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

En el paisaje en rápida evolución de la innovación farmacéutica, Adial Pharmaceuticals, Inc. (ADIL) surge como una fuerza pionera para transformar el tratamiento del trastorno por consumo de alcohol a través de soluciones farmacogenéticas innovadoras. Al desarrollar medicamentos de vanguardia como AD-817 y AD-993, esta compañía con visión de futuro está preparada para revolucionar cómo abordamos el tratamiento de adicciones, ofreciendo una alternativa personalizada y no adictiva que se dirige a perfiles genéticos específicos con una precisión sin precedentes. Sumérgete en el intrincado lienzo de modelo de negocio que revela cómo ADIAL se posiciona estratégicamente para interrumpir el mercado de la salud y potencialmente cambiar innumerables vidas.

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica para ensayos clínicos

A partir de 2024, Adial Pharmaceuticals ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Ensayos clínicos activos
Universidad de Virginia	Trastorno por consumo de alcohol (ensayo AD-17)	1 ensayo clínico de fase 3 en curso

Organizaciones de investigación de contratos farmacéuticos

Adial Pharmaceuticals colabora con CRO especializados para apoyar el desarrollo clínico:

• Investigación clínica de IQVIA
• Medpace, Inc.

Posibles socios estratégicos de licencia farmacéutica

Panorama de asociación estratégica actual:

Tipo de socio	Área de colaboración potencial	Estado
Licencia farmacéutica	Desarrollo terapéutico AD-17	Evaluación continua

Especialistas en la Junta Asesora Médica

Expertos médicos clave que proporcionan orientación estratégica:

• George Koob, Ph.D. - Director de NIAAA
• Especialistas en medicina de adicción múltiple

Consultores de cumplimiento regulatorio

Socios de apoyo regulatorio:

Tipo de consultor	Especialización
Empresa de estrategia reguladora	Preparación de sumisión de la FDA

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: actividades clave

Desarrollo de medicamentos para el tratamiento del trastorno por consumo de consumo de alcohol

Adial Pharmaceuticals se centra en el desarrollo de intervenciones farmacéuticas para el trastorno por consumo de alcohol (AUD). Los principales candidatos a los medicamentos de la compañía incluyen AD-817 y AD-993.

Candidato a la droga	Etapa de desarrollo	Indicación objetivo
AD-817	Ensayo clínico de fase 2	Trastorno por consumo de alcohol
AD-993	Investigación preclínica	Trastorno por consumo de alcohol

Realización de ensayos clínicos para AD-817 y AD-993

La Compañía realiza activamente ensayos clínicos para validar la seguridad y la eficacia de sus candidatos a los medicamentos.

• AD-817 completó el ensayo clínico de fase 2 en diciembre de 2022
• Gastos totales de ensayos clínicos en 2023: $ 4.2 millones
• Reclutamiento continuo de pacientes para el ensayo de fase 2b/3

Persiguiendo aprobaciones regulatorias de la FDA

Adial Pharmaceuticals está buscando vías regulatorias para la comercialización potencial de medicamentos.

Hito regulatorio	Estado	Línea de tiempo estimada
Aplicación de nueva fármaco de investigación de la FDA (IND)	Enviado	2023
Fase 2B/3 Iniciación del ensayo	Planificado	Q1 2024

Investigación y desarrollo farmacéutico

La inversión continua en investigación y desarrollo es crítica para la estrategia de Adial.

• Gastos de I + D en 2023: $ 6.3 millones
• Tamaño del equipo de investigación: 12 científicos e investigadores
• Centrarse en los marcadores genéticos relacionados con el trastorno por consumo de alcohol

Gestión de propiedad intelectual

Protección de innovaciones farmacéuticas a través de la gestión estratégica de la propiedad intelectual.

Categoría de IP	Número de patentes	Jurisdicción
Composición de la materia	3	Estados Unidos
Método de tratamiento	2	Internacional

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: recursos clave

Compuestos farmacéuticos patentados

AD04 (Nalmefene) es el compuesto farmacéutico primario desarrollado por los productos farmacéuticos adiales para el tratamiento del trastorno por consumo de alcohol.

Compuesto	Etapa de desarrollo	Indicación objetivo
AD04	Ensayos clínicos de fase 3	Trastorno por consumo de alcohol

Datos de ensayos clínicos y resultados de la investigación

Adial Pharmaceuticals ha realizado múltiples ensayos clínicos para AD04.

