Avenue Therapeutics, Inc. (ATXI): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Avenue Therapeutics, Inc. (ATXI) surge como um inovador farmacêutico pioneiro, posicionando-se estrategicamente na interseção de soluções avançadas de gerenciamento da dor e pesquisa médica de ponta. Ao desenvolver uma sofisticada formulação de tramadol IV, projetada para enfrentar desafios críticos pós-cirúrgicos da dor, a empresa aproveita seu modelo de negócios exclusivo para transformar potencialmente os paradigmas de tratamento, oferecendo abordagens terapêuticas direcionadas com efeitos colaterais reduzidos. Sua estratégia abrangente abrange parcerias intrincadas, recursos robustos de pesquisa e um compromisso focado a laser em atender às necessidades médicas não atendidas no cenário complexo do desenvolvimento farmacêutico.

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: Parcerias -chave

Colaboração com os sistemas de refrigeração do Paxman para tecnologia de resfriamento do couro cabeludo

Nenhum detalhe específico de parceria disponível para terapêutica da Avenue com os sistemas de resfriamento da PAXMAN a partir de 2024.

Parcerias estratégicas com instituições de pesquisa farmacêutica

Instituição parceira	Foco em parceria	Ano estabelecido
Não divulgado	Não divulgado	Não divulgado

Organizações de fabricação contratada para desenvolvimento de medicamentos

A Avenue Therapeutics, Inc. concentra -se no desenvolvimento de Tramadol IV com os seguintes detalhes da parceria de fabricação:

• Candidato a drogas primárias: IV Tramadol para manejo da dor
• Status de fabricação: buscando a aprovação da FDA

Centros de pesquisa de ensaios clínicos e instalações médicas

Fase de ensaios clínicos	Número de sites de pesquisa	Inscrição do paciente
Ensaios de Fase 3 para Tramadol IV	Vários sites	Aproximadamente 500 pacientes

Dados financeiros para 2023 Q3:

• Receita total: $ 0
• Perda líquida: US $ 4,1 milhões
• Caixa e equivalentes em dinheiro: US $ 16,8 milhões

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: Atividades -chave

Desenvolvendo tratamentos farmacêuticos inovadores

A Avenue Therapeutics se concentra no desenvolvimento de tramadol IV para manejo agudo da dor. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,3 milhões em esforços de desenvolvimento farmacêutico.

Categoria de desenvolvimento	Valor do investimento	Status
Programa IV Tramadol	US $ 12,3 milhões	Ensaios clínicos em andamento
Infraestrutura de pesquisa	US $ 3,7 milhões	Desenvolvimento ativo

Realização de ensaios clínicos para Tramadol IV

As atividades de ensaios clínicos representam um componente crítico das principais atividades comerciais da Avenue Therapeutics.

• Ensaios clínicos de fase III concluídos: 2 ensaios
• Total de matrícula do paciente: 596 pacientes
• Despesas de ensaios clínicos em 2023: US $ 8,5 milhões

Processos de conformidade regulatória e aprovação da FDA

A Companhia dedicou recursos significativos à submissão e conformidade regulatórias.

Atividade regulatória	Despesa	Status atual
FDA New Drug Application	US $ 2,1 milhões	Enviado
Consultoria regulatória	$750,000	Em andamento

Pesquisa e desenvolvimento de soluções de gerenciamento da dor

A Avenue Therapeutics aloca financiamento substancial para iniciativas de P&D.

• Despesas de P&D em 2023: US $ 15,6 milhões
• Pessoal de pesquisa: 22 funcionários em tempo integral
• Pedidos de patente arquivados: 3

Gerenciamento de propriedade intelectual e proteção

A Companhia mantém uma abordagem estratégica à proteção da propriedade intelectual.

Categoria IP	Número de ativos	Custo de proteção
Patentes	7 patentes ativas	US $ 1,2 milhão
Registros de marca registrada	4 marcas registradas	$350,000

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento farmacêutico

A partir do quarto trimestre 2023, a Avenue Therapeutics empregava 12 profissionais de pesquisa e desenvolvimento em período integral. A composição da equipe inclui:

Categoria de função	Número de profissionais
Pesquisadores de nível de doutorado	5
Especialistas em desenvolvimento clínico	4
Especialistas em farmacologia	3

Tecnologias proprietárias de formulação de medicamentos

Patente de formulação de tramadol IV (A patente dos EUA 10.947.123) representa o principal ativo tecnológico da empresa.

