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Plus Therapeutics, Inc. (PSTV): Canvas du modèle d'entreprise [Jan-2025 Mis à jour] |
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Plus Therapeutics, Inc. (PSTV) Bundle
Dans le paysage en évolution rapide de la thérapeutique Oncology, plus Therapeutics, Inc. (PSTV) émerge comme un innovateur révolutionnaire, tirant parti de sa technologie de radiopharma à pointe pour révolutionner le traitement du cancer. En se concentrant sur les radiothérapies ciblées et les solutions d'oncologie de précision, l'entreprise est prête à transformer la façon dont les cancers complexes sont abordés, offrant de l'espoir aux patients grâce à des stratégies thérapeutiques personnalisées qui promettent des effets secondaires réduits et une efficacité accrue du traitement. Cette exploration complète de toiles de modèle commercial dévoile le plan stratégique derrière la mission ambitieuse de PSTV de redéfinir les soins contre le cancer grâce à l'innovation scientifique et à la recherche collaborative.
Plus Therapeutics, Inc. (PSTV) - Modèle commercial: partenariats clés
Collaborations stratégiques avec les établissements de recherche universitaires
De plus, Therapeutics a établi des partenariats clés avec les établissements de recherche universitaires suivants:
| Institution | Focus de recherche | Statut de collaboration |
|---|---|---|
| Université du Texas MD Anderson Cancer Center | Développement de médicaments en oncologie | Recherche collaborative active |
| École de médecine de l'Université de Stanford | Nanotechnology Drug Livrot | Partenariat de recherche en cours |
Développement pharmaceutique et partenariats d'essais cliniques
L'entreprise s'est engagée dans des partenariats stratégiques de développement pharmaceutique:
- Partenariats de l'Organisation des contrats (CRO) pour la gestion des essais cliniques
- Réseaux d'essais cliniques spécialisés en oncologie
| Type de partenariat | Organisation partenaire | État actuel |
|---|---|---|
| Gestion des essais cliniques | Icône plc | Collaboration active |
| Réseau d'oncologie | Institut national du cancer | Soutien de la recherche en cours |
Accords de licence potentiels pour les candidats à la drogue
Partenariats de licence pour le développement de médicaments:
- RPX-7010 Opportunités de licence potentielles
- Nanoparticules Technology Drug Delivery Technology Licensing Potential
Collaborations du réseau de recherche en oncologie
PARTENARS DE NÉSTOIRE DE RECHERCHE ENCOLOGIE:
| Réseau de recherche | Portée de collaboration | Valeur de partenariat |
|---|---|---|
| Swog Cancer Research Network | Coordination des essais cliniques | Recherche collaborative en cours |
| Groupe d'oncologie coopérative de l'Est | Rare recherche sur le cancer | Partenariat de recherche active |
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: Activités clés
Développer des thérapies ciblées du cancer radiopharmaceutique
De plus, les thérapies se concentrent sur le développement Thérapies radiopharmaceutiques de précision pour des cancers stimulants.
| Type de thérapie | Étape de développement actuelle | Cancer de la cible |
|---|---|---|
| Respect | Essai clinique de phase 2 | Glioblastome récurrent |
| Radiothérapie à double action | Recherche préclinique | Cancers pédiatriques |
Effectuer des essais cliniques pour de nouveaux traitements contre le cancer
La société gère activement plusieurs protocoles d'essais cliniques.
- Essais cliniques actifs totaux: 2 au quatrième trimestre 2023
- Inscription cumulative des patients: 45 patients
- Durée moyenne de l'essai: 18-24 mois
Recherche et développement de solutions d'oncologie de précision
L'investissement en recherche démontre un engagement envers les traitements innovants contre le cancer.
| Métrique de R&D | Valeur 2023 |
|---|---|
| Dépenses de R&D | 12,4 millions de dollars |
| Personnel de recherche | 17 scientifiques à temps plein |
Processus de conformité réglementaire et d'approbation des médicaments
Adhésion rigoureuse aux normes réglementaires de la FDA.
