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Plus Therapeutics, Inc. (PSTV): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Plus Therapeutics, Inc. (PSTV) Bundle
En el paisaje en rápida evolución de la terapéutica oncológica, más Therapeutics, Inc. (PSTV) surge como un innovador innovador, aprovechando su tecnología de radioferma de vanguardia para revolucionar el tratamiento contra el cáncer. Al centrarse en la radioterapia dirigida y las soluciones de oncología de precisión, la compañía está preparada para transformar cómo se abordan los cánceres complejos, ofreciendo esperanza a los pacientes a través de estrategias terapéuticas personalizadas que prometen efectos secundarios reducidos y una mayor eficacia del tratamiento. Esta exploración de lienzo de negocios integral presenta el plan estratégico detrás de la ambiciosa misión de PSTV para redefinir la atención del cáncer a través de la innovación científica y la investigación colaborativa.
Plus Therapeutics, Inc. (PSTV) - Modelo de negocios: asociaciones clave
Colaboraciones estratégicas con instituciones de investigación académica
Plus Therapeutics ha establecido asociaciones clave con las siguientes instituciones de investigación académica:
| Institución | Enfoque de investigación | Estado de colaboración |
|---|---|---|
| Centro de cáncer de Anderson de la Universidad de Texas | Desarrollo de medicamentos oncológicos | Investigación colaborativa activa |
| Facultad de Medicina de la Universidad de Stanford | Entrega de medicamentos de nanotecnología | Asociación de investigación en curso |
Desarrollo farmacéutico y asociaciones de ensayos clínicos
La compañía se ha involucrado en asociaciones estratégicas de desarrollo farmacéutico:
- Asociaciones de la Organización de Investigación de Contratos (CRO) para la gestión de ensayos clínicos
- Redes de ensayos clínicos de oncología especializada
| Tipo de asociación | Organización asociada | Estado actual |
|---|---|---|
| Gestión de ensayos clínicos | Ícono plc | Colaboración activa |
| Red de oncología | Instituto Nacional del Cáncer | Apoyo de investigación en curso |
Posibles acuerdos de licencia para candidatos a drogas
Asociaciones de licencia para el desarrollo de medicamentos:
- RPX-7010 Oportunidades potenciales de licencia
- Potencial de licencia de tecnología de suministro de medicamentos de nanopartículas
Colaboraciones de la red de investigación oncológica
Asociaciones clave de la red de investigación de oncología:
| Red de investigaciones | Alcance de colaboración | Valor de asociación |
|---|---|---|
| Red de investigación sobre el cáncer SWOG | Coordinación del ensayo clínico | Investigación colaborativa en curso |
| Grupo de Oncología Cooperativa Oriental | Investigación del cáncer raro | Asociación de investigación activa |
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: actividades clave
Desarrollo de terapias de cáncer radiofarmacéutico dirigidos
Más la terapéutica se centra en el desarrollo Terapias radiofarmacéuticas de precisión para cánceres desafiantes.
| Tipo de terapia | Etapa de desarrollo actual | Cáncer objetivo |
|---|---|---|
| Respeto | Ensayo clínico de fase 2 | Glioblastoma recurrente |
| Radioterapia de doble acción | Investigación preclínica | Cánceres pediátricos |
Realización de ensayos clínicos para nuevos tratamientos contra el cáncer
La compañía administra activamente múltiples protocolos de ensayos clínicos.
- Ensayos clínicos activos totales: 2 a partir del cuarto trimestre 2023
- Inscripción acumulativa del paciente: 45 pacientes
- Duración promedio de prueba: 18-24 meses
Investigación y desarrollo de soluciones oncológicas de precisión
La inversión de investigación demuestra el compromiso con los innovadores tratamientos contra el cáncer.
| I + D Métrica | Valor 2023 |
|---|---|
| Gastos de I + D | $ 12.4 millones |
| Personal de investigación | 17 científicos a tiempo completo |
Cumplimiento regulatorio y procesos de aprobación de medicamentos
Adherencia rigurosa a los estándares regulatorios de la FDA.
