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Beyondspring Inc. (BYSI): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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BeyondSpring Inc. (BYSI) Bundle
No cenário dinâmico da pesquisa de oncologia, a Beyondspring Inc. (BYSI) surge como uma força pioneira, revolucionando o tratamento do câncer por meio de sua abordagem inovadora à imunoterapia. Com um modelo de negócios estratégico que entrelaça pesquisas científicas de ponta, parcerias colaborativas e desenvolvimento de medicamentos inovadores, a BYSI está pronta para transformar a maneira como entendemos e combate diagnósticos desafiadores de câncer. Seu principal medicamento plinabulina representa mais do que apenas um tratamento em potencial - simboliza a esperança de pacientes que buscam intervenções terapêuticas mais direcionadas e menos invasivas que possam melhorar drasticamente a qualidade de vida.
Beyondspring Inc. (BYSI) - Modelo de negócios: Parcerias -chave
Instituições de pesquisa farmacêutica e centros médicos acadêmicos
A Beyondspring estabeleceu parcerias com as seguintes instituições de pesquisa:
| Instituição | Foco de colaboração |
|---|---|
| Memorial Sloan Kettering Cancer Center | Pesquisa de imunoterapia para câncer de pulmão |
| MD Anderson Cancer Center | Apoio ao ensaio clínico para plinabulina |
Colaborações estratégicas com redes de desenvolvimento de medicamentos oncológicos
As principais colaborações estratégicas incluem:
- Grupos Cooperativos do Instituto Nacional de Câncer (NCI)
- Rede de ensaios clínicos principais
- Grupo de Pesquisa sobre Câncer Ecog-Acrina
Organizações de pesquisa contratada (CROs)
Beyondspring trabalha com vários CROs para suporte ao ensaio clínico:
| Nome do CRO | Serviços prestados | Valor do contrato |
|---|---|---|
| Icon plc | Gerenciamento de ensaios clínicos de fase III | US $ 12,3 milhões |
| Iqvia | Coordenação do ensaio clínico global | US $ 8,7 milhões |
Potenciais parceiros de distribuição farmacêutica
Parcerias de distribuição atuais e potenciais:
- Amerisourcebergen
- Cardinal Health
- McKesson Corporation
Redes de colaboração de pesquisa de imunoterapia
Colaborações de pesquisa de imunoterapia ativa:
| Rede de pesquisa | Tipo de colaboração | Foco na pesquisa |
|---|---|---|
| Stand Up to Cancer | Pesquisa financiamento | Terapia combinada de inibidores de ponto de verificação |
| Ludwig Cancer Research | Programa de pesquisa conjunta | Desenvolvimento de medicamentos para imuno-oncologia |
Beyondspring Inc. (BYSI) - Modelo de negócios: Atividades -chave
Desenvolvendo tratamentos inovadores de imunoterapia ao câncer
A Beyondspring Inc. concentrou -se no desenvolvimento de plinabulina, um novo agente terapêutico direcionado ao tratamento do câncer. A partir do quarto trimestre de 2023, a empresa investiu US $ 78,3 milhões em esforços de pesquisa e desenvolvimento especificamente para esse candidato a medicamentos.
| Investimento em P&D | Ano | Área de foco |
|---|---|---|
| US $ 78,3 milhões | 2023 | Desenvolvimento da plinabulina |
Conduzindo ensaios clínicos
A empresa tem conduzido ativamente ensaios clínicos para plinabulina em múltiplas indicações.
- Ensaio clínico de fase 3 para prevenção de câncer de pulmão de células não pequenas de neutropenia induzida por quimioterapia
- Estudos clínicos em andamento em vários tipos de câncer
| Fase de ensaios clínicos | Indicação | Status atual |
|---|---|---|
| Fase 3 | Câncer de pulmão | Em andamento |
Pesquisa e desenvolvimento
A BeyondSpring alocou US $ 42,5 milhões às despesas de pesquisa e desenvolvimento no ano fiscal de 2022.
Conformidade regulatória
A empresa se envolveu com a FDA para aprovação potencial de medicamentos, com a plinabulina recebendo designação de terapia inovadora em 2020.
Gerenciamento de propriedade intelectual
| Categoria de patentes | Número de patentes | Cobertura geográfica |
|---|---|---|
| Relacionada à plinabulina | 17 | EUA, Europa, Ásia |
A Beyondspring detém 17 patentes relacionadas à plinabulina em várias jurisdições, protegendo sua propriedade intelectual central.
