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Y-Mabs Therapeutics, Inc. (YMAB): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Y-mAbs Therapeutics, Inc. (YMAB) Bundle
No mundo da oncologia de precisão de ponta, a Y-Mabs Therapeutics surge como um farol de esperança, terapias transformadoras pioneiras para cânceres pediátricos raros por meio de seu inovador modelo de negócios. Ao alavancar a tecnologia avançada de anticorpos monoclonais e colaborações estratégicas, a empresa está redefinindo o tratamento direcionado ao câncer, concentrando -se intensamente em soluções inovadoras para o neuroblastoma e outras malignidades pediátricas desafiadoras. Sua abordagem única combina experiência científica, infraestrutura de pesquisa robusta e uma missão centrada no paciente, posicionando o Y-MABS como um potencial mudança de jogo no complexo cenário de imunoterapêuticos especializados.
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: Parcerias -chave
Colaborações estratégicas com instituições de pesquisa acadêmica
A Y-MABS Therapeutics estabeleceu parcerias críticas de pesquisa com as seguintes instituições acadêmicas:
| Instituição | Foco na pesquisa | Ano de colaboração |
|---|---|---|
| Memorial Sloan Kettering Cancer Center | Pesquisa de neuroblastoma | 2015 |
| Universidade de Copenhague | Desenvolvimento de anticorpos | 2017 |
Acordos de licenciamento com empresas de biotecnologia e farmacêutica
As principais parcerias de licenciamento incluem:
- Memorial Sloan Kettering Cancer Center - Licenciamento exclusivo para tecnologias de anticorpos de alvo GD2
- Genentech - Acordo de Pesquisa Colaborativa para Tratamentos de Oncologia Pediátrica
Organizações de manufatura contratadas para suporte à produção
| Parceiro de fabricação | Serviços prestados | Valor do contrato |
|---|---|---|
| Lonza Group AG | Fabricação biológica em escala comercial | US $ 12,5 milhões anualmente |
| Samsung Biologics | Produção biológica em estágio clínico | US $ 8,3 milhões por projeto |
Parceiros de pesquisa de ensaios clínicos e centros médicos
Colaborações de ensaios clínicos ativos:
- Hospital de Pesquisa Infantil de St. Jude - ensaios de oncologia pediátrica
- Instituto de Câncer Dana -Farber - Estudos de Pesquisa de Neuroblastoma
- Centro Médico do Hospital Infantil de Cincinnati - Investigações de câncer pediátrico raros
Investimento total de parceria em 2023: US $ 37,6 milhões
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: Atividades -chave
Oncologia e neuroblastoma Pesquisa e desenvolvimento terapêuticos
A Y-MABS Therapeutics se concentra no desenvolvimento de terapias de anticorpos direcionadas para câncer pediátrico raro. A partir de 2023, a empresa tem 2 terapias aprovadas pela FDA: Danyelza (Naxitamab) e omburtamab.
| Foco na pesquisa | Número de programas ativos | Estágio de desenvolvimento |
|---|---|---|
| Terapias de neuroblastoma | 3 | Estágio clínico |
| Outras terapias de câncer pediátricas | 2 | Estágio pré -clínico |
Gerenciamento de ensaios clínicos e avanço de candidatos a drogas
A empresa mantém um pipeline de desenvolvimento clínico ativo com vários ensaios em andamento.
- Total de ensaios clínicos: 5 ensaios ativos a partir do quarto trimestre 2023
- Investimento em P&D: US $ 95,3 milhões em 2022
- Locais de ensaios clínicos: principalmente Estados Unidos
Processos de conformidade regulatória e submissão da FDA
| Marco regulatório | Data | Resultado |
|---|---|---|
| Danyelza FDA Aprovação | Novembro de 2020 | Aprovado para neuroblastoma |
| Omburtamab FDA Aprovação | Dezembro de 2021 | Aprovado para metástases CNs/leptomeningeais |
Proteção à propriedade intelectual e desenvolvimento de patentes
O Y-MABS mantém um portfólio robusto de propriedade intelectual.
