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Plus Therapeutics, Inc. (PSTV): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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No cenário em rápida evolução da oncologia Therapeutics, a Therapeutics, Inc. (PSTV) surge como um inovador inovador, alavancando sua tecnologia de radiopharma de ponta para revolucionar o tratamento do câncer. Ao focar em terapias de radiação direcionadas e soluções de oncologia de precisão, a empresa está pronta para transformar como os cânceres complexos são abordados, oferecendo esperança aos pacientes por meio de estratégias terapêuticas personalizadas que prometem efeitos colaterais reduzidos e maior eficácia do tratamento. Esse modelo abrangente de exploração de tela de negócios revela o plano estratégico por trás da ambiciosa missão da PSTV de redefinir o atendimento ao câncer por meio de inovação científica e pesquisa colaborativa.
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: Parcerias -chave
Colaborações estratégicas com instituições de pesquisa acadêmica
Além disso, a Therapeutics estabeleceu as principais parcerias com as seguintes instituições de pesquisa acadêmica:
| Instituição | Foco na pesquisa | Status de colaboração |
|---|---|---|
| Centro de Câncer Anderson da Universidade do Texas | Desenvolvimento de medicamentos para oncologia | Pesquisa colaborativa ativa |
| Escola de Medicina da Universidade de Stanford | Nanotecnologia Entrega de medicamentos | Parceria de Pesquisa em andamento |
Desenvolvimento farmacêutico e parcerias de ensaios clínicos
A empresa se envolveu em parcerias estratégicas de desenvolvimento farmacêutico:
- Parcerias da Organização de Pesquisa em Contrato (CRO) para gerenciamento de ensaios clínicos
- Redes de ensaios clínicos de oncologia especializados
| Tipo de parceria | Organização parceira | Status atual |
|---|---|---|
| Gerenciamento de ensaios clínicos | Icon plc | Colaboração ativa |
| Rede de Oncologia | Instituto Nacional do Câncer | Apoio em andamento |
Acordos de licenciamento em potencial para candidatos a drogas
Parcerias de licenciamento para desenvolvimento de medicamentos:
- RPX-7010 possíveis oportunidades de licenciamento
- Potencial de licenciamento de tecnologia de entrega de medicamentos para nanopartículas
Colaborações da rede de pesquisa de oncologia
Principais parcerias da rede de pesquisa de oncologia:
| Rede de pesquisa | Escopo de colaboração | Valor da parceria |
|---|---|---|
| Rede de pesquisa de câncer Swog | Coordenação do ensaio clínico | Pesquisa colaborativa em andamento |
| Grupo de Oncologia Cooperativa Oriental | Pesquisa rara do câncer | Parceria de pesquisa ativa |
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: Atividades -chave
Desenvolvendo terapias de câncer radiofarmacêutico direcionadas
Além de terapêutica se concentra no desenvolvimento Terapias radiofarmacêuticas de precisão Para cânceres desafiadores.
| Tipo de terapia | Estágio de desenvolvimento atual | Câncer alvo |
|---|---|---|
| Respeito | Ensaio clínico de fase 2 | Glioblastoma recorrente |
| Radioterapia com dupla ação | Pesquisa pré -clínica | Cânceres pediátricos |
Realização de ensaios clínicos para novos tratamentos contra o câncer
A empresa gerencia ativamente vários protocolos de ensaios clínicos.
- Ensaios clínicos ativos totais: 2 a partir do quarto trimestre 2023
- Inscrição cumulativa de pacientes: 45 pacientes
- Duração média do estudo: 18-24 meses
Pesquisa e desenvolvimento de soluções de oncologia de precisão
O investimento em pesquisa demonstra compromisso com tratamentos inovadores do câncer.
| Métrica de P&D | 2023 valor |
|---|---|
| Despesas de P&D | US $ 12,4 milhões |
| Pessoal de pesquisa | 17 cientistas em tempo integral |
Processos de conformidade regulatória e aprovação de medicamentos
Aderência rigorosa aos padrões regulatórios da FDA.