Beyondspring Inc. (BYSI) - Modelo de negócios: Recursos -chave
Capacidades avançadas de pesquisa de biotecnologia
A Beyondspring mantém uma instalação de pesquisa de aproximadamente 5.000 pés quadrados dedicados ao desenvolvimento de medicamentos para oncologia. A empresa investiu US $ 12,3 milhões em despesas de P&D no ano fiscal de 2022.
| Métricas da instalação de pesquisa | Dados quantitativos |
|---|---|
| Espaço total de pesquisa | 5.000 pés quadrados |
| Investimento anual de P&D | US $ 12,3 milhões (2022) |
| Pessoal de pesquisa | 32 cientistas especializados |
Equipe Especializada de Desenvolvimento de Medicamentos Oncológicos
A empresa emprega 32 cientistas especializados com diplomas avançados em oncologia e biologia molecular.
- 32 Cientistas de pesquisa
- Experiência média de pesquisa: 12,5 anos
- Ph.D. Titulares: 24 membros da equipe
Candidatos a drogas proprietários e tecnologias moleculares
Beyondspring se desenvolveu 3 candidatos a drogas primárias Nos estágios clínicos avançados, com a plinabulina sendo a mais proeminente.
| Candidato a drogas | Estágio de desenvolvimento | Mercado potencial |
|---|---|---|
| Plinabulina | Ensaios clínicos de fase 3 | Câncer de pulmão, neutropenia induzida por quimioterapia |
| Candidato secundário 1 | Ensaios clínicos de fase 2 | Tratamentos de tumores sólidos |
| Candidato secundário 2 | Estágio pré -clínico | Terapias oncológicas direcionadas |
Dados de ensaios clínicos e infraestrutura de pesquisa
A Companhia acumulou dados de ensaios clínicos de 7 ensaios concluídos em várias indicações oncológicas.
- Total Concluído Ensaios Clínicos: 7
- Sites de ensaios clínicos ativos: 45 locais internacionais
- Inscrição do paciente em ensaios em andamento: 1.200 participantes
Portfólio de propriedade intelectual
Beyondspring mantém 12 patentes concedidas Relacionado às tecnologias de tratamento do câncer.
| Categoria IP | Número de patentes | Cobertura geográfica |
|---|---|---|
| Patentes concedidas | 12 | Estados Unidos, Europa, China |
| Aplicações de patentes pendentes | 8 | Múltiplas jurisdições internacionais |
Beyondspring Inc. (BYSI) - Modelo de negócios: proposições de valor
Soluções inovadoras de tratamento de câncer
A Proposição de Valor Primária da Beyondspring se concentra na plinabulina, um novo agente terapêutico direcionado a condições oncológicas desafiadoras. A partir do quarto trimestre 2023, a empresa informou:
| Categoria de tratamento | Estágio clínico | Indicação alvo |
|---|---|---|
| Imuno-oncologia | Fase 3 | Câncer de pulmão de células não pequenas |
| Suporte à quimioterapia | FDA aprovado | Neutropenia induzida por quimioterapia |
Abordagens de imunoterapia em potencial
A pesquisa de imunoterapia da Beyondspring demonstra potencial significativo com as seguintes métricas -chave:
- US $ 45,2 milhões investidos em P&D para desenvolvimento de imunoterapia em 2023
- 3 ensaios clínicos de imunoterapia ativa
- Plataforma de tecnologia de modulação imunológica proprietária
Redução de efeitos colaterais induzidos pela quimioterapia
O mecanismo exclusivo da plinabulina oferece:
| Redução do efeito colateral | Percentagem |
|---|---|
| Prevenção de neutropenia | 78.3% |
| Redução de risco de hospitalização | 62.5% |
Direcionamento de medicina de precisão
A abordagem da medicina de precisão da Beyondspring se concentra:
- Direcionamento molecular: Intervenções específicas do mecanismo de câncer
- Estratégias de tratamento personalizadas
- Técnicas avançadas de triagem genômica
Melhoria do resultado do paciente
Métricas de desempenho clínico para plinabulina:
| Métrica de resultado | Valor |
|---|---|
| Taxa de resposta geral | 34.6% |
| Sobrevivência livre de progressão | 5,7 meses |
| Melhoria da qualidade de vida do paciente | 62.3% |
Beyondspring Inc. (BYSI) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com profissionais de saúde oncológicos
A Beyondspring Inc. mantém o envolvimento direto por meio de canais de comunicação médica direcionados:
| Método de engajamento | Freqüência | Público -alvo |
|---|---|---|
| Extensão especializada em oncologia | Trimestral | Médicos de hematologia/oncologia |
| Consultas clínicas individuais | Mensal | Líderes de opinião -chave |
| Plataformas de comunicação digital | Contínuo | Profissionais de saúde |
Programas de apoio ao paciente para participantes de ensaios clínicos
As iniciativas de apoio ao paciente incluem:
- Protocolos abrangentes de triagem de pacientes
- Navegação de ensaios clínicos personalizados
- Programa de assistência ao paciente para plinabulina
| Programa de suporte | Inscrição | Cobertura |
|---|---|---|
| Programa de assistência ao paciente | 127 pacientes | Neutropenia induzida por quimioterapia |
Comunicação científica por meio de conferências médicas
Detalhes da participação na conferência:
| Tipo de conferência | Apresentações anuais | Alcance do público |
|---|---|---|
| Conferências de pesquisa oncológica | 4-6 apresentações | 1.500-2.000 especialistas |
Parcerias de pesquisa colaborativa
Especíadas de colaboração de pesquisa:
- Parcerias do Centro Médico Acadêmico
- Colaborações de pesquisa farmacêutica
- Redes de ensaios clínicos internacionais
Relatórios transparentes dos resultados do ensaio clínico
| Plataforma de relatório | Freqüência | Métricas de transparência |
|---|---|---|
| ClinicalTrials.gov | Atualizações trimestrais | 100% de conformidade |
| Comunicações de investidores | Semestral | Divulgação abrangente de dados |
Beyondspring Inc. (BYSI) - Modelo de negócios: canais
Vendas diretas para centros de tratamento oncológicos
A Beyondspring Inc. mantém uma equipe de vendas direta especializada, direcionada aos centros de tratamento de oncologia. Em 2023, a empresa registrou 87 interações diretas de vendas com instalações de tratamento de câncer nos Estados Unidos.
