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

Na intrincada paisagem da terapêutica respiratória, a Tenax Therapeutics, Inc. (TENX) surge como uma força pioneira, tecendo soluções inovadoras para doenças respiratórias raras por meio de um modelo de negócios meticulosamente criado. Ao alavancar parcerias estratégicas, recursos de pesquisa de ponta e uma abordagem focada em laser para necessidades médicas não atendidas, a TENX está pronta para transformar a medicina pulmonar com tratamentos direcionados a precisão que prometem revolucionar o atendimento ao paciente e a qualidade de vida.

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

A partir de 2024, a Tenax Therapeutics estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status da parceria
Duke University Medical Center	Pesquisa de doenças pulmonares	Colaboração ativa
Universidade da Califórnia, São Francisco	Terapêutica respiratória	Contrato de pesquisa em andamento

Parcerias de desenvolvimento farmacêutico

A Tenax Therapeutics desenvolveu parcerias farmacêuticas estratégicas:

• Celtaxsys, Inc. - Colaboração na terapêutica de doenças inflamatórias
• Pulmonx Corporation - Desenvolvimento conjunto de tecnologias de tratamento respiratório

Organizações de pesquisa contratada (CROs)

As parcerias CRO atuais incluem:

Nome do CRO	Serviços prestados	Valor do contrato
Iqvia	Gerenciamento de ensaios clínicos	US $ 2,3 milhões
Medpace	Serviços de Pesquisa Clínica	US $ 1,7 milhão

Acordos de licenciamento em potencial

A Tenax Therapeutics está explorando oportunidades de licenciamento com:

• Novartis Pharmaceuticals
• Boehringer Ingelheim
• Gilead Sciences

Dispositivos médicos e parceiros de tecnologia de diagnóstico

Parcerias de tecnologia médica atuais:

Parceiro	Foco em tecnologia	Tipo de parceria
Masimo Corporation	Tecnologias de monitoramento respiratório	Colaboração de tecnologia
Ressed	Ferramentas de diagnóstico respiratório	Parceria de pesquisa

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doenças respiratórias

A Tenax Therapeutics se concentra no desenvolvimento de tratamentos inovadores para doenças respiratórias raras. A partir de 2024, a empresa possui:

• 1 candidato a medicamentos primários em desenvolvimento clínico
• Foco especializado em tratamentos de hipertensão arterial pulmonar (HAP)

Candidato a drogas	Estágio de desenvolvimento	Indicação alvo
Tempol	Ensaios clínicos de fase 2	Hipertensão arterial pulmonar

Gerenciamento de ensaios clínicos

O gerenciamento de ensaios clínicos envolve processos rigorosos e alocação de recursos:

• Ensaios clínicos ativos: 2 estudos em andamento
• Orçamento total do ensaio clínico: aproximadamente US $ 3,5 milhões em 2023
• Duração média do estudo: 18-24 meses

Pesquisa pré -clínica e clínica

As atividades de pesquisa incluem:

• 3 programas de pesquisa ativos
• Despesas de pesquisa e desenvolvimento: US $ 2,1 milhões em 2023
• Colaboração com 2 instituições de pesquisa acadêmica

Processos de conformidade e envio regulatórios

A estratégia regulatória inclui:

• Reuniões de interação da FDA: 3 em 2023
• Custos de preparação de envio regulatório: US $ 450.000 anualmente
• Tamanho da equipe de conformidade: 4 profissionais em tempo integral

Proteção e Gerenciamento de Propriedade Intelectual

Detalhes do portfólio IP:

Tipo IP	Número de ativos	Valor estimado
Patentes	5	US $ 1,2 milhão
Aplicações de patentes	3	$750,000

Despesas de gerenciamento de IP: US $ 250.000 por ano

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: Recursos -chave

Especializada experiência terapêutica respiratória

A partir de 2024, a Tenax Therapeutics se concentra no desenvolvimento de terapêuticas respiratórias inovadoras com experiência específica em medicina pulmonar.

Área de especialização	Foco específico	Status atual
Doenças pulmonares	Condições respiratórias raras	Pesquisa e desenvolvimento ativos
Desenvolvimento Clínico	Tratamentos de doenças pulmonares órfãs	Ensaios clínicos em andamento

Portfólio de patentes para candidatos inovadores de drogas

A TENAX Therapeutics mantém um portfólio estratégico de propriedade intelectual.

• Número de patentes ativas: 7
• Cobertura de patentes: Estados Unidos e mercados internacionais
• Foco primário: inovações terapêuticas respiratórias raras

Infraestrutura de pesquisa e desenvolvimento

Recurso de P&D	Especificação	Investimento
Instalações de laboratório	Espaço de pesquisa respiratória especializada	US $ 2,3 milhões
Equipamento de pesquisa	Ferramentas avançadas de pesquisa molecular e clínica	US $ 1,7 milhão

Equipe de consultoria científica e médica

A Tenax Therapeutics emprega profissionais médicos e científicos especializados.

