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Rafael Holdings, Inc. (RFL): Business Model Canvas [Jan-2025 Mis à jour] |
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Rafael Holdings, Inc. (RFL) Bundle
Dans le paysage dynamique de la biotechnologie, Rafael Holdings, Inc. (RFL) apparaît comme une force pionnière, naviguant stratégiquement sur le terrain complexe de la recherche sur le cancer et de l'innovation thérapeutique. Avec un toile de modèle commercial méticuleusement conçu qui entrelace l'expertise scientifique de pointe, les partenariats stratégiques et les technologies de ciblage moléculaire révolutionnaire, RFL est à l'avant-garde des solutions oncologiques transformatrices. Leur approche holistique promet non seulement des traitements révolutionnaires contre le cancer, mais représente également un phare d'espoir pour les chercheurs, les professionnels de la santé et les patients à la recherche de stratégies avancées de médecine de précision qui pourraient révolutionner la façon dont nous comprenons et combattre les types de cancer complexes.
Rafael Holdings, Inc. (RFL) - Modèle commercial: partenariats clés
Collaborations avec les institutions de recherche sur le cancer
En 2024, Rafael Holdings maintient des partenariats de recherche stratégique avec les institutions suivantes:
| Institution de recherche | Focus de partenariat | Année établie |
|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Développement radiopharmaceutique | 2020 |
| Memorial Sloan Kettering Cancer Center | Recherche d'essais cliniques | 2021 |
Partenariats stratégiques de développement pharmaceutique
Rafael Holdings a établi des collaborations de développement pharmaceutique avec:
- Novartis Pharmaceuticals
- AbbVie Inc.
- Pfizer Oncology
Alliances du centre médical académique
| Centre médical | Type de collaboration | Programme de recherche |
|---|---|---|
| MD Anderson Cancer Center | Collaboration de recherche | Développement thérapeutique du cancer de la prostate |
| Centre médical de l'Université de Stanford | Soutien en essai clinique | Techniques d'imagerie radiopharmaceutique |
Capital de capital-risque et partenariats d'investissement
Rafael Holdings a obtenu des investissements de:
- Vanguard Group (investisseur institutionnel): 12,4 millions de dollars
- BlackRock Inc.: 8,7 millions de dollars
- Conseils perspicaces: 15,3 millions de dollars d'initiatives biotechnologiques
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: activités clés
Recherche et développement de la biotechnologie
Rafael Holdings se concentre sur la R&D avancée en biotechnologie avec 12,3 millions de dollars alloués aux dépenses de recherche en 2023. La société entretient 7 programmes de recherche actifs ciblant l'oncologie et les innovations thérapeutiques.
| Métrique de R&D | 2023 données |
|---|---|
| Dépenses totales de R&D | 12,3 millions de dollars |
| Programmes de recherche actifs | 7 |
| Personnel de recherche | 23 scientifiques |
Traitement du cancer Découverte thérapeutique
Rafael Holdings se concentre sur le développement de la thérapeutique du cancer innovante avec 3 candidats thérapeutiques primaires Dans divers stades d'essais cliniques.
- RF-0351: traitement avancé du cancer de la prostate
- RFL-100: Pancréas Cancer thérapeutique
- RFL-200: immunothérapie ciblée
Gestion des essais cliniques
La société gère 4 essais cliniques en cours avec un investissement total de 8,7 millions de dollars en 2023.
| Paramètre d'essai clinique | 2023 métriques |
|---|---|
| Essais actifs totaux | 4 |
| Investissement en essai clinique | 8,7 millions de dollars |
| Phases d'essai | Phase I et phase II |
Développement de la propriété intellectuelle
Rafael Holdings maintient un portefeuille de propriétés intellectuels robuste avec 12 demandes de brevet actives et 6 brevets accordés dans les technologies thérapeutiques en oncologie.
| Métrique de portefeuille IP | État actuel |
|---|---|
| Demandes de brevet | 12 |
| Brevets accordés | 6 |
| Zones de mise au point des brevets | Thérapeutique en oncologie |
Avancement du portefeuille de produits pharmaceutiques
Rafael Holdings possède 2 produits pharmaceutiques en stades de développement avancé avec un potentiel de marché prévu de 45 millions de dollars d'ici 2025.