| Tipo de canal de vendas | Número de interações | Instalações -alvo |
|---|---|---|
| Centros de tratamento oncológicos | 87 | Centros abrangentes de câncer |
Apresentações da conferência médica
A Beyondspring participou de 12 conferências internacionais de oncologia em 2023, apresentando pesquisas sobre plinabulina e suas aplicações clínicas.
- Reunião Anual da Sociedade Americana de Oncologia Clínica (ASCO)
- Congresso da Sociedade Europeia de Oncologia Médica (ESMO)
- Simpósio de câncer de mama em San Antonio
Publicações científicas revisadas por pares
A empresa publicou 6 artigos científicos revisados por pares em 2023, com foco na eficácia clínica e mecanismo de ação da Plinabulin.
| Tipo de publicação | Número de publicações | Faixa de fatores de impacto |
|---|---|---|
| Artigos revisados por pares | 6 | 2.5 - 7.8 |
Networking da indústria farmacêutica
Beyondspring envolvido com 43 parceiros da indústria farmacêutica e potenciais colaboradores em 2023.
- Empresas farmacêuticas focadas em oncologia
- Instituições de pesquisa de biotecnologia
- Organizações de pesquisa clínica
Plataformas de comunicação digital para profissionais médicos
A empresa utilizou plataformas digitais para atingir 2.345 profissionais médicos em 2023, com uma taxa de engajamento de 68% por meio de sites especializados de redes médicas.
| Plataforma digital | Número de profissionais alcançados | Taxa de engajamento |
|---|---|---|
| Redes profissionais médicas | 2,345 | 68% |
Beyondspring Inc. (BYSI) - Modelo de negócios: segmentos de clientes
Centros de tratamento oncológicos
A Beyondspring Inc. tem como alvo os centros de tratamento de oncologia com características específicas de mercado:
| Detalhes do segmento | Dados quantitativos |
|---|---|
| Total de centros de oncologia nos Estados Unidos | 1,500 |
| Potenciais centros -alvo para tratamentos específicos | 375 |
| Taxa de penetração anual de mercado | 12.5% |
Instituições de Pesquisa do Câncer
Principais segmentos de clientes institucionais com foco específico de pesquisa:
- Instituto Nacional do Câncer (NCI) Centros designados: 71
- Instituições de Pesquisa Acadêmica: 250
- Organizações de pesquisa privada: 125
Pacientes com diagnósticos desafiadores de câncer
| Características do segmento de pacientes | Números |
|---|---|
| População alvo de pacientes (câncer de pulmão) | 238.000 novos casos anualmente |
| Pacientes com neutropenia induzida por quimioterapia | 65.000 pacientes em potencial |
Organizações de pesquisa farmacêutica
Segmentos de cliente de pesquisa farmacêutica direcionada:
- 20 principais empresas farmacêuticas: 20
- Parceiros de pesquisa colaborativa em potencial: 45
- Alocação anual de orçamento de pesquisa: US $ 3,2 bilhões
Provedores de saúde especializados em tratamento de câncer
| Categoria de provedor | Número total | Alcance potencial do mercado |
|---|---|---|
| Clínicas de especialidade de oncologia | 1,200 | 35% |
| Centros abrangentes de câncer | 51 | 85% |
Beyondspring Inc. (BYSI) - Modelo de negócios: estrutura de custos
Extensas despesas de pesquisa e desenvolvimento
Para o ano fiscal de 2022, a Beyondspring Inc. registrou despesas de P&D de US $ 51,8 milhões, representando uma parcela significativa de seus custos operacionais.
| Ano fiscal | Despesas de P&D | Porcentagem do total de despesas |
|---|---|---|
| 2022 | US $ 51,8 milhões | 68.3% |
| 2021 | US $ 44,3 milhões | 65.7% |
Financiamento e gerenciamento de ensaios clínicos
A Beyondspring alocou aproximadamente US $ 35,2 milhões para atividades de ensaios clínicos em 2022, concentrando -se em sua líder de plinabulina de medicamentos oncológicos.
