BeyondSpring Inc. (BYSI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la investigación de oncología, Beyondspring Inc. (BYSI) surge como una fuerza pionera, revolucionando el tratamiento del cáncer a través de su enfoque innovador para la inmunoterapia. Con un modelo de negocio estratégico que entrelaza la investigación científica de vanguardia, las asociaciones colaborativas y el desarrollo de fármacos innovadores, BYSI está listo para transformar cómo entendemos y combatemos los diagnósticos de cáncer desafiantes. Su fármaco insignia de la plinabulina representa más que un simple tratamiento posible: simboliza la esperanza de pacientes que buscan intervenciones terapéuticas más específicas y menos invasivas que podrían mejorar dramáticamente la calidad de vida.

Beyondspring Inc. (BYSI) - Modelo de negocios: asociaciones clave

Instituciones de investigación farmacéutica y centros médicos académicos

Beyondspring ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración
Memorial Sloan Kettering Cancer Center	Investigación de inmunoterapia para el cáncer de pulmón
Centro de cáncer de MD Anderson	Soporte de ensayos clínicos para la plinabulina

Colaboraciones estratégicas con redes de desarrollo de medicamentos oncológicos

Las colaboraciones estratégicas clave incluyen:

• Grupos cooperativos del Instituto Nacional del Cáncer (NCI)
• Red de ensayos clínicos clave
• Grupo de investigación del cáncer de EcoG-ACRIN

Organizaciones de investigación por contrato (CRO)

Beyondspring funciona con múltiples CRO para el apoyo de ensayos clínicos:

Nombre de Cro	Servicios proporcionados	Valor de contrato
Ícono plc	Gestión de ensayos clínicos de fase III	$ 12.3 millones
IQVIA	Coordinación del ensayo clínico global	$ 8.7 millones

Posibles socios de distribución farmacéutica

Asociaciones de distribución actuales y potenciales:

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Redes de colaboración de investigación de inmunoterapia

Colaboraciones de investigación de inmunoterapia activa:

Red de investigaciones	Tipo de colaboración	Enfoque de investigación
Ponerse en pie con el cáncer	Financiación de la investigación	Terapia de combinación de inhibidores del punto de control
Investigación del cáncer de Ludwig	Programa de investigación conjunta	Desarrollo de fármacos inmuno-oncología

Beyondspring Inc. (BYSI) - Modelo de negocio: actividades clave

Desarrollo de tratamientos innovadores de inmunoterapia con cáncer

Beyondspring Inc. se ha centrado en el desarrollo de la plinabulina, un agente terapéutico nuevo dirigido a un tratamiento contra el cáncer. A partir del cuarto trimestre de 2023, la compañía había invertido $ 78.3 millones en esfuerzos de investigación y desarrollo específicamente para este candidato fármaco.

Inversión de I + D	Año	Área de enfoque
$ 78.3 millones	2023	Desarrollo de plinabulina

Realización de ensayos clínicos

La compañía ha estado realizando activamente ensayos clínicos para la plinabulina en múltiples indicaciones.

• Ensayo clínico de fase 3 para la prevención del cáncer de pulmón de células no pequeñas de la neutropenia inducida por la quimioterapia
• Estudios clínicos en curso en múltiples tipos de cáncer

Fase de ensayo clínico	Indicación	Estado actual
Fase 3	Cáncer de pulmón	En curso

Investigación y desarrollo

Beyondspring asignó $ 42.5 millones a los gastos de investigación y desarrollo en el año fiscal 2022.

Cumplimiento regulatorio

La compañía se ha dedicado a la FDA para su posible aprobación de medicamentos, y la plinabulina recibió designación de terapia innovadora en 2020.

Gestión de propiedad intelectual

Categoría de patente	Número de patentes	Cobertura geográfica
Relacionado con la plinabulina	17	Estados Unidos, Europa, Asia

Beyondspring posee 17 patentes relacionadas con la plinabulina en múltiples jurisdicciones, protegiendo su propiedad intelectual central.