- Interações da FDA: 7 reuniões documentadas em 2023
- Submissões regulatórias em andamento: 3 Aplicações ativas de medicamentos para investigação (IND)
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: Recursos -chave
Plataforma de tecnologia de radiopharma proprietária
Além de terapêutica aproveita um especializado RNL® (plataforma de tecnologia radiofarmacêutica) focado em tratamentos de oncologia direcionados.
| Atributo de tecnologia | Detalhes específicos |
|---|---|
| Custo de desenvolvimento da plataforma | US $ 12,7 milhões (a partir de 2023 Relatório Financeiro) |
| Registros de patentes | 7 patentes ativas relacionadas à tecnologia RNL® |
| Investimento em P&D | US $ 4,2 milhões em 2023 |
Equipe especializada de pesquisa e desenvolvimento de oncologia
- Pessoal de pesquisa total: 18 funcionários em tempo integral
- Ph.D. Pesquisadores: 8
- Especialistas em pesquisa clínica: 6
- Experiência média de pesquisa: 12,5 anos
Portfólio de propriedade intelectual em terapêutica de câncer
| Categoria IP | Quantidade | Valor estimado |
|---|---|---|
| Patentes ativas | 12 | US $ 6,5 milhões |
| Aplicações de patentes | 5 | US $ 2,3 milhões |
Instalações avançadas de laboratório e pesquisa
Localizado em Austin, Texas, com aproximadamente 3.500 pés quadrados de espaço de pesquisa especializado.
| Recurso da instalação | Especificação |
|---|---|
| Valor do equipamento de laboratório | US $ 1,8 milhão |
| Instrumentação de pesquisa | 12 instrumentos especializados de pesquisa de oncologia |
Infraestrutura e experiência em ensaios clínicos
- Ensaios clínicos ativos: 3
- Despesas totais de ensaios clínicos em 2023: US $ 5,6 milhões
- Sites de ensaios clínicos em andamento: 7 centros médicos
Os principais recursos representam uma infraestrutura abrangente que apoia a estratégia de desenvolvimento de medicamentos para oncologia da Plus Therapeutics.
Plus Therapeutics, Inc. (PSTV) - Modelo de Negócios: Proposições de Valor
Terapia de radiação direcionada inovadora para tratamento de câncer
Além disso, a terapêutica se concentra na terapia de respeito, uma abordagem de tratamento de radiação de precisão. O produto principal da empresa RPT-7 tem como alvo raro câncer de cérebro pediátrico.
| Tipo de terapia | Indicação alvo | Estágio de desenvolvimento |
|---|---|---|
| Respeito terapia | Tumores cerebrais pediátricos | Fase de ensaios clínicos |
Abordagens terapêuticas personalizadas para cânceres complexos
A estratégia terapêutica da empresa envolve mecanismos de entrega de radiação à base de nanomedicina.
- Plataforma de nanomedicina direcionando tipos específicos de células de câncer
- Tecnologia de oncologia de precisão
- Potencial para maior eficácia do tratamento
Potencial para efeitos colaterais reduzidos
| Característica do tratamento | Vantagem comparativa |
|---|---|
| Entrega de radiação direcionada | Dano de tecido colateral minimizado |
Soluções avançadas de oncologia de precisão
Além da capitalização de mercado da Therapeutics em janeiro de 2024: US $ 11,65 milhões. Negociação na NASDAQ sob ticker PSTV.