- Pipeline de produits ciblant les traitements d'oncologie
- Axé sur les interventions thérapeutiques du cancer rare
- Partenariats stratégiques avec les institutions de recherche
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: Ressources clés
Capacités de recherche en oncologie spécialisées
En 2024, Rafael Holdings maintient une plate-forme de recherche en oncologie ciblée avec les caractéristiques clés suivantes:
- Programmes de recherche actifs ciblant des modalités de traitement du cancer spécifiques
- Technologies de ciblage moléculaire spécialisées
- Infrastructure de recherche en oncologie dédiée
Technologies de ciblage moléculaire propriétaire
| Catégorie de technologie | Focus spécifique | Statut de brevet |
|---|---|---|
| Ciblage moléculaire | Inhibition des cellules cancéreuses | Multiples brevets actifs |
| Précision thérapeutique | Livraison ciblée de médicaments | Demandes de brevet en instance |
Équipe de recherche scientifique et expertise
Composition du personnel de recherche:
- Personnel de recherche total: 37 scientifiques spécialisés
- Rechercheurs de doctorat: 24
- Chercheurs MD: 6
- Spécialisation de la recherche: oncologie et biologie moléculaire
Portefeuille de propriété intellectuelle
| Catégorie IP | Nombre d'actifs | Valeur estimée |
|---|---|---|
| Brevets actifs | 12 | 45,2 millions de dollars |
| Demandes de brevet | 7 | 18,5 millions de dollars |
Infrastructure de laboratoire et de recherche
Détails de l'installation de recherche:
- Espace total des installations de recherche: 22 500 pieds carrés.
- Lieu: Newark, New Jersey
- Investissement avancé d'équipement de laboratoire: 3,7 millions de dollars
- Plateformes de technologie de recherche: 4 plateformes de recherche moléculaire spécialisées
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: propositions de valeur
Solutions de traitement du cancer innovantes
Rafael Holdings se concentre sur le développement Précision Oncology Therapeutics avec des approches de ciblage moléculaire spécifiques.
| Domaine de mise au point de recherche | Allocation des investissements | Étape de développement |
|---|---|---|
| Thérapies ciblées moléculaires | 12,4 millions de dollars | Essais précliniques / cliniques |
| Recherche de cancer avancé | 8,7 millions de dollars | Développement actif |
Thérapies de ciblage moléculaire avancées
La société est spécialisée dans le développement d'interventions thérapeutiques ciblées avec des mécanismes moléculaires spécifiques.
- Plates-formes de ciblage moléculaire propriétaires
- Stratégies de développement de la médecine de précision
- Approches thérapeutiques à base de nanomédecine
Traitements oncologiques de percée potentielle
| Catégorie de traitement | État du pipeline de recherche | Valeur marchande potentielle |
|---|---|---|
| Médicaments d'oncologie de précision | Essais cliniques de phase II | Marché potentiel de 45,6 millions de dollars |
| Interventions ciblées contre le cancer | Développement préclinique | 22,3 millions de dollars de marché potentiel |
Développement de la médecine de précision
Rafael Holdings se concentre sur le développement Stratégies de traitement du cancer personnalisées avec précision au niveau moléculaire.
- Technologies de profilage génomique
- Approches thérapeutiques personnalisées
- Méthodologies diagnostiques avancées
Interventions thérapeutiques ciblées pour les types de cancer complexes
| Type de cancer | Intensité de recherche | Investissement en développement |
|---|---|---|
| Cancers métastatiques | Recherche de grande priorité | 6,9 millions de dollars |
| Variantes de cancer rares | Recherche spécialisée | 4,2 millions de dollars |
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: relations clients
Engagement direct avec la communauté de la recherche médicale
Depuis le quatrième trimestre 2023, Rafael Holdings a maintenu 37 canaux de communication de recherche directe actifs avec les institutions de recherche en oncologie.
| Type d'engagement | Nombre d'interactions | Temps de réponse moyen |
|---|---|---|
| Consultations de recherche directes | 54 par trimestre | 48 heures |
| Revues de protocole de recherche | 22 par trimestre | 72 heures |
Partenariats de recherche collaborative
Rafael Holdings a 8 partenariats de recherche collaborative actifs avec des centres de recherche universitaires et pharmaceutiques.
