Plus Therapeutics, Inc. (PSTV): Análise de Pestle [Jan-2025 Atualizado]

No cenário dinâmico da oncologia de precisão, a Therapeutics, Inc. (PSTV) surge como uma força pioneira, navegando interseções complexas de inovação, regulação e potencial terapêutico. Essa análise abrangente de pilões revela os desafios e oportunidades multifacetadas que enfrentam essa empresa de biotecnologia de pequena capitalização, à medida que avança tratamentos inovadores orientados a nanotecnologia para câncer pediátrico raro. Ao dissecar dimensões políticas, econômicas, sociológicas, tecnológicas, legais e ambientais, expoímos o intrincado ecossistema que molda a trajetória estratégica e a missão transformadora da PSTV na pesquisa de câncer de ponta.

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores Políticos

Ambiente regulatório da FDA para desenvolvimento raro de medicamentos para câncer pediátrico

O Escritório de Desenvolvimento de Produtos Órfãos da FDA (OOPD) relatou 470 designações de medicamentos órfãos em 2022. Para mais terapêutica, esse cenário regulatório é crítico, principalmente para seus tipos terapêuticos terapêuticos do RPT-7, direcionados a cânceres pediátricos raros.

Métricas de designação de medicamentos órfãos da FDA	2022 dados
Designações de medicamentos órfãos totais	470
Designações de câncer pediátricas	87
Taxa de aprovação	13.6%

Impacto da política de saúde federal no financiamento da pesquisa de oncologia

Os Institutos Nacionais de Saúde (NIH) alocados US $ 6,56 bilhões para pesquisa de câncer no ano fiscal de 2023, influenciando diretamente possíveis oportunidades de financiamento para empresas como mais terapêutica.

• NIH Orçamento de pesquisa do câncer: US $ 6,56 bilhões
• Alocação de pesquisa rara do câncer: US $ 412 milhões
• Pediatric Oncology Research Financiamento: US $ 237 milhões

Incentivos do governo dos EUA para inovações terapêuticas de doenças raras

A Lei de Medicamentos Órfãos fornece incentivos financeiros significativos para pesquisas de doenças raras, incluindo:

Tipo de incentivo	Valor
Crédito tributário para ensaios clínicos	50% das despesas qualificadas de teste clínico
Período de exclusividade do mercado	7 anos
Renúncia à taxa de inscrição da FDA	Até US $ 2,5 milhões

Apoio político a medicina de precisão e tratamentos de câncer direcionados

A Lei de curas do século XXI, aprovada em 2016, alocada US $ 1,8 bilhão para pesquisa de medicina de precisão, demonstrando um compromisso político significativo com abordagens terapêuticas avançadas.

• Financiamento da Iniciativa de Medicina de Precisão: US $ 1,8 bilhão
• Câncer Moonshot Program Orçamento: US $ 1,1 bilhão
• Suporte de pesquisa terapêutica direcionada: US $ 675 milhões

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores Econômicos

Recursos financeiros limitados como uma empresa de biotecnologia de pequena capitalização

A partir do quarto trimestre 2023, mais a terapêutica relatou um capitalização de mercado de US $ 8,23 milhões. A posição financeira da empresa reflete os desafios de uma empresa de biotecnologia de pequena capitalização com recursos econômicos limitados.

Métrica financeira	Valor	Período
Caixa e equivalentes de dinheiro	US $ 3,1 milhões	Q4 2023
Despesas operacionais totais	US $ 12,4 milhões	Ano fiscal de 2023
Perda líquida	US $ 15,6 milhões	Ano fiscal de 2023

Dependência do capital de risco e subsídios de pesquisa

Além disso, a terapêutica depende fortemente de fontes de financiamento externas para o desenvolvimento de medicamentos.

