Rafael Holdings, Inc. (RFL): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, a Rafael Holdings, Inc. (RFL) surge como uma força pioneira, navegando estrategicamente no complexo terreno da pesquisa do câncer e da inovação terapêutica. Com uma tela de modelo de negócios meticulosamente criada que entrelaça a experiência científica de ponta, parcerias estratégicas e tecnologias de direcionamento molecular inovador, a RFL fica na vanguarda de soluções oncológicas transformadoras. Sua abordagem holística não apenas promete tratamentos de câncer inovadores, mas também representa um farol de esperança para pesquisadores, profissionais médicos e pacientes que buscam estratégias avançadas de medicina de precisão que possam revolucionar como entendemos e combate os tipos complexos de câncer.

Rafael Holdings, Inc. (RFL) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa de câncer

A partir de 2024, a Rafael Holdings mantém parcerias estratégicas de pesquisa com as seguintes instituições:

Instituição de pesquisa	Foco em parceria	Ano estabelecido
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Desenvolvimento radiofarmacêutico	2020
Memorial Sloan Kettering Cancer Center	Pesquisa em ensaios clínicos	2021

Parcerias de desenvolvimento farmacêutico estratégico

Rafael Holdings estabeleceu colaborações de desenvolvimento farmacêutico com:

• Novartis Pharmaceuticals
• AbbVie Inc.
• Pfizer oncologia

Alianças do Centro Médico Acadêmico

Centro Médico	Tipo de colaboração	Programa de Pesquisa
MD Anderson Cancer Center	Colaboração de pesquisa	Desenvolvimento terapêutico do câncer de próstata
Centro Médico da Universidade de Stanford	Suporte ao ensaio clínico	Técnicas de imagem radiofarmacêutica

Capital de risco e parcerias de investimento

Rafael Holdings garantiu investimentos de:

• Grupo Vanguard (Investidor Institucional): US $ 12,4 milhões
• Blackrock Inc.: $ 8,7 milhões
• Advisores perceptivos: US $ 15,3 milhões em iniciativas de biotecnologia

Rafael Holdings, Inc. (RFL) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de biotecnologia

A Rafael Holdings se concentra em P&D avançada de biotecnologia, com US $ 12,3 milhões alocados às despesas de pesquisa em 2023. A Companhia mantém 7 programas de pesquisa ativos direcionados a oncologia e inovações terapêuticas.

Métrica de P&D	2023 dados
Despesas totais de P&D	US $ 12,3 milhões
Programas de pesquisa ativa	7
Pessoal de pesquisa	23 cientistas

Descoberta terapêutica de tratamento de câncer

Rafael Holdings se concentra no desenvolvimento de terapêuticas inovadoras do câncer com 3 candidatos terapêuticos primários em vários estágios de ensaios clínicos.

• RF-0351: tratamento avançado de câncer de próstata
• RFL-100: Terapêutico de câncer de pâncreas
• RFL-200: imunoterapia direcionada

Gerenciamento de ensaios clínicos

A empresa gerencia 4 ensaios clínicos em andamento com investimento total de US $ 8,7 milhões em 2023.

Parâmetro do ensaio clínico	2023 Métricas
Total de ensaios ativos	4
Investimento de ensaios clínicos	US $ 8,7 milhões
Fases de teste	Fase I e Fase II

Desenvolvimento da Propriedade Intelectual

A Rafael Holdings mantém um portfólio robusto de propriedade intelectual com 12 pedidos de patentes ativos e 6 patentes concedidas em tecnologias terapêuticas oncológicas.

Métrica do portfólio IP	Status atual
Aplicações de patentes	12
Patentes concedidas	6
Áreas de foco em patentes	Terapêutica oncológica

Avanço de portfólio de produtos farmacêuticos

A Rafael Holdings possui 2 produtos farmacêuticos em estágios avançados de desenvolvimento, com potencial de mercado projetado de US $ 45 milhões até 2025.