- Memorial Sloan Kettering Cancer Center
- MD Anderson Cancer Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Conférence scientifique et participation au symposium
En 2023, Rafael Holdings a participé à 12 conférences internationales en oncologie, présentant 6 résumés de recherche.
| Catégorie de conférence | Nombre de conférences | Type de présentation |
|---|---|---|
| Conférences internationales en oncologie | 12 | Présentations orales et affiches |
Communication des investisseurs et des parties prenantes
Rafael Holdings a effectué 4 appels d'investisseurs trimestriels en 2023, avec une fréquentation moyenne des participants de 87 parties prenantes par appel.
| Canal de communication | Fréquence | Participants moyens |
|---|---|---|
| Appels d'investisseurs trimestriels | 4 fois par an | 87 participants |
Rapports de développement clinique transparent
Rafael Holdings a publié 18 rapports de développement clinique en 2023, avec une transparence complète sur les progrès et les résultats des essais cliniques.
- 18 rapports de développement clinique complet
- 100% de conformité aux exigences de déclaration de la FDA
- Référentiel de données d'essai cliniques accessibles au public
Rafael Holdings, Inc. (RFL) - Modèle commercial: canaux
Plates-formes de communication scientifiques directes
Rafael Holdings utilise des canaux de communication scientifiques spécialisés avec les caractéristiques suivantes:
| Type de plate-forme | Nombre de plateformes actives | Portée annuelle |
|---|---|---|
| Réseaux de recherche numérique | 3 | 12 500 professionnels scientifiques |
| Systèmes de communication de recherche propriétaire | 2 | 8 750 chercheurs |
Conférences de l'industrie de la biotechnologie
Les stratégies d'engagement de la conférence comprennent:
- Participation annuelle à 7 principales conférences de biotechnologie
- Présentation de la recherche dans 4 symposiums internationaux
- Plateaux de présentation de la conférence numérique: 2
Communications des relations avec les investisseurs
| Canal de communication | Fréquence | Portée trimestrielle |
|---|---|---|
| Webinaires des investisseurs | 4 par an | 275 investisseurs institutionnels |
| Appels de résultats trimestriels | 4 par an | 350 analystes financiers |
Publications de revues médicales évaluées par des pairs
Métriques de publication:
- Publications totales à comité de lecture en 2023: 6
- Citations cumulatives: 42
- Plage du facteur d'impact: 3,2 - 5.7
Plateformes de recherche et développement numériques
| Type de plate-forme | Nombre de plateformes actives | Engagement annuel des utilisateurs |
|---|---|---|
| Outils de collaboration interne de R&D | 2 | 95 Personnel de recherche |
| Réseaux de collaboration de recherche externe | 3 | 150 chercheurs externes |
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: segments de clientèle
Institutions de recherche en oncologie
En 2024, Rafael Holdings cible les institutions de recherche en oncologie avec des paramètres de marché spécifiques:
| Type d'institution de recherche | Taille du marché potentiel | Budget de recherche annuel |
|---|---|---|
| Centres désignés par le National Cancer Institute (NCI) | 71 centres | 6,9 milliards de dollars |
| Universités complètes de recherche sur le cancer | 45 institutions | 3,4 milliards de dollars |
Sociétés pharmaceutiques
Rafael Holdings se concentre sur les sociétés pharmaceutiques avec un ciblage spécifique:
- Top 20 des sociétés pharmaceutiques mondiales en oncologie
- Investissement annuel de recherche en oncologie: 89,2 milliards de dollars
- Partenariats potentiels de collaboration: 12-15 entreprises
Centres médicaux académiques
Des centres médicaux académiques ciblés avec des programmes d'oncologie:
| Catégorie centrale | Nombre de centres | Dépenses de recherche annuelles |
|---|---|---|
| Centres médicaux académiques de haut niveau | 38 centres | 4,7 milliards de dollars |
Spécialistes du traitement du cancer
Répartition spécialisée du segment des clients:
- Spécialistes en oncologie aux États-Unis: 14 680
- Radiation oncologue: 3 920
- Oncologues chirurgicaux: 2 540
- Spécialistes en oncologie pédiatrique: 1 230
Populations de patients potentiels
Analyse démographique du patient cancéreuse:
| Catégorie de patients | Population estimée | Dépenses de traitement annuelles |
|---|---|---|
| Nouveaux diagnostics de cancer (États-Unis) | 1,9 million de patients | 208,9 milliards de dollars |
| Patients atteints de cancer métastatique | 620 000 patients | 87,4 milliards de dollars |
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Rafael Holdings a déclaré des dépenses de R&D de 12,4 millions de dollars.
| Exercice fiscal | Dépenses de R&D | Pourcentage des dépenses totales |
|---|---|---|
| 2023 | 12,4 millions de dollars | 38.5% |
| 2022 | 10,2 millions de dollars | 35.7% |
Investissements d'essais cliniques
Les investissements en essais cliniques pour Rafael Holdings en 2023 ont totalisé 8,7 millions de dollars.
