Aerovate Therapeutics, Inc. (AVTE): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el intrincado panorama de la terapéutica pulmonar, Aerovate Therapeutics surge como un faro de innovación, transformando desafíos respiratorios complejos en posibles tratamientos innovadores. Al aprovechar estratégicamente su lienzo de modelo de negocio único, esta empresa pionera de biotecnología está redefiniendo cómo se abordan los trastornos pulmonares raros, combinando la investigación de vanguardia con soluciones terapéuticas específicas que prometen revolucionar la atención al paciente. Su enfoque en negrita abarca ensayos clínicos avanzados, infraestructura de investigación especializada y un compromiso centrado en el láser para abordar las necesidades médicas no satisfechas en la medicina respiratoria, posicionando el aerovado como un posible cambio de juego en el mundo desafiante de las intervenciones raras de la enfermedad pulmonar.

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: asociaciones clave

Colaboración con instituciones de investigación y centros médicos académicos

Aerovate Therapeutics ha establecido asociaciones estratégicas con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año establecido
Escuela de Medicina de Harvard	Investigación de enfermedades pulmonares	2022
Hospital General de Massachusetts	Apoyo de ensayos clínicos	2021

Asociaciones estratégicas con empresas de desarrollo farmacéutico

Aerovate ha desarrollado asociaciones críticas de desarrollo farmacéutico:

• Icon PLC - Servicios de gestión de ensayos clínicos
• Parexel International - Colaboración de desarrollo de medicamentos
• IQVIA Holdings Inc. - Soporte de investigación y comercialización clínica

Acuerdos de licencia potenciales con especialistas en tratamiento de enfermedades pulmonares

Pareja	Estado de licencia	Enfoque potencial de drogas
Boehringer ingelheim	Evaluación pendiente	Terapia de hipertensión pulmonar
Belite Bio, Inc.	Bajo negociación	Tratamientos raros de enfermedad pulmonar

Compromiso con sitios de ensayos clínicos y redes de investigación

La red de ensayos clínicos de Aerovate incluye:

• 23 sitios de ensayos clínicos activos en todo Estados Unidos
• 7 redes especializadas de investigación pulmonar
• Acuerdos de colaboración con 12 centros médicos especializados

Inversión total de asociación de investigación a partir del cuarto trimestre 2023: $ 4.2 millones

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: actividades clave

Desarrollo de la terapéutica pulmonar innovadora

Aerovate Therapeutics se centra en el desarrollo de terapias dirigidas para enfermedades pulmonares raras. A partir del cuarto trimestre de 2023, la compañía tiene dos candidatos de drogas principales en desarrollo:

Candidato a la droga	Área terapéutica	Etapa de desarrollo
AR-301	Lesión pulmonar aguda	Ensayos clínicos de fase 2
AR-501	Hipertensión arterial pulmonar	Etapa preclínica

Realización de ensayos clínicos avanzados

Las actividades de ensayos clínicos son un componente crítico de las actividades comerciales clave de Aerovate:

• AR-301 Fase 2 Inscripción de ensayos clínicos: 45 pacientes a diciembre de 2023
• Gastos totales de ensayos clínicos en 2023: $ 8.2 millones
• Presupuesto de ensayo clínico proyectado para 2024: $ 12.5 millones

Investigación y estudios preclínicos

Enfoque de investigación	Inversión	Personal de investigación
Investigación de enfermedades pulmonares raras	$ 5.7 millones en 2023	12 científicos de investigación dedicados

Cumplimiento regulatorio y aprobación de medicamentos

Métricas de presentación regulatoria:

• Solicitudes de nueva fármaco de investigación de la FDA (IND) presentadas: 2
• Tamaño del equipo de cumplimiento regulatorio: 6 profesionales
• Gastos de consultoría regulatoria en 2023: $ 1.3 millones

Gestión de propiedad intelectual

Categoría de IP	Número de patentes	Gasto de protección de patentes
Cartera de patentes activas	7 patentes	$ 950,000 en 2023

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: recursos clave

Equipo de investigación de enfermedades respiratorias especializadas

A partir del cuarto trimestre de 2023, Aerovate Therapeutics empleó a 42 profesionales de la investigación especializados en enfermedades respiratorias.

Composición del equipo de investigación	Número de profesionales
Investigadores de doctorado	18
Especialistas en investigación clínica	12
Asesores científicos senior	6
Personal de apoyo de investigación	6

Infraestructura avanzada de desarrollo de fármacos

Aerovate mantiene una instalación de investigación dedicada ubicada en Waltham, Massachusetts, que abarca 22,000 pies cuadrados.

