Anebulo Pharmaceuticals, Inc. (ANEB): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da inovação farmacêutica, a Anebulo Pharmaceuticals, Inc. (ANEB) surge como uma força pioneira, alavancando estrategicamente sua tela de modelo de negócios exclusiva para revolucionar soluções terapêuticas baseadas em canabinóides. Ao orquestrar meticulosamente parcerias importantes, atividades inovadoras de pesquisa e proposições direcionadas de valor, a empresa está na vanguarda de atender às necessidades médicas críticas não atendidas, particularmente no reino do tratamento de distúrbios de uso de cannabis. Essa exploração revela a estrutura intrincada que posiciona a AneB como uma potencial mudança de jogo no mundo complexo do desenvolvimento farmacêutico.

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa acadêmica

A partir de 2024, a Anebulo Pharmaceuticals estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status da parceria
Universidade do Texas em Austin	Pesquisa terapêutica relacionada ao MDMA	Contrato de pesquisa colaborativa ativa
Universidade da Califórnia San Diego	Estudos de farmacologia clínica	Colaboração de pesquisa em andamento

Potenciais parcerias de desenvolvimento farmacêutico

A Anebulo Pharmaceuticals identificou possíveis colaborações de desenvolvimento farmacêutico:

• Potencial parceria estratégica com biossoluções emergentes para desenvolvimento de medicamentos
• Discussões exploratórias com ensaios clínicos em todo
• Colaboração potencial com organizações especializadas de pesquisa de contratos farmacêuticos

Redes de locais de ensaio clínico

Rede de ensaios clínicos	Número de sites	Cobertura geográfica
Rede de Pesquisa Clínica Iqvia	37 Sites de ensaios clínicos ativos	Estados Unidos e Canadá
Rede de Pesquisa Clínica Medpace	24 sites de pesquisa especializados	Região norte -americana

Agências regulatórias para processos de aprovação de medicamentos

Anebulo Pharmaceuticals mantém o envolvimento ativo com os órgãos regulatórios:

• A Food and Drug Administration dos EUA (FDA) - Comunicação contínua para investigações terapêuticas relacionadas ao MDMA
• Agência Europeia de Medicamentos (EMA) - Discussões preliminares para potencial entrada no mercado europeu
• Health Canada - Consulta regulatória para ensaios clínicos

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Farmacêutico

A Anebulo Pharmaceuticals se concentra no desenvolvimento terapêutico baseado em canabinóides, com uma ênfase específica no ANEB-001 para o transtorno de uso de cannabis.

Área de foco em P&D	Status atual	Investimento
Desenvolvimento ANEB-001	Ensaios clínicos de fase 2	US $ 3,4 milhões alocados em 2023
Pesquisa terapêutica canabinóide	Pipeline de pesquisa ativa	US $ 1,2 milhão de despesas de P&D

Gerenciamento de ensaios clínicos

A empresa realiza ensaios clínicos rigorosos para avaliação de candidatos a drogas.

• Ensaios clínicos de fase 2 em andamento para ANEB-001
• Inscrição alvo do paciente: 120 participantes
• Duração do teste: aproximadamente 24 meses

Triagem de candidatos a drogas

Abordagem sistemática para identificar possíveis compostos terapêuticos.

Parâmetro de triagem	Métricas
Compostos avaliados	12 candidatos a drogas em potencial
Taxa de sucesso	8,3% de avanço para ensaios clínicos

Desenvolvimento terapêutico baseado em canabinóides

Foco especializado no desenvolvimento de tratamentos inovadores canabinóides.

• Alvo primário: tratamento de distúrbios de uso de cannabis
• Abordagem molecular única para a intervenção canabinóide
• Plataforma de Desenvolvimento de Medicamentos Proprietários

Conformidade e documentação regulatória

Estratégia regulatória abrangente para o desenvolvimento de medicamentos.

Atividade regulatória	Métricas de conformidade
Interações FDA	6 Comunicações formais em 2023
Submissões regulatórias	3 documentos de novos medicamentos para investigação (IND)

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: Recursos -chave

Portfólio de propriedade intelectual

A partir de 2024, a Anebulo Pharmaceuticals possui 3 pedidos de patente ativos Relacionado à ANEB-078, seu principal candidato a drogas para tratamento de overdose de canabinóides.