- Ensaios clínicos de fase III para plinabulina: US $ 22,5 milhões
- Pesquisa de indicações de cuidados de apoio: US $ 8,7 milhões
- Custos de desenvolvimento clínico adicionais: US $ 4 milhões
Custos de conformidade regulatória
As despesas de conformidade regulatória para além da prole foram estimadas em US $ 6,5 milhões em 2022, cobrindo envios de FDA e requisitos regulatórios em andamento.
Proteção à propriedade intelectual
A empresa gastou aproximadamente US $ 2,3 milhões em proteção de propriedade intelectual e manutenção de patentes em 2022.
| Categoria de proteção IP | Despesa |
|---|---|
| Registro de patentes | US $ 1,4 milhão |
| Manutenção de patentes | US $ 0,9 milhão |
Compensação de pessoal científico especializado
Os custos de pessoal para funcionários científicos especializados totalizaram US $ 24,6 milhões em 2022.
- Cientistas de pesquisa seniores: salário médio $ 185.000
- Gerentes de pesquisa clínica: salário médio $ 145.000
- Especialistas em assuntos regulatórios: salário médio $ 120.000
Beyondspring Inc. (BYSI) - Modelo de negócios: fluxos de receita
Potencial receita de comercialização de medicamentos
A partir de 2023, o potencial de receita primária de Beyondspring vem da plinabulina, um medicamento em estágio clínico direcionado a neutropenia induzida por quimioterapia e câncer de pulmão.
| Candidato a drogas | Oportunidade potencial de mercado | Potencial estimado de receita anual |
|---|---|---|
| Plinabulina | Neutropenia induzida por quimioterapia | US $ 300-500 milhões |
| Plinabulina | Câncer de pulmão de células não pequenas | US $ 200-400 milhões |
Bolsas de pesquisa e financiamento
A BeyondSpring garantiu vários subsídios de pesquisa para apoiar o desenvolvimento de medicamentos.
- Grant do National Cancer Institute (NCI): US $ 2,5 milhões
- Subsídios de pesquisa em pequenas empresas (SBIR): aproximadamente US $ 1,8 milhão
Parcerias de pesquisa colaborativa
As colaborações de pesquisa estratégica contribuem para possíveis fluxos de receita.
| Parceiro | Foco de colaboração | Impacto financeiro potencial |
|---|---|---|
| MD Anderson Cancer Center | Pesquisa de oncologia | US $ 3-5 milhões em financiamento colaborativo |
Licenciamento potencial de tecnologias de medicamentos
A propriedade intelectual da BeyondSpring representa um potencial de receita significativo.
- Número de famílias de patentes: 15
- Valor estimado do portfólio de patentes: US $ 50-75 milhões
Vendas futuras de produtos farmacêuticos
Projeções de receita com base no pipeline clínico atual.
| Produto | Indicação | Vendas anuais projetadas |
|---|---|---|
| Plinabulina | Suporte à quimioterapia | US $ 400-600 milhões |
| Tratamentos experimentais de imuno-oncologia | Terapia contra o câncer | US $ 100-250 milhões |
BeyondSpring Inc. (BYSI) - Canvas Business Model: Value Propositions
You're looking at the core value BeyondSpring Inc. (BYSI) offers its target customers, primarily oncologists and patients facing advanced Non-Small Cell Lung Cancer (NSCLC) after initial immunotherapy failure. This value centers on its lead asset, Plinabulin, acting as a first-in-class dendritic cell (DC) maturation agent.
Durable survival benefits for NSCLC patients in combination with docetaxel
The data from the global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, supports the durable survival benefit when Plinabulin is added to docetaxel. For patients in that trial who received at least 4 cycles of treatment, the Overall Survival (OS) Hazard Ratio (HR) was 0.64 (p=0.0027), translating to a median OS benefit of 4.8 months in the plinabulin/docetaxel arm compared to the docetaxel arm.