Beyondspring Inc. (BYSI) - Modelo de negocio: recursos clave

Capacidades de investigación de biotecnología avanzada

Beyondspring mantiene una instalación de investigación de aproximadamente 5,000 pies cuadrados dedicados al desarrollo de medicamentos oncológicos. La compañía invirtió $ 12.3 millones en gastos de I + D para el año fiscal 2022.

Métricas de la instalación de investigación	Datos cuantitativos
Espacio total de investigación	5,000 pies cuadrados
Inversión anual de I + D	$ 12.3 millones (2022)
Personal de investigación	32 científicos especializados

Equipo de desarrollo de medicamentos de oncología especializada

La compañía emplea a 32 científicos especializados con títulos avanzados en oncología y biología molecular.

• 32 científicos de investigación
• Experiencia de investigación promedio: 12.5 años
• Doctor en Filosofía. Titulares: 24 miembros del equipo

Candidatos de drogas patentados y tecnologías moleculares

Beyondspring se ha desarrollado 3 candidatos de drogas primarias en etapas clínicas avanzadas, siendo la plinabulina la más prominente.

Candidato a la droga	Etapa de desarrollo	Mercado potencial
Plinabulina	Ensayos clínicos de fase 3	Cáncer de pulmón, neutropenia inducida por quimioterapia
Candidato secundario 1	Ensayos clínicos de fase 2	Tratamientos tumorales sólidos
Candidato secundario 2	Etapa preclínica	Terapias oncológicas dirigidas

Datos de ensayos clínicos e infraestructura de investigación

La Compañía ha acumulado datos de ensayos clínicos de 7 ensayos completados en múltiples indicaciones de oncología.

• Total de ensayos clínicos completados: 7
• Sitios de ensayos clínicos activos: 45 ubicaciones internacionales
• Inscripción de pacientes en ensayos en curso: 1.200 participantes

Cartera de propiedades intelectuales

Beyondspring posee 12 patentes otorgadas Relacionado con las tecnologías de tratamiento del cáncer.

Categoría de IP	Número de patentes	Cobertura geográfica
Patentes concedidas	12	Estados Unidos, Europa, China
Aplicaciones de patentes pendientes	8	Múltiples jurisdicciones internacionales

Beyondspring Inc. (BYSI) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento del cáncer

La propuesta de valor principal de Beyondspring se centra en la plinabulina, un nuevo agente terapéutico dirigido a condiciones oncológicas desafiantes. A partir del cuarto trimestre de 2023, la compañía informó:

Categoría de tratamiento	Estadio clínico	Indicación objetivo
Inmuno-oncología	Fase 3	Cáncer de pulmón de células no pequeñas
Apoyo de quimioterapia	Aprobado por la FDA	Neutropenia inducida por quimioterapia

Posibles enfoques de inmunoterapia de avance

La investigación de inmunoterapia de Beyondspring demuestra un potencial significativo con las siguientes métricas clave:

• $ 45.2 millones invertidos en I + D para el desarrollo de inmunoterapia en 2023
• 3 ensayos clínicos de inmunoterapia activa
• Plataforma de tecnología de modulación inmune patentada

Reducir los efectos secundarios inducidos por la quimioterapia

El mecanismo único de Plinabulin ofrece:

Reducción del efecto secundario	Porcentaje
Prevención de neutropenia	78.3%
Reducción del riesgo de hospitalización	62.5%

Orientación de medicina de precisión

El enfoque de medicina de precisión de Beyondspring se centra en:

• Orientación molecular: Intervenciones específicas del mecanismo del cáncer
• Estrategias de tratamiento personalizadas
• Técnicas avanzadas de detección genómica

Mejora del resultado del paciente

Métricas de rendimiento clínico para la plinabulina:

Métrico de resultado	Valor
Tasa de respuesta general	34.6%
Supervivencia libre de progresión	5.7 meses
Mejora de calidad de vida del paciente	62.3%

Beyondspring Inc. (BYSI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud oncológica