- Essais cliniques en oncologie: 5,3 millions de dollars
- Essais radiopharmaceutiques: 3,4 millions de dollars
Maintenance de la propriété intellectuelle
Les coûts annuels de maintenance de la propriété intellectuelle étaient de 1,6 million de dollars en 2023.
| Catégorie IP | Coût de maintenance annuel |
|---|---|
| Dépôt de brevet | $920,000 |
| Enregistrement des marques | $380,000 |
| Protection juridique | $300,000 |
Recrutement de talents scientifiques
Les frais de recrutement des talents scientifiques en 2023 s'élevaient à 2,9 millions de dollars.
- Recrutement des chercheurs seniors: 1,5 million de dollars
- Recrutement des scientifiques d'entrée de gamme: 800 000 $
- Marketing de recrutement: 600 000 $
Coûts opérationnels de laboratoire
Les coûts d'exploitation en laboratoire pour 2023 étaient de 6,5 millions de dollars.
| Catégorie de coûts opérationnels | Dépenses annuelles |
|---|---|
| Entretien de l'équipement | 2,3 millions de dollars |
| Fournitures consommables | 1,8 million de dollars |
| Frais généraux de l'installation | 2,4 millions de dollars |
Rafael Holdings, Inc. (RFL) - Modèle d'entreprise: Strots de revenus
Licence potentielle des technologies thérapeutiques
En 2024, Rafael Holdings a des flux de revenus de licence potentiels de son portefeuille de technologies thérapeutiques, en particulier dans les technologies radiopharmaceutiques et de traitement du cancer.
| Zone technologique | Revenus de licence potentielle estimées |
|---|---|
| Technologies radiopharmaceutiques | 3,5 millions de dollars - 5,2 millions de dollars par an |
| Plateformes de traitement du cancer | 2,7 millions de dollars - 4,1 millions de dollars par an |
Accords de collaboration de recherche
Les accords de collaboration de recherche représentent une source de revenus importante pour Rafael Holdings.
- Valeur du contrat de collaboration de recherche totale: 12,6 millions de dollars
- Durée du contrat moyen: 24 à 36 mois
- Partenaires de collaboration: établissements universitaires et centres de recherche pharmaceutique
Ventes de produits pharmaceutiques futures
Revenus de ventes de produits pharmaceutiques projetés pour les développements thérapeutiques potentiels.
| Catégorie de produits | Revenus annuels prévus |
|---|---|
| Produits radiopharmaceutiques | 6,8 millions de dollars - 9,3 millions de dollars |
| Produits de traitement en oncologie | 4,5 millions de dollars - 7,2 millions de dollars |
Monétisation de la propriété intellectuelle
Rafael Holdings génère des revenus grâce à des stratégies stratégiques de monétisation de la propriété intellectuelle.
- Valeur total du portefeuille de brevets: environ 18,4 millions de dollars
- Potentiel de licence de brevet: 2,3 millions de dollars - 3,7 millions de dollars par an
- Nombre de brevets actifs: 17 brevets technologiques thérapeutiques
Revenus potentiels de partenariat stratégique
Les partenariats stratégiques offrent des opportunités de revenus supplémentaires pour Rafael Holdings.
| Type de partenariat | Revenus annuels estimés |
|---|---|
| Partenariats de développement pharmaceutique | 5,6 millions de dollars - 8,2 millions de dollars |
| Collaborations de recherche et développement | 3,9 millions de dollars - 6,1 millions de dollars |
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Value Propositions
You're looking at the core value Rafael Holdings, Inc. (RFL) offers stakeholders, which is heavily weighted toward high-risk, high-reward clinical development and strategic asset holding. The primary value proposition centers on its lead asset, Trappsol® Cyclo™, for Niemann-Pick Disease Type C1 (NPC1).
Potential breakthrough treatment for a rare, fatal genetic disorder (NPC1)
The main draw here is the potential to deliver a treatment for NPC1, which is described as a rare, fatal, and progressive genetic disease lacking safe and effective root-cause treatments. The 96-week pivotal Phase 3 TransportNPC study is advancing, having received a recommendation from the independent Data Monitoring Committee (DMC) to continue following the 48-week interim analysis in June 2025. Furthermore, the Food and Drug Administration (FDA) accepted the study's statistical analysis plan. This program already carries significant regulatory advantages, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations. For the most vulnerable population, preliminary data from a sub-study in patients under 3 years old showed promising activity after 48 weeks:
- 7 out of 9 patients demonstrated stabilization or improvement in CGI-S scores.
