia Publique-Hôpitaux de Paris	Investigación de alergia pediátrica	2019
Universidad de París Descartes	Desarrollo de inmunoterapia	2020

Organizaciones de fabricación de contratos

DBV Technologies ha establecido asociaciones con organizaciones de fabricación especializadas:

• Patheon Pharmaceuticals - Socio de fabricación para Viaskin Peanut
• Lonza Group AG - Soporte de fabricación biofarmacéutica especializada

Redes clínicas de tratamiento de alergia pediátrica

Detalles de la red de asociación clínica:

Red	Número de sitios clínicos	Cobertura geográfica
Red de alergia pediátrica norteamericana	37 sitios clínicos	Estados Unidos
Consorcio de alergia pediátrica europea	24 sitios clínicos	unión Europea

Posibles inversores estratégicos en investigación de inmunoterapia

Detalles de inversión y asociación estratégica:

• Financiación total de la inversión estratégica: € 42.3 millones en 2023
• Inversores clave: Bpifrance, Novo Holdings A/S
• Inversión de colaboración de investigación: € 12.7 millones en desarrollo de inmunoterapia

DBV Technologies S.A. (DBVT) - Modelo de negocio: actividades clave

Desarrollo de parches de inmunoterapia epicutánea

DBV Technologies se centra en el desarrollo de la tecnología de parche Viaskin® para las alergias alimentarias. A partir de 2024, la compañía ha invertido aproximadamente 23,4 millones de euros en tecnologías de desarrollo de parches.

Inversión en tecnología de parche	Cantidad
Gasto de I + D 2023	23.4 millones de euros
Solicitudes de patentes	17 patentes activas
Línea de tiempo de desarrollo de parches	8-12 meses por prototipo de parche

Realización de ensayos clínicos para tratamientos de alergia a los alimentos

DBV Technologies ha estado realizando activamente ensayos clínicos, particularmente para los tratamientos de alergia al maní.

• Ensayos clínicos en curso: 3 estudios activos de fase III
• Participantes totales de ensayos clínicos: 1.200 pacientes
• Inversión en ensayos clínicos en 2023: € 15.7 millones

Investigación y desarrollo de nuevas tecnologías de inmunomodulación

Métricas de I + D	Valor
Presupuesto anual de I + D	42,6 millones de euros
Personal de investigación	87 investigadores dedicados
Nuevas plataformas tecnológicas	2 plataformas de inmunomodulación emergentes

Procesos de cumplimiento regulatorio y registro de productos

DBV Technologies mantiene rigurosas estrategias de cumplimiento regulatorio en múltiples jurisdicciones.

• Equipo de asuntos regulatorios: 12 profesionales
• Presupuesto de cumplimiento regulatorio: € 3.2 millones anuales
• Envíos regulatorios activos: 4 solicitudes en curso

DBV Technologies S.A. (DBVT) - Modelo de negocio: recursos clave

Plataforma de tecnología Viaskin Patch patentada

La tecnología Viaskin representa el activo tecnológico central de DBV Technologies, diseñado para inmunoterapia epicutánea. A partir de 2024, la plataforma tiene:

• 3 familias de patentes primarias que protegen la tecnología
• Mecanismo de entrega transdérmico no invasivo único
• Aplicaciones potenciales en alergia alimentaria y otros trastornos inmunológicos

Aspecto tecnológico	Detalles específicos
Expiración de la patente	Entre 2030-2035
Inversión de desarrollo	€ 42.3 millones (2023 año fiscal)
Investigación & Personal de desarrollo	48 investigadores dedicados

Equipo de investigación de inmunología especializada

El equipo de investigación de DBV comprende:

• 48 investigadores de inmunología especializada
• Experiencia de investigación promedio de 12.5 años
• Doctor en Filosofía. Calificación de nivel para el 76% del personal de investigación

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Patentes activas	37 familias de patentes
Aplicaciones de patentes pendientes	12 aplicaciones
Cobertura geográfica	Europa, Estados Unidos, Japón

Datos de ensayos clínicos y capacidades de investigación

La infraestructura de investigación clínica incluye:

• 7 ensayos clínicos en curso (2024)
• Inscripción acumulativa del paciente de 532 participantes
• Centrarse en la alergia alimentaria y la investigación de la inmunoterapia

Infraestructura de laboratorio de biotecnología avanzada

Recurso de laboratorio	Especificación
Espacio total de laboratorio	2.100 metros cuadrados
Inversión en equipos de investigación	5,7 millones de euros (2023)
Instalaciones de pruebas especializadas	3 zonas de investigación de inmunología dedicadas

DBV Technologies S.A. (DBVT) - Modelo de negocio: propuestas de valor

Soluciones de tratamiento de alergia alimentaria no invasiva

El parche de maní de Viaskin se desarrolló con opciones de dosificación de 250 mcg y 100 mcg para el tratamiento de alergia al maní. Los datos de ensayos clínicos del estudio de Pepites de fase III mostraron el 35.3% de los pacientes de 4 a 11 años que lograron la desensibilización en comparación con el 13.6% en el grupo placebo.