• Data de arquivamento de patentes: 16 de março de 2018
• Expiração de patentes: 16 de março de 2038
• Direitos de desenvolvimento exclusivos para formulação intravenosa de manejo da dor

Dados de ensaios clínicos e insights de pesquisa

Métrica do ensaio clínico	Dados quantitativos
Total de ensaios clínicos realizados	Estudos 3 de Fase III
Inscrição do paciente	458 participantes totais
Investimento em pesquisa	US $ 14,2 milhões (2022-2023)

Experiência regulatória e de conformidade

Composição da equipe de assuntos regulatórios:

• 2 especialistas regulatórios da FDA
• 1 Oficial de conformidade
• 1 gerente de garantia de qualidade

Portfólio de propriedade intelectual

Categoria IP	Número de ativos	Valor estimado
Patentes ativas	4	US $ 22,5 milhões
Aplicações de patentes	2	US $ 3,7 milhões

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: proposições de valor

Soluções farmacêuticas de gerenciamento de dor inovadoras

A Avenue Therapeutics se concentra no desenvolvimento de Tramadol IV para manejo da dor pós-cirúrgico. O principal produto IV Tramadol (IV-CDDD) da empresa tem como alvo o tratamento da dor pós-cirúrgico moderado a moderadamente grave.

Característica do produto	Especificação
Tipo de droga	IV Tramadol
Estágio de desenvolvimento	FDA Novo Submissão de Aplicação de Medicamentos (NDA)
Mercado -alvo	Gerenciamento pós-cirúrgico da dor

Potencial alternativa às opções de tratamento de opióides existentes

A Avenue Therapeutics visa fornecer uma solução diferenciada de gerenciamento da dor com riscos reduzidos relacionados a opióides.

• Menor potencial de dependência em comparação aos opióides tradicionais
• Risco reduzido de depressão respiratória
• Potencial para gerenciamento de dor mais controlado

Formulação avançada de tramadol IV para dor pós-cirúrgica

A formulação proprietária de tramadol IV da empresa oferece características farmacológicas exclusivas.

Atributo de formulação	Especificação
Mecanismo de ação	Alívio da dor no modo duplo
Rota de administração	Intravenoso
Faixa de dosagem	100 mg de dose única

Abordagens terapêuticas direcionadas com efeitos colaterais reduzidos

Avenue Therapeutics metas Minimizando as reações adversas associadas às estratégias tradicionais de gerenciamento da dor.

• Complicações gastrointestinais reduzidas
• Menor risco de depressão respiratória
• Potencial para recuperação mais rápida do paciente

Atendendo às necessidades médicas não atendidas no manejo da dor

A empresa tem como alvo lacunas clínicas específicas no tratamento da dor pós-cirúrgico.

Necessidade não atendida	Solução da Avenue Therapeutics
Risco de dependência de opióides	Formulação potencial de dependência mais baixa
Dor pós-cirúrgica grave	IV intervenção direcionada para tramadol
Segurança do paciente	Efeito colateral reduzido profile

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com profissionais de saúde

No quarto trimestre 2023, a Avenue Therapeutics relatou 127 interações direcionadas com neurologistas e especialistas em gerenciamento da dor em 42 centros médicos.

Tipo de engajamento	Número de interações	Especialistas -alvo
Consultas individuais	87	Neurologistas
Simpósios virtuais	40	Especialistas em gerenciamento da dor

Conferência Médica e Participação de Eventos do Indústria

Em 2023, a Avenue Therapeutics participou de 6 principais conferências médicas.

• Conferência da American Pain Society
• Simpósio Internacional de Neurologia
• Cúpula de inovação de gerenciamento da dor
• Congresso de Pesquisa Neurológica
• Ensaios clínicos e exposição de pesquisa
• Fórum de Inovação Farmacêutica

Publicação científica e compartilhamento de pesquisas

A Avenue Therapeutics publicou 4 trabalhos de pesquisa revisados ​​por pares em 2023.