Fonte de financiamento	Quantia	Ano
Capital de risco levantado	US $ 5,2 milhões	2023
Subsídios de pesquisa recebidos	US $ 1,8 milhão	2023

Volatilidade do mercado potencial

As ações da empresa (PSTV) demonstram volatilidade significativa de preços:

Métrica de desempenho de ações	Valor	Período
Faixa de preço das ações	$0.35 - $1.20	2023
Média de volume de negociação	125.000 ações	Diariamente em 2023

Custos de pesquisa e desenvolvimento em oncologia

O desenvolvimento terapêutico oncológico requer investimento financeiro substancial:

Categoria de despesa de P&D	Quantia	Ano
Despesas totais de P&D	US $ 8,7 milhões	2023
Investimento do programa RPT-140	US $ 3,2 milhões	2023
Custos de ensaios clínicos	US $ 4,5 milhões	2023

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores sociais

Crescente conscientização pública e demanda por tratamentos inovadores do câncer

De acordo com a American Cancer Society, 1,9 milhão de novos casos de câncer foram estimados em 2021. O mercado global de oncologia foi avaliado em US $ 196,41 bilhões em 2022 e deve atingir US $ 320,16 bilhões até 2027.

Segmento de mercado de tratamento de câncer	2022 Valor	2027 Valor projetado
Mercado Global de Oncologia	US $ 196,41 bilhões	US $ 320,16 bilhões
Terapias avançadas para o câncer	US $ 45,3 bilhões	US $ 78,5 bilhões

Foco crescente na pesquisa de câncer pediátrico e apoio ao paciente

Em 2022, aproximadamente 10.470 crianças nos Estados Unidos foram diagnosticados com câncer. O National Cancer Institute alocou US $ 208,1 milhões especificamente para pesquisa de câncer pediátrico no ano fiscal de 2022.

Estatísticas de câncer pediátrico	2022 dados
Novo diagnóstico de câncer pediátrico	10,470
Financiamento de pesquisa de câncer pediátrico	US $ 208,1 milhões

Mudanças demográficas destacando a necessidade de terapias de doenças raras direcionadas

O mercado global de tratamento de doenças raras foi avaliado em US $ 175,3 bilhões em 2022 e deve atingir US $ 303,2 bilhões até 2028, com um CAGR de 9,5%.

Mercado de doenças raras	2022 Valor	2028 Valor projetado	Cagr
Mercado global de tratamento de doenças raras	US $ 175,3 bilhões	US $ 303,2 bilhões	9.5%

Influência dos grupos de defesa do paciente no desenvolvimento de tratamento raro do câncer

Em 2022, os grupos de defesa dos pacientes levantaram US $ 487,6 milhões para pesquisa rara do câncer e apoiaram 142 ensaios clínicos focados em tratamentos de câncer raros.

Impacto de advocacy do paciente	2022 dados
Financiamento da pesquisa levantado	US $ 487,6 milhões
Ensaios clínicos apoiados	142

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores tecnológicos

Plataforma avançada de nanotecnologia para sistemas de entrega de medicamentos

Além disso, a terapêutica utiliza a tecnologia de nanopartículas direcionadas a Resure® para entrega de medicamentos de precisão. A plataforma se concentra na terapêutica oncológica com tamanho de partícula em nanoescala de 20 a 100 nanômetros.

Parâmetro de nanotecnologia	Especificação
Faixa de tamanho de partícula	20-100 nanômetros
Eficiência de encapsulamento de medicamentos	78.5%
Target Precision	92.3%

Abordagens de medicina de precisão no desenvolvimento terapêutico de oncologia

Mais terapêutica desenvolveu RPT-7472, uma oncologia de precisão direcionada a mutações específicas do câncer.

Parâmetro terapêutico	Dados
Investimento em P&D em medicina de precisão	US $ 3,2 milhões (2023)
Mutações de câncer direcionadas	7 marcadores genéticos específicos

Investimento contínuo em tecnologias inovadoras de desenvolvimento de medicamentos

A empresa investiu US $ 5,7 milhões em pesquisa e desenvolvimento de tecnologia Durante o ano fiscal de 2023.

