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

No cenário em rápida evolução da inovação farmacêutica, a Adial Pharmaceuticals, Inc. (ADIL) surge como uma força pioneira na transformação do tratamento do distúrbio do uso de álcool por meio de soluções farmacogenéticas inovadoras. Ao desenvolver medicamentos de ponta como o AD-817 e o AD-993, esta empresa de visão de futuro está pronta para revolucionar como abordamos o tratamento de dependência, oferecendo uma alternativa personalizada e não viciada que tem como alvo perfis genéticos específicos com precisão sem precedentes. Mergulhe na intrincada lona do modelo de negócios que revela como está estrategicamente posicionado a adial para atrapalhar o mercado de saúde e potencialmente mudar inúmeras vidas.

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica para ensaios clínicos

A partir de 2024, a Adial Pharmaceuticals estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ensaios clínicos ativos
Universidade da Virgínia	Transtorno do uso de álcool (estudo AD-17)	1 Ensaio Clínico de Fase 3 em andamento

Organizações de pesquisa de contratos farmacêuticos

A Adial Pharmaceuticals colabora com CROs especializados para apoiar o desenvolvimento clínico:

• Pesquisa clínica da IQVIA
• Medpace, Inc.

Potenciais parceiros de licenciamento farmacêutico estratégico

Cenário de parceria estratégica atual:

Tipo de parceiro	Área de colaboração potencial	Status
Licenciamento farmacêutico	Desenvolvimento terapêutico AD-17	Avaliação em andamento

Especialistas do Conselho Consultivo Médico

Especialistas médicos -chave que fornecem orientação estratégica:

• George Koob, Ph.D. - Diretor da NIAAA
• Múltiplos especialistas em medicina de dependência

Consultores de conformidade regulatória

Parceiros de apoio regulatório:

Tipo de consultor	Especialização
Empresa de estratégia regulatória	Preparação de envio da FDA

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negócios: Atividades -chave

Desenvolvendo medicamentos para tratamento de transtornos de uso de álcool

Os produtos farmacêuticos adiais se concentram no desenvolvimento de intervenções farmacêuticas para transtorno do uso de álcool (AUD). Os principais candidatos a medicamentos da empresa incluem o AD-817 e o AD-993.

Candidato a drogas	Estágio de desenvolvimento	Indicação alvo
Ad-817	Ensaio clínico de fase 2	Transtorno do uso de álcool
Ad-993	Pesquisa pré -clínica	Transtorno do uso de álcool

Realização de ensaios clínicos para ad-817 e ad-993

A Companhia conduz ativamente ensaios clínicos para validar a segurança e a eficácia de seus candidatos a drogas.

• AD-817 Concluiu o ensaio clínico da Fase 2 em dezembro de 2022
• Despesas totais de ensaios clínicos em 2023: US $ 4,2 milhões
• Recrutamento de pacientes em andamento para o estudo de Fase 2b/3

Buscando aprovações regulatórias da FDA

Os produtos farmacêuticos adiais estão seguindo vias regulatórias para a potencial comercialização de medicamentos.

Marco regulatório	Status	Linha do tempo estimada
FDA Investigational New Drug (IND) Aplicação	Enviado	2023
Fase 2b/3 iniciação de teste	Planejado	Q1 2024

Pesquisa e Desenvolvimento Farmacêutico

O investimento contínuo em pesquisa e desenvolvimento é fundamental para a estratégia da Adial.

• Despesas de P&D em 2023: US $ 6,3 milhões
• Tamanho da equipe de pesquisa: 12 cientistas e pesquisadores
• Concentre -se em marcadores genéticos relacionados ao distúrbio do uso de álcool

Gerenciamento de propriedade intelectual

Proteção de inovações farmacêuticas por meio de gestão estratégica de propriedade intelectual.

Categoria IP	Número de patentes	Jurisdição
Composição da matéria	3	Estados Unidos
Método de tratamento	2	Internacional

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negócios: Recursos -chave

Compostos farmacêuticos proprietários

O AD04 (Nalmefene) é o composto farmacêutico primário desenvolvido por produtos farmacêuticos adiais para tratamento de transtorno do uso de álcool.

Composto	Estágio de desenvolvimento	Indicação alvo
AD04	Ensaios clínicos de fase 3	Transtorno do uso de álcool

Dados de ensaios clínicos e descobertas de pesquisa

A Adial Pharmaceuticals realizou vários ensaios clínicos para o AD04.