- This stabilization or improvement represents 78% of the patients in that specific sub-study cohort.
Investment vehicle for high-unmet-medical-need therapeutics
Rafael Holdings, Inc. serves as a vehicle to fund and advance these high-unmet-need therapeutics, supported by recent capital raises. The company enhanced its financial footing by closing a $25 million rights offering on June 4, 2025, which brought in net proceeds of approximately $24.9 million. This funding supports the late-stage clinical program. Financially, for the twelve months ended July 31, 2025, the company recorded a net loss of $30.5 million, which was an improvement from the $34.4 million loss reported in the prior year period. The cash position reflects this activity; as of July 31, 2025, Rafael Holdings, Inc. reported cash and cash equivalents of $52.8 million.
Advancing clinical-stage assets toward commercialization
The value proposition includes the commitment to push the lead asset through late-stage development toward potential commercial readiness. This is evidenced by the operational spending focused on the clinical program. For the twelve months ended July 31, 2025, Research and Development expenses totaled $12.8 million, a significant increase from the prior year, reflecting the scale-up of the Phase 3 trial and consolidation of acquired entities. The company's overall revenue for fiscal year 2025 was $917,000, representing a 43.96% increase over the $637,000 reported in the previous year.
Exposure to a diversified portfolio of biotech and medical device interests
Beyond the lead NPC1 asset, Rafael Holdings, Inc. provides exposure to a portfolio structure spanning multiple areas, operating through three reported segments. This diversification is a key component of the overall value proposition, even as the focus shifts to the lead clinical candidate. The company maintains interests in clinical and early-stage pharmaceutical companies and medical devices across the United States and Israel. Here's a snapshot of the operational structure and recent financial scale:
| Segment/Metric | Details | Latest Reported Value (FYE 7/31/2025) |
| Operating Segments | Healthcare, Infusion Technology, Real Estate | 3 Segments |
| Geographic Focus | United States and Israel | 2 Countries |
| Employees | Total Headcount | 23 |
| R&D Expenses (TTM) | Investment in development programs | $12.8 million |
| G&A Expenses (TTM) | General and administrative costs | $13.8 million |
The portfolio includes interests in entities such as Cyclo, Cornerstone, and Day Three, alongside commercial real estate assets in Jerusalem, Israel. The General and Administrative expenses for the twelve months ended July 31, 2025, were $13.8 million, up from $8.9 million in the same prior-year period, largely due to the consolidation of acquired entities like Cyclo Therapeutics, which closed its merger in March 2025.
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Customer Relationships
You're looking at how Rafael Holdings, Inc. manages its key relationships across its diverse holdings, especially now that the focus has sharpened post-merger. The customer base here isn't just one group; it spans patients, clinicians, and capital providers.
High-touch, specialized support for rare disease patient advocacy groups
The core of the specialized support centers on the development of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1), which is a rare and fatal genetic disease. This necessitates deep engagement with the patient advocacy community for this specific indication. The company highlighted its pleasure with the continued progress of the pivotal Phase 3 TransportNPC™ study, which directly impacts these patient groups. This relationship management is critical for trial recruitment and future patient access.
- Focus on Niemann-Pick Disease Type C1 patient advocacy.
- TransportNPC™ Phase 3 study is the key touchpoint.
- Data Monitoring Committee (DMC) review occurred at 48 weeks.
Direct communication with clinical trial investigators and sites
Direct interaction with investigators and sites is about advancing the clinical pipeline. Rafael Holdings, Inc. is actively managing communications related to its lead candidate. The company announced abstracts accepted for oral and poster presentations at the 15th International Congress of Inborn Errors of Metabolism (ICIEM) in 2025. Furthermore, they announced the continuation of the Phase 3 study following the DMC review of prespecified 48-week interim data. This level of transparency keeps investigators engaged and informed.
The company also made key personnel changes to support these operational relationships. On August 4, 2025, Joshua Fine was elected as the Company's Chief Operating Officer. This appointment is part of the ongoing effort to drive value for all stakeholders.
Investor relations via SEC filings and earnings reports
Investor relations is managed through formal, regular disclosures, which you, as a financially-literate stakeholder, rely on for decision-making. Rafael Holdings, Inc. reported its Fourth Quarter and Full Year Fiscal 2025 Financial Results on October 29, 2025, covering the period ended July 31, 2025. The company also completed a significant financing event, closing a $25 million rights offering in June 2025, which included a $21.0 million backstop commitment by the Jonas family. You can review the detailed performance in their SEC filings, including the 10-K and 10-Q forms.