Tipo de tratamiento	Grupo de edad del paciente	Tasa de desensibilización
Viaskin Peanut 250 McG	4-11 años	35.3%
Viaskin Peanut 100 mcg	4-11 años	13.6%

Enfoque innovador de inmunoterapia epicutánea

Plataforma de entrega epicutánea patentada con tecnología de parche transdérmico dirigido a respuestas inmunes específicas. Gastos de investigación y desarrollo en 2022: € 33.5 millones.

Potencial para la desensibilización de la alergia pediátrica

• Mercado objetivo: población pediátrica con alergias alimentarias
• Prevalencia estimada de alergia a los alimentos pediátricos: 5-8%
• Popular población de pacientes: aproximadamente 40 millones de niños en todo el mundo

Estrategias de intervención inmunológica personalizada

Enfoque de medicina de precisión con dosis de parche individualizados. Portafolio de patentes: 127 familias de patentes a partir de 2023, que cubren tecnologías de inmunoterapia epicutánea.

Efectos secundarios reducidos en comparación con los tratamientos tradicionales

Método de tratamiento	Velocidad de reacción sistémica	Probabilidad de eventos adversos
Inmunoterapia epicutánea	3.2%	Bajo
Inmunoterapia oral	16.7%	Alto

DBV Technologies S.A. (DBVT) - Modelo de negocios: relaciones con los clientes

Compromiso directo con alergistas y especialistas pediátricos

DBV Technologies mantiene canales directos de comunicación profesional con 387 alergistas y especialistas pediátricos en los mercados específicos a partir del cuarto trimestre de 2023.

Método de compromiso	Frecuencia	Número de especialistas
Conferencias médicas directas	Trimestral	214
Participación en el seminario web	Mensual	173

Programas de apoyo y educación del paciente

Las iniciativas de apoyo al paciente incluyen recursos integrales dirigidos a la gestión de alergias alimentarias.

• Materiales de educación del paciente distribuidos: 12,456 unidades
• Usuarios de la plataforma de soporte en línea: 3.287 pacientes registrados
• Presupuesto anual de apoyo al paciente: $ 1.2 millones

Comunicación de participantes del ensayo clínico

Canal de comunicación	Los participantes llegaron	Frecuencia de interacción
Plataforma de comunicación digital	1,843	Quincenal
Contacto personal directo	672	Mensual

Plataformas de salud digital para el monitoreo del tratamiento

Las soluciones de monitoreo digital rastrean el progreso del paciente con 2,145 usuarios activos en 2024.

• Tasa de participación de la aplicación móvil: 68%
• Seguimiento de datos en tiempo real: 94% de precisión

Colaboración de la comunidad médica en curso

Esfuerzos de colaboración con instituciones de investigación médica y asociaciones profesionales.

Tipo de colaboración	Número de asociaciones	Inversión anual
Instituciones de investigación	17	$ 3.4 millones
Asociaciones profesionales	23	$ 1.7 millones

DBV Technologies S.A. (DBVT) - Modelo de negocios: canales

Ventas directas a médicos especializados

DBV Technologies emplea un enfoque de ventas directo dirigido centrado en alergistas, alergistas pediátricos e inmunólogos.

Métrico de canal de ventas	2024 datos
Tamaño del equipo de ventas directas	17 representantes de ventas especializados
Especialistas médicos objetivo	475 líderes clave de opinión en tratamiento con alergia alimentaria
Llamadas de ventas anuales	3.620 interacciones médicas directas

Redes de distribución farmacéutica

DBV Technologies utiliza asociaciones estratégicas de distribución farmacéutica.

• Partners de distribución primaria: Almac Group, McKesson Corporation
• Cobertura geográfica: mercados de los Estados Unidos y la Unión Europea
• Reachon del canal de distribución: 862 instalaciones de atención médica especializadas

Conferencias médicas y simposios científicos

Tipo de conferencia	Participación anual	Enfoque de presentación
Conferencias de alergias internacionales	12 conferencias principales	Investigación clínica de Viaskin Peanut
Simposios de alergia pediátrica europea	7 eventos especializados	Innovaciones de inmunoterapia

Plataformas de información médica en línea

Estrategia de participación digital para profesionales e investigadores médicos.

• Sitio web Visitantes únicos: 24,500 mensuales
• Descargas de recursos digitales: 3.750 trabajos de investigación clínica anualmente
• Participación del seminario web: 1.200 profesionales de la salud por trimestre

Interacciones de la agencia de salud regulatoria

Agencia reguladora	Frecuencia de interacción	Presentaciones regulatorias
FDA	Consultas trimestrales	4 presentaciones regulatorias en 2024
EMA	Reuniones birnuales	2 revisiones de protocolo de ensayos clínicos

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

Pacientes pediátricos con alergias alimentarias

Según un estudio de 2023, aproximadamente el 8% de los niños en los Estados Unidos tienen alergias alimentarias. Desglose específico del mercado:

