Tenaya Therapeutics, Inc. (TNYA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No domínio de ponta da terapêutica cardíaca genética, a terapêutica de Tenaya surge como um farol de esperança, soluções de medicina de precisão transformadora pioneira que prometem revolucionar o tratamento de doenças cardíacas complexas. Ao alavancar tecnologias avançadas de engenharia genética e colaborações estratégicas com líderes da indústria como a Roche, esta empresa inovadora de biotecnologia está desenvolvendo terapias inovadoras que visam mutações genéticas específicas, oferecendo abordagens de tratamento personalizadas para pacientes com condições genéticas cardíacas não adquiridas anteriormente. Sua abrangente modelo de negócios Canvas revela uma estratégia sofisticada pronta para remodelar a medicina cardiovascular por meio de intervenções direcionadas e cientificamente rigorosas que poderiam potencialmente desbloquear novos caminhos para a cura.

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com a Roche para pesquisa genética de doenças cardíacas

Em janeiro de 2023, a Tenaya Therapeutics anunciou uma colaboração estratégica com a Roche focada no desenvolvimento de terapias genéticas de doenças cardíacas. Os principais detalhes da parceria incluem:

Aspecto da parceria	Detalhes específicos
Foco de colaboração	Pesquisa genética de doenças cardíacas e desenvolvimento terapêutico
Termos financeiros	Pagamento antecipado de US $ 65 milhões da Roche para Tenaya
Potenciais pagamentos marcantes	Até US $ 700 milhões com base em realizações de pesquisa e desenvolvimento

Parceria com centros médicos acadêmicos para ensaios clínicos

A Tenaya Therapeutics estabeleceu parcerias de ensaios clínicos com vários centros médicos acadêmicos:

• Escola de Medicina da Universidade de Stanford
• Universidade da Califórnia, São Francisco
• Escola de Medicina de Harvard
• Johns Hopkins University Medical Center

Colaboração com instituições de pesquisa farmacêutica

Instituição de pesquisa	Foco de colaboração	Ano estabelecido
American Heart Association	Pesquisa genética cardiovascular	2022
Institutos Nacionais de Saúde	Desenvolvimento terapêutico da doença genética	2021

Parcerias em potencial com laboratórios de testes genéticos

Tenaya está explorando parcerias com laboratórios de testes genéticos para avançar abordagens de medicina de precisão:

• Invitae Corporation
• Saúde genômica
• 23andme

Valor potencial de parceria total: Aproximadamente US $ 765 milhões em colaborações atuais e potenciais a partir de 2024.

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapias genéticas de precisão

A Tenaya Therapeutics se concentra no desenvolvimento de terapias genéticas de precisão com um investimento total em P&D de US $ 83,4 milhões a partir de 2023 ano fiscal. A empresa mantém três plataformas distintas de pesquisa de terapia genética direcionadas a doenças genéticas cardíacas.

Área de foco em P&D	Investimento ($ m)	Estágio de pesquisa
Terapias cardíacas genéticas	42.6	Pré -clínico/Fase 1
Tecnologias de edição de genes	25.8	Fase de descoberta
Direcionamento molecular	15.0	Pesquisa translacional

Realização de ensaios clínicos avançados para tratamentos de doenças cardíacas

As atividades de ensaios clínicos abrangem vários estudos em andamento com os gastos atuais de US $ 47,2 milhões em 2023. A Companhia possui 2 programas de estágio clínico primário em desenvolvimento.

• TDN-001: Ensino clínico genético da cardiomiopatia
• TDN-002: Estudo de intervenção genética de insuficiência cardíaca

Desenvolvimento de produtos de terapia genética

A Tenaya mantém 3 pipelines distintos de desenvolvimento de produtos de terapia genética com custos totais de desenvolvimento de produtos de US $ 62,7 milhões em 2023.

Oleoduto de produto	Estágio de desenvolvimento	Investimento projetado
Terapia genética cardíaca	Pré -clínico	US $ 28,3M
Plataforma de intervenção genética	Descoberta	US $ 19,5m
Terapia de direcionamento molecular	Pesquisar	$ 14,9M

Pesquisa molecular e celular

A pesquisa se concentra em condições cardíacas genéticas com uma equipe de pesquisa dedicada de 42 cientistas e um orçamento anual de pesquisa de US $ 35,6 milhões.

Medicina translacional e inovação terapêutica

A empresa investiu US $ 22,1 milhões em pesquisa de medicina translacional, visando 4 mecanismos específicos de doenças cardíacas genéticas em 2023.