- Total de pedidos de patente: 18
- Patentes concedidas: 12
- Jurisdições de patentes: Estados Unidos, Europa, Japão
Engenharia de anticorpos de precisão e inovação terapêutica
| Plataforma de tecnologia | Características únicas | Status de desenvolvimento |
|---|---|---|
| Engenharia de anticorpos de precisão | Terapias de câncer pediátricas direcionadas | Pesquisa em andamento |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: Recursos -chave
Plataformas de tecnologia de anticorpos proprietários
A terapêutica Y-MABS aproveita 2 plataformas de tecnologia de anticorpos primários:
| Plataforma | Características | Número de anticorpos desenvolvidos |
|---|---|---|
| Plataforma de anticorpos humanizados em Y-Mabs | Anticorpos terapêuticos de engenharia de precisão | 5 anticorpos em estágio clínico |
| Plataforma de receptor de antígeno quimérico (CAR) | Imunoterapia com câncer direcionado | 3 candidatos a anticorpos de desenvolvimento |
Equipe de Pesquisa e Desenvolvimento Científica
Composição da força de trabalho em P&D a partir de 2023:
- Funcionários totais de P&D: 87
- Pesquisadores no nível de doutorado: 42
- Pesquisadores no nível do MD: 15
- Áreas de especialização de pesquisa: oncologia, neuroblastoma, imunoterapia
Experiência especializada em câncer e neuroblastoma
| Foco na pesquisa | Ensaios clínicos ativos | Investimento em pesquisa |
|---|---|---|
| Neuroblastoma | 4 ensaios clínicos em andamento | US $ 24,3 milhões de despesas de pesquisa anuais |
| Outros tipos de câncer | 3 programas de desenvolvimento | US $ 18,7 milhões de despesas de pesquisa anuais |
Portfólio de propriedade intelectual
Detalhes da propriedade intelectual:
- Total de patentes concedidas: 37
- Aplicações de patentes pendentes: 22
- Regiões de proteção de patentes: Estados Unidos, Europa, Japão
- Faixa de expiração de patentes: 2030-2040
Infraestrutura de laboratório e pesquisa avançada
| Tipo de instalação | Localização | Capacidade de pesquisa |
|---|---|---|
| Principal sede da pesquisa | Nova York, NY | 15.000 pés quadrados no espaço de laboratório |
| Instalação de colaboração de pesquisa | Memorial Sloan Kettering Cancer Center | Infraestrutura de pesquisa compartilhada |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: proposições de valor
Terapias de câncer direcionadas inovadoras para câncer pediátrico raro
A Y-MABS Therapeutics se concentra no desenvolvimento de terapias especializadas contra o câncer com as seguintes métricas-chave:
| Produto | Câncer alvo | Estágio de desenvolvimento | Potencial de mercado |
|---|---|---|---|
| Naxitamab | Neuroblastoma | FDA aprovado (2020) | Receita anual potencial de US $ 120 milhões |
| Omburtamab | Neuroblastoma | Ensaios clínicos | Tamanho estimado de mercado de US $ 85 milhões |
Potenciais tratamentos inovadores no neuroblastoma
A Y-MABS desenvolveu terapias direcionadas com características específicas:
- Sobrevivência mediana sem progressão de 15,4 meses para Naxitamab
- Eficácia do tratamento em pacientes com neuroblastoma de alto risco
- Designação de medicamentos órfãos pela FDA
Soluções de imunoterapia personalizadas
Abordagem de imunoterapia com mecanismos de segmentação precisos:
| Abordagem de imunoterapia | Mecanismo específico | População de pacientes |
|---|---|---|
| Terapia com anticorpos monoclonais | Direcionamento de GD2 | Pacientes com câncer pediátrico |
Tecnologia avançada de anticorpos monoclonais
Especificações da plataforma de tecnologia:
- 3 plataformas de anticorpos monoclonais proprietários
- Investimento de P&D de US $ 52,3 milhões em 2022
- Portfólio de patentes com 15 patentes concedidas
Melhores resultados dos pacientes em desafiar indicações de câncer
Métricas de desempenho clínico:
| Métrica de resultado | Desempenho de Naxitamab |
|---|---|
| Taxa de resposta geral | 45% |
| Taxa de resposta completa | 22% |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: Relacionamentos do cliente
Engajamento direto com profissionais de saúde oncológicos
A Y-MABS Therapeutics mantém o envolvimento direto por meio de interações da equipe de assuntos médicos direcionados. A partir do quarto trimestre de 2023, a empresa registrou 87 interações especializadas em oncologia direta por trimestre.
| Tipo de engajamento | Freqüência | Especialistas -alvo |
|---|---|---|
| Consultas individuais | 42 por trimestre | Oncologistas pediátricos |
| Briefings médicos virtuais | 35 por trimestre | Especialistas em hematologia |
| Reuniões de consultoria clínica | 10 por trimestre | Diretores de pesquisa de oncologia |
Apoio ao paciente e programas educacionais
A empresa implementa estratégias abrangentes de apoio ao paciente com recursos dedicados.