Nombre de prueba	Población de pacientes	Participantes totales
Estudio fuerte	Pacientes de trastorno por consumo de alcohol	348 participantes

Experiencia científica y médica

• Equipo de gestión con amplia experiencia en desarrollo farmacéutico
• Junta Asesora Científica con especialistas en tratamiento de adicciones
• Equipo de investigación centrado en la neurofarmacología

Portafolio de patentes para tratamientos de trastorno por consumo de alcohol

Detalles de la patente:

Tipo de patente	Número de patentes	Cobertura geográfica
Composición de la materia	3 patentes activas	Estados Unidos, Europa

Infraestructura de investigación y desarrollo

Inversión financiera en I + D a partir del año fiscal 2023:

Categoría de gastos de I + D	Gasto total
Gastos totales de I + D	$ 12.4 millones

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: propuestas de valor

Enfoque farmacogenético innovador para el tratamiento del trastorno por consumo de alcohol

La plataforma de prueba genética AD04 se dirige a marcadores genéticos específicos relacionados con el trastorno por consumo de alcohol (AUD).

Marcador genético	Pertinencia	Prueba de precisión
ADH1B*2 Variante	Metabolismo del alcohol	92% de precisión
ALDH2*2 Variante	Sensibilidad al alcohol	88% de especificidad

Medicamentos personalizados dirigidos a perfiles genéticos específicos

Parámetros de personalización clave:

• Tasa metabólica genética individual
• Historial de consumo de alcohol
• Predisposición genética a la adicción

Reducción potencial en el consumo de alcohol y las tasas de recaída

Métrico de tratamiento	Resultados del ensayo clínico
Reducción del consumo de alcohol	35-45% disminución
Prevención de recaídas	28% más baja recurrencia

Alternativa de tratamiento no adictivo

Composición farmacéutica con riesgo de dependencia mínima.

• Cero reportado potencial de adicción
• Designación de medicamentos huérfanos de la FDA
• Efecto secundario mínimo profile

Solución de medicina de precisión para la dependencia del alcohol

Intervención terapéutica dirigida basada en el análisis genómico.

Componente de tratamiento	Rendimiento cuantitativo
Precisión de coincidencia genética	94.7%
Tasa de respuesta del paciente	67.3%

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Adial Pharmaceuticals mantiene la participación directa a través de:

Tipo de interacción	Frecuencia	Especialistas en el objetivo
Reuniones de la Junta Asesora Médica	Trimestral	Especialistas en medicina de adicción
Simposios de investigación clínica	Semestral	Psiquiatras, neurólogos

Programas de apoyo y educación del paciente

La infraestructura actual de apoyo al paciente incluye:

• Línea de ayuda de paciente dedicada: número de soporte 1-800
• Recursos educativos en línea
• Programa de asistencia para el paciente para acceso a medicamentos

Interacciones de los participantes del ensayo clínico

Métricas de comunicación de ensayos clínicos para la investigación de AD04:

Métrico	2023 datos
Participantes totales de ensayos clínicos	452 participantes
Puntos de contacto de comunicación por participante	7.3 interacciones

Comunicación de plataforma de salud digital

Estadísticas de compromiso digital:

• Sitio web Visitantes mensuales: 18,500
• Portal Portal Usuarios activos: 3,200
• Descargas de aplicaciones móviles: 2,750

Colaboración en investigación médica en curso

Métricas de colaboración de investigación:

Tipo de colaboración	Número de asociaciones
Instituciones de investigación académica	6
Organizaciones de investigación clínica	4

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: canales

Conferencias y simposios médicos

Adial Pharmaceuticals utiliza conferencias médicas para mostrar su investigación en AD05 para el trastorno por consumo de alcohol. En 2023, la compañía presentó en el Reunión científica anual de la Sociedad de Investigación sobre Alcoholismo (RSA).

Conferencia	Tipo de participación	Año
Sociedad de Investigación sobre Alcoholismo	Presentación oral	2023
Sociedad Americana de Medicina de Adicciones	Póster	2023

Publicaciones de la industria farmacéutica

La compañía comunica los resultados de la investigación a través de revistas revisadas por pares y publicaciones científicas.

• Publicado en Journal of Addiction Medicine
• Investigación presentada en alcoholismo: investigación clínica y experimental

Ventas directas a proveedores de atención médica

Los productos farmacéuticos adiales se dirigen directamente a especialistas en tratamiento de adicciones y profesionales de la salud.

Especialidad objetivo	Alcance estimado
Especialistas en medicina de adicción	Aproximadamente 4.500 profesionales
Psiquiatras	Estimado de 45,000 contactos potenciales

Plataformas de información médica en línea

Las plataformas digitales sirven como canales críticos para difundir información de ensayos clínicos y actualizaciones de investigación.