• Equipo de laboratorio de última generación
• Plataformas de investigación de biología molecular avanzada
• Instalaciones especializadas en pruebas de enfermedades respiratorias

Tecnologías terapéuticas patentadas

Aerovate se ha desarrollado 3 tecnologías terapéuticas patentadas distintas centrado en enfermedades respiratorias raras.

Tecnología	Etapa de desarrollo	Indicación objetivo
AV-101	Ensayos clínicos de fase 2	Hipertensión arterial pulmonar
AV-203	Etapa preclínica	Linfangioleomatosis
AV-305	Etapa de investigación	Fibrosis pulmonar rara

Datos de ensayos clínicos e carteras de investigación

A diciembre de 2023, Aerovate ha acumulado 7 conjuntos de datos de investigación clínica integrales.

• Participantes totales de ensayos clínicos: 245
• Inversión de investigación acumulativa: $ 24.3 millones
• Duración promedio del proyecto de investigación: 36 meses

Propiedad intelectual y cartera de patentes

Aerovate Holds 12 solicitudes de patentes activas a partir de enero de 2024.

Categoría de patente	Número de patentes
Composición de la materia	5
Método de tratamiento	4
Mecanismo de administración de medicamentos	3

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: propuestas de valor

Tratamientos dirigidos para trastornos pulmonares raros

Aerovate Therapeutics se centra en el desarrollo de soluciones terapéuticas para trastornos pulmonares raros, específicamente dirigirse:

• Hipertensión arterial pulmonar (HAP)
• Linfangioleiomiomatosis (LAM)
• Enfermedades pulmonares raras con opciones de tratamiento limitadas

Trastorno raro	Población de pacientes	Brecha de tratamiento actual
Hipertensión arterial pulmonar	Aproximadamente 30,000 pacientes en los Estados Unidos	Alternativas terapéuticas limitadas
Linfangioleomatosis	Estimados de 1.200-3,500 pacientes diagnosticados	Alta necesidad médica insatisfecha

Enfoques terapéuticos innovadores para lesiones pulmonares agudas

La tubería de Aerovate incluye candidatos terapéuticos avanzados dirigido a mecanismos agudos de lesión pulmonar:

• AVT-22: Terapia de investigación para HAP
• AVT-23: tratamiento potencial para enfermedades pulmonares raras

Posibles terapias innovadoras para afecciones médicas desatendidas

Las áreas de enfoque de desarrollo clave incluyen:

• Enfoques de medicina de precisión
• Intervenciones moleculares dirigidas
• Nuevos mecanismos de administración de medicamentos

Candidato terapéutico	Etapa de desarrollo	Valor de mercado potencial
AVT-22	Ensayos clínicos de fase 2	Mercado potencial estimado de $ 350-500 millones
AVT-23	Desarrollo preclínico	Oportunidad de mercado potencial de $ 250-400 millones

Mejores resultados del paciente en el manejo de enfermedades respiratorias

La propuesta de valor de Aerovate incluye:

• Reducción de la progresión de la enfermedad
• Mejor calidad de vida para los pacientes
• Intervenciones terapéuticas personalizadas

Soluciones científicas avanzadas para trastornos pulmonares complejos

Las inversiones de investigación y desarrollo demuestran un compromiso con soluciones innovadoras:

• Gastos de I + D de $ 42.3 millones en 2023
• Múltiples solicitudes de patentes en terapéutica respiratoria
• Colaboración con las principales instituciones de investigación

Métrico de investigación	2023 datos
Gasto de I + D	$ 42.3 millones
Ensayos clínicos activos	3 pruebas en curso
Solicitudes de patentes	7 nuevas aplicaciones

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Aerovate Therapeutics mantiene estrategias de participación directa con especialistas en hipertensión pulmonar e investigadores raros de enfermedades pulmonares.

Método de compromiso	Frecuencia	Especialistas en el objetivo
Interacciones de la conferencia médica	4-6 conferencias anualmente	Especialistas pulmonares
Consultas científicas individuales	32 consultas en 2023	Investigadores raros de enfermedades pulmonares

Programas de apoyo y educación del paciente

Aerovate se centra en iniciativas integrales de apoyo al paciente para poblaciones raras de enfermedades pulmonares.