- Programa de Apoio ao Paciente de Neuroblastoma: 156 Inscrições Ativas de Pacientes
- Plataforma de Recursos Educacionais Digital: 3.742 Profissionais de Saúde Registrados
- Programa de assistência ao paciente: US $ 2,3 milhões alocados para apoio do paciente em 2023
Conferência Científica e Participação do Simpósio Médico
O Y-MABS participa ativamente de conferências importantes de oncologia para mostrar pesquisas e envolver profissionais.
| Conferência | Apresentações | Os participantes chegaram |
|---|---|---|
| Sociedade Americana de Oncologia Clínica (ASCO) | 7 apresentações | 4.500 especialistas |
| Sociedade de Imunoterapia do Câncer (SITC) | 4 apresentações | 2.100 pesquisadores |
Comunicação transparente sobre desenvolvimentos terapêuticos
A empresa mantém canais de comunicação transparentes através de várias plataformas.
- Chamadas trimestrais de investidor/analista: 4 por ano
- Portal de transparência de ensaios clínicos: atualizações em tempo real em 5 ensaios clínicos ativos
- Relatório anual de progresso científico: publicado com insights abrangentes de pesquisa
Parcerias de pesquisa colaborativa
O Y-MABS estabelece colaborações estratégicas de pesquisa para promover inovações terapêuticas.
| Instituição parceira | Foco na pesquisa | Valor de colaboração |
|---|---|---|
| Memorial Sloan Kettering Cancer Center | Imunoterapia com neuroblastoma | Granta de pesquisa de US $ 3,7 milhões |
| Instituto de Câncer Dana-Farber | Ensaios de oncologia pediátrica | Financiamento colaborativo de US $ 2,5 milhões |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: canais
Equipe direta de vendas direcionando especialistas em oncologia pediátrica
No quarto trimestre 2023, a Y-MABS manteve uma força de vendas especializada de 35 representantes focados exclusivamente em especialistas em oncologia pediátrica nos Estados Unidos.
| Métrica da equipe de vendas | Quantidade |
|---|---|
| Total de representantes de vendas | 35 |
| Cobertura geográfica | Estados Unidos |
| Foco de especialização | Oncologia Pediátrica |
Apresentações da conferência médica
Em 2023, o Y-MABS participou de 12 principais conferências de oncologia, apresentando dados clínicos para Danyelza e outros produtos de pipeline.
- Reunião Anual da Sociedade Americana de Oncologia Clínica (ASCO)
- Conferência da Sociedade de Imunoterapia do Câncer (SITC)
- Congresso da Sociedade Europeia de Oncologia Médica (ESMO)
Publicações científicas e revistas revisadas por pares
A Y-MABS publicou 8 artigos científicos revisados por pares em 2023, com um impacto cumulativo de citação de 42.6.
| Métrica de publicação | Valor |
|---|---|
| Total de publicações revisadas por pares | 8 |
| Impacto cumulativo de citação | 42.6 |
Marketing digital e plataformas científicas on -line
A Y-MABS investiu US $ 1,2 milhão em estratégias de marketing digital em 2023, visando profissionais de saúde por meio de plataformas on-line especializadas.
- Rede Profissional do LinkedIn
- Plataforma médica de Doximity
- Webinars científicos direcionados
Redes de distribuidores farmacêuticos
A Y-MABS colaborou com 7 principais distribuidores farmacêuticos para facilitar a distribuição de Danyelza em 350 centros de oncologia pediátrica nos Estados Unidos.
| Métrica de rede de distribuição | Quantidade |
|---|---|
| Distribuidores farmacêuticos totais | 7 |
| Centros de oncologia pediátricos atingiram | 350 |
| Cobertura geográfica | Estados Unidos |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: segmentos de clientes
Centros de tratamento de oncologia pediátrica
A partir de 2024, a Y-MABS Therapeutics tem como alvo aproximadamente 250 centros especializados de tratamento de oncologia pediátrica nos Estados Unidos.
| Região | Número de centros | Volume anual do paciente |
|---|---|---|
| Estados Unidos | 250 | 12.500 pacientes com câncer pediátrico |
| Europa | 180 | 8.750 pacientes com câncer pediátrico |
Hospitais especializados de pesquisa de câncer
O Y-MABS se concentra em 75 hospitais especializados em pesquisa de câncer em todo o mundo.