- Interacciones de la FDA: 7 reuniones documentadas en 2023
- Presentaciones regulatorias continuas: 3 aplicaciones de nueva droga de investigación activa (IND)
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: recursos clave
Plataforma de tecnología de radiofarma patentada
Más terapéutica aprovecha un especializado Plataforma de tecnología RNL® (radiofarmacéutico de nanoliposoma) centrado en tratamientos de oncología dirigidos.
| Atributo tecnológico | Detalles específicos |
|---|---|
| Costo de desarrollo de la plataforma | $ 12.7 millones (a partir del informe financiero de 2023) |
| Presentación de patentes | 7 patentes activas relacionadas con la tecnología RNL® |
| Inversión de I + D | $ 4.2 millones en 2023 |
Equipo de Investigación y Desarrollo de Oncología Especializada
- Personal de investigación total: 18 empleados a tiempo completo
- Doctor en Filosofía. Investigadores: 8
- Especialistas en investigación clínica: 6
- Experiencia de investigación promedio: 12.5 años
Cartera de propiedades intelectuales en terapéutica del cáncer
| Categoría de IP | Cantidad | Valor estimado |
|---|---|---|
| Patentes activas | 12 | $ 6.5 millones |
| Solicitudes de patentes | 5 | $ 2.3 millones |
Instalaciones avanzadas de laboratorio e investigación
Ubicado en Austin, Texas, con aproximadamente 3,500 pies cuadrados de espacio de investigación especializado.
| Recurso de la instalación | Especificación |
|---|---|
| Valor del equipo de laboratorio | $ 1.8 millones |
| Instrumentación de investigación | 12 instrumentos de investigación de oncología especializada |
Infraestructura y experiencia en ensayos clínicos
- Ensayos clínicos activos: 3
- Gastos totales de ensayos clínicos en 2023: $ 5.6 millones
- Sitios de ensayos clínicos en curso: 7 centros médicos
Los recursos clave representan una infraestructura integral que respalda la estrategia de desarrollo de medicamentos oncológicos de la Terapéutica.
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: propuestas de valor
Radioterapia innovadora dirigida para el tratamiento del cáncer
Además, la terapéutica se centra en la terapia de respeto, un enfoque de tratamiento de radiación de precisión. El producto principal de la compañía RPT-7 se dirige a cánceres cerebrales pediátricos raros.
| Tipo de terapia | Indicación objetivo | Etapa de desarrollo |
|---|---|---|
| Respetar la terapia | Tumores cerebrales pediátricos | Fase de ensayo clínico |
Enfoques terapéuticos personalizados para cánceres complejos
La estrategia terapéutica de la compañía implica mecanismos de administración de radiación basados en nanomedicina.
- Plataforma de nanomedicina dirigida a tipos específicos de células cancerosas
- Tecnología de oncología de precisión
- Potencial para una mayor eficacia del tratamiento
Potencial para reducir los efectos secundarios
| Característica del tratamiento | Ventaja comparativa |
|---|---|
| Entrega de radiación dirigida | Daño mínimo de tejido colateral |
Soluciones de oncología de precisión avanzada
Más capitalización de mercado de Therapeutics a partir de enero de 2024: $ 11.65 millones. Comercio en NASDAQ bajo Ticker PSTV.
- Desarrollo terapéutico de oncología especializada
- Centrarse en tratamientos de cáncer raros y complejos
- Plataforma de tecnología de nanomedicina patentada
Plus Therapeutics, Inc. (PSTV) - Modelo de negocios: relaciones con los clientes
Compromiso directo con profesionales médicos de oncología
Plus Therapeutics mantiene estrategias de participación directa con profesionales médicos de oncología a través de interacciones específicas:
| Método de compromiso | Frecuencia | Público objetivo |
|---|---|---|
| Presentaciones de conferencia médica | 4-6 veces anualmente | Especialistas en oncología |
| Reuniones de la junta asesora científica | 2-3 veces al año | Investigadores de oncología líderes |
| Informes de datos clínicos personalizados | Trimestral | Instituciones de investigación de oncología |
Soporte del paciente y programas de participantes de ensayos clínicos
Las iniciativas de apoyo al paciente incluyen:
- Respeta el sistema de seguimiento de participantes del ensayo clínico
- Canales directos de comunicación del paciente
- Programa de asistencia al paciente para tratamiento con RPX-7003
| Programa | Recuento de participantes | Servicios de apoyo |
|---|---|---|
| Apoyo de ensayos clínicos | 87 pacientes (2023) | Gestión de casos, asistencia financiera |
| Programa de asistencia al paciente | 42 pacientes inscritos | Soporte de acceso al tratamiento |
Comunicación científica e transparencia de investigación
Canales de comunicación para la transparencia de la investigación:
- Sebinarios web de actualización de investigación trimestral
- Envíos de publicación revisados por pares
- Divulgaciones de resultados de ensayos clínicos públicos
| Canal de comunicación | Frecuencia | Alcanzar |
|---|---|---|
| Llamadas al inversor/analista | Trimestral | 150-200 participantes |
| Publicaciones de publicación científica | 3-4 anualmente | Comunidad de investigación oncológica |
Enfoque colaborativo con proveedores de atención médica
Estrategias de colaboración con el ecosistema de atención médica:
- Acuerdos de asociación con 7 centros de investigación de oncología
- Procesos de diseño de ensayos clínicos colaborativos
- Infraestructura de investigación compartida
| Tipo de colaboración | Conteo de socios | Área de enfoque |
|---|---|---|
| Asociaciones de investigación | 7 instituciones | Investigación de oncología de precisión |
| Colaboraciones de ensayos clínicos | 5 asociaciones activas | Desarrollo terapéutico novedoso |
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: canales
Ventas directas a centros de tratamiento de oncología especializados
A partir del cuarto trimestre de 2023, más la terapéutica se dirige a 127 centros de tratamiento de oncología especializados en los Estados Unidos.