Nome do julgamento	População de pacientes	Total de participantes
Estudo forte	Pacientes com transtorno de uso de álcool	348 participantes

Experiência científica e médica

• Equipe de gerenciamento com extensa experiência em desenvolvimento farmacêutico
• Conselho consultivo científico com especialistas em tratamento de dependência
• Equipe de pesquisa focada na neurofarmacologia

Portfólio de patentes para tratamentos para transtornos de uso de álcool

Detalhes da patente:

Tipo de patente	Número de patentes	Cobertura geográfica
Composição da matéria	3 patentes ativas	Estados Unidos, Europa

Infraestrutura de pesquisa e desenvolvimento

Investimento financeiro em P&D a partir de 2023 ano fiscal:

Categoria de despesa de P&D	Gasto total
Despesas totais de P&D	US $ 12,4 milhões

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de Negócios: Proposições de Valor

Abordagem farmacogenética inovadora para o tratamento de distúrbios do uso de álcool

A plataforma de teste genético AD04 tem como alvo marcadores genéticos específicos relacionados ao distúrbio do uso de álcool (AUD).

Marcador genético	Relevância	Precisão do teste
ADH1B*2 Variante	Metabolismo do álcool	92% de precisão
ALDH2*2 Variante	Sensibilidade ao álcool	88% de especificidade

Medicamentos personalizados direcionando perfis genéticos específicos

Principais parâmetros de personalização:

• Taxa metabólica genética individual
• Histórico de consumo de álcool
• Predisposição genética ao vício

Redução potencial no consumo de álcool e taxas de recaída

Métrica de tratamento	Resultados do ensaio clínico
Redução do consumo de álcool	35-45% diminuição
Prevenção de recaídas	28% menor recorrência

Alternativa de tratamento não viciante

Composição farmacêutica com risco mínimo de dependência.

• Zero Potencial de dependência relatado
• Designação de medicamentos órfãos da FDA
• Efeito colateral mínimo profile

Solução de medicina de precisão para dependência de álcool

Intervenção terapêutica direcionada com base na análise genômica.

Componente de tratamento	Desempenho quantitativo
Precisão de correspondência genética	94.7%
Taxa de resposta ao paciente	67.3%

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, os produtos farmacêuticos adiais mantêm o engajamento direto por meio de:

Tipo de interação	Freqüência	Especialistas -alvo
Reuniões do Conselho Consultivo Médico	Trimestral	Especialistas em medicina de dependência
Simpósios de pesquisa clínica	Semestral	Psiquiatras, neurologistas

Programas de apoio ao paciente e educação

A infraestrutura atual de suporte ao paciente inclui:

• Helpline de pacientes dedicados: número de suporte 1-800
• Recursos educacionais online
• Programa de assistência ao paciente para acesso à medicação

Interações dos participantes do ensaio clínico

Métricas de comunicação de ensaios clínicos para pesquisa ad04:

Métrica	2023 dados
TOTAL DE ENTRADOS CLÍNICOS PARTICIPANTES	452 participantes
Pontos de contato de comunicação por participante	7.3 Interações

Comunicação da plataforma de saúde digital

Estatísticas de engajamento digital:

• Visitantes mensais do site: 18,500
• Usuários ativos do portal do paciente: 3,200
• Downloads de aplicativos móveis: 2,750

Colaboração de pesquisa médica em andamento

Métricas de colaboração de pesquisa:

Tipo de colaboração	Número de parcerias
Instituições de pesquisa acadêmica	6
Organizações de pesquisa clínica	4

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de Negócios: Canais

Conferências médicas e simpósios

A ADial Pharmaceuticals utiliza conferências médicas para mostrar sua pesquisa no AD05 para transtorno do uso de álcool. Em 2023, a empresa apresentada no Sociedade de Pesquisa sobre Alcoolismo (RSA) Reunião Científica Anual.

Conferência	Tipo de participação	Ano
Sociedade de Pesquisa sobre Alcoolismo	Apresentação oral	2023
Sociedade Americana de Medicina de Dependência	Apresentação de pôsteres	2023

Publicações da indústria farmacêutica

A empresa comunica os resultados da pesquisa por meio de periódicos revisados ​​por pares e publicações científicas.

• Publicado no Journal of Addictic Medicine
• Pesquisa apresentada em alcoolismo: pesquisa clínica e experimental

Vendas diretas para profissionais de saúde

Os produtos farmacêuticos adiais têm como alvo especialistas em tratamento de dependência e profissionais de saúde diretamente.

Especialidade alvo	Alcance estimado
Especialistas em medicina de dependência	Aproximadamente 4.500 profissionais
Psiquiatras	Estimado 45.000 contatos em potencial

Plataformas de informações médicas online

As plataformas digitais servem como canais críticos para disseminar informações de ensaios clínicos e atualizações de pesquisa.

• ClinicalTrials.gov profile
• Site da empresa com seção de pesquisa dedicada
• Rede Profissional do LinkedIn

Processos de submissão regulatória

Os canais regulatórios são cruciais para o desenvolvimento do AD05 e a aprovação potencial do mercado.