- Instituto Nacional do Câncer (NCI) Centros de Câncer Abrangentes Designados: 51
- Centros Médicos Acadêmicos com Programas de Pesquisa em Oncologia Pediátrica: 24
Populações de pacientes com neuroblastoma pediátrico
População alvo de pacientes para tratamentos de neuroblastoma:
| Região geográfica | Casos anuais de neuroblastoma | Potencial de mercado |
|---|---|---|
| Estados Unidos | 650-700 novos casos anualmente | Mercado potencial de US $ 85 milhões |
| União Europeia | 500-550 novos casos anualmente | Mercado potencial de US $ 65 milhões |
Profissionais de Saúde Oncológicos
Aparelhamento do segmento de clientes:
- Oncologistas pediátricos: 1.200 profissionais
- Especialistas em hemato-oncologia pediátrica: 850 profissionais
- Pesquisadores clínicos: 500 profissionais
Instituições de pesquisa focadas em cânceres raros
Instituições de pesquisa direcionadas especializadas em câncer pediátrico raro:
| Tipo de instituição | Número de instituições | Orçamento de pesquisa anual |
|---|---|---|
| Centros de pesquisa acadêmica | 68 | US $ 120 milhões |
| Centros dedicados de pesquisa de câncer pediátrico | 42 | US $ 85 milhões |
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: estrutura de custos
Extensos investimentos em pesquisa e desenvolvimento
Para o ano fiscal de 2022, a Y-MABS Therapeutics registrou despesas de P&D de US $ 104,4 milhões. Os custos de pesquisa e desenvolvimento da Companhia têm sido consistentemente uma parcela significativa de suas despesas operacionais totais.
| Ano | Despesas de P&D ($ M) | Porcentagem do total de despesas |
|---|---|---|
| 2021 | 95.7 | 68% |
| 2022 | 104.4 | 71% |
Despesas de ensaios clínicos
Os custos de ensaios clínicos para a terapêutica Y-MABS em 2022 foram de aproximadamente US $ 62,3 milhões, cobrindo vários programas terapêuticos de oncologia e neuroblastoma.
- Custo médio por fase de ensaios clínicos: US $ 15-20 milhões
- Número de ensaios clínicos ativos em 2022: 4-5 ensaios simultâneos
Processos de conformidade e aprovação regulatórios
As despesas de conformidade regulatória para Y-MABs em 2022 totalizaram aproximadamente US $ 8,2 milhões, incluindo custos de envio da FDA e manutenção regulatória em andamento.
Pessoal e recrutamento de talentos científicos
As despesas totais de pessoal para Y-MABs em 2022 foram de US $ 53,6 milhões, com uma compensação média da equipe científica variando de US $ 120.000 a US $ 250.000 anualmente.
| Categoria de funcionários | Compensação média anual | Headcount (2022) |
|---|---|---|
| Cientistas de pesquisa | $185,000 | 45-50 |
| Pesquisadores clínicos | $145,000 | 30-35 |
Manutenção de tecnologia e infraestrutura
Os custos de manutenção de tecnologia e infraestrutura para Y-MABs em 2022 foram estimados em US $ 12,5 milhões, incluindo equipamentos de laboratório, recursos computacionais e infraestrutura de TI.
- Manutenção de equipamentos de laboratório: US $ 6,3 milhões
- TI e infraestrutura computacional: US $ 4,2 milhões
- Manutenção da instalação: US $ 2 milhões
Y -Mabs Therapeutics, Inc. (YMAB) - Modelo de negócios: fluxos de receita
Vendas potenciais de produtos terapêuticos
A partir do quarto trimestre 2023, a Y-Mabs Therapeutics relatou os seguintes detalhes da receita do produto:
| Produto | Receita anual (2023) |
|---|---|
| Danyelza (Naxitamab) | US $ 36,7 milhões |
| Lisodase (efgartigimod alfa) | US $ 0,1 milhão |
Acordos de colaboração de pesquisa
Y-MABS possui acordos de colaboração ativos gerando receita:
- Memorial Sloan Kettering Cancer Center Collaboration
- Parcerias de pesquisa em andamento, gerando possíveis pagamentos de marcos
Propriedade intelectual de licenciamento
Receita de licenciamento de propriedade intelectual para 2023:
| Categoria de licenciamento | Valor da receita |
|---|---|
| Licenciamento de patentes | US $ 2,5 milhões |
Subsídios do governo e de pesquisa privada
Concessão de receita para 2023:
- Institutos Nacionais de Saúde (NIH) Subsídios: US $ 1,2 milhão
- Subsídios da Fundação de Pesquisa Privada: US $ 0,8 milhão
Potenciais pagamentos marcantes de parcerias
Estrutura potencial de pagamento em marcos:
| Parceria | Pagamento em potencial |
|---|---|
| Parceria de Pesquisa de Oncologia | Até US $ 50 milhões |
| Parceria do Transtorno Neurológico | Até US $ 35 milhões |
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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