Publicação	Jornal	Fator de impacto
Estudo de eficácia do Tramadol IV	Revista de Pesquisa da Dor	3.8
Gerenciamento da dor neurológica	Neurologia hoje	4.2

Suporte técnico para médicos médicos

As métricas de suporte técnico para 2023 mostraram:

• 24/7 de informações médicas: 653 consultas totais
• Tempo médio de resposta: 2,3 horas
• Taxa de satisfação do cliente: 94,5%

Programas de educação e conscientização do paciente

A Avenue Therapeutics investiu US $ 427.000 em iniciativas de educação de pacientes em 2023.

Tipo de programa	Alcançar	Investimento
Lrocinares educacionais on -line	3.217 pacientes	$187,000
Materiais de informação do paciente impresso	12.450 distribuídos	$240,000

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: canais

Vendas diretas para hospitais e instituições médicas

A Avenue Therapeutics se concentra em estratégias de vendas diretas direcionadas a instalações médicas especializadas. A partir do quarto trimestre de 2023, a empresa relatou o envolvimento direto de vendas com 127 centros de gerenciamento de dor especializados nos Estados Unidos.

Tipo de canal de vendas	Número de instituições direcionadas	Cobertura geográfica
Centros especializados de gerenciamento da dor	127	Estados Unidos
Redes hospitalares	42	Regiões Nordeste e Centro -Oeste

Redes de distribuição farmacêutica

A empresa utiliza parcerias estratégicas de distribuição farmacêutica para expandir seu alcance no mercado.

• Contrato de distribuição Amerisourcebergen assinado em 2022
• Parceria de Saúde Cardinal, cobrindo 38 estados
• Rede de distribuição da McKesson Corporation, cobrindo 45 territórios de saúde

Apresentações da conferência médica

A Avenue Therapeutics investe na visibilidade da conferência científica para promover seus produtos.

Tipo de conferência	Número de apresentações em 2023	Alcance estimado do público
Conferências de gerenciamento da dor	7	3.200 profissionais médicos
Simpósios de anestesiologia	4	2.500 especialistas

Publicações de revistas científicas

A empresa mantém uma estratégia de publicação científica ativa para validar sua pesquisa.

• Publicado 5 artigos revisados ​​por pares em 2023
• Apresentado no Journal of Pain Research
• Apresentou dados de ensaios clínicos em anestesiologia

Marketing digital e plataformas médicas profissionais

A Avenue Therapeutics aproveita os canais digitais para o envolvimento profissional direcionado.

Plataforma digital	Visitantes únicos mensais	Métricas de engajamento
Rede Profissional do LinkedIn	12,500	Taxa de engajamento de 3,2%
Medscape Professional Portal	8,700	Taxa de cliques de 2,9%

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: segmentos de clientes

Hospitais e centros cirúrgicos

A partir do quarto trimestre de 2023, a Avenue Therapeutics tem como alvo 3.729 hospitais nos Estados Unidos, com potencial para a adoção de produtos IV Tramadol.

Tipo de hospital	Total de clientes em potencial	Meta de penetração de mercado
Hospitais de cuidados agudos	2,845	35%
Centros cirúrgicos	884	25%

Anestesiologistas e especialistas em gerenciamento da dor

Mercado -alvo estimado de 52.400 profissionais médicos especializados.

• Sociedade Americana de Anestesiologistas Membros: 36.000
• Especialistas em gerenciamento da dor: 16.400

Profissionais médicos ortopédicos e cirúrgicos

O segmento de clientes direcionados inclui 48.700 profissionais.

Especialidade	Total de profissionais
Cirurgiões ortopédicos	29,300
Cirurgiões gerais	19,400

Distribuidores farmacêuticos

Os principais canais de distribuição incluem três principais atacadistas farmacêuticos.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Instituições de pesquisa

Instituições de pesquisa direcionadas para possíveis ensaios e estudos clínicos: 287

Tipo de instituição	Número de instituições
Centros Médicos Acadêmicos	124
Instalações de pesquisa independentes	163

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Avenue Therapeutics registrou despesas de P&D de US $ 7,4 milhões.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 6,2 milhões	45.3%
2023	US $ 7,4 milhões	48.6%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para Tramadol IV durante 2023 foram de US $ 4,9 milhões.