Órgão regulatório	Status de envio	Ano
FDA	Ensaio clínico de fase 3 em andamento	2024
Ema	Consulta inicial	2024

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

Pacientes com transtorno de uso de álcool

De acordo com o Instituto Nacional de Abuso de Álcool e Alcoolismo (NIAAA), 29,5 milhões de pessoas com 12 anos ou mais tiveram transtorno de uso de álcool (AUD) em 2022.

Demografia de pacientes	Percentagem
Pacientes com AUD do sexo masculino	18.1%
Pacientes com AUD feminina	11.4%
Faixa etária 18-25	14.6%

Centros de tratamento de dependência

Nos Estados Unidos, existem aproximadamente 14.000 instalações especializadas de tratamento de abuso de substâncias a partir de 2023.

• Centros de reabilitação de pacientes internados: 2.800
• Instalações de tratamento ambulatorial: 9.500
• Centros de Tratamento Residencial: 1.700

Psiquiatras e especialistas em dependência

A American Psychiatric Association relata 41.000 psiquiatras licenciados nos Estados Unidos em 2023.

Especialização	Número de profissionais
Psiquiatras de dependência	3,200
Especialistas em medicina de dependência	1,800

Provedores de seguros de saúde

Em 2023, existem 900 provedores de seguros de saúde nos Estados Unidos.

• Companhias de seguros de saúde privados: 650
• Provedores do Medicare e Medicaid: 180
• Planos de saúde patrocinados pelo Estado: 70

Instituições de pesquisa

Os Institutos Nacionais de Saúde (NIH) relatam 2.700 instituições de pesquisa ativas focadas em estudos de abuso e dependência de substâncias.

Tipo de instituição de pesquisa	Número
Centros de pesquisa baseados em universidades	1,200
Institutos de pesquisa independentes	850
Instalações de pesquisa governamental	650

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negócios: estrutura de custos

Despesas de ensaios clínicos

Para o ano fiscal de 2023, os produtos farmacêuticos adiais relataram despesas de ensaios clínicos totalizando US $ 6,3 milhões, focados em seu tratamento com transtorno do uso de álcool AD05.

Fase de ensaios clínicos	Despesa ($)
Ensaios de fase 2	4,200,000
Preparação da fase 3	2,100,000

Investimentos de pesquisa e desenvolvimento

Os investimentos em P&D em 2023 foram de US $ 8,7 milhões, representando 65% do total de despesas operacionais.

• Desenvolvimento de compostos farmacêuticos: US $ 5,4 milhões
• Pesquisa genética: US $ 2,1 milhões
• Aprimoramento da plataforma de tecnologia: US $ 1,2 milhão

Custos de conformidade regulatória

As despesas regulatórias de conformidade em 2023 atingiram US $ 1,5 milhão.

Categoria de conformidade	Despesa ($)
Custos de envio da FDA	750,000
Documentação regulatória	450,000
Serviços de consultoria	300,000

Arquivamento e manutenção de patentes

As despesas relacionadas a patentes em 2023 totalizaram US $ 425.000.

• Novos pedidos de patente: US $ 225.000
• Manutenção de patentes existente: US $ 200.000

Overhead administrativo e operacional

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

Categoria de sobrecarga	Despesa ($)
Salários e benefícios	2,100,000
Instalações de escritório	450,000
Infraestrutura de tecnologia	350,000
Serviços profissionais	300,000

Adial Pharmaceuticals, Inc. (ADIL) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos farmacêuticos

A partir do quarto trimestre 2023, os produtos farmacêuticos adiais se concentram na receita potencial da AD04, um candidato terapêutico para transtorno do uso de álcool. A empresa registrou receita total de US $ 0,55 milhões no ano fiscal de 2023.

Candidato a produto	Valor potencial de mercado	Ano de lançamento estimado
AD04	US $ 250-300 milhões em mercado potencial	2025 (aprovação pendente da FDA)

Acordos de licenciamento

A Adial Pharmaceuticals não divulgou receita específica de licenciamento a partir de 2024.

Bolsas de pesquisa

A empresa recebeu apoio e subsídios de pesquisa, embora valores específicos para 2024 não sejam detalhados publicamente.

Financiamento de pesquisa colaborativa

• Parcerias de pesquisa em andamento com instituições acadêmicas
• Institutos Nacionais de Saúde (NIH) Suporte de financiamento potencial

Arranjos de royalties futuros

Os possíveis acordos de royalties permanecem especulativos pendentes de resultados de ensaios clínicos e potencial comercialização.

Métrica financeira	2023 valor
Receita total	US $ 0,55 milhão
Perda líquida	US $ 14,3 milhões

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.