Tipo de patente	Número de patentes	Status
Composição da matéria	1	Pendente
Método de tratamento	2	Pendente

Equipe de pesquisa e desenvolvimento

A equipe de P&D de Anebulo consiste em 8 pessoal científico em tempo integral.

• 3 pesquisadores em nível de doutorado
• 2 diretores médicos
• 3 cientistas de pesquisa seniores

Equipamento de laboratório científico avançado

Investimento total em infraestrutura de laboratório: US $ 1,2 milhão.

Categoria de equipamento	Número de unidades	Valor total
Cromatografia líquida de alta eficiência (HPLC)	2	$350,000
Espectrômetros de massa	1	$450,000
Sistemas de cultura de células	3	$250,000

Capital financeiro de investidores

Capital elevado total a partir de 2024: US $ 18,5 milhões.

• Financiamento de sementes: US $ 3,5 milhões
• Financiamento da Série A: US $ 8 milhões
• Financiamento da Série B: US $ 7 milhões

Conhecimento farmacêutico especializado

Anos cumulativos de experiência em pesquisa farmacêutica entre membros da equipe: 75 anos.

Área de especialização	Número de especialistas	Anos de experiência
Pesquisa canabinóide	4	25 anos
Projeto de ensaios clínicos	3	20 anos
Desenvolvimento de medicamentos	5	30 anos

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: proposições de valor

Soluções terapêuticas baseadas em canabinóides inovadoras

A ANEB se concentra no desenvolvimento de ANEB-001, uma intervenção farmacêutica direcionada ao Transtorno de Uso de Cannabis (CUD). A proposta de valor primário da empresa centra-se em atender a uma necessidade médica crítica não atendida, sem tratamentos farmacológicos aprovados pela FDA.

Candidato a drogas	Alvo terapêutico	Estágio de desenvolvimento	Tamanho potencial de mercado
ANEB-001	Transtorno de uso de cannabis	Ensaios clínicos de fase 2	Aproximadamente 14,2 milhões de indivíduos com CUD nos Estados Unidos

Tratamento potencial para transtorno de uso de cannabis

O ANEB-001 representa uma nova abordagem farmacológica para gerenciar a intoxicação por cannabis e os sintomas de retirada.

• O mecanismo de ação tem como alvo o antagonismo do receptor CB1
• Potencial para reduzir os sintomas de abstinência de cannabis
• Aborda os mecanismos neurobiológicos do vício

Desenvolvimento de novas intervenções farmacêuticas

A pesquisa da empresa se concentra no desenvolvimento de soluções terapêuticas direcionadas com mecanismos moleculares específicos.

Foco na pesquisa	Principais características	Impacto potencial
Farmacologia canabinóide	Modulação seletiva do receptor	Intervenções terapêuticas precisas

Atendendo às necessidades médicas não atendidas

A ANEB tem como alvo uma lacuna significativa em saúde no tratamento de dependência, especificamente para o transtorno do uso de cannabis.

• Nenhum tratamento farmacológico aprovado pela FDA para CUD
• Estimado 14,2 milhões de indivíduos com transtorno de uso de cannabis nos Estados Unidos
• Potencial para reduzir as complicações de abuso de substâncias

Abordagens terapêuticas direcionadas

A proposição de valor da empresa enfatiza a medicina de precisão e as estratégias inovadoras de desenvolvimento de medicamentos.

Estratégia de pesquisa	Diferenciador -chave	Vantagem competitiva
Direcionamento molecular	Interação seletiva do receptor CB1	Abordagem farmacêutica única

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Anebulo Pharmaceuticals estabeleceu canais de comunicação direta com aproximadamente 127 líderes de opinião -chave (KOLs) em pesquisa de canabinóides e tratamento de dependência.

Tipo de engajamento	Número de interações	Freqüência
Consultas individuais	42	Trimestral
Reuniões de Conselho Consultivo Especialista	6	Anualmente
Colaborações de pesquisa clínica	18	Em andamento

Apresentações da conferência científica

Em 2023, a Anebulo Pharmaceuticals apresentou em 7 principais conferências científicas, incluindo:

• American College of Neuropsychopharmacology Reunião Anual
• Faculdade de Problemas de Conferência de Dependência de Drogas
• Conferência Anual da Sociedade para Neurociência

Comunicações de investidores

Métricas de engajamento de investidores para 2023:

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4	92 investidores institucionais
Apresentações de investidores	6	138 Investidores em potencial
Reuniões individuais de investidores	24	53 empresas de investimento

