Anebulo Pharmaceuticals, Inc. (ANEB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la innovación farmacéutica, Anebulo Pharmaceuticals, Inc. (ANEB) emerge como una fuerza pionera, aprovechando estratégicamente su lienzo de modelo de negocio único para revolucionar las soluciones terapéuticas basadas en cannabinoides. Al orquestar meticulosamente las asociaciones clave, las actividades de investigación innovadores y las propuestas de valor específicas, la compañía está a la vanguardia de abordar las necesidades médicas no satisfechas críticas, particularmente en el ámbito del tratamiento del trastorno por uso del cannabis. Esta exploración presenta el intrincado marco que posiciona a Aneb como un posible cambio de juego en el complejo mundo del desarrollo farmacéutico.

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocios: asociaciones clave

Colaboración con instituciones de investigación académica

A partir de 2024, Anebulo Pharmaceuticals ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de asociación
Universidad de Texas en Austin	Investigación terapéutica relacionada con MDMA	Acuerdo de investigación colaborativa activa
Universidad de California San Diego	Estudios de farmacología clínica	Colaboración de investigación en curso

Potencios de desarrollo farmacéutico de desarrollo farmacéutico

Anbulo Pharmaceuticals ha identificado posibles colaboraciones de desarrollo farmacéutico:

• Potencial asociación estratégica con biosoluciones emergentes para el desarrollo de fármacos
• Discusiones exploratorias con ensayos clínicos mundiales para el apoyo al desarrollo de fármacos
• Colaboración potencial con organizaciones especializadas de investigación de contratos farmacéuticos

Redes de sitios de ensayos clínicos

Red de ensayos clínicos	Número de sitios	Cobertura geográfica
Red de investigación clínica de IQVIA	37 sitios de ensayos clínicos activos	Estados Unidos y Canadá
Red de investigación clínica de Medpace	24 sitios de investigación especializados	Región norteamericana

Agencias reguladoras para procesos de aprobación de medicamentos

Anebulo Pharmaceuticals mantiene un compromiso activo con cuerpos reguladores:

• Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) - Comunicación continua para investigaciones terapéuticas relacionadas con MDMA
• Agencia Europea de Medicamentos (EMA) - Discusiones preliminares para la posible entrada del mercado europeo
• Health Canada - Consulta regulatoria para ensayos clínicos

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocio: actividades clave

Investigación y desarrollo farmacéutico

Anebulo Pharmaceuticals se centra en el desarrollo terapéutico a base de cannabinoides, con un énfasis específico en ANEB-001 para el trastorno por uso del cannabis.

Área de enfoque de I + D	Estado actual	Inversión
Desarrollo ANEB-001	Ensayos clínicos de fase 2	$ 3.4 millones asignados en 2023
Investigación terapéutica cannabinoide	Tubería de investigación activa	Gastos de I + D de $ 1.2 millones

Gestión de ensayos clínicos

La Compañía realiza ensayos clínicos rigurosos para la evaluación del candidato a fármacos.

• Entensos ensayos clínicos de fase 2 para ANEB-001
• Inscripción de pacientes dirigido: 120 participantes
• Duración del ensayo: aproximadamente 24 meses

Detección de candidatos a drogas

Enfoque sistemático para identificar compuestos terapéuticos potenciales.

Parámetro de detección	Métrica
Compuestos evaluados	12 candidatos potenciales de drogas
Tasa de éxito	8.3% de avance a los ensayos clínicos

Desarrollo terapéutico a base de cannabinoides

Enfoque especializado en desarrollar tratamientos innovadores de cannabinoides.

• Objetivo primario: tratamiento del trastorno por consumo de cannabis
• Enfoque molecular único para la intervención de cannabinoides
• Plataforma de desarrollo de fármacos patentados

Cumplimiento y documentación regulatoria

Estrategia regulatoria integral para el desarrollo de fármacos.

Actividad regulatoria	Métricas de cumplimiento
Interacciones de la FDA	6 Comunicaciones formales en 2023
Presentaciones regulatorias	3 Documentos de investigación de nuevos medicamentos en investigación (IND)

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocio: recursos clave

Cartera de propiedades intelectuales

A partir de 2024, Anbulo Pharmaceuticals sostiene 3 solicitudes de patentes activas Relacionado con ANEB-078, su principal candidato a la droga para el tratamiento con sobredosis de cannabinoides.

Tipo de patente	Número de patentes	Estado
Composición de la materia	1	Pendiente
Método de tratamiento	2	Pendiente

Equipo de investigación y desarrollo

El equipo de I + D de Anebulo consiste en 8 personal científico a tiempo completo.

• 3 investigadores a nivel de doctorado
• 2 directores médicos
• 3 científicos de investigación senior

Equipo de laboratorio científico avanzado

Inversión total en infraestructura de laboratorio: $ 1.2 millones.