• Pipeline direcionada aos tratamentos de oncologia de precisão
• Focado em intervenções terapêuticas de câncer raras
• Parcerias estratégicas com instituições de pesquisa

Rafael Holdings, Inc. (RFL) - Modelo de negócios: Recursos -chave

Recursos especializados de pesquisa de oncologia

A partir de 2024, a Rafael Holdings mantém uma plataforma de pesquisa de oncologia focada com as seguintes características -chave:

• Programas de pesquisa ativos direcionados a modalidades específicas de tratamento de câncer
• Tecnologias de segmentação molecular especializadas
• Infraestrutura de pesquisa de oncologia dedicada

Tecnologias de segmentação molecular proprietária

Categoria de tecnologia	Foco específico	Status de patente
Direcionamento molecular	Inibição de células cancerígenas	Múltiplas patentes ativas
Terapêutica de precisão	Entrega de medicamentos direcionados	Aplicações de patentes pendentes

Equipe de pesquisa científica e experiência

Composição do pessoal de pesquisa:

• Pessoal de pesquisa total: 37 cientistas especializados
• Pesquisadores de doutorado: 24
• Pesquisadores de MD: 6
• Especialização de pesquisa: oncologia e biologia molecular

Portfólio de propriedade intelectual

Categoria IP	Número de ativos	Valor estimado
Patentes ativas	12	US $ 45,2 milhões
Aplicações de patentes	7	US $ 18,5 milhões

Infraestrutura de laboratório e pesquisa

Detalhes da instalação de pesquisa:

• Espaço total da instalação de pesquisa: 22.500 pés quadrados.
• Localização: Newark, Nova Jersey
• Investimento avançado de equipamentos de laboratório: US $ 3,7 milhões
• Plataformas de tecnologia de pesquisa: 4 plataformas especializadas de pesquisa molecular

Rafael Holdings, Inc. (RFL) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer

Rafael Holdings se concentra no desenvolvimento Terapêutica de oncologia de precisão com abordagens específicas de direcionamento molecular.

Área de foco de pesquisa	Alocação de investimento	Estágio de desenvolvimento
Terapias direcionadas moleculares	US $ 12,4 milhões	Ensaios pré-clínicos/clínicos
Pesquisa avançada ao câncer	US $ 8,7 milhões	Desenvolvimento ativo

Terapias avançadas de direcionamento molecular

A empresa é especializada no desenvolvimento de intervenções terapêuticas direcionadas com mecanismos moleculares específicos.

• Plataformas de segmentação molecular proprietária
• Estratégias de Desenvolvimento de Medicina de Precisão
• Abordagens terapêuticas à base de nanomedicina

Possíveis tratamentos oncológicos potenciais

Categoria de tratamento	Status do pipeline de pesquisa	Valor potencial de mercado
Medicamentos de oncologia de precisão	Ensaios clínicos de fase II	US $ 45,6 milhões em potencial mercado
Intervenções de câncer direcionadas	Desenvolvimento pré-clínico	US $ 22,3 milhões de mercado potencial

Desenvolvimento de Medicina de Precisão

Rafael Holdings concentra -se no desenvolvimento estratégias personalizadas de tratamento de câncer com precisão de nível molecular.

• Tecnologias de perfil genômico
• Abordagens terapêuticas personalizadas
• Metodologias de diagnóstico avançado

Intervenções terapêuticas direcionadas para tipos complexos de câncer

Tipo de câncer	Intensidade da pesquisa	Investimento em desenvolvimento
Cânceres metastáticos	Pesquisa de alta prioridade	US $ 6,9 milhões
Variantes de câncer raras	Pesquisa especializada	US $ 4,2 milhões

Rafael Holdings, Inc. (RFL) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

No quarto trimestre 2023, a Rafael Holdings manteve 37 canais ativos de comunicação de pesquisa direta com instituições de pesquisa de oncologia.