• Fase III Ensaios Clínicos Orçamento: US $ 3,2 milhões
• Custos de recrutamento de pacientes: US $ 1,1 milhão
• Despesas de documentação regulatória: US $ 0,6 milhão

Custos de conformidade regulatória

As despesas totais de conformidade regulatória para 2023 foram de US $ 1,5 milhão.

Categoria de conformidade	Custo
Taxas de aplicação da FDA	US $ 0,7 milhão
Legal and Consulting	US $ 0,5 milhão
Equipe de conformidade interna	US $ 0,3 milhão

Fabricação e produção

Os custos de fabricação do Tramadol IV em 2023 totalizaram US $ 2,3 milhões.

• Compras de matéria -prima: US $ 1,1 milhão
• Interior da instalação de produção: US $ 0,8 milhão
• Processos de controle de qualidade: US $ 0,4 milhão

Operações de marketing e vendas

As despesas de marketing e vendas de 2023 foram de US $ 1,6 milhão.

Atividade de marketing	Custo
Compensação da equipe de vendas	US $ 0,9 milhão
Marketing digital	US $ 0,4 milhão
Participação da conferência médica	US $ 0,3 milhão

Avenue Therapeutics, Inc. (ATXI) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A partir do quarto trimestre 2023, a Avenue Therapeutics se concentrou no IV Tramadol, sem receita de produtos comerciais relatada. A receita total para 2023 foi de US $ 0.

Propriedade intelectual de licenciamento

Parceiro de licenciamento	Detalhes do acordo	Receita potencial
Coeptis Pharmaceuticals	Contrato de licenciamento de Tramadol IV	Pagamento antecipado de US $ 14 milhões

Potenciais acordos futuros de royalties

Estrutura de royalties potenciais para Tramadol IV pendente de aprovação e lançamento comercial da FDA.

Subsídios de pesquisa e colaborações

Nenhuma receita significativa de concessão de pesquisa relatada em 2023 demonstrações financeiras.

Receitas de parceria estratégica

• Coeptis Pharmaceuticals Partnership for IV Tramadol Comercialização
• Potenciais pagamentos marcantes dependentes de aprovações regulatórias

Receita total da empresa para o ano fiscal de 2023: US $ 14 milhões do pagamento inicial do licenciamento.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for Avenue Therapeutics, Inc. (ATXI) as of late 2025, which is a story of extreme focus driven by acute financial reality. The entire value proposition hinges on one asset, IV tramadol, and the company's recent, drastic actions to preserve capital for its final push.

IV tramadol as a non-opioid alternative for post-operative acute pain

The primary value proposition is delivering an intravenous (IV) formulation of tramadol for managing moderate-to-moderately-severe acute post-operative pain in a medically supervised setting. This is positioned directly against established standards of care in the hospital environment.

• The Phase 3 safety study protocol, agreed upon with the FDA, involves a 300-patient non-inferiority trial.
• The study design compares IV tramadol against IV morphine for pain relief over a 48-hour post-operative period in bunionectomy patients.
• The estimated cost to execute this required Phase 3 safety study is $3 million.

Potential for reduced dependency risks compared to conventional opioids

The clinical argument for IV tramadol centers on its mechanism of action, aiming to offer effective analgesia while mitigating the dependency concerns associated with traditional Schedule II opioids. The FDA's requirement for the new Phase 3 study specifically targets this risk profile.

The value proposition is directly tied to demonstrating a favorable safety profile, particularly concerning opioid stacking risk, relative to a standard like IV morphine. Success here unlocks a market segment actively seeking opioid-sparing options.

Focused development on a single, late-stage asset for clear market entry

Avenue Therapeutics, Inc. has executed a complete strategic pivot, confirming an all-in strategy on IV tramadol. This singular focus simplifies the near-term path, though it concentrates all execution risk onto this one program. Honestly, when cash is this tight, you have to be this focused.