Categoría de equipo	Número de unidades	Valor total
Cromatografía líquida de alto rendimiento (HPLC)	2	$350,000
Espectrómetros de masas	1	$450,000
Sistemas de cultivo celular	3	$250,000

Capital financiero de los inversores

Total de capital elevado a partir de 2024: $ 18.5 millones.

• Financiación de semillas: $ 3.5 millones
• Financiación de la Serie A: $ 8 millones
• Financiación de la Serie B: $ 7 millones

Conocimiento farmacéutico especializado

Años acumulativos de experiencia en investigación farmacéutica entre los miembros del equipo: 75 años.

Área de especialización	Número de expertos	Años de experiencia
Investigación de cannabinoides	4	25 años
Diseño de ensayo clínico	3	20 años
Desarrollo de drogas	5	30 años

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras a base de cannabinoides

ANEB se centra en el desarrollo de ANEB-001, una intervención farmacéutica dirigida al trastorno por uso del cannabis (CUD). La propuesta de valor principal de la Compañía se centra en abordar una necesidad médica no satisfecha crítica sin tratamientos farmacológicos aprobados por la FDA.

Candidato a la droga	Objetivo terapéutico	Etapa de desarrollo	Tamaño potencial del mercado
Aneb-001	Trastorno por consumo de cannabis	Ensayos clínicos de fase 2	Aproximadamente 14.2 millones de personas con CUD en los Estados Unidos

Tratamiento potencial para el trastorno por consumo de cannabis

ANEB-001 representa un nuevo enfoque farmacológico para controlar la intoxicación por cannabis y los síntomas de abstinencia.

• El mecanismo de acción se dirige al antagonismo del receptor CB1
• Potencial para reducir los síntomas de abstinencia de cannabis
• Aborda los mecanismos neurobiológicos de la adicción

Desarrollo de nuevas intervenciones farmacéuticas

La investigación de la compañía se centra en el desarrollo de soluciones terapéuticas dirigidas con mecanismos moleculares específicos.

Enfoque de investigación	Características clave	Impacto potencial
Farmacología cannabinoide	Modulación selectiva del receptor	Intervenciones terapéuticas precisas

Abordar las necesidades médicas no satisfechas

ANEB se dirige a una brecha de salud significativa en el tratamiento de adicciones, específicamente para el trastorno por consumo de cannabis.

• No hay tratamientos farmacológicos aprobados por la FDA para CUD
• Estimado de 14,2 millones de personas con trastorno por consumo de cannabis en los Estados Unidos
• Potencial para reducir las complicaciones del abuso de sustancias

Enfoques terapéuticos dirigidos

La propuesta de valor de la compañía enfatiza la medicina de precisión y las estrategias innovadoras de desarrollo de medicamentos.

Estrategia de investigación	Diferenciador clave	Ventaja competitiva
Orientación molecular	Interacción selectiva del receptor CB1	Enfoque farmacéutico único

Anbulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Anebulo Pharmaceuticals ha establecido canales de comunicación directa con aproximadamente 127 líderes de opinión clave (KOL) en la investigación de cannabinoides y el tratamiento de adicciones.

Tipo de compromiso	Número de interacciones	Frecuencia
Consultas individuales	42	Trimestral
Reuniones de la Junta Asesora de Expertos	6	Anualmente
Colaboraciones de investigación clínica	18	En curso

Presentaciones de conferencias científicas

En 2023, Anbulo Pharmaceuticals presentó en 7 conferencias científicas principales, que incluyen:

• Reunión anual del Colegio Americano de Neuropsicofarmacología
• Colegio sobre problemas de dependencia de drogas conferencia
• Conferencia anual de la Sociedad de Neurociencia

Comunicaciones de los inversores

Métricas de participación de los inversores para 2023:

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4	92 inversores institucionales
Presentaciones de inversores	6	138 inversores potenciales
Reuniones de inversores individuales	24	53 empresas de inversión

Interacciones de la agencia reguladora

Métricas de interacción de la FDA para ALKS 5461 (programa antagonista de MDMA):

• Reuniones previas a la India: 3
• Solicitudes de reunión de Tipo B: 2
• Intercambios de comunicación escrita: 7

Programas potenciales de apoyo al paciente

Desarrollo del marco de apoyo al paciente planificado para un posible tratamiento de ansiedad inducida por MDMA:

• Recursos de educación del paciente: en desarrollo
• Línea directa de soporte: implementación planificada
• Programa de seguimiento de los participantes del ensayo clínico: etapa conceptual

Anbulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocios: canales

Publicaciones científicas

Anebulo Pharmaceuticals ha publicado investigaciones en las siguientes revistas revisadas por pares en 2023:

Nombre del diario	Recuento de publicaciones	Factor de impacto
Revista de Farmacología	2	3.7
Neuropsicofarmacología	1	4.2

Presentaciones de conferencia médica

Detalles de participación de la conferencia para 2023-2024:

• Reunión anual del Colegio Americano de Neuropsicofarmacología
• Simposio de la Sociedad Internacional de Investigación de Cannabinoides
• Conferencia anual de la Asociación Americana de la Asociación Psiquiatría

Plataformas de relaciones con los inversores

Plataforma	Métricas de compromiso	Presentaciones de inversores trimestrales
Portal de relaciones con inversores NASDAQ	3.742 vistas únicas	4
Sección IR del sitio web corporativo	5.216 visitantes únicos	4

Equipo directo de ventas farmacéuticas

Composición del equipo de ventas: 6 representantes farmacéuticos dedicados especializados en investigación clínica y neuropsicofarmacología.