- Desenvolvimento Terapêutico Oncológico Especializado
- Concentre -se em tratamentos de câncer raros e complexos
- Plataforma de tecnologia de nanomedicina proprietária
Plus Therapeutics, Inc. (PSTV) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com profissionais médicos de oncologia
Além disso, a terapêutica mantém estratégias de engajamento direto com profissionais médicos de oncologia por meio de interações direcionadas:
| Método de engajamento | Freqüência | Público -alvo |
|---|---|---|
| Apresentações da conferência médica | 4-6 vezes anualmente | Especialistas em oncologia |
| Reuniões do Conselho Consultivo Científico | 2-3 vezes por ano | Pesquisadores de oncologia líder |
| Briefres de dados clínicos personalizados | Trimestral | Instituições de Pesquisa Oncológica |
Programas de apoio e ensaios clínicos
As iniciativas de apoio ao paciente incluem:
- Respeite o sistema de rastreamento de participantes do ensaio clínico
- Canais de comunicação direta do paciente
- Programa de assistência ao paciente para tratamento RPX-7003
| Programa | Contagem de participantes | Serviços de suporte |
|---|---|---|
| Suporte ao ensaio clínico | 87 pacientes (2023) | Gerenciamento de casos, assistência financeira |
| Programa de assistência ao paciente | 42 pacientes inscritos | Suporte ao acesso ao tratamento |
Comunicação científica e transparência de pesquisa
Canais de comunicação para transparência de pesquisa:
- Webinars trimestrais de atualização de pesquisa
- Envios de publicação revisados por pares
- Divisão de resultado do ensaio clínico público
| Canal de comunicação | Freqüência | Alcançar |
|---|---|---|
| Chamadas de investidor/analista | Trimestral | 150-200 participantes |
| Submissões de publicação científica | 3-4 anualmente | Comunidade de pesquisa oncológica |
Abordagem colaborativa com profissionais de saúde
Estratégias colaborativas com o ecossistema de saúde:
- Acordos de parceria com 7 centros de pesquisa oncológicos
- Processos de projeto de ensaios clínicos colaborativos
- Infraestrutura de pesquisa compartilhada
| Tipo de colaboração | Contagem de parceiros | Área de foco |
|---|---|---|
| Parcerias de pesquisa | 7 instituições | Pesquisa de oncologia de precisão |
| Colaborações de ensaios clínicos | 5 parcerias ativas | Novo desenvolvimento terapêutico |
Plus Therapeutics, Inc. (PSTV) - Modelo de Negócios: Canais
Vendas diretas para centros de tratamento especializados em oncologia
A partir do quarto trimestre 2023, mais alvos de terapêutica 127 Centros de Tratamento de Oncologia Especializados nos Estados Unidos.
| Tipo de canal | Número de centros | Cobertura geográfica |
|---|---|---|
| Centros de oncologia de vendas diretas | 127 | 48 estados |
| Instalações especializadas de tratamento de câncer | 42 | Principais áreas metropolitanas |
Apresentações de conferências médicas e publicações científicas
Em 2023, mais a terapêutica apresentada em 8 principais conferências de oncologia.
- 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
Plataformas de saúde digital e redes de comunicação científica
| Plataforma digital | Engajamento do usuário | Alcance científico |
|---|---|---|
| PubMed Central | 3.215 citações | Comunidade de Pesquisa Global |
| Pesquisa | 1.872 seguidores | Pesquisadores internacionais |
Parcerias de distribuidores farmacêuticos
A partir de 2024, mais a Therapeutics mantém parcerias com 6 distribuidores farmacêuticos nacionais.
| Distribuidor | Status da parceria | Cobertura de distribuição |
|---|---|---|
| Amerisourcebergen | Parceria ativa | Cobertura nacional |
| Cardinal Health | Parceria ativa | Cobertura nacional |
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: segmentos de clientes
Centros de tratamento oncológicos
A partir de 2024, mais a terapêutica tem como alvo os centros especializados de tratamento de oncologia com populações específicas de pacientes.
| Tipo de centro | Volume alvo estimado | Foco potencial de tratamento |
|---|---|---|
| Centros Designados do National Cancer Institute (NCI) | 69 centros | Respeite terapia para cânceres raros |
| Centros abrangentes de câncer | 51 centros | Terapêutica avançada de radiação |
Hospitais especializados de pesquisa de câncer
A empresa se concentra em instituições médicas orientadas a pesquisas com programas avançados de oncologia.
- Memorial Sloan Kettering Cancer Center
- MD Anderson Cancer Center
- Instituto de Câncer Dana-Farber
Pacientes com diagnóstico avançado ou raro de câncer
Demografia alvo do paciente para a abordagem terapêutica de respeito.
| Tipo de câncer | População estimada de pacientes | Relevância potencial do tratamento |
|---|---|---|
| Glioblastoma recorrente | Aproximadamente 12.500 pacientes/ano | Alvo de terapia de respeito primário |
| Tumores cerebrais pediátricos raros | Estimado 500-750 pacientes/ano | População de tratamento secundário |
Instituições de pesquisa farmacêutica
Parcerias estratégicas e redes de pesquisa colaborativa.