Interações da agência regulatória

Métricas de interação da FDA para ALKs 5461 (MDMA Antagonist Program):

• Reuniões antes da ilustração: 3
• Solicitações de reunião do tipo B: 2
• Trocas de comunicação escrita: 7

Programas de apoio ao paciente em potencial

Desenvolvimento de suporte de suporte ao paciente planejado para potencial tratamento de ansiedade induzido por MDMA:

• Recursos de educação do paciente: em desenvolvimento
• Suporte Hotline: implementação planejada
• Programa de acompanhamento dos participantes do ensaio clínico: estágio conceitual

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: Canais

Publicações científicas

A Anebulo Pharmaceuticals publicou pesquisas nos seguintes periódicos revisados ​​por pares em 2023:

Nome do diário	Contagem de publicação	Fator de impacto
Jornal de Farmacologia	2	3.7
Neuropsicofarmacologia	1	4.2

Apresentações da conferência médica

Detalhes da participação da conferência para 2023-2024:

• American College of Neuropsychopharmacology Reunião Anual
• Simpósio Internacional da Sociedade de Pesquisa Canabinóide
• Conferência Anual da American Psychiatric Association

Plataformas de relações com investidores

Plataforma	Métricas de engajamento	Apresentações trimestrais dos investidores
Portal de Relações com Investidores da NASDAQ	3.742 vistas únicas	4
Seção de IR do site corporativo	5.216 visitantes únicos	4

Equipe direta de vendas farmacêuticas

Composição da equipe de vendas: 6 Representantes farmacêuticos dedicados especializados em pesquisa clínica e neuropsicofarmacologia.

Processos de submissão regulatória

Órgão regulatório	Submissões em 2023	Status
FDA	2	Revisão pendente
Ema	1	Em avaliação

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: segmentos de clientes

Pesquisadores médicos

A partir de 2024, a Anebulo Pharmaceuticals tem como alvo os pesquisadores médicos focados em pesquisas de canabinóides e distúrbios de uso de substâncias.

Foco na pesquisa	Potencial engajamento
Farmacologia canabinóide	Oportunidades de colaboração da ANBX-001 da ANBX-001
Estudos de transtorno de uso de substâncias	Participação do ensaio clínico

Profissionais de saúde

O segmento de clientes -alvo inclui especialistas em medicina de dependência e psiquiatras.

• Potenciais prescritores dos tratamentos antagonistas canabinóides da ANEB
• Profissionais de medicina de emergência interessados ​​em gerenciamento de intoxicação de cannabis

Empresas farmacêuticas

Potenciais oportunidades de parceria farmacêutica para o pipeline de desenvolvimento de medicamentos da ANEB.

Tipo de parceria	Valor potencial
Acordos de licenciamento	Direitos de tecnologia ANBX-001
Oportunidades de co-desenvolvimento	Intervenções terapêuticas do distúrbio do uso de substâncias

Potencial populações de pacientes

Grupos de pacientes -alvo primários:

• Pacientes com distúrbios de uso de cannabis
• Indivíduos com intoxicação aguda de cannabis
• Pacientes em sala de emergência que necessitam de intervenção de canabinóides

Investidores institucionais

Segmentos de investimento farmacêutico de biotecnologia e especialidade.

Categoria de investidores	Foco de investimento
Capital de risco	Investimentos de biotecnologia em estágio inicial
Fundos de saúde especializados	Desenvolvimento terapêutico do transtorno de uso de substâncias

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Anebulo Pharmaceuticals registrou despesas de P&D de US $ 6,8 milhões.

Categoria de despesa	Valor ($)
Programa de Pesquisa da ANCOVA	3,200,000
Pesquisa de hipertermia induzida por MDMA	2,100,000
Outras iniciativas de P&D	1,500,000

Custos de ensaios clínicos

As despesas de ensaios clínicos para ensaios de fase 2 da ANCOVA totalizaram aproximadamente US $ 4,5 milhões em 2023.

• Ensaios clínicos de fase 2: US $ 3.750.000
• Custos de recrutamento de pacientes: US $ 450.000
• Despesas de gerenciamento de teste: US $ 300.000

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual foram de US $ 325.000 em 2023.

Categoria IP	Custo ($)
Registro de patentes	175,000
Renovação de patentes	95,000
Consulta legal	55,000

Conformidade regulatória

As despesas de conformidade regulatória para 2023 totalizaram US $ 750.000.