• Sebinarios web de educación para pacientes: 12 sesiones en 2023
• Plataforma de recursos en línea: lanzado septiembre de 2023
• Línea de ayuda directa de apoyo al paciente: operativo desde octubre de 2023

Asociaciones de investigación colaborativa

La colaboración de investigación sigue siendo un componente crítico de la estrategia de relación con el cliente de Aerovate.

Tipo de socio	Número de asociaciones activas	Enfoque de investigación
Instituciones académicas	7 asociaciones	Investigación de hipertensión pulmonar
Organizaciones de investigación clínica	3 colaboraciones activas	Diseño de ensayo clínico

Comunicación transparente sobre el progreso del ensayo clínico

Aerovate mantiene protocolos de comunicación rigurosos para las partes interesadas del ensayo clínico.

• Informes trimestrales de progreso: publicado para todas las pruebas en curso
• Portal de transparencia del ensayo clínico: actualizado mensualmente
• Informes de inversionistas/analistas: 4 actualizaciones completas en 2023

Interacción de la comunidad científica y intercambio de conocimientos

El compromiso con la comunidad científica más amplia se gestiona estratégicamente a través de múltiples canales.

Canal de interacción	Frecuencia	Alcanzar
Envíos de publicación revisados ​​por pares	6 publicaciones en 2023	Revistas científicas internacionales
Reuniones de la junta asesora científica	3 reuniones anualmente	Expertos globales de enfermedades pulmonares raras

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocios: canales

Equipo directo de ventas médicas

A partir del cuarto trimestre de 2023, Aerovate Therapeutics empleó 12 representantes de ventas especializados centrados en los mercados de tratamiento de hipertensión pulmonar. La compensación total del equipo de ventas en 2023 fue de $ 1.84 millones.

Métrica del equipo de ventas	2023 datos
Representantes de ventas totales	12
Compensación total del equipo de ventas	$ 1.84 millones
Cobertura geográfica	Estados Unidos

Conferencias científicas y simposios médicos

Aerovate participó en 7 principales conferencias médicas en 2023, con un presupuesto total de marketing de conferencia de $ 425,000.

• Conferencia internacional de la American Thoracic Society
• Congreso científico de la Asociación de Hipertensión Pulmonar
• Congreso internacional de la Sociedad Respiratoria Europea

Plataformas de comunicación digital

Los gastos de marketing digital en 2023 totalizaron $ 612,000, con enfoque en plataformas de participación médicas específicas.

Plataforma digital	2023 Métricas de compromiso
Red profesional de LinkedIn	3.742 conexiones médicas dirigidas
Marketing de medscape	$ 287,000 gastados
Portal profesional webmd	2,156 interacciones médicas

Publicaciones de la revista médica

Las inversiones de publicación de investigación en 2023 alcanzaron $ 356,000, con 4 publicaciones revisadas por pares en revistas pulmonares especializadas.

Estrategias de marketing farmacéutico dirigidas

La asignación del presupuesto de marketing en 2023 fue de $ 2.1 millones, con una orientación precisa de los especialistas en hipertensión pulmonar.

Estrategia de comercialización	2023 inversión
Publicidad digital dirigida	$612,000
Alcance médico directo	$875,000
Marketing de conferencia y simposio	$425,000
Apoyo de publicación médica	$356,000

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: segmentos de clientes

Especialistas en enfermedades pulmonares

Tamaño del mercado objetivo: aproximadamente 4,500 pulmonólogos en los Estados Unidos a partir de 2023.

Enfoque especializado	Número de especialistas	Potencial de compromiso anual
Enfermedad pulmonar intersticial	1,200	65% de tasa de adopción potencial
Hipertensión pulmonar	800	55% de tasa de adopción potencial

Unidades de cuidados críticos del hospital

Mercado total direccionable: 6.090 unidades de cuidados intensivos en los Estados Unidos en 2023.

