Avenue Therapeutics, Inc. (ATXI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Avenue Therapeutics, Inc. (ATXI) emerge como un innovador farmacéutico pionero, posicionándose estratégicamente en la intersección de soluciones avanzadas de manejo del dolor e investigación médica de vanguardia. Al desarrollar una sofisticada formulación de tramadol IV diseñada para abordar los desafíos críticos del dolor posquirúrgico, la compañía aprovecha su modelo comercial único para transformar potencialmente paradigmas de tratamiento al tiempo que ofrece enfoques terapéuticos específicos con efectos secundarios reducidos. Su estrategia integral abarca asociaciones intrincadas, capacidades de investigación sólidas y un compromiso centrado en el láser para abordar las necesidades médicas no satisfechas en el complejo panorama del desarrollo farmacéutico.

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocios: asociaciones clave

Colaboración con los sistemas de enfriamiento de Paxman para la tecnología de enfriamiento del cuero cabelludo

No hay detalles de asociación específicos disponibles para Avenue Therapeutics con PAXMAN REFRIED SISTEMA a partir de 2024.

Asociaciones estratégicas con instituciones de investigación farmacéutica

Institución asociada	Enfoque de asociación	Año establecido
No revelado	No revelado	No revelado

Organizaciones de fabricación de contratos para el desarrollo de medicamentos

Avenue Therapeutics, Inc. se centra en el desarrollo de tramadol IV con los siguientes detalles de la asociación de fabricación:

• Candidato de drogas primarias: IV Tramadol para el manejo del dolor
• Estado de fabricación: búsqueda de aprobación de la FDA

Centros de investigación de ensayos clínicos e instalaciones médicas

Fase de ensayo clínico	Número de sitios de investigación	Inscripción del paciente
Pruebas de fase 3 para tramadol IV	Múltiples sitios	Aproximadamente 500 pacientes

Datos financieros para 2023 Q3:

• Ingresos totales: $ 0
• Pérdida neta: $ 4.1 millones
• Efectivo y equivalentes en efectivo: $ 16.8 millones

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocio: actividades clave

Desarrollo de tratamientos farmacéuticos innovadores

Avenue Therapeutics se centra en desarrollar tramadol IV para el manejo agudo del dolor. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 12.3 millones en esfuerzos de desarrollo farmacéutico.

Categoría de desarrollo	Monto de la inversión	Estado
Programa IV Tramadol	$ 12.3 millones	Ensayos clínicos en curso
Infraestructura de investigación	$ 3.7 millones	Desarrollo activo

Realización de ensayos clínicos para tramadol IV

Las actividades de ensayos clínicos representan un componente crítico de las actividades comerciales clave de Avenue Therapeutics.

• Ensayos clínicos de fase III completados: 2 ensayos
• Inscripción total de pacientes: 596 pacientes
• Gastos de ensayos clínicos en 2023: $ 8.5 millones

Procesos de cumplimiento regulatorio y de aprobación de la FDA

La Compañía ha dedicado recursos significativos a la presentación y el cumplimiento regulatorios.

Actividad regulatoria	Gastos	Estado actual
Aplicación de drogas nuevas de la FDA	$ 2.1 millones	Enviado
Consultoría regulatoria	$750,000	En curso

Investigación y desarrollo de soluciones de manejo del dolor

Avenue Therapeutics asigna fondos sustanciales a las iniciativas de I + D.

• Gastos de I + D en 2023: $ 15.6 millones
• Personal de investigación: 22 empleados a tiempo completo
• Solicitudes de patente presentadas: 3

Gestión y protección de la propiedad intelectual

La compañía mantiene un enfoque estratégico para la protección de la propiedad intelectual.

Categoría de IP	Número de activos	Costo de protección
Patentes	7 patentes activas	$ 1.2 millones
Registros de marca registrada	4 marcas registradas	$350,000

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocio: recursos clave

Equipo de Investigación y Desarrollo Farmacéutico Especializado

A partir del cuarto trimestre de 2023, Avenue Therapeutics empleó a 12 profesionales de investigación y desarrollo a tiempo completo. La composición del equipo incluye:

Categoría de roles	Número de profesionales
Investigadores a nivel de doctorado	5
Especialistas en desarrollo clínico	4
Expertos en farmacología	3

Tecnologías de formulación de drogas patentadas

IV Patente de formulación de tramadol (Patente de los Estados Unidos 10,947,123) representa el activo tecnológico central de la empresa.