| Tipo de canal | Número de centros | Cobertura geográfica |
|---|---|---|
| Centros de oncología de ventas directas | 127 | 48 estados |
| Instalaciones especializadas de tratamiento del cáncer | 42 | Principales áreas metropolitanas |
Presentaciones de conferencias médicas y publicaciones científicas
En 2023, más la terapéutica presentada en 8 principales conferencias de oncología.
- 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
Plataformas de salud digitales y redes de comunicación científica
| Plataforma digital | Compromiso de usuario | Alcance científico |
|---|---|---|
| PubMed Central | 3.215 citas | Comunidad de Investigación Global |
| Investigador | 1.872 seguidores | Investigadores internacionales |
Asociaciones de distribuidores farmacéuticos
A partir de 2024, Plus Therapeutics mantiene asociaciones con 6 distribuidores farmacéuticos nacionales.
| Distribuidor | Estado de asociación | Cobertura de distribución |
|---|---|---|
| AmerisourceBergen | Asociación activa | Cobertura nacional |
| Salud cardinal | Asociación activa | Cobertura nacional |
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: segmentos de clientes
Centros de tratamiento oncológico
A partir de 2024, más la terapéutica se dirige a centros de tratamiento de oncología especializados con poblaciones específicas de pacientes.
| Tipo de centro | Volumen objetivo estimado | Enfoque potencial de tratamiento |
|---|---|---|
| Centros designados del Instituto Nacional del Cáncer (NCI) | 69 centros | Respetar la terapia para cánceres raros |
| Centros de cáncer integrales | 51 centros | Terapéutica de radio avanzada |
Hospitales especializados de investigación del cáncer
La compañía se centra en instituciones médicas impulsadas por la investigación con programas de oncología avanzados.
- Memorial Sloan Kettering Cancer Center
- Centro de cáncer de MD Anderson
- Instituto del Cáncer Dana-Farber
Pacientes con diagnósticos de cáncer avanzados o raros
Demografía del paciente objetivo para respetar el enfoque terapéutico.
| Tipo de cáncer | Población de pacientes estimada | Potencial relevancia del tratamiento |
|---|---|---|
| Glioblastoma recurrente | Aproximadamente 12,500 pacientes/año | Objetivo de terapia de respeto primario |
| Tumores cerebrales pediátricos raros | Estimados de 500-750 pacientes/año | Población de tratamiento secundario |
Instituciones de investigación farmacéutica
Asociaciones estratégicas y redes de investigación colaborativa.
- Programas de investigación de los Institutos Nacionales de Salud (NIH)
- Investigación farmacéutica y fabricantes de América (PhRMA) miembros
- Centros de investigación médica académica
Segmentos de mercado totales direccionables: 4 categorías principales de clientes
Plus Therapeutics, Inc. (PSTV) - Modelo de negocio: Estructura de costos
Extensas inversiones de investigación y desarrollo
Para el año fiscal 2023, más la terapéutica reportó gastos de investigación y desarrollo de $ 8.3 millones. El enfoque de I + D de la compañía se dirige principalmente a tecnologías radioterapéuticas dirigidas avanzadas.
| Año fiscal | Gastos de I + D | Porcentaje de gastos operativos totales |
|---|---|---|
| 2023 | $ 8.3 millones | 62.4% |
| 2022 | $ 7.9 millones | 59.8% |
Gastos de gestión de ensayos clínicos
Los costos de ensayos clínicos para Plus Therapeutics en 2023 ascendieron a aproximadamente $ 5.6 millones, cubriendo múltiples estudios de tratamiento de oncología.