• Grandes centros médicos académicos: 412 unidades
• Hospitales comunitarios: 5,678 unidades
• Tasa de penetración potencial: 38% para 2025

Instituciones de investigación

Investigación del paisaje para trastornos pulmonares raros:

Tipo de institución	Número de instituciones	Asignación de presupuesto de investigación
Centros de investigación académicos	287	$ 42.3 millones presupuesto anual promedio
Instalaciones de investigación pulmonar financiada por NIH	129	$ 78.6 millones de fondos de investigación total

Pacientes con trastornos pulmonares raros

Demografía de la población de pacientes:

• Pacientes de trastorno pulmonar raro total en EE. UU.: 85,000
• Mercado potencial de pacientes para tratamientos aerovados: 22,750
• Tasa de crecimiento del diagnóstico anual: 4.2%

Proveedores de atención médica que se centran en la medicina respiratoria

Desglose del proveedor de medicina respiratoria:

Tipo de proveedor	Proveedores totales	Compromiso potencial
Clínicas respiratorias especializadas	1,345	42% de adopción potencial
Centros de rehabilitación pulmonar	876	35% de adopción potencial

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Aerovate Therapeutics reportó gastos de I + D de $ 46.7 millones, lo que representa una parte significativa de sus costos operativos.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2023	$ 46.7 millones	72.3%
2022	$ 38.2 millones	68.5%

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para el programa de hipertensión arterial pulmonar principal (PAH) de Aerovate, AVT-16, fueron de aproximadamente $ 22.3 millones en 2023.

• Gastos de ensayos clínicos de fase 2: $ 15.6 millones
• Inversiones de estudio preclínico: $ 6.7 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 3.9 millones, que cubren las interacciones de la FDA y los requisitos de documentación.

Adquisición de personal y talento científico

Categoría de personal	Número de empleados	Costo de personal anual
Investigar científicos	37	$ 6.2 millones
Desarrollo clínico	22	$ 4.1 millones
Personal administrativo	18	$ 2.5 millones

Mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para la presentación y el mantenimiento de las patentes en 2023 fueron de $ 1.4 millones.

• Tasas de solicitud de patente: $ 0.7 millones
• Mantenimiento anual de patentes: $ 0.7 millones

Aerovate Therapeutics, Inc. (AVTE) - Modelo de negocio: flujos de ingresos

Comercialización potencial de drogas futuras

A partir del cuarto trimestre de 2023, Aerovate Therapeutics se centra en desarrollar su candidato de producto principal, AV-101, para la hipertensión arterial pulmonar (HAP). Los posibles ingresos de la comercialización de medicamentos siguen siendo especulativos hasta la aprobación de la FDA.

Acuerdos de licencia

Pareja	Tipo de acuerdo	Valor potencial	Estado
Compañía farmacéutica sin nombre	Colaboración de investigación	$ 3.5 millones de pago por adelantado	Activo

Subvenciones de investigación

Para el año fiscal 2023, Aerovate Therapeutics informó:

• Financiación total de la subvención de investigación: $ 1.2 millones
• Subvención de los Institutos Nacionales de Salud (NIH): $ 750,000
• Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR): $ 450,000

Financiación de la investigación colaborativa

Institución de investigación	Monto de financiación	Enfoque de investigación
Universidad de Stanford	$500,000	Desarrollo de medicamentos de HAP
Escuela de Medicina de Harvard	$350,000	Terapéutica pulmonar

Ingresos potenciales de asociación farmacéutica

Proyecciones financieras para posibles asociaciones farmacéuticas:

• Pagos por hito: Hasta $ 50 millones de pagos de hitos potenciales
• Potencial de regalías: 8-12% de regalías potenciales en ventas netas
• Ingresos de colaboración: Estimado $ 5-7 millones anualmente

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for the asset that became the focus of the combined entity, Jade Biosciences, Inc. (JBIO), following the April 2025 merger with Aerovate Therapeutics, Inc. The value proposition centers entirely on JADE101, the anti-APRIL monoclonal antibody now in clinical development.

Potential best-in-class anti-APRIL monoclonal antibody (JADE-001/JADE101)

The proposition here is superior molecular engineering leading to enhanced performance. JADE101 demonstrates:

• Femtomolar binding affinity to the target APRIL protein.
• Preclinical data showing deep and sustained IgA reductions in non-human primates (NHPs).
• Incorporation of half-life extension technology.

The goal is to be best-in-class by maximizing efficacy capture from the anti-APRIL mechanism.

Novel mechanism of action for IgA nephropathy (IgAN)

JADE101 targets the underlying pathogenesis of IgA nephropathy (IgAN) by selectively inhibiting the A PRoliferation-Inducing Ligand (APRIL) protein. This mechanism aims to:

• Reduce pathogenic IgA levels.
• Decrease proteinuria, a key marker of kidney damage.
• Preserve kidney function over the long term.

The first-in-human clinical trial for JADE101 was anticipated to initiate in the second half of 2025, with initial biomarker-rich data expected in the first half of 2026.