• Identificação da mutação genética
• Técnicas de reprogramação celular
• Direcionamento molecular avançado
• Desenvolvimento terapêutico de precisão

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: Recursos -chave

Tecnologias avançadas de engenharia genética

Tenaya Therapeutics desenvolveu 3 tecnologias genéticas proprietárias direcionando doenças cardíacas:

• Plataforma de terapia genética para doenças cardíacas genéticas
• Plataforma de terapia celular para regeneração cardíaca
• Plataforma de moléculas pequenas para distúrbios cardíacos genéticos

Plataformas de terapia gene proprietária

Plataforma	Tipo de tecnologia	Condição alvo
TNYA-001	Terapia genética AAV	Distúrbios genéticos do músculo cardíaco
TNYA-002	Regeneração celular	Insuficiência cardíaca
TNYA-003	Intervenção de pequenas moléculas	Mutações genéticas cardíacas

Equipe especializada de pesquisa e desenvolvimento

Composição do pessoal de pesquisa:

• Equipe total de P&D: 68 funcionários
• Pesquisadores de doutorado: 42
• Especialistas em Engenharia Genética: 26

Portfólio de propriedade intelectual

Categoria IP	Número de patentes	Status de patente
Tecnologias de terapia genética	12	Garantido
Métodos de regeneração celular	8	Pendente
Técnicas de intervenção molecular	6	Arquivado

Instalações de laboratório e pesquisa de ponta

Detalhes da infraestrutura de pesquisa:

• Espaço total da instalação de pesquisa: 35.000 pés quadrados
• Localização: South San Francisco, Califórnia
• Equipamento avançado de sequenciamento genético: 7 plataformas
• Investimento anual de P&D: US $ 48,3 milhões (2023 ano fiscal)

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: proposições de valor

Terapias genéticas de precisão inovadora para doenças cardíacas

Tenaya Therapeutics se concentra no desenvolvimento de terapias genéticas direcionadas às condições cardíacas específicas com os seguintes programas terapêuticos -chave:

Programa	Condição alvo	Estágio de desenvolvimento
TDN-1	Cardiomiopatia genética dilatada	Pré -clínico
TDN-2	Cardiomiopatia hipertrófica	Investigação
TDN-3	Insuficiência cardíaca genética	Estágio de pesquisa

Abordagens de tratamento personalizadas para condições cardíacas genéticas

A abordagem de precisão de Tenaya envolve intervenções genéticas direcionadas com plataformas tecnológicas específicas:

• Modulação de terapia genética
• Edição de genes de precisão
• Estratégias de direcionamento molecular

Potencial para atender às necessidades médicas não atendidas em distúrbios cardíacos genéticos

Categoria de distúrbio	População estimada de pacientes	Limitações atuais de tratamento
Cardiomiopatia dilatada	1 em 2.500 indivíduos	Terapias limitadas específicas para genéticas
Cardiomiopatia hipertrófica	1 em 500 indivíduos	Apenas gestão sintomática

Soluções terapêuticas avançadas direcionadas a mutações genéticas específicas

As plataformas tecnológicas de Tenaya permitem estratégias precisas de intervenção genética:

• Edição de genes baseada em CRISPR
• Abordagens terapêuticas de RNA
• Mecanismos de correção molecular

Potencial promissor para tratamentos genéticos cardíacos transformadores

O investimento financeiro em pesquisa e desenvolvimento demonstra compromisso com terapias genéticas inovadoras:

Ano fiscal	Despesas de P&D	Aplicações de patentes
2022	US $ 42,3 milhões	7 novas aplicações
2023	US $ 56,7 milhões	12 novas aplicações

Tenaya Therapeutics, Inc. (TNYA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A Tenaya Therapeutics mantém o envolvimento direto por meio de canais de comunicação médica direcionados.

Método de engajamento	Freqüência	Público -alvo
Apresentações da conferência científica	4-6 por ano	Cardiologistas, geneticistas
Webinars médicos especializados	3-4 por trimestre	Médicos de pesquisa
Atualizações de pesquisa personalizadas	Trimestral	Líderes de opinião -chave

Programas de apoio ao paciente e educação

Tenaya fornece mecanismos abrangentes de suporte focados no paciente.

• Recursos de aconselhamento genético
• Portal de informações de pacientes online
• Oficinas de conscientização sobre doenças
• Orientação de tratamento individualizada

Comunicação científica e transparência

A comunicação transparente dos resultados da pesquisa é priorizada.

Canal de comunicação	Frequência de publicação	Plataforma
Publicações de revistas revisadas por pares	2-3 por ano	Natureza, Cell, Jama
Relatórios de transparência de dados de pesquisa	Bianually	Site da empresa

Interações dos participantes do ensaio clínico

Abordagem estruturada para gerenciar as relações dos participantes do ensaio clínico.

• Protocolos de consentimento informado
• Monitoramento regular de saúde
• Comunicação abrangente de acompanhamento
• Mecanismos de proteção de privacidade do paciente

Colaboração de pesquisa em andamento com a comunidade médica

Colaboração ativa com instituições de pesquisa e centros médicos.

