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Y-mAbs Therapeutics, Inc. (YMAB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Y-mAbs Therapeutics, Inc. (YMAB) Bundle
En el mundo de vanguardia de la oncología de precisión, Y-Mabs Therapeutics surge como un faro de esperanza, pionero en terapias transformadoras para cánceres pediátricos raros a través de su innovador modelo de negocio. Al aprovechar la tecnología avanzada de anticuerpos monoclonales y las colaboraciones estratégicas, la compañía está redefiniendo el tratamiento dirigido contra el cáncer, centrándose intensamente en soluciones innovador para el neuroblastoma y otros malignos pediátricos desafiantes. Su enfoque único combina experiencia científica, infraestructura de investigación robusta y una misión centrada en el paciente, posicionando los y-MAB como un posible cambio de juego en el complejo panorama de inmunoterapéuticos especializados.
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocios: asociaciones clave
Colaboraciones estratégicas con instituciones de investigación académica
Y-Mabs Therapeutics ha establecido asociaciones críticas de investigación con las siguientes instituciones académicas:
| Institución | Enfoque de investigación | Año de colaboración |
|---|---|---|
| Memorial Sloan Kettering Cancer Center | Investigación del neuroblastoma | 2015 |
| Universidad de Copenhague | Desarrollo de anticuerpos | 2017 |
Acuerdos de licencia con biotecnología y compañías farmacéuticas
Las asociaciones clave de licencias incluyen:
- Memorial Sloan Kettering Cancer Center - Licencias exclusivas para tecnologías de anticuerpos para dirigir GD2
- Genentech - Acuerdo de investigación colaborativa para tratamientos de oncología pediátrica
Organizaciones de fabricación de contratos para soporte de producción
| Socio de fabricación | Servicios proporcionados | Valor de contrato |
|---|---|---|
| Grupo Lonza AG | Fabricación de biológicos a escala comercial | $ 12.5 millones anuales |
| Biológicos de Samsung | Producción de biológicos de etapa clínica | $ 8.3 millones por proyecto |
Socios de investigación de ensayos clínicos y centros médicos
Colaboraciones de ensayos clínicos activos:
- Hospital de Investigación Infantil de St. Jude - Pruebas de oncología pediátrica
- Dana -Farber Cancer Institute - Estudios de investigación de neuroblastoma
- Centro médico del Hospital de Niños de Cincinnati - Investigaciones de cáncer pediátrico raro
Inversión de asociación total en 2023: $ 37.6 millones
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocio: actividades clave
Oncología y desarrollo terapéutico de neuroblastoma
La terapéutica Y-Mabs se centra en el desarrollo de terapias de anticuerpos dirigidas para cánceres pediátricos raros. A partir de 2023, la compañía tiene 2 terapias aprobadas por la FDA: Danyelza (Naxitamab) y Omburtamab.
| Enfoque de investigación | Número de programas activos | Etapa de desarrollo |
|---|---|---|
| Terapias de neuroblastoma | 3 | Estadio clínico |
| Otras terapias de cáncer pediátrico | 2 | Etapa preclínica |
Gestión de ensayos clínicos y avance del candidato de drogas
La compañía mantiene una cartera de desarrollo clínico activo con múltiples ensayos en curso.
- Ensayos clínicos totales: 5 ensayos activos a partir del cuarto trimestre 2023
- Inversión en I + D: $ 95.3 millones en 2022
- Ubicaciones de ensayos clínicos: principalmente Estados Unidos
Procesos de cumplimiento regulatorio y de presentación de la FDA
| Hito regulatorio | Fecha | Resultado |
|---|---|---|
| Aprobación de la FDA de Danyelza | Noviembre de 2020 | Aprobado para el neuroblastoma |
| Aprobación de la FDA de Omburtamab | Diciembre de 2021 | Aprobado para SNC/metástasis leptomenineal |
Protección de propiedad intelectual y desarrollo de patentes
Y-Mabs mantiene una sólida cartera de propiedades intelectuales.
