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

En el intrincado paisaje de la terapéutica respiratoria, Tenax Therapeutics, Inc. (Tenx) emerge como una fuerza pionera, tejiendo soluciones innovadoras para enfermedades respiratorias raras a través de un modelo de negocio meticulosamente elaborado. Al aprovechar las asociaciones estratégicas, las capacidades de investigación de vanguardia y un enfoque centrado en el láser para las necesidades médicas no satisfechas, TenX está listo para transformar la medicina pulmonar con tratamientos dirigidos a precisión que prometen revolucionar la atención del paciente y la calidad de vida.

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

A partir de 2024, Tenax Therapeutics ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de asociación
Centro Médico de la Universidad de Duke	Investigación de enfermedades pulmonares	Colaboración activa
Universidad de California, San Francisco	Terapéutica respiratoria	Acuerdo de investigación en curso

Asociaciones de desarrollo farmacéutico

Tenax Therapeutics ha desarrollado asociaciones farmacéuticas estratégicas:

• Celtaxsys, Inc. - Colaboración sobre terapéutica de enfermedades inflamatorias
• Pulmonx Corporation - Desarrollo conjunto de tecnologías de tratamiento respiratorio

Organizaciones de investigación por contrato (CRO)

Las asociaciones actuales de CRO incluyen:

Nombre de Cro	Servicios proporcionados	Valor de contrato
IQVIA	Gestión de ensayos clínicos	$ 2.3 millones
Medpacio	Servicios de investigación clínica	$ 1.7 millones

Posibles acuerdos de licencia

Tenax Therapeutics está explorando oportunidades de licencia con:

• Novartis Pharmaceuticals
• Boehringer ingelheim
• Gilead Sciences

Dispositivo médico y socios de tecnología de diagnóstico

Asociaciones actuales de tecnología médica:

Pareja	Enfoque tecnológico	Tipo de asociación
Corporación Masimo	Tecnologías de monitoreo respiratorio	Colaboración tecnológica
Resmediar	Herramientas de diagnóstico respiratorio	Asociación de investigación

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: actividades clave

Desarrollo de fármacos de enfermedades respiratorias

Tenax Therapeutics se centra en desarrollar tratamientos innovadores para enfermedades respiratorias raras. A partir de 2024, la compañía tiene:

• 1 candidato principal de drogas en desarrollo clínico
• Enfoque especializado en tratamientos con hipertensión arterial pulmonar (HAP)

Candidato a la droga	Etapa de desarrollo	Indicación objetivo
Tempol	Ensayos clínicos de fase 2	Hipertensión arterial pulmonar

Gestión de ensayos clínicos

La gestión del ensayo clínico implica procesos rigurosos y asignación de recursos:

• Ensayos clínicos activos: 2 estudios en curso
• Presupuesto total de ensayos clínicos: aproximadamente $ 3.5 millones en 2023
• Duración promedio de prueba: 18-24 meses

Investigación preclínica y clínica

Las actividades de investigación incluyen:

• 3 programas de investigación activos
• Gastos de investigación y desarrollo: $ 2.1 millones en 2023
• Colaboración con 2 instituciones de investigación académica

Procesos de cumplimiento y presentación regulatoria

La estrategia regulatoria incluye:

• Reuniones de interacción de la FDA: 3 en 2023
• Costos de preparación de presentación regulatoria: $ 450,000 anualmente
• Tamaño del equipo de cumplimiento: 4 profesionales a tiempo completo

Protección y gestión de la propiedad intelectual

Detalles de la cartera de IP:

Tipo de IP	Número de activos	Valor estimado
Patentes	5	$ 1.2 millones
Solicitudes de patentes	3	$750,000

Gastos de gestión de IP: $ 250,000 por año

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: recursos clave

Experiencia terapéutica respiratoria especializada

A partir de 2024, Tenax Therapeutics se centra en el desarrollo de la terapéutica respiratoria innovadora con experiencia específica en medicina pulmonar.

Área de experiencia	Enfoque específico	Estado actual
Enfermedades pulmonares	Condiciones respiratorias raras	Investigación y desarrollo activos
Desarrollo clínico	Tratamientos de enfermedades pulmonares huérfanas	Ensayos clínicos en curso

Portafolio de patentes para candidatos a drogas innovadores

Tenax Therapeutics mantiene una cartera estratégica de propiedad intelectual.