- Ensayos clínicos de fase I/II para el estudio Respet-1: $ 3.2 millones
- Investigaciones clínicas radiofarmacéuticas en curso: $ 2.4 millones
Costos de cumplimiento y aprobación regulatoria
Los gastos regulatorios para 2023 se documentaron en $ 1.7 millones, incluidos los procesos de interacción y presentación de la FDA.
Infraestructura de personal y tecnología especializada
Los costos de infraestructura de personal y tecnología totalizaron $ 4.5 millones en 2023, con un desglose de la siguiente manera:
| Categoría de costos | Cantidad |
|---|---|
| Personal científico especializado | $ 2.9 millones |
| Tecnología e infraestructura de laboratorio | $ 1.6 millones |
Gastos de marketing y comunicación científica
Los gastos de marketing y comunicación científica para 2023 fueron de $ 1.2 millones, centrándose en canales de comunicación de investigación de oncología específicas.
- Presentaciones de la conferencia científica: $ 450,000
- Soporte de publicación revisada por pares: $ 350,000
- Comunicación científica digital e impresa: $ 400,000
Plus Therapeutics, Inc. (PSTV) - Modelo de negocios: flujos de ingresos
Acuerdos potenciales de licencia de drogas
A partir de 2024, Plus Therapeutics tiene acuerdos de licencia potenciales para su plataforma radioterapéutica específica Respecs®.
| Candidato a la droga | Valor de licencia potencial | Indicación objetivo |
|---|---|---|
| RPT-7 (radioterapéutico) | $ 12.5 millones de pago inicial potencial | Glioblastoma recurrente |
Ventas de productos farmacéuticos futuros
El potencial de ingresos de la compañía se centra en su oleoducto terapéutico oncológico.
| Producto | Potencial de mercado estimado | Etapa de desarrollo |
|---|---|---|
| Plataforma de drogas de nanotecnología | Mercado potencial de $ 75 millones | Desarrollo clínico |
Subvenciones de investigación y fondos colaborativos
Además, la terapéutica asegura fondos a través de colaboraciones de investigación estratégica.
- Subvención del Instituto Nacional del Cáncer: $ 2.3 millones
- Financiación del Departamento de Investigación de Defensa: $ 1.7 millones
Ingresos de asociación estratégica potenciales
Las asociaciones estratégicas brindan oportunidades de ingresos adicionales.
| Pareja | Valor de asociación potencial | Área de enfoque |
|---|---|---|
| Institución de investigación académica | Acuerdo de colaboración de $ 5.6 millones | Investigación oncológica |
Monetización de la propiedad intelectual
La propiedad intelectual de la compañía representa un flujo de ingresos significativo.
- Portafolio Total de IP: 12 familias de patentes
- Valoración estimada de IP: $ 18.4 millones
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Value Propositions
Targeted, high-dose radiation delivery to CNS tumors, minimizing off-target toxicity, is quantified by clinical trial results showing absorbed doses delivered of >300 Gy observed in the ReSPECT-LM single dose trial. For the ReSPECT-GBM trial, a maximum absorbed tumor dose of 739.5 Gy was achieved during the Phase 1 dose-escalation study.
REYOBIQ™ addresses high-unmet-need cancers like leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The ReSPECT-LM Phase 1 trial reported a recommended Phase 2 dose of 44.1 mCi. The ReSPECT-PBC trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.
CNSide® provides rapid, high-sensitivity diagnosis and monitoring for LM, with commercial availability in Texas starting in August 2025. The platform secured a national coverage agreement with UnitedHealthcare effective September 15, 2025, covering over 51 million people, later expanding total coverage to 67 million people with the addition of Humana coverage effective October 29, 2025.
Image-guided local beta radiation for better dosing control and efficacy is demonstrated by the Rhenium-186 radioisotope's properties, which allow for real-time imaging via gamma energy. The ReSPECT-LM single dose trial showed the treatment was well-tolerated up to a maximum tolerated dose of 66mCi.