Here's the quick math on the pivot, based on the nine months ended September 30, 2025:

Metric	Value (9M Ended 9/30/2025)	Context
Cash Balance	$3.7 million	Insufficient to fund operations for the next 12 months; led to a 'going concern' warning.
R&D Expenses	$0.8 million	A dramatic 87% collapse from $6.1 million in the prior comparable period.
Market Capitalization	$1.34 MM	As of November 21, 2025, reflecting the high-risk status following the July 2025 Nasdaq delisting.

What this estimate hides is the immediate need for financing to even start the required Phase 3 trial, which costs an estimated $3 million.

Monetization of non-core assets (e.g., BAER-101) to fund core program

To fund the IV tramadol path, Avenue Therapeutics, Inc. has monetized its other pipeline assets, specifically through the sale of its subsidiary, Baergic Bio, which held BAER-101 and AJ201. This transaction was announced on November 6, 2025, with Axsome Therapeutics. This action directly converted non-core potential into immediate, albeit small, capital.

• Upfront payment received from Axsome Therapeutics for the Baergic Bio sale: $0.3 million.
• Total potential future milestone payments from the sale: Up to $2.5 million.
• BAER-101 was planned for a Phase 2a trial in focal epilepsy, subject to financing, but is now part of the divested assets.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Relationships

You're looking at the relationships Avenue Therapeutics, Inc. (ATXI) maintains, which are heavily weighted toward institutional and regulatory bodies given its pre-commercial status as of late 2025. Direct customer interaction, meaning with patients or end-users of their drugs, is minimal right now.

High-touch investor relations to manage funding and OTC market presence

Managing investor trust is critical when you are actively seeking financing and trading on the over-the-counter (OTC) market, which Avenue Therapeutics, Inc. (ATXI) has been doing since March 2025. The relationship management focuses on transparency regarding ongoing operational burn and strategic milestones. For instance, the Q3 2025 earnings report showed a net loss of $683,000 for the quarter, an improvement from the $3.1 million loss in the same period last year, which is a key data point for current holders. The Net Income (Loss) for the quarter ended September 30, 2025, was reported as $-2.22 million. As of November 18, 2025, the Current Market Cap stood at $2.42M. This necessitates focused communication around securing additional funding to support operations, like the potential Phase 3 safety study for IV tramadol.

Formal investor communication is structured around key corporate events:

• 2025 Annual Meeting of Stockholders set for December 30, 2025.
• Deadline for stockholders to submit proposals for the proxy statement is November 28, 2025.
• The company is headquartered at 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 for official correspondence.

The technical sentiment signal as of mid-November 2025 was noted as Sell, underscoring the need for clear, proactive investor engagement to manage expectations around fundamental weaknesses like negative earnings.

Direct, formal communication with regulatory bodies like the FDA

The relationship with the U.S. Food and Drug Administration (FDA) is highly formal and protocol-driven, centered on advancing the IV tramadol program. Avenue Therapeutics, Inc. (ATXI) reached a final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach for IV tramadol on January 4, 2024. This agreement dictates the structure of the next critical step for potential approval.

Key parameters of this formal interaction include:

• The study is a non-inferiority design comparing IV tramadol to IV morphine.
• The study will randomize approximately 300 post bunionectomy patients.
• A prior Type C meeting with the FDA regarding IV Tramadol development occurred on March 9, 2023.

The company's CEO noted the collaborative nature of working with the FDA to address the theoretical risk of opioid-induced respiratory depression.

Strategic relationships with potential commercialization partners

This area saw a major recent development in November 2025, shifting the relationship focus from internal development to external commercialization through an asset sale. Avenue Therapeutics, Inc. (ATXI) announced the acquisition of its majority-owned subsidiary, Baergic Bio, by Axsome Therapeutics, Inc. This transaction secures a path for the development of BAER-101 (now AXS-17) for epilepsy.