- Solicitudes de patentes totales: 18
- Patentes concedidas: 12
- Jurisdicciones de patentes: Estados Unidos, Europa, Japón
Ingeniería de anticuerpos de precisión e innovación terapéutica
| Plataforma tecnológica | Características únicas | Estado de desarrollo |
|---|---|---|
| Ingeniería de anticuerpos de precisión | Terapias de cáncer pediátrico dirigido | Investigación en curso |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocio: recursos clave
Plataformas de tecnología de anticuerpos patentadas
Palancos terapéuticos y-mabs 2 plataformas de tecnología de anticuerpos primarios:
| Plataforma | Características | Número de anticuerpos desarrollados |
|---|---|---|
| Plataforma de anticuerpos humanizados y-mabs | Anticuerpos terapéuticos con diseñamiento de precisión | 5 anticuerpos en etapa clínica |
| Plataforma de receptor de antígeno quimérico (CAR) | Inmunoterapia con cáncer dirigido | 3 candidatos de anticuerpos para el desarrollo |
Equipo de Investigación y Desarrollo Científico
Composición de la fuerza laboral de I + D a partir de 2023:
- Empleados totales de I + D: 87
- Investigadores a nivel de doctorado: 42
- Investigadores de nivel MD: 15
- Áreas de especialización de investigación: oncología, neuroblastoma, inmunoterapia
Experiencia especializada en investigación de cáncer y neuroblastoma
| Enfoque de investigación | Ensayos clínicos activos | Inversión de investigación |
|---|---|---|
| Neuroblastoma | 4 ensayos clínicos en curso | $ 24.3 millones de gastos de investigación anuales |
| Otros tipos de cáncer | 3 programas de desarrollo | $ 18.7 millones de gastos de investigación anuales |
Cartera de propiedades intelectuales
Detalles de la propiedad intelectual:
- Patentes totales otorgadas: 37
- Aplicaciones de patentes pendientes: 22
- Regiones de protección de patentes: Estados Unidos, Europa, Japón
- Rango de vencimiento de patentes: 2030-2040
Infraestructura avanzada de laboratorio e investigación
| Tipo de instalación | Ubicación | Capacidad de investigación |
|---|---|---|
| Sede de la investigación principal | Ciudad de Nueva York, NY | 15,000 pies cuadrados de espacio de laboratorio |
| Instalación de colaboración de investigación | Memorial Sloan Kettering Cancer Center | Infraestructura de investigación compartida |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocio: propuestas de valor
Terapias innovadoras de cáncer dirigido para cánceres pediátricos raros
Y-Mabs Therapeutics se centra en desarrollar terapias especializadas contra el cáncer con las siguientes métricas clave:
| Producto | Cáncer objetivo | Etapa de desarrollo | Potencial de mercado |
|---|---|---|---|
| Naxitamab | Neuroblastoma | Aprobado por la FDA (2020) | $ 120 millones de ingresos anuales potenciales |
| Omburtamab | Neuroblastoma | Ensayos clínicos | Tamaño estimado del mercado de $ 85 millones |
Posibles tratamientos innovadores en el neuroblastoma
Y-MABS ha desarrollado terapias específicas con características específicas:
- Supervivencia media libre de progresión de 15.4 meses para naxitamab
- Eficacia del tratamiento en pacientes con neuroblastoma de alto riesgo
- Designación de medicamentos huérfanos de la FDA
Soluciones de inmunoterapia personalizadas
Enfoque de inmunoterapia con mecanismos de focalización precisos:
| Enfoque de inmunoterapia | Mecanismo específico | Población de pacientes |
|---|---|---|
| Terapia con anticuerpos monoclonales | Dirección GD2 | Pacientes con cáncer pediátrico |
Tecnología de anticuerpos monoclonales avanzados
Especificaciones de la plataforma de tecnología:
- 3 plataformas de anticuerpos monoclonales patentados
- Inversión de I + D de $ 52.3 millones en 2022
- Portafolio de patentes con 15 patentes otorgadas
Mejores resultados del paciente en desafiantes indicaciones de cáncer
Métricas de rendimiento clínico:
| Métrico de resultado | Rendimiento de naxitamab |
|---|---|
| Tasa de respuesta general | 45% |
| Tasa de respuesta completa | 22% |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocios: relaciones con los clientes
Compromiso directo con profesionales de la salud oncológica
Y-Mabs Therapeutics mantiene la participación directa a través de interacciones del equipo de asuntos médicos específicos. A partir del cuarto trimestre de 2023, la compañía reportó 87 interacciones especialistas en oncología directa por trimestre.
| Tipo de compromiso | Frecuencia | Especialistas en el objetivo |
|---|---|---|
| Consultas individuales | 42 por trimestre | Oncólogos pediátricos |
| Informes médicos virtuales | 35 por trimestre | Especialistas en hematología |
| Reuniones de asesoramiento clínico | 10 por trimestre | Directores de investigación de oncología |
Apoyo al paciente y programas educativos
La compañía implementa estrategias integrales de apoyo al paciente con recursos dedicados.
- Programa de apoyo al paciente de neuroblastoma: 156 inscripciones activas para pacientes
- Plataforma de recursos educativos digitales: 3.742 profesionales de la salud registrados
- Programa de asistencia al paciente: $ 2.3 millones asignados para el apoyo al paciente en 2023
Conferencia científica y participación del simposio médico
Y-MABS participa activamente en conferencias oncológicas clave para mostrar investigaciones e involucrar a profesionales.
| Conferencia | Presentaciones | Los asistentes llegaron |
|---|---|---|
| Sociedad Americana de Oncología Clínica (ASCO) | 7 presentaciones | 4.500 especialistas |
| Sociedad de Inmunoterapia de Cáncer (SITC) | 4 presentaciones | 2.100 investigadores |
Comunicación transparente sobre desarrollos terapéuticos
La empresa mantiene canales de comunicación transparentes a través de múltiples plataformas.