Tipo de colaboração	Número de parcerias ativas	Foco na pesquisa
Parcerias de pesquisa acadêmica	7 colaborações ativas	Distúrbios genéticos cardíacos
Redes de pesquisa clínica	12 instituições participantes	Iniciativas de Medicina de Precisão

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: canais

Publicações de pesquisa médica direta

Tenaya Therapeutics publica pesquisas em periódicos revisados ​​por pares, como:

Nome do diário	Frequência de publicação	Fator de impacto
Biotecnologia da natureza	Mensal	41.4
Célula	Quinzenal	38.6

Conferências científicas e simpósios

Detalhes da participação da conferência -chave:

• Sessões científicas da American Heart Association
• Conferência de Tecnologias de Pesquisa Cardiovascular
• Congresso da Sociedade Europeia de Cardiologia

Networking da indústria farmacêutica

Plataformas de rede e métricas de engajamento:

Plataforma de rede	Conexões anuais	Valor potencial de colaboração
Convenção Bio Internacional	16.000 participantes	US $ 45 milhões em potencial parcerias
Conferência de Saúde JP Morgan	9.000 participantes	US $ 30 milhões em potenciais investimentos

Plataformas de pesquisa médica online

Canais de engajamento de pesquisa digital:

• Pesquisa
• PubMed Central
• Ciência direta

Alcance médico segmentado

Especificações da estratégia de divulgação:

Método de divulgação	Alcance anual	Taxa de engajamento
Campanhas de e -mail direto	5.200 cardiologistas	12.3%
Série de webinar	3.800 profissionais médicos	8.7%

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: segmentos de clientes

Pacientes com doenças genéticas cardíacas

População total de pacientes endereçáveis ​​para doenças cardíacas genéticas: 1,5 milhão nos Estados Unidos

Segmento de pacientes	População estimada	Necessidade de tratamento potencial
Cardiomiopatia hipertrófica	200,000	Alto
Cardiomiopatia dilatada	500,000	Médio
Síndromes herdadas de arritmia	100,000	Alto

Cardiologistas e especialistas genéticos

Número de cardiologistas praticantes nos Estados Unidos: 33.700

• Subespecialistas da cardiologia genética: 1.200
• Volume anual de teste genético: 250.000 testes genéticos cardíacos

Instituições de Pesquisa Médica Acadêmica

Número de instituições de pesquisa com foco na genética cardíaca: 87

Tipo de instituição	Número de instituições	Orçamento de pesquisa anual
Universidades de pesquisa de primeira linha	22	US $ 500 milhões - US $ 1,2 bilhão
Centros de Pesquisa Médica	45	US $ 100 milhões - US $ 400 milhões
Centros de pesquisa cardíaca especializados	20	US $ 50 milhões - US $ 200 milhões

Organizações de pesquisa farmacêutica

Total de gastos farmacêuticos de P&D em terapias genéticas: US $ 15,2 bilhões em 2023

• Número de empresas farmacêuticas que investem em terapias cardíacas genéticas: 42
• Investimento anual médio por empresa: US $ 362 milhões

Sistemas de saúde focados em terapias genéticas

Número de sistemas de saúde com programas de terapia genética dedicados: 63

Tipo de sistema de saúde	Número de sistemas	Investimento de terapia genética
Grandes centros médicos acadêmicos	28	US $ 75 milhões - US $ 250 milhões
Redes regionais de saúde	35	US $ 20 milhões - US $ 100 milhões

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

De acordo com o relatório financeiro da Tenaya Therapeutics 2023, as despesas de pesquisa e desenvolvimento foram de US $ 31,4 milhões para o trimestre encerrado em 30 de setembro de 2023.

Categoria de despesa	Valor (Q3 2023)
Custos de pessoal	US $ 12,6 milhões
Suprimentos de laboratório	US $ 8,2 milhões
Contratos de pesquisa externa	US $ 6,9 milhões
Custos da instalação	US $ 3,7 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para o ano de 2023 totalizaram aproximadamente US $ 45,2 milhões.

• Ensaios de fase 1: US $ 15,6 milhões
• Ensaios de fase 2: US $ 22,8 milhões
• Conformidade regulatória: US $ 6,8 milhões

Proteção à propriedade intelectual

A Tenaya Therapeutics gastou US $ 2,3 milhões em proteção de propriedade intelectual em 2023.

Categoria de proteção IP	Custo
Registro de patentes	US $ 1,4 milhão
Taxas legais	US $ 0,9 milhão

Investimentos avançados de tecnologia e equipamentos

Os investimentos em tecnologia e equipamentos para 2023 atingiram US $ 7,5 milhões.