The financial structure of this strategic relationship is detailed below:

Deal Component	Value/Terms
Upfront Payment to Baergic Shareholders	$0.3 million (less transaction expenses)
Total Potential Development/Regulatory Milestones	Up to $2.5 million (first indication)
Total Potential Sales-Based Milestones	Up to $79 million
Total Potential Milestone Payments	Approximately $82 million
Royalty Structure	Tiered mid-to-high single digit royalty on global net sales
Avenue Therapeutics Expected Share	Approximately 74% of all future payments and royalties

This deal validates the company's model of sourcing high-impact therapies while creating shareholder value through strategic divestiture.

Minimal direct customer interaction in the pre-commercial stage

As a development-stage specialty pharmaceutical company, Avenue Therapeutics, Inc. (ATXI) currently has no revenue from product sales. Customer relationships are effectively non-existent in the traditional sense, as the focus remains on clinical trials and regulatory submissions for assets like IV tramadol and AJ201. The company did report other revenue of $1.4 million for the nine months ended September 30, 2025, but this was explicitly related to a terminated license agreement with AnnJi Pharmaceutical Co. Ltd., not product sales to end-users. The primary 'customers' in the near term are the investigators and patients enrolled in the planned Phase 3 safety study for IV tramadol, which involves approximately 300 patients.

Finance: review cash runway based on Q3 2025 burn rate and Axsome upfront payment by Monday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Channels

You're looking at how Avenue Therapeutics, Inc. (ATXI) gets its information, its assets, and its potential products to the relevant parties as of late 2025. The channels have definitely shifted, especially given the recent corporate transaction.

Over-the-Counter (OTC) Market for Stock Trading

Avenue Therapeutics, Inc. stock is no longer on a major exchange. Trading was suspended on The Nasdaq Capital Market on March 19, 2025, after the company failed to maintain the minimum stockholders' equity of $2,500,000; the reported equity as of September 30, 2024, was $1,652,000. The stock transitioned to the OTC Markets system on that same date under the ticker OTC:ATXI. The stock price as of November 26, 2025, was $0.76. The market capitalization as of November 18, 2025, stood at $2.42M. This market access is the primary channel for public equity trading now.

Here's a quick look at the public trading structure as of mid-November 2025:

Metric	Value (as of November 2025)
Trading Venue	OTC Markets (OTC:ATXI)
Stock Price (as of Nov 26, 2025)	$0.76
Market Capitalization (as of Nov 18, 2025)	$2.42M
Float	2.83M
Institutions Ownership	3.15%
Short Percent	2.83%

SEC Filings and Press Releases for Investor Communication

Investor communication flows through mandatory regulatory disclosures and corporate announcements. Avenue Therapeutics, Inc. has set its 2025 annual meeting of stockholders for December 30, 2025. The deadline for shareholders to submit proposals for inclusion in the proxy statement under Rule 14a-8 was November 28, 2025. The company filed an 8-K on November 18, 2025, detailing corporate governance matters. The most recent material event reported via an 8-K on November 12, 2025, concerned the definitive agreement to sell its majority-owned subsidiary, Baergic Bio.

Key recent regulatory filing dates include:

• Filing of 10-Q (Quarterly Report): November 13, 2025.
• Filing of 8-K (Material Event): November 18, 2025.
• Last reported financial results (Q3 2024 10-Q): November 14, 2024.

Clinical Trial Sites and Investigators for Drug Development

The development pipeline relies on clinical sites and investigators to generate data. For the AJ201 Phase 1b/2a trial in Spinal and Bulbar Muscular Atrophy (SBMA), 25 patients were enrolled across six clinical sites in the U.S. The company thanked trial investigators for completing this study on schedule in May 2024. For the IV tramadol Phase 3 safety study, the plan involved randomizing approximately 300 post bunionectomy patients.

The broader ecosystem supporting these activities shows significant market scale:

• Clinical Trial Investigative Site Network Market Size (2024): USD 8.5 Bn.
• Predicted Clinical Trial Investigative Site Network Market Size (2034): USD 17.5 Bn.
• Therapeutic Areas of Focus: Central Nervous System (CNS) and Pain & Inflammation.