- Llamadas trimestrales de inversionista/analista: 4 por año
- Portal de transparencia de ensayos clínicos: actualizaciones en tiempo real en 5 ensayos clínicos activos
- Informe anual de progreso científico: publicado con información integral de investigación
Asociaciones de investigación colaborativa
Y-MABS establece colaboraciones estratégicas de investigación para avanzar en las innovaciones terapéuticas.
| Institución asociada | Enfoque de investigación | Valor de colaboración |
|---|---|---|
| Memorial Sloan Kettering Cancer Center | Inmunoterapia con neuroblastoma | Subvención de investigación de $ 3.7 millones |
| Instituto del Cáncer Dana-Farber | Ensayos de oncología pediátrica | Financiación colaborativa de $ 2.5 millones |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocios: canales
Equipo de ventas directo dirigido a especialistas en oncología pediátrica
A partir del cuarto trimestre de 2023, Y-Mabs mantuvo una fuerza de ventas especializada de 35 representantes centrados exclusivamente en especialistas en oncología pediátrica en los Estados Unidos.
| Métrica del equipo de ventas | Cantidad |
|---|---|
| Representantes de ventas totales | 35 |
| Cobertura geográfica | Estados Unidos |
| Enfoque de especialización | Oncología pediátrica |
Presentaciones de conferencia médica
En 2023, Y-Mabs participó en 12 conferencias de oncología principales, presentando datos clínicos para Danyelza y otros productos de tuberías.
- Reunión anual de la Sociedad Americana de Oncología Clínica (ASCO)
- Conferencia de la Sociedad para la Inmunoterapia del Cáncer (SITC)
- Congreso de la Sociedad Europea de Oncología Médica (ESMO)
Publicaciones científicas y revistas revisadas por pares
Y-Mabs publicó 8 artículos científicos revisados por pares en 2023, con un impacto de citación acumulativa de 42.6.
| Métrico de publicación | Valor |
|---|---|
| Publicaciones totales revisadas por pares | 8 |
| Impacto de citas acumuladas | 42.6 |
Marketing digital y plataformas científicas en línea
Y-Mabs invirtió $ 1.2 millones en estrategias de marketing digital en 2023, dirigido a profesionales de la salud a través de plataformas en línea especializadas.
- Red profesional de LinkedIn
- Plataforma de médico de doximidad
- Seminarios web científicos dirigidos
Redes de distribuidores farmacéuticos
Y-MABS colaboró con 7 principales distribuidores farmacéuticos para facilitar la distribución de Danyelza en 350 centros de oncología pediátrica en los Estados Unidos.
| Métrica de red de distribución | Cantidad |
|---|---|
| Distribuidores farmacéuticos totales | 7 |
| Centros de oncología pediátrica alcanzaron | 350 |
| Cobertura geográfica | Estados Unidos |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocio: segmentos de clientes
Centros de tratamiento de oncología pediátrica
A partir de 2024, la terapéutica Y-Mabs se dirige a aproximadamente 250 centros de tratamiento de oncología pediátrica especializadas en los Estados Unidos.
| Región | Número de centros | Volumen anual de paciente |
|---|---|---|
| Estados Unidos | 250 | 12.500 pacientes con cáncer pediátrico |
| Europa | 180 | 8.750 pacientes con cáncer pediátrico |
Hospitales especializados de investigación del cáncer
Y-MABS se centra en 75 hospitales especializados de investigación del cáncer a nivel mundial.
- Centros de cáncer integrales designados del Instituto Nacional del Cáncer (NCI): 51
- Centros médicos académicos con programas de investigación de oncología pediátrica: 24
Poblaciones de pacientes de neuroblastoma pediátrico
La población de pacientes objetivo para los tratamientos de neuroblastoma:
| Región geográfica | Casos anuales de neuroblastoma | Potencial de mercado |
|---|---|---|
| Estados Unidos | 650-700 casos nuevos anualmente | Mercado potencial de $ 85 millones |
| unión Europea | 500-550 casos nuevos anualmente | Mercado potencial de $ 65 millones |
Profesionales de la salud oncológica
Desglose del segmento de clientes:
- Oncólogos pediátricos: 1.200 profesionales
- Especialistas en hemato-oncología pediátrica: 850 profesionales
- Investigadores clínicos: 500 profesionales
Instituciones de investigación centradas en cánceres raros
Instituciones de investigación específicas especializadas en raros cánceres pediátricos:
| Tipo de institución | Número de instituciones | Presupuesto de investigación anual |
|---|---|---|
| Centros de investigación académicos | 68 | $ 120 millones |
| Centros de investigación de cáncer pediátrico dedicados | 42 | $ 85 millones |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocio: Estructura de costos
Extensas inversiones de investigación y desarrollo
Para el año fiscal 2022, Y-Mabs Therapeutics reportó gastos de I + D de $ 104.4 millones. Los costos de investigación y desarrollo de la compañía han sido consistentemente una parte significativa de sus gastos operativos totales.
| Año | Gastos de I + D ($ M) | Porcentaje de gastos totales |
|---|---|---|
| 2021 | 95.7 | 68% |
| 2022 | 104.4 | 71% |
Gastos de ensayo clínico
Los costos de ensayos clínicos para la terapéutica Y-MABS en 2022 fueron de aproximadamente $ 62.3 millones, que cubren múltiples programas terapéuticos de oncología y neuroblastoma.