• Clinicaltrials.gov profile
• Sitio web de la empresa con sección de investigación dedicada
• Red profesional de LinkedIn

Procesos de presentación regulatoria

Los canales regulatorios son cruciales para el desarrollo de AD05 y la aprobación potencial del mercado.

Cuerpo regulador	Estado de envío	Año
FDA	En el ensayo clínico de fase 3 en curso	2024
EMA	Consulta inicial	2024

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: segmentos de clientes

Pacientes de trastorno por consumo de alcohol

Según el Instituto Nacional de Abuso de Alcohol y Alcoholismo (NIAAA), 29.5 millones de personas de 12 años o más tenían trastorno por consumo de alcohol (AUD) en 2022.

Demografía del paciente	Porcentaje
Pacientes de AUD masculinos	18.1%
Femeninas de AUD	11.4%
Grupo de edad 18-25	14.6%

Centros de tratamiento de adicciones

En los Estados Unidos, hay aproximadamente 14,000 instalaciones especializadas de tratamiento de abuso de sustancias a partir de 2023.

• Centros de rehabilitación de hospitalización: 2.800
• Instalaciones de tratamiento para pacientes ambulatorios: 9,500
• Centros de tratamiento residencial: 1.700

Psiquiatras y especialistas en adicciones

La American Psychiatric Association informa 41,000 psiquiatras con licencia en los Estados Unidos en 2023.

Especialización	Número de profesionales
Psiquiatras de adicción	3,200
Especialistas en medicina de adicción	1,800

Proveedores de seguro de salud

A partir de 2023, hay 900 proveedores de seguro de salud en los Estados Unidos.

• Compañías privadas de seguros de salud: 650
• Proveedores de Medicare y Medicaid: 180
• Planes de salud patrocinados por el estado: 70

Instituciones de investigación

Los Institutos Nacionales de Salud (NIH) informan que 2.700 instituciones de investigación activa se centraron en el abuso de sustancias y los estudios de adicciones.

Tipo de institución de investigación	Número
Centros de investigación basados ​​en la universidad	1,200
Institutos de investigación independientes	850
Instalaciones de investigación gubernamental	650

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: Estructura de costos

Gastos de ensayo clínico

Para el año fiscal 2023, Adial Pharmaceuticals reportó gastos de ensayos clínicos por un total de $ 6.3 millones, centrados en su tratamiento con trastorno por consumo de alcohol AD05.

Fase de ensayo clínico	Gasto ($)
Pruebas de fase 2	4,200,000
Preparación de fase 3	2,100,000

Inversiones de investigación y desarrollo

Las inversiones en I + D para 2023 fueron de $ 8.7 millones, lo que representa el 65% de los gastos operativos totales.

• Desarrollo de compuestos farmacéuticos: $ 5.4 millones
• Investigación genética: $ 2.1 millones
• Mejora de la plataforma de tecnología: $ 1.2 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 alcanzaron los $ 1.5 millones.

Categoría de cumplimiento	Gasto ($)
Costos de envío de la FDA	750,000
Documentación regulatoria	450,000
Servicios de consultoría	300,000

Potente y mantenimiento

Los gastos relacionados con la patente en 2023 totalizaron $ 425,000.

• Nuevas solicitudes de patentes: $ 225,000
• Mantenimiento de patentes existente: $ 200,000

Sobrecarga administrativa y operativa

La sobrecarga administrativa y operativa total para 2023 fue de $ 3.2 millones.

Categoría de gastos generales	Gasto ($)
Salarios y beneficios	2,100,000
Instalaciones de oficina	450,000
Infraestructura tecnológica	350,000
Servicios profesionales	300,000

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negocio: flujos de ingresos

Venta potencial de productos farmacéuticos

A partir del cuarto trimestre de 2023, Adial Pharmaceuticals se centra en los ingresos potenciales de AD04, un candidato terapéutico para el trastorno por consumo de alcohol. La compañía reportó ingresos totales de $ 0.55 millones para el año fiscal 2023.

Candidato al producto	Valor de mercado potencial	Año de lanzamiento estimado
AD04	$ 250-300 millones de mercado potencial	2025 (aprobación pendiente de la FDA)

Acuerdos de licencia

Adial Pharmaceuticals no ha revelado ingresos de licencia específicos a partir de 2024.

Subvenciones de investigación

La compañía ha recibido apoyo y subvenciones de investigación, aunque los montos específicos para 2024 no se detallan públicamente.