• Equipamento de pesquisa de terapia genética: US $ 4,2 milhões
• Infraestrutura de biologia computacional: US $ 2,1 milhões
• Instrumentação de laboratório especializada: US $ 1,2 milhão

Recrutamento e retenção especializados de talentos

As despesas totais relacionadas ao talento em 2023 foram de US $ 18,6 milhões.

Categoria de despesa de talentos	Quantia
Compensação	US $ 14,3 milhões
Recrutamento	US $ 2,5 milhões
Treinamento e desenvolvimento	US $ 1,8 milhão

Tenaya Therapeutics, Inc. (TNYA) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos terapêuticos futuros

No quarto trimestre 2023, a Tenaya Therapeutics ainda não gerou receita de produtos comerciais. Os principais candidatos a terapia genética da empresa para doenças cardíacas estão em estágios de desenvolvimento clínico.

Acordos de colaboração de pesquisa

Parceiro de colaboração	Tipo de contrato	Valor potencial
Pharmaceuticals de vértice	Colaboração de pesquisa	Pagamento antecipado de US $ 65 milhões em 2022

Licenciamento de tecnologias de terapia genética

Portfólio de propriedade intelectual:

• 3 plataformas de tecnologia de terapia genética centrais
• Múltiplas aplicações de patentes em terapia genética cardiovascular

Potenciais pagamentos marcantes de parcerias farmacêuticas

Programa	Potenciais pagamentos marcantes	Estágio de desenvolvimento
Colaboração de vértices	Até US $ 700 milhões em possíveis pagamentos marcantes	Desenvolvimento pré -clínico/clínico

Conceder financiamento e suporte de pesquisa

Total de financiamento do subsídio recebido: US $ 12,3 milhões do NIH e de outras instituições de pesquisa a partir de 2023.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Value Propositions

Potentially curative, one-time treatment for genetic heart diseases.

Tenaya Therapeutics, Inc. is advancing gene therapies designed to offer a single-administration solution for inherited cardiomyopathies, aiming to halt or reverse disease progression. As of the third quarter of 2025, the company reported a net loss of $20.3 million, with Research & Development Expenses at $15.4 million for the quarter, reflecting investment in these pipeline assets. The cash, cash equivalents, and investments stood at $56.3 million as of September 30, 2025, which management believes, along with potential loan availability, funds operations into the second half of 2026.

The core value proposition is rooted in the potential for durable, disease-modifying effects from a single dose, contrasting with chronic management strategies. The company's market capitalization was reported at $221.5 million in early December 2025.

Program	Indication	Trial Phase/Status (Late 2025)	Key Clinical Data Point
TN-201	MYBPC3-associated HCM	Phase 1b/2a MyPEAK-1 (Dose Expansion)	LVPWT reduced 21-39% at week 52 in Cohort 1
TN-401	PKP2-associated ARVC	Phase 1 RIDGE-1 (Cohort 2 Dosing Complete)	Safety/biopsy data from Cohort 1 expected by year-end 2025
TN-301	HFpEF	Preclinical/Early Stage	Small molecule HDAC6 inhibitor

Addressing the underlying cause of MYBPC3-HCM and PKP2-ARVC.

For MYBPC3-HCM, the value proposition is correcting the genetic defect causing the disease. The MyPEAK-1 trial has dosed a total of seven patients to date, with the study designed to recruit up to 30 patients. Data presented in November 2025 showed that all Cohort 1 patients achieved NYHA Class I by one year post-treatment.

For PKP2-ARVC, the therapy aims to restore the structural integrity of heart muscle cells by delivering a functional PKP2 gene. The RIDGE-1 trial is assessing a one-time intravenous infusion of TN-401.

• The MyClimb natural history study for pediatric MYBPC3-associated HCM enrolled over 200 individuals across 29 clinical sites worldwide.
• In a study of MYBPC3-associated HCM patients, nearly 95% would be below the 1:80 neutralizing antibody (NAb) titer threshold for the AAV9 vector used in TN-201.
• For TN-401, a seroprevalence study in PKP2-associated ARVC indicated 84% of volunteers had NAb titers of less than 1:20 against AAV9.
• The PKP2 mutation is found in about 45% of people diagnosed with genetic ARVC in the U.S.

Therapies targeting rare diseases with high unmet medical need.

The gene therapies target rare, progressive, and life-threatening conditions where current treatment options are largely supportive rather than curative. The scale of the need is defined by the prevalence of the underlying genetic variants.

Condition	Pathogenic Variant Prevalence (Per 1,000,000)	Disease Status
ARVC (Pathogenic Variants)	Approximately 1,730 (1 in 578)	Fewer than 200,000 people affected in the U.S.
HCM (Pathogenic Variants)	Approximately 6,711 (1 in 149)	MYBPC3 variants account for 20 of 32 individuals in one HCM G+ cohort.