A dual-platform approach offers both a diagnostic revenue stream and a therapeutic pipeline, which is supported by the company's financial structure. For the third quarter ended September 30, 2025, Plus Therapeutics, Inc. recognized $1.4 million in total revenue, which was almost entirely grant revenue. The company ended Q3 2025 with a cash balance of $16.6 million, while carrying total debt of approximately $6.40 million against total shareholder equity of about $5.05 million. The therapeutic pipeline development for LM is funded in part by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
Here is a look at the quantitative aspects of the dual-platform strategy as of late 2025:
| Platform Component | Key Metric | Value/Amount |
| REYOBIQ™ (LM Trial) | Recommended Phase 2 Dose | 44.1 mCi |
| REYOBIQ™ (GBM Trial) | Maximum Absorbed Tumor Dose (Phase 1) | 739.5 Gy |
| CNSide® Diagnostics | Total US Population Coverage (by late 2025) | 67 million people |
| CNSide® Diagnostics | UnitedHealthcare Coverage Start Date | September 15, 2025 |
| Financial/Funding | Q3 2025 Total Revenue | $1.40 million |
| Financial/Funding | Cash & Investments (as of 9/30/2025) | $16.6 million |
| Financial/Funding | CPRIT Grant for ReSPECT-LM | $17.6 million |
The value proposition is supported by these operational milestones:
- REYOBIQ™ MTD in ReSPECT-LM trial reached 66mCi.
- CNSide® Houston lab achieved CLIA accreditation.
- Q3 2025 Net Loss was $4.4 million.
- Debt-to-Equity Ratio stood at 1.27.
- Forecasted annual EBITDA for 2025 is negative $12 million.
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Customer Relationships
Plus Therapeutics, Inc. engages its customer base through distinct, data-driven relationship channels, reflecting its dual focus on clinical development and diagnostic commercialization.
High-touch, specialized engagement with Key Opinion Leaders (KOLs) and cancer centers.
Engagement with Key Opinion Leaders (KOLs) and cancer centers is centered around the clinical progress of REYOBIQ and the adoption of the CNSide platform. The clinical data itself serves as a primary point of engagement for KOLs.
- Median overall survival of 17 months achieved in glioblastoma patients receiving a radiation dose >100 Gy of REYOBIQ, more than double the standard of care, as presented at the May 9-10, 2025 conference.
- The ReSPECT-PBC trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense.
- Plus Therapeutics is scheduled to present ReSPECT Phase 1 Dose Escalation Study Results for Leptomeningeal Metastases at the 2025 San Antonio Breast Cancer Symposium (December 1, 2025).
- The company highlighted three REYOBIQ clinical data presentations at the 2025 WFNOS/SNO Annual Meeting.
Direct service model for CNSide® testing with healthcare professionals.
The relationship with healthcare professionals is established through the centralized testing service for the CNSide® CSF assay platform, which launched commercially in the second half of 2025. This model requires establishing trust based on performance metrics.
| Metric | Value/Detail |
| U.S. Total Addressable Market (TAM) for CNSide CSF Tumor Cell Enumeration (TCE) | $6 billion |
| Initial Commercial Launch Geography/Timeline | Texas in the third quarter of 2025 |
| Expansion Plan Timeline | Additional states by late 2025 and 2026 |
| Assay Sensitivity / Specificity | 92% sensitivity and 95% specificity |
| Historical Test Volume (Since 2020) | Over 11,000 tests performed |
| Number of U.S. Cancer Institutions Using CNSide (Historical) | More than 200 |
| Impact on Treatment Decisions (Historical) | Over 90% of cases |
| Projected Q3 2025 Revenue (Analyst Forecast) | $1 million |
| Projected Q4 2025 Revenue (Analyst Forecast) | $0 million |
| Expected Meaningful Revenue Contribution Year | Fiscal year 2026 |
The CNSide Diagnostics, LLC subsidiary has established a centralized laboratory in Houston and received a certificate of accreditation from the Centers for Medicare and Medicaid Services. Plus Therapeutics anticipates transitioning to an operational revenue generating company with the launch of CNSide in 2025.
Investor relations focused on clinical milestones and capital structure transparency.
Investor relationships are managed through clear communication of financing activities, capital structure simplification, and progress against clinical and regulatory timelines. You need to know where the cash is and what the dilution looks like.
Here's the quick math on the capital structure changes:
- Gross proceeds raised from a private placement financing in March 2025: $15 million.
- Restructuring of the March 2025 $15 million equity financing completed June 17, 2025.
- Warrants canceled in restructuring that could have issued approximately 1.51 billion shares.
- Shares remaining issuable under amended Series B Warrants post-restructuring: about 36 million.
- Cash and Investments Balance as of March 31, 2025: $9.9 million.
- Cash and Investments Balance as of June 30, 2025: $6.9 million.