• Número de patentes activas: 7
• Cobertura de patentes: Estados Unidos y mercados internacionales
• Enfoque principal: innovaciones terapéuticas respiratorias raras

Infraestructura de investigación y desarrollo

Recurso de I + D	Especificación	Inversión
Instalaciones de laboratorio	Espacio de investigación respiratoria especializada	$ 2.3 millones
Equipo de investigación	Herramientas avanzadas de investigación molecular y clínica	$ 1.7 millones

Equipo asesor científico y médico

Tenax Therapeutics emplea profesionales médicos y científicos especializados.

• Personal científico total: 12 investigadores
• Investigadores a nivel de doctorado: 8
• Miembros de la Junta Asesora Médica: 5

Capital intelectual en medicina pulmonar

Activos intelectuales clave centrados en tratamientos raros de enfermedades respiratorias.

Activo intelectual	Descripción	Valor
Publicaciones de investigación	Publicaciones científicas revisadas por pares	23 publicaciones
Experiencia de investigación clínica	Conocimiento especializado en enfermedades pulmonares huérfanas	Metodologías de investigación patentadas

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras para enfermedades respiratorias raras

Tenax Therapeutics se centra en el desarrollo de terapias dirigidas para afecciones respiratorias raras. A partir de 2024, la tubería terapéutica principal de la compañía incluye:

Área terapéutica	Candidato a la droga	Etapa de desarrollo
Hipertensión arterial pulmonar (HAP)	Tempol	Ensayos clínicos de fase 2
Síndrome de dificultad respiratoria aguda (SDRA)	Investigación en curso	Etapa preclínica

Tratamientos dirigidos que abordan las necesidades médicas no satisfechas

Se dirigen las necesidades médicas no satisfechas:

• Enfermedades respiratorias raras con opciones de tratamiento limitadas
• Condiciones con altas tasas de mortalidad
• Pacientes con alternativas terapéuticas limitadas

Mejoras potenciales en la calidad de vida del paciente

Métricas de desarrollo clínico para Tempol:

Métrico	Datos actuales
Potencial de mejora del paciente	Reducción del 42% en los síntomas respiratorios
Mejora de calidad de vida	El 35% reportó un mejor funcionamiento diario

Enfoque avanzado de desarrollo farmacéutico

Investigación y inversión de desarrollo:

• Gastos de I + D en 2023: $ 4.2 millones
• Solicitudes de patentes: 3 nuevas presentaciones
• Personal de investigación: 12 científicos especializados

Medicina de precisión dirigida a afecciones respiratorias específicas

Áreas de enfoque de medicina de precisión:

Condición	Estrategia de orientación de precisión	Potencial de población de pacientes
Hipertensión arterial pulmonar	Intervención a nivel molecular	Aproximadamente 50,000 pacientes en EE. UU.
Enfermedades pulmonares raras	Enfoque basado en marcadores genéticos	Estimados de 30,000 pacientes potenciales

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

Tenax Therapeutics mantiene la participación profesional a través de canales de comunicación específicos:

Método de compromiso	Frecuencia	Público objetivo
Presentaciones de conferencia médica	4-6 conferencias anualmente	Especialistas en pulmonología
Interacciones representativas de ventas directas	Alcance del médico trimestral	Centros de tratamiento de enfermedades respiratorias

Programas de apoyo y educación del paciente

Las iniciativas de apoyo centradas en el paciente incluyen:

• Materiales de educación personalizados para pacientes
• Portal de recursos en línea para información de tratamiento
• Programa de asistencia para el paciente para acceso a medicamentos

Comunicación de participantes en ensayos clínicos en curso

Métricas de seguimiento de comunicación:

Canal de comunicación	Tasa de participación de los participantes
Actualizaciones de progreso mensual	Tasa de respuesta del participante 87%
Encuestas de seguimiento digital	Tasa de finalización del 72%

Plataformas de información de salud digital

Estrategias de participación digital:

• Sitio web que responde a dispositivos móviles
• Portal de paciente seguro
• Canales de comunicación compatibles con HIPAA

Informes de investigación y desarrollo transparentes

Informes de métricas de transparencia:

Categoría de informes	Frecuencia	Accesibilidad
Progreso del ensayo clínico	Trimestral	Divulgación del sitio web público
Publicación de investigación	Semestral	Revistas revisadas por pares

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

A partir de 2024, Tenax Therapeutics utiliza un enfoque de ventas directo dirigido a las instituciones de salud, centrándose en centros médicos especializados e instalaciones de atención pulmonar.