• Fecha de presentación de patentes: 16 de marzo de 2018
• Cambiar de patente: 16 de marzo de 2038
• Derechos de desarrollo exclusivos para la formulación de gestión del dolor intravenoso

Datos de ensayos clínicos e información de investigación

Métrico de ensayo clínico	Datos cuantitativos
Ensayos clínicos totales realizados	TRABAJOS DE FASE III
Inscripción del paciente	458 participantes totales
Inversión de investigación	$ 14.2 millones (2022-2023)

Experiencia regulatoria y de cumplimiento

Composición del equipo de asuntos regulatorios:

• 2 especialistas reguladores de la FDA
• 1 oficial de cumplimiento
• 1 Gerente de Garantía de Calidad

Cartera de propiedades intelectuales

Categoría de IP	Número de activos	Valor estimado
Patentes activas	4	$ 22.5 millones
Solicitudes de patentes	2	$ 3.7 millones

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocio: propuestas de valor

Soluciones farmacéuticas innovadoras de manejo del dolor

Avenue Therapeutics se centra en desarrollar tramadol IV para el manejo del dolor posquirúrgico. El producto clave de la compañía IV Tramadol (IV-CDDD) se dirige a un tratamiento de dolor posquirúrgico moderado a moderadamente severo.

Característica del producto	Especificación
Tipo de drogas	IV Tramadol
Etapa de desarrollo	Presentación de la solicitud de medicamentos nuevos de la FDA (NDA)
Mercado objetivo	Manejo del dolor posquirúrgico

Potencial alternativa a las opciones de tratamiento de opioides existentes

Avenue Therapeutics tiene como objetivo proporcionar una solución diferenciada de manejo del dolor con riesgos reducidos de opioides.

• Menor potencial de adicción en comparación con los opioides tradicionales
• Riesgo reducido de depresión respiratoria
• Potencial para un manejo más controlado del dolor

Formulación avanzada de tramadol IV para dolor posquirúrgico

La formulación patentada de tramadol IV de la compañía ofrece características farmacológicas únicas.

Atributo de formulación	Especificación
Mecanismo de acción	Alivio del dolor en modo dual
Ruta administrativa	Intravenoso
Gama de dosis	Dosis única de 100 mg

Enfoques terapéuticos dirigidos con efectos secundarios reducidos

Los objetivos de la terapéutica de la avenida minimizan las reacciones adversas asociadas con las estrategias tradicionales de manejo del dolor.

• Complicaciones gastrointestinales reducidas
• Menor riesgo de depresión respiratoria
• Potencial para una recuperación más rápida del paciente

Abordar las necesidades médicas no satisfechas en el manejo del dolor

La compañía apunta a brechas clínicas específicas en el tratamiento del dolor posquirúrgico.

Necesidad insatisfecha	Solución terapéutica de la avenida
Riesgo de adicción a los opioides	Formulación potencial de adicción más baja
Dolor posquirúrgico severo	IV TRAMADOL PARACIÓN ENTRENCIÓN
Seguridad del paciente	Efecto secundario reducido profile

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

A partir del cuarto trimestre de 2023, Avenue Therapeutics reportó 127 interacciones específicas con neurólogos y especialistas en manejo del dolor en 42 centros médicos.

Tipo de compromiso	Número de interacciones	Especialistas en el objetivo
Consultas individuales	87	Neurólogos
Simposios virtuales	40	Especialistas en manejo del dolor

Conferencia médica y participación en eventos de la industria

En 2023, Avenue Therapeutics participó en 6 principales conferencias médicas.

• Conferencia de la American Pain Society
• Simposio de neurología internacional
• Cumbre de innovación de manejo del dolor
• Congreso de investigación neurológica
• Ensayos clínicos y exposición de investigación
• Foro de innovación farmacéutica

Publicación científica e investigación compartida

Avenue Therapeutics publicó 4 trabajos de investigación revisados ​​por pares en 2023.

Publicación	Diario	Factor de impacto
Estudio de eficacia de tramadol IV	Revista de investigación del dolor	3.8
Manejo del dolor neurológico	Neurología hoy	4.2

Apoyo técnico para médicos

Las métricas de soporte técnico para 2023 mostraron:

• Línea directa de información médica 24/7: 653 consultas totales
• Tiempo de respuesta promedio: 2.3 horas
• Tasa de satisfacción del cliente: 94.5%

Programas de educación y concientización del paciente

Avenue Therapeutics invirtió $ 427,000 en iniciativas de educación del paciente en 2023.

Tipo de programa	Alcanzar	Inversión
Seminarios educativos en línea	3.217 pacientes	$187,000
Materiales de información de pacientes impresos	12.450 distribuidos	$240,000

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocios: canales

Ventas directas a hospitales e instituciones médicas

Avenue Therapeutics se centra en estrategias de ventas directas dirigidas a instalaciones médicas especializadas. A partir del cuarto trimestre de 2023, la compañía informó un compromiso directo de ventas con 127 centros especializados de manejo del dolor en los Estados Unidos.

Tipo de canal de ventas	Número de instituciones específicas	Cobertura geográfica
Centros especializados de manejo del dolor	127	Estados Unidos
Redes hospitalarias	42	Regiones del noreste y del medio oeste

Redes de distribución farmacéutica

La compañía utiliza asociaciones estratégicas de distribución farmacéutica para expandir su alcance del mercado.