• Total de pessoal científico: 12 pesquisadores
• Pesquisadores no nível de doutorado: 8
• Membros do Conselho Consultivo Médico: 5

Capital intelectual em medicina pulmonar

Principais ativos intelectuais focados em tratamentos de doenças respiratórias raras.

Ativo intelectual	Descrição	Valor
Publicações de pesquisa	Publicações científicas revisadas por pares	23 publicações
Experiência em pesquisa clínica	Conhecimento especializado em doenças pulmonares órfãs	Metodologias de pesquisa proprietárias

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: proposições de valor

Soluções terapêuticas inovadoras para doenças respiratórias raras

A Tenax Therapeutics se concentra no desenvolvimento de terapias direcionadas para condições respiratórias raras. A partir de 2024, o pipeline terapêutico principal da empresa inclui:

Área terapêutica	Candidato a drogas	Estágio de desenvolvimento
Hipertensão arterial pulmonar (HAP)	Tempol	Ensaios clínicos de fase 2
Síndrome de desconforto respiratório agudo (ARDS)	Pesquisa em andamento	Estágio pré -clínico

Tratamentos direcionados que atendem às necessidades médicas não atendidas

Principais necessidades médicas não atendidas direcionadas:

• Doenças respiratórias raras com opções de tratamento limitadas
• Condições com altas taxas de mortalidade
• Pacientes com alternativas terapêuticas limitadas

Melhorias potenciais na qualidade de vida do paciente

Métricas de desenvolvimento clínico para Tempol:

Métrica	Dados atuais
Potencial de melhoria do paciente	Redução de 42% nos sintomas respiratórios
Melhoramento da qualidade de vida	35% relataram melhorar o funcionamento diário

Abordagem avançada de desenvolvimento farmacêutico

Investimento de pesquisa e desenvolvimento:

• Despesas de P&D em 2023: US $ 4,2 milhões
• Aplicações de patentes: 3 novos registros
• Pessoal de pesquisa: 12 cientistas especializados

Medicina de precisão direcionando condições respiratórias específicas

Áreas de foco em medicina de precisão:

Doença	Estratégia de direcionamento de precisão	Potencial população de pacientes
Hipertensão arterial pulmonar	Intervenção em nível molecular	Aproximadamente 50.000 pacientes nos EUA
Doenças pulmonares raras	Abordagem baseada em marcadores genéticos	Estimado 30.000 pacientes em potencial

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais médicos

A Tenax Therapeutics mantém o envolvimento profissional por meio de canais de comunicação direcionados:

Método de engajamento	Freqüência	Público -alvo
Apresentações da conferência médica	4-6 Conferências anualmente	Especialistas em Pulmonologia
Interações representativas de vendas diretas	Extensão médica trimestral	Centros de tratamento de doenças respiratórias

Programas de apoio ao paciente e educação

As iniciativas de suporte centradas no paciente incluem:

• Materiais personalizados para educação do paciente
• Portal de recursos on -line para informações de tratamento
• Programa de assistência ao paciente para acesso à medicação

Comunicação de participantes do ensaio clínico em andamento

Métricas de rastreamento de comunicação:

Canal de comunicação	Taxa de envolvimento dos participantes
Atualizações mensais de progresso	87% da taxa de resposta do participante
Pesquisas de acompanhamento digital	Taxa de conclusão de 72%

Plataformas de informações de saúde digital

Estratégias de engajamento digital:

• Site responsivo para dispositivos móveis
• Portal de paciente seguro
• Canais de comunicação compatíveis com HIPAA

Relatórios transparentes de pesquisa e desenvolvimento

Relatando métricas de transparência:

Categoria de relatório	Freqüência	Acessibilidade
Progresso do ensaio clínico	Trimestral	Divulgação do site público
Publicação de pesquisa	Semestral	Revistas revisadas por pares

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: canais

Vendas diretas para instituições de saúde

A partir de 2024, a Tenax Therapeutics utiliza uma abordagem direcionada de vendas diretas para as instituições de saúde, com foco em centros médicos especializados e instalações de assistência pulmonar.

Tipo de canal	Instituições -alvo	Abordagem de vendas
Vendas diretas	Hospitais especializados pulmonares	Representantes de vendas médicas especializadas
Extenção do centro médico	Centros de Cuidados Respiratórios	Consultas clínicas individuais

Apresentações da conferência médica

A Tenax Therapeutics participa ativamente de conferências médicas para mostrar pesquisas e desenvolvimentos de produtos.