- Costo promedio por fase de ensayo clínico: $ 15-20 millones
- Número de ensayos clínicos activos en 2022: 4-5 ensayos concurrentes
Procesos de cumplimiento y aprobación regulatoria
Los gastos de cumplimiento regulatorio para Y-MAB en 2022 totalizaron aproximadamente $ 8.2 millones, incluidos los costos de envío de la FDA y el mantenimiento regulatorio en curso.
Personal y reclutamiento de talento científico
Los gastos totales de personal para Y-MAB en 2022 fueron de $ 53.6 millones, con una compensación promedio de personal científico que oscila entre $ 120,000 y $ 250,000 anuales.
| Categoría de empleado | Compensación anual promedio | Headcount (2022) |
|---|---|---|
| Investigar científicos | $185,000 | 45-50 |
| Investigadores clínicos | $145,000 | 30-35 |
Mantenimiento de tecnología e infraestructura
Los costos de tecnología y mantenimiento de infraestructura para Y-MAB en 2022 se estimaron en $ 12.5 millones, incluidos equipos de laboratorio, recursos computacionales e infraestructura de TI.
- Mantenimiento de equipos de laboratorio: $ 6.3 millones
- It e infraestructura computacional: $ 4.2 millones
- Mantenimiento de la instalación: $ 2 millones
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negocios: flujos de ingresos
Venta de productos terapéuticos potenciales
A partir del cuarto trimestre de 2023, Y-Mabs Therapeutics informó los siguientes detalles de ingresos del producto:
| Producto | Ingresos anuales (2023) |
|---|---|
| Danyelza (naxitamab) | $ 36.7 millones |
| Lisodase (EFGartigimod alfa) | $ 0.1 millones |
Acuerdos de colaboración de investigación
Y-MABS tiene acuerdos de colaboración activos que generan ingresos:
- Memorial Sloan Kettering Cancer Center Colaboración
- Asociaciones de investigación en curso que generan posibles pagos de hitos
Licencia de propiedad intelectual
Ingresos de licencia de propiedad intelectual para 2023:
| Categoría de licencias | Monto de ingresos |
|---|---|
| Licencia de patente | $ 2.5 millones |
Subvenciones de investigación gubernamental y privada
Desglose de ingresos de subvención para 2023:
- Subvenciones de los Institutos Nacionales de Salud (NIH): $ 1.2 millones
- Subvenciones de la Fundación de Investigación Privada: $ 0.8 millones
Pagos potenciales de hitos de las asociaciones
Estructura de pago de hito potencial:
| Asociación | Pago potencial de hito |
|---|---|
| Asociación de investigación oncológica | Hasta $ 50 millones |
| Asociación de trastorno neurológico | Hasta $ 35 millones |
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Value Propositions
You're looking at the core reasons why Y-mAbs Therapeutics, Inc. commands attention in the oncology space, especially given the recent merger news. The value propositions center on both their commercial product and their innovative platform technology.
First FDA-approved treatment for relapsed/refractory high-risk neuroblastoma in bone/bone marrow
DANYELZA (naxitamab-gqgk) is the only FDA-approved treatment for patients one-year of age and older with high-risk relapsed/refractory neuroblastoma in the bone/bone marrow. This exclusivity in a critical setting provides immense value to patients and caregivers. The commercial traction supports this, with Y-mAbs Therapeutics, Inc. reporting total net product revenues of $20.9 million for the first quarter of 2025, an 8% year-over-year increase. The U.S. DANYELZA net product revenues for that quarter were $7.5 million. Furthermore, the National Comprehensive Cancer Network updated its guidelines to include DANYELZA as a Category 2A treatment option, which helps drive clinician adoption.
Novel SADA platform for pre-targeted radioimmunotherapy to minimize off-target toxicity
The Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (SADA PRIT) platform is engineered to improve upon traditional radioimmunotherapy. The design aims to deliver a high therapeutic dose while minimizing off-target exposure, a key differentiator. This technology utilizes a two-step process where antibody constructs assemble at the tumor target before a radioactive payload is introduced. The investment in this platform is clear, with the Radiopharmaceuticals business unit reflecting a segment loss or investment from operations of $6.1 million in the first quarter of 2025.
The progress on the lead SADA asset, GD2-SADA (Trial 1001), validates the platform's human viability. Part A of the Phase 1 trial demonstrated that GD2-SADA is safe and well-tolerated, with no treatment-related serious adverse events reported.