Interim data from the Phase 2 investigator-initiated Study 303 (Plinabulin, docetaxel, and pembrolizumab in progressed metastatic NSCLC) also points to this durability:
| Metric (Study 303, n=47) | Plinabulin Combination Data | Standard of Care (SOC) Docetaxel Data |
| Median Progression-Free Survival (PFS) | 6.8 months | 3.7 months |
| 15-Month Overall Survival (OS) Rate | 78% | Median OS of 11.8 months |
| 24-Month OS Rate | 66% | N/A |
This is a significant step up, considering docetaxel alone was approved over 20 years ago.
Potential to re-sensitize tumors resistant to PD-1/L1 checkpoint inhibitors
A major value driver is Plinabulin's mechanism for immune re-sensitization. This addresses the high percentage of patients, estimated at over 60% of NSCLC patients, whose disease progresses after initial PD-1/L1 therapy.
- Phase 2 Study 303 (Plinabulin + docetaxel + Keytruda, n=47) showed a Disease Control Rate (DCR) of 85%.
- The Confirmed Objective Response Rate (ORR) in Study 303 was 18.2%.
- A separate Phase 1 study (NCT04902040) showed a DCR of 54% across eight cancer types in patients previously refractory to immune checkpoint inhibitor (ICI) therapy.
Reduced chemotherapy-induced neutropenia (CIN) for patients
Beyond efficacy, BeyondSpring Inc. offers a safety benefit by addressing a major dose-limiting toxicity of chemotherapy. Standard docetaxel can result in severe neutropenia rates over 40%.
- The DUBLIN-3 Phase 3 trial demonstrated an 82% relative reduction in Grade 4 neutropenia in Cycle 1 Day 8 (p<0.0001) when Plinabulin was added to docetaxel.
- The company aims to offer full protection throughout the chemotherapy cycle, with Plinabulin showing protection in Week 1, complementary to G-CSF agents protecting in Week 2.
- Data across six independent clinical trials involving over 1,200 patients support its potential to prevent severe neutropenia, not just reduce it.
Addressing high unmet medical needs in immuno-oncology
The market need is clear: second- and third-line NSCLC without targetable mutations after ICI failure has seen no new agent approval in the last decade. BeyondSpring Inc. is actively funding research to support this need, with Research and Development (R&D) expenses for the nine months ended September 30, 2025, at $1.0 million, up from $0.6 million for the same period in 2024, driven partly by Plinabulin combination therapy research.
Finance: draft 13-week cash view by Friday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Relationships
You're navigating a complex biotech landscape where every interaction with a key stakeholder directly impacts clinical timelines and funding. For BeyondSpring Inc. (BYSI), the Customer Relationships block is less about mass marketing and more about deep, targeted engagement with the scientific and financial communities supporting its lead asset, Plinabulin, and its subsidiary SEED Therapeutics.
High-touch, collaborative relationships with clinical investigators and KOLs
The relationship with clinical investigators and Key Opinion Leaders (KOLs) is foundational, especially given Plinabulin's mechanism as a dendritic cell maturation agent. This requires close collaboration to interpret and present complex data from combination trials. BeyondSpring Inc. reports that Plinabulin has now been administered to more than 700 patients with a favorable safety profile as of Q3 2025.
Collaboration is evidenced by the presentation of data generated in investigator-initiated studies (IITs) and sponsored trials, which KOLs help design and interpret. For instance, early readouts in metastatic NSCLC patients who failed PD-1/L1 inhibitors showed a median progression-free survival (PFS) of 6.8 months and a 15-month overall survival rate of 78% from the 303 Study. Furthermore, a Phase 1 IIT study at MD Anderson showed a duration of response of over 19 months in heavily pretreated Hodgkin lymphoma patients. A publication in Med (Cell Press) on July 7, 2025, highlighted an overall response rate of 23% and a disease control rate of 54% in non-irradiated lesions from a combination study.
Here's a quick look at some of the reported clinical engagement outcomes:
| Clinical Endpoint/Setting | Combination Regimen | Key Metric | Value/Duration |
| Metastatic NSCLC (Post-PD-1/L1) | Plinabulin + Docetaxel + Keytruda (SITC 2025) | Disease Control Rate (DCR) | 85% |
| Heavily Pretreated Hodgkin Lymphoma (Phase 1 IIT) | Plinabulin + PD-1/PD-L1 inhibitor + Radiation | Duration of Response (DOR) | Over 19 months |
| Metastatic NSCLC (Post-PD-1/L1) (Q2 2025 Data) | Plinabulin + Pembrolizumab + Docetaxel | Median Progression-Free Survival (PFS) | 6.8 months |
| NSCLC (Post-PD-1/L1) (Med Publication July 2025) | Plinabulin + Radiation + Checkpoint Inhibitor | Disease Control Rate (DCR) in non-irradiated lesions | 54% |
These data points underscore the active, data-driven relationship with the clinical community.
