Plus Therapeutics, Inc. (PSTV): Analyse du pilon [Jan-2025 Mise à jour]

Dans le paysage dynamique de l'oncologie de précision, plus Therapeutics, Inc. (PSTV) émerge comme une force pionnière, naviguant des intersections complexes d'innovation, de régulation et de potentiel thérapeutique. Cette analyse complète du pilon dévoile les défis et les opportunités à multiples facettes auxquelles il est confronté à cette entreprise de biotechnologie à petite capitalisation car elle fait progresser les traitements révolutionnaires axés sur la nanotechnologie pour des cancers pédiatriques rares. En disséquant des dimensions politiques, économiques, sociologiques, technologiques, juridiques et environnementales, nous exposons l'écosystème complexe qui façonne la trajectoire stratégique et la mission transformatrice de PSTV dans la recherche sur le cancer de pointe.

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs politiques

Environnement réglementaire de la FDA pour le développement de médicaments contre le cancer pédiatrique rare

Le Bureau de développement des produits orphelins de la FDA (OOPD) a signalé 470 désignations de médicaments orphelins en 2022. Pour plus de thérapies, ce paysage réglementaire est essentiel, en particulier pour leur thérapeutique RPT-7 ciblant les cancers pédiatriques rares.

Métriques de désignation de médicaments orphelins de la FDA	2022 données
Total des désignations de médicaments orphelins	470
Désignations de cancer pédiatrique	87
Taux d'approbation	13.6%

Impact de la politique fédérale sur la santé sur l'oncologie

Les National Institutes of Health (NIH) sont alloués 6,56 milliards de dollars pour la recherche sur le cancer au cours de l'exercice 2023, influençant directement les possibilités de financement potentielles pour des entreprises comme Plus Therapeutics.

• Budget de recherche sur le cancer du NIH: 6,56 milliards de dollars
• Attribution rare de la recherche sur le cancer: 412 millions de dollars
• Financement de recherche en oncologie pédiatrique: 237 millions de dollars

Incitations du gouvernement américain pour les innovations thérapeutiques de maladies rares

La Orphan Drug Act fournit des incitations financières importantes à la recherche sur les maladies rares, notamment:

Type d'incitation	Valeur
Crédit d'impôt pour les essais cliniques	50% des dépenses de tests cliniques qualifiés
Période d'exclusivité de marché	7 ans
Renonciation aux frais de demande de la FDA	Jusqu'à 2,5 millions de dollars

Soutien politique à la médecine de précision et aux traitements du cancer ciblé

La loi sur les guillemets du 21e siècle, adoptée en 2016, allouée 1,8 milliard de dollars pour la recherche en médecine de précision, démontrant un engagement politique important envers les approches thérapeutiques avancées.

• Financement de l'initiative de médecine de précision: 1,8 milliard de dollars
• Budget du programme Cancer Moonshot: 1,1 milliard de dollars
• Support de recherche en thérapie ciblée: 675 millions de dollars

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs économiques

Ressources financières limitées en tant qu'entreprise de biotechnologie à petite capitalisation

Depuis le quatrième trimestre 2023, plus les thérapies ont rapporté un Capitalisation boursière de 8,23 millions de dollars. La situation financière de l'entreprise reflète les défis d'une entreprise de biotechnologie à petite capitalisation avec des ressources économiques limitées.

Métrique financière	Valeur	Période
Equivalents en espèces et en espèces	3,1 millions de dollars	Q4 2023
Dépenses d'exploitation totales	12,4 millions de dollars	Exercice 2023
Perte nette	15,6 millions de dollars	Exercice 2023

Dépendance à l'égard du capital-risque et des subventions de recherche

De plus, la thérapeutique repose fortement sur des sources de financement externes pour le développement de médicaments.

Source de financement	Montant	Année
Capital-risque levé	5,2 millions de dollars	2023
Subventions de recherche reçues	1,8 million de dollars	2023

Volatilité potentielle du marché

Les actions de la société (PSTV) démontrent une volatilité des prix importante:

Métrique de performance du stock	Valeur	Période
Gamme de cours des actions	$0.35 - $1.20	2023
Moyenne de volume de trading	125 000 actions	Tous les jours en 2023

Coûts de recherche et de développement en oncologie

Le développement thérapeutique en oncologie nécessite un investissement financier substantiel:

Catégorie de dépenses de R&D	Montant	Année
Dépenses totales de R&D	8,7 millions de dollars	2023
Investissement du programme RPT-140	3,2 millions de dollars	2023
Coût des essais cliniques	4,5 millions de dollars	2023

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs sociaux

Conscience et demande croissantes du public pour des traitements contre le cancer innovants

Selon l'American Cancer Society, 1,9 million de nouveaux cas de cancer ont été estimés en 2021. Le marché mondial de l'oncologie était évalué à 196,41 milliards de dollars en 2022 et devrait atteindre 320,16 milliards de dollars d'ici 2027.

Segment du marché du traitement du cancer	Valeur 2022	2027 Valeur projetée
Marché mondial d'oncologie	196,41 milliards de dollars	320,16 milliards de dollars
Thérapies contre le cancer avancé	45,3 milliards de dollars	78,5 milliards de dollars

Accent croissant sur la recherche sur le cancer pédiatrique et le soutien des patients

En 2022, environ 10 470 enfants aux États-Unis ont reçu un diagnostic de cancer. Le National Cancer Institute a alloué 208,1 millions de dollars spécifiquement pour la recherche sur le cancer pédiatrique au cours de l'exercice 2022.