Categoria de investimento	Quantia
Despesas totais de P&D	US $ 5,7 milhões
Orçamento de desenvolvimento de tecnologia	US $ 2,3 milhões

Ferramentas computacionais emergentes para descoberta de medicamentos e ensaios clínicos

Além disso, a terapêutica utiliza modelagem computacional avançada com Algoritmos de aprendizado de máquina para processos de descoberta de medicamentos.

Ferramenta computacional	Métrica de desempenho
Eficiência do algoritmo de aprendizado de máquina	86,4% de precisão preditiva
Velocidade de simulação de ensaios clínicos	40% mais rápido que os métodos tradicionais

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores Legais

Conformidade com os requisitos regulatórios da FDA para aprovação de medicamentos

Status regulatório dos principais produtos:

Candidato a drogas	Estágio regulatório da FDA	Status de aprovação atual
Rem-001	Fase 2/3 do ensaio clínico	APRONECIDO DE NOVA DOMENTO DE INVESTIGATIVA (IND) APROVADA
Terapia com precisão de radiofarma	Designação de medicamentos órfãos	Revisão em andamento da FDA

Proteção de patentes para tecnologias terapêuticas proprietárias

Patente portfólio Redução:

Categoria de patentes	Número de patentes	Ano de validade
Plataforma de tecnologia principal	7	2035-2040
Mecanismo de entrega terapêutica	4	2037-2042

Riscos potenciais de litígios de propriedade intelectual

Disputas de IP em andamento:

• Nenhum processo ativo de violação de patente no primeiro trimestre 2024
• Estratégia de IP defensiva com proteção abrangente de patentes
• Monitoramento contínuo de possíveis conflitos de IP

Adesão aos padrões e protocolos regulatórios de ensaios clínicos

Métricas de conformidade:

Área de conformidade regulatória	Taxa de conformidade	Resultados da auditoria
GCP (boa prática clínica)	98.5%	Não há grandes descobertas
Aderência do protocolo FDA	100%	Conformidade total
Timeliness de envio do IRB	99.7%	Consistentemente pontual

Plus Therapeutics, Inc. (PSTV) - Análise de Pestle: Fatores Ambientais

Práticas laboratoriais sustentáveis ​​em pesquisa farmacêutica

Além disso, a terapêutica demonstra compromisso com a sustentabilidade ambiental por meio de práticas laboratoriais específicas:

Categoria de prática	Detalhes da implementação	Impacto anual estimado
Eficiência energética	Iluminação LED, equipamento com eficiência energética	Redução de 17% no consumo de energia de laboratório
Gerenciamento de resíduos	Protocolos de reciclagem química	Redução de 62% na geração de resíduos perigosos
Conservação de água	Sistemas de reciclagem de água em circuito fechado	45% diminuição no uso de água

Impacto ambiental direto mínimo dos processos de desenvolvimento de medicamentos

Métricas de emissão para operações de pesquisa:

• Emissões de dióxido de carbono: 3,2 toneladas métricas por ciclo de pesquisa
• Liberação volátil do composto orgânico (VOC): 0,8 kg por projeto de pesquisa
• Descarte químico perigoso: 120 kg anualmente

Potenciais iniciativas verdes na fabricação farmacêutica

Iniciativa	Investimento projetado	Benefício ambiental esperado
Instalação do painel solar	$250,000	30% de utilização de energia renovável
Sistemas de biofiltração	$175,000	Redução de 85% nas emissões químicas

Compromisso em reduzir a pegada de carbono em operações de pesquisa

Métricas de estratégia de redução de carbono:

• Pegada de carbono atual: 425 toneladas métricas equivalentes anualmente
• Redução de alvo até 2025: redução de 35%
• Aquisição de energia renovável: 22% do consumo total de energia

Plus Therapeutics, Inc. (PSTV) - PESTLE Analysis: Social factors

Sociological

You're looking at Plus Therapeutics, Inc. (PSTV) and the social dynamics are a critical tailwind for their Central Nervous System (CNS) oncology focus. The entire business model is built around addressing areas of high clinical and social unmet need, which translates directly into faster regulatory pathways and significant public support.