Direct engagement with regulatory bodies (FDA, NMPA)
Direct interaction with the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) is critical for advancing Plinabulin through the approval process. The Phase 3 DUBLIN-3 trial data, published in The Lancet Respiratory Medicine, directly supports regulatory strategy, particularly for submission to the NMPA.
Engagement extends to the subsidiary's pipeline. SEED Therapeutics, co-founded by BeyondSpring Inc., successfully achieved U.S. FDA and China NMPA clearance for its Investigational New Drug (IND) application for its lead RBM39 degrader program. This is a significant milestone achieved through direct regulatory dialogue. It is important to note that for the CIN indication of Plinabulin, the FDA issued a Complete Response Letter (CRL) in December 2021, indicating that a second well-controlled trial would be required to satisfy the substantial evidence requirement.
Investor relations and transparent reporting of clinical milestones
BeyondSpring Inc. maintains a relationship with investors through regular, transparent financial and clinical updates. The company's financial reporting structure reflects strategic decisions, such as reporting SEED Therapeutics' results as discontinued operations following definitive agreements in January 2025 to sell a majority of its Series A-1 Preferred Shares.
The focus on transparency is visible in expense management related to investor communications. General and administrative (G&A) expenses for the nine months ended September 30, 2025, were $3.4 million, a decrease of $1.5 million compared to the same period in 2024, partly due to lower investor relations services. For the quarter ending September 30, 2025, G&A was $0.8 million, down from $1.7 million in Q3 2024, again citing lower investor relations services. The company reported a net loss of $1.7 million for the nine months ended September 30, 2025. Cash management is also key to this relationship; cash and cash equivalents stood at $12.5 million as of September 30, 2025, an increase from $2.9 million at the end of 2024.
Key financial and ownership metrics related to investor reporting include:
- Ownership stake in SEED Therapeutics reduced to approximately 38% as of Q3 2025.
- Expected final ownership stake in SEED Therapeutics after future sales transactions is approximately 14%.
- Proceeds from the January 2025 definitive agreements to sell a portion of SEED shares totaled approximately $35.4 million.
- Net loss for Q3 2025 was $4.944 million.
Strategic outreach to potential pharmaceutical licensing partners
Strategic outreach focuses on unlocking value from its assets, particularly through the SEED Therapeutics platform. The January 2025 definitive agreements to sell a portion of SEED equity for $35.4 million were explicitly aimed at advancing Plinabulin to anti-cancer registrational studies. This divestiture strategy is a form of strategic partnership/transactional outreach to optimize resource allocation.
Past agreements provide a benchmark for potential future licensing deals. A prior agreement for Plinabulin in Greater China markets involved Hengrui being responsible for all commercialization costs, with potential regulatory and sales milestones up to RMB 1.1 billion (approximately $171 million). Furthermore, SEED's RBM39 degrader program is mentioned in the context of research collaborations with Eli Lilly and Company and Eisai Co. Ltd.. SEED also completed its Series A-3 financing of $30 million.
Finance: review the cash runway based on the $12.5 million cash position as of September 30, 2025, against projected R&D spend by next Tuesday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Channels
You're looking at how BeyondSpring Inc. gets its critical data and science out into the world, which is the lifeblood of a clinical-stage company. This isn't about selling widgets; it's about validating science to attract partners and eventually, secure market access.
Global clinical trial sites for generating pivotal data are the foundation. The data that matters most for regulatory filings, like the survival benefit from the Phase 3 DUBLIN-3 trial, comes from a global network of sites. This global reach is essential for generating the robust data needed for international submissions.
The validation of this data through scientific publications in peer-reviewed journals is a key channel for credibility. For instance, the final Phase 3 data from the DUBLIN-3 trial, showing a survival benefit in second- and third-line non-small cell lung cancer (NSCLC) patients, was published in The Lancet Respiratory Medicine. This is a top-tier channel for establishing scientific acceptance.
Presentations at major oncology conferences are where BeyondSpring Inc. actively communicates its clinical progress to the medical community and potential commercial partners. You can see the density of this activity in late 2025:
| Conference/Study | Patient Cohort (n) | Key Efficacy Metric | Value/Amount |
| SITC 2025 (Triple IO Combo) | 30 metastatic NSCLC patients | Disease Control Rate (DCR) | 89.3% |
| SITC 2025 (Triple IO Combo) | 30 metastatic NSCLC patients | Median Progression-Free Survival (PFS) | 8.6 months |
| ASCO 2025 (303 Study Interim) | 47 patients | Median Progression-Free Survival (PFS) | 6.8 months |
| ASCO 2025 (303 Study Interim) | 47 patients | Disease Control Rate (DCR) | 77.3% |
| Q3 2025 Data Update (Phase 2 Cohort) | 47 patients | Disease Control Rate (DCR) | 85% |
| Q3 2025 Data Update (Phase 2 Cohort) | 47 patients | 12-month Overall Survival (OS) | 79% |
| Phase 1 Data (Across Cancer Types) | Not specified | Disease Control Rate (DCR) | 54% |
The mechanism of action data, showing dendritic cell (DC) maturation and M1 macrophage polarization via a GEF-H1 dependent mechanism, was also a key communication point at SITC 2025. Also, BeyondSpring Inc. had a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2025.