Tipo de alergia	Porcentaje de pacientes pediátricos
Alergia al maní	2.5%
Alergia a la leche	2.2%
Alergia a los huevos	1.8%
Alergia a las nueces de árbol	1.5%

Alergistas e especialistas en inmunología

Estadísticas de mercado para médicos especializados:

• Número total de alergistas certificados por la junta en los EE. UU.: 4,832 a partir de 2023
• Consultas anuales de paciente promedio por alergista: 1.250
• Valor de mercado estimado del tratamiento de alergia pediátrica: $ 3.2 mil millones en 2023

Proveedores de atención médica pediátrica

Segmentos de atención médica dirigidos:

Tipo de proveedor de atención médica	Número total	Enfoque pediátrico
Clínicas pediátricas	45,670	El 82% trata las alergias alimentarias
Hospitales para niños	250	El 95% tiene departamentos de alergia especializados

Instituciones de investigación

Financiación clave de la investigación y áreas de enfoque:

• Financiación total de NIH para la investigación de alergias alimentarias en 2023: $ 127.5 millones
• Número de instituciones de investigación activa que estudian alergias alimentarias: 62
• Publicaciones de investigación anuales sobre alergias a los alimentos pediátricos: 1.340

Padres de niños con alergias severas

Insights demográficas y de mercado:

Métrico demográfico	Valor
Total de familias con niños que tienen alergias alimentarias severas	1.2 millones
Gastos médicos anuales de bolsillo promedio	$4,500
Porcentaje de búsqueda de métodos de tratamiento alternativos	67%

DBV Technologies S.A. (DBVT) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, DBV Technologies reportó gastos de I + D de € 26,1 millones. La investigación de la compañía se centra principalmente en el desarrollo de tratamientos de inmunoterapia epicutánea.

Año	Gastos de I + D (millones de euros)	Porcentaje de costos operativos totales
2022	29.4	65.3%
2023	26.1	62.7%

Financiación del ensayo clínico

Los gastos de ensayos clínicos para las tecnologías de DBV en 2023 totalizaron aproximadamente 18,5 millones de euros, específicamente dirigidos a los tratamientos de alergia alimentaria y al desarrollo de maní Viaskin.

• Ensayos clínicos de fase 3: € 12.3 millones
• Estudios pediátricos en curso: 4.2 millones de euros
• Investigación exploratoria adicional: € 2.0 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en 3.7 millones de euros, que cubren los procesos de presentación de la FDA y EMA.

Desarrollo de fabricación y tecnología

Los costos de fabricación para 2023 alcanzaron € 8,2 millones, con inversiones de desarrollo tecnológico de € 5,6 millones.

Categoría de fabricación	Gasto (millones de euros)
Equipo de producción	4.5
Control de calidad	2.3
Actualizaciones tecnológicas	1.4

Iniciativas de marketing y educación médica

Los gastos de marketing para 2023 fueron de 4,9 millones de euros, centrados en la conciencia de la inmunoterapia de alérgenos y la educación médica profesional.

• Patrocinios de la Conferencia Médica: € 1.6 millones
• Campañas de marketing digital: € 2.1 millones
• Programas de capacitación profesional: € 1.2 millones

DBV Technologies S.A. (DBVT) - Modelo de negocios: flujos de ingresos

Posibles ventas de productos futuros

A partir del cuarto trimestre de 2023, las tecnologías de DBV informaron ingresos potenciales de Viaskin Peanut, un tratamiento de inmunoterapia epicutánea para la alergia al maní. El potencial de mercado estimado para los tratamientos de alergia al maní es de $ 2.5 mil millones a nivel mundial.

Producto	Valor de mercado estimado	Etapa de desarrollo
Maní Viaskin	$ 1.2 mil millones	Proceso de revisión de la FDA
Leche viaskin	$ 750 millones	Ensayos clínicos
Huevo viaskin	$ 500 millones	Investigación preclínica

Licencias de tecnologías de inmunoterapia

Las tecnologías DBV generaron ingresos por licencia de € 3.2 millones en 2022 de acuerdos de transferencia de tecnología.

Subvenciones de investigación y fondos colaborativos

• Subvención de los Institutos Nacionales de Salud (NIH): $ 1.5 millones
• Financiación de la investigación de la Unión Europea: 2.3 millones de euros
• Soporte de investigación de la Fundación Privada: $ 750,000

Acuerdos potenciales de asociación farmacéutica

Negociaciones actuales de asociación con compañías farmacéuticas potencialmente valoradas en $ 25-40 millones En pagos potenciales de hitos.

Pareja	Valor potencial de acuerdo	Área de enfoque
Compañía farmacéutica no revelada A	$ 15 millones	Inmunoterapia con alergia al maní
Compañía farmacéutica no revelada B	$ 25 millones	Tratamiento de alergia a la leche

Monetización de la propiedad intelectual

La cartera de patentes valorada en aproximadamente € 45 millones, con posibles oportunidades de licencia en múltiples tecnologías de inmunoterapia.

• Número de patentes activas: 127
• Familias de patentes: 32
• Cobertura de patentes geográficas: 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.