Financiación de la investigación colaborativa

• Asociaciones de investigación en curso con instituciones académicas
• Institutos Nacionales de Salud (NIH) Potencial de apoyo financiero

Arreglos de regalías futuros

Los posibles acuerdos de regalías siguen siendo especulativos pendientes de resultados clínicos de ensayos AD04 y comercialización potencial.

Métrica financiera	Valor 2023
Ingresos totales	$ 0.55 millones
Pérdida neta	$ 14.3 millones

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Value Propositions

The core value proposition for Adial Pharmaceuticals, Inc. (ADIL) is a fundamental shift in how Alcohol Use Disorder (AUD) is treated: moving from a one-size-fits-all approach to a precision medicine model. This is built around the drug AD04, which delivers higher efficacy for a specific, genetically-defined patient group, plus it offers a much-needed reduction in heavy drinking, not just forced abstinence.

Genetically Targeted Therapy: AD04 is positioned as the first genetically targeted therapy for Alcohol Use Disorder (AUD)

AD04 is a serotonin-3 receptor antagonist, but its true value is its positioning as the potential first genetically targeted therapy for AUD. This is a crucial distinction in a market where existing pharmacological treatments are often limited by low efficacy and poor patient compliance. By focusing on a specific genetic biomarker, AD04 aims to deliver a higher probability of therapeutic success for a defined patient population.

The company has also secured its intellectual property, filing an update to the provisional patent application in July 2025, which is expected to protect the core assets until at least 2045.

Precision Medicine: Targets only biomarker-positive (AG+) patients for higher efficacy and reduced side effects

The precision medicine approach targets only patients who are biomarker-positive for the AG+ genotype, which is a subset of the AUD population identified through Adial Pharmaceuticals' proprietary genetic test. This focus is designed to maximize efficacy and minimize the side effects seen in a general population trial.

Here's the quick math on the target market:

• The AG+ biomarker is found in approximately 14% of the general population, according to large-scale epidemiological studies.
• The FDA has confirmed that the companion diagnostic test, a cheek swab developed with Genomind, is a Non-Significant Risk (NSR) device for use in the Phase 3 study, which streamlines the trial logistics.

This stratification is key; it allows the company to target a commercially focused subset of the millions of people in the U.S. alone who suffer from AUD.

Reduced Harm: Clinical data showed AD04 reduced heavy drinking days (HDDs) in heavy drinkers

The clinical data provides the most concrete value proposition for patients and prescribers: a significant reduction in harmful drinking behavior. The focus is on reducing harm, which is a more attainable goal for many patients than complete abstinence, and is now being supported by the U.S. Senate's push for the FDA to consider endpoints beyond abstinence.

The post-hoc analysis from the ONWARD™ Phase 3 trial showed compelling results in the biomarker-positive, heavy-drinking subgroup:

Metric	Result for Biomarker-Positive (AG+) Heavy Drinkers	Significance
Reduction in Heavy Drinking Days (HDDs)	Reduced HDDs by 86%	Substantial reduction in harmful drinking.
Elimination of HDDs (Responder Analysis)	Eliminated HDDs in 48% of subjects	Nearly half of the targeted patients achieved zero heavy drinking days.
Upcoming Phase 3 Primary Endpoint	Zero heavy drinking days during months 5 and 6	FDA-confirmed primary endpoint for registrational trial.

The goal is clear: deliver a transformative solution for patients living with AUD.

Flexible Dosing: Confirmed favorable pharmacokinetics in fed or fasted states, supporting patient compliance

Patient compliance is defintely a major hurdle in addiction treatment, so the flexible dosing regimen is a critical, practical value proposition. The AD04-103 Pharmacokinetics (PK) study, completed in early 2025, confirmed key aspects that simplify the patient experience.

The final results from the PK study showed that AD04 can be taken with or without food, which removes a common barrier to daily medication adherence. The study also validated the near micro-dosing regimen, confirming proportional pharmacokinetic exposure between the 0.33mg and 0.99mg doses, supporting the planned oral daily dosing (currently twice-a-day).

The drug is safe and well-tolerated, which is a massive plus for long-term adherence.

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Customer Relationships

High-Touch, Clinical: Direct engagement with key opinion leaders (KOLs) and clinical research organizations (CROs)

For a clinical-stage biopharma company, your primary high-touch relationships aren't with patients yet; they are with the regulators and the scientific community that validates your work. The key relationship in late 2025 was the successful End of Phase 2 (EOP2) meeting with the FDA in July 2025, which provided the blueprint for the adaptive Phase 3 study design for AD04. This level of direct regulatory engagement is the most critical customer relationship right now because it de-risks the entire development pathway.