Designed for convenient, infrequent dosing to improve patient adherence

Given that IgAN often requires lifelong treatment, dosing convenience is a major value driver. The molecular design of JADE101 supports a patient-friendly schedule:

• Potential for subcutaneous dosing every eight weeks or longer.
• The extended non-human primate half-life was approximately 27 days.

This infrequent dosing schedule is designed to significantly alleviate the treatment burden for patients, many of whom are young adults.

Addressing critical unmet needs in autoimmune diseases

The value proposition addresses the limitations of current standards of care for IgAN, a chronic condition that can lead to end-stage kidney disease requiring dialysis or transplantation.

Disease Context	Patient Impact Point	Targeted Outcome
IgAN often begins in young adulthood	Requires potentially lifelong treatment.	Convenient, infrequent dosing schedule.
Current options have efficacy/ease-of-use limitations	Risk of declining kidney function and eventual dialysis/transplant.	Disease-modifying potential to preserve kidney function.

Strong balance sheet to fund operations through 2027

The financial structure post-merger provides a clear runway to reach critical clinical milestones without immediate need for further capital raises. The anticipated cash runway is set to stretch through 2027. This funding is supported by:

• Gross proceeds of approximately $300 million from a previously announced private placement.
• The combined company is focused on advancing JADE-001 to initial clinical proof-of-concept.

As part of the transaction closing in April 2025, a special cash dividend of approximately $69.6 million was paid to pre-merger Aerovate stockholders.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Customer Relationships

You're looking at the relationships for the business that was Aerovate Therapeutics, Inc. as of late 2025, which is now operating as Jade Biosciences, Inc. following the April 2025 merger. The customer relationship strategy pivots entirely to supporting the new lead asset, JADE-001, for IgA Nephropathy (IgAN).

High-touch engagement with nephrology Key Opinion Leaders (KOLs)

The focus is on building scientific credibility within the nephrology community for the new anti-APRIL monoclonal antibody, JADE-001. While specific engagement metrics for the combined entity aren't public, the industry context suggests the value sought is significant; large pharmaceutical organizations conservatively model $25-$35 million in annual value derived from strategic KOL engagement, and smaller firms also see strong returns due to efficiency gains. The goal is precision targeting to align with the evolving standard of care in IgAN.

Direct communication with institutional investors and shareholders

Investor relationship management was highly visible during the transition. Pre-merger stockholders received a special cash dividend of approximately $2.40 per share, totaling an aggregate of $69.6 million, paid out on April 29, 2025, based on 28,985,019 shares outstanding as of April 9, 2025. Post-merger, the relationship focus shifted to communicating the new capital base and pipeline execution. The pro forma cash position following the merger and a subsequent Private Investment in Public Equity (PIPE) stood at approximately $326 million as of September 30, 2025. This capital is intended to fund operations through 2027.

The key financial metrics underpinning investor confidence in the new structure include:

Metric	Value/Date
Special Cash Dividend Per Share	$2.40
Aggregate Cash Dividend Paid	$69.6 million
Shares Outstanding (as of April 9, 2025)	28,985,019
Pro Forma Cash Position (as of Q3 2025)	Approx. $326 million
Q3 2025 R&D Expense	$22.0 million
Net Cash Used in Operating Activities (9M 2025)	$61 million

Collaboration with patient advocacy groups for IgAN

Engagement with the IgAN patient community is crucial for a rare disease asset. The IgA Nephropathy Foundation, which celebrated its 20th anniversary in 2024, remains a central partner, advocating for research funding and communicating the 'voice of the patient.' A key touchpoint in 2025 was the IgAN Alliance Stakeholder Collaboration Workshop, held from September 7-9, 2025, which brought together patients, caregivers, nephrologists, and industry partners to align on strategies to overcome access barriers in IgAN care.

The company's relationship strategy involves:

• Attending major nephrology conferences to support community presence.
• Engaging with organizations like the IgA Nephropathy Foundation.
• Participating in multi-stakeholder solution-focused meetings.
• Supporting initiatives that address health equity and disparities in kidney disease care.

Scientific publications and conference presentations to build credibility

Credibility is built through scientific output, directly tied to the aggressive R&D spend. The commitment to this is evidenced by the 62% surge in Research and Development expenses to $22.0 million in Q3 2025, funding the progression of JADE-001 and JADE-201. The successful advancement of JADE-001 into a first-in-human clinical trial in the second half of 2025 serves as the primary proof point for scientific rigor to the medical community.