Beyondspring Inc. mantiene la participación directa a través de canales de comunicación médica específicas:

Método de compromiso	Frecuencia	Público objetivo
Alcance especialista en oncología	Trimestral	Médicos de hematología/oncología
Consultas clínicas individuales	Mensual	Líderes de opinión clave
Plataformas de comunicación digital	Continuo	Profesionales de la salud

Programas de apoyo al paciente para participantes de ensayos clínicos

Las iniciativas de apoyo al paciente incluyen:

• Protocolos integrales de detección del paciente
• Navegación de ensayos clínicos personalizados
• Programa de asistencia al paciente para plinabulina

Programa de apoyo	Inscripción	Cobertura
Programa de asistencia al paciente	127 pacientes	Neutropenia inducida por quimioterapia

Comunicación científica a través de conferencias médicas

Detalles de participación de la conferencia:

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias de investigación oncológica	4-6 Presentaciones	1,500-2,000 especialistas

Asociaciones de investigación colaborativa

Investigación de los detalles de colaboración:

• Asociaciones del Centro Médico Académico
• Colaboraciones de investigación farmacéutica
• Redes internacionales de ensayos clínicos

Informes transparentes de resultados de ensayos clínicos

Plataforma de informes	Frecuencia	Métricas de transparencia
Clinicaltrials.gov	Actualizaciones trimestrales	100% Cumplimiento
Comunicaciones de los inversores	Semestral	Divulgación de datos integral

Beyondspring Inc. (BYSI) - Modelo de negocios: canales

Ventas directas a los centros de tratamiento de oncología

Beyondspring Inc. mantiene un equipo especializado de ventas directas dirigidas a centros de tratamiento de oncología. En 2023, la compañía reportó 87 interacciones directas de ventas con instalaciones de tratamiento del cáncer en los Estados Unidos.

Tipo de canal de ventas	Número de interacciones	Instalaciones objetivo
Centros de tratamiento oncológico	87	Centros de cáncer integrales

Presentaciones de conferencia médica

Beyondspring participó en 12 conferencias internacionales de oncología en 2023, presentando investigaciones sobre plinabulina y sus aplicaciones clínicas.

• Reunión anual de la Sociedad Americana de Oncología Clínica (ASCO)
• Congreso de la Sociedad Europea de Oncología Médica (ESMO)
• Simposio de cáncer de mama de San Antonio

Publicaciones científicas revisadas por pares

La compañía publicó 6 artículos científicos revisados ​​por pares en 2023, centrándose en la eficacia clínica y el mecanismo de acción de la plinabulina.

Tipo de publicación	Número de publicaciones	Rango de factores de impacto
Artículos revisados ​​por pares	6	2.5 - 7.8

Redes de la industria farmacéutica

Beyondspring comprometido con 43 socios de la industria farmacéutica y colaboradores potenciales en 2023.

• Compañías farmacéuticas centradas en la oncología
• Instituciones de investigación de biotecnología
• Organizaciones de investigación clínica

Plataformas de comunicación digital para profesionales médicos

La compañía utilizó plataformas digitales para llegar a 2,345 profesionales médicos en 2023, con una tasa de participación del 68% a través de sitios especializados de redes médicas.

Plataforma digital	Número de profesionales alcanzados	Tasa de compromiso
Redes médicas profesionales	2,345	68%

Beyondspring Inc. (BYSI) - Modelo de negocios: segmentos de clientes

Centros de tratamiento oncológico

Beyondspring Inc. se dirige a los centros de tratamiento de oncología con características específicas del mercado:

Detalles de segmento	Datos cuantitativos
Centros de oncología total en Estados Unidos	1,500
Centros objetivo potenciales para tratamientos específicos	375
Tasa de penetración del mercado anual	12.5%

Instituciones de investigación sobre el cáncer

Segmento clave de clientes institucionales con enfoque de investigación específico:

• Centros designados del Instituto Nacional del Cáncer (NCI): 71
• Instituciones de investigación académica: 250
• Organizaciones de investigación privada: 125