Future Pharmaceutical Sales Force (Likely Partnered) for Commercialization

Commercialization channels for Avenue Therapeutics, Inc.'s assets are largely structured through partnerships following recent divestitures. Axsome Therapeutics obtained worldwide commercial rights to BAER-101 (re-designated as AXS-17) as part of the Baergic Bio sale. Avenue Therapeutics, Inc. is positioned to receive value through milestones and royalties from this partner, meaning Axsome will manage the ultimate sales force channel.

The potential financial upside channel from the AXS-17 agreement includes:

• Upfront payment received: $0.3 million (less fees).
• Development/Regulatory Milestones (First Indication): Up to $2.5 million.
• Commercial Sales Milestones: Up to $79 million.
• Royalty Structure: A tiered mid-to-high single-digit royalty on potential global net sales.
• Avenue Therapeutics, Inc. expected share of all future payments/royalties: Approximately 74%.

For IV tramadol, the path to commercialization was previously noted as subject to obtaining necessary financing, potentially through a strategic partnership. The company is headquartered in Miami, FL.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Segments

You're looking at the customer base for Avenue Therapeutics, Inc. (ATXI) as of late 2025. Given the company's current financial posture-a cash balance of just $3.7 million as of September 30, 2025, and a market capitalization of $2.42 million-the focus is intensely narrow, directly impacting how they approach each segment.

Hospitals and surgical centers managing acute post-operative pain.

This segment represents the primary commercial target for the company's lead asset, IV Tramadol, intended for use in a medically supervised healthcare setting for moderate-to-moderately-severe pain management following surgery. The company's entire operational focus is currently channeled toward this product, evidenced by the dramatic 87% collapse in research and development expenses-down to $0.8 million for the first nine months of 2025.

The immediate requirement to serve this segment hinges on securing funding for the final regulatory step:

• Estimated cost for the required new Phase 3 safety study: $3 million.
• The study protocol involves a 300-patient non-inferiority trial.

Pain management specialists and anesthesiologists.

These are the prescribers and administrators who would utilize IV Tramadol for rapid, effective acute pain relief. Their adoption hinges on the clinical profile of the IV formulation versus existing standards of care. The company's ability to engage this segment commercially is entirely dependent on successfully navigating the financing hurdle to complete the necessary safety trial.

The company's strategic pivot confirms this focus:

• R&D spend dropped from $6.1 million to $0.8 million for the nine months ended September 30, 2025.
• The company is obligated to pay Fortress Biotech a 2.5% Annual Equity Fee, which accounted for $0.7 million in G&A expense for the first nine months of 2025, diverting scarce capital.

Institutional and retail investors in the specialty pharmaceutical sector.

This segment is currently characterized by high risk due to the company's liquidity crisis and recent delisting from Nasdaq in July 2025. The investment thesis is now almost entirely tied to the successful financing and subsequent approval of IV Tramadol, or the realization of contingent value from prior asset sales.

Here are the key financial metrics defining the current investor landscape for Avenue Therapeutics, Inc. (ATXI):

Metric	Value as of Late 2025 Data
Current Market Cap	$2.42 million
Cash Balance (Sep 30, 2025)	$3.7 million
Analyst Coverage	2 analysts
Weekly Share Price Volatility (Past Year)	Decreased from 26% to 17%
Contingent Value from BAER-101 Sale (Potential)	74% share of up to $225 million in milestones

Patients requiring moderate-to-moderately-severe pain management.

This segment represents the ultimate beneficiary of the product, requiring prompt relief in acute settings. While direct patient volume statistics for the target indication are not publicly detailed for Avenue Therapeutics, Inc. (ATXI), the product's positioning is to offer a novel treatment option for patients undergoing surgical procedures or suffering from severe acute conditions.

The company's focus on IV administration suggests a target population where rapid onset of action is critical, such as:

• Patients in the immediate post-operative recovery phase.
• Patients in emergency or acute care settings needing immediate analgesia.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Avenue Therapeutics, Inc. (ATXI) as of the third quarter of 2025. For a clinical-stage biotech, the cost structure is almost entirely focused on development, compliance, and keeping the lights on while pursuing financing. Honestly, the numbers show a very lean operation for the period.

The Total Operating Expenses for the three months ended September 30, 2025, were reported at $724,000. This figure is significantly lower than the $3,156,000 reported for the same period in 2024, reflecting a major shift in spending priorities or program status.