Small molecule (TN-301) for more prevalent heart failure (HFpEF).

TN-301 is a small molecule HDAC6 inhibitor being developed for Heart Failure with preserved Ejection Fraction (HFpEF), a more prevalent condition than the rare cardiomyopathies in the pipeline. This program diversifies the value proposition toward a larger patient population, though it is in earlier development stages as of late 2025. The company's Q3 2025 operating expenses totaled $20.9 million, demonstrating cost control while advancing this and other pipeline assets.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so the relationship with the scientific and investment communities is everything right now. Tenaya Therapeutics, Inc. (TNYA) focuses its customer relationship strategy on deep engagement with the specialized groups that validate its science and fund its pipeline.

High-touch, direct engagement with clinical investigators and key opinion leaders

Direct scientific exchange is paramount for a clinical-stage company. Tenaya Therapeutics, Inc. actively engages investigators through trial execution and scientific presentations. For instance, interim clinical data from the MYPEAK™-1 Phase 1b/2a trial of TN-201 for MYBPC3-associated Hypertrophic Cardiomyopathy (HCM) was presented at the American Heart Association Scientific Sessions in November 2025. This trial, a multi-center, open-label, dose-escalation study, had dosed a total of seven patients with TN-201 across two dose levels as of November 10, 2025. Also, the company hosted a Virtual Key Opinion Leader event on August 19, 2025, focused on 'Measuring Protein Expression in Cardiac Gene Therapy,' featuring experts like Michael Previs, Ph. That kind of focused event helps shape the perception of the science among the most influential clinicians.

The RIDGE™-1 trial for TN-401 also required close investigator management, with Cohort 2 dosing completed as of the Q3 2025 update. The company's visibility is amplified by presenting at major medical meetings; for example, late-breaker data on MyPEAK-1 was featured at the ACC Annual Scientific Session in March 2025.

Patient advocacy groups for support and natural history studies (MyClimb, RIDGE)

Tenaya Therapeutics, Inc. treats patients with rare genetic cardiomyopathies, making advocacy groups crucial partners for understanding disease burden and trial recruitment. The company runs two significant non-interventional natural history studies to characterize the patient populations they aim to treat. These studies provide the real-world context needed to design better trials and manage expectations with regulators and investors alike.

Here's a quick look at the scale of engagement in these patient-centric studies as of mid-to-late 2025:

Study Name	Indication	Patient Count (Approx.)	Site Count (Approx.)	Key Data Event (2025)
MyClimb™	Pediatric MYBPC3-associated HCM	More than 200	29 worldwide	Interim Data at ESC Congress
RIDGE™	Adult PKP2-associated ARVC	191 (as of April 2025 cut-off)	18 (U.S., UK, Europe)	Interim Data at HRS Meeting

The MyClimb study, initiated in 2021, characterized disease burden in patients under eighteen, where 93% of participants had the nonobstructive HCM phenotype, an area with no approved treatments. For the RIDGE study, data showed a high burden of disease, with more than 80% of participants experiencing $\ge \mathbf{500}$ premature ventricular contractions (PVCs) per day.

Investor relations and conference presentations to manage market expectations

Managing market expectations is a constant relationship Tenaya Therapeutics, Inc. maintains with its shareholders. The company provided a business update alongside its Third Quarter 2025 Financial Results on November 10, 2025. Financially, the Q3 2025 Net Loss narrowed to $20.3 million, an improvement from $25.6 million a year prior. Cash and cash equivalents stood at $56.3 million as of September 30, 2025, supported by net proceeds of approximately $48.8 million from a March 2025 follow-on offering. The management team held a conference call that day at 8:00 a.m. ET/5:00 a.m. PT to discuss the latest clinical data and financial standing.

Investor engagement is structured around key milestones. Beyond the earnings call, Tenaya Therapeutics, Inc. participated in several investor conferences:

• H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025.
• Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025.

These events are used to communicate progress, such as the positive Data Safety Monitoring Board (DSMB) recommendations for both TN-201 and TN-401 programs, which allowed for dose escalation and expansion cohorts.

Regulatory body interactions (FDA, EMA) for expedited pathways (Fast Track, Orphan Drug)

Regulatory interactions define the path to market for orphan and rare disease therapies. Tenaya Therapeutics, Inc. has secured significant designations for its lead candidates, which streamlines development and provides market exclusivity incentives. The relationship with the FDA and EMA is characterized by these positive regulatory acknowledgments.

Key regulatory statuses as of late 2025 include:

• TN-401 (for PKP2-associated ARVC): Received Orphan Drug and Fast Track Designations from the FDA, plus orphan medicinal product designation from the European Commission.
• TN-201 (for MYBPC3-associated HCM): Received Fast Track, Orphan Drug and Rare Pediatric Drug Designations from the FDA, and orphan medicinal product designation from the European Commission.