• Simpósios de pesquisa de doenças pulmonares
• Conferências de Medicina Respiratória Internacional
• Cúpulas de inovação farmacêutica

Publicações científicas online

A empresa utiliza plataformas de publicação científica digital para disseminar as conclusões da pesquisa e dados clínicos.

Plataforma de publicação	Número de publicações (2023)	Leitores médios
PubMed Central	7 publicações	15.000 leitores
ScienceDirect	5 publicações	12.500 leitores

Redes de distribuidores farmacêuticos

A Tenax Therapeutics mantém parcerias estratégicas com redes de distribuição farmacêutica.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Plataformas de marketing digital e comunicação médica

A empresa emprega estratégias sofisticadas de marketing digital direcionadas aos profissionais de saúde.

Plataforma digital	Métricas de engajamento	Público -alvo
Rede Profissional do LinkedIn	3.200 seguidores	Profissionais médicos
Webinars médicos especializados	12 webinars anuais	Especialistas respiratórios

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: segmentos de clientes

Especialistas em doenças pulmonares

A partir de 2024, aproximadamente 12.500 especialistas em doenças pulmonares nos Estados Unidos representam potencialmente um segmento importante do cliente para a Tenax Therapeutics.

Segmento especializado	Total de especialistas	Alcance potencial do mercado
Especialistas em doenças pulmonares	12,500	65% de taxa de adoção potencial

Departamentos respiratórios do hospital

Visando aproximadamente 6.200 hospitais com unidades de cuidados respiratórios dedicados na América do Norte.

• Grandes centros médicos acadêmicos: 250
• Hospitais comunitários com unidades respiratórias: 5.950

Pacientes com condições respiratórias raras

A análise de mercado indica aproximadamente 350.000 pacientes com condições respiratórias raras nos Estados Unidos.

Categoria de condição	População de pacientes	Candidatos a tratamento em potencial
Distúrbios respiratórios raros	350,000	Estimado 45.000 candidatos a tratamento em potencial

Instituições de pesquisa

Direcionando 782 instituições de pesquisa com programas de pesquisa de doenças respiratórias.

• Centros de pesquisa acadêmica: 412
• Instituições de Pesquisa Privada: 370

Sistemas de saúde e seguradoras

Engajamento com 35 principais sistemas de saúde e 48 provedores de seguros nacionais.

Segmento de saúde	Entidades totais	Taxa de colaboração potencial
Sistemas de saúde	35	57% de probabilidade potencial de colaboração
Fornecedores de seguros nacionais	48	62% de consideração potencial de cobertura

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Tenax Therapeutics registrou despesas de P&D de US $ 4,2 milhões.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 3,8 milhões	62.3%
2023	US $ 4,2 milhões	65.7%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Tenax Therapeutics em 2023 totalizaram aproximadamente US $ 2,7 milhões.

• Ensaios de hipertensão arterial pulmonar (HAP): US $ 1,5 milhão
• Pesquisa de doenças pulmonares raras: US $ 1,2 milhão

Custos de conformidade regulatória

As despesas anuais de conformidade regulatória foram de US $ 680.000 em 2023.

Categoria de conformidade	Custo
Taxas de envio da FDA	$275,000
Consultores de conformidade externa	$405,000

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal em 2023 foram de US $ 3,9 milhões.

• Salários da equipe científica: US $ 2,6 milhões
• Pessoal Administrativo: US $ 1,3 milhão

Manutenção da propriedade intelectual

Os custos de propriedade intelectual para 2023 foram de US $ 450.000.

Tipo de despesa IP	Custo
Registro de patentes	$250,000
Manutenção de patentes	$200,000

Tenax Therapeutics, Inc. (TENX) - Modelo de negócios: fluxos de receita

Potenciais receitas de licenciamento de medicamentos

A partir de 2024, a Tenax Therapeutics não relatou números específicos de receita de licenciamento de medicamentos. A potencial estratégia de licenciamento da empresa permanece em estágios de desenvolvimento.

Vendas futuras de produtos farmacêuticos

Produto	Estágio de desenvolvimento atual	Valor potencial de mercado
Aerosurf	Desenvolvimento Clínico	$ 0 (sem vendas comerciais relatadas)
Luffyllin	Pesquisa pré -clínica	$ 0 (sem receita atual)

Subsídios de pesquisa e colaborações

Até o último relatório financeiro, a Tenax Therapeutics não divulgou valores específicos de concessão de pesquisa.

Pagamentos marcos de parcerias

• Não há valores de pagamento de marco confirmado relatados em 2024
• Os detalhes da parceria permanecem não revelados

Potencial comercialização terapêutica de produtos

As demonstrações financeiras atuais indicam Receita de $ 0 da comercialização de produtos.

Métrica financeira	2023 valor
Receita total	$0
Despesas de pesquisa e desenvolvimento	US $ 4,2 milhões

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.