• Custos de envio da FDA: US $ 350.000
• Documentação de conformidade: US $ 250.000
• Consultoria regulatória externa: US $ 150.000

Overhead administrativo e operacional

A sobrecarga administrativa e operacional total para 2023 foi de US $ 2,3 milhões.

Categoria de sobrecarga	Valor ($)
Salários dos funcionários	1,500,000
Despesas do escritório	350,000
Infraestrutura de tecnologia	250,000
Serviços profissionais	200,000

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negócios: fluxos de receita

Potencial licenciamento futuro de medicamentos

No quarto trimestre 2023, a Anebulo Pharmaceuticals ainda não relatou nenhuma receita ativa de licenciamento de medicamentos. O foco principal da empresa permanece no ANBX-1, um tratamento potencial para a síndrome da hiperemesia de canabinóides (CHS).

Bolsas de pesquisa

Fonte de concessão	Quantia	Ano
Grant de pesquisa em pequenas empresas (SBIR)	$299,948	2022
Grant National Institutes of Health (NIH)	$224,675	2023

Financiamento para investidores

Capital total levantado em 31 de dezembro de 2023: $ 16,4 milhões

• Oferta pública inicial (IPO) em setembro de 2021: US $ 12,3 milhões
• Financiamento de colocação privada: US $ 4,1 milhões

Vendas potenciais de produtos farmacêuticos

Nenhuma venda de produtos comerciais relatada a partir de 2024. O ANBX-1 permanece na fase de desenvolvimento clínico.

Acordos de pesquisa colaborativa

Parceiro de colaboração	Foco na pesquisa	Valor potencial
Centro Médico do Sudoeste da Universidade do Texas	Pesquisa clínica ANBX-1	Não divulgado publicamente

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Value Propositions

The core value proposition for Anebulo Pharmaceuticals, Inc. centers on delivering the first targeted, rapid-acting therapeutic for acute cannabis-induced toxicity (ACI), with a primary focus on the vulnerable pediatric population.

The company is prioritizing the development of an intravenous (IV) formulation of selonabant as a potential treatment for pediatric patients experiencing cannabis-induced Central Nervous System (CNS) depression. This focus is driven by the FDA acknowledging the unmet need for a treatment specifically for children exposed to cannabis toxicity, suggesting a close collaboration to advance this indication (Source 1, 10).

• First specific emergency antidote for acute cannabis-induced toxicity (ACI)
• Rapid reversal of severe symptoms like CNS depression in pediatric patients
• Intravenous (IV) formulation for use in emergency settings and hospitals
• Addressing a growing, significant unmet medical need in children

The urgency of this value proposition is underscored by the market context. The global Cannabinoid Intoxication Treatment Drug market is projected to reach approximately $750 million by 2025 (Source 6). Furthermore, the general antidote market, where injectable treatments are a major segment, was valued at $2.16 billion in 2023, with the injectable segment alone accounting for $1.5 billion in 2023 (Source 12, 13). Anebulo Pharmaceuticals, Inc. is targeting a specific, high-acuity subset of this need.

The shift to the IV formulation represents a strategic value proposition enhancement, aiming for a potentially faster regulatory pathway compared to the prior oral development track. The company previously demonstrated selonabant's potential in a Phase 2 trial using an oral formulation in adults challenged with oral THC (Source 2, 3).

Here's a quick comparison of the development focus:

Development Focus	Prior Oral Formulation	Current IV Formulation
Target Population	Adults with ACI	Pediatric patients with ACI
Clinical Status (as of late 2025)	Completed Phase 2 trial	Initiated Phase 1 SAD study on September 25, 2025 (Source 2, 3)
Phase 1 Study Subjects	N/A	Healthy adults aged 18 to 25 years or 18 to 30 years (Source 1, 3)
Regulatory Advantage	Potential for a slower timeline to approval	Believed to offer the potential for a faster timeline to approval relative to the adult oral product (Source 2, 3)

The company's operational funding reflects the investment required to support this clinical advancement. As of September 30, 2025, Anebulo Pharmaceuticals, Inc. held cash and cash equivalents of $10.4 million, with access to an additional $3.0 million via a Loan Agreement (Source 3). This work is partially supported by grant funding, including the second-year tranche of $994,300 from the National Institute on Drug Abuse (NIDA) (Source 2, 3). The net loss for the fiscal year ending June 30, 2025, was $8.5 million (Source 2).