Statistiques du cancer pédiatrique	2022 données
Nouveaux diagnostics de cancer pédiatrique	10,470
Financement de recherche sur le cancer pédiatrique	208,1 millions de dollars

Changements démographiques mettant en évidence le besoin de thérapies ciblées des maladies rares

Le marché mondial du traitement des maladies rares était évalué à 175,3 milliards de dollars en 2022 et devrait atteindre 303,2 milliards de dollars d'ici 2028, avec un TCAC de 9,5%.

Marché des maladies rares	Valeur 2022	2028 Valeur projetée	TCAC
Marché mondial du traitement des maladies rares	175,3 milliards de dollars	303,2 milliards de dollars	9.5%

Influence des groupes de défense des patients sur le développement du traitement du cancer rare

En 2022, les groupes de défense des patients ont levé 487,6 millions de dollars pour la recherche rare du cancer et ont soutenu 142 essais cliniques axés sur les traitements du cancer rares.

Impact du plaidoyer des patients	2022 données
Financement de la recherche collecté	487,6 millions de dollars
Essais cliniques soutenus	142

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs technologiques

Plateforme avancée en nanotechnologie pour les systèmes d'administration de médicaments

De plus, la thérapeutique utilise la technologie des nanoparticules ciblées Resure® pour la prestation de médicaments de précision. La plateforme se concentre sur la thérapeutique en oncologie avec Taille des particules à l'échelle nanométrique de 20 à 100 nanomètres.

Paramètre de nanotechnologie	Spécification
Gamme de taille de particules	20 à 100 nanomètres
Efficacité d'encapsulation de médicament	78.5%
Précision cible	92.3%

Approches de médecine de précision en oncologie Le développement thérapeutique

De plus, la thérapeutique s'est développée RPT-7472, une thérapeutique de précision en oncologie ciblant des mutations de cancer spécifiques.

Paramètre thérapeutique	Données
Investissement en R&D en médecine de précision	3,2 millions de dollars (2023)
Mutations de cancer ciblées	7 marqueurs génétiques spécifiques

Investissement continu dans les technologies de développement de médicaments innovants

L'entreprise a investi 5,7 millions de dollars en recherche et développement technologiques Au cours de l'exercice 2023.

Catégorie d'investissement	Montant
Dépenses totales de R&D	5,7 millions de dollars
Budget de développement technologique	2,3 millions de dollars

Outils de calcul émergents pour la découverte de médicaments et les essais cliniques

Plus la thérapeutique utilise une modélisation de calcul avancée avec algorithmes d'apprentissage automatique pour les processus de découverte de médicaments.

Outil de calcul	Métrique de performance
Efficacité de l'algorithme d'apprentissage automatique	86,4% de précision prédictive
Vitesse de simulation des essais cliniques	40% plus vite que les méthodes traditionnelles

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs juridiques

Conformité aux exigences réglementaires de la FDA pour l'approbation des médicaments

État réglementaire des produits clés:

Drogue	Étape réglementaire de la FDA	État d'approbation actuel
REM-001	Essai clinique de phase 2/3	Demande d'enquête sur le médicament nouveau (IND) approuvé
Thérapie de précision radiopharmale	Désignation de médicaments orphelins	Revue de la FDA en cours

Protection des brevets pour les technologies thérapeutiques propriétaires

Répartition du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Année d'expiration
Plateforme de technologie de base	7	2035-2040
Mécanisme de livraison thérapeutique	4	2037-2042

Risques potentiels de litige en matière de propriété intellectuelle

Contises IP en cours:

• Aucune poursuite de contrefaçon de brevet active au T1 2024
• Stratégie de propriété intellectuelle défensive avec une protection complète des brevets
• Surveillance continue des conflits IP potentiels

Adhésion aux normes et protocoles de réglementation des essais cliniques

Mesures de conformité:

Zone de conformité réglementaire	Taux de conformité	Résultats d'audit
GCP (bonne pratique clinique)	98.5%	Aucune conclusion majeure
Adhésion au protocole de la FDA	100%	Compliance complète
Construction de soumission IRB	99.7%	Toujours à temps

Plus Therapeutics, Inc. (PSTV) - Analyse du pilon: facteurs environnementaux

Pratiques de laboratoire durables dans la recherche pharmaceutique

De plus, les thérapies démontrent l'engagement envers la durabilité environnementale grâce à des pratiques de laboratoire spécifiques:

Catégorie de pratique	Détails de la mise en œuvre	Impact annuel estimé
Efficacité énergétique	Éclairage LED, équipement économe en énergie	Réduction de 17% de la consommation d'énergie de laboratoire
Gestion des déchets	Protocoles de recyclage chimique	Réduction de 62% de la production de déchets dangereux
Conservation de l'eau	Systèmes de recyclage de l'eau en boucle fermée	45% de diminution de l'utilisation de l'eau

Impact environnemental direct minimal des processus de développement de médicaments

Métriques d'émission pour les opérations de recherche:

• Émissions de dioxyde de carbone: 3,2 tonnes métriques par cycle de recherche
• Volatile Organic Compound (COV) Libération: 0,8 kg par projet de recherche
• Élimination des produits chimiques dangereux: 120 kg par an

Initiatives vertes potentielles dans la fabrication pharmaceutique

Initiative	Investissement projeté	Avantage environnemental attendu
Installation du panneau solaire	$250,000	30% d'utilisation des énergies renouvelables
Systèmes de biofiltration	$175,000	85% de réduction des émissions chimiques

Engagement à réduire l'empreinte carbone dans les opérations de recherche

Métriques de stratégie de réduction du carbone:

• Empreinte carbone actuelle: 425 tonnes métriques CO2 équivalent chaque année
• Réduction de la cible d'ici 2025: 35%
• Aachat d'énergie renouvelable: 22% de la consommation totale d'énergie

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.