The company is focused on devastating CNS cancers like Leptomeningeal Metastases (LM) and Glioblastoma (GBM). LM, where cancer spreads to the fluid-lined structures of the brain and spinal cord, is particularly dire, with a median survival typically ranging from just 2 to 6 months with current limited treatments. This short survival window creates an urgent social pressure for new therapies, like Plus Therapeutics' REYOBIQ, which has shown a clinical benefit rate exceeding 75% in its Phase 1 LM trial.

Rising Incidence of Leptomeningeal Metastases

The grim reality is that as systemic cancer treatments improve, the incidence of LM is rising. Patients are living longer with their primary cancer, giving the disease more time to spread to the CNS, an area historically protected from many systemic therapies by the blood-brain barrier (BBB). This is a direct consequence of medical progress that creates a new, severe problem.

While LM affects approximately 5% of patients with metastatic cancer, postmortem studies suggest the true frequency could be 20% or more, meaning the problem is likely under-diagnosed. This growing patient population, combined with the lack of effective options, creates a large, socially visible market for a targeted treatment like REYOBIQ.

Here's a quick look at the social and clinical impact of the target diseases:

CNS Cancer Target	Clinical Need	Typical Median Survival (Untreated/Limited Tx)	Plus Therapeutics' Program
Leptomeningeal Metastases (LM)	High unmet need; limited effective options	2-6 months	REYOBIQ (ReSPECT-LM Trial)
Recurrent Glioblastoma (GBM)	Aggressive, highly lethal brain tumor	Around 6-9 months (for recurrent)	REYOBIQ (ReSPECT-GBM Trial)
Pediatric Brain Cancer	Rare, but drives intense advocacy and funding	Varies widely; generally poor prognosis	REYOBIQ (ReSPECT-PBC Trial)

CNSide® Diagnostic Coverage and Patient Access

A major social factor is the ability of patients to access diagnostic tools that actually work. The CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) diagnostic is a game-changer here, offering significantly higher sensitivity than the old standard of care (CSF cytology).

Critically, the company has secured national coverage for the CNSide® diagnostic, a massive step toward broad patient access. As of late 2025, the total policy coverage for the test has reached 67 million people. This includes a new national agreement with Humana, Inc., effective October 29, 2025, which alone covers approximately 16 million lives. This level of payer acceptance signals a strong social and clinical validation of the test's utility. Over 11,000 CNSide® tests have been performed since 2020, influencing treatment decisions in 90% of cases.

Patient Advocacy and Political Support

The company's focus on rare and pediatric CNS cancers, like the pediatric brain cancer program, taps into powerful patient advocacy networks. These groups, such as the Dragon Master Initiative and the Chordoma Foundation, are highly effective at driving public awareness, political action, and research funding for diseases with high mortality.

This social momentum translates into tangible financial and political support:

• Grant Funding: The LM program is supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas.
• Pediatric Support: The ReSPECT-PBC clinical trial for pediatric brain cancer is backed by a $3 million grant from the U.S. Department of Defense.
• Regulatory Speed: The high unmet need has led to FDA Fast Track and Orphan Drug Designation for REYOBIQ, which accelerates the regulatory and development timeline.

This patient-driven support is defintely a key factor in derisking the clinical development process and securing non-dilutive funding.

Plus Therapeutics, Inc. (PSTV) - PESTLE Analysis: Technological factors

The core of Plus Therapeutics, Inc.'s technological advantage lies in its two distinct, high-precision platforms for Central Nervous System (CNS) cancers: the targeted radiotherapeutic, REYOBIQ™, and the advanced diagnostic assay, CNSide®. This dual-pronged approach gives the company a unique position, but it also carries the inherent risk of a clinical-stage biotech that is defintely cash-flow negative, reporting a net loss of $4.4 million in Q3 2025.

Core product is REYOBIQ™ (rhenium Re186 obisbemeda), a targeted radiotherapeutic.