- Stockholders' Equity as of June 30, 2025: $3 million.
- Nasdaq minimum stockholders' equity requirement met: $2.5 million.
- Nasdaq minimum bid price compliance deadline extension granted until November 12, 2025.
- Another extension granted as of November 20, 2025.
- Average one-year price target from 3 analysts: $9.83.
- Consensus brokerage recommendation from 4 firms: 2.3 ('Outperform').
Collaborative relationships with grant funding agencies.
The company maintains active, collaborative relationships with major non-dilutive funding sources, which directly support clinical trial execution and platform advancement. This funding is critical to extending the cash runway.
| Grant Agency / Program | Total Award / Expected Amount | 2025 Disbursement / Recognition |
| Cancer Prevention and Research Institute of Texas (CPRIT) - Total Award | $17.6 million | Received $1.9 million (second installment) |
| CPRIT - Expected Funding (Next 12 Months) | Approximately $6 million additional funding expected | Recognized $1.1 million in Q1 2025 |
| CPRIT - Expected Funding (Overall 2025 Range) | Expected to be in the range of $6 to $8 million | Recognized $1.4 million in Q2 2025 |
| U.S. Department of Defense (DoD) - Respect Trial | $3 million award | $2 million remaining to be received as of May 30, 2025 |
| Total Grant Revenue in 2024 | N/A | $5.8 million |
CPRIT is noted as the second-largest public cancer research funder globally, having committed $6 billion to cancer research and prevention in Texas.
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Channels
You're looking at how Plus Therapeutics, Inc. gets its diagnostic tests and future drug candidates to the market and to the patients who need them. This company uses a dual-pronged channel strategy: a commercial channel for its diagnostic platform and a clinical/development channel for its lead therapeutic, REYOBIQ™.
Direct Diagnostic Sales and Clinical Adoption
The direct sales channel is channeled through its wholly-owned subsidiary, CNSide Diagnostics, LLC. This entity is responsible for the commercialization of the CNSide® Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT).
The adoption of this diagnostic service has been building since 2020, with the following usage metrics as of late 2025:
- Over >11,000 tests performed since 2020.
- Tests delivered to >120 U.S. cancer institutions.
- The test demonstrated a 92% sensitivity and 95% specificity.
- The results influenced treatment decisions in 90% of cases reviewed.
The operational channel for the test is now federally compliant, as CNSide Diagnostics, LLC received a certificate of accreditation from CMS for its lab in Houston, Texas, following an audit. Management plans to build on this momentum by expanding the commercial team and footprint for CNSide in the fourth quarter of 2025.
Diagnostic Reimbursement Networks
Securing national insurance coverage is a critical channel for ensuring broad access and reimbursement for the CNSide® LDT. Plus Therapeutics, Inc. has successfully established significant policy coverage through major payors:
| Payer/Agreement | Effective Date | Covered Lives Added | Total Cumulative Coverage |
|---|---|---|---|
| UnitedHealthcare | September 15, 2025 | Over 51 million | N/A (Part of Total) |
| Humana, Inc. | October 29, 2025 | Approximately 16 million | 67 million in the U.S. |
This national policy coverage now totals 67 million covered lives in the U.S. as of late 2025.
Clinical Trial Sites for REYOBIQ™ Development
The channel for developing the lead therapeutic, REYOBIQ™ (rhenium Re186 obisbemeda), relies heavily on academic and clinical partnerships to conduct trials and secure non-dilutive funding. These sites are the pathway to future commercialization for this targeted radiotherapeutic for central nervous system cancers.
Key funding and site relationships include:
- The ReSPECT-LM dose optimization trial is supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).
- The ReSPECT-GBM trial is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH).
- The ReSPECT-PBC trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.
The company recently used these clinical channels to advance regulatory strategy, concluding a Type B meeting with the FDA on November 7th to align on the design for a potential pivotal trial.
Supply Chain via Contract Manufacturing
Plus Therapeutics, Inc. has established a supply chain designed to support the development, manufacturing, and eventual commercialization of its products, including REYOBIQ™. This channel is managed through strategic partnerships with contract development and manufacturing organizations (CDMOs).
While the specific financial terms with CDMOs are not detailed, the operational reliance on this external manufacturing capability is a stated component of the business model to enable future product delivery.
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Customer Segments
You're looking at the core groups Plus Therapeutics, Inc. (PSTV) targets with its REYOBIQ™ radiotherapeutics and CNSide® diagnostics. Honestly, these segments are highly specialized, reflecting the company's focus on difficult-to-treat central nervous system (CNS) cancers.