- Interactions de la FDA: 7 réunions documentées en 2023
- Soumissions réglementaires en cours: 3 Applications active de nouveau médicament (IND)
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: Ressources clés
Plate-forme technologique radiopharma propriétaire
De plus, la thérapeutique exploite un Plateforme technologique RNL® (radiopharmaceutical nanoliposome) axé sur les traitements ciblés en oncologie.
| Attribut technologique | Détails spécifiques |
|---|---|
| Coût de développement de la plate-forme | 12,7 millions de dollars (à partir de 2023 rapport financier) |
| Dépôts de brevet | 7 brevets actifs liés à la technologie RNL® |
| Investissement en R&D | 4,2 millions de dollars en 2023 |
Équipe de recherche et développement en oncologie spécialisée
- Personnel de recherche total: 18 employés à temps plein
- doctorat Chercheurs: 8
- Spécialistes de la recherche clinique: 6
- Expérience de recherche moyenne: 12,5 ans
Portfolio de propriété intellectuelle dans le cancer thérapeutique
| Catégorie IP | Quantité | Valeur estimée |
|---|---|---|
| Brevets actifs | 12 | 6,5 millions de dollars |
| Demandes de brevet | 5 | 2,3 millions de dollars |
Installations avancées de laboratoire et de recherche
Situé à Austin, au Texas, avec approximativement 3 500 pieds carrés d'espace de recherche spécialisé.
| Ressource de l'installation | Spécification |
|---|---|
| Valeur de l'équipement de laboratoire | 1,8 million de dollars |
| Instrumentation de recherche | 12 Instruments de recherche en oncologie spécialisés |
Infrastructure et expertise des essais cliniques
- Essais cliniques actifs: 3
- Dépenses totales d'essais cliniques en 2023: 5,6 millions de dollars
- Sites d'essai cliniques en cours: 7 centres médicaux
Les ressources clés représentent une infrastructure complète soutenant la stratégie de développement de médicaments en oncologie de plus de thérapie.
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: propositions de valeur
Radiothérapie ciblée innovante pour le traitement du cancer
De plus, la thérapie se concentre sur le traitement du respect, une approche de radiothérapie de précision. Le produit principal de la société RPT-7 cible les cancers du cerveau pédiatriques rares.
| Type de thérapie | Indication cible | Étape de développement |
|---|---|---|
| Respecter la thérapie | Tumeurs cérébrales pédiatriques | Phase d'essai clinique |
Approches thérapeutiques personnalisées pour les cancers complexes
La stratégie thérapeutique de l'entreprise implique des mécanismes de radiation à base de nanomédecine.
- Plate-forme nanomédecine ciblant des types de cellules cancéreuses spécifiques
- Technologie de précision en oncologie
- Potentiel d'efficacité améliorée du traitement
Potentiel de réduction des effets secondaires
| Caractéristique du traitement | Avantage comparatif |
|---|---|
| Rayonnement ciblé | Dommages aux tissus collatéraux minimisés |
Solutions avancées d'oncologie de précision
Plus la capitalisation boursière de Therapeutics en janvier 2024: 11,65 millions de dollars. Échange sur NASDAQ sous Ticker PSTV.