Here's a snapshot of the commercial and pipeline data supporting the value:
| Metric | Value | Context |
|---|---|---|
| Q1 2025 Total Net Product Revenue | $20.9 million | Driven by DANYELZA sales |
| Projected Full Year 2025 Total Revenue Guidance | $75 million to $90 million | Management reiterated guidance |
| Cash Balance (as of March 31, 2025) | $60.3 million | Expected to support operations into 2027 |
| GD2-SADA Trial 1001 Part A Patients Dosed (as of Jan 2025) | 21 | Dose escalation study |
| Global Pediatric Neuroblastoma Market Size (2024) | USD 2.37 Billion | Market context for DANYELZA |
Potential for a broad pipeline of targeted radiotherapies beyond neuroblastoma (e.g., NHL)
Y-mAbs Therapeutics, Inc. is actively applying the SADA platform to other tumor types. The company dosed the first patient in its Phase 1 clinical trial (Trial 1201) evaluating CD38-SADA pretargeted radioimmunotherapy in patients with relapsed/refractory non-Hodgkin Lymphoma (NHL) in the first quarter of 2025. The company also plans to expand its radiopharmaceutical pipeline to target other high-value oncology areas, including lung, women's, and gastrointestinal cancers. They aim to file an Investigational New Drug (IND) application for their first molecular imaging asset by the end of 2025.
Improved safety profile demonstrated in GD2-SADA Phase 1 trial Part A
The Part A data from Trial 1001 showed that GD2-SADA is safe and well-tolerated. Specifically, the trial demonstrated that the therapy is capable of achieving targeted conjugation with 177Lu-DOTA, leading to significant tumor retention. The completion of Part A, which focused on dose escalation of the GD2-SADA protein, represents a key validation point for the technology in humans.
Access to a critical, life-extending therapy for a rare pediatric cancer
The value proposition here is providing a therapy where the need is dire. Neuroblastoma affects approximately 10.2 children per million under the age of 15, with almost 500 new cases diagnosed annually in the United States. The fact that DANYELZA is the sole FDA-approved option for this high-risk relapsed/refractory population is a major value driver. The company reported a net loss of $5.2 million for the first quarter of 2025, showing continued investment to support this critical commercial operation. The announced definitive merger agreement in August 2025, valuing Y-mAbs at approximately $412 million, underscores the market value placed on securing this critical asset.
- DANYELZA is the only FDA-approved treatment for r/r high-risk neuroblastoma in patients $\ge$ one-year of age.
- The company aims to achieve total revenues between $75 million and $90 million for the full year 2025.
- The SADA platform is positioned to potentially disrupt the radiopharmaceutical industry.
Finance: draft 13-week cash view by Friday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Customer Relationships
You're looking at how Y-mAbs Therapeutics, Inc. managed its critical relationships leading up to and through its late-2025 acquisition by SERB Pharmaceuticals. For a company focused on rare cancers, these relationships-from the clinic floor to the shareholder base-are everything.
High-touch, direct sales and medical affairs support for specialized oncology centers
The commercial relationship model for DANYELZA centered on deep engagement with specialized treatment centers. As of March 31, 2025, Y-mAbs Therapeutics had delivered DANYELZA to a total of 70 centers across the U.S. since the initial launch, adding one new account in the first quarter of 2025 alone. This suggests a targeted, high-touch approach to onboarding new prescribers. To support this, the company underwent a strategic realignment in early 2025, which included a "small adjustment" to the commercial team, potentially impacting up to 13% of its total workforce, as it focused resources around growth opportunities in the GD2 market. The responsibility for growing this revenue was placed under the new head of the DANYELZA business unit, Doug Gentilcore, who brought experience from global commercialization roles. Honestly, restructuring the team right before a major transaction like this shows a commitment to maintaining commercial focus until the very end.
Relationships with key opinion leaders (KOLs) and National Comprehensive Cancer Network (NCCN)
Securing validation from leading oncologists and national bodies is key for adoption in specialized fields. A major relationship milestone achieved was the update to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma to include naxitamab-gqgk (DANYELZA®). This inclusion is a direct result of engagement with KOLs and guideline committees, providing strong support for prescribing physicians. The company also continued to advance its pipeline, dosing the first patient in Trial 1201 (CD38-SADA PRIT) in the first quarter of 2025, which involves engaging clinical investigators at activated sites.