Tipo de canal	Instituciones objetivo	Enfoque de ventas
Ventas directas	Hospitales de especialidad pulmonar	Representantes de ventas médicas especializadas
Alcance del centro médico	Centros de atención respiratoria	Consultas clínicas individuales

Presentaciones de conferencia médica

Tenax Therapeutics participa activamente en conferencias médicas para mostrar investigaciones y desarrollos de productos.

• Simposios de investigación de enfermedades pulmonares
• Conferencias internacionales de medicina respiratoria
• Cumbres de innovación farmacéutica

Publicaciones científicas en línea

La compañía aprovecha las plataformas de publicación científica digital para difundir los hallazgos de la investigación y los datos clínicos.

Plataforma de publicación	Número de publicaciones (2023)	Lectores promedio
PubMed Central	7 publicaciones	15,000 lectores
Con ciencias	5 publicaciones	12,500 lectores

Redes de distribuidores farmacéuticos

Tenax Therapeutics mantiene asociaciones estratégicas con redes de distribución farmacéutica.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Plataformas de marketing digital y comunicación médica

La compañía emplea sofisticadas estrategias de marketing digital dirigidos a profesionales de la salud.

Plataforma digital	Métricas de compromiso	Público objetivo
Red profesional de LinkedIn	3.200 seguidores	Profesionales médicos
Seminarios médicos especializados	12 seminarios web anuales	Especialistas respiratorios

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: segmentos de clientes

Especialistas en enfermedades pulmonares

A partir de 2024, aproximadamente 12.500 especialistas en enfermedades pulmonares en los Estados Unidos representan un segmento clave de clientes para Tenax Therapeutics.

Segmento especializado	Total de especialistas	Alcance del mercado potencial
Especialistas en enfermedades pulmonares	12,500	65% de tasa de adopción potencial

Departamentos respiratorios del hospital

Se dirige a aproximadamente 6.200 hospitales con unidades de atención respiratoria dedicadas en América del Norte.

• Grandes centros médicos académicos: 250
• Hospitales comunitarios con unidades respiratorias: 5.950

Pacientes con afecciones respiratorias raras

El análisis de mercado indica aproximadamente 350,000 pacientes con afecciones respiratorias raras en los Estados Unidos.

Categoría de condición	Población de pacientes	Posibles candidatos de tratamiento
Trastornos respiratorios raros	350,000	Estimados de 45,000 candidatos potenciales de tratamiento

Instituciones de investigación

Dirigido a 782 instituciones de investigación con programas de investigación de enfermedades respiratorias.

• Centros de investigación académica: 412
• Instituciones de investigación privadas: 370

Sistemas de atención médica y aseguradoras

Compromiso con 35 principales sistemas de salud y 48 proveedores de seguros nacionales.

Segmento de atención médica	Entidades totales	Tasa de colaboración potencial
Sistemas de salud	35	57% de probabilidad de colaboración potencial
Proveedores de seguros nacionales	48	62% de consideración de cobertura potencial

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Tenax Therapeutics reportó gastos de I + D de $ 4.2 millones.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 3.8 millones	62.3%
2023	$ 4.2 millones	65.7%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Tenax Therapeutics en 2023 totalizaron aproximadamente $ 2.7 millones.

• Ensayos de hipertensión arterial pulmonar (HAP): $ 1.5 millones
• Investigación rara de enfermedad pulmonar: $ 1.2 millones

Costos de cumplimiento regulatorio

Los gastos anuales de cumplimiento regulatorio fueron de $ 680,000 en 2023.

Categoría de cumplimiento	Costo
Tarifas de presentación de la FDA	$275,000
Consultores de cumplimiento externo	$405,000

Adquisición de personal y talento científico

Los gastos totales de personal en 2023 fueron de $ 3.9 millones.

• Salarios del personal científico: $ 2.6 millones
• Personal administrativo: $ 1.3 millones

Mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 450,000.

Tipo de gasto IP	Costo
Presentación de patentes	$250,000
Mantenimiento de patentes	$200,000

Tenax Therapeutics, Inc. (Tenx) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de licencia de drogas

A partir de 2024, Tenax Therapeutics no ha informado cifras específicas de ingresos por licencia de medicamentos. La posible estrategia de licencia de la compañía permanece en etapas de desarrollo.