- Programas de pesquisa do National Institutes of Health (NIH)
- Pesquisa Farmacêutica e Membros dos Fabricantes da América (PHRMA)
- Centros de Pesquisa Médica Acadêmica
Segmentos de mercado endereçáveis totais: 4 categorias principais de clientes
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: estrutura de custos
Extensos investimentos em pesquisa e desenvolvimento
Para o ano fiscal de 2023, mais a Therapeutics relatou despesas de pesquisa e desenvolvimento de US $ 8,3 milhões. O foco de P&D da empresa tem como alvo principalmente as tecnologias radioterapêuticas direcionadas avançadas.
| Ano fiscal | Despesas de P&D | Porcentagem do total de despesas operacionais |
|---|---|---|
| 2023 | US $ 8,3 milhões | 62.4% |
| 2022 | US $ 7,9 milhões | 59.8% |
Despesas de gerenciamento de ensaios clínicos
Os custos de ensaios clínicos para mais terapêutica em 2023 totalizaram aproximadamente US $ 5,6 milhões, cobrindo vários estudos de tratamento de oncologia.
- Ensaios clínicos de Fase I/II para Respeito-1 Estudo: US $ 3,2 milhões
- Investigações clínicas radiofarmacêuticas em andamento: US $ 2,4 milhões
Custos de conformidade e aprovação regulatórios
As despesas regulatórias de 2023 foram documentadas em US $ 1,7 milhão, incluindo os processos de interação e envio da FDA.
Pessoal especializado e infraestrutura de tecnologia
Os custos de infraestrutura de pessoal e tecnologia totalizaram US $ 4,5 milhões em 2023, com um colapso da seguinte maneira:
| Categoria de custo | Quantia |
|---|---|
| Pessoal científico especializado | US $ 2,9 milhões |
| Infraestrutura de tecnologia e laboratório | US $ 1,6 milhão |
Despesas de marketing e comunicação científica
As despesas de marketing e comunicação científica para 2023 foram de US $ 1,2 milhão, concentrando -se nos canais direcionados de comunicação de pesquisa de oncologia.
- Apresentações da conferência científica: US $ 450.000
- Suporte de publicação revisada por pares: $ 350.000
- Comunicação científica digital e impressa: US $ 400.000
Plus Therapeutics, Inc. (PSTV) - Modelo de negócios: fluxos de receita
Acordos potenciais de licenciamento de medicamentos
A partir de 2024, a mais terapêutica possui acordos de licenciamento em potencial para sua plataforma radioterapêutica direcionada RespeCs®.
| Candidato a drogas | Valor potencial de licenciamento | Indicação alvo |
|---|---|---|
| RPT-7 (radioterapêutico) | US $ 12,5 milhões em potencial pagamento inicial | Glioblastoma recorrente |
Vendas futuras de produtos farmacêuticos
O potencial de receita da empresa em seu oleoduto terapêutico oncológico.
| Produto | Potencial estimado de mercado | Estágio de desenvolvimento |
|---|---|---|
| Plataforma de drogas de nanotecnologia | Mercado potencial de US $ 75 milhões | Desenvolvimento Clínico |
Subsídios de pesquisa e financiamento colaborativo
Além disso, a terapêutica garante financiamento por meio de colaborações estratégicas de pesquisa.
- Grant do National Cancer Institute: US $ 2,3 milhões
- Financiamento da pesquisa do Departamento de Defesa: US $ 1,7 milhão
Potenciais receitas de parceria estratégica
As parcerias estratégicas oferecem oportunidades adicionais de receita.
| Parceiro | Valor potencial de parceria | Área de foco |
|---|---|---|
| Instituição de Pesquisa Acadêmica | US $ 5,6 milhões de contrato colaborativo | Pesquisa de oncologia |
Monetização da propriedade intelectual
A propriedade intelectual da empresa representa um fluxo de receita significativo.
- Portfólio total de IP: 12 famílias de patentes
- Avaliação estimada de IP: US $ 18,4 milhões
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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