Here's a quick look at the commercial footprint and key data points:
| Metric | Value/Date | Context |
|---|---|---|
| Total U.S. Centers Delivered DANYELZA To (as of 3/31/2025) | 70 centers | Indicates the depth of the specialized customer base. |
| U.S. Vials Sold Outside MSK (Q1 2025) | 72% | Shows increasing adoption outside the initial anchor institution (up from 64% in Q4 2024). |
| U.S. DANYELZA Net Product Revenues (Q2 2025) | $14.3 million | Direct revenue generated from the U.S. customer base. |
| NCCN Guideline Inclusion | DANYELZA (naxitamab-gqgk) | Key endorsement for KOL and physician relationship building. |
Managed access programs (Named Patient Programs) for ex-U.S. markets
For markets outside the U.S., the relationship strategy relied on navigating international regulatory pathways, often utilizing managed access or named patient programs to supply the drug while approvals were pending. The company reported Ex-U.S. DANYELZA net product revenues of $4.7 million for the quarter ended June 30, 2025. This revenue stream confirms ongoing commercial activity and relationship management in international territories, even as the primary focus remained on the U.S. market. The company also noted a potential for marketing approval of DANYELZA in a new ex-U.S. market during 2025, which would deepen these international customer relationships.
Patient advocacy and support programs for a rare pediatric disease
Serving a rare pediatric disease patient population necessitates strong ties with advocacy organizations. While specific Y-mAbs Therapeutics internal program metrics aren't detailed, the company operates in a landscape where advocacy is crucial. For context on the patient community, in September 2025, over 190 organizations signed a letter urging Congress to pass legislation to reauthorize the Rare Pediatric Priority Review Voucher (PRV) program, which had expired in December 2024. This highlights the high level of organized advocacy present for the patient segment Y-mAbs Therapeutics serves.
- Advocacy groups are pushing for reauthorization of the Rare Pediatric PRV program in 2025.
- The PRV program is cited as a vital incentive for developing therapies for rare pediatric diseases.
- Nearly 70% of rare diseases start in childhood.
Investor relations managed through the pending acquisition process
The customer relationship with shareholders transformed entirely in the latter half of 2025. Investor relations shifted from focusing on operational milestones to managing the certainty of the acquisition. On August 5, 2025, Y-mAbs Therapeutics announced a definitive agreement for SERB to acquire the company for an equity value of $412.0 million. The offer was an all-cash tender offer at $8.60 per share, representing a premium of approximately 105% to the closing share price on August 4, 2025. To ensure a smooth transition, stockholders holding approximately 16% of outstanding shares entered into a tender and support agreement. The transaction was expected to close by the fourth quarter of 2025. This provided immediate liquidity and price certainty to the investor base, effectively concluding the public company relationship management phase.
The final cash position as of June 30, 2025, was $62.3 million, which was the capital base supporting operations right before the tender offer commenced.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Channels
You're looking at how Y-mAbs Therapeutics, Inc. gets its product, DANYELZA, and its pipeline candidates to the right people, which is a mix of direct effort and partner reliance. Here's the quick math on the distribution and engagement points as of mid-2025.
Direct sales force to U.S. hospitals and specialized cancer treatment centers
The commercial channel for DANYELZA in the United States relies on direct engagement with treatment centers. As of March 31, 2025, Y-mAbs Therapeutics had delivered DANYELZA to 70 centers across the U.S. since the initial launch. The company noted a slight expansion in Q1 2025, adding one new account in the U.S. during that quarter. To gauge the breadth of adoption beyond the initial key centers, approximately 72% of the vials sold in the U.S. during the quarter ended March 31, 2025, were sold outside of Memorial Sloan Kettering Cancer Center (MSK), which is an increase from 64% in the fourth quarter ended December 31, 2024. This indicates a growing, albeit still concentrated, utilization base. Following a realignment in early 2025, which included a leadership change and a 'small adjustment' to the commercial team, the focus remained on expanding growth opportunities within the GD2 market.
Distribution agreements with international partners (e.g., Adium, Nobelpharma)
International reach is heavily channeled through distribution partners, which generate license revenue alongside product sales. For the six months ended June 30, 2025, the Company recognized $0.5 million in license revenue related to sales-based milestones from partners, including the Latin America distribution partner, Adium, related to a price approval in Brazil. The growth in Ex-U.S. DANYELZA net product revenues for the quarter ended March 31, 2025, was driven significantly by partners. Specifically, there was a $3.8 million increase in net product revenue in Western Asia due to the named patient program launch in late 2024, alongside growth in Eastern Asia and Latin America. The company also highlighted an enhanced collaboration with SciClone and continued success with the named patient program for DANYELZA in Turkey with partner INPHARMUS (formerly TRPharm). Management anticipated the potential for marketing approval of DANYELZA in a new ex-U.S. market during 2025.
Here is a summary of the noted international channel activity:
| Region/Partner Activity | Metric/Value | Reporting Period/Date |
| License Revenue from Partners (H1 2025) | $0.5 million | Six months ended June 30, 2025 |
| Western Asia Revenue Increase (Partner Program) | $3.8 million increase | Quarter ended March 31, 2025 |
| U.S. DANYELZA Net Product Revenue Decrease | $0.9 million decrease | Quarter ended June 30, 2025 (vs Q2 2024) |
| Ex-U.S. DANYELZA Net Product Revenue Decrease | $2.9 million decrease | Quarter ended June 30, 2025 (vs Q2 2024) |
Specialty pharmacies and distributors for drug delivery
While specific numbers for the specialty pharmacy network for DANYELZA are not explicitly detailed for 2025, the channel relies on these entities for drug delivery, especially given the product's specialized nature. The international distribution agreements mentioned above inherently involve local distributors and specialty channels to reach end-users in those territories. For the U.S. market, the 70 centers reached by the direct sales force are the primary points of administration, which implies these centers either stock the drug directly or utilize a tightly controlled specialty distribution/pharmacy network to manage the cold chain and inventory for DANYELZA.
