Tenaya Therapeutics, Inc. (TNYA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le domaine de la pointe de la thérapeutique cardiaque génétique, Tenaya Therapeutics apparaît comme un phare d'espoir, pionnier des solutions de médecine de précision transformatrice qui promettent de révolutionner le traitement des maladies cardiaques complexes. En tirant parti des technologies de génie génétique avancées et des collaborations stratégiques avec des leaders de l'industrie comme Roche, cette entreprise de biotechnologie innovante développe des thérapies révolutionnaires qui ciblent des mutations génétiques spécifiques, offrant des approches de traitement personnalisées pour les patients présentant des conditions génétiques cardiaques cardiaques auparavant incomparables. Leur toile complète du modèle commercial révèle une stratégie sophistiquée sur le point de remodeler la médecine cardiovasculaire grâce à des interventions ciblées et scientifiquement rigoureuses qui pourraient potentiellement débloquer de nouvelles voies de guérison.

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec Roche pour la recherche sur les maladies cardiaques génétiques

En janvier 2023, Tenaya Therapeutics a annoncé une collaboration stratégique avec Roche axée sur le développement de thérapies génétiques sur les maladies cardiaques. Les détails clés du partenariat comprennent:

Aspect de partenariat	Détails spécifiques
Focus de la collaboration	Recherche génétique des maladies cardiaques et développement thérapeutique
Conditions financières	65 millions de dollars de paiement initial de Roche à Tenaya
Paiements de jalons potentiels	Jusqu'à 700 millions de dollars sur la base des réalisations de la recherche et du développement

Partenariat avec les centres médicaux académiques pour les essais cliniques

Tenaya Therapeutics a établi des partenariats d'essais cliniques avec plusieurs centres médicaux universitaires:

• École de médecine de l'Université de Stanford
• Université de Californie, San Francisco
• École de médecine de Harvard
• Centre médical de l'Université Johns Hopkins

Collaboration avec les institutions de recherche pharmaceutique

Institution de recherche	Focus de la collaboration	Année établie
American Heart Association	Recherche génétique cardiovasculaire	2022
Instituts nationaux de santé	Développement thérapeutique de la maladie génétique	2021

Partenariats potentiels avec les laboratoires de tests génétiques

Tenaya explore les partenariats avec les laboratoires de tests génétiques pour faire progresser les approches de médecine de précision:

• Invitatione Corporation
• Santé génomique
• 23andme

Valeur potentielle totale du partenariat: Environ 765 millions de dollars dans les collaborations actuelles et potentielles en 2024.

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: Activités clés

Recherche et développement de thérapies génétiques de précision

Tenaya Therapeutics se concentre sur le développement de thérapies génétiques de précision avec un investissement en R&D total de 83,4 millions de dollars à l'exercice 2023. La société maintient 3 plateformes de recherche de thérapie génétique distinctes ciblant les maladies génétiques cardiaques.

Zone de focus R&D	Investissement ($ m)	Étape de recherche
Thérapies cardiaques génétiques	42.6	Préclinique / phase 1
Technologies d'édition de gènes	25.8	Phase de découverte
Ciblage moléculaire	15.0	Recherche translationnelle

Effectuer des essais cliniques avancés pour les traitements de maladie cardiaque

Les activités des essais cliniques englobent plusieurs études en cours avec des dépenses actuelles de 47,2 millions de dollars en 2023. La société a 2 programmes de développement clinique principal.

• TDN-001: essai clinique de cardiomyopathie génétique
• TDN-002: Étude d'intervention génétique de l'insuffisance cardiaque

Développement de produits de thérapie génique

Tenaya maintient 3 pipelines de développement de produits de thérapie génique distinctes avec des coûts totaux de développement de produits de 62,7 millions de dollars en 2023.