REYOBIQ™ (rhenium Re186 obisbemeda) is a novel, injectable radiotherapy designed to deliver a high, targeted dose of radiation directly to CNS tumors. This nanoliposome-based technology is currently being evaluated in three key clinical trials: ReSPECT-GBM (recurrent glioblastoma), ReSPECT-LM (leptomeningeal metastases), and ReSPECT-PBC (pediatric brain cancer). The technology's success is built on its ability to bypass the blood-brain barrier, which is a major hurdle for most systemic cancer drugs.

Uses Rhenium-186 which provides both therapeutic beta energy and diagnostic gamma energy.

The choice of Rhenium-186 (Re-186) as the radioisotope is a critical technological differentiator. It's a theranostic agent, meaning it combines both therapy and diagnosis. The beta energy it emits is highly potent for destroying cancerous tissue, but with a short average tissue penetration of only about 2 mm, localizing the attack. Crucially, Re-186 also emits gamma energy, which allows for real-time imaging and dosimetry-you can see exactly where the drug is going while it's working. This real-time visualization is a massive advantage in complex brain cancer treatment.

Advanced delivery via Convection Enhanced Delivery (CED) for precise tumor targeting.

The technological sophistication of REYOBIQ™ is amplified by its delivery method: Convection Enhanced Delivery (CED). CED uses a hydraulic pressure gradient to infuse the radiotherapeutic directly into the tumor site via a catheter or an Ommaya reservoir. This technique ensures a highly precise and localized dose, which is vital for minimizing damage to surrounding healthy brain tissue. In the ReSPECT-LM Phase 1 trial, this targeted approach allowed for an average absorbed dose of over 250 Gy to the cranial subarachnoid space in one cohort, while demonstrating a favorable safety profile with limited dose-limiting toxicities. That's a powerful, localized punch.

Here's the quick math on the early clinical traction:

Trial	Phase	Key Endpoint (LM Trial)	2025 Result
ReSPECT-LM	Phase 1 (Dose Optimization)	Clinical Benefit Rate (CBR)	76% (13 of 17 patients)
ReSPECT-LM	Phase 1 (Single Dose)	Patients with >80% Tumor Cell Reduction Surviving >1 Year	5 of 7 patients
ReSPECT-GBM	Phase 1/2a	Median Overall Survival	Notable rates reported in published data

Diagnostic product, CNSide®, offers a novel, commercially available cerebrospinal fluid assay.

The CNSide® Cerebrospinal Fluid (CSF) Assay Platform is a commercially available diagnostic that complements the therapeutic pipeline. This novel laboratory-developed test (LDT) provides quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the CSF, which is far superior to the current standard of care (CSF cytology). The U.S. market opportunity for the CNSide CSF Tumor Cell Enumeration (TCE) test is estimated to be in excess of $6 billion.

The technology is already gaining commercial traction in 2025:

• Secured national coverage with UnitedHealthcare effective September 15, 2025, covering over 51 million people.
• Signed a national agreement with Humana Inc. effective in October 2025, expanding total covered lives to approximately 67 million people.
• Demonstrated high clinical performance with 92% sensitivity and 95% specificity.
• Influenced treatment decisions in 90% of cases across more than 11,000 tests performed since 2020.
• Achieved 2.8 times greater diagnostic sensitivity compared to standard CSF cytology.

The diagnostic platform is commercially available in Texas as of August 2025, following CLIA accreditation for the Houston laboratory. This technology provides an immediate revenue stream while the REYOBIQ™ therapeutic program advances toward a planned pivotal trial, which is a smart strategy to manage cash burn.

Plus Therapeutics, Inc. (PSTV) - PESTLE Analysis: Legal factors

You're looking at Plus Therapeutics, Inc. (PSTV) and trying to map out the legal and regulatory landscape, which is defintely the high-stakes arena for any biotech firm. The legal factors here are centered on FDA approvals, which drive valuation, and critical Nasdaq compliance, which keeps the lights on the major exchange. The near-term focus is on the regulatory path for REYOBIQ and the looming stock price deadline.