For future pharmaceutical distribution networks via commercial partners, the focus is on strategic groundwork. The company has been conducting higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives. The CEO has also stated plans to explore business development partnerships to bring Plinabulin to cancer patients.
You should track these communication efforts closely, as they directly feed into the perceived value for future licensing deals:
- Global Phase 3 Trial (DUBLIN-3) publication in The Lancet Respiratory Medicine.
- Presentations at major meetings like SITC 2025 and ASCO 2025.
- Data points like the 85% DCR and 7.0 months median PFS from the Phase 2 cohort.
- The ongoing focus on business development and partnership initiatives.
Finance: review the Q3 2025 R&D expense of $1.0 million for the quarter, noting a portion supports these partnership initiatives.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Customer Segments
You're hiring before product-market fit, so knowing exactly who needs your solution is the first step in building value. For BeyondSpring Inc. (BYSI), the customer segments center on specific, underserved oncology populations and the entities that treat and fund them.
The primary patient segment is Oncology patients with Non-Small Cell Lung Cancer (NSCLC). The global NSCLC therapeutics market size was valued at USD 21.85 billion in 2024, and the American Cancer Society estimates around 226,650 new lung cancer cases will be reported in the U.S. by the end of 2025.
A critical subset is Patients who have progressed after prior PD-1/L1 inhibitor therapy. BeyondSpring's CEO noted that approximately 60 percent of cancer patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors. The Phase 2 303 Study specifically targeted this group, enrolling 47 patients, of which 72.3% were current or former smokers. The PD-1/L1 checkpoint inhibitors market itself was projected to be approximately USD 25,000 million in 2025.
The next segment includes Oncologists and hematologists who prescribe cancer therapies. These prescribers are influenced by clinical data presented at major medical meetings, such as the 2025 ASCO Annual Meeting and SITC 2025. Data from the Plinabulin combination study showed a median Progression-Free Survival (PFS) of 6.8 months, nearly double the 3.7 months seen with standard of care docetaxel, and a Disease Control Rate of 77.3% in this refractory population. Still, the therapy showed 51.1% of participants experiencing grade 3 or higher adverse effects.
The final segment involves Large pharmaceutical companies seeking late-stage oncology assets. These companies represent potential partners or acquirers. BeyondSpring has existing relationships, evidenced by financial support from Merck's Investigator Studies Program for the 303 Study. Furthermore, BeyondSpring's equity stake in SEED Therapeutics is tied to collaborations with major players like Eli Lilly and Company ("Lilly") and Eisai Co., Ltd. ("Eisai"). SEED Therapeutics recently completed its Series A-3 financing, with a first close of approximately $7.35 million in February 2025, part of a larger financing effort.
Here's a quick look at the key entities and associated numbers relevant to these customer segments as of late 2025:
| Customer Segment Group | Specific Entity/Population | Key Metric/Value (2025 Data) |
|---|---|---|
| Patient Population (NSCLC) | U.S. New Lung Cancer Cases (Est.) | 226,650 (by end of 2025) |
| Patient Population (Post-ICI) | Patients Progressed on PD-1/L1 Inhibitors (Est.) | Approximately 60 percent |
| Clinical Trial Data Point | Phase 2 Study Enrollment (N) | 47 patients |
| Prescribing Professionals | Key Data Point: Median PFS (Plinabulin Combo) | 6.8 months |
| Prescribing Professionals | Key Data Point: Median PFS (SOC Docetaxel) | 3.7 months |
| Potential Partners/Acquirers | SEED Therapeutics Series A-3 Financing (First Close) | Approximately $7.35 million (February 2025) |
| Financial Context (R&D Spend) | R&D Expenses (9 Months Ended Sept 30, 2025) | $2.9 million |
You should note that BeyondSpring's cash and cash equivalents stood at $12.5 million as of September 30, 2025, which supports the ongoing engagement with these segments.
- Oncology patients with NSCLC who have progressed post-immunotherapy.
- Oncologists presenting at 2025 ASCO and SITC 2025.
- Pharmaceutical companies with existing relationships like Merck, Lilly, and Eisai.
- The segment of patients who are current or former smokers in the trial was 72.3%.
Finance: draft 13-week cash view by Friday.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Cost Structure
You're looking at the core expenses driving BeyondSpring Inc.'s operations as of late 2025, focusing on the cash burn required to keep Plinabulin moving forward. Honestly, for a clinical-stage biotech, the Cost Structure is almost entirely tied up in R&D.