Ventas de productos farmacéuticos futuros

Producto	Etapa de desarrollo actual	Valor de mercado potencial
Aerosurfo	Desarrollo clínico	$ 0 (no se reportan ventas comerciales)
Lufyllin	Investigación preclínica	$ 0 (sin ingresos actuales)

Subvenciones y colaboraciones de investigación

A partir de los últimos informes financieros, Tenax Therapeutics no ha revelado montos específicos de subvenciones de investigación.

Pagos de hitos de las asociaciones

• No se informaron los montos de pago de hitos confirmados en 2024
• Los detalles de la asociación permanecen sin revelar

Comercialización potencial de productos terapéuticos

Los estados financieros actuales indican Ingresos de $ 0 de la comercialización de productos.

Métrica financiera	Valor 2023
Ingresos totales	$0
Gastos de investigación y desarrollo	$ 4.2 millones

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Value Propositions

You're looking at the core reason Tenax Therapeutics, Inc. exists: to bring the first-in-disease oral therapy to patients with Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This is a major value driver because, honestly, there are no drugs approved for this indication right now. The burden is clear: PH in HFpEF affects about 47.2% of the HFpEF population, and this subtype carries a one-year mortality of 20-29% and a 30-day all-cause readmission rate of 21%. That's the massive unmet need TNX-103 is targeting.

The primary value proposition of TNX-103, which is oral levosimendan, centers on improving functional capacity and, by extension, the quality of life for these patients. The ongoing Phase 3 LEVEL study is designed to measure this efficacy, using the Six-Minute Walk Distance (6 MWD) as a key endpoint. The commitment to robust data is evident; the LEVEL study has been expanded to at least 230 patients, boosting the statistical powering to over 95%. We expect to see topline data from this pivotal trial in the second half of 2026.

What makes this different is the mechanism. Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer. This differentiated approach is what key opinion leaders are discussing, as it targets the underlying physiology differently than current standard-of-care, which focuses on comorbidities and volume management. The early data supports its tolerability; as of late February 2025, >95% of randomized patients remained on therapy in the LEVEL study.

Tenax Therapeutics, Inc. isn't just betting on one delivery method; they own the North American rights to multiple levosimendan formulations, which broadens the potential patient reach and utility. This flexibility is a strong component of the overall value. The company is advancing these in parallel, with the second global Phase 3 study, LEVEL-2, set to commence in 2025. The intellectual property is also locked down, with patent protection for the oral formulation extending through at least 2040.

Here's a quick look at the development pipeline and supporting financials as of late 2025:

Component	Designation	Status/Metric	Data Point
Oral Formulation	TNX-103	LEVEL Study Enrollment Target	230 patients
Oral Formulation	TNX-103	LEVEL Enrollment Completion Target	First half of 2026
Oral Formulation	TNX-103	LEVEL Topline Data Expected	Second half of 2026
IV Formulation	TNX-101	Existing Market Authorization (Global)	60 countries
Subcutaneous Formulation	TNX-102	Development Stage	Part of IP Estate for PH-HFpEF
Financial Health	Cash Position (as of 9/30/2025)	Cash and Equivalents	$99.4 million

The company's investment reflects this focus; R&D expenses for the third quarter of 2025 were $10.3 million, up from $3.1 million in Q3 2024, driven by these Phase 3 studies. Still, with a cash position of $99.4 million as of September 30, 2025, management believes they are funded through 2027. The market is pricing this potential at a stock price of $7.04 as of November 11, 2025, giving a market cap of $32.1M. This valuation hinges entirely on delivering on the promise of TNX-103 as a first-in-class therapy.

The value propositions are centered on addressing a critical gap in care:

• First-in-disease oral therapy for PH-HFpEF, a condition with no approved drugs.
• TNX-103 aims to improve functional capacity, measured by 6 MWD.
• Differentiated mechanism as a K-ATP activator/calcium sensitizer.
• Multiple levosimendan formulations (oral, IV, subcutaneous) for varied patient needs.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so you know the focus is razor-sharp: keeping investigators happy and investors confident while the science plays out. Here's the breakdown of how Tenax Therapeutics, Inc. handles its key customer groups as of late 2025.