Pipeline de produits	Étape de développement	Investissement projeté
Thérapie génique cardiaque	Préclinique	28,3 M $
Plate-forme d'intervention génétique	Découverte	19,5 M $
Thérapie de ciblage moléculaire	Recherche	14,9 M $

Recherche moléculaire et cellulaire

La recherche se concentre sur les conditions cardiaques génétiques avec une équipe de recherche dédiée de 42 scientifiques et un budget de recherche annuel de 35,6 millions de dollars.

Médecine translationnelle et innovation thérapeutique

La société a investi 22,1 millions de dollars dans la recherche en médecine translationnelle, ciblant 4 mécanismes de maladies cardiaques génétiques spécifiques en 2023.

• Identification de mutation génétique
• Techniques de reprogrammation cellulaire
• Ciblage moléculaire avancé
• Développement thérapeutique de précision

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: Ressources clés

Technologies de génie génétique avancées

Tenaya Therapeutics a développé 3 technologies génétiques propriétaires Cibler une maladie cardiaque:

• Plate-forme de thérapie génique pour les maladies cardiaques génétiques
• Plate-forme de thérapie cellulaire pour la régénération cardiaque
• Plateforme de petites molécules pour les troubles cardiaques génétiques

Plateformes de thérapie génique propriétaire

Plate-forme	Type de technologie	Condition cible
TNYA-001	Thérapie génique AAV	Troubles musculaires du cœur génétique
TNYA-002	Régénération cellulaire	Insuffisance cardiaque
TNYA-003	Intervention de petite molécule	Mutations génétiques cardiaques

Équipe de recherche et développement spécialisée

Composition du personnel de recherche:

• Personnel total de R&D: 68 employés
• Chercheurs de doctorat: 42
• Spécialistes en génie génétique: 26

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre de brevets	Statut de brevet
Technologies de thérapie génique	12	Accordé
Méthodes de régénération cellulaire	8	En attente
Techniques d'intervention moléculaire	6	Déposé

Installations de laboratoire de pointe et de recherche

Détails de l'infrastructure de recherche:

• Espace total des installations de recherche: 35 000 pieds carrés
• Emplacement: South San Francisco, Californie
• Équipement de séquençage génétique avancé: 7 plates-formes
• Investissement annuel de R&D: 48,3 millions de dollars (2023 Exercice)

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: propositions de valeur

Thérapies génétiques de précision innovantes pour les maladies cardiaques

Tenaya Therapeutics se concentre sur le développement de thérapies génétiques ciblant des conditions cardiaques spécifiques avec les principaux programmes thérapeutiques suivants:

Programme	Condition cible	Étape de développement
Tdn-1	Cardiomyopathie dilatée génétique	Préclinique
Tdn-2	Cardiomyopathie hypertrophique	Enquête
TDN-3	Insuffisance cardiaque génétique	Étape de recherche

Approches de traitement personnalisées pour les conditions cardiaques génétiques

L'approche de précision de Tenaya implique des interventions génétiques ciblées avec des plateformes technologiques spécifiques:

• Modulation de la thérapie génique
• Édition de gènes de précision
• Stratégies de ciblage moléculaire

Potentiel pour répondre aux besoins médicaux non satisfaits dans les troubles cardiaques génétiques

Catégorie de troubles	Population estimée des patients	Limites de traitement actuelles
Cardiomyopathie dilatée	1 individus sur 2 500	Thérapies génétiques limitées
Cardiomyopathie hypertrophique	1 individus sur 500	Gestion symptomatique uniquement

Solutions thérapeutiques avancées ciblant des mutations génétiques spécifiques

Les plateformes technologiques de Tenaya permettent des stratégies d'intervention génétique précises:

• Édition de gènes basée sur CRISPR
• Approches thérapeutiques de l'ARN
• Mécanismes de correction moléculaire

Potentiel prometteur de traitements génétiques cardiaques transformateurs

L'investissement financier dans la recherche et le développement démontre un engagement envers les thérapies génétiques innovantes:

Exercice fiscal	Dépenses de R&D	Demandes de brevet
2022	42,3 millions de dollars	7 nouvelles applications
2023	56,7 millions de dollars	12 nouvelles applications

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Tenaya Therapeutics maintient l'engagement direct grâce à des canaux de communication médicale ciblés.