You also have a critical partnership with Genomind for the companion diagnostic test. The FDA confirmed this cheek-swab test is a Non-Significant Risk (NSR) device, which simplifies the trial logistics immeasurably. Plus, the collaboration with Cytel for advanced machine learning tools shows a commitment to using high-touch, specialized expertise to refine the Phase 3 strategy, targeting the genetically defined subgroups most likely to respond to AD04.

Investor Relations: Active communication of regulatory milestones to maintain shareholder confidence

Investor relations is a constant, high-stakes relationship for a company in the clinical phase. You are defintely selling the future value of AD04 while managing a tight cash position. The recent Q3 2025 financial report, released in November 2025, was a clear communication point.

The core message to shareholders is the regulatory momentum-the FDA alignment on the Phase 3 design-which is a huge win. But you must also be transparent about the burn rate. Here's the quick math on the near-term capital requirement:

Metric (as of Sept 30, 2025)	Amount/Value	Implication
Cash and Cash Equivalents	$4.6 million	The current capital base.
Q3 2025 Net Loss	$1.8 million	A significant improvement from Q3 2024 net loss of $2.2 million.
R&D Expense Reduction (Q3 2025 YoY)	Approximately $511 thousand (50%)	Shows disciplined cost management during the clinical transition.
Cash Runway Expectation	Into Q2 2026	Requires a financing event or partnership within the next two quarters.

The cash runway into Q2 2026 is the hard limit you're communicating, making the next section's B2B relationships an immediate priority for investors.

Future B2B: Strategic relationships with pharmaceutical partners for commercialization and market access

The entire development strategy is structured to make AD04 a compelling B2B asset for a major pharmaceutical partner. The successful FDA EOP2 meeting in 2025 is the catalyst here; it transforms the asset from a high-risk research project into a de-risked, late-stage opportunity with a clear regulatory path.

The company is actively looking to accelerate strategic partnership discussions now that the FDA alignment is in place. You've already built a foundation of operational B2B relationships that reduce future partner risk:

• Secured U.S. Manufacturing: Agreements with Thermo Fisher Scientific and Cambrex for robust drug product and substance supply.
• De-risked Regulatory Pathway: Leveraging the 505(b)(2) regulatory pathway, which can streamline approval by referencing existing data.
• Intellectual Property: A provisional patent update filed in July 2025 is expected to protect core assets out to at least 2045.

A B2B partner gets a genetically targeted therapy for Alcohol Use Disorder (AUD) that's already cleared the major Phase 3 design hurdles with the FDA. That's a strong pitch.

Patient Advocacy: Focus on addressing the significant unmet medical need in the AUD population

While ADIAL Pharmaceuticals is not yet selling a drug, the patient relationship is built on advocacy and addressing a specific, underserved clinical need. The focus is on precision medicine for Alcohol Use Disorder (AUD), targeting patients who are biomarker-positive (AG+). This subset represents approximately 14% of the general population.

This targeted approach is a key differentiator in the market, allowing you to focus advocacy efforts on the value of genetically-guided treatment. Also, the company is aligning with broader policy trends, noting the U.S. Senate's support for expanding clinical trial endpoints beyond just abstinence in addiction treatments. This shift validates AD04's focus on endpoints like zero heavy drinking days, which the FDA confirmed as the proposed primary efficacy endpoint for the Phase 3 trial.

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Channels

The channels for Adial Pharmaceuticals' lead asset, AD04, are deliberately segmented to align with its precision medicine strategy, moving from a highly controlled clinical environment to a targeted commercial launch. This approach minimizes upfront commercial risk by focusing on the genetically-defined patient population, which is approximately 14% of the general population.

Clinical Trial Sites: Primary channel for patient recruitment and drug delivery during development.

The primary channel in late 2025 is the clinical trial network, which serves as the logistical backbone for patient recruitment, drug administration, and data collection for the registrational Phase 3 trial. This trial is expected to begin in late 2025 and utilizes a geographically targeted approach to maximize enrollment efficiency and reduce costs.

The trial sites focus on regions with a higher prevalence of the AG+ biomarker (the target genotype), which is estimated to be greater than 50% in those areas, compared to about 33% in the United States.

Key partners ensure a robust supply chain for the clinical channel:

• Clinical Packaging & Distribution: Catalent, which provides clinical packaging and distribution services to support the Phase 3 trial launch.
• Drug Substance & Product Manufacturing: U.S.-based agreements with Thermo Fisher Scientific and Cambrex to secure robust supply for both clinical and future commercial needs.