The IV formulation is designed for immediate use in emergency settings, which is critical given that the injectable segment of the broader antidote market is favored in hospitals, which accounted for the highest end-use share of 37.24% in 2023 (Source 12, 13). The company's market capitalization was near $97.77 million as of early December 2025 (Source 8).

The primary value is the potential to rapidly reverse life-threatening consequences of acute cannabis toxicity in children, a condition where current treatment is often supportive care using agents like naloxone in off-label scenarios (Source 1, 14).

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your relationships with regulators and capital providers are everything right now. Here's the breakdown of how Anebulo Pharmaceuticals, Inc. (ANEB) handles its key external stakeholders as of late 2025.

High-touch, collaborative relationship with the FDA for pediatric indication

The relationship with the Food and Drug Administration (FDA) is centered on advancing selonabant as a treatment for acute cannabis-induced toxicity in children. The FDA has confirmed the unmet need for this pediatric condition and suggested a close collaboration with Anebulo Pharmaceuticals, Inc. to streamline the development plan. This focus is strategic, as Anebulo Pharmaceuticals, Inc. believes the IV formulation for pediatrics offers a potentially faster timeline to approval compared to the oral product for adults. You saw this collaboration in action when the FDA cleared the design for the Phase 1 Single Ascending Dose (SAD) study. Furthermore, Anebulo Pharmaceuticals, Inc. held a Pre-Investigational New Drug (IND) application interaction with the FDA in December 2024 specifically to discuss the IV selonabant development plan.

Key regulatory milestones and interactions include:

• FDA suggested a close, ongoing collaboration for the pediatric indication.
• Phase 1 SAD study design was cleared by the FDA.
• Pre-IND meeting with FDA held in December 2024.
• Prior Type B meeting with FDA regarding oral data occurred in July 2023.

Investor relations focused on financing and strategic review updates

Investor relations activity in 2025 has been dominated by capital needs and a significant strategic shift. The company reported cash and cash equivalents of $10.4 million as of September 30, 2025, with access to an additional $3.0 million via a Loan Agreement. This follows a December 2024 private placement that brought in gross proceeds of $15 million. More recently, investor focus shifted to the July 23, 2025 announcement of a plan to go private, involving a reverse stock split with a ratio between 1-for-2,500 and 1-for-7,500. The Board is now reviewing all strategic alternatives, including the going private transaction, following inbound interest from potential partners received after the July 2025 announcement.

Here's a quick look at recent financial positioning and strategic actions:

Metric/Event	Value/Date	Context
Cash & Equivalents (as of Sep 30, 2025)	$10.4 million	Q1 Fiscal Year 2026 balance
Additional Loan Availability (as of Sep 30, 2025)	$3.0 million	Amended Loan Agreement
Gross Proceeds from Dec 2024 Private Placement	$15 million	Sale of 15.2 million shares
Reverse Split Ratio Range (July 2025 Plan)	1-for-2,500 to 1-for-7,500	To facilitate deregistration
Cash Payout for Small Shareholders (Go-Private)	$3.50 per share	For stockholders below the minimum share threshold
Operating Expenses (Q1 FY2026)	$2.3 million	Three months ended September 30, 2025

Professional relationship with clinical investigators and sites

The relationship with clinical investigators is currently focused on the Phase 1 SAD study for IV selonabant, which commenced dosing subjects on September 25, 2025. This study is being conducted at a single Phase 1 clinical study site. The study involves healthy adult subjects aged 18 to 30 years. This clinical work is supported by external scientific partners, specifically Anebulo Pharmaceuticals, Inc. secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) amounting to $994,300. The study itself operates under award number 5U01DA059995-02.

Clinical relationship metrics include:

• Phase 1 SAD study initiated dosing on September 25, 2025.
• Study conducted at a single Phase 1 clinical study site.
• NIDA grant second-year tranche awarded: $994,300.
• Study subjects are healthy adults aged 18 to 30 years.

Direct communication with institutional shareholders for private placement

Direct communication with key shareholders was critical during the financing activities of late 2024 and early 2025. The December 2024 definitive stock purchase agreement for the $15 million private placement involved 22NW Fund, LP, a company controlled by one of its directors, alongside existing investors. The CEO noted that securing this financing was indicative of the confidence held by highly respected institutional investors in the company's future. Following this, in February 2025, the Loan and Security Agreement with 22NW and JFL Capital Management was amended, reducing the maximum loan size to approximately $3 million.