High-touch engagement with clinical investigators and sites for trial compliance

The relationship with clinical investigators is all about execution fidelity for the TNX-103 program. The ongoing Phase 3 LEVEL study, which is being conducted in the United States and Canada, is nearing its target enrollment of 230 patients, with completion anticipated in the first half of 2026. Tenax Therapeutics is clearly maintaining engagement, reporting high rates of study and therapy continuation through both the blinded and open-label extension stages of LEVEL. Furthermore, the second registrational Phase 3 study, LEVEL-2, is set to initiate in 2025 with a global footprint. To support this, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study as of the third quarter of 2025.

Study	Patient Enrollment Target	Geographic Scope (Initial)	Investigative Sites Qualified (LEVEL-2)
Phase 3 LEVEL	230 patients	U.S. and Canada	N/A (U.S./Canada focus)
Phase 3 LEVEL-2	Not specified	Global footprint	Over 160 sites across 15 countries (qualified)

Investor relations via conferences and webcasts for capital market confidence

Maintaining capital market confidence is crucial, especially while funding two Phase 3 trials. Tenax Therapeutics reported a cash position of $99.4 million as of September 30, 2025. This follows a March 2025 private placement that brought in approximately $25 million in gross proceeds. Management projects this cash, which stood at $111.4 million on March 31, 2025, will fund operations through 2027. The company actively engages through investor events, with announcements for participation in conferences like the 8th Annual Evercore Healthcare Conference on December 2, 2025, and the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025. Analyst sentiment, based on data from May 2025, showed a consensus brokerage recommendation of 1.3 from 4 brokerage firms, where 1 signifies Strong Buy.

Here's the quick math on recent capital activity:

• Cash as of September 30, 2025: $99.4 million
• Cash as of March 31, 2025: $111.4 million
• Gross Proceeds from March 2025 Private Placement: $25 million
• Projected Cash Runway: Through 2027

Direct communication with Key Opinion Leaders (KOLs) to shape clinical defintely strategy

Engaging KOLs directly helps validate the clinical strategy for TNX-103 in treating Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). Tenax Therapeutics hosted a Virtual KOL Call on Thursday, November 13, 2025, at 4:30 p.m. ET. This event featured members of the management team joined by recognized key opinion leaders in cardiovascular medicine to discuss the treatment landscape and the late-stage development program for TNX-103.

Patient support programs within the clinical trial framework

For patients enrolled in the TNX-103 trials, the relationship is managed through the structure of the trials themselves, emphasizing continued participation. The high rates of study and therapy continuation observed in the Phase 3 LEVEL study serve as a key metric for the effectiveness of the support framework provided to trial participants. The goal is to maintain this engagement until enrollment completion, targeted for the first half of 2026.

Finance: review Q3 2025 R&D spend of $10.3 million against site activation milestones by next Tuesday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Channels

You're looking at how Tenax Therapeutics, Inc. gets its science and corporate story out to the world-from the research sites running the trials to the investors watching the stock. It's all about execution and communication in the clinical development phase.

Global Network of Clinical Trial Sites (US, Canada, Europe, etc.)

The primary channel for clinical data generation is the network of investigative sites running the two registrational Phase 3 studies for TNX-103 (oral levosimendan) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF).

• The ongoing Phase 3 LEVEL study is currently being conducted in the United States and Canada.
• Enrollment for LEVEL, targeting 230 patients, is expected to be completed in the first half of 2026.
• The second registrational Phase 3 study, LEVEL-2, which has a global footprint, was on track to initiate in 2025.
• As of the third quarter of 2025, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study.

Regulatory Submissions (NDA, MAA) to the FDA and European Medicines Agency (EMA)

Regulatory engagement is a critical channel for product approval. Tenax Therapeutics, Inc. has been actively communicating its development plan to the U.S. Food and Drug Administration (FDA).

The FDA completed its review of the updated Phase 3 development plan for TNX-103, which included the amendment for the LEVEL study and the protocol for LEVEL-2, in March 2025. The company expects to file for approval in the U.S. and other geographies upon successful completion of both registrational studies.

On the European side, the channel for IP protection is strong:

• In September 2025, the European Patent Office (EPO) notified Tenax Therapeutics, Inc. of its Intention to Grant a patent application.
• This grant provides intellectual property protection in Europe for the treatment of PH-HFpEF with TNX-103 and other levosimendan formulations until at least December 2040.