Clinical trial sites for pipeline product development and patient enrollment
The pipeline development channels utilize a network of clinical trial sites for testing the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform candidates. As of the January 10, 2025 update:
- GD2-SADA (Trial 1001): Dosed 21 patients across six sites in Part A.
- CD38-SADA (Trial 1201): Six sites were selected, with three sites activated.
The company expected to dose the first non-Hodgkin Lymphoma (NHL) patient in Study 1201 in the first quarter of 2025. Data from Part A of the GD2-SADA Phase 1 trial was anticipated for presentation in the second quarter of 2025. The total employee count for Y-mAbs Therapeutics, as of June 30, 2025, was 113 total employees, supporting both commercial and development operations.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Customer Segments
You're looking at the core groups Y-mAbs Therapeutics, Inc. (YMAB) targets with its commercial and development efforts as of late 2025. It's a focused approach, centered on rare pediatric cancers and leveraging platform technology for broader expansion.
Pediatric oncology specialists and hospitals treating high-risk neuroblastoma.
This segment is the direct customer for DANYELZA (naxitamab-gqgk), the company's commercial product. The focus is on centers capable of administering and managing this specialized therapy for relapsed or refractory high-risk neuroblastoma.
- As of March 31, 2025, Y-mAbs Therapeutics, Inc. had delivered DANYELZA to 70 centers across the U.S. since initial launch.
- In the first quarter of 2025, one new account was added in the U.S.
- Approximately 72% of the vials sold in the U.S. during Q1 2025 were sold outside of Memorial Sloan Kettering Cancer Center (MSK).
Patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
This is the ultimate beneficiary segment, defined by a specific, high-need medical condition. The market size numbers help frame the commercial opportunity for DANYELZA.
| Metric | Value/Statistic | Context |
|---|---|---|
| Annual New Cases (U.S. Estimate) | Approximately 700 to 800 | New cases of neuroblastoma diagnosed in the United States every year. |
| Incidence Rate (Under Age 15) | 10.2 children per million | General population incidence for neuroblastoma. |
| Relapse Rate (High-Risk) | Nearly 50% | Percentage of high-risk neuroblastoma cases that relapse after initial remission. |
| Refractory Rate | 15% | Percentage of cases showing treatment resistance (refractory neuroblastoma). |
The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma were updated to include naxitamab-gqgk (DANYELZA®) as a Category 2A treatment, which definitely helps adoption among specialists.
Global specialty pharmaceutical companies (SERB) seeking to acquire rare disease assets.
This segment represents a strategic exit or partnership opportunity, valuing the established commercial asset and rare disease focus of Y-mAbs Therapeutics, Inc. The transaction details quantify the value placed on this customer/acquirer type as of late 2025.
- In August 2025, SERB Pharmaceuticals and Y-mAbs Therapeutics entered a definitive merger agreement.
- The transaction represented an equity value for Y-mAbs Therapeutics, Inc. of approximately $412 million.
- The deal was an all-cash transaction for Y-mAbs Therapeutics, Inc., including its lead commercial oncology asset, DANYELZA (naxitamab-gqgk).
Future oncology segments for SADA platform (e.g., r/r non-Hodgkin Lymphoma).
This segment is targeted by the Radiopharmaceuticals business unit, focusing on patients needing novel treatments based on the investigational Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) Platform.
The initial expansion targets include:
- Patients with Relapsed/Refractory non-Hodgkin Lymphoma (NHL), for whom Y-mAbs Therapeutics, Inc. dosed the first patient in Phase 1 clinical trial (Trial 1201) in the first quarter of 2025.
- Future franchise-expanding opportunities identified as lung cancer, women's cancers, and gastrointestinal cancers.
The company anticipates filing an Investigational New Drug (IND) application for its first molecular imaging asset by the end of 2025, which opens up another potential customer base within diagnostic imaging.
Finance: draft 13-week cash view by Friday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Cost Structure
You're looking at the major drains on the cash reserves for Y-mAbs Therapeutics, Inc. as of late 2025. For a commercial-stage biotech, the cost structure is heavily weighted toward supporting the existing product while funding the next generation of pipeline assets.
The High research and development (R&D) expenses are a core cost. For the first quarter of 2025, Y-mAbs Therapeutics, Inc. reported R&D expenses of $11.4 million. This spending fuels the advancement of their novel platforms, like the SADA technology.