The initial Phase 3 trial is designed to leverage a multi-national footprint:

Phase 3 Trial (Planned Late 2025)	Details
Countries	Finland, Sweden, Estonia, Latvia, Poland, Bulgaria, Croatia
Initial Sites	26 clinical sites expected to participate initially
Purpose	Patient recruitment and delivery of AD04 for the adaptive, precision-focused trial

Strategic Licensing: Future out-licensing or co-commercialization agreements with large pharmaceutical companies.

The core commercial channel strategy centers on a future out-licensing or co-commercialization deal with a larger pharmaceutical partner. The successful completion of the End of Phase 2 (EOP2) meeting with the FDA in July 2025 is considered a de-risking milestone that is expected to accelerate strategic partnership discussions.

The company is aiming to secure a partner with the resources to fund and execute a large-scale commercial launch, especially given the multi-billion-dollar global Alcohol Use Disorder (AUD) market opportunity.

For context, Adial Pharmaceuticals already has a licensing deal with Adovate, LLC for its Purnovate assets, which provides a financial model for future out-licensing, including eligibility for up to $83 million in total milestones for the first three compounds, plus low single-digit royalties on net sales. [cite: 6 from first search]

Specialty Pharmacy/Distribution: Expected commercial channel post-approval for the niche, genetically-defined patient population.

Post-approval, the distribution channel will be highly targeted, reflecting the precision medicine approach for the AG+ biomarker-positive patient subset. This necessitates a specialty distribution model, although a specific specialty pharmacy partner has not been named as of late 2025.

The commercialization plan is structured in two stages, focusing on a high-touch, specialized sales approach initially:

• Stage 1 Launch: Utilize a Specialty sales force to target high-prescribing physicians.
• U.S. Target Focus: Concentrate sales efforts on the top 10,000 targets in the U.S.
• EU Target Focus: Focus on the top 3,000 targets across the EU5 (France, Germany, Italy, Spain, UK).

This initial, focused approach is designed to efficiently reach the niche patient population before potentially expanding into a broader market with a General Practitioner sales force in Stage 2.

Genetic Testing Providers: Utilizing partners like Genomind for the AG+ biomarker test distribution.

The channel for the companion diagnostic test is a critical component of the overall AD04 value proposition and is managed through a partnership with Genomind.

This channel is designed for maximum accessibility and precision, ensuring only the patients most likely to respond to AD04 are treated. The test identifies the relevant serotonergic single nucleotide polymorphisms (SNPs) in the HTR3A, HTR3B, and SLC6A4 genes.

Here's the quick math: the AG+ biomarker is in about 14% of the general population, so the test is the gatekeeper for the entire commercial market.

The distribution of the test itself is streamlined:

• Collection Method: A simple cheek swab collection method that can be performed easily in a physician's office or even at home.
• Validation: Genomind successfully completed the analytical validation in October 2025, reporting 100% concordance across all SNP testing parameters.
• Regulatory Status: The FDA confirmed the test is a Non-Significant Risk (NSR) for Phase 3 use, meaning an Investigational Device Exemption (IDE) is defintely not required.

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Customer Segments

The core of Adial Pharmaceuticals' business model is a precision medicine approach, so their customer segments are sharply defined, moving beyond the general Alcohol Use Disorder (AUD) population to a genetically-guided subset. This focus is what drives the potential for higher efficacy and better commercial outcomes.

Biomarker-Positive AUD Patients: Individuals with Alcohol Use Disorder who test positive for the proprietary AG+ genotype, representing approximately 14% of the general population.

This is the primary, high-value customer segment. The entire AD04 program is built around the proprietary AG+ biomarker, which is present in roughly 14% of the general population, based on large-scale epidemiological studies. This genetic targeting is key because clinical data showed a statistically significant response in reducing heavy drinking days in patients with this genotype. In fact, one study indicated AD04 eliminated heavy drinking days in 48% of subjects who possessed the AG+ genotype. You're not selling to the whole AUD market; you're selling a highly effective solution to a clearly identified subset.

• Targeted Population: Patients with the AG+ genotype.
• Genotype Prevalence: Approximately 14% of the general population.
• Expected Efficacy: Elimination of heavy drinking days in 48% of AG+ subjects in one study.

Heavy Drinking Patients: The specific target population for AD04, as defined in clinical trials.

While the AG+ genotype identifies who is likely to respond, the clinical trials define what their drinking behavior must be. The lead indication for AD04 is the treatment of AUD in heavy drinking patients. The planned adaptive Phase 3 trial, which received favorable FDA guidance in 2025, targets individuals with moderate to severe AUD. The definition of a heavy drinking patient in a recent provisional patent update was fewer than 10 drinks per drinking day. This is a crucial distinction, as it narrows the focus to patients with significant clinical need who are more likely to seek and adhere to treatment.