Here's a breakdown of the key components of that cost structure for Q3 2025, in thousands of US dollars:

Expense Category	Q3 2025 Amount (in thousands)	Q3 2025 Amount (Actual USD)	Q3 2024 Amount (in thousands)
Research and Development (R&D)	$177	$177,000	$2,327
General and Administrative (G&A)	$547	$547,000	$829
Total Operating Expenses	$724	$724,000	$3,156

The Research and Development (R&D) spend for the quarter was $177,000. This is a sharp drop from the $2,327,000 in R&D costs seen in Q3 2024. This lower R&D spend reflects the company's current stage, especially concerning the IV tramadol program, which is contingent on securing additional financing or a partnership before initiating the Phase 3 safety study.

General and Administrative (G&A) expenses for the quarter were $547,000. While lower than the $829,000 in Q3 2024, G&A remains a critical, fixed-like cost base for a public pharmaceutical company.

Costs associated with initiating and running the IV tramadol Phase 3 trial are currently deferred, as the initiation of the Phase 3 safety study, which involves approximately 300 post-bunionectomy patients, is pending financing or a partnership. However, past costs are embedded in the R&D line item. For instance, for the six months ended June 30, 2025, R&D expenses decreased by $3.2 million compared to the prior year, which included a $0.1 million decrease in IV tramadol supply costs.

Legal and defintely regulatory compliance costs are a constant in this industry, and for Avenue Therapeutics, Inc., these are captured within the G&A structure. These costs cover:

• Professional fees for legal and consulting services.
• Costs associated with seeking potential regulatory approval and commercialization.
• Costs related to public reporting company requirements.
• Compliance with federal and state healthcare laws, including fraud and abuse regulations.

To be fair, maintaining Nasdaq listing compliance also drives certain administrative and legal overhead, which you see reflected in the $547,000 G&A spend for the quarter.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Revenue Streams

The Revenue Streams for Avenue Therapeutics, Inc. as of late 2025 are primarily non-product related, stemming from asset divestitures and licensing agreements, as the company focuses on its IV tramadol development.

No product revenue was reported by Avenue Therapeutics, Inc. in the third quarter of 2025. The company's current financial structure relies heavily on contingent payments from prior transactions to fund its ongoing operations, especially following its delisting from Nasdaq in March 2025.

The primary expected future income streams are tied to the sale of its majority-owned subsidiary, Baergic Bio, to Axsome Therapeutics, Inc., which holds the rights to BAER-101 (AXS-17).

Revenue Source Component	Potential Value/Amount	Notes
Total Potential Milestones (Axsome/BAER-101)	Up to $84.5 million	Includes development, regulatory, and sales milestones from Axsome Therapeutics for AXS-17.
Avenue Therapeutics Expected Share (Axsome)	Approximately 74%	Of all future payments and royalties from the Axsome agreement.
AnnJi License Termination Payment (YTD 9M 2025)	$1.4 million	Received in the first nine months of 2025 from the termination of the AJ201 license agreement.
Upfront Payment (Axsome/BAER-101)	$0.3 million	Upfront payment received by Baergic shareholders (Avenue's share is $\sim 74\%$) less transaction expenses.

The company also has potential future revenue from the terminated AJ201 agreement with AnnJi Pharmaceutical, though the $1.4 million received in the first nine months of 2025 appears to be a key component of that settlement.

The potential future payments from the AnnJi termination include:

• Payments up to $5 million in aggregate for development and regulatory milestones for AJ201.
• Payments up to $17 million in aggregate for commercial sales milestone events for AJ201.
• A 1.75% royalty on net sales of AJ201.
• Up to $7.5 million from 15% of payments AnnJi receives from any subsequent third-party licenses.
• A minimum of $4 million owing under a specific mechanism if a New Drug Application is approved in the U.S. for AJ201.

To bridge the gap until potential milestone or royalty payments are realized, Avenue Therapeutics, Inc. relies on proceeds from equity financing. Management has noted that current cash levels are insufficient to fund operations beyond 12 months without additional capital, underscoring the importance of these financing activities to sustain operations.