However, these relationships also involve managing challenges; for example, the FDA placed the MyPEAK-1 trial for TN-201 on a clinical hold to standardize monitoring and immunosuppression protocol activities, a situation the company is actively working to resolve.

Finance: draft 13-week cash view by Friday.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Channels

You're looking at how Tenaya Therapeutics, Inc. gets its investigational therapies and corporate story out to the world-from clinical sites to the capital markets. This isn't about selling widgets; it's about reaching highly specialized physicians, researchers, and investors, so the channels are very targeted.

Specialized cardiac and genetic disease clinical centers worldwide

The core channel for clinical validation is the network of specialized centers running the trials. Tenaya Therapeutics, Inc. uses a global footprint to enroll patients in its gene therapy programs for genetic cardiomyopathies. This is how they generate the safety and efficacy data needed for regulatory approval.

For the MyPEAK-1 trial of TN-201 (for MYBPC3-associated HCM), the trial is multi-center, and the company has been advancing through dose cohorts. For the RIDGE-1 trial of TN-401 (for PKP2-associated ARVC), the structure is also global multicenter.

Here's a look at the scale of their natural history studies, which feed into trial design and site identification:

Study/Trial Program	Patient Population/Focus	Enrollment/Site Count (as of late 2025)	Geographic Reach Mentioned
MyClimb (Natural History)	Pediatric MYBPC3-associated HCM	More than 200 participants across 29 clinical sites worldwide	Worldwide
RIDGE (Natural History)	PKP2-associated ARVC	More than 100 participants across 18 clinical sites (as of Jan 2025)	U.S., UK, and EU
RIDGE-1 (Clinical Trial)	PKP2-associated ARVC (TN-401)	Cohort 1 enrollment completed (3 patients at 3E13 vg/kg dose)	Global multicenter

The company was planning to activate its first ex-U.S. RIDGE-1 clinical site in the first half of 2025.

Scientific and medical conferences (ACC, ASGCT) for data dissemination

Disseminating clinical and preclinical data is crucial for establishing scientific credibility. Tenaya Therapeutics, Inc. prioritizes high-impact medical meetings to present their findings directly to key opinion leaders and the broader scientific community. This is where they showcase the results from trials like MyPEAK-1 and RIDGE-1.

Key conference engagements in 2025 included:

• Presenting new TN-201 clinical data at the American Heart Association (AHA) 2025 Scientific Sessions in New Orleans, Louisiana (November 7-10, 2025).
• Presenting data at the American College of Cardiology's (ACC) Annual Scientific Session in Chicago, IL (March 29-31, 2025).
• Presenting a poster detailing the RIDGE-1 trial design at the European Society of Gene and Cell Therapy (ESGCT 2025) Annual Congress in October 2025.
• Presenting interim data from the MyClimb study at the European Society of Cardiology Congress in August 2025.

For investor awareness, the CEO participated in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, and the H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025.

Direct communication with patient advocacy organizations

Direct engagement with patient advocacy groups is a primary channel for gathering insights into the patient journey and driving awareness for genetic testing and precision medicines. Tenaya Therapeutics, Inc. states they partner with leading heart disease patient organizations to better understand community needs and inform drug development efforts.

The company's patient advocacy team connects with patients, caregivers, and advocates to drive awareness of the unmet needs in conditions like MYBPC3-associated HCM and PKP2-associated ARVC. However, for their investigational products, clinical trial participation remains the main pathway for access; for instance, the Expanded Access Policy for TN-201 is specifically limited to pediatric patients with confirmed MYBPC3-associated HCM.

Investor presentations and press releases for capital markets

Keeping the capital markets informed is vital for a clinical-stage company funding its pipeline. This channel relies heavily on formal financial reporting and strategic presentations to analysts and investors. You need to know the cash position to gauge operational runway.

Key financial metrics reported as of the end of Q3 2025 (September 30, 2025) include:

Financial Metric	Amount (Q3 2025 or As of Sept 30, 2025)
Cash, Cash Equivalents, and Investments	$56.3 million
Net Loss (Q3 2025)	$20.3 million
R&D Expenses (Q3 2025)	$15.4 million
G&A Expenses (Q3 2025)	$5.6 million
Total Operating Expenses (Q3 2025)	$20.9 million
Shares Outstanding (as of Nov 4, 2025)	166,505,885

Capital raising efforts are also part of this channel; Tenaya Therapeutics, Inc. completed a March 2025 follow-on offering that brought in net proceeds of approximately $48.8 million. Furthermore, an SVB loan agreement offers the right to draw $10.0 million through December 31, 2025. As of November 10, 2025, the Market Cap stood at $226.45 million, with Institutional Ownership at 22.21%. The company stated that existing resources, potential loan availability, and warrant exercises will fund operations for at least twelve months following the filing.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Customer Segments

You're looking at the core groups Tenaya Therapeutics, Inc. (TNYA) targets with its gene therapy pipeline, which is still pre-revenue as of late 2025. These segments are defined by the specific, rare genetic heart conditions they are trying to address, and the financial ecosystem that supports their development.