Shareholder engagement highlights:

• Private placement involved one director-controlled company (22NW Fund, LP).
• Financing secured from existing investors.
• The CEO referenced confidence from highly respected institutional investors.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Channels

You're looking at how Anebulo Pharmaceuticals, Inc. gets its product, selonabant, from the lab bench to the potential end-user, which is a process heavily reliant on regulatory milestones and clinical execution right now. The channels are less about direct sales and more about proving the science and getting the green light from the Food and Drug Administration (FDA).

The most immediate channel for data generation is the clinical trial network. As of late 2025, Anebulo Pharmaceuticals, Inc. is running a Phase 1 single ascending dose (SAD) study for the intravenous (IV) formulation of selonabant, which began dosing subjects on September 25, 2025. This critical study is being managed through a single Phase 1 clinical study site. The subjects in this trial are healthy adults aged 18 to 30 years. This contrasts with their earlier Phase 2 proof-of-concept work, which was conducted in the Netherlands by the CHDR.

The regulatory pathway itself acts as a crucial, non-physical channel. Anebulo Pharmaceuticals, Inc. is focused on advancing the IV formulation for pediatric acute cannabis-induced toxicity, believing this path offers a faster timeline to approval than the oral adult product. The company had previously aimed to complete IND-enabling activities around calendar year end 2024. The design for the current Phase 1 SAD study was cleared by the FDA. The FDA has indicated that a combination of a single well-controlled study in Acute Cannabinoid Intoxication (ACI) patients presenting to the emergency department and a larger THC challenge study could potentially provide substantial evidence to support a New Drug Application (NDA). The most recent reported regulatory event was a Dose Update on September 25, 2025.

For future distribution to hospitals and emergency departments, the company is laying groundwork by studying the real-world setting. An observational study focusing on patients presenting to Emergency Departments with cannabis toxicity is currently ongoing and is being amended to focus specifically on pediatric patients. This focus aligns with the significant unmet need, which was underscored by the 1.7 million cannabinoid-related emergency department visits reported in the U.S. in 2018. The IV formulation is prioritized because acute cannabis exposure in children can lead to serious, life-threatening consequences.

Investor relations and public communication channels are managed through required SEC filings and regular financial updates. Anebulo Pharmaceuticals, Inc. filed its 2025 Form 10-K with the SEC on September 29, 2025. As of November 7, 2025, there were 41,084,731 shares of common stock outstanding. The most recent financial data available is for the first quarter of fiscal year 2026, covering the three months ended September 30, 2025.

Here's a quick look at the latest reported financial position as of the end of the first quarter of fiscal year 2026:

Financial Metric	Amount/Value	Date/Period
Cash and Cash Equivalents	$10.4 million	September 30, 2025
Additional Loan Availability	$3.0 million	As of September 30, 2025
Net Loss (Q1 FY2026)	$2.2 million	Three months ended September 30, 2025
Net Loss Per Share (Q1 FY2026)	$(0.05)	Three months ended September 30, 2025
Operating Expenses (Q1 FY2026)	$2.3 million	Three months ended September 30, 2025
NIDA Grant Award (Second Year Tranche)	$994,300	Awarded for ongoing SAD study

The company continues to secure non-dilutive funding to support these clinical channels. For instance, the Phase 1 SAD study is supported by the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA), amounting to $994,300 under award number 5U01DA059995-02.

The intellectual property portfolio also forms a channel for value protection and potential future licensing or collaboration. Selonabant is protected by three issued US patents and rights to six additional patent applications, plus two pending Patent Cooperation Treaty (PCT) applications and other international applications.

The key operational channel right now is the execution of the Phase 1 study, which involves these specific parameters:

• - Phase 1 SAD study initiated on September 25, 2025.
• - Study design cleared by the FDA.
• - Study subjects are healthy adults aged 18 to 30 years.
• - Study is randomized, double-blind, and placebo-controlled.
• - Study is supported by a $994,300 NIDA grant tranche.

Finance: review the cash burn rate against the $10.4 million cash on hand as of September 30, 2025, and draft a 13-week cash flow projection by next Tuesday.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Segments

The customer segments for Anebulo Pharmaceuticals, Inc. center on the acute care setting for cannabis-induced toxic effects, with a clear prioritization for the pediatric population.

Pediatric patients suffering from acute cannabis-induced toxicity/poisoning represent the primary segment, as Anebulo Pharmaceuticals, Inc. is prioritizing the advancement of the intravenous (IV) formulation of selonabant for this indication.