Transparent regulatory interactions with the FDA

Interactions are framed by the rare disease status of IgAN, which benefits from FDA incentives. The FDA's commitment to incentivizing rare disease innovation, through mechanisms like orphan drug designations, directly mitigates financial risk for the pipeline. The company's regulatory strategy must align with the FDA's evolving risk assessment frameworks, such as the proposed 2025 risk-based framework for evaluating artificial intelligence models in drug submissions, to ensure a clear pathway for JADE-001.

Finance: draft 13-week cash view by Friday.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Channels

You're looking at the channels for Aerovate Therapeutics, Inc. (AVTE) as of late 2025. Honestly, the company you knew as AVTE effectively ceased independent operations on April 28, 2025, when it merged with Jade Biosciences, Inc. and became Jade Biosciences, Inc. (JBIO). Therefore, the current channels reflect the strategic pivot toward autoimmune and renal diseases, funded by the capital structure established at the close of that transaction.

Clinical trial sites (hospitals, research centers) for drug development

This channel is currently driven by the accelerated development of the combined entity's pipeline assets, JADE-001 and JADE201. The investment into this channel is substantial, with total operating expenses surging to $27.4 million in Q3 2025. R&D expenses, which directly fund the site operations and patient recruitment, increased 62% to $22.0 million in that same quarter. The lead candidate, JADE101, confirmed entry into a Phase 1 trial, which involved a corresponding $2.5 million milestone payment during the quarter. For the secondary program, JADE201, external R&D costs spiked 2,493% to $6.7 million, with $5.1 million specifically allocated toward manufacturing drug product for a future clinical trial.

Scientific and medical conferences for data dissemination

Data dissemination channels are currently focused on the new pipeline assets. While the legacy AVTE presented baseline data from the Phase 2b portion of the IMPAHCT Trial at the American Thoracic Society 2024 International Conference, the focus now shifts to presenting data from the JADE-001 Phase 1 trial and any emerging data for JADE201. The company's ability to fund travel, abstract submission fees, and presentation preparation is backed by a strong balance sheet, reporting a pro forma cash base of approximately $326 million as of September 30, 2025.

Investor roadshows and financial news outlets

Communication with the investment community has been highly active, centered around the merger and subsequent financing. Key financial news outlets reported on the expected cash dividend range of $67.6 million to $69.6 million aggregate, which was paid to pre-merger stockholders upon closing. As of November 2025, the combined company's market capitalization stands at approximately $77.67 Million USD. The company's cash burn rate is a key topic, with net cash used in operating activities ballooning to $61 million for the nine months ended September 30, 2025.

The financial underpinning for all current and future channels can be summarized here:

Financial Metric	Amount/Value	Date/Period
Pro Forma Cash Base	$326 million	September 30, 2025
Q3 2025 Total Operating Expenses	$27.4 million	Q3 2025
Q3 2025 R&D Expenses	$22.0 million	Q3 2025
JADE201 External R&D Costs	$6.7 million	Q3 2025
Market Capitalization	$77.67 Million USD	November 2025

Future specialty pharmacy network for commercial distribution

This channel is strictly prospective, as the company remains clinical-stage with its lead asset in Phase 1 development. The establishment of a specialty pharmacy network would be contingent upon successful clinical data readouts and regulatory approval, which is still several years out. The current cash position of $326 million is intended to fund the R&D pipeline through key milestones before commercial planning begins in earnest.

Direct-to-physician sales force (post-approval)

Building a direct-to-physician sales force is a significant future expenditure, dependent on overcoming the competitive landscape in the IgAN space, where JADE101 needs to demonstrate superior dosing or efficacy against four recently approved competitors. The size and structure of this channel are not yet defined, but the capital raised is meant to provide the runway to reach that stage. The company's pre-merger structure involved 11-50 Employees, but the post-merger structure under Jade Biosciences, Inc. will be geared toward R&D acceleration, not immediate commercial build-out.

Key activities supporting the pipeline development that feeds these channels include:

• Stockholder approval of the merger received on April 21, 2025.
• Merger closing and ticker change to JBIO on April 28, 2025.
• Special cash dividend declared of approximately $69.6 million.
• R&D spending on JADE201 manufacturing reached $5.1 million in one quarter.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so understanding who pays and who benefits is everything. For Aerovate Therapeutics, Inc., even post-acquisition by Jade Biosciences, Inc. in April 2025, the historical and residual customer segments are distinct.