Patients with life-threatening CNS cancers, specifically LM and recurrent GBM.
This group represents the ultimate end-user for the therapeutic candidates. The market size, while small in absolute terms, is characterized by high unmet need and limited options, which is key for orphan drug designation value. Here's a quick look at the patient context for the lead programs as of late 2025:
| Condition | Estimated Incidence/Prevalence Context | Historical Median Overall Survival (OS) | PSTV Trial Data Context (Phase 1) |
|---|---|---|---|
| Leptomeningeal Metastases (LM) | Occurs in approximately 5% of patients with metastatic cancer. | Typically 2-6 months. | Phase 1 single dose trial showed a recommended Phase 2 dose of 44.1 mCi. |
| Recurrent Glioblastoma (rGBM) | Glioblastoma affects approximately 15,000 patients annually in the U.S. | Standard of care median OS approximately eight months. | Phase 1 data showed median OS of 11 months for all 21 patients, a 38% increase over standard of care. |
What this estimate hides is the exact number of patients eligible for REYOBIQ™ based on specific inclusion criteria across the ongoing Phase 1/2 trials (ReSPECT-LM and ReSPECT-GBM).
Neuro-oncologists and oncology specialists at major U.S. cancer institutions.
These are the prescribers and key opinion leaders who influence adoption. Plus Therapeutics, Inc. (PSTV) engages them through clinical trial participation and data presentations at key medical meetings. For instance, they presented data at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting in November 2025. The clinical trial sites themselves are at major academic medical centers across North America.
- Key prescribers for LM and recurrent GBM treatments.
- Influencers for the adoption of the CNSide® CSF diagnostics platform.
- Presenters and attendees at major CNS oncology conferences.
Major U.S. health insurance payers (e.g., UnitedHealthcare, Humana).
Payer coverage is critical for commercial success, especially for diagnostics like CNSide®. The company has made concrete progress here. They announced a national coverage agreement with UnitedHealthcare effective September 15, 2025, which covers over 51 million people throughout the U.S. for the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT). This is a defintely material step toward revenue generation from the diagnostic arm.
- UnitedHealthcare: Coverage secured for CNSide® LDT for over 51 million lives as of late 2025.
- Payer acceptance drives reimbursement for the CNSide® platform.
Government and non-profit research funders (e.g., CPRIT, DoD).
Non-dilutive funding from these entities validates the science and bolsters the capital structure. As of their Q3 2025 report, Plus Therapeutics, Inc. (PSTV) had received an additional $1.9 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT). This is part of a previously awarded non-dilutive $17.6 million grant supporting LM targeted radiotherapeutic development. Furthermore, the ReSPECT-PBC trial for pediatric brain cancer is supported by a $3.0 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. The company recognized $1.4 million in grant revenue in Q3 2025.
- CPRIT: Secured a total non-dilutive grant of $17.6 million for LM development.
- Department of Defense (DoD): Provided a $3.0 million grant supporting the ReSPECT-PBC trial.
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Cost Structure
You're looking at the cost side of Plus Therapeutics, Inc. (PSTV), and it's what you expect from a clinical-stage biotech: heavy investment in the pipeline before product sales kick in. The entire structure is geared toward advancing REYOBIQ™ and scaling up CNSide®.
High Research and Development (R&D) expenses are the classic biotech cash burn you need to account for. This spending directly fuels the development of their targeted radiotherapeutics. For instance, R&D expenses in the third quarter of 2025 were reported at $2.44 million. To give you a broader view of the burn rate, R&D in the second quarter of 2025 was $5.5 million.
The significant clinical trial costs for REYOBIQ™ Phase 1/2 studies are largely supported by non-dilutive funding, which is a key financial structure element. The development of REYOBIQ™ for leptomeningeal metastases (LM) is supported by a substantial $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Furthermore, the pediatric brain cancer trial is backed by a $3 million grant from the U.S. Department of Defense. This grant structure helps offset the direct cash outlay for these critical studies.
Selling, General, and Administrative (SG&A) costs reflect the company's pivot toward generating commercial revenue from its diagnostics platform. In Q3 2025, SG&A expense hit $3.44 million, marking a year-over-year increase of 43.6%, which is directly tied to the commercialization push for CNSide®. This is a clear signal that Plus Therapeutics, Inc. is building out the infrastructure to support product sales. For comparison, SG&A costs, including marketing, were $4.4 million in Q2 2025.