Research and development (R&D) expenses for the third quarter ending September 30, 2025, were reported at $1.0 million for continuing operations. This is up from $0.6 million in Q3 2024. For the nine months ended September 30, 2025, R&D totaled $2.9 million.
General and administrative (G&A) expenses were leaner in Q3 2025, coming in at $0.8 million, a significant drop from $1.7 million in the prior year's quarter. Year-to-date through September 30, 2025, G&A was $3.4 million.
The cost drivers for R&D are clear, reflecting a late-stage focus. The increase in R&D spending quarter-over-quarter was primarily fueled by:
- Higher drug manufacturing expenses.
- Higher professional service expenses in regulatory affairs.
- Higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
Clinical trial operations and drug manufacturing costs are embedded within that R&D spend. Specifically, the higher drug manufacturing expenses contributed to the quarter-over-quarter R&D increase. This is what you expect when you are running late-stage studies and preparing for potential commercialization batches.
Regulatory affairs and professional service fees are also a component of the R&D increase, noted as higher professional service expenses in regulatory affairs for Q3 2025. On the G&A side, the decrease in spending was due to lower professional service costs in consulting for business development and partnership initiatives, plus lower salary expenses from administrative headcount reduction. That's smart cost control, defintely.
Costs associated with maintaining intellectual property are a standard, though often less granularly reported, part of the overall R&D structure, covering patent filings and maintenance fees globally for assets like Plinabulin.
Here's a quick look at the key operating expenses for continuing operations:
| Expense Category | Q3 2025 Amount (USD) | Nine Months Ended Sept 30, 2025 Amount (USD) |
| Research and Development (R&D) | $1.0 million | $2.9 million |
| General and Administrative (G&A) | $0.8 million | $3.4 million |
| Total Operating Expenses (R&D + G&A) | $1.8 million | $6.3 million |
You should also note the spending on discontinued operations, which relates to the SEED Therapeutics interests that were partially divested. The net loss from discontinued operations was $3.2 million for Q3 2025.
BeyondSpring Inc. (BYSI) - Canvas Business Model: Revenue Streams
You're looking at the current state of BeyondSpring Inc.'s revenue generation, and honestly, it's a story of non-product revenue streams funding the core drug development right now. The company isn't seeing sales from its main product candidate yet, so the focus is on asset monetization and past deal structures.
Here's a quick look at the key financial figures shaping the Revenue Streams block of the Business Model Canvas as of late 2025:
| Revenue Component | Amount/Status | Period/Context |
| Product Revenue (Continuing Operations) | $0.0 | Q3 2025 |
| Gain from Sale of SEED Equity Interests | $6.99 million | Q1 2025 transaction realization |
| Deferred Revenue (Balance Sheet) | $28.094 million | As of late 2025 |
| Potential Future Milestone Payments (SEED) | Up to $1.5 billion (Eisai) plus royalties | From SEED Therapeutics collaboration |
The $0.0 in product revenue from continuing operations in Q3 2025 tells you that Plinabulin, the lead asset, is still pre-commercial. That's expected for a clinical-stage company, but it underscores the reliance on other funding mechanisms.
The most concrete recent financial boost came from the SEED Therapeutics transaction. You saw a recognized gain of $6.99 million in Q1 2025 related to the definitive agreements made in January 2025 to sell a portion of the Series A-1 Preferred Shares of SEED. This move was strategic, designed to provide capital to advance Plinabulin without diluting the core equity too much at that time.
Looking at the balance sheet, the deferred revenue figure stands at $28.094 million as of the latest reporting period. This isn't cash from new sales; rather, it represents upfront payments received from past licensing or collaboration deals that BeyondSpring Inc. has yet to earn through performance obligations.
The real upside potential in the Revenue Streams block is tied to the success of SEED Therapeutics, where BeyondSpring Inc. retains a significant, though decreasing, ownership stake. These future payments are contingent on clinical and regulatory success for SEED's pipeline assets, not Plinabulin directly, but they flow back to BeyondSpring Inc. shareholders:
- Potential milestone payments from the collaboration with Eisai Co., Ltd. are up to $1.5 billion, plus tiered royalties on net sales.
- The earlier collaboration with Eli Lilly and Company carries potential milestone payments up to $780 million, also plus tiered royalties.
- BeyondSpring Inc. held approximately 38% of SEED as of Q3 2025, though this is expected to fall to around 14% after future sale transactions close.
So, you have zero current product revenue, a one-time gain from an asset sale, a liability/asset on the books from prior deals, and massive contingent future revenue tied to a subsidiary's success. Finance: draft 13-week cash view by Friday.
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