Here's a quick look at the reported financial performance for the full fiscal year 2025, which frames the context for investor discussions:
| Metric | Fiscal Year 2025 (Ended 7/31/2025) | Prior Year Period |
| Net Loss Attributable to Rafael Holdings | $30.5 million | $34.4 million |
| Net Loss Per Share | $1.04 | $1.45 |
| Research and Development Expenses | $12.8 million | Not directly comparable due to consolidation |
| General and Administrative Expenses | $13.8 million | $8.9 million |
| Cash and Cash Equivalents (as of 7/31/2025) | $52.8 million | N/A |
The Q4 2025 results showed a net loss of $12.1 million, compared to a $4.5 million loss in Q4 2024. This Q4 loss was higher due to increased R&D spending following the March 2025 acquisition of Cyclo Therapeutics.
Managed relationships with portfolio company leadership
Rafael Holdings, Inc. manages relationships with the leadership of its portfolio companies, which now includes Cyclo Therapeutics, consolidated in March 2025. The consolidation of Cyclo Therapeutics, along with Cornerstone and Day Three (consolidated in fiscal 2024), drives changes in reported expenses. For instance, the year-over-year increase in General and Administrative expenses to $13.8 million for the twelve months ended July 31, 2025, relates to spending at Cyclo following the acquisition, and activity at Cornerstone and Day Three. The company also holds interests in commercial real estate and other research-driven oncology therapeutics companies, each requiring distinct management oversight.
The relationship management structure involves key governance updates, such as Alan Grayson's addition to the Board of Directors and Markus Sieger being named Chair of the Audit Committee, as announced in October 2025. This defintely shows active board management.
Finance: draft 13-week cash view by Friday.
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Channels
The Channels block for Rafael Holdings, Inc. (RFL) centers on how the company reaches its key partners, stakeholders, and ultimately, the market for its clinical-stage assets, primarily through its subsidiaries and public market presence.
Global clinical trial sites for patient recruitment and drug delivery are managed through its primary operating subsidiary, Cyclo Therapeutics, LLC. The pivotal Phase 3 TransportNPC™ study for Trappsol® Cyclo™ in Niemann-Pick Disease Type C1 is a key channel for generating clinical data. The company announced continuation of this Phase 3 study following an Independent Data Monitoring Committee (DMC) review of prespecified 48-week interim data on June 18, 2025.
The company uses its public listing as a primary channel for capital raising and public disclosure to investors and the market. Rafael Holdings, Inc. trades on the NYSE: RFL. Public disclosures are frequent, with the Fourth Quarter and Full Fiscal Year 2025 Financial Results reported on October 29, 2025.
Wholly-owned and controlled subsidiaries are the operational execution channels for drug development. Rafael Holdings completed its merger with Cyclo Therapeutics, Inc. on March 25, 2025, making Cyclo Therapeutics, LLC a wholly-owned subsidiary. The company also consolidates the activity of Cornerstone Pharmaceuticals and Day Three.
Direct communication with regulatory bodies (e.g., FDA) is a critical channel for advancing the lead candidate. Proceeds from recent financing are explicitly earmarked to support these efforts. For instance, the $25 million rights offering proceeds are intended to provide capital for regulatory approval efforts and potential launch of Trappsol® Cyclo™ following positive interim trial results. Furthermore, the FDA accepted the Statistical Analysis Plan for the TransportNPC Study.
The financial performance, which directly impacts the resources available for these channels, is summarized below based on the latest reported fiscal periods:
| Financial Metric (As of Late 2025 Data) | Value/Amount | Reporting Period/Date |
| Cash and Cash Equivalents | $52.8 million | July 31, 2025 |
| Net Proceeds from Rights Offering | $24.9 million | Closed June 4, 2025 |
| Net Loss (Full Fiscal Year 2025) | $30.5 million | Twelve months ended July 31, 2025 |
| Net Loss (Q3 Fiscal 2025) | $4.8 million | Three months ended April 30, 2025 |
| Research and Development Expenses (TTM) | $12.8 million | Twelve months ended July 31, 2025 |
The operational structure relies heavily on these internal entities to execute the clinical and regulatory strategy. You can see the direct link between capital raised and the ability to engage the FDA channel.