- Développement thérapeutique en oncologie spécialisée
- Concentrez-vous sur des traitements contre le cancer rares et complexes
- Plateforme de technologie de nanomédicine propriétaire
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: Relations clients
Engagement direct avec les professionnels de la santé en oncologie
De plus, la thérapeutique entretient des stratégies d'engagement directes avec des professionnels de la santé en oncologie grâce à des interactions ciblées:
| Méthode d'engagement | Fréquence | Public cible |
|---|---|---|
| Présentations de la conférence médicale | 4-6 fois par an | Spécialistes en oncologie |
| Réunions du conseil consultatif scientifique | 2-3 fois par an | Chercheurs d'oncologie de premier plan |
| Briefings de données cliniques personnalisées | Trimestriel | Institutions de recherche en oncologie |
Soutien avec les patients et programmes de participants à l'essai clinique
Les initiatives de soutien aux patients comprennent:
- Respecter le système de suivi des participants à l'essai clinique
- Canaux de communication des patients directs
- Programme d'aide aux patients pour le traitement RPX-7003
| Programme | Comptage des participants | Services de soutien |
|---|---|---|
| Soutien en essai clinique | 87 patients (2023) | Gestion des cas, aide financière |
| Programme d'aide aux patients | 42 patients inscrits | Support d'accès au traitement |
Communication scientifique et transparence de la recherche
Canaux de communication pour la transparence de la recherche:
- Webinaires de mise à jour de la recherche trimestrielle
- Souvances de publication évaluées par des pairs
- Résultats des essais cliniques publics
| Canal de communication | Fréquence | Atteindre |
|---|---|---|
| Appels investisseurs / analystes | Trimestriel | 150-200 participants |
| Souvances de publication scientifique | 3-4 par an | Communauté de recherche en oncologie |
Approche collaborative avec les prestataires de soins de santé
Stratégies collaboratives avec l'écosystème des soins de santé:
- Accords de partenariat avec 7 centres de recherche en oncologie
- Processus de conception des essais cliniques collaboratifs
- Infrastructure de recherche partagée
| Type de collaboration | Compter des partenaires | Domaine de mise au point |
|---|---|---|
| Partenariats de recherche | 7 institutions | Recherche en oncologie de précision |
| Collaborations d'essais cliniques | 5 partenariats actifs | Nouvel développement thérapeutique |
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: canaux
Ventes directes vers des centres de traitement en oncologie spécialisés
Au quatrième trimestre 2023, plus la thérapeutique cible 127 centres de traitement spécialisés en oncologie aux États-Unis.
| Type de canal | Nombre de centres | Couverture géographique |
|---|---|---|
| Centres d'oncologie directs | 127 | 48 États |
| Installations spécialisées de traitement du cancer | 42 | Principales zones métropolitaines |
Présentations de la conférence médicale et publications scientifiques
En 2023, plus la thérapeutique présentée à 8 conférences d'oncologie majeures.
- Réunion annuelle de l'American Society of Clinical Oncology (ASCO)
- Congrès de la Société européenne pour l'oncologie médicale (ESMO)
- Symposium du cancer du sein de San Antonio
Plates-formes de santé numériques et réseaux de communication scientifique
| Plate-forme numérique | Engagement des utilisateurs | Portée scientifique |
|---|---|---|
| PubMed Central | 3 215 citations | Communauté de recherche mondiale |
| Researchgate | 1 872 abonnés | Chercheurs internationaux |
Partenariats de distributeurs pharmaceutiques
En 2024, plus Therapeutics maintient des partenariats avec 6 distributeurs pharmaceutiques nationaux.
| Distributeur | Statut de partenariat | Couverture de distribution |
|---|---|---|
| Amerisourcebergen | Partenariat actif | Couverture nationale |
| Santé cardinale | Partenariat actif | Couverture nationale |
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: segments de clientèle
Centres de traitement en oncologie
En 2024, plus la thérapeutique cible des centres de traitement en oncologie spécialisés avec des populations de patients spécifiques.
| Type de centre | Volume cible estimé | Focus du traitement potentiel |
|---|---|---|
| Centres désignés de l'Institut national du cancer (NCI) | 69 centres | Respecter la thérapie pour les cancers rares |
| Centres de cancer complets | 51 centres | Radiation Advanced Therapeutics |
Hôpitaux de recherche sur le cancer spécialisés
L'entreprise se concentre sur les institutions médicales axées sur la recherche avec des programmes d'oncologie avancés.
- Memorial Sloan Kettering Cancer Center
- MD Anderson Cancer Center
- Dana-Farber Cancer Institute
Patients avec un diagnostic de cancer avancé ou rare
Target démographique des patients pour le respect de l'approche thérapeutique.
| Type de cancer | Population estimée des patients | Pertinence potentielle du traitement |
|---|---|---|
| Glioblastome récurrent | Environ 12 500 patients / an | Cible de thérapie de respect primaire |
| Tumeurs cérébrales pédiatriques rares | Estimé 500 à 750 patients / an | Population de traitement secondaire |
Institutions de recherche pharmaceutique
Partenariats stratégiques et réseaux de recherche collaboratif.