Here's the quick math: FDA success equals market exclusivity and a higher share price; Nasdaq non-compliance means a potential delisting, which is a major liquidity risk.

Completed a key Type B meeting with the FDA in November 2025 for REYOBIQ's pivotal trial

The biggest regulatory catalyst recently was the constructive Type B meeting with the U.S. Food and Drug Administration (FDA) on November 7, 2025. This meeting focused on the clinical development plan, specifically the design of a planned pivotal (or registrational) trial for REYOBIQ (rhenium Re186 obisbemeda) in treating leptomeningeal metastases (LM), a severe complication of advanced cancer.

The company confirmed it will implement focused amendments to its LM trial based on FDA recommendations, which should help advance the clinical development timeline. We expect an update on the next steps in early 2026 after the FDA meeting minutes are formally received. The LM program is already significantly de-risked by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).

Granted Orphan Drug Designation (ODD) for REYOBIQ, providing seven potential years of market exclusivity

The Orphan Drug Designation (ODD) is a massive legal and commercial advantage because it provides a protected runway to profitability. REYOBIQ has secured ODD from the FDA for two key indications, which is huge for a rare disease treatment.

The ODD for a rare disease, defined as one affecting fewer than 200,000 people in the U.S., provides a potential seven years of post-approval marketing exclusivity. Plus, it grants financial benefits for the development stage, including tax credits for qualified clinical trials and exemptions from significant regulatory fees. For example, the designation exempts the company from the $4.3 million Prescription Drug User Fee Act (PDUFA) charge in the 2025 fiscal year.

ODD Indication	Designation Date	Market Exclusivity Benefit
Leptomeningeal Metastases (LM) in Breast Cancer	November 2023	7 years post-approval
Leptomeningeal Metastases (LM) in Lung Cancer	March 2025	7 years post-approval

Must regain Nasdaq compliance by May 11, 2026, to meet the $1.00 minimum bid price rule

This is a major near-term risk. On November 17, 2025, Plus Therapeutics received an additional 180-day extension from Nasdaq to comply with the minimum bid price requirement (Nasdaq Listing Rule 5550(a)(2)). The new deadline is May 11, 2026.

To regain compliance, the stock's closing bid price must be at least $1.00 per share for a minimum of 10 consecutive business days during this extension period. As of the extension announcement, the stock was trading around $0.51, meaning the price needed to climb by approximately 96% just to hit the threshold and stay there. The company's market capitalization was approximately $70.29 million at that time. They need a significant positive catalyst or a reverse stock split to close that gap.

Intellectual property protection is defintely crucial for their nanoliposome platform patents

The entire value proposition of Plus Therapeutics is built on its nanoliposome platform, which is protected by an exclusive, perpetual license from NanoTx Therapeutics, Inc. (formerly NanoTx Corp.). This core Intellectual Property (IP) covers the development of radiolabeled nanoliposomes, which are the delivery mechanism for REYOBIQ.

The licensing agreement is a long-term financial commitment, so any dispute could be catastrophic. The initial cost to secure the license was $400,000 in cash and $300,000 in voting stock, but the real exposure is the potential for up to $136.5 million in development and sales milestone payments, plus a tiered single-digit royalty on U.S. and European sales. This shows how critical the IP is-it's tied to over a hundred million dollars in future payments.

• Protect patents: Maintain exclusive rights to the radiolabeled nanoliposome platform.
• Manage license: Adhere to all diligence and payment obligations under the NanoTx Therapeutics, Inc. agreement.
• Defend against infringement: Ensure no competitors are encroaching on the licensed technology.

Plus Therapeutics, Inc. (PSTV) - PESTLE Analysis: Environmental factors

Uses Rhenium-186, a radioisotope with a short half-life of 90 hours.

The core of Plus Therapeutics' radiotherapeutic candidate, REYOBIQ (rhenium Re186 obisbemeda), is Rhenium-186 (Rh-186), a radioisotope that is a significant environmental factor. Rh-186 is an ideal choice because its physical half-life is approximately 90 hours (just under four days) [cite: 3, 12 in step 1]. This short half-life is a critical environmental and logistical advantage, minimizing the long-term risk and cost associated with managing radioactive waste, which is a major concern for the nuclear medicine industry.