Méthode d'engagement	Fréquence	Public cible
Présentations de la conférence scientifique	4-6 par an	Cardiologues, généticiens
Webinaires médicaux spécialisés	3-4 par trimestre	Médecins de la recherche
Mises à jour de la recherche personnalisée	Trimestriel	Leaders d'opinion clés

Programmes de soutien aux patients et d'éducation

Tenaya fournit des mécanismes de soutien complets axés sur les patients.

• Ressources de conseil génétique
• Portail d'informations sur les patients en ligne
• Ateliers de sensibilisation aux maladies
• Guide de traitement individualisée

Communication scientifique et transparence

La communication transparente des résultats de la recherche est priorisée.

Canal de communication	Fréquence de publication	Plate-forme
Publications de journal évaluées par des pairs	2-3 par an	Nature, cellule, Jama
Rapports de transparence des données de recherche	Biannialement	Site Web de l'entreprise

Interactions des participants aux essais cliniques

Approche structurée pour gérer les relations avec les participants à l'essai clinique.

• Protocoles de consentement éclairés
• Surveillance régulière de la santé
• Communication de suivi complète
• Mécanismes de protection de la vie privée des patients

Collaboration de recherche en cours avec la communauté médicale

Collaboration active avec les institutions de recherche et les centres médicaux.

Type de collaboration	Nombre de partenariats actifs	Focus de recherche
Partenariats de recherche universitaire	7 collaborations actives	Troubles génétiques cardiaques
Réseaux de recherche clinique	12 institutions participantes	Initiatives de médecine de précision

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: canaux

Publications de recherche médicale directes

Tenaya Therapeutics publie des recherches dans des revues à comité de lecture telles que:

Nom de journal	Fréquence de publication	Facteur d'impact
Biotechnologie de la nature	Mensuel	41.4
Cellule	Bihebdomadaire	38.6

Conférences scientifiques et symposiums

Détails de la participation à la conférence clé:

• Sessions scientifiques de l'American Heart Association
• Conférence des technologies de recherche cardiovasculaire
• Congrès de la Société européenne de cardiologie

Réseautage de l'industrie pharmaceutique

Plateformes de réseautage et mesures d'engagement:

Plate-forme de réseautage	Connexions annuelles	Valeur de collaboration potentielle
Convention internationale de bio	16 000 participants	45 millions de dollars de partenariats potentiels
Conférence JP Morgan Healthcare	9 000 participants	30 millions de dollars investissements potentiels

Plateformes de recherche médicale en ligne

Canaux d'engagement de la recherche numérique:

• Researchgate
• PubMed Central
• Science directe

Outre professionnel de la santé ciblée

Spécifications de la stratégie de sensibilisation:

Méthode de sensibilisation	Portée annuelle	Taux d'engagement
Campagnes par e-mail directes	5 200 cardiologues	12.3%
Webinaire Series	3 800 professionnels de la santé	8.7%

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: segments de clientèle

Patiens de maladies génétiques cardiaques

Population totale de patients adressables pour les maladies cardiaques génétiques: 1,5 million aux États-Unis

Segment des patients	Population estimée	Besoin de traitement potentiel
Cardiomyopathie hypertrophique	200,000	Haut
Cardiomyopathie dilatée	500,000	Moyen
Syndromes d'arythmie héréditaire	100,000	Haut

Cardiologues et spécialistes génétiques

Nombre de cardiologues praticiens aux États-Unis: 33 700

• Subspécialistes de cardiologie génétique: 1 200
• Volume annuel des tests génétiques: 250 000 tests génétiques cardiaques