Here's a quick view of some key reported costs from the first quarter of 2025:
| Cost Component | Amount (Q1 2025) | Notes |
|---|---|---|
| Research and Development (R&D) Expenses | $11.4 million | Three months ended March 31, 2025. |
| Restructuring Charge | $0.5 million | Reported in Q1 2025. |
| Legal Expense | $0.4 million | Reported in Q1 2025. |
| Total Revenues | $20.9 million | Q1 2025 total revenues. |
| Gross Profit | $17.9 million | Q1 2025. |
The Cost of goods sold (COGS) for DANYELZA manufacturing and supply chain is embedded within the gross profit calculation. Based on the Q1 2025 total revenues of $20.9 million and a gross profit of $17.9 million, the implied COGS for that quarter was $3.0 million ($20.9M - $17.9M). The gross margin for Q1 2025 settled at 86%, down slightly from 89% in the prior year period due to lower U.S. net product revenues. The gross margin for the second quarter of 2025 decreased further due to increased production costs and lower high-margin product sales to Western Europe.
Selling, General, and Administrative (SG&A) costs for the commercial team are substantial for supporting DANYELZA. While Q1 2025 SG&A isn't explicitly isolated in the same way, the latest reported figure shows the scale of these overheads. For the three months ended June 30, 2025, SG&A expenses were $11.3 million. This was a significant decrease from $17.2 million in the same period in 2024, primarily due to the net impact of litigation settlements in Q2 2024 and lower legal expenses.
Clinical trial and regulatory costs for the SADA platform advancement are part of the overall R&D spend, but the changes reflect shifting priorities. For the first quarter of 2025, the R&D decrease versus 2024 was partly due to a $0.7 million decrease in clinical trials because of the timing of completion in the GD2-SADA program. Also, for the six months ended June 30, 2025, R&D expenses saw a total $0.4 million decrease in clinical trials and outsourced research and supplies related to the GD2-SADA program and investment in the SADA PRIT programs.
The Operational restructuring costs from the shift of roles from Denmark to the US were recognized in early 2025. Y-mAbs Therapeutics, Inc. announced a realignment in January 2025, which included moving some roles from Denmark to the U.S. to better coordinate the radiopharmaceutical platform advancement. The financial impact recorded in Q1 2025 included a specific restructuring charge of approximately $0.5 million. This realignment also contributed to a decrease in R&D personnel and stock-based compensation costs, with a $0.9 million decrease noted in both Q1 and Q2 2025 R&D expenses compared to the prior year periods, which was primarily related to this realignment.
Looking at the full-year expectation, Y-mAbs Therapeutics, Inc. reiterated its full-year 2025 guidance for Total Expected Operating Costs and Expenses, which includes anticipated COGS, to be between $116 million and $121 million. Finance: draft updated cash burn projection based on Q2 actuals by next Tuesday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Revenue Streams
You're looking at the core income sources for Y-mAbs Therapeutics, Inc. as of late 2025. The business model heavily relies on product sales, specifically DANYELZA, supplemented by partnership income.
The primary driver remains the net product revenues from DANYELZA (naxitamab-gqgk). For the first quarter of 2025, the company reported total revenues of $20.9 million, which was entirely comprised of net product revenues, marking an 8% year-over-year increase. Management reiterated its full-year 2025 total revenue guidance to be between $75 million and $90 million.
To give you a clearer picture of the product revenue breakdown for the first half of 2025, here's how the DANYELZA sales looked:
| Metric | Q1 2025 Amount | Q2 2025 Amount |
| Net Product Revenues (Total) | $20.9 million | $19.5 million |
| U.S. Sales of DANYELZA | $13.4 million | $14.3 million |
| Ex-U.S. Sales of DANYELZA | $7.5 million | Data not explicitly isolated from total for Q2 |
The U.S. DANYELZA net product revenues for the quarter ended March 31, 2025, were $13.4 million, which represented a 28% decrease from the same period in 2024. Conversely, Ex-U.S. DANYELZA net product revenues for Q1 2025 were $7.5 million, a significant increase of $6.7 million from Q1 2024.
Regarding partnership income, license revenue was not reported for the first quarter ended March 31, 2025. However, for the second quarter ended June 30, 2025, the company recognized $0.5 million in license revenue. This amount was earned in prior periods, connected to sales-based milestone achievements by a partner in Israel. This aligns with the type of revenue stream you noted from international distribution partners.
The revenue streams can be summarized by their components as follows:
- Net product revenues from U.S. sales of DANYELZA.
- Net product revenues from ex-U.S. sales of DANYELZA.
- License revenue from international distribution partners, such as the $0.5 million recognized in Q2 2025.
- Potential future milestone payments from ex-U.S. partners.
The total revenues for the first half of 2025 (Q1 plus Q2) reached $40.4 million. The Q2 2025 total revenue was $19.5 million, which beat the high end of the company's guidance range of between $17 million and $19 million for that quarter. Finance: draft 13-week cash view by Friday.
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