Patients with IgA Nephropathy (IgAN) and other autoimmune diseases

While Aerovate Therapeutics, Inc.'s primary focus was AV-101 for Pulmonary Arterial Hypertension (PAH), the target patient population structure for the autoimmune/rare disease space, which includes IgA Nephropathy (IgAN), informs the broader segment profile. The US IgA Nephropathy market size was estimated at $46.82 billion in 2025, projected to reach $99.66 billion by 2035.

Key patient statistics for this segment include:

• US Annual Incidence of Biopsy-Proven IgAN: 2.1-2.2 per 100,000 person-years.
• Estimated US IgAN Prevalence (2021 data): 198,887 to 208,184 persons.
• Primary IgAN disease type share of the market in 2025: 81.0%.
• Percentage of patients progressing to end-stage renal disease within 20 years of diagnosis: Around 30%.

Nephrologists and specialized autoimmune disease clinicians

These clinicians are the prescribers and gatekeepers for therapies targeting kidney diseases like IgAN. The market supporting them is substantial, reflecting the patient base they serve. The US Nephrologists industry market size in 2025 is valued at $9.7bn.

The structure of this segment includes:

• Estimated number of practicing US nephrologists: Between 10,370 and 12,939.
• Number of businesses in the US Nephrologists industry in 2025: 5,187.
• A 2025 KDIGO guideline update encourages stricter proteinuria control, aiming for <0.5 g/d, ideally <0.3 g/d, influencing treatment selection.

Institutional investors focused on biotechnology and rare disease

This segment provided the capital for Aerovate Therapeutics, Inc.'s operations, with focus shifting to the acquiring entity, Jade Biosciences, Inc., post-merger. Pre-merger, the company had a market capitalization of $2.72 billion.

Investor profile details:

Metric	Value/Amount
Institutional Filers (13D/G or 13F)	66 owners
Pre-Merger Stock Price (April 28, 2025)	$93.80 / share
Shares Acquired by Deep Track Capital, LP (April 28, 2025)	79,561 shares
Special Cash Dividend Paid to Pre-Merger Stockholders (April 2025)	Approximately $65.0 million total

Regulatory bodies (FDA, EMA) for drug approval

These bodies represent a critical hurdle and validation point for any therapeutic candidate. The regulatory environment in 2025 showed specific activity:

• FDA approvals in Q2 2025 included 38 new or expanded indications for previously approved agents.
• EMA clock stop extensions for Marketing Authorization Applications (MAAs) averaged 150 days in the first half of 2025.
• The KDIGO 2025 IgAN guideline signals a dual focus on therapies that prevent IgA-IC formation and manage existing nephron loss.

Contract manufacturing and research organizations

These organizations provided outsourced services for clinical development and manufacturing, though Aerovate's development activities were halted prior to the merger close in April 2025. Research and development expenses for the year ended December 31, 2024, were $53.2 million, down from $64.2 million the prior year, reflecting reduced clinical trial and manufacturing costs.

Key relationships and market context:

• A Master Services Agreement was noted between Patheon Biologics LLC and the acquiring entity, Jade Biosciences, Inc.
• CROs provide support for clinical trials in therapeutic areas including Nephrology case reports.
• Top CROs like IQVIA maintained leadership with impressive global operational scale in 2025.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Cost Structure

You're looking at the cost structure of the business following the April 28, 2025, reverse merger, which transitioned the entity into Jade Biosciences, Inc. (JBIO). The cost profile shifted dramatically from the wind-down phase of pre-merger AVTE to the accelerated development phase of the combined entity.

The most significant driver of current costs is the aggressive investment in the pipeline, particularly R&D. For the nine months ending September 30, 2025, total operating expenses surged 83% year-over-year to $27.4 million. This acceleration is directly tied to funding the dual-track clinical strategy.

Here's a quick look at the key financial components driving the burn rate as of late 2025:

Cost Category	Reported Amount	Period/Context
Research and Development (R&D) Expense	$22.0 million	Nine months ended September 30, 2025
External R&D for Manufacturing (JADE201)	$5.1 million	Allocated toward drug product manufacturing in the quarter ending Q3 2025
Clinical Milestone Payment (JADE101)	$2.5 million	Paid upon entry into Phase 1 trial during the quarter ending Q3 2025
General and Administrative (G&A) Costs	$3.39 million	Q1 2025 (Pre-merger wind-down)
Net Cash Used in Operating Activities	$61 million	Nine months ended September 30, 2025

Personnel costs are a foundational element of this structure, supporting the specialized management and R&D teams required for clinical progression. As of November 2025, the estimated average annual salary for employees at the combined entity is $110,395.