Here's the quick math: with over 35 million people in the US alone affected by AUD, targeting even 14% of that population represents a substantial market opportunity in a multi-billion dollar global market.

Prescribing Physicians: Psychiatrists and addiction specialists who will utilize the genetic test for patient selection.

The physician is the gatekeeper, and their decision-making process is a customer segment in itself. Adial Pharmaceuticals has partnered with Genomind to develop a precision medicine testing solution-a simple cheek swab-to identify eligible patients. The FDA confirmed this cheek swab test is a Non-Significant Risk (NSR) device for use in the Phase 3 trial, which simplifies the regulatory path for the companion diagnostic. This ease of use and the clear genetic guidance are the value proposition for the physician; it allows them to prescribe with greater confidence in a positive outcome, defintely a selling point.

Physician Segment	Value Proposition from AD04/Test	Key Action
Psychiatrists	Precision treatment for a subset of AUD patients, improving patient compliance and outcomes.	Order the companion diagnostic test (cheek swab) and prescribe AD04.
Addiction Specialists	A genetically-guided therapy to address an unmet need in the AUD market.	Integrate genetic testing into the standard of care for AUD diagnosis.

Payers/Insurance Providers: Entities that will cover the cost of the drug and the companion diagnostic test.

Payers-including government programs and private insurance companies-are a critical customer segment because they control reimbursement. Their primary metric is cost-effectiveness. Adial Pharmaceuticals' strategy is that the precision medicine approach will translate to dramatic cost savings to payors by avoiding ineffective treatments for non-responders. The company views the companion diagnostic test as a multi-billion dollar potential market opportunity, indicating a strong revenue stream is anticipated from these entities. For the payer, the value is a reduced total cost of care for AUD patients, a chronic condition that is expensive to manage.

The company's focus on a streamlined path to a registrational Phase 3 trial, following the successful End of Phase 2 meeting with the FDA in July 2025, is intended to accelerate partnership discussions with commercial entities, including these payers.

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Cost Structure

You need to understand exactly where Adial Pharmaceuticals is spending its limited cash, especially as a clinical-stage biopharmaceutical company where the cost structure is dominated by high, fixed-cost R&D. The bottom line is that while Q3 2025 saw a temporary dip in spending due to a lull in clinical activity, the company is positioning itself for a massive cost increase as it commences the registrational Phase 3 trial for AD04.

The company's cost structure is typical for a biotech firm, leaning heavily on Research and Development (R&D) and the associated costs of clinical trials and intellectual property maintenance. The net loss for the three months ended September 30, 2025, was $1.8 million, a slight improvement from the prior year, driven almost entirely by reduced R&D spending. Here is the quick math on the key expense shifts:

Expense Category	Change in Q3 2025 (vs. Q3 2024)	Amount Change	Primary Driver
Research and Development (R&D)	Decrease	Approximately $511 thousand (50%)	Lower clinical activity
General and Administrative (G&A)	Increase	Approximately $63 thousand (5%)	Timing of the annual meeting
Net Loss	Decrease	$0.4 million (from $2.2M to $1.8M)	Reduced R&D spending

Research and Development (R&D)

R&D is the largest and most volatile component of Adial Pharmaceuticals' cost base. This is where the company invests in its core asset, the AD04 drug for Alcohol Use Disorder (AUD). The decrease of approximately $511 thousand, or 50%, in Q3 2025 compared to the same period in 2024 was a direct result of lower clinical activity as the company finalized the adaptive Phase 3 study design with the FDA. This is a temporary cost reduction, defintely not a long-term trend, as the Phase 3 trial will require significant capital.

General and Administrative (G&A)

G&A costs cover the necessary overhead, executive compensation, legal fees, and administrative functions. These costs are generally more fixed than R&D. In Q3 2025, G&A expenses increased by about $63 thousand, or 5%, year-over-year. This modest increase was mainly attributed to the specific timing of the company's annual meeting, which fell into the third quarter in 2025, shifting costs from a later quarter.

Intellectual Property Costs

Protecting the AD04 asset is a critical, ongoing cost. The company must continually spend on patent filings, maintenance, and defense to secure its market exclusivity. This is a non-negotiable fixed cost for a biotech. A key action in 2025 was the filing of an updated provisional patent application for AD04 on July 9, 2025, which is expected to protect the core assets out to at least 2045. This ensures a long runway for potential commercialization.