Procesos de presentación regulatoria

Cuerpo regulador	Presentaciones en 2023	Estado
FDA	2	Revisión pendiente
EMA	1	Bajo evaluación

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

Investigadores médicos

A partir de 2024, Anebulo Pharmaceuticals se dirige a los investigadores médicos centrados en la investigación de cannabinoides y los trastornos de uso de sustancias.

Enfoque de investigación	Compromiso potencial
Farmacología cannabinoide	ANEB's ANBX-001 Oportunidades de colaboración de investigación
Estudios de trastorno por uso de sustancias	Participación del ensayo clínico

Profesionales de la salud

El segmento de clientes de Target incluye especialistas en medicina de adicciones y psiquiatras.

• Los prescriptores potenciales de los tratamientos antagonistas cannabinoides de Aneb
• Profesionales de medicina de emergencia interesados ​​en la gestión de la intoxicación por cannabis

Compañías farmacéuticas

Oportunidades potenciales de asociación farmacéutica para la tubería de desarrollo de fármacos de Aneb.

Tipo de asociación	Valor potencial
Acuerdos de licencia	Derechos de tecnología ANBX-001
Oportunidades de desarrollo	Intervenciones terapéuticas del trastorno por uso de sustancias

Populaciones de pacientes potenciales

Grupos de pacientes objetivo primarios:

• Pacientes de trastorno por consumo de cannabis
• Individuos que experimentan intoxicación por cannabis aguda
• Pacientes de la sala de emergencias que requieren intervención cannabinoide

Inversores institucionales

Segmentos de inversión farmacéutica de biotecnología y especialidad.

Categoría de inversionista	Enfoque de inversión
Capital de riesgo	Inversiones en biotecnología en etapa inicial
Fondos de atención médica especializados	Desarrollo terapéutico del trastorno por uso de sustancias

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Anebulo Pharmaceuticals reportó gastos de I + D de $ 6,8 millones.

Categoría de gastos	Monto ($)
Programa de investigación de ANCOVA	3,200,000
Investigación de hipertermia inducida por MDMA	2,100,000
Otras iniciativas de I + D	1,500,000

Costos de ensayo clínico

Los gastos de ensayos clínicos para los ensayos de fase 2 de ANCOVA totalizaron aproximadamente $ 4.5 millones en 2023.

• Ensayos clínicos de fase 2: $ 3,750,000
• Costos de reclutamiento de pacientes: $ 450,000
• Gastos de gestión de la prueba: $ 300,000

Mantenimiento de la propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual fueron de $ 325,000 en 2023.

Categoría de IP	Costo ($)
Presentación de patentes	175,000
Renovación de patente	95,000
Consulta legal	55,000

Cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 ascendieron a $ 750,000.

• Costos de envío de la FDA: $ 350,000
• Documentación de cumplimiento: $ 250,000
• Consultoría regulatoria externa: $ 150,000

Sobrecarga administrativa y operativa

Los gastos generales y operativos totales para 2023 fueron de $ 2.3 millones.

Categoría de gastos generales	Monto ($)
Salarios de los empleados	1,500,000
Gastos de oficina	350,000
Infraestructura tecnológica	250,000
Servicios profesionales	200,000

Anebulo Pharmaceuticals, Inc. (ANEB) - Modelo de negocios: Freeds de ingresos

Licencias potenciales de medicamentos futuros

A partir del cuarto trimestre de 2023, Anebulo Pharmaceuticals aún no ha informado ningún ingreso activo de licencia de medicamentos. El enfoque principal de la compañía permanece en ANBX-1, un tratamiento potencial para el síndrome de hiperemesis de cannabinoides (CHS).

Subvenciones de investigación

Fuente de subvenciones	Cantidad	Año
Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$299,948	2022
Subvención de los Institutos Nacionales de Salud (NIH)	$224,675	2023

Financiación de los inversores

Total Capital recaudado al 31 de diciembre de 2023: $ 16.4 millones

• Oferta pública inicial (IPO) en septiembre de 2021: $ 12.3 millones
• Financiación de colocación privada: $ 4.1 millones

Venta potencial de productos farmacéuticos

No se informaron ventas de productos comerciales a partir de 2024. ANBX-1 permanece en la fase de desarrollo clínico.

Acuerdos de investigación colaborativos

Socio de colaboración	Enfoque de investigación	Valor potencial
Centro Médico Southwestern de la Universidad de Texas	Investigación clínica ANBX-1	No revelado públicamente

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.