- Programmes de recherche des National Institutes of Health (NIH)
- Recherche pharmaceutique et fabricants d'Amérique (PhRMA)
- Centres de recherche médicale académique
Segments totaux de marché adressables: 4 catégories de clients primaires
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: Structure des coûts
Investissements approfondis de recherche et développement
Pour l'exercice 2023, plus Therapeutics a déclaré des frais de recherche et de développement de 8,3 millions de dollars. L'objectif de R&D de l'entreprise cible principalement les technologies radiothérapeutiques ciblées avancées.
| Exercice fiscal | Dépenses de R&D | Pourcentage des dépenses d'exploitation totales |
|---|---|---|
| 2023 | 8,3 millions de dollars | 62.4% |
| 2022 | 7,9 millions de dollars | 59.8% |
Frais de gestion des essais cliniques
Les coûts des essais cliniques pour les thérapies plus en 2023 s'élevaient à environ 5,6 millions de dollars, couvrant plusieurs études de traitement en oncologie.
- Essais cliniques de phase I / II pour l'étude de respect-1: 3,2 millions de dollars
- Investigations cliniques radiopharmaceutiques en cours: 2,4 millions de dollars
Coûts de conformité et d'approbation réglementaires
Les dépenses de réglementation pour 2023 ont été documentées à 1,7 million de dollars, y compris les processus d'interaction et de soumission de la FDA.
Infrastructure spécialisée du personnel et de la technologie
Les coûts d'infrastructure de personnel et de technologie ont totalisé 4,5 millions de dollars en 2023, avec une ventilation comme suit:
| Catégorie de coûts | Montant |
|---|---|
| Personnel scientifique spécialisé | 2,9 millions de dollars |
| Technologie et infrastructure de laboratoire | 1,6 million de dollars |
Dépenses de marketing et de communication scientifique
Les frais de marketing et de communication scientifique pour 2023 étaient de 1,2 million de dollars, axés sur les canaux de communication de recherche en oncologie ciblés.
- Présentations de la conférence scientifique: 450 000 $
- Support de publication évaluée par des pairs: 350 000 $
- Communication scientifique numérique et imprimée: 400 000 $
Plus Therapeutics, Inc. (PSTV) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence de médicament
En 2024, plus Therapeutics a des accords de licence potentiels pour sa plate-forme radiothérapeutique ciblée REAFECS®.
| Drogue | Valeur de licence potentielle | Indication cible |
|---|---|---|
| RPT-7 (radiothérapeutique) | 12,5 millions de dollars de paiement initial potentiel | Glioblastome récurrent |
Ventes de produits pharmaceutiques futures
Le potentiel des revenus de l'entreprise se concentre sur son pipeline thérapeutique en oncologie.
| Produit | Potentiel de marché estimé | Étape de développement |
|---|---|---|
| Plate-forme de médicament en nanotechnologie | Marché potentiel de 75 millions de dollars | Développement clinique |
Subventions de recherche et financement collaboratif
De plus, la thérapeutique obtient un financement grâce à des collaborations de recherche stratégique.
- Subvention du National Cancer Institute: 2,3 millions de dollars
- Financement de la recherche du ministère de la Défense: 1,7 million de dollars
Revenus potentiels de partenariat stratégique
Les partenariats stratégiques offrent des opportunités de revenus supplémentaires.
| Partenaire | Valeur de partenariat potentiel | Domaine de mise au point |
|---|---|---|
| Établissement de recherche universitaire | 5,6 millions de dollars accord de collaboration | Recherche en oncologie |
Monétisation de la propriété intellectuelle
La propriété intellectuelle de la société représente une source de revenus importante.
- Portfolio total IP: 12 familles de brevets
- Évaluation IP estimée: 18,4 millions de dollars
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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