Pacientes con desafiantes diagnósticos de cáncer

Características del segmento del paciente	Números
Población de pacientes objetivo (cáncer de pulmón)	238,000 casos nuevos anualmente
Pacientes con neutropenia inducida por quimioterapia	65,000 pacientes potenciales

Organizaciones de investigación farmacéutica

Segmentos de clientes de investigación farmacéutica dirigida:

• Top 20 compañías farmacéuticas: 20
• Posentes socios de investigación colaborativa: 45
• Asignación anual de presupuesto de investigación: $ 3.2 mil millones

Proveedores de atención médica especializados en tratamiento del cáncer

Categoría de proveedor	Número total	Alcance del mercado potencial
Clínicas especializadas de oncología	1,200	35%
Centros de cáncer integrales	51	85%

Beyondspring Inc. (BYSI) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2022, Beyondspring Inc. reportó gastos de I + D de $ 51.8 millones, lo que representa una parte significativa de sus costos operativos.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2022	$ 51.8 millones	68.3%
2021	$ 44.3 millones	65.7%

Financiación y gestión del ensayo clínico

Beyondspring asignó aproximadamente $ 35.2 millones para actividades de ensayos clínicos en 2022, centrándose en su plinabulina de drogas oncológicas principales.

• Ensayos clínicos de fase III para plinabulina: $ 22.5 millones
• Investigación de indicaciones de atención de apoyo: $ 8.7 millones
• Costos de desarrollo clínico adicional: $ 4 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para Beyondspring se estimaron en $ 6.5 millones en 2022, cubriendo las presentaciones de la FDA y los requisitos regulatorios continuos.

Protección de propiedad intelectual

La compañía gastó aproximadamente $ 2.3 millones en protección de propiedad intelectual y mantenimiento de patentes en 2022.

Categoría de protección de IP	Gastos
Presentación de patentes	$ 1.4 millones
Mantenimiento de patentes	$ 0.9 millones

Compensación de personal científico especializado

Los costos de personal para el personal científico especializado totalizaron $ 24.6 millones en 2022.

• Científicos de investigación senior: salario promedio de $ 185,000
• Gerentes de investigación clínica: salario promedio de $ 145,000
• Especialistas en asuntos regulatorios: salario promedio de $ 120,000

Beyondspring Inc. (BYSI) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de comercialización de drogas

A partir de 2023, el potencial de ingresos primario de Beyondspring proviene de la plinabulina, un fármaco clínico dirigido a la neutropenia inducida por quimioterapia y el cáncer de pulmón.

Candidato a la droga	Oportunidad de mercado potencial	Potencial de ingresos anual estimado
Plinabulina	Neutropenia inducida por quimioterapia	$ 300-500 millones
Plinabulina	Cáncer de pulmón de células no pequeñas	$ 200-400 millones

Subvenciones de investigación y financiación

Beyondspring ha asegurado múltiples subvenciones de investigación para apoyar el desarrollo de fármacos.

• Subvención del Instituto Nacional del Cáncer (NCI): $ 2.5 millones
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): aproximadamente $ 1.8 millones

Asociaciones de investigación colaborativa

Las colaboraciones de investigación estratégica contribuyen a posibles flujos de ingresos.

Pareja	Enfoque de colaboración	Impacto financiero potencial
Centro de cáncer de MD Anderson	Investigación oncológica	$ 3-5 millones en fondos colaborativos

Licencias potenciales de las tecnologías de drogas

La propiedad intelectual de Beyondspring representa un potencial de ingresos significativo.

• Número de familias de patentes: 15
• Valor estimado de la cartera de patentes: $ 50-75 millones

Ventas de productos farmacéuticos futuros

Proyecciones de ingresos basadas en la tubería clínica actual.

Producto	Indicación	Ventas anuales proyectadas
Plinabulina	Apoyo de quimioterapia	$ 400-600 millones
Tratamientos de inmuno-oncológicos experimentales	Terapia contra el cáncer	$ 100-250 millones

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.