Patients with rare, monogenic cardiomyopathies (MYBPC3-HCM, PKP2-ARVC)

This is the primary, most critical segment for Tenaya Therapeutics, Inc. (TNYA) right now, as their lead candidates, TN-201 and TN-401, target specific genetic mutations. For MYBPC3-associated hypertrophic cardiomyopathy (HCM), the target population is estimated to be roughly 20% of the entire U.S. HCM patient base, which itself is estimated at 120,000 patients in the United States. The company's natural history study, MyClimb^TM, enrolled more than 200 pediatric patients diagnosed before age 18 across 29 clinical sites worldwide. Furthermore, a September 2025 seroprevalence study found that nearly 95% of these MYBPC3-associated HCM patients would be below the Nab titers of 1:80 threshold required for the TN-201 gene therapy trial. For PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), the prevalence is estimated at more than 70,000 people in the U.S. alone, with PKP2 mutations accounting for approximately 40 percent of the overall ARVC population. The RIDGE natural history study for this indication enrolled more than 175 patients across about 20 clinical sites in the U.S., UK, France, Germany, Italy and Sweden.

Here's a quick look at the patient pool sizes and study scopes:

Indication	Target Gene Therapy	Estimated U.S. Population Size	Natural History Study Enrollment (Approx.)
MYBPC3-HCM	TN-201	~24,000 (20% of 120,000)	Over 200 (MyClimb)
PKP2-ARVC	TN-401	Over 70,000	Over 175 (RIDGE)

Cardiologists and specialized heart failure treatment centers

These are the key prescribers and gatekeepers for clinical trial participation and future product adoption. They are the ones who manage the patients with these rare conditions. The clinical trial infrastructure itself shows the reach into these centers. For instance, the MyClimb study for TN-201 utilized 29 clinical sites worldwide, and the RIDGE study for TN-401 involved approximately 20 clinical sites across multiple countries. These centers are where the data on TN-201's improvements-like reductions in left ventricular posterior wall thickness (LVPWT) by 21-39% at week 52 in Cohort 1 patients-are generated and validated. It's all about building trust with the specialists who see the unmet need daily.

Payers and government health systems (future commercialization)

While Tenaya Therapeutics, Inc. (TNYA) is pre-revenue, payers-both private insurers and government systems like Medicare/Medicaid-become a critical segment upon regulatory approval. Their focus will be on the cost-effectiveness of a one-time curative therapy versus decades of standard-of-care management for chronic, progressive diseases. The company's Q3 2025 net loss was $20.3 million, reflecting the high cost of development that payers will eventually need to justify. The CIRM grant recognized the public health importance, providing $1.5 million of an $8.0 million award for the TN-401 program, which signals early validation from a public health funding body.

Investors and institutional funds focused on biotech and gene therapy

This segment provides the necessary capital to fund the expensive clinical development. As of September 30, 2025, Tenaya Therapeutics, Inc. (TNYA) held $56.3 million in cash and cash equivalents, with total assets at $105.0 million. The company completed a March 2025 follow-on offering that brought in net proceeds of approximately $48.8 million. Management stated that current resources, plus an available $10.0 million tranche from an SVB loan agreement (with an additional $20.0 million discretionary option), should fund operations for at least twelve months following the Q3 2025 filing. The stock trades on NASDAQ GS: TNYA, and the consensus target price as of late 2025 was $10.14 based on 7 estimates. The book value P/B ratio stood at 2.7, slightly below the peer average of 2.9. You've got to keep these folks happy with clinical milestones.

• Shares outstanding were 166,505,885 as of November 4, 2025.
• The nine-month net loss through Q3 2025 was $70.4 million.
• R&D expenses for Q3 2025 were $15.4 million.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Tenaya Therapeutics, Inc. as they push their gene therapies through critical clinical stages. For a company at this stage, the cost structure is almost entirely driven by research, development, and keeping the lights on while waiting for data readouts.

The Research & Development (R&D) expenses are the single largest component, reflecting the cost of advancing the TN-201 and TN-401 programs. For the first half of 2025 (H1 2025), the total R&D spend hit $38.5 million. This total is derived from the reported quarterly figures: $21.1 million in the first quarter (Q1 2025) and $17.4 million in the second quarter (Q2 2025).