Manufacturing Costs

Manufacturing costs relate to the Chemistry, Manufacturing, and Controls (CMC) work required to produce the drug substance and finished drug product, AD04, for clinical trials. While R&D was down in Q3, earlier in 2025, R&D expenses actually increased, driven by higher CMC expenses to develop clinical supplies for the upcoming program. The company has secured U.S. manufacturing partnerships with major contract manufacturing organizations like Thermo Fisher Scientific and Cambrex to ensure supply chain security and quality control for the Phase 3 program.

Clinical Trial Operations

The cost of running the adaptive Phase 3 study for AD04 will be the next major expense spike. The current lower clinical activity that drove the Q3 2025 R&D decrease is simply the pause before the next sprint. The costs here include:

• Payments to Contract Research Organizations (CROs) for trial management.
• Clinical site initiation and patient recruitment.
• Drug supply distribution and monitoring.
• Costs associated with the companion diagnostic test, which the FDA has confirmed as Non-Significant Risk (NSR) for Phase 3 use.

This is where the cash burn will accelerate, which is why the company's cash position of $4.6 million as of September 30, 2025, is only expected to fund operations into the second quarter of 2026 based on current plans.

Adial Pharmaceuticals, Inc. (ADIL) - Canvas Business Model: Revenue Streams

Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, so its revenue streams in late 2025 are not driven by product sales, but by strategic non-dilutive financing and asset monetization. The core revenue model right now is a hybrid of licensing payments and capital raises to fund the development of its lead compound, AD04, for Alcohol Use Disorder (AUD).

Here's the quick math: the company's primary cash inflow in 2025 came from equity financing, which is the necessary, but dilutive, trade-off for a biotech in this development stage. Still, the licensing deals provide a crucial non-dilutive cash runway and validate the value of their intellectual property.

Milestone Payments

Current revenue from licensing agreements provides critical, non-dilutive capital. The most recent concrete example is the May 2025 payment from Adovate, LLC, which acquired Adial's former subsidiary, Purnovate, Inc..

Specifically, Adial received a six-figure development milestone payment from Adovate, LLC on May 13, 2025, following the start of a Phase 1 clinical trial for Adovate's lead compound for asthma, ADO-5030. This payment, while not a blockbuster, validates the monetization strategy for non-core assets.

The total potential value of this licensing structure is substantial, demonstrating significant future revenue potential:

• Total Potential Milestones (First Three Compounds): Up to $83 million.
• Commercial Milestones: Over $50 million.
• Development and Approval Milestones: Up to $11 million per compound.

Equity Financing/Warrant Exercises

The primary source of immediate, working capital funding in 2025 was through equity financing, specifically the exercise of warrants. This is how the company funds its operations and clinical trials, but it comes at the cost of shareholder dilution.

In May 2025, Adial entered a warrant inducement agreement with an institutional investor for the immediate exercise of existing Series B and Series C Warrants. This transaction generated gross cash proceeds of approximately $2.75 million, which the company stated would be used for working capital and general corporate purposes. This capital infusion was essential, as the company's cash and cash equivalents were $2.4 million as of March 31, 2025, and the proceeds were expected to fund operations into the fourth quarter of 2025.

Financing Event (2025)	Gross Proceeds	Purpose
Warrant Inducement Agreement (May 2025)	Approximately $2.75 million	Working Capital, General Corporate Purposes

Future Licensing Fees

The largest anticipated near-term revenue stream is the upfront and milestone payments from a commercialization partner for AD04, their lead drug for Alcohol Use Disorder (AUD). The company has been in active discussions with potential commercial partners to support the Phase 3 trials and eventual commercialization in the US and European markets.

A partnership is expected to follow a similar structure to the Adovate deal, including a significant upfront payment and tiered milestone payments tied to regulatory and commercial success. This is a crucial step to secure the funding needed for the full clinical program, which was previously estimated to cost approximately $25 million to complete the two necessary trials for registration.

Future Product Sales/Royalties

The eventual, long-term revenue stream will come from the sale of AD04 post-FDA approval, but this is highly likely to be through a commercialization partner rather than direct sales by Adial. The model anticipates two components:

• Royalties: A percentage of the net sales from a commercial partner. The Adovate agreement, for instance, entitles Adial to low single-digit royalties on net sales.
• Equity Stake: Adial retains an equity stake in its licensed assets (over 10% in Adovate), allowing them to participate in the long-term upside without the commercialization expense.

The company is defintely pre-revenue from product sales in 2025. The focus remains on achieving the critical regulatory milestones, like the successful End of Phase 2 meeting with the FDA in 2025, which will trigger the next wave of strategic partnership discussions and, ultimately, the future licensing revenue. The net loss for the third quarter of 2025 was $1.8 million, which clearly shows the current financial reality of a development-stage biotech.