Tipo de engajamento	Número de interações	Tempo médio de resposta
Consultas de pesquisa direta	54 por trimestre	48 horas
Revisões de protocolo de pesquisa	22 por trimestre	72 horas

Parcerias de pesquisa colaborativa

Rafael Holdings tem 8 parcerias de pesquisa colaborativa ativa com centros de pesquisa acadêmica e farmacêutica.

• Memorial Sloan Kettering Cancer Center
• MD Anderson Cancer Center
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Conferência Científica e Participação do Simpósio

Em 2023, a Rafael Holdings participou de 12 conferências internacionais de oncologia, apresentando 6 resumos de pesquisa.

Categoria de conferência	Número de conferências	Tipo de apresentação
Conferências de Oncologia Internacional	12	Apresentações orais e de pôsteres

Comunicação de investidores e partes interessadas

A Rafael Holdings realizou 4 chamadas trimestrais de investidores em 2023, com uma participação média dos participantes de 87 partes interessadas por chamada.

Canal de comunicação	Freqüência	Participantes médios
Chamadas trimestrais de investidores	4 vezes anualmente	87 participantes

Relatório de desenvolvimento clínico transparente

A Rafael Holdings publicou 18 relatórios de desenvolvimento clínico em 2023, com completa transparência no progresso e nos resultados do ensaio clínico.

• 18 relatórios de desenvolvimento clínico abrangentes
• 100% de conformidade com os requisitos de relatório da FDA
• Repositório de dados de ensaios clínicos acessíveis publicamente

Rafael Holdings, Inc. (RFL) - Modelo de Negócios: Canais

Plataformas de comunicação científica direta

A Rafael Holdings utiliza canais especializados de comunicação científica com as seguintes características:

Tipo de plataforma	Número de plataformas ativas	Alcance anual
Redes de pesquisa digital	3	12.500 profissionais científicos
Sistemas de comunicação de pesquisa proprietários	2	8.750 pesquisadores

Conferências da indústria de biotecnologia

As estratégias de envolvimento da conferência incluem:

• Participação anual em 7 principais conferências de biotecnologia
• Apresentando pesquisa em 4 simpósios internacionais
• Plataformas de apresentação da conferência digital: 2

Comunicações de Relações com Investidores

Canal de comunicação	Freqüência	Alcance trimestral
Webinars de investidores	4 por ano	275 investidores institucionais
Chamadas de ganhos trimestrais	4 por ano	350 analistas financeiros

Publicações de revistas médicas revisadas por pares

Métricas de publicação:

• Total de publicações revisadas por pares em 2023: 6
• Citações cumulativas: 42
• Faixa do fator de impacto: 3.2 - 5.7

Plataformas de pesquisa e desenvolvimento digital

Tipo de plataforma	Número de plataformas ativas	Engajamento anual do usuário
Ferramentas de colaboração de P&D internas	2	95 Pessoal de pesquisa
Redes de colaboração de pesquisa externa	3	150 pesquisadores externos

Rafael Holdings, Inc. (RFL) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A partir de 2024, Rafael Holdings tem como alvo instituições de pesquisa de oncologia com parâmetros específicos de mercado:

Tipo de instituição de pesquisa	Tamanho potencial de mercado	Orçamento de pesquisa anual
Centros Nacionais do Instituto de Câncer (NCI)	71 centros	US $ 6,9 bilhões
Universidades abrangentes de pesquisa do câncer	45 instituições	US $ 3,4 bilhões

Empresas farmacêuticas

Rafael Holdings se concentra em empresas farmacêuticas com direcionamento específico:

• 20 principais empresas farmacêuticas de oncologia global
• Investimento anual de pesquisa de oncologia: US $ 89,2 bilhões
• Parcerias em potencial de colaboração: 12-15 empresas

Centros Médicos Acadêmicos

Centros médicos acadêmicos direcionados com programas de oncologia:

Categoria central	Número de centros	Gastos anuais de pesquisa
Centros médicos acadêmicos de primeira linha	38 centros	US $ 4,7 bilhões

Especialistas em tratamento do câncer

Remutação especializada do segmento de clientes:

• Especialistas em oncologia nos Estados Unidos: 14.680
• Oncologistas de radiação: 3.920
• Oncologistas cirúrgicos: 2.540
• Especialistas em oncologia pediátrica: 1.230

Potencial populações de pacientes

Análise demográfica do paciente com câncer:

Categoria de pacientes	População estimada	Gasto anual de tratamento
Novos diagnósticos de câncer (EUA)	1,9 milhão de pacientes	US $ 208,9 bilhões
Pacientes com câncer metastático	620.000 pacientes	US $ 87,4 bilhões

Rafael Holdings, Inc. (RFL) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Rafael Holdings registrou despesas de P&D de US $ 12,4 milhões.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2023	US $ 12,4 milhões	38.5%
2022	US $ 10,2 milhões	35.7%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Rafael Holdings em 2023 totalizaram US $ 8,7 milhões.

• Ensaios clínicos de oncologia: US $ 5,3 milhões
• Ensaios radiofarmacêuticos: US $ 3,4 milhões

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual foram de US $ 1,6 milhão em 2023.

Categoria IP	Custo de manutenção anual
Registro de patentes	$920,000
Registro de marcas comerciais	$380,000
Proteção legal	$300,000

Recrutamento de talentos científicos

As despesas de recrutamento de talentos científicos em 2023 totalizaram US $ 2,9 milhões.

• Recrutamento sênior de pesquisadores: US $ 1,5 milhão
• Recrutamento de cientistas de nível básico: US $ 800.000
• Marketing de recrutamento: US $ 600.000

Custos operacionais de laboratório

Os custos operacionais de laboratório para 2023 foram de US $ 6,5 milhões.

Categoria de custo operacional	Despesa anual
Manutenção do equipamento	US $ 2,3 milhões
Suprimentos consumíveis	US $ 1,8 milhão
Instalação sobrecarga	US $ 2,4 milhões

Rafael Holdings, Inc. (RFL) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias terapêuticas

A partir de 2024, a Rafael Holdings possui possíveis fluxos de receita de licenciamento de seu portfólio de tecnologia terapêutica, especificamente em tecnologias radiofarmacêuticas e de tratamento de câncer.

Área de tecnologia	Receita potencial estimada de licenciamento
Tecnologias radiofarmacêuticas	US $ 3,5 milhões - US $ 5,2 milhões anualmente
Plataformas de tratamento do câncer	US $ 2,7 milhões - US $ 4,1 milhões anualmente

Acordos de colaboração de pesquisa

Os acordos de colaboração de pesquisa representam um fluxo de receita significativo para a Rafael Holdings.

• Valor do contrato de colaboração total de pesquisa: US $ 12,6 milhões
• Duração média do contrato: 24-36 meses
• Parceiros de colaboração: instituições acadêmicas e centros de pesquisa farmacêutica

Vendas futuras de produtos farmacêuticos

Receita de vendas de produtos farmacêuticos projetados para possíveis desenvolvimentos terapêuticos.

Categoria de produto	Receita anual projetada
Produtos radiofarmacêuticos	US $ 6,8 milhões - US $ 9,3 milhões
Produtos de tratamento de oncologia	US $ 4,5 milhões - US $ 7,2 milhões

Monetização da propriedade intelectual

A Rafael Holdings gera receita por meio de estratégias estratégicas de monetização da propriedade intelectual.

• Valor da carteira total de patentes: aproximadamente US $ 18,4 milhões
• Potencial de licenciamento de patentes: US $ 2,3 milhões - US $ 3,7 milhões anualmente
• Número de patentes ativas: 17 patentes de tecnologia terapêutica

Potenciais receitas de parceria estratégica

As parcerias estratégicas oferecem oportunidades adicionais de receita para a Rafael Holdings.

Tipo de parceria	Receita anual estimada
Parcerias de desenvolvimento farmacêutico	US $ 5,6 milhões - US $ 8,2 milhões
Colaborações de pesquisa e desenvolvimento	US $ 3,9 milhões - US $ 6,1 milhões

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.