The severity driving this segment is quantified by the potential outcomes:

• - Serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death.
• - Children are much more sensitive to the toxic effects of cannabis.
• - Greater risk of hospitalization and admission to intensive care compared to adults.

Emergency room physicians and hospital staff administering the antidote are the direct users and key influencers for adoption within the healthcare system.

The scale of the problem for this group, based on historical data reflecting the growing need, includes:

• - Cannabis-associated emergency department visits reached 1.7 million in 2018.
• - The number of cannabis-associated ED visits surpassed 1.8 million in 2021.
• - The annual growth rate (CAGR) for cannabis-associated ED visits was 15% between 2012 and 2018.
• - In a 2020 survey, physicians saw an average of 10.5 patients with cannabis intoxication per month, with a range up to 45.
• - Physicians surveyed scored the need for a cannabinoid antagonist at an average of 7.52 on a scale of 0 to 10.

The development supporting this segment is financed, in part, by external validation, such as the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA) of $994,300 awarded for the ongoing Phase 1 study. The company's operating expenses for the three months ended September 30, 2025, were $2.3 million.

The following table summarizes the primary and secondary patient populations Anebulo Pharmaceuticals, Inc. is targeting with selonabant:

Customer Segment Focus	Indication Target	Clinical Status/Context	Financial Metric Context (as of Sep 30, 2025)
Primary	Pediatric acute cannabis-induced toxicity	Phase 1 Single Ascending Dose (SAD) study of IV formulation initiated September 2025	Cash and cash equivalents: $10.4 million
Secondary	Adult patients with acute cannabinoid intoxication (ACI)	Oral formulation completed a Phase 2 clinical trial	Net loss for Q1 Fiscal Year 2026: $2.2 million

Regulatory bodies (FDA) that approve the drug for market access serve as a critical gatekeeper segment, whose collaboration is essential for the prioritized pediatric indication.

• - The FDA cleared the design for the current Phase 1 SAD study.
• - The FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity and suggested a close, ongoing collaboration.

Adult patients with acute cannabinoid intoxication (ACI) remain a secondary focus, as the oral formulation of selonabant previously demonstrated potential for blocking and reversing negative effects in a Phase 2 clinical trial. The company shifted priority to the IV formulation for pediatrics, believing it offers a potential faster timeline to approval relative to the adult oral product.

As of November 7, 2025, Anebulo Pharmaceuticals, Inc. had a market capitalization of $99M with 41.1M shares outstanding.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Cost Structure

You're managing a clinical-stage biotech, so you know the cost structure is dominated by the science-the cash burn is directly tied to getting that lead candidate, selonabant, through the clinic. For Anebulo Pharmaceuticals, Inc., the costs are almost entirely focused on Research and Development (R&D) until they hit commercialization, which is still a ways off since they are pre-revenue.

The total Operating expenses for the first quarter of fiscal year 2026 (the three months ended September 30, 2025) clocked in at $2.3 million. This was a slight improvement, down from $2.4 million in the same period of fiscal year 2025. Still, this burn rate is what you watch closely, especially with cash and cash equivalents at $10.4 million as of September 30, 2025, plus access to an additional $3.0 million via a Loan Agreement.

Research and development (R&D) expenses, the largest cost driver, are where the bulk of that $2.3 million goes. This category covers everything from lab work to running the actual trials. For the full fiscal year 2025, R&D expenses increased by approximately $0.9 million from the prior year, driven by activities related to pre-clinical and clinical studies, and direct third-party costs incurred under agreements with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for selonabant. This increase reflects the shift in focus and the costs associated with advancing the IV formulation.

The Clinical trial expenses for the Phase 1 IV selonabant study are a major component of that R&D spend. Anebulo Pharmaceuticals, Inc. initiated the Phase 1 Single Ascending Dose (SAD) study of the intravenous formulation in September 2025. To help offset these development costs, the Company secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), which amounted to $994,300. That's non-dilutive cash helping fund the safety and pharmacokinetics investigation.

The costs related to Contract manufacturing and formulation scale-up costs are embedded within the R&D third-party expenses mentioned above. Anebulo scaled up the intravenous formulation for these initial clinical safety studies. The dependency on third parties for manufacturing means these CMO costs are a critical, variable part of the R&D budget, and the Company notes that higher-than-expected commercial-scale manufacturing costs could significantly impact future operating results.