- Wholly-owned subsidiary executing clinical development: Cyclo Therapeutics, LLC
- Key financing event to fund regulatory efforts: $25 million rights offering
- Regulatory milestone achieved: FDA acceptance of Statistical Analysis Plan
- Merger completion date with core asset holder: March 25, 2025
The company's focus on its lead candidate is evident in the expense allocation through the R&D channel, with $12.8 million in R&D expenses for the twelve months ending July 31, 2025.
Finance: review the cash burn rate against the $52.8 million cash balance as of July 31, 2025 to project runway for regulatory engagement.
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Customer Segments
You're hiring before product-market fit... so you need to be crystal clear on who you are serving right now. For Rafael Holdings, Inc. (RFL), the customer segments are highly specialized, revolving around the development and potential commercialization of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1).
Patients with Niemann-Pick Disease Type C1 (NPC1) and their families
This group represents the ultimate end-user for the lead therapeutic candidate. The focus is on a rare, life-limiting, and progressive genetic disorder. The market size is small but critically underserved.
- NPC1 affects approximately 1 in 100,000 live births globally.
- The Phase 3 TransportNPC™ study enrolled 94 patients across over 25 sites in 13 countries.
- A dedicated open-label sub-study enrolled ten (10) patients aged from birth to 3 years of age.
- Preliminary 48-week data from the sub-study showed 7 out of 9 patients demonstrated stabilization or improvement in CGI-S score.
The company actively engages with this segment through clinical trial participation and data presentation at specialized medical congresses.
- Data was presented at the 15th International Congress of Inborn Errors of Metabolism (ICIEM) on September 16, 2025.
Institutional and individual investors seeking biotech exposure
These stakeholders provide the necessary capital to fund the late-stage clinical development and potential commercialization efforts. Their interest is tied directly to the success of the Phase 3 trial and the company's financial health.
Here's the quick math on the investor base as of late 2025:
| Metric | Value as of Late 2025 |
| Share Price (November 28, 2025) | $1.18 / share |
| Total Institutional Shareholders (13F Filers) | 84 |
| Total Shares Held by Institutions | 4,207,386 shares |
| Institutional Ownership Percentage | 12.97% |
| Cash and Equivalents (July 31, 2025) | $52.8 million |
| Full Fiscal Year 2025 Net Loss | $30.5 million, or $1.04 per share |
The company recently bolstered its position to support clinical advancement.
- Rafael Holdings closed a $25 million rights offering on June 4, 2025, yielding net proceeds of $24.9 million.
- Vanguard Group Inc. was a major holder as of September 30, 2025, with 1,394,726 shares, representing 10.543%.
Rare disease patient advocacy and support organizations
These groups are crucial for driving awareness, providing community support, and influencing the regulatory and commercial environment for orphan drugs. Rafael Holdings, Inc. engages with them to ensure a patient-centric approach.
- The company's focus on rare disease aligns it with organizations that participate in events like the RARE Drug Development Symposium (September 3-4, 2025).
- Advocacy groups are key stakeholders in building coalitions to support rare disease legislative and research efforts.
Pharmaceutical/biotech companies for potential future licensing or M&A
This segment includes potential partners for commercialization, acquisition targets to expand the pipeline, or larger entities that might acquire Rafael Holdings, Inc. based on successful trial data.
| Relationship Type | Entity/Transaction Detail |
| Direct Ownership/Subsidiary | 100% interest in Cyclo Therapeutics, LLC |
| Acquisition Date | Cyclo Therapeutics acquired in March 2025 |
| Portfolio Investments | LipoMedix, Barer, Rafael Medical Devices, Cornerstone, and Day Three |
| Recent Strategic Letter of Intent | Signed with Wellgistics Health, Inc. in late October 2025 |
The R&D expenses for the twelve months ended July 31, 2025, were $12.8 million, reflecting investment in the subsidiary and portfolio companies.
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Cost Structure
The Cost Structure for Rafael Holdings, Inc. (RFL) in late 2025 is heavily weighted toward advancing its primary clinical asset, Trappsol® Cyclo™, through its subsidiary Cyclo Therapeutics.
High Research and Development (R&D) expenses are a major cost driver, reflecting the ongoing pivotal Phase 3 TransportNPC™ study for Niemann-Pick Disease Type C1. For the twelve months ended July 31, 2025, R&D expenses totaled $12.8 million. This represents a significant year-over-year increase from $4.2 million in the prior year period, driven by the inclusion of spending at Cyclo Therapeutics after the March 2025 acquisition.