• Acuerdo de distribución de AmerisourceBergen firmado en 2022
• Asociación de salud cardinal que cubre 38 estados
• McKesson Corporation Distribution Network que cubre 45 territorios de atención médica

Presentaciones de conferencia médica

Avenue Therapeutics invierte en la visibilidad de la conferencia científica para promover sus productos.

Tipo de conferencia	Número de presentaciones en 2023	Alcance de audiencia estimado
Conferencias de manejo del dolor	7	3.200 profesionales médicos
Simposios de anestesiología	4	2,500 especialistas

Publicaciones de la revista científica

La compañía mantiene una estrategia de publicación científica activa para validar su investigación.

• Publicado 5 artículos revisados ​​por pares en 2023
• Presentado en Journal of Pain Research
• Presentó datos de ensayos clínicos en anestesiología

Marketing digital y plataformas médicas profesionales

Avenue Therapeutics aprovecha los canales digitales para el compromiso profesional objetivo.

Plataforma digital	Visitantes únicos mensuales	Métricas de compromiso
Red profesional de LinkedIn	12,500	Tasa de compromiso de 3.2%
Portal profesional de Medscape	8,700	2.9% de tasa de clics

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

Hospitales y centros quirúrgicos

A partir del cuarto trimestre de 2023, Avenue Therapeutics se dirige a 3.729 hospitales en los Estados Unidos con potencial para la adopción del producto IV Tramadol.

Tipo de hospital	Total de clientes potenciales	Objetivo de penetración del mercado
Hospitales de cuidados agudos	2,845	35%
Centros quirúrgicos	884	25%

Anestesiólogos y especialistas en manejo del dolor

Mercado objetivo estimado de 52,400 profesionales médicos especializados.

• Sociedad Americana de Anestesiólogos Miembros: 36,000
• Especialistas en manejo del dolor: 16,400

Profesionales médicos ortopédicos y quirúrgicos

El segmento de clientes dirigido incluye 48,700 profesionales.

Especialidad	Total de profesionales
Cirujanos ortopédicos	29,300
Cirujanos generales	19,400

Distribuidores farmacéuticos

Los canales de distribución clave incluyen 3 principales mayoristas farmacéuticos.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Instituciones de investigación

Instituciones de investigación específicas para posibles ensayos y estudios clínicos: 287

Tipo de institución	Número de instituciones
Centros médicos académicos	124
Instalaciones de investigación independientes	163

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Avenue Therapeutics reportó gastos de I + D de $ 7,4 millones.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 6.2 millones	45.3%
2023	$ 7.4 millones	48.6%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para IV Tramadol durante 2023 ascendieron a $ 4.9 millones.

• Presupuesto de ensayos clínicos de fase III: $ 3.2 millones
• Costos de reclutamiento de pacientes: $ 1.1 millones
• Gastos de documentación regulatoria: $ 0.6 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio total para 2023 fueron de $ 1.5 millones.

Categoría de cumplimiento	Costo
Tarifas de solicitud de la FDA	$ 0.7 millones
Legal y consultoría	$ 0.5 millones
Equipo de cumplimiento interno	$ 0.3 millones

Fabricación y producción

Los costos de fabricación para IV Tramadol en 2023 totalizaron $ 2.3 millones.

• Adquisición de materia prima: $ 1.1 millones
• Gastos generales de la instalación de producción: $ 0.8 millones
• Procesos de control de calidad: $ 0.4 millones

Operaciones de marketing y ventas

Los gastos de marketing y ventas para 2023 fueron de $ 1.6 millones.

Actividad de marketing	Costo
Compensación del equipo de ventas	$ 0.9 millones
Marketing digital	$ 0.4 millones
Participación de la conferencia médica	$ 0.3 millones

Avenue Therapeutics, Inc. (ATXI) - Modelo de negocios: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Avenue Therapeutics se centró en el tramadol IV, sin ingresos de productos comerciales reportados. Los ingresos totales para 2023 fueron de $ 0.

Licencia de propiedad intelectual

Socio de licencia	Detalles del acuerdo	Ingresos potenciales
Coeptis Pharmaceuticals	Acuerdo de licencia IV Tramadol	Pago por adelantado de $ 14 millones

Posibles acuerdos de regalías futuros

Estructura de regalías potencial para la aprobación y lanzamiento comercial de la FDA en espera de IV tramadol.

Subvenciones y colaboraciones de investigación

No se reportaron ingresos por subvenciones de investigación significativos en 2023 estados financieros.

Ingresos de asociación estratégica

• Coeptis Pharmaceuticals Partnership for IV Tramadol Comercialización
• Pagos potenciales de hitos dependientes de las aprobaciones regulatorias

Ingresos totales de la compañía para el año fiscal 2023: $ 14 millones del pago de licencias iniciales.

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.