Établissements de recherche médicale académique

Nombre d'institutions de recherche axées sur la génétique cardiaque: 87

Type d'institution	Nombre d'institutions	Budget de recherche annuel
Universités de recherche de haut niveau	22	500 millions de dollars - 1,2 milliard de dollars
Centres de recherche médicale	45	100 millions de dollars - 400 millions de dollars
Centres de recherche cardiaque spécialisés	20	50 millions de dollars - 200 millions de dollars

Organisations de recherche pharmaceutique

Total des dépenses de R&D pharmaceutiques en thérapies génétiques: 15,2 milliards de dollars en 2023

• Nombre de sociétés pharmaceutiques investissant dans des thérapies cardiaques génétiques: 42
• Investissement annuel moyen par entreprise: 362 millions de dollars

Les systèmes de soins de santé se sont concentrés sur les thérapies génétiques

Nombre de systèmes de santé avec des programmes de thérapie génétique dédiés: 63

Type de système de santé	Nombre de systèmes	Investissement en thérapie génétique
Grands centres médicaux académiques	28	75 millions de dollars - 250 millions de dollars
Réseaux de soins de santé régionaux	35	20 millions de dollars - 100 millions de dollars

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Selon le rapport financier Tenaya Therapeutics T-T1 2023, les frais de recherche et de développement étaient de 31,4 millions de dollars pour le trimestre se terminant le 30 septembre 2023.

Catégorie de dépenses	Montant (Q3 2023)
Frais de personnel	12,6 millions de dollars
Fournitures de laboratoire	8,2 millions de dollars
Contrats de recherche externes	6,9 millions de dollars
Coûts de l'installation	3,7 millions de dollars

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour l'année 2023 ont totalisé environ 45,2 millions de dollars.

• Essais de phase 1: 15,6 millions de dollars
• Essais de phase 2: 22,8 millions de dollars
• Conformité réglementaire: 6,8 millions de dollars

Protection de la propriété intellectuelle

Tenaya Therapeutics a dépensé 2,3 millions de dollars pour la protection de la propriété intellectuelle en 2023.

Catégorie de protection IP	Coût
Dépôt de brevet	1,4 million de dollars
Frais juridiques	0,9 million de dollars

Technologies avancées et investissements d'équipement

Les investissements technologiques et d'équipement pour 2023 ont atteint 7,5 millions de dollars.

• Équipement de recherche sur la thérapie génique: 4,2 millions de dollars
• Infrastructure de biologie informatique: 2,1 millions de dollars
• Instrumentation spécialisée de laboratoire: 1,2 million de dollars

Recrutement et rétention de talents spécialisés

Les dépenses totales liées aux talents en 2023 étaient de 18,6 millions de dollars.

Catégorie de dépenses de talents	Montant
Compensation	14,3 millions de dollars
Recrutement	2,5 millions de dollars
Formation et développement	1,8 million de dollars

Tenaya Therapeutics, Inc. (TNYA) - Modèle d'entreprise: Strots de revenus

Ventes potentielles de produits thérapeutiques potentiels

Au quatrième trimestre 2023, Tenaya Therapeutics n'a pas encore généré des revenus de produits commerciaux. Les candidats principaux en thérapie génique principale de l'entreprise pour les maladies cardiaques sont aux stades de développement clinique.

Accords de collaboration de recherche

Partenaire de collaboration	Type d'accord	Valeur potentielle
Vertex Pharmaceuticals	Collaboration de recherche	65 millions de dollars de paiement initial en 2022

Licence des technologies de thérapie génétique

Portfolio de propriété intellectuelle:

• 3 plateformes de technologie de thérapie génétique de base
• Demandes de brevets multiples en thérapie génique cardiovasculaire

Paiements de jalons potentiels provenant de partenariats pharmaceutiques

Programme	Paiements de jalons potentiels	Étape de développement
Collaboration de vertex	Jusqu'à 700 millions de dollars en paiements de jalons potentiels	Développement préclinique / clinique

Financement de subvention et soutien à la recherche

Le financement total des subventions a reçu: 12,3 millions de dollars des NIH et d'autres institutions de recherche en 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.