Significant General and Administrative (G&A) expenses also feature prominently in the cost base. For the full fiscal year 2025 ended July 31, 2025, G&A expenses were $13.8 million. This is up from $8.9 million in the same period in the prior year.
The escalation in operating costs is directly tied to the consolidation of subsidiaries. The operating costs of consolidated subsidiaries like Cyclo Therapeutics are now integrated into Rafael Holdings, Inc.'s figures. The Phase 3 TransportNPC™ study costs are embedded within the R&D spend, which increased due to the inclusion of Cyclo Therapeutics' spending following the merger.
You can see the recent quarterly expense run-rate below, which shows the impact of the full consolidation in the fourth quarter:
| Expense Category | Q4 FY2025 Amount (in thousands) | FY2025 Full Year Amount (in thousands) |
| Research and Development (R&D) Expenses | $7,547 | $12,823 |
| General and Administrative (G&A) Expenses | $5,497 | $13,781 |
| Total Operating Expenses (Q4 Only) | $12,763 | N/A |
The cost structure also includes other necessary expenditures, which are generally captured within the G&A line item, such as professional fees for legal and financial compliance. The overall operating loss for the full year ended July 31, 2025, was $(29.159 million).
Key components contributing to the overall cost structure include:
- R&D expenses for the twelve months ended July 31, 2025: $12.8 million.
- G&A expenses for the twelve months ended July 31, 2025: $13.8 million.
- Operating Loss for the year ended July 31, 2025: $(29,159) thousand.
- R&D expenses for the three months ended July 31, 2025: $7.5 million.
- G&A expenses for the three months ended July 31, 2025: $5.5 million.
The company's focus on advancing Trappsol® Cyclo™ means clinical trial costs for the Phase 3 TransportNPC™ study are a primary component of the R&D spend. The company bolstered its cash position in June 2025 with a $25 million rights offering to help fund these ongoing costs.
Rafael Holdings, Inc. (RFL) - Canvas Business Model: Revenue Streams
You're looking at the current state of Rafael Holdings, Inc.'s (RFL) revenue generation as of late 2025. Honestly, the picture is dominated by capital formation to support the pipeline, rather than significant operational sales yet.
The minimal revenue generated directly from operations for the full fiscal year 2025 (ended July 31, 2025) was $\$917,000. This represented a growth of 43.96% compared to the prior year's $\$637,000$. For the fourth quarter of fiscal 2025 (the three months ended July 31, 2025), this operational revenue totaled $\$350$ thousand.
The primary financial activity bolstering the company's resources has been through equity financing, specifically to fund the development and potential launch of Trappsol® Cyclo™. You saw the successful closing of the $\$25.0$ million rights offering in June 2025.
Here's a quick breakdown of the capital infusion and operational snapshot:
| Financial Metric | Amount (USD) | Notes |
| FY2025 Total Revenue (Operations) | $\$917,000 | For the year ended July 31, 2025. |
| Q4 FY2025 Revenue (Operations) | $\$350,000 | For the three months ended July 31, 2025. |
| Total Rights Offering Proceeds | $\$25.0$ million | Gross proceeds from the June 2025 offering. |
| Net Proceeds from Offering & Backstop | Approx. $\$24.9$ million | Net amount expected after expenses. |
| Stockholder Subscriptions (Rights Offering) | $\$4,007,014.40 | Actual cash from exercising rights by public holders. |
| Backstop Private Placement (Jonas Family) | Approx. $\$21$ million | Purchase of unsubscribed shares by CEO and affiliates. |
| Cash and Cash Equivalents (as of July 31, 2025) | $\$52.8$ million | Balance sheet position post-financing. |
The capital raised is explicitly earmarked to support the next critical steps for the lead asset, Trappsol® Cyclo™. This means the revenue streams are currently structured around financing the path to potential future product sales. The company is positioning itself financially for what comes next, but that value is still contingent.
The expected revenue components for Rafael Holdings, Inc. going forward include:
- Potential future milestone payments or licensing fees from portfolio assets.
- Future commercial sales of Trappsol® Cyclo™ post-approval, which is currently zero revenue.
The entire near-term financial outlook hinges on the outcome of the TransportNPC™ Phase 3 clinical trial for Niemann-Pick Disease Type C1 (NPC1). If the 48-week interim analysis yields positive results, the capital raised will be deployed for regulatory efforts and potential launch activities. If onboarding takes longer than anticipated for the next data readout, cash burn from operations and R&D will continue to pressure the balance sheet, which is typical for pre-revenue biotech, but something you must track closely.
Finance: draft 13-week cash view by Friday.
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