These R&D costs inherently cover the heavy lifting of the clinical programs. Specifically, the costs associated with the clinical trial costs for TN-201 (for MYBPC3-associated HCM) and TN-401 (for PKP2-associated ARVC) are embedded here. The progression itself is a cost driver; for instance, the Data Safety Monitoring Boards (DSMBs) endorsed dose escalation and expansion for both programs following safety reviews.

General and administrative (G&A) expenses represent the overhead required to run the business. For Q2 2025, the G&A expense was $6.7 million. This figure was down from $8.2 million in the same period of 2024, partly due to a decrease in stock-based compensation.

The structure of these operating expenses is detailed below, showing the quarterly trend for the first half of 2025 and the subsequent third quarter (Q3 2025) data, which shows continued cost containment efforts:

Metric	Q1 2025 (Approx.)	Q2 2025	Q3 2025
Research & Development Expense	$21.1 million	$17.4 million	$15.4 million
General & Administrative Expense	Not explicitly stated	$6.7 million	$5.6 million
Total Operating Expenses (R&D + G&A)	Not explicitly stated	$24.1 million	$21.0 million

The personnel costs for specialized scientific and clinical teams are a major component within the R&D spend. While a specific dollar amount for personnel alone isn't broken out separately from R&D, we know that non-cash stock-based compensation within R&D for Q2 2025 was $1.9 million. This gives you a sense of the non-cash element of compensation for those specialized teams.

The costs related to manufacturing and process development for AAV vectors are also captured within R&D. The advancement of the trials, such as dosing patients at 6E13 vg/kg for TN-201 and dosing the second cohort for TN-401, necessitates ongoing vector production and quality control, which are significant fixed and variable costs for a gene therapy company.

You can see the operating spend is high, but management is actively managing it. Here's the quick math: the sequential drop in operating expenses from Q2 2025 ($24.1 million) to Q3 2025 ($21.0 million) helped extend the cash runway. The cash position at the end of Q2 2025 was $71.7 million, projected to last into the second half of 2026.

Key cost drivers embedded within the R&D line item include:

• Costs for AAV vector production and characterization.
• Site initiation and patient enrollment fees for clinical sites.
• Biomarker analysis, such as biopsy sample processing for TN-401 DNA/mRNA.
• Salaries and benefits for research scientists and clinical operations staff.

Finance: draft 13-week cash view by Friday.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Revenue Streams

As of late 2025, Tenaya Therapeutics, Inc. is firmly in the clinical-stage, meaning its revenue streams are entirely composed of non-operating, financing-related inflows, as the company has not yet reached commercialization for any of its product candidates.

Non-Dilutive Grant Funding

A key non-dilutive source of capital supporting clinical development is grant funding. Tenaya Therapeutics, Inc. secured a significant award from the California Institute for Regenerative Medicine (CIRM) in early 2025. This was an $8.0 million CLIN2 grant announced on February 3, 2025.

• The $8.0 million grant proceeds are earmarked to help fund clinical trial costs for the ongoing Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy.
• One record indicates a CIRM award value of $9,017,000 to Tenaya Therapeutics, Inc..

Equity Financing Proceeds

The most substantial recent inflow has been from equity financing, which provides the necessary runway to advance the lead gene therapy candidates, TN-201 and TN-401. In March 2025, Tenaya Therapeutics, Inc. executed an underwritten public offering.

Here's a look at the key figures from that financing event:

Metric	Value
Gross Proceeds (Approximate)	$52.5 million
Net Proceeds (Approximate)	$48.8 million
Units Sold	75 million
Price Per Unit	$0.70
Cash Position as of March 31, 2025	$88.2 million

The net proceeds of approximately $48.8 million from the March 2025 public offering, combined with existing cash, were expected to support planned company operations into the second half of 2026. The offering structure included warrants, which represent potential future equity dilution but are not current revenue.

Future Potential Revenue from Strategic Licensing or Collaboration Agreements

Tenaya Therapeutics, Inc. is pursuing a strategy that involves developing its portfolio of genetic medicines internally. While the current financial statements reflect no realized revenue from this area, the development of clinical candidates like TN-201 and TN-401 creates the potential for future revenue streams through strategic out-licensing or collaboration agreements with larger pharmaceutical partners upon achieving key clinical milestones.

No Product Revenue

Tenaya Therapeutics, Inc. is explicitly a pre-commercial stage company. Consequently, there is no revenue generated from the sale of products. Analyst expectations for the quarter ending September 30, 2025, reflect this reality, projecting no change in quarterly revenue.

• The company is focused on advancing its lead candidates through clinical trials, such as TN-201 in the MyPEAK-1 trial and TN-401 in the RIDGE-1 trial.
• The cash runway extension into the second half of 2026 is based on current cash levels and the assumption of continued operational expenditure without product sales.