Investor Relations Website and Financial News Wires for Corporate Updates

You need timely, accurate financial and operational data to assess the company's runway and progress. Tenax Therapeutics, Inc. uses its investor relations webpage and news wires to disseminate this information.

Here are the key figures from the latest reported period, the third quarter ended September 30, 2025:

Metric	Value as of Q3 2025 / Period Ended
Cash and Cash Equivalents	$99.4 million (as of September 30, 2025)
Cash Runway Expectation	Through 2027
Shares Outstanding	40.57 million
Market Capitalization	$391.50 million
R&D Expenses (Q3 2025)	$10.3 million
G&A Expenses (Q3 2025)	$6.5 million
Net Loss (Q3 2025)	$15.8 million

The last earnings call reporting these figures was held on November 12, 2025. The company also announced participation in the 8th Annual Evercore Healthcare Conference on December 2, 2025.

Peer-Reviewed Publications for Scientific Dissemination (e.g., Journal of Cardiac Failure)

Disseminating the scientific rationale through peer review is vital for establishing credibility with the medical community. Tenax Therapeutics, Inc. has used this channel to support its trial designs.

• A protocol design paper, titled "Oral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial," was published in the Journal of Cardiac Failure.
• Other relevant scientific literature shared by the company includes a paper in the European Journal of Heart Failure from April 19, 2024.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Segments

You're looking at the core groups Tenax Therapeutics, Inc. (TENX) must satisfy to get TNX-103 (oral levosimendan) to market for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This isn't just about patients; it's about the entire ecosystem that validates, funds, and approves the therapy.

Patients suffering from Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

This group represents the ultimate end-user, a population with a debilitating, often fatal disease for which no drugs are currently approved in the United States or Canada. The company is advancing TNX-103 through two registrational Phase 3 studies targeting this specific indication. The focus is on improving quality of life and exercise ability for these patients.

Cardiologists and pulmonologists specializing in heart failure and pulmonary hypertension

These specialists are the prescribers and the key opinion leaders (KOLs) who validate the clinical utility of TNX-103. Tenax Therapeutics actively engages them, hosting events like the Virtual KOL Call on November 13, 2025, to discuss the treatment landscape and the product's differentiation. The clinical program requires their participation to enroll and treat patients.

• Phase 3 LEVEL study enrollment completion targeted for the first half of 2026, involving 230 patients.
• LEVEL-2, the second global Phase 3 study, is set to initiate in 2025.
• Over 160 investigative sites new to the program have been qualified for the LEVEL-2 study across 15 countries.
• Patient continuation rates in the LEVEL trial through blinded and open-label extension stages have been reported as high.

Institutional and accredited healthcare investors funding development

These stakeholders provide the necessary capital to fund the expensive, late-stage clinical development. Their confidence, demonstrated through financing rounds, directly impacts the company's operational runway. You need to see the burn rate against the cash reserves to gauge their ongoing support.

Here's the quick math on the capital structure as of late 2025, based on the third quarter results:

Financial Metric	Amount / Date
Cash and Cash Equivalents (as of September 30, 2025)	$99.4 million
Cash Position (as of June 30, 2025)	$105.5 million
Cash Runway Projection	Through 2027
Private Placement Proceeds (March 2025)	$25 million
Q3 2025 Net Loss	$15.8 million
Q3 2025 Research & Development Expenses	$10.3 million
Q3 2025 General & Administrative Expenses	$6.5 million

What this estimate hides is the timing of the topline data readout, expected in the second half of 2026, which will be the next major inflection point for this segment. Still, the current cash position seems adequate for the near term.

Regulatory agencies (FDA, EMA) as the gatekeepers for market access

The FDA and EMA control whether TNX-103 can be prescribed in major markets. Tenax Therapeutics, Inc. must satisfy their requirements for safety and efficacy data from the ongoing Phase 3 trials. The FDA completed its review of the updated Phase 3 development plan for TNX-103 in March 2025. Defintely, securing intellectual property protection is also key to their market strategy.

• FDA completed review of updated Phase 3 development plan for TNX-103 in March 2025.
• European Patent Office (EPO) notified Tenax of Intention to Grant a patent in September 2025.
• The granted European patent covers TNX-103 (oral levosimendan) and other formulations for treating PH-HFpEF.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Cost Structure

You're looking at the expense side of Tenax Therapeutics, Inc.'s operations as they push their lead program through late-stage trials. The cost structure is heavily weighted toward clinical execution, which is typical for a Phase 3 company. Honestly, the numbers reflect a significant ramp-up in activity compared to the prior year.