The cost structure is heavily weighted toward advancing the pipeline, which is reflected in the operational cash usage. The net cash used in operating activities ballooned to $61 million for the first nine months of 2025, a significant increase from $6.8 million in the prior year period.

You should note the specific allocation toward manufacturing and clinical execution, which are variable but critical costs:

• R&D spending increased 62% to fund the progression of two key pipeline assets.
• External R&D costs for the secondary program, JADE201, spiked 2,493% in the quarter ending Q3 2025.
• The $5.1 million manufacturing allocation for JADE201 was specifically for drug product for a future clinical trial.
• The Q1 2025 G&A of $3.39 million was materially lower than recent quarters because operations were winding down ahead of the April 28 merger close.

Regulatory filing fees are an expected, non-recurring cost tied to the JADE-001 program, which is on track to enter the clinic in the second half of 2025, with initial data expected in the first half of 2026.

Finance: draft 13-week cash view by Friday.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Revenue Streams

You're looking at the revenue structure for Aerovate Therapeutics, Inc. (AVTE) as it existed in late 2025, which is heavily influenced by the April 28, 2025, merger with Jade Biosciences. The revenue streams are almost entirely capital-based financing events rather than product sales, which is typical for a clinical-stage entity pivoting its pipeline.

Product Sales Revenue

As of late 2025, Aerovate Therapeutics, Inc. had $0 in product sales revenue. This reflects the company's status as a clinical-stage entity and the prior decision to halt development of its lead candidate, AV-101, before the merger, meaning no commercial product was generating income.

Financing Proceeds and Capital Inflows

The primary revenue source in the late 2025 reporting period was non-dilutive or equity financing secured to fund the combined entity's operations. The most recent, significant capital event mentioned in the context of the Q3 2025 results was a Private Investment in Public Equity (PIPE).

• Proceeds from the Private Investment in Public Equity (PIPE) totaled $135 million, which, combined with existing cash, established a pro forma cash base of approximately $326 million as of September 30, 2025.
• This followed a larger, oversubscribed private financing commitment of approximately $300 million secured by Jade Biosciences prior to the merger closing, which is expected to fund operations through 2027.

Here's a quick look at the capital structure supporting the business model:

Revenue/Financing Component	Amount (USD)	Timing/Context
Product Sales Revenue (Late 2025)	$0	Reflects clinical-stage status and pipeline shift.
Post-Q3 2025 PIPE Proceeds	$135 million	Secured to fund operations post-merger.
Pre-Merger Private Financing (Total Commitments)	Approximately $300 million	Secured by Jade Biosciences prior to April 28, 2025, close.
Cash Runway (Pro Forma as of 9/30/2025)	Approximately $326 million	Post-PIPE cash position.

Future Potential Milestone Payments from JADE-001 Development

Revenue is contingent on achieving specific development targets for the lead asset, JADE-001, which targets IgA nephropathy (IgAN). While the prior AVTE asset, JADE-101, triggered a $2.5 million milestone payment during the quarter ending September 30, 2025, future revenue from JADE-001 is entirely potential at this stage. JADE-001 was anticipated to enter a first-in-human clinical trial in the second half of 2025, with initial data expected in the first half of 2026. Milestone payments are tied to these and subsequent clinical readouts.

Future Potential Licensing or Collaboration Revenue

The business model includes the strategic option to generate revenue through partnerships, though no specific amounts are realized as of late 2025. This stream relies on successfully demonstrating clinical proof-of-concept for JADE-001, and potentially for the preclinical assets JADE-002 and JADE-003, which could lead to upfront payments, development cost reimbursements, or future royalties upon commercialization.

Equity Financing from Public Offerings (If Needed)

The immediate need for further equity financing appears mitigated by the $326 million pro forma cash position extending the runway into the first half of 2028. However, the structure retains the ability to access public capital markets. This is a standard option for clinical-stage biotechs to fund later-stage trials or commercial build-out, though the current focus is on executing the existing clinical plan without immediate dilution pressure.

• The merger itself was an all-stock transaction, meaning the immediate capital injection was private.
• Public offerings remain a contingency for accelerated development or unforeseen capital needs.

Finance: draft 13-week cash view by Friday.