Data on manufacturing and supply chain costs for radiopharmaceutical production is often embedded in the Cost of Revenue. For the trailing twelve months (TTM) ending September 30, 2025, the Cost of Revenue was $7.62 million, which exceeded the TTM revenue of $5.26 million. This indicates significant costs being incurred, likely related to building up inventory and capacity for radiopharmaceutical production before major sales volume is achieved.
The cumulative effect of these expenditures is reflected in the bottom line. The operating loss of $4.5 million in Q3 2025 represents an increase of about 18% year-over-year. The net loss for that same quarter was $4.4 million, a jump of roughly 52% year-over-year. You can see the scale of the burn in earlier quarters, such as the net loss of $17.4 million reported for Q1 2025.
Here is a breakdown of the key operating expenses for recent quarters:
| Expense Category | Q3 2025 (Millions USD) | Q2 2025 (Millions USD) | Y/Y Change (Q3 2025 SG&A) |
| Research & Development (R&D) | 2.44 | 5.5 | N/A |
| Selling, General, & Administrative (SG&A) | 3.44 | 4.4 | +43.6% |
| Total Operating Loss | 4.5 | 10.5 (Operating Income Negative) | ~18% Increase (Loss) |
The company's spending priorities are clear, focusing on the pipeline and commercial readiness:
- Funding for REYOBIQ™ LM trial via CPRIT grant: $17.6 million.
- Funding for REYOBIQ™ pediatric trial via DoD grant: $3 million.
- Q3 2025 SG&A spend: $3.44 million.
- TTM ending Q3 2025 Cost of Revenue: $7.62 million.
Finance: draft 13-week cash view by Friday.
Plus Therapeutics, Inc. (PSTV) - Canvas Business Model: Revenue Streams
You're looking at the revenue engine for Plus Therapeutics, Inc. (PSTV) as of late 2025. For a clinical-stage company, the revenue streams are heavily weighted toward non-dilutive funding that supports the pipeline, rather than product sales.
Non-dilutive Grant Revenue from CPRIT and other sources forms the bedrock of current operations. For the third quarter ended September 30, 2025, Plus Therapeutics, Inc. recognized total revenue of $1.4 million. This figure is almost entirely grant revenue, which is reimbursement for costs associated with the development of their lead therapeutic candidate, REYOBIQ™ (rhenium 186re obisbemeda). This quarterly recognition is slightly down from the $1.5 million in grant revenue reported in Q3 2024. The trailing twelve months (TTM) revenue ending September 30, 2025, stood at $5.26 million.
The company's capital structure strength is directly tied to these non-dilutive awards. The CPRIT grant for REYOBIQ™ development in leptomeningeal metastases is a substantial $17.6 million.
Advance payments from grants provide immediate liquidity. In Q3 2025 alone, Plus Therapeutics, Inc. received an additional $1.9 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT) as part of that larger grant. This is a critical component of their cash management, as the company reported an operating loss of $4.5 million in the same quarter.
The second major component is Diagnostic testing fees from the commercial CNSide® CSF Assay platform. This stream is designed to build commercial revenue while the therapeutic progresses. The platform began its commercial introduction in 2025.
- The CNSide® CSF Assay platform secured a national coverage agreement with UnitedHealthcare in September 2025.
- This agreement instantly covers over 51 million people.
- The company also secured a national coverage agreement with Humana, Inc..
- The company planned to launch the CNSide cerebrospinal fluid diagnostic platform in the second half of 2025.
Here's a quick look at the key financial figures driving these revenue streams as of the end of Q3 2025:
| Revenue Component | Financial Metric | Amount |
|---|---|---|
| Grant Revenue (Q3 2025) | Total Recognized Revenue | $1.4 million |
| CPRIT Grant Funding | Total Award Value | $17.6 million |
| CPRIT Advance Payment (Q3 2025) | Cash Received | $1.9 million |
| CNSide Coverage | UnitedHealthcare Covered Lives | Over 51 million |
| TTM Revenue (Ending Sep 30, 2025) | Total Revenue | $5.26 million |
Future commercial sales of REYOBIQ™ (post-regulatory approval) is the defintely big prize. REYOBIQ is being evaluated for recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-LM and ReSPECT-GBM clinical trials. Success here would transition the revenue model from grant-dependent to product-based, which is the fundamental shift for Plus Therapeutics, Inc.
Finance: Finance needs to model the cash runway based on the $16.6 million cash balance as of September 30, 2025, against the Q3 2025 operating loss of $4.5 million.
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