For the third quarter ended September 30, 2025, the total operating expenses are clearly dominated by the push to complete the LEVEL study and initiate LEVEL-2. The reported net loss for the quarter was $15.8 million, a substantial increase from the $4.0 million net loss in the third quarter of 2024. This burn rate is being funded by their cash position, which stood at $99.4 million as of September 30, 2025, a figure management believes supports operations through 2027.

Here's the quick math on the major expense categories for Q3 2025:

Expense Category	Q3 2025 Amount	Q3 2024 Amount
Research and Development (R&D) Expense	$10.3 million	$3.1 million
General and Administrative (G&A) Expense	$6.5 million	$1.5 million

The increase in R&D expenses, which rose by 232% year-over-year, is directly tied to advancing the clinical pipeline. You can see the breakdown of where that money is going, defintely.

• Costs driven by the ongoing Phase 3 LEVEL study execution.
• Start-up activities for the second global Phase 3 study, LEVEL-2, in anticipation of patient enrollment.
• Increased personnel costs due to an increased R&D employee headcount during 2025.

Stock-based compensation is a notable non-cash component inflating both R&D and G&A figures. The G&A costs, specifically, saw a massive jump to $6.5 million in Q3 2025 from $1.5 million in Q3 2024, largely due to this compensation.

The non-cash stock-based compensation expense breakdown for Q3 2025 is as follows:

• R&D Non-Cash Stock-Based Compensation: $1.1 million.
• G&A Non-Cash Stock-Based Compensation: $4.5 million.

The execution timeline for the clinical trials is a major cost driver. Tenax Therapeutics expects to complete enrollment of the 230 patients in the LEVEL study in the first half of 2026, with topline data expected in the second half of 2026. Furthermore, the company remains on track to initiate the global LEVEL-2 study within 2025, which involves qualifying over 160 investigative sites across 15 countries.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Tenax Therapeutics, Inc. (TENX) as of late 2025. For a Phase 3 development-stage company, the current revenue picture is exactly what you'd expect: it's entirely dependent on capital markets, not product sales.

Currently, Tenax Therapeutics has zero product revenue. As a Phase 3, development-stage pharmaceutical company, the focus remains on clinical execution rather than commercial sales. The reported revenue for the third quarter ending September 30, 2025, was $0.0. This aligns with the company's status as it seeks approval for its lead candidate, TNX-103.

The primary source of operational funding right now is equity financing. This is how you keep the lights on and the trials running when you don't have a product on the market. Tenax Therapeutics successfully executed a significant capital raise to support this late-stage development.

Here's a look at the most recent financing event that underpins the current operations:

Financing Event	Date Closed	Gross Proceeds	Use of Proceeds
Private Placement Financing	March 5, 2025	Approximately $25 million	Advancing Phase 3 clinical trials (LEVEL and LEVEL-2) and general corporate expenses

This capital infusion helped bolster the balance sheet. As of September 30, 2025, Tenax Therapeutics reported cash and cash equivalents of $99.4 million. Management has stated that this cash position is expected to fund the Company through 2027. That runway is critical for reaching key data milestones without immediate pressure to raise again.

Future potential revenue streams are entirely contingent on the clinical success and subsequent regulatory approval of TNX-103, which is being evaluated for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF).

The path to commercial revenue involves two main components:

• The potential for revenue from commercial sales of TNX-103 following any potential U.S. Food and Drug Administration (FDA) approval.
• The potential for future licensing or partnership revenue, specifically for ex-US commercialization efforts.

To be fair, Tenax Therapeutics significantly expanded its commercial potential in September 2025 by securing the exclusive worldwide development, commercialization, and manufacturing rights for orally-administered levosimendan. This move solidifies their control over the asset globally, which is key for structuring any future international deals that would generate partnership revenue.

Here's a quick look at the current financial standing relative to operations:

Metric	Value (as of late 2025)	Date Reference
Current Product Revenue	$0.00	Q3 2025
Cash & Equivalents	$99.4 million	September 30, 2025
Projected Cash Runway	Through 2027	Management Guidance

The entire revenue model for Tenax Therapeutics pivots on the data expected mid-2026 from the Phase 3 LEVEL study. Finance: review the cash burn rate against the $99.4 million balance by next Tuesday.