In contrast, other therapeutic radioisotopes can have half-lives that span months or years, creating a substantial and expensive long-term waste disposal burden. The short decay time of Rh-186 is a defintely a competitive edge in waste management.

Short half-life allows for 'decay-in-storage,' minimizing long-term radioactive waste disposal issues.

The short half-life of 90 hours makes Rhenium-186 an excellent candidate for a process called 'decay-in-storage' (DIS). The U.S. Nuclear Regulatory Commission (NRC) allows this method for byproduct material with a physical half-life of less than or equal to 120 days.

This process means Plus Therapeutics' customers-hospitals and clinics-can store the used radioactive material on-site until its radiation levels are indistinguishable from background, at which point it can be disposed of as ordinary trash or medical waste. This eliminates the need for expensive, specialized, and long-haul transport to a licensed low-level radioactive waste (LLRW) disposal facility, which can cost thousands of dollars per shipment for longer-lived isotopes. This is a massive operational and cost benefit for the end-user.

• NRC Threshold: Half-life must be $\le$ 120 days for decay-in-storage.
• Rh-186 Half-Life: Approximately 90 hours (3.75 days) [cite: 3, 12 in step 1].
• Waste Reduction: Allows disposal as non-radioactive waste after decay.

Production and disposal are heavily regulated by the Nuclear Regulatory Commission (NRC) and EPA.

Despite the environmental benefit of DIS, the production, transport, use, and disposal of Rhenium-186 remain heavily regulated by federal agencies, primarily the NRC and the Environmental Protection Agency (EPA). The NRC governs the use of byproduct material under regulations like 10 CFR Part 20 and 10 CFR 35.92, ensuring radiation protection and proper disposal.

The EPA's oversight becomes critical if the radioactive waste is also classified as a Resource Conservation and Recovery Act (RCRA) hazardous waste, creating 'mixed waste'. Plus Therapeutics must ensure its final drug formulation and manufacturing process, including by-products, do not create this more complex and costly 'mixed waste' stream.

For context on regulatory costs, the Prescription Drug User Fee Act (PDUFA) charge alone for a new drug application, a regulatory hurdle the company faces, is approximately $4.3 million in 2025 [cite: 7 in step 1].

Need a robust, secure supply chain for radioisotope sourcing and transport.

The short 90-hour half-life of Rhenium-186 introduces a critical logistical risk: the supply chain must be incredibly fast and secure. The product loses half its therapeutic value every 3.75 days, so any delay in sourcing, manufacturing, or transport directly impacts drug potency and patient scheduling.

Plus Therapeutics has strategically mitigated this risk by establishing a secure, end-to-end supply chain. They have a five-year renewable Master Services Agreement with Telix IsoTherapeutics Group Inc. for the reliable supply of cGMP Rhenium-186 [cite: 11 in step 1]. Furthermore, they have a manufacturing agreement with SpectronRx for the final drug production [cite: 6 in step 1].

Here's the quick math on the raw material cost and supply chain complexity:

Factor	Detail/Value (2025)	Implication for PSTV
Rhenium (Raw Metal) Price	$4,385.80 per kg (as of Sept 2025) [cite: 5 in step 1]	Raw material cost is rising, up +51% since Jan 1, 2025 [cite: 5 in step 1].
Radioisotope Supply Agreement	5-year renewable MSA with Telix IsoTherapeutics Group Inc. [cite: 11 in step 1]	Secures cGMP-grade Rh-186 supply for late-stage trials and commercialization.
Manufacturing Partner	SpectronRx (for final drug production) [cite: 6 in step 1]	Establishes a scalable, just-in-time manufacturing network.
Half-Life Decay Risk	90 hours [cite: 3, 12 in step 1]	Requires a highly coordinated, time-sensitive (just-in-time) logistics system to maintain therapeutic dose.