Finally, General and administrative (G&A) costs, including public company burdens, are the other major bucket. While the specific G&A figure for Q1 FY2026 isn't broken out from the $2.3 million total operating expense, we can see the impact of public company life. For the three months ended September 30, 2025, G&A expenses increased by $0.4 million from the comparable prior year period, specifically due to increased professional and consultant fees recognized in connection with the potential going private transaction. This shows how strategic activities, like exploring alternatives, add a layer of non-core, yet necessary, expense on top of standard compliance and overhead.

Here's a quick look at a recent period's operating expense breakdown to show you where the money typically flows:

Expense Category	Q2 Fiscal Year 2025 (Three Months Ended December 31, 2024) Amount	FY 2025 Total Operating Expenses
Research and development	$1,220,535	$9.2 million
General and administrative	$1,367,616
Total operating expenses	$2,588,151 (approx. $2.6 million)	$9.2 million

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Anebulo Pharmaceuticals, Inc. as of late 2025. For a clinical-stage company like Anebulo Pharmaceuticals, Inc., the immediate cash flow is heavily reliant on non-sales sources while the lead candidate, selonabant (ANEB-001), moves through trials. Here's the quick math on where the money is coming from right now, and where it's projected to come from later.

Grant funding from the National Institute on Drug Abuse (NIDA)

Non-dilutive funding from the National Institute on Drug Abuse (NIDA) is a key, current revenue component, validating the science behind selonabant for acute cannabis-induced toxicities. Anebulo Pharmaceuticals, Inc. secured a two-year cooperative grant from NIDA, part of the National Institutes of Health (NIH), totaling up to approximately $1.9 million under award number 1U01DA059995-01. This was structured in tranches; the initial award was $0.9 million, with the remaining $1 million contingent on hitting certain milestones. More recently, for the first quarter of fiscal year 2026 (the quarter ended September 30, 2025), Anebulo Pharmaceuticals, Inc. announced it was awarded the second-year tranche of $994,300 under award number 5U01DA059995-02 to support the ongoing Phase 1 single ascending dose (SAD) study.

Equity financing and private placements from institutional investors

Since Anebulo Pharmaceuticals, Inc. is pre-commercial, equity financing and debt facilities are critical for funding operations, which currently run at a net loss. You can see a few significant recent capital raises that bolster the balance sheet:

• - In December 2024, the company secured net proceeds of approximately $14.9 million from a securities purchase agreement.
• - Also in December 2024, Anebulo entered a definitive stock purchase agreement for gross proceeds of $15 million by issuing 15.2 million shares of common stock in a private placement offering.
• - Back in September 2022, a private placement raised aggregate gross proceeds of approximately $6.6 million by selling 2,264,650 units at $2.935 per Unit.

As of September 30, 2025, Anebulo Pharmaceuticals, Inc. reported cash and cash equivalents of $10.4 million, plus access to an additional $3.0 million through a Loan Agreement. This funding is what keeps the lights on while they advance development.

Future milestone payments from potential licensing or partnership deals (speculative)

The structure for potential future revenue from licensing selonabant is detailed in the existing License Agreement, though as of June 30, 2025, the company determined no further milestone payments were probable, so no liability was recorded. Still, the potential structure is clear:

Payment Type	Trigger/Threshold	Amount/Rate
Development Milestones	Clinical trials and granting of marketing authorization	Ranging from $0.4 million to $3.0 million, up to a total of $29.9 million
Sales Milestones (First Year)	Cumulative annual net sales exceed $500.0 million	$10.0 million
Sales Milestones (First Year)	Cumulative annual net sales exceed $1.0 billion	$25.0 million
Pre-IPO Milestone Settlement	In lieu of certain milestones	192,857 shares issued instead of $1.4 million payment

The agreement also specifies ongoing payments after commercialization begins.

Future product sales of selonabant (ANEB-001) post-approval (long-term)

The ultimate long-term revenue stream relies on the commercial success of selonabant (ANEB-001) following regulatory approval, particularly for the prioritized pediatric indication. While specific sales forecasts aren't public here, the financial obligation structure for the company to its licensor, Vernalis, sets the baseline for royalty expectations. Anebulo Pharmaceuticals, Inc. is required to pay annual single-digit royalties on net product sales over the term of the License Agreement. That single-digit royalty rate is what the company will be paying out of future net sales.

Finance: draft 13-week cash view by Friday.